Chapter 12

Rehabilitation Service
Outline Page
Chapter 12 ................................................................................................................................................. 1
Rehabilitation Service ............................................................................................................................... 1
Section 1 Introduction............................................................................................................................... 3
Section 2 Operational Standards .............................................................................................................. 5
Section 3 Implementation Guidance ......................................................................................................... 6
3.1 Rehabilitation services Unit/department structure ........................................................................ 6
3.2 Work Force ...................................................................................................................................... 6
3.2.1 Capacity Building: .................................................................................................................... 6
3.3.1 Rehabilitation Service Process ................................................................................................. 8
3.4 Infrastructure ................................................................................................................................ 12
3.4.1 Separate room for different purposes: ................................................................................... 12
3.4.2 Accessibility for persons with disabilities ............................................................................... 12
3.5 Device management for rehabilitation service ............................................................................. 13
3.6 Collaborations with public-private ............................................................................................... 13
3.7 The hospital rehabilitation unit/department clinical audit .......................................................... 13
Clinical Audit Cycle.............................................................................................................................. 14
3.7. Client education material and outcome measures. ...................................................................... 14
3.6.1 Education Materials ............................................................................................................... 14
3.6.2 Outcome measures .................................................................................................................. 15
3.8. Medical Record Management System.......................................................................................... 16
Annexes 1. Minimum equipment required18
Annex 2: National priority assistive products list .............................................................................. 18
Source Documents ................................................................................................................................... 22

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 Section 1 Introduction

Rehabilitation is "a set of interventions designed to optimize functioning and reduce disability in
individuals with health conditions in interaction with their environment” (WHO, 2022).
Rehabilitation’ refers to the participation and collaboration of professionals with clients, which
takes place within a hospital/medical environment to address physical, sensory, cognitive, and
mental impairments to facilitate improved functional outcomes for an individual. A process aimed
at enabling persons with disability to reach and maintain their optimal physical, sensory,
intellectual, psychological, and social functional levels.

Rehabilitation can include a wide range of interventions, as needed, including prevention of

disability through timely interference, counseling compensation, and supply of various
appliances. Rehabilitation professionals provide several services, including physical therapy/
physiotherapy, occupational therapy, orthotics and prosthetics, rehabilitation nursing, physical
medicine and rehabilitation, psychology, speech and language therapy, nutrition, and social work.
Ideally, These professionals work collaboratively in a multidisciplinary team, each contributing
their specialty to achieve comprehensive, high-quality care.

Rehabilitation professionals understand that rehabilitating individuals with disabilities of all ages
and providing basic counseling for mothers of children with disabilities requires a unique
combination of passion, commitment, and expertise. They know this work is challenging and
deeply rewarding as they help their clients achieve their maximum potential and improve their
quality of life. These professionals have acquired knowledge, skills, and experience in their
discipline, and they apply these tools with care, empathy, and kindness to provide top-quality care
to those they serve.

Currently, the need for rehabilitation is largely unmet. In some low- and middle-income
countries, more than 50% of people do not receive the required rehabilitation services (WHO,
2022). The WHO Rehabilitation Needs Estimator shows that in 2019, approximately 1 in 5
Ethiopians (21 million people) had health conditions that could benefit from rehabilitation,
conditions such as musculoskeletal disorders and injuries (approximately 57%) and sensory
impairments including vision and hearing loss (approximately 30%).

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Even though the Rehabilitation service in Ethiopia started fifty years ago with an independent
non-profit organization, it doesn’t show remarkable improvement as expected relative to its era.
Few hospitals /rehabilitation centers are nationally engaged in providing rehabilitation services,
and the only service provided in most hospitals is physiotherapy with limited equipment,
inadequate rooms, training gaps, weak reporting systems, and interdepartmental communication.
Thus, the main objective of this chapter is to provide a set of operational standards that ensures
comprehensive rehabilitation care to fill the above-identified gaps and improve the Accessibility
and quality of rehabilitation services in hospitals.

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Section 2 Operational standards

1. The hospital shall have a rehabilitation unit/department led by a physiotherapist or

equivalent rehabilitation professional who is a member of the senior management team
and accountable to the medical director.

2. The hospital's rehabilitation unit/department shall have a multidisciplinary team with

established job descriptions.

3. The hospital's rehabilitation unit/department shall provide physical therapy/physiotherapy,

psychosocial and mental rehabilitation, and occupational therapy and facilitate
community-based rehabilitation.

4. The rehabilitation unit/department premises shall be accessible for persons with

disabilities.

5. The rehabilitation unit/department shall have appropriate equipment and supplies per
regulatory standards.

6. The head of the rehabilitation unit/department shall be a member of the hospital's medical
equipment management committee and has to contribute to the inventory management
system.

7. The rehabilitation unit/department shall provide and facilitate rehabilitation services in

collaboration with public-private partnerships per the memorandum of understanding. The
unit displays the list of available services at appropriate locations.

8. The rehabilitation unit/department shall have a quality assurance system and conduct
regular clinical audits linked with quality improvement activities.

9. The rehabilitation unit/department shall have a plan for continued professional

development and performance appraisal and evaluation procedures.

10. The hospital's rehabilitation unit/department shall develop and implement client education
materials and outcome measures.

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 Section 3 Implementation guidance
3.1 Rehabilitation services Unit/department structure
It is recommended that a rehabilitation team leader be assigned by senior management with a
formal letter and work in parallel with other team leaders, such as the emergency team, inpatient
and outpatient, to deliver an overall clinical service. The team leader should be a physiotherapist
or other equivalent rehabilitation professional.
The rehabilitation service head should be accountable to the hospital medical director and be a
member of the senior management team (SMT). The rehabilitation service should also be visible
as part of the hospital organogram and be incorporated into the hospital's strategic and annual
plans, including the budget
3.2 Work Force
A multidisciplinary rehabilitation team should include physiotherapists, psychosocial
professionals, occupational therapists, orthopedic appliances, medical social workers, health
education practitioners, speech therapists, ophthalmic nurses, and audiologists/Trained.
The unit/department should provide established job descriptions for the rehabilitation workforce
with detailed roles and responsibilities of each rehabilitation professional.
The hospital should establish a rehabilitation workforce that:
 Identifies priority areas of patient/client needs and establishes procedures for collaboration
with other rehabilitation healthcare professionals and cross-referrals within the unit.
 Takes into consideration the skill mix of professionals.
 Establishes procedures for referring patients/clients to specialized services.
Capacity Building:
 There should be an assessment of the training needs of rehabilitation professionals.
 A capacity-building plan should be developed based on the findings.
 Rehabilitation professionals should be capacitated as per the plan.

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 3.3 Rehabilitation service
The rehabilitation service needs a multidisciplinary team approach, essential for successfully
implementing rehabilitation services. It allows for collaborative support from various experts,
improves service coordination, and enables comprehensive and continuous care.

The team collaborates to develop a treatment plan that addresses the client's specific goals and
needs. They may assess the client's physical, cognitive, and emotional functioning—the
developed interventions aimed at improving their quality of life and functional independence.

There are several types of rehabilitation services that healthcare professionals may provide
depending on the needs of the client. These include:

Physical therapy: Physical therapy involves exercise, manual therapy, and other techniques to
improve mobility, strength, and function. It may treat various conditions, including
musculoskeletal injuries, neurological disorders, and chronic pain.

Occupational therapy: Occupational therapy focuses on helping clients develop the skills
needed to perform activities of daily living, such as dressing, grooming, and cooking. It may be
used to treat conditions such as stroke, traumatic brain injury, and developmental disabilities.

Speech therapy: Speech therapy involves assessing and treating communication and swallowing
disorders. It may be used to treat speech disorders following conditions such as stroke, brain
injury, and developmental delays.

Cognitive rehabilitation: Cognitive rehabilitation involves using specific techniques and

exercises to improve cognitive function, such as memory, attention, and problem-solving.

Mental rehabilitation: Involves rehabilitation to individuals with depression, anxiety disorders,

post-traumatic stress disorder (PTSD), schizophrenia, substance use disorders via Psychotherapy,
diversion therapy, provision of medications, Group therapy, skills training, recreation therapy,
family therapy and so on

Cardiac rehabilitation: Cardiac rehabilitation involves the use of exercise, education, and
counseling to improve the health and function of clients with heart disease or who have
undergone cardiac procedures.

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Pulmonary rehabilitation: Pulmonary rehabilitation involves using exercise, education, and
breathing techniques to improve the lung function and quality of life of clients with chronic
respiratory conditions, such as COPD and asthma.

These services aim to restore or support function and address safety, comfort, and quality of life
in clients.

3.3.1 Rehabilitation service process

The rehabilitation service involves assessment, treatment plan development,

progress monitoring, discharge, and referral to pertinent healthcare professionals
and facilities or rehabilitation units/departments.

Rehabilitation Process

Point of referral Rehabilitation Rehabilitation Referral or

Unit
Service Discharge

After the client has been referred to the rehabilitation service via central triage or inpatient or
outpatient services, the client arrives at the rehabilitation unit, where the client's relevant
information will be recorded to ensure that they are referred to the appropriate rehabilitation
personnel.
Once the appropriate rehabilitation personnel (s) have been identified, the rehabilitation staff
must make a complete and detailed assessment and identify the client's specific problem list.

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The following factors should be considered when making a diagnosis:
When diagnosing clients with rehabilitation needs, there are several factors that rehabilitation
professionals should consider. These include:

Medical history: A thorough understanding of the client's medical history, including any
previous illnesses, injuries, or surgeries, can help inform the rehabilitation plan.

Functional limitations: Assessing the client's functional limitations, such as mobility, strength,
and balance, can help determine the appropriate rehabilitation interventions.

Psychosocial factors: The client's psychosocial factors, such as their living situation, social
support, and mental health status, can impact their ability to participate in and benefit from
rehabilitation.

Goals: Understanding the client's goals for rehabilitation, such as returning to work, improving
their quality of life, or increasing their independence, can help guide the rehabilitation plan.

All care and treatment of clients must be documented in the rehabilitation plan. This care plan
should be specific to the client's problems or needs. Factors to be considered when implementing
care include:
When implementing rehabilitation care, there are several factors that healthcare professionals
should consider. These include:

Assessment and evaluation: A comprehensive assessment and evaluation of the client's needs
and goals should be conducted to develop an individualized rehabilitation plan.

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Goal setting: The client's goals for rehabilitation should be identified and incorporated into the
rehabilitation plan to ensure that it is client-centered and focused on achieving the desired
outcomes.
Evidence-based practice: Rehabilitation care should be based on the best available evidence,
and healthcare professionals should stay up to date with the latest research and guidelines.
Client education: Clients should be educated about their conditions, treatment options, and
rehabilitation goals and should be encouraged to participate actively in their rehabilitation.

Cultural competence: Healthcare professionals should be aware of and respectful of the client's
cultural background and beliefs and should adapt their rehabilitation care accordingly.

Continuity of care: Rehabilitation care should be coordinated and seamless, with clear
communication and handoffs between healthcare professionals to ensure that the client receives
consistent and effective care.
Use of technology: Technology, such as telerehabilitation or assistive devices, can enhance the
delivery of rehabilitation care and improve outcomes for clients.
Family and caregiver involvement: Family members and caregivers should be involved in the
rehabilitation care plan, as they can provide valuable support and assistance to the client. By
considering these factors when implementing rehabilitation care, healthcare professionals can
ensure that their practice is client-centered, evidence-based, and tailored to each client's needs.
This can lead to better outcomes and an improved overall experience for the client.
The particular rehabilitation healthcare professional involved in the client's care should
implement the rehabilitation care plan. Implementation of the care plan should be documented
on the follow-up sheet and/or the client's chart.
As rehabilitation is a dynamic process that involves changes in clients' health status over time,
the plan of care needs to be continuously evaluated. As problems are resolved, new goals and
activities related to the client's condition should be reassessed.

If the client gains lost functions, he/she will be discharged. The client is referred to the
appropriate service if further specialist treatment is required. The rehabilitation professional in
charge of the client's care is responsible for written and verbal communication with other

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healthcare professionals and services; all communication should be documented in the
rehabilitation care plan

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3.4 Infrastructure
3.4.1 Separate room for different purposes:
 Reception, recording & Waiting area, if possible 20 sq. m
 Consultation/ examination room, if possible 12sq. m
 Exercise room, if possible 20sq. m
 Treatment room, if possible 12sq. m
 Toilet room (male & female)
 The mental health rehabilitation room is separate from other discipline
 Reception, recording & Waiting area, if possible 20 sq. m
 Consultation/ examination room, if possible 12sq. m
 Exercise room, if possible 20sq. m
 Treatment room, if possible 12sq. m
 Toilet room (male & female)
 The mental health rehabilitation room is separate from other discipline
3.4.2 Accessibility for persons with disabilities
 For persons with physical impairment, the door's width must be 90 cm, and the door
handle should not have to be above 90 cm tall.
 Doors must be easy to open, and they should be long and easy to hold for the
opening, which should be accessible to wheelchair users.
 If the door is made of glass, a partial glass should be painted to prevent damage to the
person with low vision.
 Windows should be well-lit. This is ideal for treating clients with limited vision and
interpreting sign language or lip reading.
 Pathways must have a free space, allowing the wheelchair to rotate freely. The free
space size should be 1.50 cm in diameter
 The floor of the stairs should not be sleeper; it must be built with rough
substances/materials
 If there are various steps/stairs on the way to service delivery rooms and if there is no
elevator/lift, the ramp is required to be in place for wheelchair users
 The bathroom should be inaccessible location and suitable for persons with
disabilities

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3.5 Device management for rehabilitation service
The rehabilitation unit/department head should be a member of the hospital device management
committee having TOR. Standard equipment and consumables shall be available for all
rehabilitation services. Equipment shall be clean and functional and stored in a safe and
accessible place. Hospitals should ensure that all rehabilitation healthcare professionals have
access to and are trained to use equipment and resources correctly and efficiently. Rehabilitation
healthcare professionals are responsible for keeping up to date about current equipment and
resources available for hospital use. Standard equipment and consumables that should be
available for rehabilitation services include (See Annex 1)

3.6 Collaborations with public-private

As per the agreement or memorandum of understanding, the rehabilitation unit/department has
to work with the public and private sectors to address the continuum of care for clients with a
wide range of rehabilitation demands.

3.7 The hospital rehabilitation unit/department clinical audit

Rehabilitation care providers and clients know where their service is doing well and where there
could be improvements. Quality improvement (Q.I.) for rehabilitation services aims to improve
client satisfaction and provide direction for rehabilitation professionals on their focus while
performing routine tasks.

Rehabilitation care providers and clients know where their service is doing well and where there
could be improvements. Quality improvement (Q.I.) for rehabilitation services aims to improve
client satisfaction and give direction to rehabilitation professionals on their focus while doing
routine tasks. Clients

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Clinical Audit Cycle

Identifying a
problem

Defining
Re-Audit
Standards/Criteria
CLINICAL
AUDIT CYCLE

Implementing Collect Data

Changes

Analysis

3.8. Client education material and outcome measures.

3.8.1 Education materials
The client's education material will provide direction on self-help rehabilitation and prevention
of further complications that may arise secondary to existing impairments or disabilities. The
material should include pictorial messages and steps for rehabilitation, as well as precautions on
how to use assistive devices. (See annex 2)

Audiovisual materials may also be included to help beneficiaries and their families clearly
understand the procedures for the rehabilitation of identified conditions. The client's education
material will provide direction on self-help rehabilitation and prevention of further complications
that may arise secondary to existing impairments or disabilities. The material should include
pictorial messages and steps for rehabilitation, as well as precautions on how to use assistive
devices.

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3.8.2 Outcome measures
Outcome measures are necessary in rehabilitation setups for several reasons:

Evaluation of Progress: Outcome measures help to evaluate the progress of clients undergoing
rehabilitation. By using standardized measures, healthcare providers can track changes in the
client's condition over time and adjust the treatment plan if necessary.

Goal Setting: Outcome measures can help clients and healthcare providers set realistic goals for
rehabilitation. By using objective measures, healthcare providers can determine what goals are
achievable and appropriate for the client's condition.

Quality Improvement: Outcome measures can be used to evaluate the quality of rehabilitation
services being provided. By tracking the outcomes of rehabilitation programs, healthcare
providers can identify areas for improvement and make changes to improve the quality of care.

Evidence-based practice: Outcome measures are an essential component of evidence-based

practice. By using standardized measures, healthcare providers can evaluate the effectiveness of
different treatment approaches and make evidence-based decisions about the care provided to
clients.

Accountability: Outcome measures can be used to demonstrate accountability to clients, payers,

and regulatory bodies. By tracking outcomes, healthcare providers can demonstrate the
effectiveness of their services and provide evidence of the value of rehabilitation services.

In summary, outcome measures are an essential tool for evaluating the effectiveness of
rehabilitation programs, setting goals, and improving the quality of care. By using standardized
measures, healthcare providers can make evidence-based decisions, demonstrate accountability,
and ultimately improve the outcomes for clients undergoing rehabilitation.

Things to be considered while using outcome measures

When using rehabilitation outcome measures, there are several things that should be considered
to ensure accurate and meaningful results. Some important considerations include:

Selecting the Appropriate Measure: It is essential to select an outcome measure that is

appropriate for the client's condition and the goals of the rehabilitation program. Choosing an
inappropriate measure can result in inaccurate or irrelevant results.

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Validity and Reliability: The selected outcome measure should be valid and reliable, meaning
that it measures what it is intended to measure and produces consistent results.

Baseline Measurements: A baseline measurement should be taken before starting the

rehabilitation program so that progress can be tracked over time.

Standardized Administration: Outcome measures should be administered in a standardized

manner to ensure consistent results. This includes following the instructions for administering
the measure and using the same equipment and procedures for each assessment.

Interpretation of Results: Results should be interpreted in the context of the client's condition
and the goals of the rehabilitation program. It is essential to consider factors that may influence
the results, such as pain or fatigue, and to adjust the treatment plan accordingly.

Communication with the Client: Clients should be informed about the purpose of the outcome
measures and how the results will be used to guide their rehabilitation program. It is essential to
communicate the results in a clear and understandable manner and to involve the client in setting
goals and making decisions about their care.

The outcome measures should be attached to clients' individual folders, and it can help as a
reference for quality assurance.

3.9. Medical record management system

A medical record is a comprehensive document that contains all vital information related to a
client’s health and medical history, as well as details of their interactions with healthcare
professionals. A complete medical record should include the following:

Client Information: This includes the client's name, date of birth, address, contact information,
and other biographical details.

Medical History: This includes a record of the client’s past illnesses, surgeries, and medical
conditions. It should also include details of any medications the client is taking, including dosage
and frequency.

Physical Examination: This includes the results of physical examinations, including vital signs
such as blood pressure, heart rate, and temperature.

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Diagnostic Tests: This includes the results of any laboratory tests, imaging studies, or other
diagnostic tests that have been performed on the clients.

Functional tests: used to evaluate a person's ability to perform activities of daily living (ADLs)
and instrumental activities of daily living (IADLs). ADLs include basic self-care tasks such as
bathing, dressing, grooming, and toileting, while IADLs include more complex tasks such as
cooking, shopping, and managing finances. These tests use appropriate tools to assess a person's
physical, cognitive, and psychosocial function and are an essential part of rehabilitation and
geriatric care.

Special tests: Special tests are diagnostic tools used in rehabilitation services to evaluate
specific impairments or dysfunctions that are not easily observed during a physical examination.
These tests are essential because they help healthcare providers identify the underlying causes of
a person's impairment or dysfunction and develop appropriate treatment plans.

Treatment Plan: This includes details of the treatments the clients have received, including
medications, surgeries, and other interventions.

Progress Notes: This includes notes from healthcare professionals documenting the clients’
progress, any changes to the treatment plan, and any other relevant information.

Consultation Notes: This includes notes from specialists or other healthcare professionals who
have been consulted regarding the clients’ care.

Informed Consent: This includes documentation of any informed consent obtained from the
clients or their representative for treatments, procedures, or other interventions.

Discharge Summary: This includes a summary of the client's care, including any follow-up
appointments or recommendations for ongoing care.

Legal Documents: This includes any legal documents related to the client’s care, such as
advance directives or power of attorney documents.

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Annex 1. Minimum equipment required
• Physiotherapy mats
• Manipulation couch
• Splinting materials
• Playing cards
• Books
• Mirror
• Walking trail/ parallel bars
• Crutches
• Walking aids/ walking frames (adjustable)
• Pulley
• Electrical modalities
• Chair and table
• Physiotherapy ball (general and tertiary)
• Gonio meter
• Tape measure
• Stair ca

Annex 2: National priority assistive products list

Area/Type & Mobility

• Clubfoot braces
• Foot Orthoses (F.O.)
• Ankle Foot Orthoses (AFO)
• Knee Ankle Foot Orthoses (KAFO)
• Hip Knee Ankle Foot Orthosis (HKAFO)
• Spinal Orthoses (SO)
• Shoulder Elbow Wrist Hand Orthoses (SEWHO)
• Trans_ Tibial (Below Knee(BK))
• Above Knee (A.K.)
• Trans Femoral
• Trans-Radial (below elbow)
• Trans-Humeral (above elbow)

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• Crutches
• Walking Canes/sticks
• Walker & Frames
• Manual wheelchairs
• Tricycle

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Cognitive
• Fall detectors
• Apps That Help People with Speech and Communication
• Multiplication machine

Vision
• Spectacles
• Filters
• Audio Players with DAISY Capability
• Braille displays (note-takers)
• Manual Braille writing equipment
• White canes
• Talking/touching watch
• Global Positioning System (GPS)
• Balls with Bell sound
• Screen readers
• Keyboard and mouse emulation software
• Balls with Bell sound
• Braille embossers
• Magnifying Devices
• Audio players with DAISY

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Hearing & communication
• Hearing aids
• Hearing loops /F.M. system/ personal wireless remote
• Microphone system
• Alarm signals with light /sound/ vibration
• Closed capturing displays
• Deafblind communicator
• Capability
• Step-by-step communicator
• Sets of picture exchange communication system
• Communication boards /books/ cards
• Talk pad

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Source Documents

1. FDRE Ministry of Health (2020) National Rehabilitation and Assistive Technology

Services guideline

2. FDRE Ministry of Health (2018) Physical Rehabilitation Service guideline

3. FDRE Ministry of Health national specialty and sub-specialty service road map (2020 –
2029 G.C.)

4. EFMHACA standards for Primary, General, and referral hospitals

5. Previous version of EHSTG Volume II

6. Health Sector Disability Mainstreaming Manual Federal Democratic Republic of

Ethiopia Ministry of Health January 2017

7. Federal ministry of health National Rehabilitation and Assistive Technology Services

Management Guideline (December 2020)

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 Chapter 13
Pain and Palliative Service

1
Outline
Abbreviation ...................................................................................................................................................................... 3
Section 1 Introduction ........................................................................................................................................................ 4
Section 2 Operational standards ........................................................................................................................................ 6
Section 3. Implementation Guidance................................................................................................................................... 7
3.1 Department of Pain and Palliative Care Services ................................................................................................... 7
3.2 Pain and Palliative care multidisciplinary team .................................................................................................... 7
Palliative care multi- disciplinary team members are ................................................................................................... 8
Very useful, but Optional, are ..................................................................................................................................... 8
3.3 Standard documents and tools for pain and Palliative care ........................................................................................... 9
3.4 Medication, equipment and supplies ............................................................................................................................. 9
3.5.1 WHO Analgesic Ladder Step 1 – Non-opioids .................................................................................................. 11
3.5.2 WHO Analgesic Ladder Step 2 – Weak Opioids ............................................................................................... 11
3.5.3 WHO Analgesic Ladder Step 3—Strong Opioids.............................................................................................. 11
3.6 Important consideration in pain assessment ................................................................................................................. 12
3.7 The Principles for Pain management ................................................................................................................... 13
3.9 Pain and palliative care health education ....................................................................................................................... 1
3.9.1 One to one education:......................................................................................................................................... 1
3.9.2 Patient mass education: ...................................................................................................................................... 1
Types of home care ........................................................................................................................................................ 4
Personal Care and Companionship .................................................................................................................................. 4
Essential Palliative Care Medicines List ........................................................................................................................... 18
1. Numeric Pain Rating Scale.................................................................................................................................... 25
Procedures ................................................................................................................................................................ 25
Figure 6: Numeric Pain Rating Scale......................................................................................................................... 25
Faces scale................................................................................................................................................................ 27
Annex 9 ........................................................................................................................................................................... 32
Job Description of Pain and Palliative Care Work Force ................................................................................................... 32
Job Description of palliative care Unit/ Department Head ................................................................................................. 32

2
Abbreviation

WHO - World Health Organization

QI - Quality Improvement

MCH - Maternal and Child Health

SMT - Senior Management Team

NGO - Non Governmental Organizations

TOR - Term of Reference

GFR - estimated Glomerular Filtration Rate

NSAID - Non Steroidal antiinflamatory Drugs

3
Section 1 Introduction

The latest definition of palliative care as used by the World Health Organization is: ‘an approach
that improves the quality of life of patients and their families facing the problem associated with
life-threatening illness, through the prevention and relief of suffering by means of early
identification and impeccable assessment and treatment of pain and other problems, physical,
psychosocial and spiritual WHO (2002). Palliative care for children as defined by the World
Health Organization is:‘ The active total care of the child's body, mind and spirit, and also
involves giving support to the family. It begins when illness is diagnosed and continues
regardless of whether or not a child receives treatment directed at the disease’. WHO (1998).

Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue
damage. Pain is a subjective experience. The experience varies from person to person and from
time to time. Pain is whatever the experiencing person says it. Palliative care is all about looking
after people with illnesses that cannot be cured, relieving their suffering and supporting them
through difficult times. WHO (2004)

Pain and palliative care extends beyond just pain and symptom control, also addressing the
psychosocial and emotional suffering of patients and their families. Pain is now established as
the 5th vital sign and the need for palliative care in Ethiopia is rapidly increasing. Healthcare
workers often underestimate the impact of poorly managed pain in their work. Unmanaged pain
affects individuals' daily functioning, emotional wellbeing, and sometimes their families too. It
can lead to reduced mobility and strength; compromise the immune system; and interfere with
eating, concentration, sleep, or social interaction.

Pain touches not only individuals; it affects any individual's ability to work and consequently
impacts on both their community and society. So the implementation guideline touches expected
leadership engagement, multidisciplinary team participation, trained human resource, budget,
medications, equipment, supplies and monitoring and evaluation system for the quality and
sustainability of the service.

4
Recent relevant studies show that, with the rapidly growing population, pain and palliative care
services must expand accordingly to meet increasing demands. Therefore, the main objective of
this chapter is to provide operational standards that ensure comprehensive pain and palliative
care provision in Ethiopian hospitals.

5
Section 2 Operational standards
1) The hospital has functional pain and palliative care service organization.
2) The hospital has multidisciplinary team for pain and palliative care service
3) The hospital has written standard Documents/tools for pain and palliative care services.
4) The hospital has all the necessary medications, equipment and supplies for pain and
palliative care.
5) The hospital has implemented pain as a 5th vital sign
6) Pain is managed according to WHO analgesic ladder
7) The hospital has regular health education program on pain and palliative care
8) The hospital has regular pain assessment and management audit system
9) The hospital should provide pain management service at outpatient, inpatient,
emergency, MCH, and other needy area.
10) Pain and Palliative care unit/ department facilitates the delivery of home based care
palliative care

6
Section 3. Implementation Guidance
3.1 Department of Pain and Palliative Care Services

All hospitals should have a department and assign a full time pain and palliative care service
director/coordinator. A pain and palliative care director should be a senior physician, general
practitioner or trained health officer. The director should have enough knowledge about the
service, in addition to that take basic pain free hospital initiative and palliative care training.

The pain and palliative care director shall report to the hospital's medical director and be a
member of the SMT. Pain and palliative care services shall also be incorporated into the
hospital's organizational chart under the medical director. The service shall have a detailed
strategic and annual action plan with budgeting. The pain and palliative care team leader shall
work alongside other leaders to ensure integrated clinical services.

3.2 Pain and Palliative care multidisciplinary team

Pain assessment and management is cross-sectional issue. All service delivery points must
incorporate patient pain management into daily clinical activities. Most palliative care patients
have comorbidities tied to multiple hospital departments. Establishing a multidisciplinary
committee/team is vital for quality pain and palliative care services. The team members work
exclusively within the department. The ideal and useful composition and responsibilities are
indicated below. Each member shall also understand and perform according to specific job
descriptions (See Annex 9).

The established team shall develop terms of reference (TOR) outlining members' roles and
responsibilities and an operational plan. All members must undergo training/orientation in pain
and palliative care. Regular monthly meetings and action plans shall address discussion topics.
The team shall submit pain and palliative care agendas to the SMT for decisions and follow-up
schedules.

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Team members may organize and manage community-based care. The member overseeing the
patient's care is responsible for written and verbal communication with other professionals and
services, documenting all communications in the palliative care plan.

Palliative care supports patients until end-of-life and continues family bereavement support. If
struggling physically, psychologically, or spiritually after a loved one's death, the team can assess
and support the family at the palliative care outpatient clinic.

Palliative care multi- disciplinary team members are

1. Focal person Department head
2. physician
3. Nurses
4. Social workers
5. Clinical Psychologist/General Psychologist/Counselor
6. Clinical Pharmacies
7. Spiritual leaders
8. Secretary

Very useful, but Optional, are

 Dietician

 Occupational therapist

 Music and art therapists, volunteers

 Other personnel, as required

*Volunteers play an important role in many palliative care services

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3.3 Standard documents and tools for pain and Palliative care
The hospital should avail pediatric and adult pain and palliative care protocols approved by the
hospital management. All the hospital wards and clinical areas should receive a soft and hard
copy of the protocols. The standard pain and palliative care guidelines should be available,
understood and adhered to by all clinical staff in all service delivery points. The service should
be audited regularly by reviewing patient medical records and QI activities should be done
whenever gaps are identified.

All clinical staffs of the hospital should be trained on pediatric and adult pain management
protocols. Pain and Palliative care team members are also expected to be trained on palliative
care service and appropriate use of pain and palliative patient reporting formats.

3.4 Medication, equipment and supplies

Availability of medical equipment’s, Supplies and consumables are essential for the provision of
pain and palliative care. Hospitals shall identify and avail the national package of essential
medications, standard equipment, and minimum supplies (see Annex 4). An inventory checklist
shall be prepared with capacity assessment and gap identification in medications, supplies, and
equipment.

Evidence-based quantification of medications, supplies, and equipment shall inform procurement

of these essential items. A robust follow-up system shall be established for procurement and
distribution. Hospitals must ensure pain and palliative care professionals are trained on proper
and efficient use of equipment and resources. Professionals are responsible for keeping current
on available hospital equipment and resources.

9
3.5 WHO Analgesic Ladder
The WHO analgesic ladder provides a general guide for pain management based on severity.
However, it does not replace individualized management based on careful patient assessment.

Table-1 the WHO three-step analgesic ladder for adult

SN - Step 1 - Step 2 - Step 3
NON-OPIOID WEAK OPIOID STRONG OPIOID
± adjuvants ± non-opioid ± non-opioid ±
± adjuvants adjuvants
1 Paracetamol 500mg 2 If pain is persistent or Persistent or worsening pain
tabs q/6 hrs. worsening: Commence strong opioid
Start codeine 30-60mg four e.g. oral morphine
times a day regularly Oral solution 10mg/5mL
2 NSAID e.g. ibuprofen, or Tramadol 50 mg twice a day

3 Naproxen250-500mg ± non-opioid ±non-opioid ±

twice daily ± adjuvants adjuvants
4 celecoxib100mg twice
daily, increased if
necessary to 200mg
twice daily
± adjuvants
Persistence and Worsening pain
N.B Consider Prophylactic Laxative to avoid Constipation for Morphine

10
 3.5.1 WHO Analgesic Ladder Step 1 – Non-opioids
- For patients without risk factors for Paracetamol hepatotoxicity, the standard regimen is 1g four
times a day.
- For patients with more than one hepatic risk factor (old age, weight less than 50kg, poor nutritional
status, fasting/ anorexia, chronic alcohol use) – reduced dose of 500mg four times a day, increased if
necessary to a maximum of 3g per day in divided doses, is advisable.
- For patients with severe renal impairment (eGFR<10ml/min) reduce dose (maximum 3g/24hrs)

3.5.2 WHO Analgesic Ladder Step 2 – Weak Opioids

- Low Dose Morphine generally provides quicker and better relief from cancer pain than weak
opioids.
- If considering prescribing a weak opioid be aware that: Codeine has to be converted to morphine in
the body to achieve an analgesic effect. Poor metabolizers of codeine may not experience analgesia.
- Ultra-rapid metabolizers may experience toxicity.
- Tramadol 50 mg twice a day

3.5.3 WHO Analgesic Ladder Step 3—Strong Opioids

- Strong Opioids Morphine is the strong opioid of choice for management of moderate to severe pain
in palliative care patients, based on familiarity, availability and cost.
- The oral route is preferred as long as the patient has no problems with swallowing or absorption.
Other strong opioids are used mostly when morphine is not readily available.
- There are generally no absolute contraindications to the use of strong opioids in palliative care
patients with advanced progressive disease, provided the dose is titrated carefully against the
patient’s pain.

Non-opioids ibuprofen or other NSAID, paracetamol (acetaminophen), or aspirin

Weak opioids codeine, tramadol, or low-dose morphine
Strong opioids morphine, fentanyl, oxycodone, hydromorphone, buprenorphine
Adjuvants antidepressant, anticonvulsant, antispasmodic, muscle relaxant, bisphosphonate,
or corticosteroid
Combining an opioid and non-opioid is effective, but do not combine drugs of the
same class.
Time doses based on drug half-life (“dose by the clock”); do not wait for pain to recur

11
Table-2 - WHO Analgesic Pediatrics ladder

Step-1 Mild Pain Step-2 Moderate/Sever pain

Non-Opioid Strong Opioid
Morphine

± adjuvants ± non-opioid
± adjuvants

N.B Consider Prophylactic Laxative to avoid Constipation for Morphine

 .Step-1 For Mild Pain Age>3 months Ibiprufin, Paracetamol, Age <3 months Paracetamol
based on KG formula
 Step-2 Strong Opioid :Morphine is medicine of choice/may available or Phentaline,
Oxicodine, Hydromorphine,
 Adjuvants: Antidepresants, Anticonvelsant, Antispasmodics, Muscle relaxants,
bisphosphonate or Corticosteroid
- Combine an opoid and non-opoid is effective but, do not combine the same class
- Time doses based on drug half-life (dose by the clock) do not wait pain to recur

3.5 Pain as a 5th vital sign

Pain should refer to as the “fifth vital sign,” (along with temperature, pulse rate, blood
pressure and respiratory rate) and should be assessed regularly and frequently. Pain is
individualized and subjective; therefore, the patient’s self- report of pain is the most reliable
gauge of the experience. All hospitals should have proper assessment of pain and this is
essential for successful management.

“Pain is a more terrible lord of mankind than even

death itself”

Albert Schweitzer

3.6 Important consideration in pain assessment

◾ Pain is subjective and two patients may report severity differently from each other

◾ Despite the fact that pain is specific to each person, patients can usually

12
 accurately and reproducibly indicate the severity of their symptom by using a
scale
◾ Scales enhance the ability of patients to communicate the severity of their pain
to health care professionals and the ability of clinicians to communicate among
themselves
◾ Scales also allow the clinician to assess the effect of medications

◾ Pain is always subjective. Therefore, the patient’s self-report of pain is the

single most reliable indicator of pain. A clinician needs to accept and respect
this self-report, absent clear reasons for doubt.
◾ Assessment approaches, including tools, must be appropriate for the patient
population. Special considerations are needed for patients with difficulty
◾ Pain can exist even when no physical cause can be found. Thus, pain without an
identifiable cause should not be routinely attributed to psychological causes.
◾ Different patients experience different levels of pain in response to comparable
stimuli. That is, a uniform pain threshold does not exist.
◾ Pain tolerance varies among and within individuals depending on factors
including heredity, energy level, coping skills, and prior experiences with pain.

3.7 The Principles for Pain management

◾ By the Mouth: Giving analgesics by mouth are the simplest and most reliable
method for most patients. If the patient cannot take tablets by mouth, then the
subcutaneous, rectal, and ducal routes are alternatives.
◾ By the clock: Administer analgesics according to regular schedule based on
duration of effectiveness rather than “as needed”, except when titrating dose.
Constant pain needs regular analgesics to keep it away. Pain that is allowed
to build up is more difficult to
Control. Do not wait for the pain to return but give analgesics at regular intervals according to their
duration of action, e.g morphine 5mg every 4hourly.

◾ By the ladder: Use the WHO analgesic ladder. If after giving the optimum dose an analgesic does not
control pain, move up the ladder; do not move sideways in the same level (combination to achieve
maximal effects through analgesic synergy and to counter side effects of large doses we can use multiple
analgesia with different mechanism of Action.
By the patient: The right dose is the one that relieves pain

13
3.8 Common Pain Scales

There is a variety of pain scales used for pain assessment, for patients from neonates through advanced
ages. The three most common scales recommended for use with pain assessment are: all scales are annexed
on Annex 7

1. The Numeric Pain Rating Scale

2. The Hand scales

3. The Wong-Baker scale (also known as the FACES scale)

4. The FLACC scale

5. PAINAD
NB: Professionals should consider to assess the pain onset, Provoking factors, Radiation, Severity,
timing and impacts of the pain

Pain is influenced by many different factors and therefore total pain encompasses

14
 The following factors need to be considered when making a full assessment. Firstly, the different
components of ‘Total Pain’ should be assessed. Pain is not only a physical alignment but has
psychological, spiritual and social components (see diagram). A baseline pain assessment score should
be obtained during the initial assessment (pain is the 5th vital sign) and should be reassessed regularly by
the palliative care team.

3.9 Pain and palliative care health education

Hospital staff should give health education for all patients about reporting pain levels and seeking
health workers support whenever they feel pain, also to incorporate family members and other
caregivers, who often play a strong role in facilitating patient care. Patient education may be mass
education or one to one- educations.

3.9.1 One to one education:

Providers should explain pain assessment purpose and benefits (e.g. “this helps us determine the
right medication and dose”). For communicating adults, explain the scale (0 = no pain, 10 = worst
possible pain) and ask them to score their pain. Educate on safe handling and proper medication use,
stressing dangers of sharing without prescription. Support shall accommodate all patients (educated,
uneducated, disabled, etc.).

3.9.2 Patient mass education:

Hospitals can efficiently educate patients/caregivers through
 Post information about how to report pain in a visible area
 If the hospital has a video facility, a short video can teach patients and caregivers in the patient
waiting area.
 Lectures in patient waiting area; give education on how to report pain and proper utilization of pain
medication.
 Information pamphlets, brochures and other cost-effective education material can be used for patients
and care givers who can read and understand.
3.10 Regular pain and Palliative care clinical audit

12-1
 Clinical audits are quality improvement processes that review care against explicit criteria and
implement changes as needed to improve services (NICE, 2002). Regular audits are critical for good
pain management and palliative care practices. Comparing practice to standards identifies areas for
improvement.

3.10.1 Pain and Palliative Care Clinical Audit Process

 The hospital should ensure that clinical audit for pain and Palliative care. The audit should be
incorporated in the regular hospital wide clinical audit process and program.
 The hospital should conduct a monthly Pain and Palliative care clinical audit. Simultaneously quarterly
and monthly pain and palliative care service indicators listed below are also expected to be done. The
objective of the clinical audit is to review the practice of the patient’s pain management and palliative
care in the hospital, both inpatient and outpatient against the standard protocols and guidelines. The
pain and palliative care Service Director of the hospital shall be responsible to coordinate pain and
palliative care clinical audit aligned with clinical audit team of the hospital.
 The clinical audit result should be summarized to see if there is a discrepancy of pain management or
palliative care practice with the standard. Following the clinical audit findings, an action plan or quality
improvement project should be prepared with the appropriate timeline and with the responsible
persons.
 Follow up actions should be recorded for the implementation of the action plan and QI project.
It is recommended to repeat the above process for 12 consecutive months. When pain management
and palliative care practice is well integrated to the routine health service delivery according to the
protocol, the frequency of clinical audit can be scheduled accordingly.
3.11 Palliative care service provision
A model of care is an overarching service design for delivering a particular type of healthcare. For
palliative care, services must address patient and family needs coping with life-threatening illness.
Main models are hospital and community-based, each with strengths and weaknesses. Hospital-based
models alone cannot fully address dying patients’ and families’ needs without home-based services.
Community-based models often start with home care before requiring inpatient hospice facilities.

In 2015, the Ministry of Health performed a palliative care service needs assessment, considering
various models. For Ethiopia's large, mostly rural population, a community-based model is most
suitable (WHO 2009). However, this requires a hospital "hub" supporting morphine access and
specialized services and training. Since morphine is currently hospital-level only, a hospital hub and
spoke model was deemed most appropriate. The hospital has a multidisciplinary palliative care team
that supports other departments with inpatient and outpatient care and assigns nurses for home-based
care in the catchment area, linking to health centers and NGOs providing home services. The
backbone of services will be trained nurses and physicians supporting clinical delivery. Nursing’s
holistic focus on psychological, social, spiritual, and physical wellbeing positions nurses to deliver
palliative care. Hospital hub nurses and doctors will support community nurses, who will work with
and mentor health extension workers and family health teams. Health extension workers will provide
basic care and refer patients to health centers. All clinical services will be overseen by the palliative
care working group/core team. Capacity will also expand through developing a volunteer network and
communication strategies between providers and clinical pathways. Services shall be incorporated into
existing healthcare systems like hospitals. They will be established in tertiary, regional hospitals, and
health centers with the following competencies:

3.11.1 Hospital Based pain/ Palliative Care

Hospitals will have inpatient units, outpatient clinics, and home-based care teams. The leadership will
establish a multidisciplinary team that provides consultations for admitted patients. Strong referral
systems must exist between hospitals, health centers, and home-based providers to ensure continuous
care and support at home.

3. 11.2 Home Based Care and Regular Supervision Service

Home care includes any professional support services that allow a person to live safely in their
home. In-home care services can help someone who is aging and needs assistance to live
independently; is managing chronic health issues; is recovering from a medical setback; or has
special needs or a disability. Professional caregivers such as nurses, aides, and therapists provide
short-term or long-term care in the home, depending on a person's needs.

Home care can be the key to achieving the highest quality of life possible. It can enable safety,
security, and increased independence; it can ease management of an ongoing medical condition; it
can help avoid unnecessary hospitalization; it can aid with recovery after an illness, injury, or
hospital stay—all through care given in the comfort and familiarity of home. Home care can
include:

 Help with daily activities such as dressing and bathing

 Assistance with safely managing tasks around the house
  Companionship
 Therapy and rehabilitative services
 Short- or long-term nursing care for an illness, disease, or disability—including
tracheostomy and ventilator care

Types of home care

Not all home care providers offer all the different types of home care services. This short guide will
provide an overview of the different types of home care. Care is customized to your individual needs
and may include services from one or more of the types described. While the multiple types of home
care may serve different needs, they share a common goal: to enable happier, more independent living
for the people receiving care, and to provide support and peace of mind for their families.

Personal Care and Companionship

Help with everyday activities like bathing and dressing, meal preparation, and household
tasks to enable independence and safety listed below:

- Assistance with self-care, such as grooming, bathing, dressing, and using the toilet
- Enabling safety at home by assisting with ambulation, transfer (eg, from bed to
wheelchair, wheelchair to toilet), and fall prevention
- Assistance with meal planning and preparation, light housekeeping, laundry, errands,
medication reminders, and escorting to appointments
- Companionship and engaging in hobbies and activities
- Supervision for someone with dementia or Alzheimer's disease

Private duty and Nursing Care

 Long-term, hourly nursing care at home for adults with a chronic illness, injury, or disability listed
below:
- Tracheostomy care
- Monitoring vital signs
- Administering medications
- Ostomy/gastrostomy care
 - Feeding tube care
- Catheter care
- End stage chronic illness

Home health Care

 Short-term, physician-directed care designed to help a patient prevent or recover from an

illness, injury, or hospital stay listed below:(Bayada.com/home health care,2022)

- Short-term nursing services

- Physical therapy
- Occupational therapy
- Speech language pathology
- Medical social work
- Home health aide services
4. Annexes
Annex 1: Reporting Format
A. Registration format for palliative care service (Inpatient, Outpatient and HBC
Name of Hospital----------------------------------------

S.N. Name of patient Age Sex Religion Case/Dx management Outcome

Progress
Annex 2. Palliative Care Assessment Form

Name: ____________________________________________ PC No._____________________

Age Date

Sex Religion

Nationality Tribe

Place of assessment Sub-city & Wereda

Seen By House No

Contact telephone (for Pt.)

Address:

Care giver name /relationship

Referred by: CVWs_________________ Nurse ______________ Self _______________
other________
Give name: ___________________________
Address _______________________
Contact tel No __________________

History from patient ___________ Career _____________ Volunteers ___________ other

___________

Reason for referral: Pain and Symptom control _______________ other

__________________________
Diagnosis (Include details of metastasis)

Histology _________________________

HIV status Non-reactive  Reactive Unknown

Information on RVI status is obtained from Patient/Family/Referral paper. NB: If the result is
Reactive, please pass to PLWHA chart

History of Present Illness (HPI)

_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
Past Medical /Surgical History (list below with dates of onset e.g. diabetes, hypertension, TB,
_____________________________________________________________________________________
previous unrelated hospital admission, other relevant information) list Medication given
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
__________________________________________________________________________________
_____________________________________________________________________________________
__________________________________________________________________________________
_____________________________________________________________________________________
__________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
Present Medication: all medication including ARVS, prophylaxis, anti-pain
Current medications Dose , frequency and Route Start date

Is the patient receiving herbal medicine? _______________ If yes, how long?

____________________

Is the patient receiving Opioids previously or now e.g. Morphine? ____________ Dosage__________

Is the patient on steroids? ______________________

If the patient stop the above medication/s, why? _______________________________

Give the details information if the patient has allergic history?

__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
____________

Spiritual Assessment

Are you at peace with God?

_____________________________________________________________

Has your illness in any way affected your relationship with god? What way, if yes?
__________________________________________________________________________________
__

Do you pray with other? If not, why?

_____________________________________________________

Do you feel your illness is a punishment from God?

__________________________________________
Do you need support from spiritual fathers? If yes, what type of help?
__________________________________________________________________________________
__

Social History

Family tree (Include age of children):

Male  Female ⃝
Male Female
(died)  (died) 
patient X

Marital status
________________________________________________________________________
Main physical
career___________________________________________________________________
Dependents including children and /or siblings
______________________________________________
No of children in school
_________________________________________________________________
Other household members
______________________________________________________________
Occupational history /source of income ___________________________________________
Employment status :- Employed __________ unemployed _______ retired _______house wife
_______
Present employment status = unemployed due to illness
_______________________________________
Main source of income & main economic career relationships to
patient__________________________
Physical Examination

____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
Functional assessment (FA)
____________________________________________________________________________________
____________________________________________________________________________________
Keys: - 1 fully independent
____________________________________________________________________________________
____________________________________________________________________________________
Function Score
2-independent with aid
____________________________________________________________________________________
Walking
____________________________________________________________________________________
3-needs assistance of one person \
____________________________________________________________________________________
Dressing
____________________________________________________________________________________
Toileting 4- Assistance of two persons
____________________________________________________________________________________
Self-care
____________________________________________________________________________________
5- Completely dependent
____________________________________________________________________________________
Total
____________________________________________________________________________________
Average score of FA NB- average FA scored ≤ 2 does not need CVW
____________________________________________________________________________________
____________________________________________________________________________________
> 3 needs assistance of care giver
_______________________

Pain Chart to be filled at First Visit

Describe the type of pain experienced using this table and give a possible cause of each pain

Mark site of pain and assign number Body chart

 Pain 1 Pain 2 Pain 3 Pain 4
Duration of pain
Character description of pain
Numerical scale 0-5
Periodicity (constant /intermittent/
Precipitating factors
Relieving factors
Does pain affect sleep? Y/N
Does pain affect mobility ?Y/N
Effect of current medication –none
, partial, complete controlled
Did you sleep last night
Possible causes of each pain?

Initial problem list

No Initial problem list

Problem Possible cause Management plan
 Prescription &supplied
1
2
3

Understanding of illness and consequences

What do you understand by your illness? Diagnose and
prognosis
What does your family understand? ask the family too
What is your main distress? ask the family too
What is your expectation from the treatment?
Has your illness affected your relationship with
friends/families?
What do expect from Hospice Ethiopia? explain about HE
Case summary (Includes brief summary of present illness, and plan of care that include physical,
psychological, social and spiritual)

---------------------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------

Conclusion: Physical __________ Psychological ___________ Social __________Spiritual

__________

Seen by: ______________________________Signature: _________________ next visit

_____________

Breaking Bad News delivery (to be done on 2nd or 3rd visit and please briefly write what is done)
 ---------------------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------------------
------------------------------------------

Meaningful communication sheet

Date Note

Problem List

No Problems Active date Inactive date

1
2
3
4

Continuation Sheet

Date Site of Prob. Note on problem and plan of management

visit No
 Medication Sheet

S. Date Medications Dose, Frequency and Prescribed Remark

N. Route by
1
2
3
4

Annex 3:

Palliative Care at outpatient department Patient satisfaction survey

Exit interview questionnaire

Date of survey………………………………

Facility Name………………………….. Survey code ...........Department name………………

Age…………………… Gender……………….. Level of educations…………………………

Instruction: Please circle or write in relevant boxes

Diagnosis Cancer HIV NCDs Others ……………………..

type…………………

Strongl Disagree Agree Strongly agree

y
2 3 4
disagree

1
1- During this visit, the health care worker 1 2 3 4
treated me with courtesy and respect
2- During this visit, the health care worker 1 2 3 4
listened carefully to me
3- During this visit, the health care worker 1 2 3 4
explained things in a way I understand
4- I had enough time to discuss my problems Yes No
with the health care worker
5- Were you given health information and Yes no
education on the disease you are told to
have?
6- How do you rate this health facility? 0 1 2 3 4 5 6 7 8 9 10
- On scale of 1 to 10 (0 being the worst
Worst ………….to………………………..best
and 10 being the the best facility)
7- Would you recommend this outpatient 1 2 3 4
department /clinic to your family and friends
no not sure yes Yes Very
,never ,probably sure
Annex 4:

Essential Palliative Care Medicines List

Drug Name Properties Clinical Uses Alternative Drugs

Paracetamol Non opioid Fever
Analgesic Pain

Aspirin Antipyretic
Non opioid Pain
Analgesic Antipyretic Fever

Ibuprofen Anti-
NSAID inflammatory Sore mouthbone
Pain (esp. Diclofenac
pain) Fever Indomethacin
Tramadol Weak opioid Pain
Anti-inflammatory Low dose
Codeine Analgesic morphine

Morphine liquid Strong opioid Pain Morphine slow

Analgesic Introduction release tablets
Breakthrough pain
Difficulty swallowing
children
Morphine (slow Strong opioid Pain Morphine
Breathlessness Severe
release tablets) Severe diarrhea Liquid
Dexamethasone Corticosteroid Diarrhea
Painful swelling and Prednisolone
Anti- inflammatory inflammation

Amitriptyline Tricyclic Poor appetitepain

Neuropathic Carbamazepine
Antidepressant (nerve pain) Phenytoin
Amitriptyline Tricyclic Depression Imipramine
Antidepressant
Hyoscine Butyl Antimuscarinic Abdominal pain Propantheline
bromide Antispasmodic (Colic)
(Buscopan)
Diazepam Benzodiazepine Muscle spasm Lorazepam
Anticonvulsant Seizure
Anxiety, sedation
Phenobarbitone Anticonvulsant Seizure Diazepam
Metoclopramide Antiemetic Vomiting Haloperidol
Domperidone

Metoclopramide Pro-kinetic Abdominal Fullness Promethazine

Chlorpromazine Antipsychotic Hiccups Metoclopromide
Nifedipine
Magnesium Trislicate Antacid Indigestion
Gastro-esophageal

Loperamide Antidiarrheal reflux

Chronic diarrhea
Bisacodyl Stimulant Gastritis
Constipation
laxative
ORS Rehydration Diarrhea
Salt Rehydration

Chlorpheniramine Antihistamine Drug reactions

Flucloxacillin Antibiotic Chest infection

Skin infection

Cotrimoxazole Broad PCP treatment &

Spectrum prophylaxis
Antibiotic Infective diarrhea in
HIV/AIDS
Metronidazole Antibacterial Foul smelling
Urinary Tract Infection
for anaerobic infections wounds
gingivitis dysentery
Lumefantrine Anti- malarial Malarial treatment
Vaginal discharge
artemether (LA)
Acyclovir Antiviral Herpes zoster
Chloramphenicol eye Antibacterial Eye infections
ointment/drops
Fluconazole Antifungal Oral & esophageal
candidiasis

Clotrimazole 1% Cream Topical Cryptococcal

Fungal Skin
antifungal meningitis
Infection
Nystatin Antifungal Oral & vaginal
Suspension and pessaries candidiasis Prophylaxis
for patients on steroids
Annex 5:

Pain medication drug availability reporting format

Record of Pain management drug

Name of reporting
pharmacy…………………………………………………Address……………………………

Region……………………………….zone………………………woreda………………………………
……….kebele………………………..tel………………..

Reporting month………………………………to……………………..of the

year………………………………….

Ser.No Type of pain Patient Drug prescribed Prescriber’s Date of

management Address prescription
Drug
Name Card description quantity
no.
Pain Assessment and management Format

S. Name of B. Pressure Tempera puls O2 Score 0-10 Pain

No patients N ture e Saturati Mil Mo Severe management Name
o on d der accordingly &Signature
ate
0 5 7 to 10
to4 to7
Annex 6:

Palliative care Equipment and supplies list

 Examination room
 Patient Couch
 Pillows
 Sheets
 Blankets
 Slippers
 Desk for Health Care Professional
 Chairs for HCPs, patient and family members
 Filing Cabinet
 Nursing/Dressing Trolley
 Material for Dressings- Gauze, cotton wool, bandages.
 Stitch material
 Surgical blades
 Normal Saline for cleaning wounds
 Chlorhexidine
 Hydrogen Peroxide
 Antiseptic Cream
 Sphygmomanometer
 Stethoscopes
 Thermometers
 Lock box for medicines
 Syringes and Needles
 Pain Measurement Scales
 Coffee table and comfortable chairs for counselling and breaking bad news
 Oxygen, tubing and mask.
 Wheelchair
 Commode and bed pan
 Sanitary towels and pads for incontinence
 Incontinence Pants
 Mackintosh sheeting –plastic-for incontinent patients
 Gloves- surgical and clean-all-sizes
 Kidney dishes
 Vomit bowls
 Dressing sets
 Aprons
 Face Masks
 Hand Sanitiser-soap
 Cleaning Materials
 Air Fresheners
 Charcoal Dressings
 Jugs for vaginal douches
 Toilet Paper
 Paper Towels and Material towels
 Uretheral Catheters and catheter bags
 IV catheters
 IV fluids
 Blood Transfusion sets
 Bandages for IVS
 Adhesive Tape
 Small Gauze
 Rubbish bin
 Bin to dispose of dressings and soiled matter
 Patient gowns
 Stationary including paper, pens, markers, envelopes, stapler, tape.
 Log book for patients
 Suction Catheter
 Bedside commodes.
 Geriatric recliners (geri chairs)
 Nebulizers.
 Overbed tables.
 Shower chairs.
 Wheelchairs
 Pain assessment tools
Annex 7:

Common Pain Scales

There are a variety of pain scales used for pain assessment, for patients from neonates through advanced
ages. The three most common scales recommended for use with pain assessment are:

1. The Numeric Pain Rating Scale

2. The Hand scale

3. The Wong-Baker scale (also known as the FACES scale)

4. The FLACC scale

5. PAINAD

1. Numeric Pain Rating Scale

The health worker asks the patient to rate their pain intensity on a numerical scale that ranges from
(indicating ‘no pain’) to 10 (indicating the ‘worst possible pain’).

Procedures

a) Explain to the patient about what you are going to do (eg. ‘I want to assess your painlevel to help us
properly manage the pain’
b) Ask the patient ‘please rate your pain in a scale from zero to 10 (0 = no pain and 10 = worst
Possible pain). You can use a scale like below
c) Numeric Pain Rating Scale Record the patient scored pain level on the necessary form to make
treatment decisions, follow-up, and compare between examinations

No pain Mild pain Moderate pain Severe pain Very severe painWorst possible pain

0 1 2 3 4 5 6 7 8 9 10

Figure 6: Numeric Pain Rating Scale

2. The Hand Scale

 The hand scale ranges from a clenched hand (which represents ‘no hurt’) to five extended digits (which
represents ‘hurts worst’), with each extended digit indicating increasing levels of pain.

Note: It is important to explain this to the patient as a closed fist could be interpreted as worst possible
pain in some cultures

a) Explain to the patient about what you are going to do (eg.‘I want to assess your pain level that will
help us properly manage your pain’

Show your hands to the patient and ask ‘please rate your pain level. You should show your hands like
below or use the drawing use a scale

b) Multiply the result by two to score the pain to 0 to 10 and record on the necessary forms ( if the
patient reports hurts whole lot mean four figures the result will be recorded as 4*2= 8 on the routine
observation form).
Suggested tools for Pain Measurement in children

3. Faces Scale

*Use in children who can talk (usually 3 years and older)

Show the Child the Following picture and explain to the child that each face is for a person who feels
happy because he has no pain, or a little sad because he has a little pain, or very sad because he has a
lot of pain

Faces scale

a. Ask the child to pick one face that best describes his or her current pain intensity.
b. Multiply number of the pain level that the child reports by two and record on the necessary form to make
treatment decisions, follow-up, and compare between examinations.

c. Record the summation of observation on the necessary form to make treatment decisions, follow-up,
and compare between examinations

4) FLACC Scale

FLACC is the acronym for Face, Legs, Activity, Cry, and Consolability. This scale is based on observed
behaviors, and is most commonly used with paediatric patients less than three years of age. The behaviors
that are described are associated with a number; each component is totaled for a number ranging from 0
to 10. This scale is also appropriate with patients who have developmental delays or are non-verbal.

Use it like an APGAR (Appearance, Pulse, Grimace, Activity, Respiration) score, arriving at a score out
of 10.
5) Pain assessment in advanced dementia (PAINAD)

Items 0 1 2 Score

Breathing Normal Occasional labored Noisy labored

independent of breathing. Short breathing. Long periods
vocalization period of of hyperventilation.
hyperventilation Cheyne-Stokes
respiration

Negative None Occasional moan or Repeated troubled

vocalization groan. Low level calling out. Loud
speech with a moaning or groaning.
negative or Crying
disapproving quality

Facial expression Smiling or Sad. Frightened. Facial grimacing (an

inexpressive Frown ugly or disapproving
facial expression)

Body language Relaxed Tense. Distressed Rigid. Fists clenched.

pacing. Fidgeting Knees pulled up.
Pulling or pushing
away. Striking out

CONSOL ability No need to Distracted or Unable to console,

console reassured by voice or distract, or reassure
touch
Annex 8:

Palliative Care Audit Tool

1 Does the hospital clinic have a functioning palliative Yes NO Remark

care team?
2 Do they have the minimum number of palliative care
staff in the team? (according to WHO guidelines)
3 Have the palliative care team attended a one-week
training course?
4 Do they have a room or office to meet and see patients?
5 Do they have a hospital palliative care policy with
referral criteria?
6 Do they have palliative care notes which are stored
appropriately for their patients? Check 6 Patient
Records)
7 Do they have access to palliative care medicines
including morphine -including liquid form?
8 Is there evidence of a palliative assessment including
pain as the 5th vital sign Check 6 Patient Records)
9 Is there evidence of pain and symptom control
assessment and appropriate treatment (Check 6 Patient
Records)
10 Do they have palliative care equipment (according to
list)
11 Do they have a linked home-care service?
12 Do they offer a bereavement service?
13 Have any of the team any post-graduate education in
palliative care?
14 Does the palliative care hub have volunteers to support
 patients and family?
15 Does the hub have a clear referral pathway for patients
from all appropriate departments?
16 Do the palliative care hub team provide basic
updates/experience sharing with other health care
professionals in the hospital
17 Do Pain and palliative care team have schedule for HBC
and working based on standard
Annex 9
Job Description of Pain and Palliative Care Work Force

Job Description of palliative care Unit/ Department Head

1. Lead the team
2. Timely report palliative care activity ,opoid consumption report monthly to the stakeholders
(IPD,MD,RHB,MOH)
3. Facilitate the working environment
4. Perform monthly meeting with the hospital management about palliative care
5. To procast training need and propose training for the team members
6. To procast opoid medication timely
7. Ensure medicine and other necessary medical supplies are purchased and available in the
hospital
8. To prepare documentation in collaboration with other stake holders ( protocols
,TOR,SOP,patient history form and others )
9. To prepare annual plan of the unity which is in favor of fulfilling national strategy plan
10. To organize and deliver appropriate training for the team time

Job description of palliative care physician

1. Assess patient’s need for total pain and symptom control and offer quality care and support based on
the palliative care national guideline.
2. Take history, physical examination and necessary investigation to reach on diagnosis.
3. Treat the patient by using holistic approach and treat pain using standard WHO pain ladder approach
4. To have regular schedule for the patient OPD and inpatient visit
5. Refer patient with the proper form to different discipline if needed.

Job description of palliative care nurse

1. Care out physician order and also assess patient’s need for total pain and symptom control and offer
quality care and support based on the palliative care national guideline.
2. Perform standard nursing care for kept palliative care patient
3. Keeping the patient information and records well
4. Recording and controlling medicines useful for palliative care
5. Make sure bereavement support is provided for patient family as necessary
6. Ensure medicine and other necessary medical supplies are available in the unit
7. Ensure there is good patient referral system and linkage with necessary stakeholders
 8. Facilitate and participate during case discussion among the clinical staff
9. Supervise and lead the work of care givers who are directly involved in patient care
10. Help students who may be assigned at hospital from medical school in PC attachment
11. Ensure psychosocial and spiritual supports are provided by experts when needed
12. Provide holistic Home care service as per the schedule in addition to the outpatient and inpatient care
13. Develop work plan every month or quarter and communicate with palliative focal person
14. Have a great team approach
15. Perform any other duty assigned by immediate supervisory
16. Accept tasks assigned by the palliative care team leaders which is related to palliative care service

Job description of palliative care Social workers

1. assess patient’s need for social pain and its management

2. asses patients family need for social pain and its management
3. to have regular visit with the team to palliative care patient
4. Have regular meeting with palliative care team and handling social problem happen in the
team ( involving in care for care giver service)
5. To prepare gate together ceremony for the team and if it can with other stakeholders and
patients
6. Accept tasks assigned by the palliative care team leaders which is related to palliative care
service

Job description of Psychologist

1. Asses the patient psychological problems of the patient and families

2. Document the patient psychological problems clearly
3. Manage the psychological problems of the patient and families
4. Have regular meeting with palliative care team and handling psychological problem
happen in the team ( involving in care for care giver service)
5. To give onsite training on psychological problem identification and managing for the team
6. Refer the patient if needed
7. Accept tasks assigned by the palliative care team leaders which is related to palliative care
service

Job description of Clinical Pharmacist

1. To assess the standard who pain management implemented to the palliative care patient
2. To report opoiod consumption report to the focal person timely
 3. To involve in DTC meeting regularly
4. To give health education on opoid medication use and there side effect
5. To promote appropriate use of opoid
6. To prepare and distribute leaflet about pain medication and how to use
7. Record and manage side-effect and negative outcome regarding to pain medication
8. Update pain medication medicine timely
9. Give information the availability, stock out stats of pain medication to palliative care
unit timely.
10. Accept tasks assigned by the palliative care team leaders which is related to palliative
care service

Job description of Spiritual leaders

1. To assess the patient spiritual issues

2. To manage the patient spiritual issues
3. To assess the patient family spiritual issues
4. To document the patient spiritual problems appropriately
5. To train others how to handle spiritual problems
6. Have regular meeting with palliative care team and handling spiritual problem happen in
the team ( involving in care for care giver service)
7. Accept tasks assigned by the palliative care team leaders which is related to palliative care
service

Job description of Volunteers

1. To help the patient in need

2. To transport and direct the patient to appropriate place
3. To involve in community visit
4. To involve in patient tracing system for delivering palliative care service
5. Accept tasks assigned by the palliative care team leaders which is related to palliative
care service (The team can refer from strategic plan)

3.3 Pain and Palliative Care work force

Pain and palliative care require teamwork and a multi-disciplinary approach. Regular planning clinics are
required to discuss patient cases as well as regular ward rounds with the team. Furthermore, patients can
be seen in outpatient clinics run by pain and palliative care staff.
The hospital human resources development plan is expected to incorporate pain and palliative care
training need.
All clinical staffs working in all service delivery points should get training on pain management and
palliative care service. Since pain is assessed and managed in all service areas, the hospital should assign
facilitators in all departments. Availability of pain and palliative care trained personnel is important to
support other hospital in the hubs and make need based capacity building.
The hospital should establish a pain and palliative care workforce that identifies priority areas of patient
need and establishes procedures for collaboration with other pain and palliative care health care
professionals and cross- referral in the unit. Take the skill mix of professionals into consideration.
Establishes procedures to refer patients to specialized services.
Each palliative care professional is responsible for the following:
 Collaborate with patient and their family and cares
 Work with palliative care team, to form overall goals and plan for patient
 Make referrals to specialized rehabilitation/palliative care professionals and
other clinical staff and community services.
 Collaborate with other health care professionals in teaching, consulting, and
management and research activities
Source document

1. National Palliative Care guidelines (2016) MOH, Ethiopia

2. Hospice Fundamentals, LLC PALLIATIVE CARE HANDBOOK (2019) Jean Acevedo, LHRM, CPC,
CHC, CENTC, AAPC Fellow,
3. World Health Organization (1990) Cancer Pain Relief and Palliative Care. Available at:
http://whqlibdoc.who.int/publications/9241544821.pdf (Accessed: 8 September 2011).
4. World Health Organization (2002) WHO Definition of Palliative Care. Available at:
http://www.who.int/cancer/palliative/definition/en/ (Accessed: 10 November 2010).
5. World Health Organization (2014a) WHO African Region: Ethiopia. Available at:
http://www.who.int/countries/eth/en/ (Accessed: 4 August 2014).
6. World Health Organization (2014b) ‘Strengthening of Palliative Care as a Component of Integrated
Treatment throughout the Life Course’, Executive Board 134th Session, Provisional Agenda Item 9.4.
EB134/28, World Health Organization.
7. World Palliative Care Association (2005) an Advocacy Tool Kit for Hospice and Palliative Care
Organizations. Available at: http://www.wpca.org.uk/advocacy_toolkit_05April (1).pdf (Accessed: 10
August 2014).
8. Wright, M., Clark, D., Hunt, J. and Lynch, T. (2006) Hospice and Palliative Care in Africa. A review of
developments and challenges. 1st edition. New York: Oxford University Press.
9. Wube, M., Horne, C. J. and Stuer, F. (2010) ‘Building a Palliative Care Program for Ethiopia: the impact
on HIV and AIDS patients and their families’, Journal of Pain and Symptom Management. 40, (1) pp.6-8.
10. Palliative Home Care and Services provided in a Rural Area – Kerala, India’, Indian Journal of Palliative
Care, 18 (3), pp.213-218
 CHAPTER 14
PHARMACY SERVICES AND
PHARMACEUTICAL SUPPLY
MANAGEMENT

1
Outline
1. Introduction 2
2. Operational Standards for Pharmacy Services and Pharmaceutical supply management 2
3. Implementation Guidance 3
3.1. Pharmacy Service and Pharmaceutical Supply Management Organization 3
3.1.3. Resources needed for pharmacy and pharmaceutical supply management services 7
a. Personnel 7
3.2. Drug and Therapeutics Committee 8
3.3. Pharmaceutical selection, quantification, procurement, warehouse, inventory management,
distribution, and an effective information management system 16
d. Pharmaceutical emergency supply chain management system 19
3.4. Pharmaceutical cold chain and vaccine management 22
3.5. Medical Oxygen Supply management 33
3.6. Pharmaceutical waste management 36
3.7. Auditable pharmaceutical transactions and services (APTS) and good dispensing practices.
37
3.8. Clinical pharmacy services 43
3.9. Drug Information Services 47
3.10. Compounding services 48
3.11. Antimicrobial Stewardship Program (ASP) 49
3.12. Narcotic drugs and psychotropic substances rational use, distribution and handling system.
52
3.13. Monitoring and Evaluation of pharmacy service and supply mana 54
6. Annexes 55

Annexes
Annex 1: DTC functionality criteria 55
Annex 2: ADR reporting format 56
Annex 3: Pharmaceutical Good storage guideline 59
Annex 4: Bin Card 61
Annex 5: Internal Facility Report and Resupply Form (IFRR) Error! Bookmark not defined.
Annex 6: Report and Requisition Form (RRF) 64
Annex 7: Refrigerator tag temperature recording sheet 66
Annex 8: Procured medical oxygen cylinders checking form during receiving at store to ensure proper
filling 66
Annex 9: Medical oxygen Internal Reporting and Requesting form (maintained separately for each ward)
67
Annex 10: Medical oxygen monthly consumption tracking report 67
Annex 11: Expired and unfit for use product registration form 67
Annex 12: Prescription evaluation and intervention register 68
Annex 13: Data collection form for patient knowledge and labelling interview 69
Annex 14: Data collection form for client satisfaction with dispensing services 70
Annex 15: In-patient Medication Profile Form 71
Annex 16: Pharmaceutical Care Progress Note Recording Form 72
Annex 17: DIS Summary and Report form 74
Annex 18: Drug Information Response Form 76
Annex 19: Drug Information Query Form 78
Annex 20: Drug information service feedback form 79
Annex 21: List of basic compounding equipment 80
Annex 22: Compounding Process Recoding Form (Compounding sheet) 81
Annex 23፡ Compounding Prescription Register Forms 82
Annex 24: Antimicrobial Stewardship program functionality Criteria 82
Annex 25: AMS review/Audit form 84
Annex 26: Dispensed and administered Narcotic drugs record format 85
Annex 27: Dispensed and administered psychotropic drugs record format 86
Annex 28: Annual report of narcotic drugs 88
Annex 29: Annual report of Psychotropic substance 89
List of Tables
Table 1: pharmaceutical service positions and corresponding number of professionals 8
Table 2: Criteria to classify pharmaceuticals into ABC category 12
Table 3: Selected indicator to assess prescribing, patient care and facility practices 13
Table 4: Heat sensitive Vaccines 24
Table 5: Freeze sensitive Vaccines 25
Table 6: Pharmacy Service and Supply Management Standard and Verification criteria Error!
Bookmark not defined.

List of Figures
Figure 1: Hospital pharmacy service and pharmaceutical supply management organogram 6
Figure 2: Arrangement of vaccines in a refrigerator compartment 27
Figure 3: Vaccine and diluent arrangement in a front-opening kerosene vaccine refrigerator 27
Figure 4: Vaccine and diluent arrangement in a top-opening refrigerator without baskets 29
Figure 5: Vaccine and diluent arrangement in a top-opening refrigerator with baskets 29
Figure 6: Vaccine vial monitoring criteria 31
Figure 7: Key result areas of APTS 38
Figure 8: Pharmacy patient flow arrangement in APTS implementing health facilities 40
Abbreviations and Acronyms
ADE Adverse Drug Event
AMC Average monthly consumption
AMS Antimicrobial Stewardship
APTS Auditable Pharmaceutical Transactions and Services
ASP Antimicrobial Stewardship Program
AWaRe Access, Watch and Restrict
DMAT Disaster Medical Assistance Team
DTP Drug Therapy Problem
DUE Drug Use Evaluation
EFDA Ethiopian Food and Drug Administration
EHSTG Ethiopian Hospital Service Transformation Guideline
EPSS Ethiopian Pharmaceutical Supply and Service
GCP Good Compounding Practice
HFSML Health Facility Specific Medicine List
HSTP Health Sector Transformation Plan
IFRR Internal Facility Report and Resupply
ILR Ice Lined Refrigerator
NPS Narcotic drugs and psychotropic substances
PIS Patient Information Sheet
PMIS Pharmaceutical Management Information system
PMP Patient Medication Profile
PTC Patient Tracking Chart
SSA Stock Status Analysis
VEN Vital, essential, Non-essential
VVM Vaccine Vial Monitor

1
Section 1 Introduction

Pharmaceutical supply chain management and pharmacy service activities are integral parts and
crosscutting activities of the health care system. Managing the pharmaceutical supply chain and
pharmacy service is key to fulfilling basic customer satisfaction and is all about obtaining the
right product in the right quantity and condition at the required time. The ultimate health
outcome is determined by the appropriate selection, quantification, procurement, and rational use
of pharmaceuticals. Pharmacy service and pharmaceutical supply management are essential
components of health care delivery in hospitals. It contributes to improved treatment outcomes
by ensuring the availability and rational use of quality, safe, and effective medicines.
The provision of an effective pharmacy service is also crucial for the early recognition and
prevention of medication errors and adverse drug events, as well as the prevention and
containment of antimicrobial resistance. Effective pharmacy service and pharmaceutical supply
chain management also promote optimal use of meagre resources, thereby improving the quality
of care and resulting in better health outcomes. Accordingly, pharmacy services should provide
assurance that quality and safety are maintained at all stages of service provision and that clients’
satisfaction is given the utmost importance. The pharmacy chapter of the previous versions of
EHRIG and EHSTG has guided hospitals in the implementation of critical operational standards.
It helped hospitals in the delivery of quality services and enabled the Ministry of Health, regional
health bureaus, and hospitals to evaluate their performance using predefined indicators.
Consequently, commendable achievements have been registered in terms of improving pharmacy
service delivery. Currently, the majority of hospitals in the country have achieved many of the
operational standard’s verification criteria set in the last two versions of this document. In the
last five years and recently, new initiatives like the antimicrobial stewardship program, oxygen
supply management, pharmaceutical cold chain management, and other new initiatives have
been implemented in Ethiopian hospitals. Subsequently, it was found necessary to update
operational standards and implementation guidance.
In addition, there was a need to develop robust measurement approaches and applicable
indicators that are in line with the health sector's expectations for the coming years. Therefore,
the standards and guidance set in this chapter are designed to align with and support hospital
pharmaceutical services and supply management systems to meet the demands of the nation's
health sector transformation plan.
Section 2 Operational Standards for Pharmacy Services and Pharmaceutical supply management
The hospital pharmacy service and supply management are organized in a way that facilitates
pharmaceutical care and coordination
The hospital has a functional Drug and Therapeutics Committee (DTC).
The hospital has an effective system for pharmaceutical selection, quantification, procurement,
inventory management and distribution
The hospital has a standardized pharmaceutical cold chain management system.
The hospital has an effective oxygen supply management system.
The hospital conducts continuous segregation, documentation, and safe disposal of
pharmaceutical wastes.
The hospital has functional Auditable Pharmaceutical Transactions and Services (APTS) and
executes good dispensing practices at all outlets.
The hospital has functional clinical pharmacy services in the inpatient, outpatient, and
emergency departments.
The hospital provides drug information services.
The hospital has a functional compounding service.
The hospital has an Antimicrobial Stewardship Program (ASP).
The hospital has a system for rational use, distribution and handling of narcotic/psychotropic
substances
The performance of pharmacy service and supply management is regularly monitored and
evaluated.
Section 3 Implementation Guidance
3.1. Pharmacy Service and Pharmaceutical Supply Management Organization
Pharmacy services should be organized and managed in such a way that ensures patient safety,
convenience, privacy, and satisfaction. The organization and management should also improve
performance and be convenient for practitioners.
3.1.1 Management of pharmacy service and pharmaceutical supply management
Hospital pharmacy should be managed in a manner that facilitates the provision of patient-centered
pharmaceutical services consistent with the standards outlined in this guideline. A head or director
appointed by the hospital management is responsible for overseeing the hospital pharmacy. The hospital
management also assigns unit coordinators. Whereas the pharmacy director or head assigns team leaders
as deemed necessary.
The head or director of the pharmacy department performs the following activities:
Develops, implements, monitors, and follows the approval of the pharmacy service and pharmaceutical
supply management annual action plan.
Cascading the pharmacy service and pharmaceutical supply management plan to coordinators and unit
leaders
Follows developments and trends in health care and makes sure national service standards and guidelines
pertaining to hospital pharmacy service and pharmaceutical supply management practice are
communicated to everyone involved in the provision of pharmacy services and pharmaceutical supply
management.
Makes sure vaccine and medical oxygen supply management are properly implemented.
Continuously perform workload analysis, communicate, and follow the hospital management's
instructions for action.
Participate in hospital committees and meetings representing the pharmacy department.
Makes sure that new staff are properly oriented and supervised, and skill transfer is undertaken while staff
are rotating to other units or leaving the hospital.
Designs and follows the implementation of professional development programs for all staff as appropriate
to enhance their knowledge and skills.
Regularly ensure evaluation of the performance of pharmacy staff and take measures accordingly.
Communicates and collaborates with other departments and services throughout the hospital.
Communicates performance reports to the hospital management and relevant government bureaus and
agencies with the approval of the responsible body in charge of leading the hospital.
Discharging his or her roles and responsibilities as DTC and ASP secretary
3.1.2. Pharmacy Service and Pharmaceutical Supply Management Organization
Pharmacy service and supply management in the hospital should be organized as an outpatient pharmacy
services unit, an inpatient pharmacy services unit, an emergency pharmacy services unit, a pharmaceutical
supply management unit, a clinical pharmacy services unit, a drug information services unit, a
compounding pharmacy services unit, and other units, depending on the hospital's service. Each unit
should be led by a registered pharmacist and shall be organized and function as follows:
OPD Pharmacy Unit: shall be organized in multiple locations (e.g., general OPD pharmacy, ART/TB
pharmacy, chronic care pharmacy, MCH pharmacy, etc.) depending on the arrangement of the OPD
clinics, proximity, and complexity of the hospital to improve accessibility and convenience to patients.
Patient waiting areas at the OPD pharmacy units should be fitted with adequate seats and ventilation to
ensure patient safety.
Chronic Care Pharmacies: Depending on the hospital’s level and service specialization, one or more
chronic care pharmacies shall be established. All patients who have follow-up in these pharmacies shall
have individual patient medication profile (PMP) records. The dispensing pharmacist should update the
PMP whenever a refill medication are dispensed to the patient. When a patient presents to the pharmacy
for a refill, the pharmacist must assess the patient for signs of compliance, adherence, effectiveness, and
safety of the therapy. Whenever the need arises, the pharmacist should communicate with the prescriber
for any therapeutic modification.
Inpatient pharmacy unit: depending on patient load, number of beds, and accessibility, there should be an
adequate number of inpatient dispensaries and specialty pharmacies located near the major wards.
Pharmacists (preferably clinical pharmacists) should lead these dispensaries. Inpatient pharmacy services
should function under a unit dose dispensing system and work 24 hours a day, 7 days a week.
Emergency Pharmacy Service Unit: This should be organized within or near the emergency department.
The dispensing process should be organized such that medicines reach the patient as quickly as possible.
Emergency pharmacies should function 24 hours a day, 7 days a week. The unit also prepares ambulance
kits for the hospital.
Besides routine prescription-based dispensing, an emergency crash cart system shall be used to avoid
delays in availing pharmaceuticals to emergency patients, and orders received by word of mouth or
through telephone during an emergency should later be endorsed by the prescriber and documented in
writing before the next shift. The quantity prescribed should be limited to the emergency period only.
Clinical pharmacy services: The hospital pharmacy shall provide clinical pharmacy services in all units.
The service should be well integrated into all clinical departments. Clinical pharmacy services should
function 24 hours a day, 7 days a week. All services provided in these departments should be recorded,
documented, and reported.
Compounding Unit: in order to respond to specific patient needs, the hospital pharmacy should have
compounding services on separate premises equipped with the necessary facilities and materials and
meeting all other minimum requirements.
Pharmaceutical Supply Management Unit: To ensure uninterrupted supply of pharmaceuticals, the
hospital pharmacy should have a pharmaceutical supply management unit. The unit shall have separate
pharmaceutical stores for medicines, medical equipment, and supplies, including medical oxygen,
chemicals, and lab reagents. A dedicated pharmacist should coordinate the overall operation of the unit
(selection, quantification, procurement, inventory management, warehousing, and distribution), and each
store should be managed by a separate store manager.
Drug Information Service (DIS) Unit: The hospital pharmacy should have a drug information service unit
to effectively provide evidence-based and up-to-date drug information for health care providers and
patients or clients, led by a registered pharmacist.
 Hospital head/CCO

Pharmacy service and pharmaceutical supply management head

Deputy Head/Drug supply management unit Deputy Head /Pharmacy services unit

OPD Ward Clinical

Quantification pharmacy pharmacies Emergency
pharmacy Drug
and Store (internal pharmacy
service information
procurement/DS managers medicine,
ART/TB team service team
M Officers pediatrics,
pharmacy
surgical,
Other chronic
gyn/obs,
care
ICU
pharmacies
pharmacies
etc.
Compounding
service

Figure 1: Hospital pharmacy service and pharmaceutical supply management organogram

6
3.1.3. Resources needed for pharmacy and pharmaceutical supply management services
Personnel
Based on the volume of services and workload the hospital pharmacy should be staffed with an
appropriate professional mix and number. Hospital pharmacies should have at least the following
positions and professional mix:
Pharmacy Services and Pharmaceutical Supply Management Head/Director: in charge of the overall
activities of the pharmacy services
Pharmacy Unit Coordinators: coordinate the overall activity in each unit. When necessary, there will be
team leaders under coordinators.
Pharmacist: Manages dispensing and related functions at the following service areas:
OPD pharmacists: They avail and dispense medicines to outpatients and manage assigned bins in
dispensaries. In addition, a chronic care pharmacist provides pharmaceutical care for patients with chronic
diseases.
Inpatient pharmacists: They avail and dispense medicines to inpatients and manage assigned bins in
dispensaries.
Clinical pharmacists: Provides pharmaceutical care, document and report their activities.
Drug Information Pharmacist: provides up-to-date and unbiased drug information for the healthcare
provider, patients and public.
A compounding pharmacist: Undertakes hospital-based pharmaceutical preparations.
Pharmaceutical supply management pharmacist: manages the selection, quantification, procurement,
storage, inventory, and distribution of pharmaceuticals.
Emergency pharmacist: provides pharmaceutical services in the emergency pharmacy unit.
Pharmacy accountants: Are in charge of aggregating, reporting, and documenting pharmacy transactions
and services.
Cashiers: receive cash from clients, deposit it in banks, and deliver financial documents to accountants.
Porters: Are responsible for loading, unloading, delivering, and arranging pharmaceuticals under the
supervision of the respective unit coordinators of the pharmacy.
Cleaners are responsible for keeping service delivery premises clean and tidy all the time.
Patient assistants or guards: Are responsible for keeping order at dispensing outlets so that patients can be
served in an orderly and secure manner.
Workload analysis and human power deployment
The pharmacy head/coordinator has to conduct a workload analysis for each pharmacy unit and propose
an adequate and competent work force to the management or human resources department of the health
facility. Based on the results of the workload analysis and the services provided, the hospital’s human

7
resources department should deploy the required professionals. Key assumptions used for workload
analysis for service areas are:
For dispensaries, 1000 prescriptions or encounters (or 1800 counselling episodes) per pharmacist per
month
For clinical pharmacy services in wards, there are 25, 30, and 35 beds per pharmacist per day for tertiary,
secondary, and primary hospitals, respectively.
For chronic pharmacies, 30 prescriptions per day per pharmacist
Other service units shall deploy staff as per their workload and services provided.
Table 1: pharmaceutical service positions and corresponding number of professionals
Position Number
Pharmacy services and supply management One pharmacist
director/ head
Deputy Pharmacy service and supply Two Pharmacists
management/ coordinators
Pharmacy units team leaders One pharmacist per unit
Dispenser: Prescription evaluator/biller Based on workload analysis
Dispenser: Medicine counselor Based on workload analysis
Medicine information pharmacist One pharmacist
Clinical pharmacist (in patient) Based on workload analysis
Compounding pharmacist Based on workload analysis
Pharmaceutical supply management officer: One or more per the size of the hospital
Pharmaceuticals store manager: 2 or more as per the size of the health facilities and store number
Pharmacy accountants Based on workload analysis
Cashiers Workload analysis for each dispensing unit
Porters Ranges from 1 to 5 as per the size of the hospital
Cleaners As per the size of the hospital
Patient assistant/ Guard One per each dispensing unit
Note: Calculations for staff number should consider leaves such as annual, sick, and maternity leaves.

3.2. Drug and Therapeutics Committee

8
Each hospital shall establish a functional Drug and Therapeutics Committee (DTC) with multidisciplinary
representative members. The hospital DTC has the responsibility of promoting safe, rational, and cost-
effective use of pharmaceuticals. The hospital DTC functionality can be evaluated using verification
criteria.
Membership of DTC
Hospital-level DTCs shall have the following members, as a minimum:
Chief Clinical Officer (chairperson) Head/representatives of major clinical
departments
Head/Director of Pharmacy (Secretary)
Chairman of the hospital quality improvement
One relevant representative from the pharmacy team
department
Head of Finance Department
Head of laboratory department
From other services as deemed necessary
Head of Nursing Service (Matron)
Other non-voting participants can be invited to attend DTC meetings to discuss specific issues that require
their particular expertise. Sub-committees and ad hoc committees of the DTC may be formed to address
specific issues as the need arises (for example, a policy on the use of antimicrobials, etc.). All DTC
members, especially the chair and secretary, should be given sufficient time for their DTC functions, and
this should be included in their job descriptions.
DTC meetings
The DTC should meet regularly every two months, or more often as the need arises. The agenda,
supplementary materials, and minutes of the previous meeting should be prepared by the secretary and
distributed to members in sufficient time before the meeting. These documents should be kept as
permanent records of the hospital. All DTC recommendations should be disseminated to the medical staff
and other concerned parties and authorities in the hospital. 75% of the membership of the committee will
constitute a quorum for any meeting, and 50% plus members support will approve the decision.
Roles and responsibilities of the DTC
The DTC should develop a TOR detailing the objectives, scope, meeting frequency, membership of the
DTC, and roles and responsibilities of each member. The DTC is expected to develop and implement an
annual action plan in line with its roles and responsibilities. To effectively carry out its mandated
objectives, the DTC should have the following roles and responsibilities.
Advise the medical, pharmacy, and administrative departments on medicine-related issues.
Develops the policies and procedures needed to ensure pharmaceutical availability and their rational use.
Policies should be developed for drug supply management, disposal, drug information services, generic
substitution, and therapeutic interchange, monitoring and evaluation of medicine supply and use,
interventions to promote rational use of medicines, pharmaceutical promotion, and use of specific
medications such as narcotics and psychotropic, chemotherapeutic agents, highly expensive medications,
etc.
The DTC develops and maintains the hospital’s specific list of pharmaceuticals.

9
The list should comprise medicines, medical supplies, consumable medical equipment, and laboratory
reagents that are prioritized as vital (V), essential (E), and non-essential (N).
All relevant departments of the hospital should take part in the selection and prioritization of
pharmaceuticals needed by the hospital.
This list shall be developed based on the MOH Master Medicine List and other lists and National
Essential Medicine List.
Antibiotics shall be classified as "access, watch, and reserve (AWaRe).
The hospital should use the list for procurement purposes and the procurement should be monitored using
ABC and VEN analysis methods.
Tertiary hospitals shall have a formulary manual for specific medicines used for their specialty services.
The selection of pharmaceuticals for the hospital-specific medicine list or formulary manual should be
based on:
The local pattern of disease Level expertise in the hospital
Standard treatment guidelines Diagnostic capacity of the hospital
The recent national master's medicine list Global and national updates and
recommendations
Health services package given by the hospital
During the preparation of the drug list or formulary, emphasis should be placed on:
Medicines descriptions using generic names
Dosage form and strength in basic units (for example, Amoxicillin 500mg capsule)
Inclusion of a limited number of drugs to improve drug availability, adherence to treatment, focused
prescribing, and supply management
The pharmaceutical list should be reviewed and updated at least annually
The medicine list should be available in clinical departments, the pharmaceutical store, dispensaries,
laboratories, finance, etc. to be used as references.
Monitor medicine procurement and inventory management.
Developing policies to facilitate the pharmaceutical supply management
Identifying problems and recommend interventions to streamline the supply management of
pharmaceuticals.
Promoting the adoption and utilisation of standard treatment guidelines (STG).
STGs promote the rational use of medicines and provide a benchmark for optimum treatment for the
monitoring and audit of drug use.
Specialised hospitals may also develop their own STGs based on the availability of the required expertise,
facilities, etc.

10
Identifying and addressing medicine supply and use problems.
Monitoring the rational use of medicines by conducting medicine use studies to identify problems.
The DTC can use a number of qualitative and quantitative methods to investigate problems with medicine
use and supply.
The DTC should establish policies and procedures for identifying and managing drug use problems,
including, at a minimum:
Monitoring adverse drug reactions Drug utilisation monitoring
Prescription monitoring Rational use of antimicrobials
The DTC follows up on the implementation of these activities by setting up a taskforce composed of
relevant departments.
When problems are identified, the DTC should devise specific interventions to improve practises.
Interventions may be any one or a combination of the following strategies:
Educational programmes such as in-service training,
Managerial interventions such as the use of standard treatment guidelines and formularies and
establishing antimicrobial stewardship programmes
Regulatory actions such as controlling medicine promotions, etc.
Establishing and overseeing the Drug Information Service (DIS).
Drug information service provides information and advice to health professionals, patients, and the
public.
Cooperating and sharing experiences with other hospital committees and regional or national DTCs.
Promoting the monitoring and management of ADEs
The DTC should have a plan to monitor, assess, report, correct identified problems, and prevent ADEs to
assure that medicines are efficacious, safe, and of high quality.
To monitor the use of medications in the hospital, the pharmacy department in collaboration with the
DTC should undertake activities periodically using the following methods.
Monitoring of prescriptions Aggregate data methods
Monitoring of patient charts for medication Indicator study methods
therapy
Drug use evaluation methods
Prescription Monitoring
Prescriptions should be regularly monitored to identify trends and ensure proper prescribing and
dispensing practice in the hospital. This activity should be conduct ed quarterly. The results should be
communicated to the DTC for proper implementation and follow-up. Patients and their medicine therapy
should be monitored for:

11
Legality, legibility and completeness of Compliance treatment guidelines
prescription
Dose and route of administration
Appropriateness of prescription papers used
The appropriate duration of therapy
Appropriateness of the medication for the
Significant interactions
diagnosis
Duplication of therapy
Aggregate methods: ABC-VEN Analysis
ABC and VEN analysis are aggregate data methods that are used to identify medication use problems.
ABC analysis is a method for determining and comparing pharmaceutical costs within the formulary
system. It follows the Pareto principle of "separating the vital few from the trivial many". ABC analysis is
explained in terms of budget consumed and number of drugs in the budget list as follows:
Table 2: Criteria to classify pharmaceuticals into ABC category
S. N Category % of budget % of Explanation
consumed pharmaceuticals

1. A – pharmaceuticals 70-80% 10-20% High percentage of funds spent on large-

volume or high-cost items
Greatest potential for budget
Savings

2. B – Pharmaceuticals 15-20% 10-20% Moderate cost and moderate

number of items; important items

3. C – Pharmaceuticals 5-10% 60-80% Small amount of funds spent on

most of the inventory
VEN analysis
VEN analysis is a method that is used to classify pharmaceuticals into vital (V), essential (E), or
nonessential/less essential (N) as per their clinical importance. It should be included in the hospital-
specific medicine list. It is important that the health facility's DTC ensure that pharmaceuticals are
classified by VEN. This categorization should guide the forecasting, procurement, and inventory
management decisions of the health facility. The criteria for prioritizing pharmaceuticals in VEN are as
follows:
Vital (V)
Vital pharmaceuticals are very essential pharmaceuticals that fulfil one or more of the following criteria:
Potentially life-saving,
Patients may die, be harmed, or be disabled due to a lack of these pharmaceuticals.

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It is crucial to provide basic health services, without which it is impossible to deliver the basic services (in
their absence, service may be discontinued).
N.B.: It is mandatory for these pharmaceuticals always be available; any stock out is not tolerable.
Essential (E)
Essential pharmaceuticals are those that fulfil one or more of the following criteria:
Effective against less severe but significant illnesses (it is between vital and essential).
It is important to provide basic health services, without which patients can face difficulty.
May be somehow substituted.
Essential to the service, without which it is difficult to provide health services.
Nonessential (N)
Non-essential pharmaceuticals are less-essential pharmaceuticals that are:
Effective for minor illnesses and have a low therapeutic advantage
Necessary to provide the health service; however, health service delivery will not be discontinued in the
absence of these pharmaceuticals.
Note: Assignment to the non-essential or less essential category does not mean that the
Pharmaceuticals are no longer on the health facility’s pharmaceutical list.
Indicator study methods
In indicator studies, a selected indicator is set, and performance against this indicator is measured.
Indicators can be developed to assess prescribing, patient care, or facility practices. Table 3 presents
possible indicators that could be used for an indicator study.
Table 3: Selected indicator to assess prescribing, patient care and facility practices

Prescribing Indicators Patient Care Indicators Facility Indicators

Average number of medicines per Average consultation time Availability of essential

encounter medicine list or formulary
Average dispensing times
% of medicines prescribed by generic Availability of key set of
% of medicines actually
name indicator medicines
dispensed
% of encounters with an antibiotic Availability of standard
% of medicines that are
prescribed treatment guideline (STG)
adequately labeled
% of encounters with an injection
% of patients who know
prescribed
how to take their medicines
% of medicines prescribed which are
from the essential medicines list or

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 formulary list

Drug Use Evaluation (DUE) methods

Drug use evaluation studies measure the use of a specific drug and/or adherence to standard treatment
guidelines (STGs). Studies are particularly important to investigate:
Perceived overuse or underuse of medications,
Problems identified by indicator studies,
High numbers of ADRs,
Excessive amounts of non-formulary medicines used,
Use of high-cost medicines when less expensive alternatives exist, and
Use of excessive numbers of medicines within a therapeutic category
Problems identified by aggregate methods, indicator studies, and DUE studies may be further investigated
using the qualitative methods: in-depth interviews, focus group discussions, structured observations, and
structured questionnaires.
Medicine and Vaccine use and safety monitoring
Medication safety is a growing concern in today’s medical practice because patients are getting harm
because of medication errors, ADR, poor quality products, and system problems. Medication use and
safety monitoring include proper dosing, administration, and toxicity management of oxygen therapy.
Therefore, it is crucial to ensure patient safety through the implementation of safe medication use
practices. Each hospital should implement medication safety program, including ADE monitoring and
reporting, medication reconciliation activities, identifying high-alert medications, medication and vaccine
safety self-assessment, and implementing new and existing national standards and systems.
The detection of side effects and adverse reactions is important on an individual basis to optimize patient
care, prevent harm, and take any necessary action. DTC coordinate this activity, in cooperation with
pharmacy, medical, and nursing staff, and possibly other facilities. This shall include:
The identification and immediate reporting of adverse drug reactions to the prescribing physician and
pharmacy,
The investigation and validation of adverse drug reactions, including the collection of follow-up
information, treatment, and outcome,
Documentation in the patient’s health care record,
The regular reporting of adverse drug reactions to the Drug and Therapeutics Committee,
The regular reporting of adverse drug reactions to EFDA
The pharmacy department shall maintain current information about adverse drug reactions occurring
within the hospital and in the literature. All health care professionals should vigilantly monitor susceptible
individuals for ADR. A standardized form should be used to record and report ADRs (Annex 2). An

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online reporting form is also available on the EFDA website. An ADR focal person should be appointed
by the DTC. He or she is responsible for:
Ensure that all health professionals are involved in detecting, assessing, managing, and reporting potential
ADRs.
Ensure that ADR report forms are readily available in all clinical areas and that health professionals are
familiar with the form and how to complete it.
Receive ADR report forms from clinical staff.
Analyze ADR data and compile reports.
Provide regular reports to the DTC and hospital management on ADRs in the facility.
Report all ADRs to the regulatory body.
The DTC should receive regular reports from the ADR focal person and make any necessary decisions
regarding the use of the drug in the facility. Where necessary, the hospital formulary should be amended
to take account of detected ADRs. Suspected ADRs should be investigated and managed as follows:
Assess suspected ADR with respect to patient details, medicine details, and comprehensive adverse
reaction details.
Perform a causality assessment.
The ADR should be classified as:
Certain: a clear temporal association is established between medicine administration and the reaction;
and/or the results of investigations confirm that there is a relationship between the administration of the
medicine and the reaction; and/or the reaction recurs upon re-exposure to the drugs; and/or the reaction is
commonly known to occur with suspected drug;
Probable: the reaction is known to occur with the suspected drug, and there is a possible temporal
association between the reaction and medicine administration; and/or the reaction resolves or improves
upon withdrawal of the suspected medicine and other medicine therapy remains unchanged; and/or an
uncommon clinical event occurs in the absence of other potentially causative factors;
Possible: an alternative explanation for the reaction exists; and/or more than one medicine is suspected;
and/or recovery follows withdrawal of more than one drug; and/or the temporal association between the
reaction and administration of the medicine is unclear; or
Doubtful: another cause is more likely to have accounted for the clinical event, e.g., underlying disease.
Make recommendations on treatment options, including possible alternative treatments.
Document the ADR and provide follow up advice.
All ADRs should be clearly highlighted in the patient’s case notes. Any patient who has experienced an
ADR should receive advice about the drug and reaction, be advised to avoid the drug in the future, and be
given an ‘alert card’ that states the drug involved and the nature of the reaction. He or she should be
advised to show this card at any future clinical consultation to prevent the same drug from being
prescribed again.

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The hospital pharmacy section should complete the reporting form, retain the necessary documentation,
and also mail the ADR report to the regulatory authority, EFDA, as per the guidance provided.
3.3. Pharmaceutical selection, quantification, procurement, warehouse, inventory management,
distribution, and an effective information management system
To ensure uninterrupted supply of safe, effective, and quality pharmaceuticals, the hospital pharmacy
shall have an effective and efficient supply chain management system. This requires well-organized and
functioning pharmaceutical management information systems (PMIS). Pharmaceutical supply
management at hospitals involves the following basic functions: selection, quantification, procurement,
warehouse and inventory management, distribution, rational use, and information management.
Selection
Hospital pharmacies should have a DTC-approved list of medicines, medical supplies, equipment,
chemicals, and reagents categorized into VEN. The pharmaceutical supply management unit, in
consultation with the various departments in the hospital, selects the required medicines for procurement
as per the approved list.
Quantification and procurement
The pharmaceutical supply management unit should collect relevant data from past consumption,
morbidity, service delivery, and other relevant sources that are essential for forecasting and supply
planning. Data to be collected from these sources includes:
Consumption data: quantity of each product dispensed or consumed over the past 12-month period
Services data: number of visits, number of services provided, lab tests conducted, treatment episodes, or
number of patients on treatment over the past 12-month period
Morbidity data: incidence and prevalence of specific diseases or health conditions (may be available by
population group or through surveillance or research study groups and extrapolated to estimate national-
level incidence and prevalence of specific diseases or health conditions).
The hospital shall decide on an appropriate method for quantification. The commonly used methods for
existing facilities are consumption and morbidity methods. Based on the supply plan prepared, hospitals
procure pharmaceuticals in a way that ensures the principles of good pharmaceutical procurement practice
and procedures. All hospitals should have standard operating procedures for pharmaceutical procurement
that comply with national standards and legislation.
Pharmaceutical selection, quantification, and procurement should fulfil the following minimum standards:
Presence of annual pharmaceutical quantification (forecasting and supply plan) approved by DTC as per
the annual plan: This standard is met when
The hospital has approved a plan for quantification.
Professionals from all-important units are included in the quantification processes
There is a quantification report for the current year.

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There is a detailed supply plan for each product that shows when and how much is needed in each round
of procurement.
Approved by DTC and documented
The hospital reconciles the forecast with the available budget: This standard is met when the total
forecasted value is equivalent to the allocated budget. The allocated budget can be from internal revenue
or from treasury.
The hospital has SOPs and policies for quantification and procurement. Quantification and procurement
SOPs can be prepared as one SOP or separately. When there is any change, the SOPs should be amended.
The quantification SOP should include at least the following:
Selection standards
Methods of quantification to be used in the hospital with respective data sources
Time line for forecasting and supply planning
Professionals to be involved
Approved by DTC/management
In addition, the procurement management SOP should include at least the following:
Methods of procurement open tender, direct procurement, long-term agreements, etc.
Funding strategies
Approval by DTC or management
Responsibilities of each stakeholder involved in procurement (finance, supply chain management, and
others)
The hospital should assign a focal person who reports to the supply manager and is responsible for
Coordination of quantification
Working as secretary of the quantification committee
Updating supply planning
Conducting stock status analysis
The hospital procures all pharmaceuticals from the facility-specific medicine list. These standard
measures the number of pharmaceuticals procured from HFSML. All pharmaceuticals should be procured
from HFSML. If new medicine is to be procured, it should be approved by DTC. Once approved by DTC
and a minute is taken, it can be considered part of HFSML.
The hospital performs supplier fill rate analysis regularly: Supplier fill rate is the percentage of line items
filled against the requested quantity. There should be supplier fill rate reports for each procurement
conducted. This standard is met when there is a supplier fill rate report for at least the last three
procurements conducted. The report should contain the percentage of each product obtained, the
percentage of items in full supply (>= 80%), the percentage of items supplied from 50% to 80 be supplier

17
fill rate reports for each procurement conducted. This standard is met when there is a supplier fill rate
report for at least the last three procurements conducted. The report should contain the percentage of each
product obtained, the percentage of items in full supply (>= 80%), the percentage of items supplied from
50% to 80%, and the percentage of items supplied below 50% (categorized as full, sufficient, and low
supply).
The hospital should allocate at least 40% of its budget to pharmaceutical procurement. This standard
helps the hospital secure a sustainable supply of pharmaceuticals. It is measured by calculating the
percentage share of budget or funding allocated for pharmaceuticals from the total health care budget of
the hospital. 40% is the minimum standard expected, and it does not include the budget allocated for
capital item procurement (medical equipment budget).

Standardized medical store and inventory management system

There should be standard infrastructure, inventory, and warehouse management systems to ensure a
sustainable supply of pharmaceuticals. These should be accompanied by well-organized and functioning
logistics management information systems, regular stock status analysis, and timely decision-making. In
order to say a hospital has a standardized medical store and inventory management system, it should fulfil
the following minimum standards:
Fulfils at least 80% of medical store standards. The average percentage of the medical store standards
should be >/= 80%. This standard is measured using the assessment tool annexed (Annex 3). The
assessment tool should be posted in the medical store with an average store standard.
It should have approved store and inventory management. SOP: Hospitals should have a medical store
and inventory management SOP that describes at least:
Medical store standards
Internal distribution schedules and reports are required.
Lists of products to be distributed to each service delivery point
Medical store cleaning schedule
Responsibilities of personnel involved in medical store management (store manager, assistants, cleaners,
porters)
LMIS standards
Presence of updated bin cards (Annex 4): The quantity of all pharmaceuticals on the bin card should be
equal to the physical count at all times. To verify this, 10 products will be randomly selected, and their
actual quantity will be compared with the bin card balance. If the physical quantity for all the products
(10 items selected) is equal to the bin card balance, the hospital’s inventory accuracy is 100%; therefore,
the hospital gets a full mark. Otherwise, it will be calculated by multiplying the value given for this
standard with the quotient of accurate items divided by 10.
Implement IFRR in all dispensing and service delivery units (Annex 5):: This standard is fulfilled when:

18
The hospital uses standard IFRR to receive reports from all units; check for five reports submitted.
The hospital posted a schedule for IFRR submission; check for the schedule posted and adhere by
checking five reports.
All the information required is complete; see at least five random reports from different units.
Presence of all PMIS formats (Bin cards, RRF, IFRR, M-19 H, M-22 H): All formats required to record
pharmaceutical logistics data should always be available. The hospital should ensure the availability of
this format. This standard is fulfilled if all the forms listed above are available. For IFRR and RRF, the
availability of a soft copy can also be considered if it is in use.
Reports should be timely, complete, and accurate. RRF: This standard requires the availability of an RRF
report. Three recent RRF reports will be checked. The reports should be complete, timely, and accurate
(Annex 6):
All hospitals should conduct a physical count in the medical store every quarter. The availability of the
physical inventory report for the recent two quarters will be checked.
Conducts stock status analysis (SSA) every quarter and ABC/VEN analysis and reconciliation at least
once per year and uses them for decision-making. There should be an SSA with a possible intervention
report for the recent two quarters, an ABC/VEN analysis, and a reconciliation report for the last budget
year.
The SCM unit is a member of the DMAT (Disaster Management Assistance Team) team and has SOPs for
managing pharmaceuticals during emergencies and disaster management. Emergency and disaster
management require multidisciplinary teamwork.
Pharmaceutical emergency supply chain management system
Over the years, Ethiopia has had multiple epidemics, which have caused huge losses and continue to
affect the population, including the current COVID-19 pandemic. The response to COVID-19, which
saved lives and disabled people, is a recent and highly commended action by the country. This effort has
averted the loss of countless lives and contributed to the continuity of livelihoods and the economy.
However, the country does not have a strong emergency supply chain management system (ESCMS)
capacity to support all elements of logistic processes, including coordination of logistics activities,
material flow, inventory replenishment, and supply chain management. The country needs a robust ESC
system capacity to support all elements of logistic processes, including coordination of logistics activities,
material flow, inventory replenishment, and supply chain management.
Emergency supply chain management is a principle of supply chain and logistics operations as applied to
public health emergency preparedness and response, including the important logistic operations of
selection, quantification, procurement, and sourcing of public health emergency products as part of the
overall preparedness plans for public health emergency response. It also presents the management of
storage, distribution, and fleet management for public health emergency products, as well as waste
management and reverse logistic as related to public health emergency products.
During emergencies, supply chain management must prioritize stabilizing the critical supply chain of
medical goods, reviewing stockpile options, and identifying alternate supply chains for emergencies when
needed. Integrating the needs of supply chains into mitigation, response, recovery, and supply planning

19
and actions is key to improving supply chain resilience for health emergencies and ensuring the
availability of key goods and services. The emergency supply chain framework provides a broad
overview of the interlinked functions that support a one-health approach to the development of a plan for
the deployment of medical countermeasures during public health events. It is comprised of three broad
areas: people and processes; commodity planning and procurement warehousing; logistics; and
transportation. Stakeholders' capabilities along different dimensions of a supply chain, such as technical
expertise, personnel, warehousing, and information on the location of stockpiled commodities, funds,
transport, cold chain, and waste management facilities, shall be identified, properly documented, and
communicated to key implementers on a regular basis.
Coordination and collaboration among public health supply chain stakeholders and resource mobilization,
as well as monitoring and evaluation of emergency supply chain performance, are the cornerstones of
implementing effective emergency supply chain management. The goal of this implementation guideline
is to provide supply chain practitioners involved in the management of public health emergencies with the
basic knowledge, skills, and attitude required for the supply chain management of health emergency
products.
Therefore, it is important to strengthen the health ESCM system of Ethiopia to manage all the health and
health-related items necessary to respond to public health emergencies and ensure that the needed items
get to the point of care as quickly and efficiently as possible. So, strengthening Ethiopia's health ESCM
system will greatly enable it to manage all the health and health-related items necessary to respond to
public health emergencies and ensure that the emergency supplies get to the last mile as quickly and
efficiently as possible.
Implementing ESCM at the health facility level mainly focuses on building the capacity of four key
ESCM preparedness and response areas: people and processes, commodity planning, logistics and
transport, and response. It is mainly to strengthen the health facilities approach to emergency supply chain
preparedness and establish the key elements of emergency supply chain preparedness. It is a plan to
develop and strengthen emergency supply chain preparedness in Ethiopia with the objective of
establishing the health ESCM system to manage all the health and health-related items necessary to
respond to public health emergencies and ensure that the needed items get to the point of care as quickly
and efficiently as possible.
The core team for emergency preparedness and response will be able to:
Familiarize yourself with the core components of public health emergency operations management in
relation to emergency supply chain management.
Understand the basic concepts and framework of emergency supply chain management.
Apply the selection, quantification, procurement, distribution, fleet management, and rational use
activities during different stages of health emergency management. Use reverse logistics and waste
management principles for public health emergencies.
Emergency supply chain management at the facility level should consist of activities such as the
management of stakeholders, strategic planning, and assessment efforts to facilitate efficient and effective
responses in collaboration with other stakeholders.
It also has the following importance:

20
Reducing the loss of life due to a lack of medicines because of non-prepositioned products based on the
vulnerability index.
Increase the availability of life-saving health products for emergencies where needed.
Increase awareness of ESCM needs by the stakeholders and their coordination governance structure at all
administrative levels to increase preparedness for future epidemic or pandemic responses.
Used to design systems for humanitarian and emergency SCM, including stockpiling protocols to ensure
responsiveness to health emergencies.
Every hospital should try to implement functional ESCM by:
Availing a standard operating procedure for disaster supply management
Updating the list of medicines and supplies for disaster response regularly.
Presence of a disaster supply management response plan (a quantified list of medicines and supplies with
a budget)
Assigning a responsible workforce
Training necessary staff on disaster supply management systems and ESCM manuals
Pharmaceutical emergency kit management is used to encourage standardization of the drugs and
equipment used in an emergency; to permit swift initial supply from outside; to rationalize urgent requests
and responses; and to promote disaster preparedness by the provision of a kit that may be kept in
readiness as a stock of essential items. The composition of the kit should be based on epidemiological
data, population profiles, disease patterns, and certain assumptions borne out by emergency experiences
using the country’s emergency list and guidelines on management of specific health emergency
conditions.
The contents of the kits are frequently reviewed and updated to adapt to changing needs based on
experience in emergency situations.
The management of reverse logistics must consider not only transportation but also information
management and storage. To maintain transportation efficiency throughout the entire supply network,
reverse distribution must be carefully coordinated with the predominant downstream flow of
pharmaceuticals. Unused or overstocked emergency products should be redistributed to nearby health
facilities as per the internal resource sharing guidelines. Logistics personnel and facility heads of the
issuer and receiver health facilities are responsible for redistribution. Redistribution data should be
reported to the next higher level for planning and tracking the utilization of emergency commodities.
Monitoring and evaluation (M&E) is an integral part of the emergency pharmaceutical supply chain
management plan, which involves setting up systems to consistently review how the emergency supply
chain management response is progressing, point out areas that need improvement, and determine
whether the set goals are being met. It provides guidance for the gathering of timely, accurate, and
complete information for organizing, analyzing, reporting, monitoring, and evaluating performance;
promoting continuous improvement in the ESCM through timely identification; and addressing
implementation challenges. Moreover, it also allows ESCM stakeholders to know the impact of their
efforts and advocacy, as it can highlight program successes and areas of greatest need.

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3.4. Pharmaceutical cold chain and vaccine management
The cold chain is a system of storing and transporting vaccines and medicines at recommended
temperatures from the point of manufacture to the point of use. It includes all of the materials, equipment,
and procedures used to maintain vaccines in the required temperature range of +2 oC to +8 oC until the
product is administered to individuals. Products commonly stored in the cold chain system are vaccines,
glaucoma eye drops, aerosol sprays against asthma, insulin preparations, biological products, and others.
A vaccine is a biological preparation that provides active acquired immunity to a particular infectious
disease. Vaccines are temperature-sensitive and must be maintained at a temperature between 2 and 8 oC,
unless otherwise indicated. Potency is reduced every time a vaccine is exposed to an improper condition,
and it will become ineffective. This includes overexposure to heat, cold, or light at any step in the cold
chain.
Cold chain management policy/procedure
The hospital should have policies and procedures to monitor appropriate storage conditions for vaccines,
order and receive vaccines, report or recall damaged vaccines, and develop procedures to provide
orientation to new staff and others who are responsible for cold chain management. It should have
guidelines for safe waste disposal related to vaccines.
Therefore, the hospital should assign a responsible person and ensure the appropriate cold chain system
required for vaccine storage and transportation to maintain its efficacy. The hospital should have a SOP
for proper understanding and implementation of the cold chain system and fulfil the following basic
materials:
Ice-lined refrigerator or deep freezer
Cold boxes or vaccine carriers for transporting or storing vaccines
Ice packs to keep vaccines cool
Material to separate ice packs from the vaccines when using cold boxes (e.g., shredded paper, cardboard,
bubble wrap)
Digital, electronic, or mercury/maximum thermometer
Chart for recording daily temperature readings
The responsible person assigned to the cold chain system will:
Segregate the vaccines according to their optimum temperature categories as freeze-sensitive, heat-
sensitive, and light-sensitive, and store them to avoid any damage to the products.
Check vaccine vial monitor status as it is not to be frozen and thawed.
Prevent accidental unplugging of the refrigerator and connect the refrigerator to a dedicated electrical
circuit or attach it to a functional UPS.
Position the refrigerator in a cool area, out of direct sunlight or a heat source, and
Keep the refrigerator at least 10cm away from the wall to allow for adequate ventilation.

22
Ensure that all ice-lined refrigerators are fitted with the correct vaccine storage baskets.
Check as vaccines are not stored in a fridge door.
Store the vaccine in the center of the fridge (vaccines are not to touch the
back or sides of the fridge)
Record vaccine refrigerator temperatures twice daily, at the start and at the end of the working day
(Annex 7).
Should keep temperature logs on file for 3 years.
Should record any maintenance or repair work done on the fridge on the temperature log.
Should prevent the ice packs from coming into direct contact with the vaccine product.
Should update the bin card (vaccine ledger book) for products managed with cold chain
Ensure the presence of a cold chain management policy or procedure.
Ensure regular cleaning and the proper functioning of the refrigerator.
Should quantify the vaccine required and ensure the availability of sufficient cold chain storage systems.
should place freeze-watches or monitors in the coldest part of the fridge in every vaccine fridge that stores
freeze-sensitive vaccines.
Cold Chain Management Principles includes:
Store vaccines in a purpose-built vaccine or medication-specific refrigerator.
Nominate a staff member responsible for vaccine storage and cold chain management.
Ensure policies, procedures, and protocols are in place for vaccine management in the facility.
Develop procedures for orienting new staff and staff with new roles who are responsible for cold chain
management.
Ensure essential equipment is readily available for responses to cold chain breaches and power failures in
the facility.
Report temperatures outside the +2°C to +8°C range (excluding fluctuations up to +12°C, lasting no
longer than 15 minutes).
Follow the guidelines for using ice packs and gel packs and monitoring vaccines in coolers and cold
boxes as required during power outages.
Record the vaccine temperatures on the ‘Vaccine Cooler Temperature Chart’ when storing vaccines in a
cooler.
Perform vaccine storage self-audits at least once a year.
Vaccines arrangement in refrigerators

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In health facilities, refrigerators are used to store vaccines and diluents. Several types of refrigerators are
available, and the arrangement of items inside them varies according to the type of refrigerator. Vaccines
and diluents are stored in a dedicated refrigerator that is reserved for this purpose. In general, the
arrangement of vaccines in the refrigerator will take appropriate spacing and placement of the product to
maintain a good storage condition for easy utilization and monitoring of the products, as follows:
Put measles, BCG, OPV, yellow fever, meningococcal A conjugate, MR, MMR, and/or any other vaccines
not damaged by freezing on the top shelf.
Put DTP-HepB-Hib, PCV, IPV, Td, HPV, Rotavirus vaccine, HepB, and/or any other freeze-sensitive
vaccines on the middle or lower shelves.
Always arrange vaccines and diluents in such a way that it allows air circulation freely.
Arrange the boxes so that there is at least a 2-cm space between stacks.
Mark the cartons clearly, and make sure the markings are visible when the door or lid is opened.
If vaccines or diluents are supplied in individual containers (vials, ampoules, or tubes), use a plastic tray,
plastic box, or other arrangement to store the vaccines in an orderly fashion.
If diluents are supplied separately from the vaccine, store them in the refrigerator if there is adequate
space.
If there is no adequate space, move the diluents to the refrigerator at least 24 hours before they are needed
so they are cooled.
Place vaccines with VVMs that show the most heat exposure (darker squares) in a separate container in
the refrigerator, clearly marked "Heat-exposed vials—Use first".
If there are other vaccines of the same type in the refrigerator, the vaccines with the darkest squares
should always be used first, even if the expiration date is later than the vaccines with the lighter squares.
If an opened multi-dose vial will be used for the next session, the vials must be placed in a separate
container in the refrigerator that is clearly marked "Opened Vials—Use First."
Put water packs or plastic bottles full of colored water in the space below the bottom shelf, and this helps
stabilize the temperature if there is a power cut.
Table 4: Heat sensitive Vaccines

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Table 5: Freeze sensitive Vaccines

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DO NOT arrange the vaccines in the health facility refrigerator like this:
Never store non-vaccine products in vaccine refrigerators.
Do not open the door or lid unless it is essential to do so.
Frequent opening raises the temperature inside the refrigerator.
If there is a freezer compartment, do not use it to store vaccines and diluents.
Do not keep expired vaccines in the refrigerator.
Do not keep vaccines with VVMs that have reached their discard point.
Do not return reconstituted vials and open liquid vaccines without preservatives to the refrigerator.
Discard all these items immediately according to your national guidelines.

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Figure 2: Arrangement of vaccines in a refrigerator compartment
Specific rules for using front-opening refrigerators
Different types of front-opening vaccine refrigerators are used for storing vaccines. Figure below show
how a kerosene vaccine refrigerator or an electric front-opening refrigerator should be organized.

Figure 3: Vaccine and diluent arrangement in a front-opening kerosene vaccine refrigerator

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Note: In upright ice-lined refrigerators, there is very little variation in the temperature inside the
refrigerator compartment, so vaccines and diluents can be safely placed on any of the shelves. However,
in humid climates, there is a risk of condensation. Cartons and vials should be stored in plastic boxes with
tightly fitting lids to reduce the risk of moisture damage. Never store vaccines below the bottom shelf;
this area may be wet because it collects and drains the condensation from the roof and walls of the
compartment.

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Figure 4: Vaccine and diluent arrangement in a top-opening refrigerator without baskets

Figure 5: Vaccine and diluent arrangement in a top-opening refrigerator with baskets

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Monitoring of vaccine refrigerator temperature
To ensure good storage and distribution practices, effective, well-managed temperature monitoring and
record-keeping procedures are crucial. A standard manual temperature-recording pad or chart should be
available for each and every vaccine refrigerator. Readings should be taken twice a day (morning and
evening), seven days per week, including weekends and holidays, and for 30 days. Daily readings should
be taken from the same temperature-monitoring device each time. Recording temperatures provides
evidence that the refrigerator is being monitored and regular readings are being taken. These procedures
help to ensure that:
Vaccine quality is maintained throughout the vaccine supply chain.
Vaccines are not wasted due to exposure to heat or freezing temperatures at fixed storage locations or
during transport.
Cold chain equipment performs according to recommended standards.
Recognize and respond to temperature excursions, and take corrective action when problems occur.
To achieve these outcomes, the hospital should develop suitable policies and standard operating
procedures (SOPs) and provide adequate training, tools, supervision and resources to ensure that these
policies and procedures are properly implemented.
Vaccine vial monitors
A vaccine vial monitor (VVM) is a label containing a heat-sensitive material that is placed on a vaccine
vial to register cumulative heat exposure over time. The combined effects of time and temperature cause
the inner square of the VVM to darken gradually and irreversibly. The rate of color change increases with
temperature.
The inner square of the VVM is made of heat-sensitive material that is light in color initially and becomes
darker when exposed to heat. The inner square is initially lighter in color than the outer circle. It remains
so until the temperature and/or duration of heat reach a level that is likely to degrade the vaccine beyond
the acceptable limit. At the discard point, the inner square is the same color as the outer circle. This
indicates that the vial has been exposed to an unacceptable level of heat and that the vaccine may have
degraded beyond the acceptable limit. The inner square continues to darken as heat exposure continues,
until it is much darker than the outer circle. If the inner square becomes as dark as or darker than the outer
circle, the vial must be discarded. The pharmacist in charge should properly follow VVM and take the
necessary action accordingly.

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Figure 6: Vaccine vial monitoring criteria
Bin card update
The Bin Card should be kept with the product in the storage area. The staff in charge should record
transaction of vaccines and update bin cards, and maintained for each product. Bin Card should be used
to:
Record vaccine products received
Record vaccine products issued
Record changes in its stock balances
Track supplies moved through non-routine methods (e.g. Transfers)
Track losses/adjustments record expiry dates
Cleaning and defrosting of refrigerator
Frost formation is a sign of malfunctioning of the equipment, either due to incorrect setting
of the thermostat or incorrect operation of the equipment. Frost increases electricity
consumption and also makes the refrigerator less efficient. The accumulated frost must
be removed, i.e. the equipment must be “defrosted”. This requires technical intervention
as the vaccines are put to risk. It is recommended that the appliance be defrosted every
month or earlier if the frost thickness on the inner wall is more than 5 mm.
Therefore, to defrost the vaccine refrigerator
Transfer vaccines to a working refrigerator or cold box with conditioned icepacks
Turn off the power supply to the refrigerator
Leave the lid or door open and wait for the ice to melt

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Do not try to remove the ice with a knife or other sharp object
Doing this can permanently damage the lining
Clean and dry the inside of the appliance
Turn on the power supply to the refrigerator on again. When the temperature falls to +8°C or lower (but
not less than +2°C), return the vaccines, diluents, and/or cool water packs.
Maintaining functionality of refrigerator
The refrigerators functionality should be monitored and checked regularly
The refrigerator or freezer door seal should be regularly checked for signs of wear
Any dust residue should be cleaned from the unit’s coils and motor since it will cause the unit to work
inefficiently
Make sure all cooling fans both inside and outside the appliance move freely and clear of all dust
Check the appliances plug, make sure it is not broken, twisted up, melted or burnt looking
Be sure the units power cord and all other electrical connections are not worn out
Make sure all wires are secure and have no insulation stripped with exposed conductors showing
If any frost buildup is more than 1/4 inch thick , the refrigerator need to defrosted following the
manufacturers defrost instructions
Vaccine distribution
Distribution of vaccine requires the availability of appropriate vaccine cold chain transport equipment
such as cold boxes or vaccine carriers, and ice packs to prevent the damage of vaccine products due to
exposure to unnecessary heat, cold and light.
Cold Box
A cold box is an insulated box used for transportation and emergency storage of vaccines and ice packs.
Should be large enough to store vaccines and icepacks during transport
Used to store vaccines for transfer up to 5 days, if necessary for outreach sessions
Store vaccines in case of breakdown of ILR or when there is a power cut, as a contingency measure
It is also used for storing frozen ice packs, e.g. during emergencies and before campaigns
Its external surface material needs to be durable and robust
Lid needs to be tight fitting
Strong handles for carrying the cold box
A dedicated cool box should be used for each delivery
Packing a cold box

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Place conditioned ice packs at the bottom and sides of the cold box
Load the vaccines in cardboard cartons or polythene bags
Never place freeze-sensitive vaccines in direct contact with the ice packs
Keep a thermometer in the cold box
Place two rows of conditioned ice packs above the vaccine vials
Place a plastic sheet to cover the ice packs kept on top to ensure full holdover time
Securely close the lid of the cold box
Vaccine carrier
It is an insulated box used for carrying vaccines (16–20 vials) and diluents from the cold-chain point to
session sites and to bring back the open vials from the session sites to the cold-chain. Vaccine carrier
(with 4 conditioned ice packs) maintains the inside temperature between +2°C and +8°C for 12 hours, if
not opened frequently.
Packing a vaccine carrier
Confirm that there are no cracks in the walls of the vaccine carrier
Take out the required number of ice packs from the deep freezer and wipe them dry
Keep them outside for conditioning before placing into the carrier
Place four conditioned ice packs into the vaccine carrier along the sides
Wrap vaccine vials and ampoules in thick paper, e.g. plain white paper before putting in a polythene bag
so as to prevent them from touching the ice packs
Place the plastic bag in the center, away from the ice packs; this will prevent labels from peeling off from
the vials
Place foam pad on top of the ice packs
A foam pad is a piece of soft foam that fits on top of the conditioned ice-packs in a cold box or a vaccine
carrier
If more than one vaccine carrier is being carried, keep the whole range of vaccines required for the day’s
use in each carrier so that only one carrier is opened at a time
Ice packs
Ice packs are plastic containers filled with water. These are hard frozen in the deep freezer.
They are placed inside a vaccine carrier and cold box to improve and maintain the holdover time. They
are also used in ILRs as inside lining to improve and maintain holdover time during electricity failure.
Frozen ice packs must be used with extreme caution and not to be allowed to come into direct contact
with vaccines. Any spaces within the cool box should be filled with insulating material.
3.5. Medical Oxygen Supply management

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Medical oxygen is lifesaving and an essential element of appropriate management for a wide range of
clinical conditions. It can be used for the treatment of multiple acute and chronic cases related to
respiratory illness and other conditions, which include trauma, safe surgery, anesthesia, and obstetric care.
The ability to detect and treat hypoxemia is critical for patient care and the quality of services, especially
for children and neonates. As a life-saving medicine, oxygen should always be available at all hospitals.
Oxygen is vital to combat pneumonia-related mortality and morbidity in under-five children and for the
treatment of many emergencies.
Sustained and adequate availability of oxygen is required to ensure implementation of MOH initiatives,
including the Newborn and Child Survival Strategy, the Maternal and Neonatal Health (MNH) Road Map,
the Saving Lives Through Safe Surgery Initiative, the establishment of trauma centers, the strengthening
of emergency medical services, and the expansion of ICU services to realize the health sector
transformational plan.
Focal person and medical oxygen supply management Policy
A multidisciplinary group is responsible for the safe use of oxygen in the hospital. There are aspects of
these systems that fall under the responsibility of various professionals, including anesthesiologists,
pharmacists, nurses, engineers, maintenance personnel, and gas suppliers. The hospital should assign a
pharmacist from the PSM unit to coordinate oxygen supply and use activities. The hospital should also
have an oxygen supply management policy to guide the management of medical oxygen within the
facility. The policy should indicate the roles and responsibilities of the focal person and staff involved in
oxygen supply management. The policy should also include issues related to medical oxygen and related
devices inclusion in the medicine and medical device list, quantification and procurement of medical
oxygen and medical devices, handling, storage, distribution within the hospital, related recording
documents, and reporting.
The hospital oxygen supply management policy should include national standard systems in terms of
color coding, sizing, Paraphrase Text and units used.
Quantification and procurement
Proper oxygen delivery service requires the availability of medical oxygen and related oxygen devices.
Medical oxygen supply management should always ensure the availability of medical oxygen 24/7. To
ensure this, the hospital should include medical oxygen in its medicine list as a vital medicine and
quantify and procure it with other pharmaceuticals. The quantification and procurement should also
include consumable oxygen devices and ensure the availability of oxygen face masks (infant, pediatric,
and adult), nasal cannulas (infant, pediatric, and adult), oxygen T-pieces, oxygen tubing, oxygen
cylinders, oxygen concentrators, oxygen trolleys, pulse oximeters, oxygen regulators, oxygen analyzers,
flow meters, pulse oximeters, and other required devices. The quantification of oxygen requirement
should consider the expected number of patients that require medical oxygen in all departments of the
hospital, including emergency, inpatient, maternal, pediatric, etc. In addition, the quantification of oxygen
and its consumables should be done using the MOH quantification tool prepared for this purpose Oxygen
supplies are available in two different standards: industrial oxygen and medical oxygen. Medical oxygen
supply via cylinder includes the procurement of oxygen cylinders, their transport (both full and empty),
and their refill (Annex 8).
Medical oxygen is prescription medicines. The supply management of oxygen should ensure the
protection of the patients who need medical oxygen from cylinders. Medical oxygen provision companies

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that fill/refill medical oxygen cylinders should be registered by EFDA. These suppliers need to comply
with the required standards for medical oxygen. Proper pre-fill inspections, labeling, and testing should be
required. If the hospital is switching oxygen cylinders or suppliers, then it is susceptible to impure oxygen
due to the contaminants entering the cylinder. Due to the fact that all medical gases are considered
medicines which are only available by prescription, the standards with which they are governed are
strictly controlled by EFDA. The hospital should also establish its own standards on the handling and use
of compressed medical oxygen.
Monitoring patient’s response to Oxygen
Oxygen is expensive, so it should be used only in situations where it is necessary and discontinued as
soon as possible. Oxygen has potential risks if it is not administered safely and appropriately. Monitoring
the patient’s response to oxygen therapy is very important. To ensure the patient received an adequate
concentration of oxygen, an oximeter should be used according to the manufacturer’s instructions. The
content of cylinders should be checked, and how long they will last should be calculated. This is
especially important for cylinders on resuscitation trolleys and when transferring a patient. It is possible to
determine how long cylinders can last using the formula:
Time until the cylinder is empty = (Tank pressure (200) X cylinder conversion factor)/Flow rate (LPM)
Sources of Oxygen
The hospital should have a reliable oxygen source (preferably a central oxygen supply). The hospital
should ensure that a source of oxygen is always available. There are three main sources of oxygen. These
are oxygen cylinders, oxygen concentrators, and oxygen plant distribution systems.
Oxygen Cylinder: An oxygen cylinder is filled with oxygen under high pressure. An oxygen cylinder does
not require electricity; however, it requires a special regulator to control the flow of oxygen. It is
important to ensure that a backup cylinder is available in case the first cylinder becomes empty.
Oxygen Concentrator: An oxygen concentrator is a medical device that can serve as a reliable source of
quality, medical-grade oxygen for patients. It produces oxygen by extracting oxygen from the ambient air
and separating it from nitrogen.
Oxygen Plant:
Concentrated oxygen refers to oxygen that is a minimum of 90% pure with moisture removed to a 100-
degree Fahrenheit dew point. It can be produced from an oxygen concentrator or from a plant and
delivered in a pressurized cylinder bottle. Oxygen cylinders can be used stand-alone, in conjunction with,
or as backup for other sources of oxygen (e.g., oxygen concentrators). Oxygen cylinders can be an
alternative to oxygen concentrators; although concentrators can produce a constant flow of oxygen, they
do require intensive maintenance and a reliable power supply. Oxygen cylinders are also found in
ambulances for patient transport when oxygen is necessary.
Medical oxygen storage
Medical oxygen cylinders have to be stored in a dry and well-ventilated room. The room must not contain
flammable materials like fuel or paint, and it must always be locked. Different gases should be stored
separately. Mechanical assistance should be used when handling and it shouldn’t be rolled along the
ground. The person responsible for storing medical oxygen cylinders should ensure that cylinders are

35
stored and used away from sources of ignition. Smoking and open flames close to gas cylinders are
dangerous and are prohibited in and around this room. Warning signs in the local language should indicate
this. When medical oxygen cylinders are stored,
Always physically separate full and empty medical gas cylinders, even if they are in the same enclosure.
This can be done by using separate racks, physical barriers, or color-coding the storage rack.
Be sure to label the cylinders clearly (open, empty, full, or unopened). Staff should not have to spend
additional time trying to determine whether a cylinder is full, partial, or empty. Proper labeling from the
outset helps to avoid confusion and delay if a full cylinder is needed quickly; proper labeling could save a
life.
Consider any open cylinders "empty". Though it is perfectly reasonable to use partially filled cylinders,
these should never be stored with full or unopened ones.
The potential for fire risk must be considered when evaluating medical gas cylinder safety.
The amount of any medical gas, no matter its properties, must be monitored and managed when stored in
or near patient areas. The addition of concentrated oxygen to a fire greatly increases its intensity and can
even support the combustion of materials that normally do not burn.
Medical oxygen management information system (Bin card, IFRR, Monthly consumption tracking)
The hospital should record the stock status of oxygen using a bin card. Use the oxygen IFRR for internal
facility distribution (Annex 9) and the monthly consumption tracking chart for reporting medical oxygen
consumption every month (Annex 10).
Medical oxygen distribution
Medical oxygen can be stored in cylinders in either compressed or liquefied form. Medical-grade oxygen
could be manufactured on-site by establishing an oxygen plant or oxygen concentrator where ambient air
is extracted, compressed, and fed into a piped network in a health facility. The hospital could also get
filled medical oxygen cylinders from a nearby hospital that has an oxygen plant. Medical oxygen
cylinders could also be provided by licensed manufacturers who meet the quality controls established by
the EFDA.
An oxygen analyzer or meter should be present if oxygen is being sold or where oxygen concentrators
have to be maintained or repaired. Medical oxygen must be extremely pure; it has to correspond to
>99.995%. Be aware of the color coding of cylinders to avoid confusion between medical oxygen
cylinders and other compressed air cylinders (medical and nonmedical). It is also important to ensure the
quality of supply and that the product is not adulterated in the distribution system by meeting the agreed
specifications. When a gas cylinder is to be transported, the metal protection cap should always be
mounted. It protects the valve from tearing off in case the cylinder falls over. Oxygen cylinders shouldn’t
be transported in the passenger compartment of a vehicle.
3.6. Pharmaceutical waste management
Health commodities wastes are all wastes that are generated in the hospital while using health
commodities during diagnosis, treatment, immunization, compounding, and manufacturing of health
commodities. To protect patients, health workers, supportive staff, the community, and the environment,
handling, transportation, and disposal of health commodities wastes should be guided by regulatory

36
bodies' health commodities waste disposal guidelines. Each hospital should establish a health
commodities disposal committee comprised of representatives from pharmacy, finance/audit, and
sanitation services to ensure the proper disposal of health commodities wastes in accordance with the
country’s law. The DTC should prepare a SOP, which contains the schedule, methods, materials, and
equipment required for disposal that will be used by the committee. The SOP should also clearly identify
the responsible person for the proper management of health commodity waste, and the hospital should
work out activities to minimize pharmaceutical waste below 2%.
Hospital pharmacy and cleaning staff should be trained and well informed about the potential risks of
hazardous health commodities and their management.
The following key activities should be performed in health commodity waste management:
Segregate, count, record, and place separately all expired, damaged, or unfit for use health commodities
from the usable health commodities with registration in standard format.
Submit the segregated health commodities data to the management of the hospital to secure approval for
the disposal. It should be accompanied by lists of products to be disposed of clearly stating trade name
and/or generic name, strength (where applicable), dosage form, pack type and size, quantity, batch
number, expiry date, manufacturer, supplier, country of origin, and product price (Annex 11).
Sort the expired or unfit-for-use health commodities based on the pharmaceutical dosage forms.
Segregate and choose the appropriate disposal method. For those health commodities wastes that cannot
be disposed of at hospital level, the hospital shall submit disposal applications to central disposal sites,
respective suppliers, or licensed disposal firms and shall report or copy to the appropriate administrative
structure. In addition, it also requests approval for the disposal of medicine waste, except recyclable
materials, cartons, leaflets, and labels, by submitting applications to the appropriate organ.
The hospital should retain a signed and stamped certificate of disposal from the authorized body entitled
to dispose of the health commodities. Depending on the risk of health commodity waste and the
complexity of the disposal method, the hospital may use a disposal referral system. If that is the case,
disposal service applications to licensed disposal firms shall be filed.
Adjust the inventory management system for each disposed health commodity.
Methods of disposal of health commodities should be based on the directive of the national regulatory
body and supported by proper documentation, including the price of the products for audit and other legal
requirements.
3.7. Auditable pharmaceutical transactions and services (APTS) and good dispensing practices.
APTS is a data driven package of interventions designed to establish accountable, transparent, and
responsible pharmacy practice. It enables health facilities to optimize utilization of medicines budget,
improve access to medicines, and decrease wastages. APTS continuously monitors the number, mix &
performance of pharmacy workforce. It also improves pharmacy premise design and workflow. Through
improving recording and documentation, it generates reliable and consistent information for decision-
making. As a result, APTS improves overall quality of pharmacy services thereby increasing patient
knowledge and satisfaction. Ultimately it contributes to better health outcomes.

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APTS has five result areas: efficient budget utilization, transparent and accountable transactions, reliable
information, effective workforce development and deployment, and improved customer satisfactions. To
achieve these results, hospitals are expected implement selected interventions. The following list provides
guidance on what needs to be done to achieve each of these results.
Presence of dedicated pharmacy accountant and office with computer, shelves, file folders and
standardized premises to keep patient safety, privacy, and satisfaction are some of the five result and
verification criteria to measure APTS functionality.

Figure 7: Key result areas of APTS

Efficient Budget Utilization
Identifying the top diseases in the area and the medicines, supplies, and reagents used to treat them
Procurement should be conducted from the hospital medicine list.
The hospital should measure the waste rate of medicines on a monthly basis.
Developing an essential medicines list per health facility and identifying medicines by category (like a
master list) and by ABC/VEN matrix reconciliation analysis
Analysis: consumption to stock ratio (CSR) and stock status analysis (SSA) and using stock transfer,
resource sharing, and reverse logistics to reduce wastage and increase availability.
Result of efficient budget utilization is to improve availability and reduce misappropriations and wastage
rate.
Transparent and Accountable Transactions
The process of receiving, issuing, and dispensing pharmaceuticals in hospitals should be transparent and
accountable. Pharmaceuticals are received at the pharmacy store from EPSS and other sources. The
pharmaceuticals received by the store are issued to dispensing outlets. From the dispensing outlets,
medicines are dispensed to patients in cash, for free, or on credit. All transactions should be conducted

38
using legally approved and pharmaceutical-specific models, sales tickets, and dispensing registers. The
flow of pharmaceuticals from distributers to end users in the hospital shall include:
Receiving
All pharmaceuticals (medicines, lab reagents, medical supplies, and equipment) should be received and
managed by the hospital Pharmaceuticals Store. Pharmaceuticals need to be physically inspected before
receiving. In physical inspection, the store manager and supply management officer make sure that the
products received are as per the list, quantity ordered and expected quality. Once pharmaceuticals are
received, inventory records are immediately updated. Pharmaceuticals should be requested using standard
format (RRF) from EPSA every two month.
Issuing
Each dispensing unit should have an agreed-upon list of pharmaceuticals, including the maximum (one
month) and minimum (two weeks) quantities to be stocked in the dispensing unit. The stock list of each
dispensing unit should be approved by the pharmacy head. Each dispensing unit should maintain bin
cards for all pharmaceuticals in the unit, with shared responsibility by bin owners.
Dispensary transactions and billing
The provisions of the Health Care Finance Reform Legislation enable hospitals to raise and retain
revenue. The sale of pharmaceutical products is an important source of hospital income. Except for
exempted health program (immunization, TB, leprosy, ART, and MNCH), pharmaceuticals can be sold at
a price that covers the actual cost of the medicine plus a service charge. Transparent and uniform
procedures should be established for setting the sale price of each pharmaceutical and for recording sales.
The retail price of each pharmaceutical should come from the store when issuing vouchers (model
22/health). Each dispensing unit should sell pharmaceuticals at the stated price. All pharmaceuticals
should be dispensed or sold using a standard sales ticket designed for the purpose and approved by the
Federal Ministry of Finance and Economic Development or the respective regional finance bureaus. The
pharmacy professional is responsible for recording each medicine with full descriptions, uniquely
identifying codes, and retail prices on the intended sales tickets or free registers. The pharmacist also must
record all services provided, DTP identified by prescription evaluators, and counseling made for clients.
The pharmacy accountant summarizes all transactions (financial value, dispensed medicines, and
services) on a daily basis and prepares a report on a monthly basis as per the APTS guidelines. Auditors,
in collaboration with pharmacy professionals and DTC members, should use the document for auditing
the above transactions and improving the service. All activities should be performed using the following
legal framework and tools:
Enacted legal frameworks, APTS regulations, directives, and guidelines.
Tools: vouchers (Model 19 health and 22health), sales tickets, and registers; price control sheets, IFRR,
and RRF.
Bin ownership, role, and responsibility of professionals for controlling medicines and using physical
inventory sheets (before, during, and after) by using the best experience of IDA (international dispensary
association) principles
Unique identifier (base code) for professionals and auditors

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Auditing tools: beginning, received, issued, transferred, expired, and ending stock
Pharmacy Organization, Workflow, Workload Analysis & Deployment
All hospitals should develop detailed job descriptions for all staff in the pharmacy department. The level
of effort for each unit should be measured, and the workload should be calculated. Based on the
workload, hospitals should take subsequent measures.

Figure 8: Pharmacy patient flow arrangement in APTS implementing health facilities

The following assumptions are used for workload analysis for OPD pharmacies:
For dispensaries, 1000 prescriptions (or 1800 counseling episodes) per pharmacist per month
For clinical pharmacy services in wards, there are 25, 30, and 35 beds per pharmacist per day for tertiary,
secondary, and primary hospitals, respectively.
For chronic pharmacies, 30 prescriptions per day per pharmacist
The accountants’ practical experience showed that 5000 patients per month
For cashiers, the number of patients served by one cashier at a dispensary is up to 500 per day.
The pharmacy model for chronic patients is designed to serve them in a special counseling room that has
a table height of 0.75 meters and chairs for both pharmacists and patients.
Improved Pharmacy Service and Satisfaction of patients and professionals
The eventual success of hospital pharmacy service is to meet client demand and improve their satisfaction
through improved availability of medicines and quality pharmaceutical services. Dispensing workflow
arrangements and providing a one-stop-shopping service enhances client convenience and reduces
waiting time. Regular workload analysis and human resource deployment enable efficient manpower use
and reduce patient waiting times. This and the other create an environment whereby patients are
empowered to properly adhere to prescribed medicine by improving their knowledge and satisfaction.
Improved availability and patient knowledge on the correct dosage will increase satisfaction.

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Workflow: Entrance door (Rx evaluator, cashier, counselor) and exit doors
Rx evaluator and biller, cashier, and medicine use counselors; all in one queue, and one-stop shopping
service (in one workplace)
Increase care time and reduce waiting time.
Very suitable for both patients and professionals.
Improve patient satisfaction with good patient knowledge on the correct dosage.
Reliable Information for Decision Making
All hospitals should produce reliable information on products, financial values of medicines transacted,
and pharmaceutical services rendered on a monthly basis. The pharmacy report should be linked to the
serial numbers of financial tools for ease of documentation, reference, and validation. Information
concerning the financial values includes the value of medicines sold in cash, on credit, or for free.
Service-related information includes the total number of patients served per health facility, per dispenser,
per month, segregated by service type, which may include services rendered for paying, credit, and free
patients; outpatients, inpatients, and emergency patients; mothers and children; patients with chronic
illnesses; patients taking medicines for OIs; and so on.
This information should be used for decision-making. Hospitals should also use product information like
consumption-to-stock ratio analyses, availability of medicines for the top ten diseases, rate of expiration,
and affordability to take subsequent measures for improving services.
Generate monthly financial reports in cash, credit, or for free.
Generate a service report that indicates the number of patients served per health facility and dispenser per
month, segregated by service type and unit.
Generate information on stock and consumption analyses, availability, and affordability of medicines.
Use reliable information (referring to the serial number of receiving, issuing, and dispensing tools) for
service and financial reports so that it can be used for decision-making.
Good Prescribing and Dispensing Practice
Good Prescribing and dispensing practices provided by health professionals have a crucial role in
promoting rational drug use, ensuring treatment outcomes, and hence saving lives. For better patient
outcomes, the prescriber should identify the patient’s problem, define effective and safe treatments, select
appropriate drugs, dosage, and duration based on national standard treatment guidelines (STG) or
protocols, and then write a clear prescription. The hospital should ensure the availability and utilization of
STG among prescribers. Continuous monitoring and evaluation of adherence to STG should be done.
On the other hand, good dispensing practice is the delivery of the correct medicines to the right patient in
the required dosage and quantities in a package that maintains acceptable potency and quality for the
specific duration with clear labeling and drug information. In order to provide quality dispensing services,
the dispensing unit has to be equipped with the necessary facilities, and the premises should allow a
logical flow of the dispensing process so that it reduces waiting time, ensures patient knowledge,
convenience, safety, and confidentiality, and ultimately achieves better patient satisfaction. For these,

41
reference materials like STG/formulary/protocol, facility-specific medicine lists, and dispensing aids like
tablet counters, cutters/scissors, medicine envelopes, markers, and other labeling materials should be
available at all dispensing outlets.
As part of the outpatient pharmacy service, oral solid dosage forms reconstitution services should be
provided. Oral powders for suspension, dispersible tablets, and oral rehydration salts are the major
categories of medications that need reconstitution before administration. It helps to ensure that a safe and
clean solvent is used and minimize errors in reconstituting the medicines to a negligible level so that
adverse effects and treatment failure risks due to under- and over-dosing from incorrect reconstitution
practice by careers and patients at home could be avoided. During reconstitution, the dispenser should
properly demonstrate how to reconstitute powder forms and dilute dispersible table to the patient or
career. After the reconstitution, the first dose should be administered in the pharmacy with appropriate
counseling and labels.
The dispensing process involves stepwise activities. These are: interpretation and evaluation of
prescriptions; selection and manipulation; labeling and packaging; counseling of patients on appropriate
use of medicines; recording of information; and filing of prescriptions.
The dispensing process involves stepwise activities. These are: interpretation and evaluation of
prescriptions; selection and manipulation; labeling and packaging; counseling of patients on appropriate
use of medicines; recording of information; and filing of prescriptions.
Step 1: Receiving, validation, interpretation and checking appropriateness of a prescription
The pharmacy professional receives prescriptions in a professional manner, validates them for
completeness, legality, and legibility, and evaluates any drug therapy problems using the standard
checklist (Annex 12). Then, the pharmacist confirms the appropriateness of the drug choice, dosage form,
strength, dose, frequency, and duration of treatment with the diagnosis. The pharmacist is also required to
identify any medicine interactions, contraindications, ADRs, and treatment duplications, paying special
attention to pregnant mothers and children. He or she also monitors the utilization of standard prescription
paper.
Orders received by word of mouth or through the telephone for emergency cases should later be endorsed
by the prescriber and documented in writing. During receipt of a prescription, the pharmacist should
identify the patient, the prescriber, and the entity responsible for payment (as applicable). Any problems
identified should be discussed, and solutions should be solicited in consultation with the prescriber,
pharmacists, and patient.
Step 2: Billing and recording of transactions
The pharmacy professionals should perform the necessary calculations related to the quantity and cost of
medicines to be dispensed. Medicines dispensed should be recorded and documented as proof of the
transaction between the patient and the pharmacy professional. Prescriptions can therefore be traced back
if any need arises. Billing and recording of transactions (products and services) should be conducted using
standardized records (seriously numbered sales tickets and registers). For drugs that are not available in
the pharmacy, those items should be copied on a blank prescription and signed by the dispenser with the
word ‘copied’ on the prescriber’s signature space or using a transcription paper copy. On the original
prescription, this is retained by the pharmacy, a “mark should be placed adjacent to those items that have
been dispensed and an “X’ for items that are not dispensed?

42
In addition to standard documentation practice, in specialty pharmacy outlets such as ART, chronic care,
and other pharmacy outlets, specific service records should be maintained. For instance, patient
information sheets (PIS), patient tracking charts (PTC), and ARV drug dispensing registers should be
properly recorded and updated in the ART pharmacy; similarly, it will be for chronic and other services.
Step 3: Selection, manipulation or compounding of medicines:
Medicines should be selected carefully with a prescription at hand. The counting of tablets and capsules
should be done on a clean counting tray. Cross-checking the name, strength, and dosage form of
prescribed medicines with the container should be done at least twice to minimize errors during
assembling the medicines. Compounding of extemporaneous preparations should be done in a separate
room with the appropriate staff, equipment, and procedures (see the compounding section).
Step 4: Packaging and labeling of medicines
The packaging materials for dispensing medicines must maintain the quality and potency of the
medicines. It should be protected from moisture, light, and contamination. All medicines to be dispensed
should be labeled, and the labels should be clear, legible, and indelible. Printed labels are advisable for
patient safety. The label should at least indicate the patient's name, the generic name of the product or
active ingredients (for compounding), strength and dosage form, dose, frequency, route of administration,
and duration of treatment (Annex 13).
Step 5: Provision of medicines with counseling to a patient:
All drugs should be dispensed with adequate and appropriate information and counseling. Information
must be structured to meet the needs of individual patients. Written information should be provided to
supplement verbal communication. Counseling should ensure that the patient has an adequate
understanding of the instructions and any distinct characteristics or requirements of the medicine. The
pharmacist should confirm that the patient has understood at least the dose, frequency, duration, and route
of the dispensed medications (Annex 14).
Step 6: Filing the prescription
Each prescription (signed by the prescriber, evaluators, and counselors) should be filed properly.
3.8.Clinical pharmacy services
Clinical pharmacy services are patient-oriented services developed to promote the rational use of
medicines and, more specifically, to maximize therapeutic benefits, minimize risk, and reduce cost.
Clinical pharmacists are responsible for managing medication therapy in direct patient care settings
(inpatient, outpatient, emergency, and other departments). They assess patients to identify drug therapy
needs and problems, propose care plans, recommend choices, and hence contribute to therapeutic
decisions, thereby improving treatment outcomes. The service should be well integrated with all clinical
departments.
Clinical pharmacy services are provided based on pharmaceutical care principles. The delivery of
pharmaceutical care involves the following logical processes:
Assess the patient’s medication therapy needs and identify actual and potential drug therapy problems
(DTP).

43
Develop a care plan to resolve and/or prevent the DTPs.
Implement the care plan.
Evaluate and review the care plan.
Assess the patient’s medicine therapy needs and identify actual and potential drug therapy problems
(DTP)
A drug therapy problem is any undesirable event experienced by a patient that involves, or is suspected to
involve, medicine therapy, including medical oxygen, and which interferes with the achievement of the
desired goals of therapy. Through assessment, the pharmacist establishes the existence of any therapy
needs or problems with the drug therapy by interpreting information collected from patients, careers,
medical records, and other healthcare professionals.
Develop a care plan to resolve and/or prevent the DTPs
At this step, the pharmacist determines how to manage the patient’s medical conditions successfully with
pharmacotherapy. The pharmacist establishes the goals of therapy by negotiating and agreeing upon
endpoints and a time frame for pharmacotherapies. Then appropriate interventions are determined to
resolve DTPs, achieve goals, and prevent new problems by considering therapeutic alternatives and
selecting patient-specific pharmacotherapy, patient education, and other nondrug interventions. Finally, a
schedule is established for follow-up evaluation that is clinically appropriate and convenient for the
patient. The responsible clinician should be informed and agree on the plan before implementation. In
developing the care plan, the pharmacist should ensure that the patient is well informed of the process
being undertaken.
Implement the care plan
The pharmaceutical care plan is implemented with the patient's agreement and within the context of the
patient's overall care, in cooperation with other members of the health care team.
Evaluate and review the care plan
At this step of the pharmaceutical care process, the pharmacist evaluates the effectiveness and safety of
pharmacotherapy and makes a judgment as to the clinical status of the condition being managed with
pharmacotherapy. Patient compliance is also assessed, and new DTPs are identified, if any. Finally, the
next follow-up evaluation is scheduled.
Although all patients benefit, it is necessary to select patients who would benefit most from a
pharmaceutical care plan. Hence, the following group of patients should be considered:
Those with multiple conditions or drugs
Those whose age, weight, or clinical state may affect drug PK and PD
Patients taking medicines known to have a high risk of toxicity
Patients taking medicines with a narrow therapeutic index
Patients taking medical oxygen therapy
Patients taking medicines that may interact

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Patients whose therapy is changed frequently
Patients who have an advanced disease state and/or develop complications
Patients who failed to respond to initial therapy and continue to deteriorate
During the provision of clinical pharmacy services in the inpatient setting, the following activities need to
be performed:
Admission medication history taking
Using an in-patient medication profile form (Annex 15), a pharmacist working in a specific ward will be
responsible for taking the admission medication history either together with the admitting physician or
independently. The information collected during the process will be documented in a patient chart so that
it will be an input for subsequent decision-making for the MDT.
Admission medication history includes, but is not limited to:
Pertinent patient demographics
Past or current medications (prescription drugs, including medical oxygen, over-the-counter drugs, herbal
medicines, or supplements)
Any known drug allergy (KDA)
Adverse drug reactions
Overall patient adherence to therapy
Social habits
Immunization status for a child and pregnancy status for women
Patient monitoring and follow-up
The pharmacist shall be responsible for monitoring the outcome of drug therapy from effectiveness and
toxicity perspectives for admitted patients based upon relevant laboratory data, radiological findings,
physical findings, and subjective findings and documenting it on the pharmaceutical care progress note
recording form (Annex 16) in a patient chart. These include:
Assess whether the goals of therapy are achieved or not.
Identify existing or potential adverse reactions and/or treatment failures and recommend management
approaches.
Identify drug incompatibilities and interactions with clinical significance and discuss potential solutions.
Apply pharmacokinetic dosing principles to the dosing of selected drugs, such as the IV to PO switch.
Ward rounds, morning sessions and seminars
The pharmacist should actively engage in ward rounds, morning sessions, and seminars to contribute to
patient care decisions. These activities are performed both as part of the multidisciplinary team (MDT)
and as pharmacy-only activities. In pharmacy-only rounds, the pharmacists are also expected to

45
communicate with patients and provide patient medication counseling. They will also participate in grand
rounds and death reviews.
Medication reconciliation services
Medication reconciliation is the standardized process of obtaining a patient’s best possible history and
comparing it to admission, transfer, or discharge medication orders to prevent errors of transcription,
omission, duplication, interactions, and other medicine-related problems. It involves documenting
discrepancies identified between the medication history and current medication orders and how these
discrepancies were resolved.
All patients should have their medication reconciled as soon as possible after admission or presentation. If
medication reconciliation cannot be completed for all patients, priorities the patients most likely to obtain
maximum benefit. The service should be documented using the medication reconciliation form (Annex
17).
Drug information provision
As part of the routine clinical pharmacy service provision in the inpatient setup, pharmacists should
provide verbal and/or written drug information timely. If the service is given proactively or when asked
for by the healthcare team, it should be recorded appropriately (Annex 18).
Discharge medication counseling
Pharmacists need to be involved in discharge planning and provide medication counseling to ensure
continuity of care after patients is discharged from the hospital. Using the in-patient medication profile
form, the pharmacist will record discharge medications and counseling provided. Discharge medication
counseling includes, but is not limited to:
Informing the name of drugs by showing each (if applicable), dose, frequency, and specific time of
administration, how to administer if a skill is needed, etc.
Clear benefit and outcome of each drug therapy, expected major side effects from drugs and what to do in
the event of their occurrence, pertinent drug-drug and drug-dietary interactions, warnings if any, storage
conditions, etc.
Documentation of clinical pharmacy services
Clinical pharmacy services should be properly documented in standard formats, and relevant reports
should be produced. Documentation ensures continuity of care, and failure to document clinical pharmacy
activities adversely affects the quality of care provided to the patient. The formats include:
Inpatient Medication Profile Form
Pharmaceutical Care Progress Recording Form
Medication Reconciliation Form
Clinical Pharmacy Intervention Daily Summary Form
Clinical Pharmacy Intervention Monthly Summary and Reporting Form

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The first three forms should be part of the patient's permanent medical record (patient chart). All patients
with chronic illnesses who have a follow-up in the hospital should have a patient medication profile form
(PMP) for documentation. The PMP should be retained in the pharmacy and updated by the dispensing
pharmacist whenever drugs are dispensed to the patient.
The PMP can be in hard copy or computerized with hard copy backup and should contain the following
information:
Name of the health institution, Description of all medicines
Patient medical record number Reason for any changes made in the patient's
regimen
The full name, sex, age, and weight of the
patient, Name or initials of the prescriber and
prescription number
The address of the patient
Dispensing and/or prescription date
Diagnoses and concomitant diseases
Appointment or refill date, and
History of adverse drug reactions
Signature of the dispenser
PMPs should be filed sequentially by medical record number or alphabetically by patient name in chronic
care pharmacies. When a patient presents to the pharmacy for a refill, the pharmacist must assess the
patient for signs of compliance, effectiveness, and safety of therapy. The pharmacist should identify areas
for therapeutic modification and refer to the prescriber when appropriate.
Unit dose dispensing in ward pharmacies
Evidence shows that the unit dose dispensing system is the most cost-effective of all pharmacy
distribution systems. Through the establishment of ward pharmacies (at medical, pediatric, emergency,
ICU, gynecology, surgery, etc.), a unit dose dispensing system shall be implemented to reduce drug
wastage, improve drug availability, efficiently use pharmacy and nursing staff, and promote rational drug
use.
A unit dose system is characterized by providing 24-hour supplies in a single dose package in a ready-to-
administrate form, and pharmacy-specific documentation will be retained. In this system, the pharmacist
reviews all medication orders written by the physician (patient chart) and brought to the ward pharmacy
by the nurse. Then the pharmacy professional prepares the medication needed for a 24-hour period and
makes it ready to be taken to patient care areas by the nurses. Before administering each dose, the nurse
compares the medication label on the drug product with the appropriate medication administration record
(MAR). The nurse then administers the dose to the patient and records the fulfillment of the order on the
MAR. The hospital should also measure the functionality of its clinical pharmacy service.
3.9.Drug Information Services
Due to the vast number of medicines and the information related to them, it would be very difficult for the
health professional to search for all credible sources of information and use them in routine practice.
Hence, access to authoritative, unbiased, and well-referenced drug information is fundamental for the
rational and effective use of drugs.

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All hospitals should establish a drug information center (DIC) and provide the service to health
professionals, patients, and the public. The service generally responds to drug information queries. It also
provides education and training to health professionals and/or the public regarding the appropriate and
safe use of medicines. Regular drug information publications, such as drug alerts, newsletters,
monographs, and therapy updates, shall be prepared and distributed to keep the health care team up-to-
date. The hospital shall also provide poison information services.
The DIC should have a dedicated room that has sufficient space and appropriate furniture and equipment,
including a telephone, computer, printer, filing cabinets, and internet access. The DIC should have a
current collection of authoritative national and international reference materials such as books, journals,
guidelines, formularies, and databases. Appropriately skilled drug information pharmacists who trained in
the provision of drug information should staff the DIC.
The operations of the drug information service should be guided by appropriately formulated standard
operating procedures (SOPs) and guidelines prepared in line with national documents. The guidelines and
SOPs should be established for receiving and answering drug information queries, developing and
distributing educational materials and information publications, documentation activities, and education
and training activities. It also needs to guide monitoring and evaluation activities, participation in other
clinical pharmacy services, supporting DTC activities, and conducting research. The center is a resource
for the DTC's hospital medicine list and STG preparation and revision. The DIC should be open during
normal working hours. The services provided by the center should be documented in standard formats
prepared for this purpose. The hospital should also measure the functionality of its DIS activities.
Educating patients on the rational use of medicines through different mechanisms is a crucial activity of
the DIC. Patients need to be given appropriate information about the medicines they use to achieve
optimum adherence, which results in better treatment outcomes. Medicine use education is needed so that
people have the skills and knowledge to make informed decisions about how to use and store medicines
and to understand the role of medicines in health care and their potential benefits and risks. All relevant
staff members of the pharmacy department should be involved in the provision of education for the
patient as appropriate. Under the hospital health education program, the unit should have a weekly
breakdown of topics assigned to responsible pharmacists.
The DIC should develop an annual action plan for each activity, which should be communicated to the
head or director of the pharmacy department. All services provided should be documented, and a
performance report should be sent to the head of the pharmacy department regularly.
3.10.Compounding services
A hospital pharmacy should prepare non-sterile preparations such as prescription-based ointments,
creams, solutions, lotions, pastes, and bulk preparations (e.g., alcohol-based hand rubs, hydrogen
peroxide, alcohol of different strengths, gentian violet), which are not available commercially but are
needed for patient care. Small-scale manufacturing of sterile preparations such as intravenous fluids,
admixtures, and total parental nutrition should also be initiated, depending on the needs of the hospitals
and their feasibility. Both sterile and non-sterile preparations in the hospital should fulfill efficacy, safety,
and quality parameters. In order to produce quality-assured compounded products, good compounding
practice (GCP) should be implemented. These can be achieved by following the key principles of GCP.
These are:
Personnel are appropriately trained and qualified to perform their assigned duties.

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Compounding raw materials of appropriate identity, purity, and quality should be used, properly stored,
and labeled according to manufacturer recommendations.
All equipment used in compounding should be cleaned, status labeled, properly handled, regularly
calibrated, and used appropriately.
The compounding environment should be clean and suitable for its intended purpose.
A system must be in place to reduce any risk of contamination or cross-contamination.
A quality control (QC) and assurance system must be in place.
All aspects of compounding must be appropriately documented.
Besides, standard operating procedures and protocols that guide the preparation of the products should be
prepared. The compounding should also be done by pharmacists who have been trained in the
compounding service. The hospital should ensure the fulfillment of key equipment used for compounding
services (Annex 22) and follow its compounding services using compounding service functionality
criteria.
A proper compounding process should be followed to ensure GCP. The compounding process includes
preparatory work, compounding, a final check, sign-off, and cleanup. The room should be segregated in
such a way to facilitate the compounding process effectively. Accordingly, the room should be
categorized as weighing and measuring, compounding, quality control, and cleaning areas.
Electrical supply, water supply, lighting, temperature, humidity, and ventilation shall be appropriate such
that they do not adversely affect, directly or indirectly, either the products during their compounding or
storage.
Good documentation practice constitutes an essential part of the quality assurance system and, as such,
should be related to all aspects of GCP. A compounding record should be kept of all compounding
activities. Further guidance and a sample format for recording the compounding process and
compounding prescription register are presented in (Annex 23 & 24), respectively.
3.11. Antimicrobial Stewardship Program (ASP)
The cause of antimicrobial resistance (AMR) is complex and multi-sectorial. Inappropriate use of
antimicrobials is a key contributor. Tackling AMR requires a multi-sectorial response. Optimizing the use
of existing antimicrobial agents through the implementation of antimicrobial stewardship program in
hospital settings is pivotal to overcoming the threat. Antimicrobial stewardship is defined as a coherent
set of actions that promote the responsible use of antimicrobials. The main objectives of antimicrobial
stewardship include optimizing the use of antimicrobials, promoting behavior change in antimicrobial
prescribing and dispensing practices, improving quality of care and patient outcomes, and saving on
unnecessary health care costs.
Establishing ASP in hospital setting
The management should give due emphasis to the establishment and functionality of the ASP program in
the hospital setting. Hence, the management should be committed to organizing an ASP team that will be
accountable to the Chief Clinical Director. The management also secures the required resources (human,
financial, and information technology) for ASP implementation. The ASP team will operate in

49
collaboration with the DTC, IPC, patients’ safety team, and other hospital initiatives to enable a holistic
and coordinated approach to implementing antimicrobial stewardship program strategies. The hospital
should also measure the functionalities of its ASP activities regularly (Annex 25).

Membership of ASP team

The hospital ASP team is multi-disciplinary, and it includes: an infectious diseases’ physician (preferred if
available), an internist, a general practitioner, a clinical pharmacist, a clinically oriented pharmacist, a
pharmacist, a microbiologist, a clinical laboratory technologist, a nurse representative, a quality control
and patient safety representative, an IPC focal or representative, etc.
To operationalize the ASP team, there should be a guiding document (terms of reference or TOR) that
shows the collective and individual contributions and communication to meet the objectives of the team.
The TOR consists of the following at a minimum: background, purpose of the ASP Team, scope of the
team, roles and responsibilities of the team, membership and governance, members of the team,
accountability, and terms of service. The TOR should be reviewed by each member and secure approval
from the hospital management.
The ASP team is chaired by the hospital’s chief clinical director and co-chaired by the hospital pharmacy
head. The roles and responsibilities of the ASP leads (chair, co-chair, or secretary) should be reflected in
their respective job descriptions. Furthermore, all members of the stewardship team should be officially
appointed with a copy of the TOR.
Roles and responsibilities of ASP Team
The ASP team is responsible for developing, implementing, and managing the ASP in the hospital. These
include developing and maintaining antimicrobial policies, procedures, clinical pathways, formulary
restriction, and approval processes; overseeing interventions and educational strategies for clinical staff;
and ensuring appropriate monitoring, reporting, and feedback of AMS processes and indicators to relevant
hospital staff as per the guidelines.
Establishing/strengthening ASP in hospitals
Establishing and strengthening an antimicrobial stewardship program requires the identification and
prioritization of interventions following a stepwise approach as stipulated in the national guideline. These
include:
Undertake a facility AMS situational analysis:
Establish a sustainable AMS governance structure based on existing structures:
Prioritization of AMS interventions based on situational analysis: Start small, select relevant and feasible
activities (low-hanging fruit) to build motivation, and gradually expand coverage and types of AMS
activities, which may include:
Review or adapt national policy documents or guidelines for facility use (e.g., develop or update facility-
specific medicine lists that incorporate WHO AWaRe categorization).

50
Conduct point prevalence surveys; audit antimicrobial prescriptions; collect and analyses data; and
provide feedback on antimicrobial consumption, adverse drug reactions, or compliance with guidelines.
Select some common issues to address and improve antimicrobial prescribing.
The ASP team undertakes surveillance of antimicrobial resistance.
Establishing an antimicrobial stewardship program, The ASP, through a multidisciplinary approach
(physicians, pharmacists, nurses, laboratory professionals, the infection prevention committee, and others
as needed), has a responsibility to coordinate efforts to prevent and contain AMR by instituting policies
and implementing various strategies such as infection prevention, antimicrobial medicine prescribing
privileges, and surveillance.
Develop an AMS action plan based on the situational analysis and prioritized interventions.
Implement AMS interventions.
Monitor AMS interventions.
Continuous education
Implementing Antimicrobial Stewardship Strategies
The two core strategies that provide the foundation of an antimicrobial stewardship program include
prospective audits and feedback to prescribers, and formulary restriction and pre-authorization.
Prospective audit with feedback
A prospective audit with feedback is an intervention that consists of a case-by-case review of prescribed
antimicrobials to safeguard and optimize their use while minimizing unintended consequences such as
AMR and adverse effects. The feedback is delivered directly to the provider caring for the patient. The
prospective audit with feedback can be employed in a variety of ways depending on the need and
available resources and expertise in areas of high and/or poor quality antimicrobial use and can target and
combine a variety of interventions such as:
Targeting patients who are on antimicrobials as per the AWaRe category, specific infections, or surgical
prophylaxis,
Dose optimization
IV-to-Oral switch
Regimen de-escalation
Treatment duration
The AMS team should assign a team of experts who properly execute the audit with feedback
interventions using the audit and feedback tool (Annex 26).
Formulary restriction and preauthorization
Formulary restriction and preauthorization are restrictive measures. Hospitals should implement
formulary restrictions and preauthorization requirements for specific antimicrobial agents to reduce
microbial resistance. Decisions can be made based on the spectrum of activity, cost, or associated toxicity.

51
Preauthorization is a strategy to improve antibiotic use by requiring clinicians to get approval antibiotics
before they are prescribed. The use of preauthorization requirements is commonly implemented as a
means to restrict last-resort antibiotics.
The impact of AMS interventions on antimicrobial use and acceptance of the intervention should be
regularly communicated as part of morning sessions, other multidisciplinary meetings, or management or
DTC meetings. The AMS team can do assessments to identify areas for improvement in antimicrobial
prescribing for the whole hospital, a department, or a ward. This includes antimicrobial consumption and
point prevalence surveys using the standard tools available for this purpose.
Measures of Success
Key measures of success that help demonstrate that a facility’s AMS structure is functioning efficiently
include:
Availability of approved terms of reference (TOR) and reporting processes in place
AMS plan and implementation
Evidence of regular AMS committee meetings with documented agendas,
Implementation of and results from priority activities, including:
Assessment of antimicrobial prescribing, use, and resistance
Increased prescribing adherence to standard treatment guidelines
Based on the AWaRe classification, increased use of Access antimicrobials and streamlined use of Watch
and Reserve products
3.12. Narcotic drugs and psychotropic substances rational use, distribution and handling system.
Narcotic drugs and psychotropic substances (NPS) are classes of medicines with a high potential for
abuse. Addiction to these medicines is a global problem that crosses national, ethnic, religious, and gender
lines. Substances of abuse include substances classified under international law as controlled drugs, which
include narcotic drugs such as opium and its derivatives, cocaine and its derivatives, cannabis, and
psychotropic substances such as depressants, stimulants, hallucinogens, and tobacco. On the other hand,
substances of abuse can be classified into licit, those substances obtained legally for medical application
and research purposes, and illicit, those substances obtained illegally and used for illegitimate purposes.
Ethiopia has put in place control mechanisms to counter the illicit manufacture, distribution, and use of
these medicines. Accordingly, the procurement, storage, prescribing, distribution, and administration of
these medicines in hospitals should be in line with the following national recommendations:
Prescribing and dispensing of narcotic drugs and psychotropic substances
The hospital DTC determines the clinical units and types of professionals who can prescribe these
medicines. Hospitals need to ensure that the person who can prescribe narcotic drugs, psychotropic drugs,
and other controlled substances is a registered doctor, psychiatrist, health officer, or nurse who has
obtained a legal professional license and has a first degree or above.

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The hospital needs to ensure that only a professional designated by the management or DTC should carry
narcotic drugs and psychotropic substances (NPS). These professionals are responsible for ensuring and
monitoring that the drugs are used only for their intended purpose.
The authorized prescriber for NPS should use only special legal prescriptions printed for the purpose, and
the prescriptions that bear the name or seal of the hospital should be used only within the hospital. If the
prescriber makes a mistake or changes his or her mind while writing on the prescription paper, he or she
must fold the damaged prescription paper and leave it in the pad.
A hospital pharmacy dispenses NPS when the information mentioned in the prescription is complete,no
more than one medication is written on one prescription paper, and 15 days have not passed since the
writing of the prescription.
Movement of NPS medicines and prescriptions
Hospitals should keep narcotic drugs and psychotropic substances, prescription papers, and related
records in a lockable cabinet or a separate room that cannot be easily broken or moved. The key shall be
kept only by an authorized pharmacist.
The pharmacy department of the hospital should keep receiving and issuing models, reports, and other
records.
Any used narcotic drugs, psychotropic drugs, and other controlled substances prescribed by the hospital
should be kept by the hospital for five years from the time of use.
The pharmacy department of the hospital should receive the prescriptions in Model 19 and stamp the
prescriptions using the official seal of the hospital. Whereas wards (or service units) fill out their requests
in Model 20, the pharmacy department will issue the requested prescriptions using Model 22.
The pharmacy department issues new prescription pads only when nurses in charge of clinical
departments return the used prescription pads. Nurses in charge of clinical departments distribute the
prescription pads to prescribers at the start of each day and collect the pads after working hours.
Record management
Any person who handles narcotic drugs or psychotropic substances is responsible for keeping a record on
the day of the operation in accordance with the form prepared by the authority and submitting the record
when requested by the authority or regional health regulatory body.
A hospital should receive purchased or donated narcotic drugs and psychotropic substances using Model
19 or the legal receipt of the institution, whereas these medicines should be issued using Model 22 or the
institution's legal receipts.
Records of narcotic drugs and psychotropic substances dispensed to inpatients using respective
prescriptions should be kept on forms NPS/08/A and NPS/08/B (Annex 27&28,), respectively.
Records of narcotic drugs and psychotropic substances dispensed to outpatients using respective
prescriptions should be kept on forms NPS/08/A and NPS/08/B, respectively.

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Reporting
A hospital is expected to send a report to the regional health bureau about the narcotic drugs or
psychotropic substances they have purchased and used at the end of the year according to the European
calendar in the form NPS/15/A and NPS/15/B (Annex 29 &30), respectively.
A hospital under the Ministry of Health must send a report to the authority about the narcotic or
psychotropic drugs they have purchased and used according to the European calendar at the end of the
year in the form NPS/15/A and NPS/15/B, respectively.
A hospital must compile a report once a year by January 30, stating the number of prescriptions received,
used, and in stock with their serial numbers, and send it to the authority or regional health regulatory
agency in accordance with Form NPS/18.
A hospital, in cases where a narcotic drug or psychotropic substance or a used or unused narcotic and
psychotropic drug prescription paper has been lost, damaged, or stolen, must report the incident to the
authority, regional regulatory agency, or police within 24 hours and keep information about the
notification.
3.13. Monitoring and Evaluation of pharmacy service and supply management
All hospital pharmacy units should establish a routine monitoring and evaluation (M&E) system for the
pharmaceutical supply chain and pharmacy service to enhance efficiency and effectiveness. To ensure the
implementation of the system, the hospital pharmacy unit should have an officially assigned M&E focal
person to follow the routine activities. The focal person is responsible for following the recording and
documentation system, coordinating data collection, analysis, and interpretation, evaluating and
generating quality reports, organizing internal performance reviews, working with the hospital M&E unit,
following action taken, and promoting data use.
The hospital pharmacy M&E system helps to ensure that the right product is delivered in the right
quantity, in the right condition, and at the right time, improving the quality of pharmacy service. Proper
implementation of the M&E system demonstrates the performance of supply chain management and
pharmacy service, highlights successes, and informs areas that need improvement.
The hospital pharmacy unit should regularly report the pharmaceutical supply chain and pharmacy service
M&E indicators. The report quality shall be monitored and maintained through a good recording and
documentation system.
To ensure the quality of the report, the assigned focal considers the following data quality dimensions
before submitting the report: These include:
Completeness: Data for all data elements should have been filled.
Consistency: Data should be consistent and accurate.
Timeliness: All reports should be submitted at the appointed time.
The hospital pharmacy unit should conduct a quarterly internal performance review based on the M&E
findings to take the necessary action on the identified gaps and share their successes.

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 The hospital management utilizes pharmacy M&E findings for data-driven supply decisions and
pharmacy service improvement.

Annexes
Annex 1: DTC functionality criteria
# Operational Verification Criteria Score
Standard
Verification Result
weight
Assigned DTC members by official letter, has approved TOR and 0.75
annual action plan (0.25 for each)
1 The hospital
has a Meets regularly at least every two months with documented minutes 0.5
functional
Drug and Has updated health facility specific Medicine and Medical supplies list 1
prioritized by VEN(0.5 for each)
Therapeutics
Committee Has medicine use policy and procedures (at least one new policy 0.5
(DTC) developed during the reporting period)
The hospital DTC generates ADE/AEFI reports and take action on the 1
finding (0.5 for each)
Conduct supply and medicine use studies (at least one semiannually) and 2.75
ABC/VEN analysis annually
Take actions based on the supply and medicine use study findings 1
Report its performance activities to the management 0.5
Total score 8

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Annex 2: ADR reporting format

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57
58
 Annex 3: Pharmaceutical Good storage guideline

Activities Justification

1. Store pharmaceuticals in a dry, well- Extreme heat and exposure to direct sunlight can degrade
lit, well- ventilated storeroom - away pharmaceuticals and dramatically shorten shelf life. Direct sunlight
from direct sunlight. Temperatures in raises the temperature of the product and can reduce its shelf life or
the storeroom should not exceed may damage the product by other mechanisms.
25oC.

2. Clean and disinfect the storeroom Pests are less attracted to the storeroom if it is regularly cleaned and
regularly. Keep food and drink out disinfected. The outside of the store should also be kept clean, and
of the storeroom. any garbage should be stored in covered containers. Water should
not be allowed to stagnate near the building. Would should be
varnished or painted to discourage pests. If possible, a regular
schedule for extermination will also help eliminate pests.

3. Protect storeroom from water and Moisture can destroy both supplies and their packaging. If the
moisture. packaging is damaged, the product is still unacceptable to the
patient even when the pharmaceutical is not damaged.
4. Keep fire safety equipment available, Stopping a fire before it spreads can save expensive supplies and
accessible, and functional, and train the storage facility. The right equipment should be available; water
employees to use it. is able to put out paper fires, but is ineffective on electrical and
chemical fires. Place well-maintained fire extinguishers at suitable
positions in the storeroom. If a fire extinguisher is not available,
keep sand or soil in a bucket nearby.

5. Store latex products away from Latex products can be damaged if they are directly exposed to
electric motors and fluorescent fluorescent lights and electric motors. Electric motors and
lights. fluorescent lights create the chemical ozone which can rapidly
deteriorate latex products. Keep latex products in paper boxes and
cartons.
6. Maintain cold storage, including a Cold storage (2 to 8 degrees Celsius or 36 to 46 degrees Fahrenheit)
cold chain, as required. is essential for maintaining the shelf life of certain pharmaceuticals.
These items are irrevocably damaged if the cold chain is broken. If
electricity is unreliable, the use of cylindered gas or kerosene-
powered refrigeration is recommended. Many drugs require storage
below 25 oC. There may also be products that should be stored at a
temperature below 0oC and hence the required storage condition
should be maintained for these products.

59
7. Limit storage area access to To prevent theft and pilferage, lock the storeroom and/or limit
authorized personnel. Drugs which access to personnel other than authorized staff, and track the
need an access-controlled movement of pharmaceuticals.
environment such as narcotics,
psychotropic, etc should be stored
under lock and key separate from the
rest of stock preferably a locked wire
cage within the storage facility or a
lockable cabinet.
8. Stack cartons at least 10 cm off the Pallets keep the products off the floor so they are less susceptible to
floor, 30 cm away from the wall and pests, water and dirt damage. Stack pallets 30 cm away from the
other stacks, and no more than 2.5m walls and each other to promote air circulation and to ease
high. movement of stock, cleaning and inspection.
Do not stack cartons more than 2.5m as the weight of the products
may crush the cartons at the bottom. This will reduce potential
injury to warehouse personnel. If cartons are particularly heavy,
stack cartons less than 2.5m.
Where feasible, strong well-organized shelving is preferred.

9. Store medical supplies away from Exposure to insecticides and other chemicals may affect the shelf
insecticides, chemicals, old files, life of pharmaceuticals. Old files and office supplies may get in the
office supplies and other materials. way and reduce space for medical supplies or make them less
accessible. “De-junking” the storeroom regularly makes more space
for storage.
10. Store flammable products separately Some medical procedures use flammable products, such as alcohol,
from other products. Take cylindered gas, or mineral spirits. Such products should be stored in
appropriate safety precautions. the coolest possible place, away from electrical appliances and other
products and near a fire extinguisher.
Storage areas and cabinets should be
clearly marked to indicate that they
contain highly flammable liquids and
should display the international
hazard symbol.
Corrosive or oxidant products,
laboratory chemicals and reagents
should be stored away from
flammables, ideally in a separate
steel cabinet to prevent leakage.

11. Store pharmaceuticals to facilitate FEFO (First Expiry, First Out) is a method of managing drugs in a
FEFO procedures and stock storage facility where the drugs are managed by their expiry date.
management. Drugs that will expire first are issued first, regardless of when they
were received at the health facility.

60
12. Store drugs in their original shipping Drugs should not be opened to repackage them. Store supplies in
cartons. Arrange cartons with arrows their original shipping cartons. Items should be stored according to
pointing up, and with identification manufacturer’s instructions on the cartons; this includes paying
labels, expiry dates, and attention to the direction of the arrows.
manufacturing dates clearly visible.
Identification labels make it easier to follow FEFO, and make it
easier to select the right product.
13. Separate unusable pharmaceuticals Do not dispense expired drugs to the patients. Designate a separate
from usable pharmaceuticals and part of the storeroom for damaged and expired goods.
dispose of damaged or expired
products immediately.

Annex 4: Bin Card

Hospital Name: _______________________________
Product Name, Strength and Dosage Form: ________________________
Unit of Issue: _________________________________________________
Date Doc. No. Received Quantity Batch Expiry Remark
(Receiving from or No. Date
Received

Issued

Loss/Adj

or Issuing) Issued t Balance

61
62
Annex 5: Internal Facility Report and Resupply Form (IFRR)

63
 Annex 5: Report and Requisition Form (RRF)
Report and Requisition Form (RRF)

Name of the health facility Region: Zone: East Shoa Woreda: Adea

Reporting Period From To

(Month/day/year) (Month/day/year)

(Scenario I)Maximum Stock Level: 4 MOS Emergency Order point: 0.5 MOS

Report Part
Requisition Part
Begin
ning
Sl. Unit of Ending Balance Maximum Quantity
Balan
Issue Stock needed to
No. Product Description ce Quantity Losses/ Calculated Days Out Quantity
Quantity reach Max
Received Adjustment Consumption Of Stock Ordered
s In DU In Store

F G H
A B C D E = A + B +/- = 120*F / I= H-E-D
C – D+E) (60 – G)

64
Products with shelf life <6 months (S/No, Quantity and Expiry date): Remarks:

Name Signature Date

Prepared by: ________________________ ______________________________ _________________
Verified by: ________________________ ______________________________ _________________
Approved by: ______________________ _____________________________ ________________

65
Annex 6: Refrigerator tag temperature recording sheet

Annex 7: Procured medical oxygen cylinders checking form during receiving at store to ensure proper
filling
Date Number of Volume of Properly filled Checked by BME/T Remark
cylinders cylinders Pass/Fail Test
procured procured
Name Signature
Annex 8: Medical oxygen Internal Reporting and Requesting form (maintained separately for each ward)
Requesting Requester Requesting Number of Number of Volumes of Requester
Date name Unit cylinders cylinders cylinders (liters) Signature
requested supplied supplied

Annex 9: Medical oxygen monthly consumption tracking report

Service Medical oxygen Medical Oxygen Medical Medical Remark
units/wards supplied Supplied (in Oxygen oxygen stock
(number of liters) Supplied (in out in days
cylinders) Birr)
Emergency
Inpatient Adult
Inpatient
Pediatric
ICU adult
ICU pediatric
Maternal
Annex 10: Expired and unfit for use product registration form
S.N Description unit quantity Batch.no expired Manufacturer country unit Total
of date of cost cost
Medicines origin
Wastes
(generic &
brand name,
strength and
dosage
form)

67
Annex 11: Prescription evaluation and intervention register

68
Annex 12: Data collection form for patient knowledge and labelling interview

69
Annex 13: Data collection form for client satisfaction with dispensing services

70
Annex 14: In-patient Medication Profile Form
(Follow the instructions when completing this form)
Name of Hospital: ____________________________________ Region: _______________
In-patient Medication Profile Form In-patient Medication Profile Form
In-patient Medication Profile Form In-patient Medication Profile Form

In-patient Medication Profile Form

In-patient Medication Profile Form

In-patient Medication Profile Form
In-patient Medication In-patient Medication Profile Form Start Date Stop Date
Profile Form

In-patient Medication In-patient Medication Profile Form

Profile Form
In-patient Medication In-patient Medication Profile Form
Profile Form
In-patient Medication In-patient Medication Profile Form
Profile Form
In-patient Medication In-patient Medication Profile Form
Profile Form
In-patient Medication In-patient Medication Profile Form
Profile Form

71
In-patient Medication Profile Form

Annex 15: Pharmaceutical Care Progress Note Recording Form

Form 2: Pharmaceutical Care Progress Note Recording Sheet
(Follow the instructions when completing this form)
Patient Name: ______________________ Card No. ___________________
Annex 17: Medication Reconciliation Form
(Follow the instructions when completing this form)
Hospital __________________________Region________________
Patient name: ____________________________ Age ______ Sex _______Weight _____
Source(s) of medication list ________________________________________________________
Allergic: _______________________________________________________________________

Reconciliation

Plan on Plan on Plan On Adjustments/

Medication Regimen (Drug name, admission transfer Discharge Changes made
information Dose, Frequency,
source Duration) C DC C DC C DC
Pre-admission
Medication

72
 Current Medication

C – Continue, DC - Discontinue
Recorded by: Name _____________________________ Signature ____________ Date ______________

73
 Annex 16: DIS Summary and Report form

_____________Hospital Drug Information Service (DIS)

P.O. Box: ______, Telephone: ___________, Fax: ___________, E-mail: ____________

Drug Information Query/Response and related activities summary and reporting form

Name of DI pharmacist: Telephone E-mail

Data compilation/reporting eriod Date: Month:

1 Number of DI requests Received: Replied :

Number of Requests health facility Staff from other Health patient:

2
coming from staff: faciility: other

1 Requesters’ Sex Male: Female:

Health
Specialist GP
Officer
Requesters’ Qualification/
2
profession Nurse Pharmacist Druggist
Student Other

II-Background information on query:

Number of queries Walk-in Phone Written form

1
received through: E-mail Fax Letter

Other/ Not
2 Type of queries : Patient specific: Academic:
specified

Therapy Pregnancy ADR

Interaction Pharmaceutical Pharmacology

3 Classification of Query:
Pharmacokinetics Administration Local/Foreign
Availability Other equiv.

In-house
Reference books Journals
Sources of information database
4
used Peer reviewer Package
Internet sites
publication inserts

74
 Other DIS Previous response Other

Telephone
Oral/Verbal Written/print format
call

Provide
Response communicated
5 E-mail Notice board Reference
by:
source
Provide
Provide Internet source Other
Literature

6 Number of requesters who sent feedback

B. Additional activities of DIS

Drug ALERTS Bulletins Newsletters

Number of publications
1 Other
issued Therapy updates New arrivals/ availability
publications

Continuing Medical Eduction/Patient education (CME/PE) events:

The
2 Number of events organized to: hospital Patients/community Others
staff
The
3 Number of attendees/ target audiences: hospital Patients/community Others
staff

Drug Rational
Disease specific
4 Number of topics related to: Specific use

others
Feedback
Received
received
5 Number of ADR/ADE Reports from Sent to FMHACA
From
staff
FMHACA

DIS’ support to DTC (Formulary management/ Drug use

6 Facilitate the workshop to conduct DUE on Ceftriaxone
reviews/ studies/ DUE/ Designing strategy)

organize educational sessions and meetings with prescribers to

7 DIS’ support to clinical pharmacy/ pharmaceutical care sensitize staff on the role of pharmacists in the chronic diseases
management

75
8 Major Challenges/ constraints affecting progress None

9 Actions taken to address challenges/ constraints: None

Report compiled/reported by: Date:

Report reviewed by: Date:

For Office use only

Report sent to home office

Report received by: Date:
on:
Home/ central office-
Report received on: Report compiled and documented on:

Annex 17: Drug Information Response Form

76
 DRUG INFORMATION RESPONSE FORM

Enquiry Reference No.:

Date: Time

To(name of inquirer): Phone No: Email:

Dear

We acknowledge the receipt of your enquiry on drug information dated and documented
under ref. No We are pleased to put forward the required information as follows:

Question/query:

Answer/response:

References:

Additional information/materials and

recommendations provided:

Disclaimer:
The DIS is designed to assist health care providers and other users to provide accurate, up-to-date, reliable and complete

We hope we have served you with this information and in case you need further information/materials, please fill free to

Response completed By: Date: Initials:

77
Annex 18: Drug Information Query Form

DRUG INFORMATION QUERY FORM

Date:
Time: am/pm am
I-Requester’s contact information: (To be filled by requester or DI pharmacist)

Full Name: Dr. Mr. Mrs. Sr.): Mr

Physical address: Tel No: E-mail: Fax:
Qualification/Profession: GP Specialist Health Officer Patient
Nurse Pharmacist Druggist Student
Other (Please specify )
Method of Contact: Walk-in Phone Written form E-mail
Fax Letter Other (Please specify )

II-Background information on query:

The request is: Patient specific Academic Other
If Patient specific, Please Age Sex wt (kgs) Diagnosis
record patient information that Current Medication:
you feel may be helpful in
answering your request (such
Concurrent medication/s:
as patient’s age, sex, weight,
disease states, laboratory Allergies:
values, medications allergies Other information
etc…). related to Patient:
Request/Question:

Verbal Phone printout E-mail

Preferred method of
written form Fax
Response:

prompt 30-60 min end of day when time permits

Response needed in:

References required: YES NO

Additional Information
required:

Initials of the requester(optional) Date: Time:

For DI pharmacist use only

Enquiry Received on (Date): Time:

Enquiry Received by: Enquiry Reference No. DI001

Response given to requester on (Date): Time:

Response made by:

78
Annex 19: Drug information service feedback form

DRUG INFORMATION SERVICE FEEDBACK FORM

Enquiry Reference No.:

Date of enquiry:
Dear enquirer:

We want to hear from you

The _________hospital/H center DIS is seeking your feedback on the information we have provided in response
your enquiry under Dated . We value your
feedback because this helps us to stay in touch with your needs and for the continuous quality improvements of

We invite you to use this form to submit feedback or complaint. Provision of the information requested

1. Was the information received in time? Yes No

2. Was the presentation of the information Yes No
3. Did the information provided meet your Yes No
4. Was the information used? Yes No
5. If your answer to Question No. 4 is
Yes, what was the outcome?
6. If your Answer to Question No. 4 is
No, please describe the reason why the
7. Additional comments and suggestions
on the DIS

Name of Phone No: Email:

enquirer:

We thank you for your time and response

79
 Annex 20: List of basic compounding equipment

S.N Equipment/material Description

Working bench Level, smooth, impervious, free of cracks and crevices and non-shedding;
covered with protector sheets of plastic, rubber or absorbable paper when
appropriate

Mortar and pestle 250 ml capacity or more; glass type and porcelain type

Water distiller Stainless steel of 20 litter capacity or more

Water bath Stainless steel of 4 openings or more

Electrical hotplate Various Sizes and Features

Evaporating dish Stainless steel and porcelain type

Spatula Stainless steel/plastic type, flexible and non-flexible, different blade lengths.
Gloves disposable, non-sterile

Glass rod Different length and thicknesses

Wash bottle 250ml capacity, polyethylene

Funnel Glass type and plastic type (polyethylene)

Beakers Glass type; different capacity

Volumetric flask Glass type; different capacity

Balances Prescription, torsion, triple beam, electronic; capacities of not less than 300
gm; sensitivity of greater than 0.1 mg.
Ointment tile Glass type
Micropipettes Glass type; different capacities (less than 1ml); with pipette bulb

Pipettes Glass type; different capacities (1ml-100ml); with pipette bulb

Cylindrical graduate Glass and plastic type; different capacity

Conical graduate Glass and plastic type; different capacity

Weighing dishes Plastic, aluminum, stainless steel type

Weighing paper Normal paper; grease-proof for semisolids

Thermometers Fridge and wall thermometer

Scientific calculator Electronic calculator that can show its output in scientific notation
Packaging materials Different sizes of plastic or glass bottles

80
Annex 21: Compounding Process Recoding Form (Compounding sheet)
Name of the dispensary/health institution __________________________________Date
__________________
Batch number/control number_____________________________ Batch quantity _______________

Name or initials of the

Description of ingredients
person in charge

Name Source Batch number Quantity

Description of the steps of the preparation

Beyond use Date: …………………………………….

Yield: …………………………………………….
Loss: ……………………………………………
Reason for loss: ………………………………………………………………………………………….

Prepared by: Name ___________________ Signature_________ date _________

End control before release of the product

Parameters Comment

Approved by: Name ___________________________ Signature______________Date________

81
Annex 22፡ Compounding Prescription Register Forms

Annex 23: Antimicrobial Stewardship program functionality Criteria

82
Category Functionality parameter

0 There no ASP team in the facility

There is ASP team having approved ToR with list and responsibilities of members,

1 Availability of ASP plan addressing ASP guideline

Availability of the national ASP practical guide in hard and soft copies.

Availability of AMR trained professionals,

2 Availability of functioning diagnostic laboratory in the facility,

Presence of institutional base line data.

Conduct regular review meeting with minutes documented,

Availability of audit and feedback system, appropriate de-escalation (Spectrum),

appropriate switch from IV to oral (route de-escalation),
3
Registration of antimicrobial consumption,

Recording of HAIs in the institution

Availability of DUE finding conducted on AMs in the past one year.

83
 Annex 24: AMS review/Audit form
Name of Hospital:----------------------------------------------------------------

1. Patient demographic and clinical information

Date of Admission: Department: Ward:
Patient name (ID): Age in Yrs: Weight: Sex: Male ☐ or Female ☐
Chart Number: Allergies:
Previous admission history for >2 days with in the last 3 Yes ☐ No ☐
Previous
months antibiotic use histories within 30 days Yes ☐ No ☐
Immunosuppressed Yes ☐ No ☐
CKD10/ current AKI Yes ☐ No ☐, If yes serum creatinine_
If the patient is a neonate Gestational age (in weeks) ;
birth weight (in kgs):_

4. Initial review of antibiotic treatment

Is indication for Antibiotic treatment Is antibiotic treatment prescribed according Comments
documented? Yes ☐ No ☐ to

recommended guidelines? Yes ☐

Correct dose? Yes ☐ No ☐ Appropriate route? Yes ☐ Treatment duration or review date stated? Yes
No ☐ Why not? Comment ☐
No ☐
2. Current antibiotic prescriptions for the current indication (see below) No ☐
Antibiotics prescribed Dose (mg) Route Interval Start date End date (if
3. Indication for antibiotic treatment recorded)
Indication11 S. Prophylaxis ☐ Empirical ☐ Definitive ☐
Diagnosis (it Urinary tract Infection ☐ Gastrointestinal Infection ☐ Bloodstream Infection ☐
might be more Pneumonia ☐ CNS/Meningitis ☐ Skin infection ☐ Bone infection ☐
than one)
Other (specify):_
Diagnostic Fever recorded
WBC with differentials
workups done
X-ray findings
Cultures Sent before antibiotics ☐ Sent after antibiotics ☐ Not sent ☐
If sent, culture Blood ☐ Sputum ☐ Other (specify):
specimen source Urine ☐ CSF ☐

84
If yes, what action? Escalate Continue De-‐escalate Stop Change ☐ IV-• oral switch ☐
☐ ☐ ☐ ☐
5.If continue,
Within 72Whyhours
is review of antibiotic
Continuingtreatment
clinical by physician/AMS
signs of infection team
Confirmed infection ☐ Other (comment):
Is antibiotic
antibiotic treatment ☐ Yes ☐ No ☐
If stop, Why is antibiotic
reviewed? No evidence for Treatment duration Allergy ☐ Other (comment):
treatment being continued? infection ☐ too long ☐
treatment
If Change,being
Why stopped?
is Inappropriate Culture-sensitivity ☐ IV to PO ☐ Other (comment):
antibiotic spectrum ☐
Microbiology specimens Microbiology results received? ☐ Microbiology results acted upon? ☐
treatment
collected?being
☐ Changed?
Date: Comment:
Date:

6. General
comments/Recommendation/s:
(Review) Date:_ Name/signature (reviewer)
7. Actions based on comments/recommendation/s:
Fully accepted ☐ Partially accepted ☐ Not accepted ☐
If not accepted, Reasons:_

CKD: chronic kidney disease, AKI: acute kidney injury, CSF: cerebrospinal fluid, CNS: central nervous
system, IV: intravenous, PO: per- oral,

Annex 25: Dispensed and administered Narcotic drugs record format

85
FORM NPS/08/A
Date ------------------------------
DISPENSED AND ADMINISTRED NARCOTIC DRUGS RECORD IN HEALTH INSTITUTION
Name of Health Institution: --------------------------------------------------Serial No. --------------------
Description of Drug---------------------------------------------- Quantity Issued -------------
Ward/Department -----------------------------------------------------------------------------------
Chief pharmacist: Name----------------------------------------------------Signature -----------------------
Head Nurse: Name -------------------------------------------------------- Signature ----------------------

-------------------------------------------------------------------------------------------------
FORM NPS/08/A
Date -------------------------------------
Name of Health Institution: --------------------------------------------- Serial No. -----------------------
The following is an accurate record of -----------------------------------
Total quantity ------------------------------ each used in ward Department
Please fill the following record clearly and neatly.

Date Hour Name of Bed No. Chart No. Nurse Dose

patient

Ward physician: Name ________________ Signature ____________________

Ward Head Nurse: Name __________________ Signature _______________________

Annex 26: Dispensed and administered psychotropic drugs record format

86
FORM NPS/08/B
Date ------------------------------
DISPENSED AND ADMINISTRED PSYCHOTROPIC SUBSTANCE DRUGS RECORD IN HEALTH
INSTITUTION
Name of Health Institution: --------------------------------------------------Serial No. --------------------
Description of Drug---------------------------------------------- Quantity Issued -------------
Ward/Department -----------------------------------------------------------------------------------
Chief pharmacist: Name----------------------------------------------------Signature -----------------------
Head Nurse: Name -------------------------------------------------------- Signature ----------------------

-------------------------------------------------------------------------------------------------

FORM NPS/08/B
Date -------------------------------------
Name of Health Institution: --------------------------------------------- Serial No. -----------------------
The following is an accurate record of -----------------------------------
Total quantity ------------------------------ each used in ward Department
Please fill the following record clearly and neatly.
Date Hour Name of Bed No. Chart No. Nurse Dose
patient

Ward physician: Name ___________________ Signature ___________________

Ward Head Nurse: Name__________________ Signature ___________________

87
 Annex 27: Annual report of narcotic drugs
FORM NPS/15/A
Name of Reporting Health institution:-------------------------------------- Address: Region---------------------
City/Town ---------------------------------------------P.O. Box------------Tel. -----------------------------
These statistics Relates to the calendar year -----------------------------------------------

Balance at the balance at Remark

Beginning of the end of
Quantity Purchase d consumptio n the year
Dosage Form

the Year
purchased from during the
Narcotic
Strength
Ser. No.

during the year

Drug year

Remark: -Report on the Psychotropic Drug is required annually at the end of December.

88
Annex 28: Annual report of Psychotropic substance
FORM NPS/15/A
Name of Reporting Health institution:-------------------------------------- Address: Region-----------
City/Town ---------------------------------------------P.O. Box------------Tel. -----------------------------
These statistics Relates to the calendar year -----------------------------------------------

89
 Balance at the balance at Remark
Beginning of the end of
Quantity Purchase d consumptio n

Dosage Form
the Year the year
purchased from during the
Psychotropic

Strength
Ser. No.

during the year

substance
year

Remark: -Report on the Psychotropic Drug is required annually at the end of December.

90
 CHAPTER: 15

Laboratory Service
Management

1
CONTENT

Section 1 Introduction

Section 2 Operational Standards for Human Resource Management and Development

Section 3 Implementation Guidance

Section 4 Implementation checklists

Section 5 Performance Indicators

Section 6 Annexes

Section 7 References

1
ABBREVIATIONS
ART: Antiretroviral therapy

AFB: Acid Fast Bacilli

QMS: Quality Managements System

CPD: Continuing professional development

DNA: Deoxyribonucleic acid

EPHI: Ethiopian Public Health Institute

EQA: External Quality Assessment

EFDA: Ethiopia Food and Drug Administration Authority

MOH LEO: Ministry of Health Lead Executive Office

HMIS: Health management information system

IQC: Internal Quality Control:

NBBS: National Blood Bank Service

OHSO: Occupational Health and Safety Officer

PCR: Polymerase Chain Reaction

PIHCT: Provider Initiated HIV Counseling and Testing

PPE: Personal Protective Equipment

PT/ EQA: Proficiency Testing/ External Quality Assessment/

QA: Quality Assurance

QC: Quality Control

QI: Quality Improvement

2
RHB: Regional Health Bureau

SOPs: Standard Operating Procedures

STS: Sample Transfer Service

TAT: Turnaround time

UPS: Uninterrupted Power Supply

3
SECTION ONE: INTRODUCTION
Laboratory services strengthen the practice of modern medicine by providing information to end
users to accurately assess the status of a patient’s health, make accurate diagnoses, formulate
treatment plans, and monitor the effects of treatment. Laboratories are a major source of health
information for epidemiological and surveillance purposes, and are often the first sites for the
detection of disease outbreaks. To provide such functions laboratory data must be recorded and
reported through the appropriate channels in an accurate and timely manner.

The current laboratory service in Ethiopia is organized in a structure that follows the general
health care delivery system of the country, incorporating specialized, general and primary
hospitals in addition to health centers and health posts. At the apex of this system, there are
currently thirteen Regional Reference Laboratories and a National Reference Laboratory at the
Ethiopian Public Health Institute (EPHI). A detailed description of the responsibilities of
laboratories at different tier levels in Ethiopia is presented in Appendix A.

As part of the Ethiopian laboratory network, hospitals receive specimens for analysis from the
lower level of laboratories and also from the same level of facilities and may refer specimens to a
higher level facility, in accordance with agreed protocols and guidelines. This chapter sets
standards and guidelines to ensure that hospital laboratories provide accurate, reliable and timely
test results for patient care. Effective laboratory management ensures the implementation of
standard laboratory quality management systems to perform agreed tests with minimal ‘down
time’ in service provision.

1
SECTION TWO: OPERATIONAL STANDARDS FOR MEDICAL LABORATORY
SERVICE
1. The hospital has established laboratory management structure and accountability
arrangement.
2. The hospital laboratory management shall develop and implement quality management
system and continually quality improvement.
3. The hospital laboratory management has established system for management of
documents.
4. The hospital laboratory has established system and practice to monitor the effectiveness
of its customer/Client/ service program.
5. The hospital laboratory has established and implements a proper equipment and supply
management system.
6. The hospital laboratory shall implement a process control system (Pre-analytic, Analytic
and Post-analytic) and documented procedure to identify and manage nonconformities in
any aspect of the quality management system.
7. The hospital laboratory has established incident handling and reporting system
8. The hospital has established Laboratory Information Management System
9. The laboratory shall develop and implements a program to ensure the safety of laboratory
services and facilities.
10. The hospital laboratory shall have backup laboratory service within and between
laboratory
11. The hospital laboratories create public-private partnership in the delivery of laboratory
service.
12. The hospital has blood bank service that adhered to appropriate standards of practice

1
SECTION THREE: IMPLEMENTATION GUIDELINE

3.1 Organization and Management

3.1.1 Management structure
The laboratory shall have its own organizational structure that enables the laboratory to
communicate internally and externally with vendors, other health institutions to create
collaboration and partnership and EQA program providers by working under the organizational
umbrella of the hospital. Each laboratory must have an organizational chart (organogram) that
describes the management and supervisory arrangements in the laboratory.

The hospital laboratory should have functional central, emergency and inpatient laboratories.
Both emergency and inpatient laboratories should provide services 24hrs a day and 365 days a
year. The central laboratory should have a functional overview of all other labs to ensure the
provision of quality services. The laboratory shall have job descriptions that describe
responsibilities, authorities and tasks for all personnel.

3.1.2 Management role

The laboratory shall be managed by an experienced laboratory professional or persons with the
competence in their field and in management. The duties and responsibilities of the laboratory
manager, quality officer and safety officer should be documented.

The laboratory manager (or designate/s) shall:

1. Provide effective leadership of the medical laboratory service, including planning,

budgeting and overall financial management, in accordance with organizational
assignment.
2. By representing the hospital, liaise and work effectively with applicable regulatory
authority and accrediting agencies, appropriate administrative officials, the healthcare
community, and the patient population served.
3. Ensure that there are appropriate number of staff with the required education, training and
competence to provide medical laboratory services that meet the needs and requirements
of the users
1
 4. Ensure the implementation of laboratory quality policy
5. Implement a safe laboratory environment in compliance with good practice and
applicable requirements
6. Develop hospital laboratory specific annual plan and ensure that adequate budget is
allocated
7. Ensure the provision of clinical advice with respect to the choice of examinations, use of
the service and interpretation of examination results
8. Provide professional development programs for laboratory staff and opportunities to
participate in scientific and other activities of professional laboratory organizations
9. Define, implement and monitor standards of performance and quality improvement of the
medical laboratory service or services
10. Maintain strong communication/relationship among clinical and non-clinical staff.
3.2 Quality Managements System

The implementation of a quality management system in the hospital laboratory is a crucial step
to ensure ongoing enhancement in quality. One key aspect involves inspecting the certification of
accreditations and assessing the number of accredited scopes. If a laboratory has six or more
scopes accredited, it receives a full score, while those with fewer than six scopes receive an
equivalent score. Additionally, the evaluation includes a review of the laboratory's updated
quality manual and sample management guidelines. The presence of Standard Operating
Procedures (SOPs) for all technical and administrative procedures in all service areas is essential,
along with confirming the availability of updated formats, job aids, and instructions in the
workplace.

Moreover, the assessment delves into the awareness and adherence of laboratory staff to the
SOPs relevant to the tests they are performing. Ensuring that the laboratory has identified quality
gaps and prepared annual quality improvement plans is a critical component. Finally, the
evaluation involves confirming that at least 50% of the laboratory staff have undergone
competence assessments with documented results for their assigned tasks. This comprehensive
approach to quality management aims to establish a framework for continuous improvement and
adherence to best practices in the hospital laboratory.

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3.2.1 Committed Managements
Laboratory management shall provide evidence of its commitment to the development and
implementation of the quality management system and continually improve its effectiveness by:

1. communicating to laboratory personnel the importance of meeting the needs and

requirements of users as well as regulatory requirements;
2. establishing the quality policy
3. ensuring that quality objectives and planning are established
4. defining responsibilities, authorities and interrelationships of all personnel
5. establishing communication processes
6. appointing a quality manager
7. conducting management reviews
8. Ensuring availability of adequate resources to enable the proper conduct of pre
examination, examination and post-examination activities.
9. ensuring that all personnel are competent to perform their assigned activities
3.2.3 Competency Assessment
A competency assessment is a mechanism to test new experts' knowledge and skill in connection
to that specific laboratory service that he is allocating to do and when laboratory professional
comes to do a new kind of laboratory test. Competency evaluations might be theoretical exam,
practical exam, or a combination of the two. Each hospital laboratory shall have policy and
procedure how to do competency assessments. This policy and procedure should have the
following

1. Who is qualified to conduct competency evaluations in laboratories?

2. Who was assessed for competency?
3. When competency evaluations are conducted
4. Assessment theoretical, practical or combination
5. Standard to state "pass" and "fail"
Competency evaluations should be conducted after introducing all members about new or
updated work procedure or processes. It can be conducted regularly according to a policy or
procedure that has been established by hospital laboratory. If the laboratory personnel failed the

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competency test, he or she should be retrained and retake the exam until they pass, unless they
should be sent to another laboratory test service where they can be useful.

3.3. Documents and Records

3.3.1 Document
Documents provide written information about policies, processes, and procedures and should be
annexed in the laboratory quality manual for each laboratory. Documents are a reflection of the
laboratory’s organization and its quality management. A well-managed laboratory will always
have a strong set of documents to guide its work.

3.3.2 Quality Policy Manual

The laboratory shall prepare a policy manual that gives broad and general direction to the
laboratory quality system defined by the organization and endorsed by hospital management.

3.3.3 Procedure
The laboratory shall also prepare technical and managerial procedures for all processes. A
procedure tells “how to do it”, and shows the step-by-step instructions that laboratory staff
should meticulously follow for each activity. The term standard operating procedure (SOP) is
often used to indicate these detailed instructions on how to do it.

3.3.4 Standard Operating Procedures

Standard Operating Procedures (SOPs) are created for regularly recurring work processes that
are conducted in the laboratory. This is done to ensure that activities are performed consistently
and in a manner that achieves results of the highest quality, and that the laboratory is run as
efficiently as possible. All laboratory staff should participate in the creation of SOPs. Each SOP
should be approved by the Laboratory Manager and Quality officer prior to implementation.

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All for specimen management SOPs should include:

I. Action upon receipt of a sample:

Upon receipt the laboratory should check the availability of the requested test in that
laboratory, including the turnaround time for results. If the service is not available, the
laboratory should notify the customer and refer the sample to a different laboratory
capable of performing the request test. If the service is available, the sample must be
checked according to the acceptance and rejection criteria. A specimen can be rejected if:

● It is received without a request form,

● It is unlabeled, incompletely labeled or if the name on the label does not match
the name on the request form
● It is leaking, or broken container
● It is the wrong type of specimen for the requested test
● It was not transported according to requirements or bacterial overgrowth present
● The time since collection is too long (depending on the type of test),
● It is hemolytic (depending on the type of test) or insufficient volume of a
specimen.
II. Documentation of sample receipt:
A log book either manual or electronic should be used to record the receipt of samples.
This form should include:

● The name of the patient and identification number

● The source of the specimen
● The name of the submitter, and
● The date of collection.
III. All testing procedures:
All SOPs for individual tests should include:

1. The full test name, including the full name of the methodology used (commonly
used abbreviations should be listed at the beginning of the SOP)
2. The types of reactions, specimens, or organisms involved in the test

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 3. Guidelines for the storage of specimens to ensure their integrity until testing is
complete
4. The clinical reasoning for performing the test
5. Any calculations and formulas needed to obtain a result
6. The methodology used, including the limitations of procedures and reagents,
7. Standards by which a sample is accepted or rejected
8. Safety issues related to that particular test
9. The test procedure, including
10. A complete set of instructions
11. Detailed descriptions such as measuring units, etc
12. How to prepare slides, solution, calibrators, control, reagents, stains, etc. for use
13. The criteria for what to do if a test system becomes inoperable
14. A corrective action guideline (when necessary)
15. Interpretation of results, including: Reportable ranges, Critical or panic values
16. Methods of disposal for specimens and other products used,
17. References to relevant and pertinent materials
18. Criteria for the referral of specimens to and from other health facilities, and
19. Transport requirements (e.g. cold chain) if the specimen is to be transferred to
another laboratory.
SOPs should also be available for:

1. Testing algorithms (The procedure for analyzing a sample that has more than one test
request)
2. The maintenance and monitoring of each piece of equipment
3. Sample referrals and transportation
4. Safety procedures and waste management, including proper specimen disposal
5. Quality assurance procedures
3.3.5 Document Revision
Each SOP should be reviewed on a regular basis (usually, annually).The revision status and due
date for next review should be stated on policy.

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3.3.6 Document Identification
The laboratory shall have a uniform approach to document identification, format, status and issue
control, and to the procedure for document review and preparation is required for the continued
integrity of the system.

1. Job aids, or work instructions: are shortened versions of SOPs that can be posted at the
bench for easy reference on performing a procedure. They are meant to supplement, not
replace, the SOPs.
2. Formats: the document was designed as a tool to collect information in the course of all
laboratory activity and converted to record after capturing certain information of the
laboratory activity.
3.3.7 Control of Records
The laboratory shall have a documented procedure for identification, collection, indexing,
access, storage, maintenance, amendment and safe disposal of quality and technical records.
Records shall be created concurrently with performance of each activity that affects the quality
of the examination. Laboratory records can be in any form or type of medium and shall define
the time period that various records pertaining to the quality management system. The length of
time that records are retained may vary; however, reported results shall be retrievable for as long
as medically relevant or as required by regulation.

Legal liability concerns regarding certain types of procedures (e.g. histology examinations,
genetic examinations, pediatric examinations) may require the retention of certain records for
much longer periods than for other records. For some records, especially those stored
electronically, the safest storage may be on secure media and an offsite location. Characteristics
of records are that they:

● Need to be easily retrieved or accessed and

● Contain information that is permanent, and does not require updating.
Records shall include, at least, the following:

1. supplier selection and performance, and changes to the approved supplier list;
2. request for examination;
3. records of receipt of samples in the laboratory;

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 4. information on reagents and materials used for examinations (e.g. lot documentation,
certificates of supplies, package inserts);
5. laboratory workbooks or worksheets;
6. instrument printouts and retained data and information;
7. examination results and reports;
8. instrument maintenance records, including internal and external calibration records;
9. calibration functions and conversion factors;
10. quality control records;
11. incident records and action taken;
12. accident records and action taken;
13. risk management records;
14. nonconformities identified and immediate or corrective action taken;
15. preventive action taken;
16. complaints and action taken;
17. records of internal and external audits;
18. inter-laboratory comparisons of examination results;
19. records of quality improvement activities;
20. minutes of meetings that record decisions made about the laboratory’s quality
management activities;
21. Records of management reviews.
22. Personnel records; such as educational and professional qualifications; copy of
certification or license, when applicable; previous work experience; job descriptions;
introduction of new staff to the laboratory environment; training in current job tasks;
competency assessments; records of continuing education and achievements; reviews of
staff performance; reports of accidents and exposure to occupational hazards;
immunization status, when relevant to assigned duties.
3.3.8 Archiving documents and Records
The quality officer is responsible for the proper archiving of documents and records. The
laboratory respects the national regulations or legislations concerning the retention time of all
records. A copy of an obsolete document is kept to provide a means for review if the situation
arises.
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3.4 Customer Service
Each laboratory should develop a system to collect and measure data on how much the
laboratory services and products satisfy the customer (the patients and clinical staff) and should
take steps to address any problems identified. This could be done through suggestion boxes,
suggestion books and/or satisfaction surveys as part of or additional to the overall hospital’s
clinical governance and quality improvement program.

The laboratory should have a mechanism to record complaints from patients, staff and clients.
All complaints and problems reported to the laboratory as well as corrective action taken should
be documented and the handling procedure should be part of the overall hospital’s complaint
handling and management system.

The laboratory need to conduct the need of its customers regularly .The hospital should ensure
the laboratory management produces a list of all tests that are provided by the laboratory based
on the national regulatory guidelines, including the fee per test and turnaround time. The list
should be updated regularly and should be posted in all sample collection areas and readily
available to all clinical staff and patients. The hospital laboratory has at least a minimum test
menu based on FDA standards (Annexed appendix D, E, F).

3.4.1 Laboratory Handbook

A laboratory handbook should be prepared by the laboratory for the benefit of clinical staff
ordering diagnostic tests. The handbook should be distributed to all sample collection and patient
examination areas including wards, emergency room, operating room, labor and delivery,
outpatient department etc.

The laboratory handbook should include:

● A list of all tests with current price available in the laboratory and appropriate turn-
around time for each test.

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 ● A list of tests that may be taken by the laboratory and referred to a higher tier for
analysis, and turn-around time for each
● Important information that should be included in the laboratory handbook:
 Clinical significance of the test
 Basis for reference range
 Critical range notification
 Test interference or procedure limitations
 Any other pertinent test characteristics
 Interpretation
 Contact names and telephone numbers of key personnel
 Name and address of the laboratory
 Hours of operation of the laboratory
 List of tests that can be ordered
 Detailed information on sample collection requirements
 Sample transport requirements, if any
 Expected turnaround times
 Description of how urgent requests are handled—this should include a list of what
kinds of tests are done on an urgent basis, what are the expected turnaround times,
and how to order these tests
 Test ordering procedures
 Sample collection and sample disposal procedures
3.4.2 Advisory service
The laboratory should provide an advisory service for clinical staff to assist with the
interpretation of results and to provide advice on the process of decision making. To achieve
this, laboratory staff should make comments on the result report, either commenting on the
interpretation of the results and/or suggesting additional investigations that might aid the
diagnosis. Laboratory personnel should be available to answer queries from clinical staff about
individual test results or the need for further investigation. Additionally, the laboratory should
identify ‘panic results’ (i.e. a result which should be communicated immediately to the physician
for urgent action) for each investigation and processes by which such results are communicated
immediately to the ordering clinician.
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3.4.3 Information notification
The hospital laboratory should have a process to update clinical staff and others on areas such as
a start of new tests, discontinuation of tests and if there is a delay in test results etc. through
registered telephone calls or by filling notification format. A list of all tests with current price
available in the laboratory and appropriate turn-around time should be posted in all services
areas. There should also be a forum through which laboratory staff can discuss individual patient
care with clinicians when necessary. Possible mechanisms include:

1. ‘In house’ education sessions at which all laboratory staff members who attend
workshops/training share this knowledge with their laboratory and other clinical
colleagues.
2. Clinical review meetings of all clinical staff (nurses, physicians, X-ray, lab, pharmacy or
any other relevant staff). These meetings should be a forum for presentations and
discussion on general clinical issues. Laboratory staff should participate in these meetings
and could use these meetings to provide clinical advice and update information about
laboratory services to clinical staff.
3.5 Laboratory Equipment and Supply Management
The hospital laboratory has a system for proper laboratory equipment management to create and
ensure the provision of accurate, reliable and timely test results of its minimum standard. The
laboratory should be connected to a back-up power supply (generator) in cases of interruption to
the mains electrical supply. Additionally, the laboratory should have a telephone(s), fax machine,
sufficient computers and printers for administrative purposes and internet connection if possible.
Equipment Life book and Inventory: Every laboratory equipment’s should have a life book and
inventory mechanism of all equipment and instruments that includes:

● Name of manufacturer
● Model and serial number
● Date of purchase or acquisition
● Date of installation
● Purchase cost
● Current location
● Electric power requirement

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 ● Record of contracted maintenance, and
● Record of equipment down time

Manufacturers’ manuals should be attached to, or stored beside, each instrument. Laboratory
equipment should only be used by appropriately trained staff (s). An equipment usage logbook or
form can be completed by laboratory staff to indicate the duration of use and name of the person
who used the equipment.

3.5.1 Laboratory Equipment Maintenance

There should be a predefined program for preventive maintenance, calibration and monitoring of
equipment function. Maintenance information should be properly documented and a
maintenance activity should follow a minimum of manufacturer’s recommendations. The Quality
officer (QO) is responsible to ensure that instruments in the laboratory are maintained properly,
daily controls and calibrators are run, and maintenance logs are kept up to date.

Curative maintenance of laboratory equipment must be performed by trained senior professionals

or engineers (biomedical engineers) as soon as possible to minimize equipment down time and
decrease client waiting time in the facility. The equipment supplier office or bio-medical
engineer contact information must be posted on specific equipment. The record of curative
maintenance should be signed and documented in the equipment life book.

3.5.2 Preventive Maintenance

Periodic maintenance prior to equipment failure will prevent accidental breakdown and increase
performance. Systematic Preventive Maintenance includes adjusting, calibrating, changing
parts, following shut down procedures, and performing general cleaning procedures (such as
blowing, rinsing, wiping, flushing). Cleaning procedures should adhere to Standard Operating
Procedures that apply to each instrument.

The Operator laboratory professional (user) should perform daily, weekly, monthly and/or
quarterly preventive maintenance for each type of equipment in the laboratory. All preventive
maintenance activities should be recorded in a maintenance log for each piece of equipment.

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Service engineers from the appropriate company or EPHI should perform semi-annual or annual
preventive maintenance on the larger more complex instruments. A log must be completed with
copies held on site and by the service engineer.

3.5.3 Equipment calibration

There should be a timetable for the calibration and maintenance of each piece of equipment.
Otherwise calibration should be performed:

● Based on the specifications of the manufacturer

● After a complete change of reagents
● Where controls show unusual trends
● After major preventive maintenance
● After replacement of critical parts
● When the procedure requires more calibration
3.5.4 Laboratory Reagents and Supplies Management System
Reagents should be stored according to manufacturer’s recommendations. All reagents and other
supplies should be:

● cataloged and stored accordingly to aid retrieval

● reagents and supplies should be dispensed first expiry first out
● properly stored according to manufacturer’s instructions
● discarded when the shelf life is expired
● labeled to indicate identification and, when applicable, significant titre strength or
concentration
● marked with date of preparation or receipt
● marked with the date opened, the date that the reagent was first opened must be written
on the container with a standard plastic laminated form. If reagents are dispensed from
intact stock containers by dilution or any other treatment, the date of preparation as well
as the duration should be written
● the components of reagent kits of different lot numbers should not be interchanged unless
otherwise specified by the preparer
● reagent validation and monitoring should be done prior to use

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3.5.5 Inventory control of Reagent and supply
To ensure the smooth operation of a laboratory, the management should be involved in the
purchase, storage, and distribution of laboratory reagents and supplies. If another department,
such as finance or pharmacy, is responsible for purchasing these items, they should consult with
the Laboratory Manager beforehand. To keep track of inventory levels, the laboratory should
establish a control system using either a stock/bin card or an electronic cataloging system. This
system should record the reagent name, supply on hand, and expiration date to allow staff to
compare the current stock in the laboratory and warehouse to avoid unexpected stockouts.
Transactions of commodities should be traceable and auditable, using formats such as the
internal facility report and requisition form (IFRR). Electronic Supply Chain Management
(eSCM) systems are essential in laboratories. They help track and manage inventory levels,
monitor the movement of goods, and improve communication with suppliers and customers. This
results in better decision-making, reduced costs, and improved customer satisfaction. eSCM
systems also help reduce errors and delays in the supply chain process, improving productivity
and increasing profitability. They provide organizations with real-time visibility into their supply
chain, which helps identify areas for improvement and optimize processes.

3.5.6 Reagent and supply storage condition

The reagents and supplies should be stored in appropriate storage areas with better security,
adequate ventilation and monitored appropriate temperature. The storage temperature should be
monitored with standardized and calibrated thermometers. The reagents and chemicals should
not be exposed to direct sunlight. Laboratory reagents and supplies should be stored in a mini-
store that is managed by a person delegated by the laboratory manager.

3.6 Process control

Process control consists of several factors that are important in ensuring the quality of the
laboratory testing processes. These factors include quality control for testing, participating in
external quality assessment programs, appropriate management of the sample, including
collection and handling, and method verification and validation.

3.6.1 Pre-analytical phase

Sample management:

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 1. The laboratory should prepare a requisition form to provide all detailed information.
(Patient ID, tests requested, time and date of the sample collection, source of the sample,
clinical data and contact information for the health care provider requesting the test).
2. The laboratory should have specimen management guidelines which includes how to
handle incorrectly identified specimens.
3. Each primary sample should have a unique accession number with date and time of
receipt.
4. Specimen collection SOP should be there for all sample types.
5. Urgent requests should be handled with special attention and develop communication
procedure with physicians.
6. The laboratory should have a clear collection, labeling (minimum of two identifiers),
preservation and transport (triple packaging) procedure.
7. There should be a safety practices (leaking or broken containers, contaminated forms,
other biohazards) in the laboratory
8. The laboratory develops a system for evaluating, processing and tracking samples timely.
9. The laboratory results should be approved and assigned by responsible personnel before
it goes out from the laboratory
10. The laboratory should keep a register (log) of all incoming and referred samples. The
register should include date and time of collection; date and time the sample was received
in the laboratory; sample type; patient name and demographics; laboratory assigned
identification; and performed tests.
11. The laboratory should develop an SOP for specimen storage, retention and disposal and
practice according to these SOPs.
12. Referral samples should be registered by the laboratory for tracking and its results should
be written in a log to ensure receipt of results and for further reference.
3.6.2 Analytical phase
Internal Quality Control (IQC) programmed
The goal of IQC is to detect, evaluate, and correct errors due to test system failure,
environmental conditions or operator performance, before patient results are reported. All
laboratory tests should have a quality control mechanism. Quality control processes vary,

15
depending on whether the laboratory examinations use methods that produce quantitative,
qualitative or semi quantitative results. These examinations differ in the following ways:

Quantitative examinations measure the quantity of an analyte present in the sample, and
measurements need to be accurate and precise. The measurement produces a numeric value as an
end-point, expressed in a particular unit of measurement. The laboratory should follow the
following steps during implementing a quantitative QC:

● Establish policies and procedures

● Assign responsibility for monitoring and reviewing
● Train all staff in how to properly follow policies and procedures
● Select good QC material
● Establish control ranges for the selected material
● Develop graphs to plot control values—these are called Levey–Jennings charts
● Establish a system for monitoring control values
● Take immediate corrective action if needed
● Maintain records of QC results and any corrective actions taken.

Qualitative examinations are those that measure the presence or absence of a substance, or
evaluate cellular characteristics such as morphology. The results are not expressed in numerical
terms, but in qualitative terms such as “positive” or “negative”; “reactive” or “non-reactive”;
“normal” or “abnormal”; and “growth” or “no growth”.

● The laboratory should keep records of all QC processes and corrective actions
● When problems occur, investigate, correct, and repeat patient testing

Semi-quantitative examinations are similar to qualitative examinations, in that the results are not
expressed in quantitative terms. The difference is that results of these tests are expressed as an
estimate of how much of the measured substance is present. Results might be expressed in terms
such as “trace amount”, “moderate amount”, or “1+, 2+, or 3+”.

16
External Quality Assessment (EQA) program
EQA is a method that allows for comparison of a laboratory’s testing to a source outside the
laboratory. This comparison can be made to the performance of a peer group of laboratories or to
the performance of a reference laboratory.

The laboratory should participate in EQA challenges, and this should include EQA for all testing
procedures performed in the laboratory. Currently EPHI coordinates EQA activities at national
levels and provides panels for different laboratory tests in Ethiopia. Laboratory EQA programs
are implemented in the form of:

● Proficiency testing—an external provider sends unknown samples for testing to a set of
laboratories, and the results of all laboratories are analyzed, compared and reported to the
laboratories.
● Rechecking or retesting—slides that have been read are rechecked by a reference
laboratory; samples that have been analyzed are retested, allowing for inter-laboratory
comparison.
● On-site evaluation—usually done when it is difficult to conduct traditional proficiency
testing or to use the rechecking/retesting method.

The laboratory should ensure that all EQA samples are treated in the same manner as patient
samples tested and this will be supported with an SOP. Procedures should be developed to
address:

● Handling of samples—these will need to be logged, processed properly and stored as

needed for future use.
● Analyses of samples—consider whether EQA samples can be tested so that staff does not
recognize them as different from patient samples (blinded testing).
● Appropriate record keeping—Records of all EQA testing reporting should be maintained
over a period of time, so that performance improvement can be measured.
● Investigation of any deficiencies—for any challenges where performance is not
acceptable.

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 ● Taking corrective action when performance is not acceptable—the purpose of EQA is to
allow for detection of problems in the laboratory, and to therefore provide an opportunity
for improvement.
● Communication of outcomes to all laboratory staff and to management.
Hospital laboratories must comply with all national EQA requirements. Another method of inter-
laboratory comparison is the exchange of samples among a set of laboratories.

Point of care testing Quality assurance

Laboratory testing quality assurance is important in Ethiopia because it ensures that the results of
tests conducted in laboratories are accurate, reliable, and consistent. Quality assurance measures
help to identify and correct errors in testing processes, ensure that instruments and equipment are
calibrated correctly, and that testing personnel are properly trained and qualified. This ultimately
leads to better decision-making, improved public health outcomes, and increased confidence in
the reliability of laboratory test results.

3.6.5 Post analytical Phase

The laboratory result should be reported on a standard report format that contains laboratory,
patient, sample and other information (name of requester, person authorizing result release,
reference range, etc...) related to the test/is performed. The laboratory request should be cross-
checked with results to ensure all tests have been completed. The result should be reviewed and
signed out by the name of authorized personnel before being released to the requester or patient.
The laboratory should also have a policy and procedure for how it handles samples unsuitable for
testing and how all samples are managed after reporting the result.

3.7 Occurrence/Incidence management and Risk management

3.7.1 Occurrence/Incidence Management:

In healthcare, the occurrence or incidence management program plays a pivotal role in

addressing events that have a negative impact on an organization. These events may affect
personnel, products, equipment, or the environment in which the organization operates. To
ensure continual quality improvement, the laboratory must adopt a proactive approach, which
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includes preventive, remedial, and corrective actions. Preventive actions involve a systematic
evaluation of processes and procedures to identify potential error points, requiring planning and
team participation. Remedial actions focus on fixing consequences resulting from errors, such as
notifying concerned parties about erroneous results. Corrective actions delve into addressing the
root cause of errors and implementing steps to prevent their recurrence. The laboratory utilizes
outcomes from internal audits, proficiency testing, customer feedback, and tracking of quality
indicators to improve overall performance. These actions are monitored and documented through
occurrence reports, fostering a culture of continuous learning and improvement.

3.7.2 Risk Management:

Risk management is a crucial aspect of ensuring the stability and resilience of laboratory
operations. The laboratory's risk management policy and procedures provide a structured
framework for identifying, evaluating, and managing risks. A comprehensive risk register
documents all identified risks, assessing their likelihood and potential impact on laboratory
operations. The risk evaluation process involves a systematic assessment of each identified risk
to determine its significance. The laboratory's risk management plan outlines strategies and
actions to manage identified risks effectively. Additionally, the notification process ensures that
the Senior Management Team (SMT) is promptly informed of significant risks, allowing for
timely intervention. Evaluation of the risk management process involves assessing the
appropriateness of risk identification, evaluation, and management, as well as the effectiveness
of SMT notification procedures. This comprehensive approach to risk management contributes to
the overall stability and resilience of laboratory operations, aligning with best practices in the
healthcare industry.

3.8 Laboratory Information Management System (LIMS)

Information management is a system that incorporates all the processes needed for effectively
managing data—both incoming and outgoing patient information. The information management
system may be entirely paper-based, computer-based, or a combination of both.

The laboratory information system shall be strengthened and mainstream into other HMIS and
disease control information systems and have a system to ensure that the laboratory has an
effective information management system in place in order to achieve accessibility, accuracy,
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timeliness, security, confidentiality and privacy of patient information. When planning and
developing an information management system, whether it is a manual, paper-based system, or
an electronic system, there are some important elements to consider:

● Unique identifiers for patients and samples

● Standardized test request forms (requisitions)
● Logs and worksheets
● Checking processes to assure accuracy of data recording and transmission
● Protection against loss of data
● Protection of patient confidentiality and privacy
● Effective reporting systems
● Effective and timely communication
● It is important to establish a means to protect against loss of data. For paper based
systems, this will involve using safe materials for recording and storing the records
properly. For computerized systems, scheduled or regular backup processes are very
important.
● It is of utmost importance to safeguard a patient’s privacy and, in this regard, security
measures must be taken to protect the confidentiality of laboratory data.
● Laboratory directors/managers are responsible for putting policies and procedures in
place to ensure confidentiality of patient information is protected.
● Attention should be given to the reporting mechanism to ensure that it is timely, accurate,
legible and easily understood.
● There shall be a predefined schedule and guideline for proper data back-up.
3.9 Laboratory Safety program
A laboratory safety program is important in order to protect the lives of employees and patients,
to protect laboratory equipment and facilities, and to protect the environment. It is a minimum
requirement for a hospital to have a biosafety level 2 laboratories.

The biosafety level BSL-2 is utilized when working with human blood, body fluids, or tissues
where the presence of an infectious agent is unknown. Accidental percutaneous or mucous
membrane exposure, exposure of non-intact skin, or ingestion of infectious materials are the
20
primary hazards at BSL-2. It includes work with agents connected with human disease, or
pathogenic or infectious organisms that pose a moderate risk. When performing standard
diagnostic procedures or working with clinical specimens, examples include equine encephalitis
viruses and HIV.

● The responsibility for developing a safety program and organizing appropriate safety
measures for the laboratory is assigned to a laboratory safety officer. In smaller
laboratories, the responsibility for laboratory safety may fall to the laboratory manager or
even to the quality officer. The steps for designing a safety management program include:
● Developing a manual to provide written procedures for safety and biosafety in the
laboratory; organizing safety training and exercises that teach staff to be aware of
potential hazards and how to apply safety practices and techniques—training should
include information about universal precautions, infection control, chemical and radiation
safety, how to use personal protective equipment (PPE), how to dispose of hazardous
waste, and what to do in case of emergencies; setting up a process to conduct risk
assessments—this process should include initial risk assessments, as well as ongoing
laboratory safety audits to look for potential safety problems.
● There must be eyewash, a sink for hand washing, and emergency shower. When working
with infectious agents, use proper PPE, Standard BSL-2 PPE includes a lab coat, gloves,
and eye protection. Other protective equipment may be required like First aid equipment,
Fire extinguishers and fire blankets, appropriate storage and cabinets for flammable and
toxic chemicals and Waste disposal supplies and equipment. (Refer: see EH&S PPE
Assessment Guide and National Hospital IPC manual.
● The safety officer should be assigned with proper job description, Induction, and
appropriate training.
The laboratory shall put in place measures to safeguard against malicious use of chemicals,
infectious agents and other harmful materials. Policies should be put in place that outline the
safety practices to be followed in the laboratory. Standard laboratory safety practices include:

● Limiting or restricting access to the laboratory

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● Washing hands after handling infectious or hazardous materials and animals, after
removing gloves, and before leaving the laboratory
● Prohibiting eating, drinking, smoking, handling contact lenses, and applying cosmetics in
work areas
● Prohibiting mouth pipetting
● Using techniques that minimize aerosol or splash production when performing
procedures—biosafety cabinets should be used whenever there is a potential for aerosol
or splash creation, or when high concentrations or large volumes of infectious agents are
used
● Preventing inhalation exposure by using chemical fume hoods or other containment
devices for vapors, gasses, aerosols, fumes, dusts or powders
● Properly storing chemicals according to recognized compatibilities—chemicals posing
special hazards or risks should be limited to the minimum quantities required to meet
short-term needs and stored under appropriately safe conditions (i.e. flammables in
flammable storage cabinets)—chemicals should not be stored on the floor or in chemical
fume hoods
● Securing compressed gas cylinders at all times
● Decontaminating work surfaces daily
● Decontaminating all cultures, stocks and other regulated wastes before disposal via
autoclave, chemical disinfection, incinerator or other approved method
● Implementing and maintaining an insect and rodent control programmed
● Using PPE such as gloves, masks, goggles, face shields and laboratory coats when
working in the laboratory
● Prohibiting sandals and open-toed shoes to be worn while working in the laboratory
● Disposing of chemical, biological and other wastes according to laboratory policies.
● Hospital Laboratory staff who have direct contact with harmful infectious agents should
be vaccinated. For example, they should be vaccinated for Hepatitis B
● Construction and renovation of laboratories shall be in conformity with national
standards and guidelines (Refer FMHACA National Minimum Standard for different
Health Facilities). (Refer: National Hospital IPC Manual on Healthcare Waste
Management).
22
3.10 Backup laboratory services
The Hospital ensures that there is no interruption to laboratory services in the event of: staff
shortage, equipment breakdown, and prolonged power outages, stock outs of reagents and
consumables, fire, natural disasters.

The backup laboratory service improves the provision of the service to deliver results through
avoiding interrupted service. Therefore the Hospital shall have MOU with other nearby facilities
(Regional laboratory) and use backup service whenever their services get interrupted. The
Hospital laboratory should avail backup laboratory equipment and supplies to avoid service
interruption.

Where the hospital laboratory uses another laboratory as a backup, the performance of the back-
up laboratory shall be regularly reviewed to ensure quality results.

3.11 Public private partnership

Public private partnerships (PPPs) to strengthen laboratory services

Public-Private Partnerships are defined as a variety of co-operative arrangements between the

government and the private sector in delivering goods or services to the citizens. PPPs provide a
vehicle for coordinating with non-governmental actors to undertake integrated, comprehensive
efforts to meet community needs.

PPPs can be implemented in various areas related to laboratory services, including:

1. Diagnostic testing: PPPs can be used to provide diagnostic testing services, including
laboratory tests and imaging services. This can help to improve access to these services in
underserved areas or where public sector laboratories are overburdened.
2. Equipment and technology: PPPs can be used to acquire and maintain laboratory
equipment and technology. This can help to ensure that laboratories have access to the
latest technology and equipment, which can improve the quality of laboratory services.
3. Training and capacity building: PPPs can be used to provide training and capacity
building for laboratory staff. This can help to improve the skills of laboratory staff and
ensure that they are able to deliver high-quality laboratory services.

23
 4. Quality assurance: PPPs can be used to establish quality assurance programs for
laboratory services. This can help to ensure that laboratory services are delivered to a
high standard and that patients receive accurate and reliable test results.
5. Laboratory management: PPPs can be used to provide laboratory management services,
including procurement, inventory management, and quality control. This can help to
improve the efficiency and effectiveness of laboratory services and reduce costs.
Overall, PPPs can be implemented in various areas related to laboratory services, depending on
the specific needs and challenges faced by each country or region. By working together, the
public and private sectors can leverage their respective strengths to improve the quality and
accessibility of laboratory services.

3.12 Blood Transfusion Service

Hospital laboratories should establish a mini blood bank and provide a blood transfusion service.
Blood received from the regional blood bank should be stored in regularly monitored
refrigerator/s. Quality assurance measures should be in place to ensure the correct storage
temperature is maintained at all times. Refrigerators or freezers for blood storage should have a
back- up electricity supply in case of mains failure.

3.12.1 Facility and systems requirements

The hospital shall have a transfusion committee and sign an MOU with respective blood bank
service and should have enough space, equipment, to perform compatibility tests and to store
blood and blood products received from the blood bank service.

The minimum area of the hospitals’ blood and blood product store should be 12 meter square.
The size will increase depending on the amount of products the health facility receives from the
blood bank service and should have the following:-

1. Laboratory refrigerator to store whole blood at 2-6oc

2. Deep freezer to store plasma products <-180c
3. Platelet agitator to maintain viability of the platelet product before transfusion
4. Blood warmer
5. Space for compatibility testing
6. Water bath

24
Documents and Records of blood bank services

The hospital mini blood banks have well created, reviewed, approved and authorized documents
that are helpful for blood transfusion service like policies, process procedures, job aids and
forms.

Records

A Facility wristband containing patient’s name and unique Facility ID number must be placed on
the patient prior to specimen collection and must remain on the patient until completion of the
transfusion.

Collection of records of clerical errors and serious adverse effects of transfusion should be in
place to ensure positive identification of specimens, requisition forms, blood and blood
components, and patients.

3.12.2 Blood and Blood Components storage

Whenever possible, temperatures of refrigerators and freezers in which blood and/or blood
components are stored should be fitted with a device that continuously measures and records the
temperature inside the equipment. A maximum and minimum temperature recording
thermometer should be placed in the refrigerator or freezer and the following temperatures
should be recorded a minimum of four times a day (every 6 hours).

These temperatures should be recorded and the maximum and minimum thermometer reading
should be re-set following each reading.

3.12.3 Blood and Blood Components Transportation

The standard transfusion request form prepared by National Blood Bank Services should be
filled appropriately. Blood units are packed in a sealed, temperature-validated transport container
according to SOP for the type of component being issued. Only one patient’s components are
packed per transport container for facilities that do not have appropriate blood storage
equipment. For other facilities, components requiring different storage temperatures should be
packed in different transport containers.

25
Issue of Blood Components for Transfusion

Facilities are required to perform a final check of records relating to the component at the time of
issue. One of the records to be checked is existing records of the recipient. These records provide
the previous ABO and RhD type of the recipient, which should match the blood group of the unit
to be issued.

Special instances

1. Neonatal transfusion (i.e. for infants under the age of 4 months): To perform neonatal
exchange transfusions, the freshest (less than 7 days old), usually group O RhD negative,
blood is used.
2. ABO group compatible red blood cell-containing components shall be issued, which
should also be ABO compatible with the mother.
3. RhD compatible red blood cell components shall be issued, which should also be
compatible with the mother.
3.12.4 Blood transfused in cases of dire emergency:
The health facility shall have procedures for the issuing of blood and blood components on an
emergency basis when full compatibility testing is not possible. In this instance, the patient’s
physician must weigh the risk of transfusing blood or blood components that have not undergone
compatibility testing, or those for which compatibility testing has not been completed, against
the risk of delaying transfusion until compatibility testing is complete. When a delay in
transfusion may be detrimental to the recipient, blood and blood components that do not meet
requirements should only be released when the following conditions are met:

1. The recipient of a transfusion whose blood group is not known should receive blood
which is Group O and RhD negative (particularly if the recipient is a female with child
bearing potential).
2. Recipients of a transfusion whose blood group is known should receive ABO and RhD-
compatibility, if there has been time to test a current specimen.
3.12.5 Blood Administration
Hospital is responsible for the administration of blood and blood components shall provide
procedures for the use of all transfusion equipment such as blood warmers and the various filters

26
that are available. Information should be made available regarding the obtaining of informed
consent and the patient monitoring that is required during transfusion as well as the signs and
symptoms indicative of an adverse transfusion event. Procedures should be available for the
recognition, evaluation, and treatment and reporting of adverse events. Thawing of FFP should
be accomplished using a validated thawing device, specifically designed to thaw frozen plasma.
The thawing device should have a temperature monitoring device.

3.12.6 Adverse transfusion events

The transfusing health facility may want to develop forms to encourage the recognition and assist
in the reporting and management of adverse events related to transfusion, such as transfusion-
transmitted infections and hemolytic transfusion reaction. The health facility should encourage
the reporting of these events. When transmission of an infectious disease is suspected to be the
result of transfusion, the hospital shall report that information to the respective blood bank
service.

The hospital is responsible for transfusing blood and blood components shall have appropriately
trained and experienced personnel available to provide advice on the use of blood and blood
components, particularly in the case of transfusion events in which the treating physician may
have limited experience, such as massive transfusions, exchange transfusions, platelet
transfusions and the treatment of hemophilia

1. Laboratory management shall ensure that laboratory services, including appropriate

advisory and interpretative services, meet the needs of patients and those using the
laboratory services.
2. The Hospital laboratory shall have documented procedures for the establishment and
review of agreements for providing medical laboratory services

27
SECTION FOUR: SUMMARY
Laboratories plays significant role in provision of quality health care. Hospital laboratories are
expected to establish and maintain the quality of services they are providing. This chapter
covered list of operational standards that the laboratories are expected to comply and provides
detail guidance on implementation of these operational standards. The operational standards are
selected based the national priority areas for improvement of laboratory services and ISO and
WHO recommendations.

The operational standards mainly covered the laboratory management structure, quality
management system, management of documents and records, effective customer service
program, Laboratory equipment management system, supplies management system, process
control system, incidence handling and reporting system, laboratory information management
system, laboratory safety program, laboratory back up services and blood bank services.

Assessment checklist list has also been prepared as a supplement, which can be used for self-
evaluation and national evaluation. The laboratory management is expected to regularly review
and acquaint itself with the guideline, self-evaluate and plan and implement activities that can
improve the quality of services they are providing.

1
 Implementation Checklist Laboratory Services
CHA PTER 9. LABORATORY SERVICES MANAGEMENT
S.N OPERATIONAL VERIFICATION CRITERIA Weight Score Remark
STANDARDS
1 The hospital has View organization chart, 1
established
Check the laboratory has personnel record for 2
laboratory
each its staff (Educational qualification,
management
Experience, license, JD, training certificates,
structure and
COC…)
accountability
arrangement. Check assignment of full time quality and 1
safety officers
Check central laboratory controls the 1
emergency and inpatient laboratory services
(minutes, reports.)
View central, emergency and inpatient 1
laboratories functionality
Sub total 6
2 The hospital Inspect certification of accreditations and how 6
laboratory much scopes are accredited. If 6 and more
management has scopes accredited give full point. Below 6 will
develop and have equivalent score
implement quality
View the laboratory-produced updated quality 1
management
manual, and sample management guidelines.
system to ensure
continually quality Availability of SOPs for all technical and 1
improvement administrative procedures in all service areas
at work place
Confirm the availability of updated, Formats , 1
Job aids and instructions in work place
Check each lab, Staff are aware of and follows 1
the SOP for the laboratory tests they are
performing.
Check the laboratory has identified the quality 2
gaps and prepared annual quality improvement
plans.

1
 Confirm at least 50% of lab staff have 2
competence assessment result with the
moment assigned task
Sub total 14
3 The hospital Check SOPs for document preparation 2
laboratory has
Check SOPs for document control (Master 1
established system
List documents)
for management of
documents. Check absence of obsolete document at work 1
place
Check SOPs for record control 2
View record disposal procedure with practice 2
Sub total 8
4 The hospital Confirm the laboratory handbook is prepared 2
laboratory has and distributed to clinical departments.
established system
View customer satisfaction survey report and 2
and practice to
implementation of identified gaps
monitor the
effectiveness of its View presence of suggestion box /book, 1 ·
customer service summary of reviews and actions taken in the
program. past quarter.
The laboratory has established communication 1
mechanism for panic results. Check list of
panic test results is posted
The laboratory has all types of tests listed in 2
menu based on national standards for the
hospital level.
Sub total 8
5 The hospital Confirm if the laboratory is implementing 1 ·
laboratory has MEMS for its laboratory equipment
established and management
implements a
Check record of equipment/method 1
proper equipment
verification done.
and supply
management Check the laboratory has updated equipment 1
system. inventory

2
 Check a record of preventive and corrective 1
maintenance for all clinical laboratory
equipment as per manufacturer
recommendation (Maintenance log)
Check the implementation of electronic supply 1
chain management system.
Check record of regular calibration of 2
equipment as per the manufacturer’s
recommendation.
Check updated SOPs ( Operational, Preventive 1
maintenance) job aids, forms,… for each
M/Es at each department
View laboratory has mini store for lab supplies 2 ·
and reagents that should be clean, safe and
well ventilated with regular room temperature
monitoring
View updated Bin cards are used to manage 1
laboratory supplies and reagents (check 5
randomly selected bin to update)
Confirm the use of IFRR for requesting and 1
receiving reagents and supplies from the store
View SOP for reception, storage, acceptance 1
testing and inventory management of reagents
and consumables.
Sub total 13
6 The hospital Pre- examination: 1
laboratory shall
View well established and isolated sample
implement a
collection area.
process control
system and View sample collection manual ready for use 1
documented in work place.
procedure to
identify and check record of risk identification, evaluation 2
manage and management plan and notification to SMT
nonconformities in for a better risk apatite.
any aspect of Examination phase: 2 ·
the quality
Obtain records of valid IQC for all tests in
3
 management regular manner
system.
Confirm whether the laboratory participates in 2
any recognized EQA (PT scheme) or intra
laboratory evaluation and scored ≥80% for
tests included in that scheme.
Check IQC and EQA out comes evaluated 2
regularly with Lab. staffs and SMT with
actions for gaps
Lab. staffs forum with clinical staffs at least 1
quarterly to improve services and Pt, care
Post- Examination: 1
Confirm a system to review results before
release independent of testing personnel
View a TAT established for every test and 1
evaluated regularly
Verify And Check record of point of care 1
testing quality assurance
Sub total 14
7 The hospital View records of occurrences or incidences 2 ·
laboratory has
View deviations identified and actions taken 2
established
for improvement and prevent recurrence
incident handling
and reporting
system.
Sub total 4
8 The hospital has View written procedure for the laboratory 2
established information management system
Laboratory
The hospital established computer based 2
Information
laboratory information management system
Management
linked with the rest of EMR
System
All laboratory personnel are training in of 1
EMR recording and reporting system.
The hospital has external data backup system 1

4
Sub total 6
9 The laboratory View the laboratory has updated safety manual 1 ·
shall develops and
Ensure the laboratory has safety program 2
implements a
(check if there is annual safety objectives and
program to ensure
plans) and monitored accordingly
the safety of
laboratory services Confirm the following safety equipment and 2
and facilities supplies are available, inspected and are
working; first aid kit, fire extinguisher, and
emergency shower, eye wash, PPE etc)
Observe every laboratory staff are using 1
proper PPE while working in the laboratory
Work stations, floor and walls are clean and 1
well maintained.
Observe for restricted access when work is in 1
progress
Sub total 8
10 The hospital Confirm if a system designed for back-up 2 ·
laboratory shall laboratory service
have backup
View MOU signed with back up laboratory 1
laboratory service
facility.
within and
between hospital View back-up (water, equipment, electric 2
laboratory power, supply) made ready by the hospital

Sub total 5
11 The hospital Observe MOU of Public private partnership 1
laboratories create between
public-private
private and governments laboratory
partnership in the
delivery Check MOU contain at least following: list of 1
laboratory service. laboratory service, price, payment mechanism
and schedule, turnaround time, responsibility
on quality of service etc
Check MOU is reviewed based on the 1
schedule.

5
Sub total 3
12 The hospital has The hospital has separate mini blood bank 2 ·
blood bank service
that adhered to The laboratory has formally assigned qualified 1
appropriate laboratory personnel for blood bank and/or
standards of transfusion services.
practice The blood bank laboratory has developed and 2
updated SOPs and guidelines for its services
Check the laboratory maintains and monitors 1
temperature of storage areas for blood and
components.
The hospital has transfusion committee and 1
focal person. (Check letter of assignment
letter, TOR and annual plan of the committee
members and focal person.)
Check the HTC coordinated a blood collection 1
campaign as per the plan and schedule

Check updated equipment and supplies 1

inventory and check their functionality of each
equipment For mini blood bank
Check the presence of documents and records 1
for blood received ,blood issued and
compatibility test
Check if the laboratory is calculating average 1
daily consumption for each unit of blood and
blood product
Sub total 11
Total 100

6
Reference

1. International Organization for Standardization. (2012). ISO 15189:2012 Medical

laboratories -- Requirements for quality and competence.
2. International Organization for Standardization. (2022). ISO 15189:2012 Medical
laboratories -- Requirements for quality and competence.
3. CLSI. (2018). Laboratory Quality Control Based on Risk Management. CLSI document
QMS
4. CLSI. (2019). Understanding and Meeting Customer Needs. CLSI document QMS05.
Clinical and Laboratory Standards Institute.
5. CLSI. (2014). Method Validation and Verification for Laboratory Diagnosticians. CLSI
document EP15-A3. 3rd ed. Clinical and Laboratory Standards Institute.
6. Strengthening Laboratory Management Toward Accreditation. (2016). SLMTA Checklist.
Retrieved from https://www.slmta.org/wp-content/uploads/2016/09/SLMTA-Checklist-
English.pdf
7. Ethiopian Food, Medicine, and Healthcare Administration and Control Authority. (2020).
Test Menu. Retrieved from https://www.fmhaca.gov.et/wp-content/uploads/2020/02/TEST-
MENU-1.pdf
8. World Health Organization Regional Office for Africa. (2014). Checklist for Accreditation
of Medical Laboratories in the African Region. Retrieved
from https://www.afro.who.int/sites/default/files/2017-06/WHO AFRO Checklist for
Accreditation of Medical Laboratories in the African Region.pdf

1
Appendix A: Ministre Organo Gram

1
 Appendix B: Sample Preventive Maintenance Log
Document No:
NAME OF HOSPTAL NHCL/F5.3-25
Clinical laboratory Copy No: Rev No:
0 0
Page No: Effective date:
Sample Preventive Maintenance Log
1 of 582 01 Jan.15

Time and Activity 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

Daily

Weekly

1
Monthly

Initials

2
Appendix C: Sample Request form for New and Used spare parts of Instrument
Document No:
NAME OF HOSPTAL NHCL/F5.3-25
Organization Arma
Clinical laboratory Copy No: Rev No:
0 0

Sample Request form for New and Used spare parts of Instrument Page No: Effective date:
1 of 582 01 Jan.15

Date Department/Instrument name

Items names & New Used Requested by Received by Signature
identification No

1
Appendix D: National SOP Template
Document No:
NAME OF HOSPTAL NHCL/F5.3-25
Hospital Arma
Clinical laboratory Copy No: Rev No:
0 0

Sample Request form for New and Used sparePage No: Effective date:

parts of Instrument 1 of 582 01 Jan.15

Purpose

 Explains the management of all SOPs. This procedure ensures correct management of
SOPs.
Objective

 This procedure explains the process of SOP management.

Definitions

 SOP(s): Standard Operating Procedure(s)

References

 To be filled in if necessary
Responsibilities

 The Quality Manager is responsible for organizing and supervising SOP management. The
technical or managerial staff is responsible for writing SOPs. The senior staff with technical
(for technical SOPs) or managerial (for managerial SOPs) knowledge reviews the SOPs. The
Laboratory Director / Manager authorize release of SOPs. The Document Controller is
responsible for providing printed copies of SOPs.
Operating mode

Methodology

1
  Managing Standard Operating Procedure (SOP) documents is a critical responsibility and a
cooperative process between all users of the SOP document set. The SOPs need to be
written, reviewed, authorized, published, distributed, revised and archived.
SOPs type

SOPs provide step-by-step instructions to the laboratory’s staff with respect to performing laboratory
tests (analytical SOP), using a piece of equipment (equipment SOP), or successfully carrying out any
kind of procedure/non-test activity (procedural SOP, e.g. SOP Document Distribution).

Each type of SOP follows the same general format:

 Purpose , Objective, Definitions, References, Responsibilities, Operating mode, Related

documents, Analytical/ Technical SOPs also details for each laboratory test: principle,
sample, equipment, reagents, and quality control.
 Equipment SOP details for each piece of equipment: description, safety, start up,
calibration, validation, maintenance, operation, and troubleshooting.
Creation and editing

SOPs are produced from a template. Each section of the template is completed or deleted if not
applicable. Once a draft of the document is ready, it should be sent to senior staff with
technical (for technical SOPs) or managerial (for managerial SOPs) knowledge for review and
comments.

Review and authorization

1. The appropriate staff and the consultant review the first draft of each SOP and make notes
or comments on the draft. Any necessary revisions of the draft are made by the author(s).
This review and revision process continues until the reviewers accept a final version.
2. Each SOP is then sent to the Laboratory Director / Manager for authorization of release.
Once the SOP is authorized, it is sent to the Document Controller for hardcopies to be
printed. The authorization of the final SOP version is noted by the Laboratory Director /
Manager signature on one dated copy. The author(s) and reviewer(s) also sign this copy.
Publishing

3. Authorized SOPs should have sufficient copies printed for distribution.

2
 4. Signed documents (originals) should be stored in file cabinets.
5. Electronic versions of SOPs should be stored on a secure file server with access
restricted to authorized users.
Distribution

6. Finalized and authorized SOPs are distributed to the staff that requires them for
referral.
7. The Quality Manager will keep track of which staff members need specific SOPs,
and will determine who has actually read and demonstrated comprehension of the
documents as well. (Refer to SOP Document Distribution).
Revision of existing SOPs

1. Each SOP is reviewed every year. The review can result, or not, in modification(s)
of the SOP. The review process is coordinated by the Quality Manager.
2. The decision to modify a laboratory procedure should not be made casually, but
should only be recommended after thorough consideration. The reasons for the
revision and the changes shall be sufficiently documented to ensure that the rationale
for the revision is clear.
3. If possible, changes to existing procedures should be made by the original author(s).
If not, the Quality Manager coordinates the changes with the appropriate staff.
4. After a decision to modify a procedure has been reached, the Quality Manager will
serve as the point of contact responsible for ensuring that the new procedure is
properly reviewed, authorized, and recorded for use.
5. After a SOP has been revised, the following shall be identified on the front page of
the document:
 The date of the revision,
 The person making the revision,
 The changes made (and the reasons for the revision)
Archiving SOP versions

 When a published and distributed document has been revised, the previous version should be
stored in an archive for 2 years and later discarded. This includes both the hardcopy and any
electronic copies of the document.
3
Related documents

 4.3-01 Document Master List

 4.3-02 Form For Document Distribution List
 4.3-03 Form For Document Change Requesting Memo
 4.3-04 Form For Document Requesting
 4.3-08 Check list for new document formality
 4.3-06 Form for Quality Management System Documents Transportation Log

Prepared by:_____________________ Date:________________ Signiture:____________

Aproved by:_____________________ Date:________________ Signiture:_____________

Appendix D: List of laboratory tests to calculate laboratory test availability in Compressive

Specialized Hospital Laboratory

No Types of laboratory test Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7

1 Blood glucose
2 Cholesterol
3 Triglyceride
4 LDL
5 HDL
6 Na+
7 K+
8 Cl-
9 T. Calcium, Iodized Ca
11 PO4
12 ALKP

4
13 AST
14 ALT
15 d GT
16 Total bilirubine
17 Direct bilirubine
18 Total protein
19 Albumin
20 Urea
21 Creatinine
22 Uric acid
23 LDH
24 CK-MB
25 Troponine
26 CPK,
27 T3
28 T4
29 TSH
30 FSH
31 LH
32 Testosterone
33 Prolactine
34 Stool microscopy
35 Blood Film
36 Occult blood
37 Urinalysis chemical test
38 Urinalysis Microscopy
39 Criptococal Ag test
40 Ascitic fluid
41 Pleural fluid
42 KOH test

5
43 Fungal culture
44 Haemoglobin
45 Total WBC count
46 Differential white cell count
47 Peripheral blood film
48 ESR
49 Hematocrit
50 Platelet count
51 Bleeding time
52 Reticulocyte count
53 prothrombin time
54 APTT
55 INR
56 Hb electrophoresis
57 Lupus Erythematosus(ANA)
58 H.Pylori Ab
59 H. pylori Ag
60 Troponin
61 HBs Ag
62 HCV
63 Toxoplasma latex
64 ASO
65 RF
66 CD4 count
67 CD pannel
68 RPR
69 TPHA
70 CRP
71 Salmonella Typhi-O
72 Salmonella Typhi-H

6
73 Proteus-OX19
74 HIV-test
75 Earily Infant Diagnosis for HIV
76 Viral load,
77 Blood Group including RH
78 Compatibility testing
79 Cross match
80 Coombs Test
81 Gram stain
82 Ziehl Neelson stain
83 India Ink,
84 Aerobic Culture and sensitivity
test
85 CA-153
86 CA-125
87 CA-199
88 Iron
89 Transferrin
90 RBC folate
91 UIBC (unsaturated iron binding
capacity)
92 Vitamin B 12
93 Febernogen
94 Folate3
95 Ferrtien
96 CK-MB
97 LDH
98 CPK (creatine phosphokinase)
99 Troponine
100 Lipase

7
101 Folate3
102 Speram Ananlysis
103 HgbA1C,
104 Arterial Blood gass analysis
105 HB viral load
106 HC vira load
107 Gxp riff assay
108 OGTT
109 SSS (BI/MI, Leshmania, oncho
110 Anearobic bacterial culture and
sensitivity test

8
Appendix E: List of laboratory tests to calculate laboratory test availability in General Hospital
Laboratory
No Test Name Day1 Day 2 Day 3 Day 4 Day 5
1 Blood glucose
2 GTT
3 Cholesterol
4 Triglyceride
5 LDL
6 HDL
7 Na+
8 K+,
9 Cl-
10 ALKP
11 AST
12 ALT
13 d GT
14 Total bilirubine
15 Direct bilirubine
16 Total protein
17 Albumin
18 BUN
19 Urea
20 Creatinine
21 Uric acid
22 LDH
23 CK-MB
24 Troponine
25 CPK
26 T3
27 T4

1
28 TSH
29 FSH
30 LH
31 Prolactin
32 Testestrone
33 Stool microscopy
34 Blood film
35 Occult blood
36 Urinalysis chemical test
37 Urinalysis Microscopy
38 CSF analysis
39 Ascitic fluid
40 Pleural fluid
41 KOH
42 Haemoglobin
43 Total WBC count
44 Differential white cell count
45 Peripheral blood film ·
46 ESR
47 Hematocrit
48 Platelet count
49 Bleeding time
50 Reticulocyte count
51 prothrombin time
52 APTT
53 INR
54 H.Pylori
55 Troponin
56 HBs Ag
57 HCV

2
58 Toxoplasma latex
59 ASO
60 RF
61 RPR
62 TPHA
63 CRP
64 Troponin Qualitative
65 PAS Qualitative
66 Salmonella Typhi-O
67 Salmonella Typhi-H
68 Proteus-OX19
69 HIV-test
70 HCG
71 Blood Group
72 Compatibility testing
73 Cross match
74 Gram stain
75 Ziehl Neelson stain
76 India Ink
77 Culture and sensititivty
78 Spermatozoa

3
Appendix F: List of laboratory tests to calculate laboratory test availability in Primary Hospital
Laboratory
No Test Name Day1 Day 2 Day 3 Day 4 Day 5
1 Blood glucose
2 ALKP
3 AST
4 ALT
5 GGT
6 Total bilirubine
7 Direct bilirubine
8 Total protein o
9 Albumin
BUN
10 Urea
11 Creatinine
12 Uric acid
13 Stool microscopy
14 Occult Blood Test
15 Blood film
16 Urinalysis chemical test
17 Urinalysis Microscopy
18 CSF analysis
19 Ascitic fluid
20 Pleural fluid
21 KOH
22 Hemoglobin
23 Total WBC count
24 Differential white cell count
25 Peripheral blood film
4
26 ESR
27 Hematocrit
28 Platelet count
29 H. pylori Ags
30 H.Pylori Abs
31 HBs Ag
32 HCV
33 ASO
34 RF
35 RPR
36 Salmonella Typhi-O
37 Salmonella Typhi-H
38 Proteus-OX19
39 HIV-test
40 HCG
41 Blood Group: Anti-A, Anti-B,
AntiD,
42 Compatibility testing
43 Cross match
44 Gram stain
45 Ziehl Neelson stain
46 Indian Ink

5
6
 CHAPTER: 16
INFECTION PREVENTION
AND CONTROL

1
Outline
Section 1 Introduction 1
Section 2 Operational Standards for Infection Prevention and Control (IPC) 3
Section 3 : Implementation Guidance 4
3.1 The hospital has functional infection prevention and control (IPC) Program 4
3.2. The hospital has adapted evidence based IPC guidelines, SOPs and monitoring tools. 4
3.3 IPC Education and Training 6
3.4 Healthcare associated Infections (HAIs) Surveillance 6
3.5 Multimodal Strategies Implementation 7
3.6 Monitoring, Audit and Feedback 7
3.7 Built Environment, Materials & Equipment 7
3.8 Hand Hygiene 8
3.9 Safe Injection Practices 10
3.10 Healthcare Waste Management 12
3.11 Environmental Cleaning 12
3.12 Laundry Service 13
3.13 Medical devices decontamination and Processing Instruments and Reusable Items: 14
3.14 Food and Water Safety 15
3.15. Occupational Safety 16
Annex
…………………………………………………………………………………………………………………………
………………………………………

2
Abbreviations
ART Anti-Retroviral Therapy
CASH Clean And Safe Healthcare facilities
CDC U.S. Centers for Disease Control and Prevention
CEO Chief Executive Officer
HBV Hepatitis B Virus
HAI Healthcare Acquired Infection
HP Healthcare Personnel
HCV Hepatitis C Virus
HCW HealthCare Waste
HCWM HealthCare Waste Management
HEPA High Efficiency Particulate Air
HIV Human Immunodeficiency Virus
IMAI Integrated Management of Adolescent and Adult Illness
IMNCI Integrated Management of Newborn and Childhood Illnesses
IPC Infection Prevention and Control
IPC Infection Prevention and Patient Safety
MDT Multi-Disciplinary Team
MRSA Methicillin Resistant Staphylococcus Aureus
OSHA Occupational Safety and Health Administration
PEP Post Exposure Prophylaxis
PIHCT Provider Initiated HIV Counselling and Testing
PPE Personal Protective Equipment
STI Sexually Transmitted Infections
TB Tuberculosis
WHO World Health Organization

Tables
Table 1: IPC Checklist
Table 2: IPC Indicators

3
Section 1 Introduction

Healthcare facilities are entrusted with the responsibility of delivering high-quality services characterized by safety,
effectiveness, patient-centeredness, timeliness, efficiency, and equity. Central to this mandate is the imperative to
maintain hospital cleanliness and safety, which significantly influences the quality of care and patient satisfaction.
A clean and safe hospital environment fosters comfort and security for patients, attendants, visitors, staff, students,
and the broader community. Given the heightened risk of infection transmission in healthcare settings, both
recipients and providers of care are vulnerable to acquiring and transmitting infections through various exposures.
Healthcare-acquired infections (HAIs) present a significant challenge, defined as those acquired during healthcare
delivery in any setting. Effective infection prevention and control (IPC) practices are paramount in mitigating the
occurrence of HAIs, including those related to antimicrobial resistance, thereby underscoring a hospital's dedication
to patient and staff well-being.
Furthermore, hospitals must uphold the safety of all individuals by preventing infection acquisition and
transmission, especially amid the prevalence of infectious diseases like Tuberculosis, HIV, HBV, HCV, and the
recent COVID-19 pandemic. The recent development of a national IPC Policy and strategy by the Federal Ministry
of Health marks a pivotal step in enhancing IPC program implementation, ultimately elevating patient safety and
healthcare quality. This initiative strengthens the foundation for proactive measures aimed at safeguarding
employees, patients, and visitors, thereby reaffirming the commitment to maintaining a safe and conducive
healthcare environment.

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13-2
Section 2 Operational Standards for Infection Prevention and Control (IPC)

The hospital has functional Infection Prevention and Control (IPC) Program
The hospital has adapted evidence based IPC guidelines, SOPs and monitoring tools
The hospital has IPC training and education program for its HCWs
The hospital has active surveillance for its prioritized HAIs
The hospital implements multimodal strategy to improve its prioritized IPC interventions
The hospital conducts regular monitoring and audit and provide feedback to ensure compliance of
standardized IPC practice
The facility has appropriate built environment, materials and equipment for IPC
Hand hygiene practice is implemented and supplies are provided at all service points at all time
Safe injection practices are implemented to minimize risk to clients, staff and surrounding community
The hospital practices safe healthcare waste management
The hospital ensures cleanliness of health care environment
The hospital avails adequate and functional laundry service
The hospital has proper medical devices decontamination and reprocessing mechanism
The hospital has a monitoring system to ensure safety of food and water served in the premises
The hospital ensures all preventive and post exposure interventions and procedures are in place in case
of occurrence of occupational risks and hazards

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Section 3: Implementation Guidance

3.1 The hospital has functional infection prevention and control (IPC) Program

The purpose of an IPC program is to prevent HAI and combat AMR. Hospitals should have functional
Infection Prevention and Control (IPC) Program Management and governance. The national IPC program
policy and strategy clearly defined its objectives, functions, and activities. The activities of the facility-
level IPC program should be guided by national strategies. Having a strong and functional IPC program at
the facility level is fundamental for the implementation of IPC activities and ultimately for improving
patient safety and the quality of healthcare delivery.
The Infection prevention and control program at the hospital level should be led by well-trained,
dedicated, and full-time IPC professionals. Hospitals should have a minimum ratio of one full-time or
equivalent infection prevention nurse or doctor per 250 beds. The hospital IPC program should be
supported by an IPC team with dedicated time for IPC. In addition, the hospital IPC program should have
clearly defined objectives and operational plans based on local epidemiology and priorities. Hospitals
should have dedicated budgets to implement their operations plans. The IPC programs should cover
defined activities that at least include:
Surveillance of HAIs and AMR.
IPC activities related to patients, visitors and health care workers’ safety and the prevention of AMR
transmission.
Development or adaptation of guidelines and standardization of effective preventive practices (standard
operating procedures) and their implementation.
Outbreak prevention and response, including triage, screening, and risk assessment especially during
community outbreaks of communicable disease.
Health care worker education and practical training.
Maintaining effective aseptic techniques for health care practices.
Assessment and feedback of compliance with IPC practices.
Assurance of continuous procurement of adequate supplies relevant for IPC practices, as well as
functioning WASH services that include water and sanitation facilities and a health care waste disposal
infrastructure.
Assurance that patient care activities are undertaken in a clean and hygienic environment and supported
by adequate infrastructures.

3. 2. The hospital has adapted evidence based IPC guidelines, SOPs and monitoring tools.

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Hospitals should develop/ adapt guidelines and implement for the purpose of reducing HAI and AMR.
Guidelines should be evidence-based and reference international or national standards. Early engagement
and participation of stakeholders in the development and production of guidelines is important to achieve
consensus and support during the implementation phases.
For correct implementation, health care workers (HCWs) should be trained on IPC guideline
recommendations. Processes must be in place to ensure that HCWs in the facility are educated and
understood these guideline’s recommendations. Adherence with these guidelines should be monitored by
the IPC focal person in conjunction with hospital management.
At a minimum, the hospitals should develop/ adapt the following standard operating procedures (SOPs):
Hand hygiene,
Decontamination and reprocessing of medical devices and patient care equipment ,
Environmental cleaning,
Health care waste management,
Injection safety, HCW protection (for example, post exposure prophylaxis, vaccinations),
Aseptic techniques
Triage of infectious patients
Standard and transmission-based precautions (for example, detailed, specific SOPs for the prevention of
airborne pathogen transmission);
Aseptic technique for invasive procedures, including surgery;
Specific SOPs to prevent the most prevalent HAIs based on the local context/epidemiology;
Occupational health (specific detailed SOP).

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3.3 IPC Education and Training

The hospital should have IPC education and training for all health care workers to reduce the risk of HAI
and AMR. IPC education and training should be a part of an overall health facility education strategy,
including new employee orientation and the provision of continuous educational opportunities for
existing staff, regardless of level and position (for example, senior administrative and housekeeping staff).
The training and education should cover the following category of human resources.
IPC focal person and members of IPC team (doctors, nurses and other professionals) should be trained to
achieve an expert level of knowledge covering all areas relevant to IPC, including patient and health care
worker safety and quality improvement. To maintain high-level expertise, it is important that all IPC
personnel undergo regular updates of their competencies.
All health care workers involved in service delivery and patient care: clinical staff should understand IPC
measures embedded within clinical procedures. Healthcare workers should have access to and trained on
the facility level adapted guidelines/ SOPs
Other personnel that support health service delivery: these include cleaners responsible for the day-to-day
cleaning of the facility, auxiliary service staff and administrative and managerial staff responsible and
accountable for the safety and quality of health service delivery, including the overall implementation of
policies and guidelines and the monitoring of national and local policies. Senior managers should
understand the importance of supporting IPC infrastructure and practices to reduce harm to patient and
health care workers and therefore the associated costs.

3.4 Healthcare associated Infections (HAIs) Surveillance

At hospital level, HAI surveillance should be conducted to guide IPC interventions and detect outbreaks,
with timely feedback of results to health care workers and stakeholders. Regular reports on the levels of
healthcare associated infections within the facility should be made available to treating clinicians to make
them aware of their local resistance profiles.
The HAI surveillance should be conducted based on national Healthcare Associated infection
Surveillance Guideline and customized to the facility according to available resources. The hospital
should put in place enabling structures and supporting resources (for example, dependable laboratories,
medical records, trained staff), for an appropriate method of surveillance.
Surveillance should provide information for:
Describing the status of infections associated with health care (that is, incidence and/or prevalence, type,
etiology and, ideally, data on severity and the attributable burden of disease).
Identification of the most relevant AMR patterns.
Identification of high-risk populations, procedures and exposures.

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Existence and functioning of a WASH infrastructure, such as water supply, toilets and health care waste
destruction.
Early detection of clusters and outbreaks (that is, early warning system).
Evaluation of the impact of interventions
3.5 Multimodal Strategies Implementation

Hospitals should implement multimodal strategies to improve IPC practices and reduce HAI and AMR. A
multimodal strategy consists of several elements or components (3 or more; usually 5) implemented in an
integrated way to improve an outcome and change behavior. The 5 most common components include: (i)
system change (that is, availability of the appropriate infrastructure and supplies to enable IPC good
practices); (ii) education and training of health care workers and key players (for example, managers);
(iii) monitoring infrastructures, practices, processes, outcomes, and providing data feedback; (iv)
reminders in the workplace or communications; and (v) culture change with the establishment or
strengthening of a safety climate.
3.6 Monitoring, Audit and Feedback
The hospital should conduct regular monitoring/ audit and timely feedback of health care practices
according to IPC standards to prevent and control HAI and AMR. Monitoring and auditing allows
assessing the extent to which standards are being met, activities performed according to requirements, and
to identify aspects that may need improvement.
Monitoring, audit and feedback should also include the regular evaluation of facility compliance with
regulations and IPC best practices and standards, and identification of actions that need reinforcement or a
change in strategies, as well as successful experiences.
Feedback should be provided to all audited persons and relevant staff. Sharing the audit results and
providing feedback not only with those being audited, but also with hospital management and senior
administration is a critical step. IPC teams and committees (or quality improvement team) should also be
included as IPC care practices are quality markers for these program.
IPC program should also be periodically evaluated to assess the extent to which the objectives are met,
the goals accomplished, whether the activities are being performed according to requirements and to
identify aspects that may need improvement identified via standardized audits.

The hospital should prepare/ adapt monitoring and audit tool and performance indicators for collection
and reporting its overall IPC performance.

3.7 Built Environment, Materials & Equipment

Patient care activities should be undertaken in a clean and hygienic environment that facilitates practices
related to the prevention and control of HAI as well as AMR. This includes the availability of WASH
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infrastructure and services and the availability of appropriate IPC materials and equipment. Materials and
equipment to perform appropriate hand hygiene should be readily available at each point of care.
Infrastructure and supplies to implement other standard precautions such as personal protective
equipment, sharps safety management, safe hospital laundry, environmental cleaning, and waste
management should be in place in accordance with the national IPC guideline. The following are the
minimum requirements for the built environment, materials, and equipment for proper IPC practices:
Water should always be available from a source on the premises to perform basic IPC measures, including
hand hygiene, environmental cleaning, laundry, decontamination of medical devices and health care waste
management.
A minimum of two functional, sanitation facilities should be available for outpatients and one per 20 beds
for inpatient wards;
Functional hand hygiene facilities should always be available at points of care/toilets and include soap
and water or alcohol-based hand rub (ABHR) at points of care and soap and water within 5 meters of
toilets.
Sufficient and appropriately labelled bins to allow for health care waste segregation should be available
and used; waste should be treated and disposed of safely via autoclaving, high temperature incineration,
and/or buried in a lined, protected pit.
The facility should be designed to allow adequate ventilation (natural or mechanical, as needed) to
prevent transmission of pathogens.
There should be spacing of at least one meter between the edges of beds; and no more than one patient per
bed;
Sufficient and appropriate IPC supplies and equipment (for example, mops, detergent, disinfectant,
personal protective equipment (PPE) and sterilization) and power/energy (for example, fuel) should be
available for performing all basic IPC measures according to minimum requirements/SOPs, including all
standard precautions, as applicable; lighting should be available during working hours for providing care
The facility should have a dedicated space/area for performing the decontamination and reprocessing of
medical devices (that is, a decontamination unit) according to minimum requirements/SOPs.
The facility should have adequate single isolation rooms or at least one room for cohort patients with
similar pathogens or syndromes.
3.8 Hand Hygiene

Ensuring Proper Hand Hygiene Practices

Basic principles to be followed concerning hand hygiene
There are very important basic principles in relation to proper hand hygiene. If these principles are
followed consistently hand hygiene practices can be implemented effectively. Some of the important basic
principles to be followed are:
Guidelines on hand hygiene have to be followed
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Guidelines on hand hygiene have to be properly disseminated and promoted
Best practices on hand hygiene have to benchmarked
Every staff members have to be involved
The culture of providing positive feedbacks has to be developed
Necessary supplies have to be availed at service areas
There has to be a culture of rewarding role models of proper hand washing
Basic orientation/training has to be given to all hospital staff
Necessary infrastructures for proper hand hygiene
To practice proper hand hygiene among healthcare providers there are basic infrastructures which must be
fulfilled by the hospital as a prerequisite. The basic infrastructures (minimum requirement) which should
be put in place by hospitals for proper hand hygiene are:
Functional hand washing sinks
Functional water container (if there is no running tap water)
Water tanker for reserve water during water supply interruptions
Functional drainage system
Necessary supplies for proper hand hygiene
There are vital supplies which are needed for proper hand hygiene practices without which healthcare
providers can’t practice hand hygiene. It is expected from hospitals to ensure the continuous supply of
these vital supplies. The vital hand hygiene supplies to be put in place continuously by hospitals at hand
washing area are:
Continuous supply of water
Detergents ( bar soap, liquid soap)
Alcohol based hand rub
Alcohol solution to prepare alcohol based hand rub
Disposable paper towels
When to Perform Hand Hygiene (Hand Hygiene Opportunities)
The World Health Organization has five recommended points in time when hand hygiene should occur in
order to prevent transmission of HAIs. These recommendations are called the ―My 5 Moments for Hand
Hygiene‖ and focus on the following times:
Before making contact with a patient
Before performing a clean/aseptic task, including touching invasive devices

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After performing a task involving the risk of exposure to a body fluid, including touching Invasive
devices
After patient contact
After touching equipment in the patient‘s surrounding areas (WHO 2006a)
Hand Hygiene Promotion
Hospitals have to have a consistent, proper hand hygiene promotion system. Promotional work is needed
to change the attitudes of hospital staff and clients toward proper hand washing. To have effective
promotion work, hospitals have to:
Prepare and post signs that clearly show hand washing areas at service points.
Post five Moments of Hand Hygiene posters at visible areas of service points.
Posters of hand washing techniques posters (including alcohol-based hand rubs) at hand hygiene stations.
Select quarterly observed "Hand Washing Days" on which proper hand washing role models are
rewarded.
Prepare promotional posters using pictures of role models of proper hand washing and post them in
visible areas of the hospital.
Prepare audiovisual materials for hand washing and display them in waiting areas for patients
Monitoring hand washing practices in the hospital
The core issue of proper hand hygiene is consistently practicing hand hygiene appropriately. The other
issues discussed above are the means to achieve this important end which is practicing proper hand
hygiene. The hospital establishes systems and develops necessary tools and procedures to monitor proper
hand washing practices.
For effective hand hygiene practices monitoring the hospital:
Develops hygiene practices monitoring checklist ( in interview and observation form)
Conducts quarterly assessments using the developed checklists
Identify strengths and gaps/challenges
Disseminate the identified strengths and challenges to the staff
Prepare improvement plan and share the prepared plan to responsible bodies who are expected to
implement the planned action items
Properly document all monitoring activities
3.9 Safe Injection Practices

A) Basic principles on injection safety

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Hospitals have to adhere to some basic principles to ensure injection safety at their injection and
medication rooms. Hospitals have to follow the following principles:
Eliminating unnecessary injections is the best way of preventing risks of unsafe injections
One needle and one syringe for one injection principle has to be followed
Recapping of needles has to be avoided
Educating patients and the community at large on pros and cons of medication by injection is an
important intervention
B) Supplies and other inputs needed to ensure injection safety
There are important inputs which are needed to ensure injection safety in hospitals. Hospitals ensure the
availability of the following to make injections in their medication rooms safe:
Basic orientation/trainings for hospital staff members
Standard operating procedures of safe injection implementation
New and sterile injection devices
Necessary personal protective equipment in medication rooms
Necessary supplies for antiseptic purposes
Necessary infrastructure and supplies for proper hand washing
Sharp containers
Waste containers for non-sharp wastes
Equipment and supplies for instrument processing
C) Expected activities from healthcare providers
The following activities are performed by healthcare providers who administer injections to make those
injections safe:
Properly washing hands before applying necessary PPE
Utilizing the appropriate PPE
Giving the right injection medication for the right person, with the right dose and right time
Properly utilizing sharp containers and other waste containers
Disposing medical wastes generated in medication room according to national medical waste
management guidelines
Ensuring proper documentation of activities in the service area

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 NB. For detailed technical information on injection safety, please refer National Medical Waste
Management Guidelines and National IPC Reference Manual.
3.10 Healthcare Waste Management
Health care waste should be dispose in a manner that poses minimal hazard to patients, visitors,
healthcare workers and the community. Infectious waste materials shall be treated properly to eliminate
the potential hazard to human health and environment. Health facilities should ensure that HCWs are
safely managed along the waste stream.
Waste Management Procedures and principles
The management of health care multi-step process involving:
Waste Minimization
Segregation
Handling
Collection
Storage
Transportation
Treatment and Disposal
NB. For detailed technical information Healthcare waste Management, please refer National Medical
Waste Management Guidelines and the National IPC Reference Manual.
The 3 categories of HCW shall be segregated into color coded containers as follows
Table 1: The 3 HCW Categories
Segregation Category Color-coded container Non-color coded bins

Non-infectious waste/ Black bin Bins should be labeled non-risk waste

General waste

Infectious waste Yellow bin Bins should be labeled infectious waste

Sharp waste Yellow safety box The box should be labeled biohazard waste.

3.11 Environmental Cleaning

Maintaining a clean and safe health facility is essential to provide quality care for patients. Proper
cleaning will reduce the number of microorganisms in patient care areas and will help to minimize the
risk of exposure to infectious agents to patients, families, caregivers, visitors and hospital staff. Hospitals
may provide the housekeeping service through its own staff or, or may contract out services to an outside
vendor. However, regardless of how the service is provided and by whom, the hospital must ensure that
standards are met and the guidance adhered to.
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A. Work plan
The housekeeping department should develop operating procedures or work plan on the cleaning process
and schedule for each unit (clinical vs. administrative areas). The procedures are meant to serve as a guide
for hospitals in devising their own cleaning schedule and procedures. Further detailed guidance can be
found in National Reference Manual for Infection Prevention and Control.
B. Supplies
The hospital should have a regular supply of all necessary cleaning materials. At minimum hospitals
should provide the following:
Disinfectants and detergents, bleach, powder detergents e.g. Omo
Mops, cloths for dusting, brooms, soaps , buckets
Personal protective equipment for cleaning staff and alcohol for hand rub preparation.
The head of the department should plan for and request supplies to meet monthly consumption needs.
C. Procedures
All patient care areas should be cleaned based on as per the schedule by wet mopping, scrubbing or
dusting and or scrubbing using disinfectant cleaning solutions. Staff should be trained/ oriented on how to
prepare cleaning solutions and procedures for preparing the solution should be posted in an area visible to
the cleaning staff.
The hospital should conduct a cleaning audit using audit tool to ensure all patient areas and toilets are
clean properly and regularly. The hospitals should conduct a needs assessment to identify and ensure
availability and functionality of hand wash sinks, toilets and showers. Availability of adequate water
supply at all clinical service units should also be assessed. The assessment should be done periodically (at
a minimum quarterly) to ensure that any new needs are identified.
3.12 Laundry Service
Hospitals may provide the laundry service through its own staff or, or may contract out services to an
outside vendor. However, regardless of how the service is provided and by whom, the hospital must
ensure that standards are met and the guidance adhered to. Larger hospitals with a high volume of work
should have large capacity machines that can handle a high volume of linens and/or an increased number
of machines Heavy-duty washers/dryers are recommended for a large hospital with high patient load.
The hospital should provide leak proof plastic containers with a lid or leak proof plastic bags at each
procedure room to store soiled linens and to prevent spills from soiled linen until they are transported to
the laundry. The laundry should also at a minimum–have two separate carts to transport clean and soiled
linens to and from the laundry as well as storage shelves to store clean linens before they are returned to
the appropriate work area. Waste generated from the laundry should be decontaminated and have a proper.
It is recommended that each unit/work area should be allotted with a designated shelf to allow separation
of linens by case teams and ensure accurate management of linens. Linens should be checked regularly
for holes and/or threadbare areas. Repairs, replacement or disposal should be done based on the
assessment.

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A. Work plan
Each hospital laundry should develop an operating procedure or work plan for laundry services. The plan
would give guidance on the segregation of linen at the ward level, transport of linens to and from the
laundry, cleaning procedures, operation of machines, segregation of linen by the laundry staff after
washing, storing of linen and transport to different case teams/wards, registration of incoming and
outgoing linen and shifts for working hours. There must be hand washing facility there.

Risk category Level of disinfection/sterilization Examples

Critical Sterilization Reusable surgical instruments

Semi-critical High-level disinfection Respiratory instruments, specula used for vaginal

examination, endoscopes

The laundry space should be adequate with separated rooms for soiled and clean linens and has to have at
least three machines (washing, ironing and. drying).
B. Supplies
The laundry should ensure that there is always an available supply of detergent and bleach.
C. Laundry operations
For detailed technical recommendations on Laundry operation and processing of reusable Textiles and
Laundry Services, please refer National IPC Reference Manual Volume 1 Chapter 8.

3.13 Medical devices decontamination and Processing Instruments and Reusable Items:

Level of Disinfection or Sterilization Required

Decisions regarding the level of processing medical devices and surgical instruments for patient care
should be made based on Spaulding categories. Spaulding classified instruments and patient care devices
into three categories as follows:

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Non-critical Cleaning Blood pressure cuffs, stethoscopes

In all levels of instrument processing, special attention should be given to proper handling of the
instruments and other items to minimize the risk of accidental injury or exposure to blood and other body
fluids of the sterile processing staff and to attain a high quality end result.

NB. Soaking instruments in 0.5% chlorine solution or any other disinfectant before cleaning is not
recommended
For detailed technical recommendations on Medical devices decontamination and Processing Instruments
and Reusable Items, please refer National IPC Reference Manual Volume 1 Chapter 7.
3.14 Food and Water Safety

Food safety should be ensured through the provision of adequate, clean facilities for food preparation and
storage. It is imperative that:
The kitchen should have adequate space, well ventilated, visibly clean and free from debris, dusts,
spillages, etc
Food safety shall be monitored by Head of Kitchen or other senior manager
Kitchen staffs maintain personal hygiene and health.
Food purchase and storage
A committee consisting of representatives from the kitchen, environmental hygiene and procurement unit
should be created to oversee the delivery of food items for the kitchen. Possible committee members
could be the kitchen manager, dietician, environmental health professional, and purchaser.
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When food items are delivered to the kitchen, the kitchen manager or delegate should check the items to
ensure that the food delivered is of the desired quality. If the quality of the food is not acceptable, then
the supplier should be informed, “rejected” items returned, and if possible, the supplier should provide
replacements that meet the committee’s specifications.
The food items that are delivered to the kitchen have to be properly stored in a separate clean area in the
kitchen. Food that is perishable and warm should be cooled before storage.
Food handling and preparation
There should be separate cutting boards for meat products and non-meat products
Cooking staff should be oriented on safe handling of food
Cooking should be done at proper temperature and for the appropriate length of time
All kitchen staff should follow hand hygiene procedures. Hand hygiene should be practiced at all critical
hand washing times. In addition to hand hygiene, kitchen staff should also maintain their personal
hygiene. Facilities for bathing should be made available to all kitchen staff.
Water safety
The hospital should have a continuous clean water supply. Water used for special services (drinking,
cooking and for instrument processing) shall be tested for bacteriological and physical parameters water
quality periodically (minimum of quarterly).
Water provided for clients should be treated by either by boiling (20minutes) or using chlorine (0.001
concentrations).
For detailed technical recommendations on Food and Water Safety, please refer National IPC Reference
Manual Volume 1 Chapter 11.
3.15. Occupational Safety
Hospital staff members may be exposed to different health risks merely due to their work place. They can
be exposed to blood and other body fluids through which infections can be transmitted. They have a
potential to be exposed to different kinds of sharp materials which can transmit infections and can also
cause other health problems. Generally hospital staff members are exposed to different kinds of
occupational health hazards. They can be exposed to infections like HIV, HBV, HCV etc. or other health
hazards like excessive bleeding due to sharp injury.
Hospitals are expected to minimize occupational hazards to their staff members and they have to ensure
occupational safety practices. To minimize the occurrences of occupational hazards and ensure
occupational safety the hospital has to ensure the availability of preventive services in place. These
services can be personal protective equipment, preventive vaccinations and preventive prophylaxis
interventions. The following interventions are provided in hospitals to minimize occupational hazards to
hospital staff members.
Post Exposure Prophylaxis of HIV
To avail PEP services effectively hospitals implement the following:
Assign one service point for PEP
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Make the PEP focal person member of IPC Committee
Organize necessary trainings for the assigned focal person on PEP and HIV testing and counseling
Assign PEP focal person who can be accessed 24 hrs. a day and 7 days a week
Avail supplies and equipment for HIV testing and counseling for exposed individuals during time of not
working time
Put in place referral linkage system
Make PEP one attention area of IPC Committee activities
Place ARV drugs( starting pack ) at PEP service point always and restock it on time to avoid shortages
due to stock out
Establish documentation system for PEP
Establish reporting system for PEP activities
Establish PEP programme monitoring and evaluation system
The hospital management monitors PEP implementation by assessing:
The availability of all input materials
The continuous availability of PEP services both at regular and non-regular working hours
The adherence of healthcare workers to the national PEP protocol
Monthly PEP service uptakes
Activity plans of PEP focal person
Monthly reports of PEP focal person to hospital management
Agendas of IPC Committee meetings on PEP
NB. For technical details of PEP please refer to National IPC Reference Manual Volume 1 Chapter 13 &
National Comprehensive HIV/AIDS Care & Treatment Guidelines
Preventive interventions for HBV & HCV
Currently there are no public health level prophylactic and treatment interventions in Ethiopian for
Hepatitis B and C virus exposures and infections. What are at hand on these infections are prevention
interventions.
Hospitals utilize all preventive measures to the maximum to minimize health risks from exposure to HBV
and HCV. The following are the major intervention measures used by hospitals to minimize risks to their
staff members from HBV & HCV exposure:
Facilitating vaccination of hospital staff members for HBV
Ensuring all staff members properly utilize necessary PPE when needed
Ensuring proper waste management system in the facility to minimize sharp injuries
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Orienting staff members on how to deal with blood and other body fluids strictly
Ensuring availability of effective primary care services for those who have got exposed
Other preventive measures to ensure occupational safety
Hospitals should put in place all preventive measures which are possible and feasible to minimize
occupational risks to their staff members. The following preventive measures are put in place in hospitals
to ensure occupational safety for hospital staff members:
Train/orient all hospital staff members on basic infection prevention and patient safety
Ensure the availability and utilization of personal protective equipment at all service points
Ensure proper hand washing practices by all staff members of hospitals
Properly manage medical wastes according to national guidelines
Properly implement injection safety
Establish conducive work environment
Continuously monitor the status of standard precautions at all service point

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Annex
Infection Prevention and Control Program Facility Level Assessment Tool (IPC FLAT)
Updated June 2023

Infection Prevention and Control Program Facility Level Assessment Tool (IPC FLAT)
Updated June 2023

Overview

The IPC assessment tool is designed for use in hospital settings to:
• Evaluate the system and capacity of IPC for safe healthcare services
• Evaluate the compliance of healthcare workers to IPC standards and practices
• Aid development of work plans for improvement
• Monitor the progress of IPC quality improvement activities over time
The tool has two sections that include:
• Section I (Domains 1-8) - Facility IPC Capacity and System: This section addresses high-level IPC
systems and capacities
• Section II (Domains 1-14) - IPC Practices and Compliances to IPC standards by healthcare workers:
This section includes routine IPC practices of healthcare workers considering the IPC standards and
priorities.

This assessment will be conducted by health facilities quarterly (every three months)

The tool is developed using the World Health Organization (WHO) IPC assessment framework and other
regional IPC tools. Due to the technical nature of the questions, assessments must be carried out by IPC
experts with relatively good experience and strong familiarity with IPC requirements and standards. The
second section can be used more frequently as per the needs and available resources of the facility and
assessment can be done using particular IPC domains (e.g. Hand Hygiene compliance) or combination of
domains depending on the priority for monitoring compliance to IPC standards and practices.

Instructions for use

1 Conduct a comprehensive assessment of the facility using the agreed list of

instructions, indicators; record whether each indicator meets (Yes), does not meet
(No), or the not applicable (N/A).

2 Record additional information under Comments (Col I), for example, the reasons
why a particular indicator does not meet the target, important observations or
questions that need further investigation.

3 For each domain (IPC Program, Appropriate Personal Protective Equipment (PPE)
Use etc.), review the score at the bottom. This should calculate automatically
according to the number of indicators that have been assessed.

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Hospital General Information

Name of Hospital
and type

Location Region, Zone/Sub city, District/Woreda

Name and contact Phone No Email

of CEO

Name of Medical Phone No Email

Director

IPC Team Phone No Email

Leader/coordinat
or

Date of
Assessment
(MM/DD/YY):

Date of Previous
Assessment
(MM/DD/YY):

Total number 1. Total Number of Health Professionals ________

staff
1.1.Dedicated IPC experts_________

1.2.Total physicians _____________

1.3. Environmental Health ___________________

1.4.Total Nurses all types__________

1.5.Other Health Professionals _______

2. Total Number of Supportive staff _________

2.1.Cleaners/house keeping ______________

2.2.Laundry staff___________________
2.3.Kitchen workers________________

2.4.CSSD staff________________

2.4.Porters and runners________________

2.5.Others __________

3. Total Number of Admin staff________

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 4. Other staff

5. Total Number of staff _(1+2+3 +4)_________________

Total bed number

Basic service In-house? Outsourced Remark

1. Food

2. Cleaning

3. Security

4. Laundry
Name of
Assessors

13-21
Section –I: Facility IPC Program Capacity and System

S Domain Criteria Y N N Assessment Comment

N es o / Instructions/Guide
A
1 IPC 1.1. IPC programme supported Check the lists of IPC
Program by an IPC case team comprised team Members and look
of IPC-trained professionals. that they are certified
for IPC training and
letter of assignment and
JD.
1.2. The IPC programme has an Look for the letter of
IPC ToT-trained full-time focal assignments as IPC
person, case Team leader, or Focal person/Case Team
Director. Leader/Coordinator and
for the ToT certificate.
1.3.Check that the IPC team has Ask for the IPC updated
an evidence-based annual plan. annual plan.

1.4.The facility has a functional Ask to see a copy of the

IPC committee (with defined TOR and meeting
TOR and regular meetings) minutes and regularity
1.5. Leadership shows clear Check budget
commitment and actively allocation specifically
supports the IPC program by for the IPC program and
allocating a budget specifically senior management
for the IPC program. team minutes.
1.6.The IPC programme is Check joint planning/
linked to or integrated with performance report
other vertical or horizontal comprises those
programmes (e.g., AMR, programs and the IPC
Quality & Safety, WASH, team is a committee
immunisation,MCH,TB, member for those
Occupational Health, etc.). programs.

1.7.The IPC program has access Ask availability of

to microbiological laboratory microbiology lab
support (either onsite or offsite) services, See MoU, and
for routine day-to-day use. communicate evidence
with the regional
Laboratory or referal
facility with Private
Microbiology
laboratories.

13-22
 Domain score Total score for Yes, No
and N/A

Domain percentage score

IPC 2.1. Facility has updated See/look for the

guidelines national IPC reference guideline availability
or guidelines / or adopted
standard
operating 2.2 facility has SOP on
procedure Standard precautions for the
s (SOPs) following:

2.2.1. Hand hygiene Ask and check the

guide/ SOP

2.2.2. Instrument reprocessing Ask and check the

guide/ SOP

2.2.3. Injection safety Ask and check the

guide/ SOP
2.2.4. Waste management Ask and check the
guide/ SOP

2.2.5. Environmental cleaning Ask and check the

guide/ SOP

2.2.6. Personal Protective Ask and check the

Equipment guide/ SOP

2.3 Facility has SOP on

Transmission-based precautions

2.3.1 Prevention of vascular Ask and check the

catheter-associated bloodstream guide/ SOP
infections
2.3.2 Prevention of catheter- Ask and check the
associated urinary tract guide/ SOP
infections

2.3.3 Prevention of Surgical Site Ask and check the

infection (SSI) guide/ SOP

2.3.4 Prevention of healthcare Ask and check the

associated pneumonia (HAP) guide/ SOP
2.3.5 Prevention of healthcare Ask and check the
associated diaharrea guide/ SOP

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 2.3.6 Prevention and Ask and check the
containement of multidrug- guide/ SOP
resistant (MDR) pathogen

2.3.7 Outbreak preparedness Ask and check the

and response guide/ SOP

2.3.8 Healthcare worker Ask and check the

protection and safety guide/ SOP

2.3.9. Other(s) (List additional Ask and check the

SOPs) including dead body guide/ SOP
handling, laundry, food & water
safety
2.4. All the facility level IPC Check SOPs/guidelines
SOPs/ guidelines are easily are within the reach of
accessed by healthcare workers HCWs or easily
accessible in different
units

Domain score Total score for Yes, No

and N/A

Domain percentage score

3 IPC 3.1 The Facility has an ongoing Ask for dates of the
education development system to most recent training
and train/educate HCWs on IPC (Both on site and off site
training IPC training) including
induction training and
check training unit's
annual plan

3.2. All Health professionals Check for list of IPC

including students and new staff trained professionals
receive training/orientation on from training record
the updated IPC guideline.

3.3. Cleaning staff and non- Check for list of IPC

clinical staff directly involved in trained cleaning and
patient care receive IPC training other non-clinical staff
at least per year from training records

3.4. Administrative and Check for list of IPC

managerial staff receive general trained administrative
IPC training/orientation and managerial staff
from training records

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 3.5. IPC training is integrated Check training modules
into clinical practice and in- that incorporated into
service trainings of other IPC training .
specialties (e.g., training on
prevention of Tuberculosis)

3.6. Specific IPC training is in Ask a training

place for inpatients or family guide/programme for
members and incorporated in patients and family
the weekly hospital HE program members and check the
to minimize the potential for schedule of health
HAI. education on IPC.

3.7. Healthcare facility Confirm availability of

maintains records of IPC training record
trained HCWs

Domain score Total score for ‘Y’, ‘N’

and ‘N/A’

Domain percentage score

4 Health 4.1. Facility has adopted the Check the guidance

care- national HAI surveillance
associated guidance Check that applies to
infection the facility practices
(HAI)
surveillan 4.2. Facility has assigned a Ask for letter of
ce dedicated trained (on basic assignment and training
epidemiology/surveillance) certificate
professional for HAI
surveillance activities

4.3. Informatics/IT is available Check availability of the

to conduct surveillance (e.g., required equipment and
equipment, mobile technologies their functionality
or electronic health records)

4.4. Facility has standard Check in surveillance

surveillance case definitions guideline on use or
according to national or posted on wall
international definitions for a
disease of interest

4.5. Use standardized data Check surveillance

collection methods (e.g., active SOPs or protocols
prospective surveillance)
according to national or
international surveillance

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 protocols

4.6. Responsible personnel Check surveillance

regularly review data quality reports
(e.g., assessment of case report
forms, review of microbiology
results, denominator
determination, etc.)

4.7. Surveillance data are used Ask cases and records

to make tailored facility-based when the surveillance
plans for the implementation or data used for
improvement of IPC practices interventions

4.8. HAI surveillance is Check this domain only

currently ongoing: (if yes, check for those Hospitals
from the options below) implementing HAI
surveillance

4.8.1. Surgical site infection Check for the existing

(SSI) of SSI surveillance
ongoing

4.8.2. Catheter-associated Check for the existing

urinary tract infections (CAUTI) of CAUTI surveillance
ongoing

4.8.3. Blood stream -associated Check for the existing

bloodstream infections (BSI) of BSI surveillance
ongoing

4.8.4. Clinically-defined Look for clinical

infections (for example, definitions on HAI
definitions based only on surveillance guideline or
clinical signs or symptoms in posted on wall
the absence of microbiological
testing)
4.8.5 Facility regularly (for Check surveillance
example, quarterly/half- reports and feedback
yearly/annually) provides up-to- notes
date surveillance information to
managers, department heads
and front line HCWs
Domain score Total score for ‘Y’, ‘N’
and ‘N/A’

13-26
 Domain percentage score

5 Multimod 5. 1 Facility use multimodal Check that applies to the

al strategies including any or all of facility practices
Strategies the following elements
5.1.1 System change to ensure Check for IPC supply
the necessary infrastructure and stock monitoring
continuous availability of records
supplies are in place

5.1. 2.Education & training Randomly ask 5

professionals whether
they are trained on
specific IPC measures
to solve IPC gaps

5.1. 3. Monitoring & feedback Check filled monitoring

IPC practice report and
feedback provided

5.1.4. Communication & Check for availability of

reminders reminder poster at point
of use

5.1.5 Safety climate & culture Check for risk

change (If no, specify management
components with multimodal protocol/guidance, risk
strategies) assessments
5.2. Multi-disciplinary team Ask interventions
(organized from different reports or meeting notes
unit/department) is used to
implement IPC multimodal
strategies

5.3. Facility has conducted QI Check for conducted QI

projects on IPC, implemented, project topic on IPC,
and successful change ideas implementation and
were identified that were learning session report
implemented

Domain score Total score for ‘Y’, ‘N’

and ‘N/A’

Domain percentage score

6 Monitorin 6.1. Well-defined monitoring Ask monitoring plan

g/audit of plan with clear goals, targets that includes goals and
IPC and activities are available activity list including

13-27
 practices tools to collect data in a
and systematic way
feedback
6.2. Locally adapted facility IPC Check for IPC data
data collection tools are collection tools (e.g.
available (if yes, specify in the IPC system/capacity
comments) assessment, facility IPC
practices, and others)

6.3.At least the following

processes and indicators are to
be monitored:

6.3.1. Hand hygiene (HH) Check on

compliance (using the WHO monitoring/feedback
HH observation tool or reports (by the time of
equivalent) audit completion)

6.3.2. Transmission-based Check on

precautions and isolation to monitoring/feedback
prevent the spread of infection reports (e.g., multidrug-
resistant organisms
(MDRO),
Environmental cleaning,
Disinfection &
sterilization of medical
equipments and waste
management)

6.3 Provide feedback auditing Ask/check meeting

reports (e.g., HH compliance notes or feedback
data) on the state of the IPC reports (by the time of
activities/performance to staff in audit completion)
the areas being audited and
report performance to IPC
committee and facility
managers

6.4. Monitoring data are Ask/Check notes or

reported regularly (at least reports
quarterly to facility managers

Domain score Total score for ‘Y’, ‘N’

and ‘N/A’

Domain percentage score

13-28
7 Workload, 7.1. Facility assesses Ask assessment report
staffing appropriate staffing levels at or meeting note on
and bed least annually according to assessment of staffing
occupanc patient workload using national
y standards or WHO tool such as
the WHO workload indicators
of staffing (staff to patient ratio)

7.2. System in place to act on Ask SOP or protocol for

the results of staffing needs staffing needs
assessments when staffing levels assessment and staffing
are deemed to be too low plan

7.3. There is adequate spacing Observe randomly for

of >1 meter between patient spacing of beds
beds

7.4. System in place to assess Check facility bed

and respond when adequate bed occupancy rate report, a
capacity is exceeded plan document for
higher bed demands

Domain score

Domain percentage score

8 Built 8.1. Functional Hand hygiene Check availability and
environm stations are available at the functionality of hand
ent, entrance and at all points of care hygiene stations
materials
and 8.2. Designated isolation areas Check isolation areas
equipmen are available for patients with
t for IPC suspected and confirmed
infectious diseases including
COVID-19, tuberculosis, Ebola
Virus Disease, MDRO & others
as applicable

8.3. Reliable safe drinking water Check drinking water is

are present and accessible for available all the time,
staff, patients and families at all ask if water quality test
times and in all locations/wards is regularly performed
(at least every quarter)

8.4. At least 4 toilets or Observe toilets or

improved latrines are available improved latrines
for outpatient settings or ≥ 1 per
20 users for inpatient settings

13-29
 8.5. Facility has sufficient Ask if sufficient power
energy/power supply available is available 24/7. If not,
at day and night for all uses please specify how
(e.g., pumping and boiling frequently there is a
water, sterilization and power outage, check
decontamination, incineration or power availability
alternative treatment
technologies, electronic medical
devices)

8.6. Facility has functioning and Check for availability of

sufficient environmental functional ventilation of
ventilation (natural or any type in patient care
mechanical) available in patient areas
care areas

8.7. Facility has a:

8.7.1.Fenced and functional Check for functionality
burial pit waste dump available and fenced waste
for disposal of non-infectious disposal area
(non-hazardous/general waste)

8.7.2. Municipal pick-up Check for contract

available for disposal of non- agreement with
infectious (non- municipality or waste
hazardous/general waste) transporting facility

8.7.3. Facility has an incinerator Check/ observe its

or alternative treatment availability
technology for the treatment of
infectious and sharp waste that
is functional and of a sufficient
capacity

8.7.4. Facility has a waste water Check/ observe its

treatment system (for example, availability
septic tank followed by drainage
pit) present on or off site and
functioning reliably
8.7. 5. Facility has dedicated Check/ observe its
decontamination area and/or availability
sterile supply department (either
present on or off site and
operated by a licensed
decontamination management
service) for the decontamination
and sterilization of medical
13-30
 devices and other
items/equipment

8.8. Disposable items available Check availability

when necessary (e.g., injection during the assessment
safety devices, examination
gloves)

8.9. A designated person is Check for assignments

responsible for managing and of designated person for
requesting critical IPC supplies managing IPC supplies
(provide consumption rate(per 2 and observe for recent
weeks) for critical supplies and inventory activities and
performs an inventory of IPC requisition
supplies at least monthly) records/documents

8.10. PPE stored in a safe Observe how stocks are

location off the floor stored

8.11. Facility has adequate

quantities (enough for at least
one month) of the following
supplies in stock at the time of
the assessment
8.12. PPE For the following PPEs,
check whether there is
sufficient stock and use
for the specific
procedure/work area

8.12.1. Non-sterile gloves Check for the

availability of sufficient
stock

8.12.2. Gowns Check for the

availability of sufficient
stock

8.12.3. Aprons Check for the

availability of sufficient
stock
8.12.4. Eye protection (face Check for the
shields or goggles) availability of sufficient

13-31
 stock

8.12.5. Medical masks Check for the

availability of sufficient
stock
8.12.6. N95, FFP2, or Check for the
equivalent respirators availability of sufficient
stock

8.13. Hand hygiene supplies Check for the

availability of sufficient
stock

8.13.1. Alcohol-based hand rub Check for the

availability of sufficient
stock

8.13.2. Soap Check for the

availability of sufficient
stock

8.13.3. Disposable or reusable Check for the

towels availability of sufficient
stock

8.13.4. Veronica buckets with Check for the

functional taps, lids and basin availability of sufficient
for collecting used handwashing stock
water
* If functional sinks are not
available in registration or
waiting areas

8.14. Cleaning supplies Check for the

availability of sufficient
stock

8.14.1. Neutral detergent, liquid Check for the

or powdered soap availability of sufficient
stock

8.14.2. Cleaning cloths Check for the

availability of sufficient
stock

8.14.2. Mops currently available Check for the

availability of sufficient
stock

13-32
 8.14.3. Portable buckets (for Check for the
mopping and surface cleaning availability of sufficient
solutions) currently available stock

8.14.4. Hospital-grade Check for the

disinfectants (e.g., sodium availability of sufficient
hypochlorite) stock

Domain Score

Domain score percentage

Section-I subtotal Total

Section-I subtotal percentage

score

Section II - IPC Practices and Compliances by Healthcare Workers

S Domain Criteria Y N N Assessment Instructions/Guide Com
N e o / ment
s A

1 Appropri 1.1. SOPs for PPE use are Check the availability and
ate easily available and accessibility of SOP at least in the
Personal accessible to staff. following sites for routine use: OR,
Protectiv Maternity, ICU, NICU, and Labour
e ward.
Equipme
nt (PPE) 1.2. HCWs are trained on Ask 3-5 staff randomly whether
Use proper PPE use, including training /orientation on the proper
donning and doffing use of PPE including donning &
doffing provided to them.

1.3. Availability of sufficient Check the availability of the

PPE supplies at different following PPEs: Medical masks
service delivery points N95, FFP2, or equivalent
respirator; aprons; eye protection
(face shields, eye goggles); gowns;
sterile gloves; non-sterile gloves;
Heavy-duty gloves, rubber or
plastic boots, and head caps.

1.4. Appropriate PPE is used Observe at least three HCWs in

during patient care delivery four service areas (e.g., emergency,
ICU, OR, maternity, etc.) using the
standard PPE observation
checklist.

13-33
 1.5.PPE is donned and doffed Observe at least four HCWs in four
in appropriate steps and service areas (e.g., Emergency,
sequence. ICU, OR, Maternity, etc.) using
standard PPE and an observation
checklist

1.6. PPE is stored in a safe Observe how the PPE supplies are
and accessible location stored in closed and safe location
(keeping it in a clean, and easily accessible for use at
designated area away from service delivery points.
chemicals, temperature
extremes, etc.).

Domain score Total score for ‘Y’, ‘N’ and ‘N/A’

Domain percentage score

2 Hand 2.1. All hand hygiene stations Observe the availability of HH

Hygiene have alcohol-based hand rubs supplies and check the functionality
(HH) or soap and water. of HH stations (check at least 5 HH
Practice stations at the service delivery
Complia point).
nce
2.2. Hand hygiene posters or Check for the availability of posters
job aids are available at all and observe the five moments of
HH stations. HH for hand washing steps that are
posted.

2.3. The facility conducts HH Check the HH assessment report

audits quarterly using the and audit score (HH audits were
WHO HH observation tool. conducted at least at five different
service delivery points).

2.4. Hand hygiene audit Check for documents showing

report findings are regularly feedback was provided or pictures
analyzed, and feedback is of meetings with stakeholders on
shared with staff and feedback sharing.
respective stakeholders.

2.5. Hand hygiene Check for pictures and an activity

celebration days are report.
conducted quarterly.

Domain score Total score for ‘Y’, ‘N’ and ‘N/A’

Domain percentage score

13-34
3 Transmis 3.1.The facility has a Observe or look for a labeled
sion- designated isolation room for isolated room, and if cohorted
based the care of patients with the patients are placed at least 1 meter
Precauti same active infection who are apart.
ons isolated or cohorted in a
Adheren designated ward or room
ce (who need transmission
based precautions).

3.2. Hand hygiene facilities Check if ABHR and/or water and

are available in isolation soap are available in the isolation
areas. room.

3.3. The PPE required for Check if the required PPEs are
transmission-based available for the defined TBP.
precautions is available in • N95 or other respirators (airborne)
inpatient departments. • Face masks, face shields, or
goggles (droplets)
• Gowns (contact precaution)
• Disposable gloves
• Boots and
• Hazma Suits

3.4. Staff don appropriate Observe the practice of applying

PPE (gloves and other PPE PPE (interview staff if there is no
as indicated) as per the risk patient under TBP). Check if there
level. are designated donning and doffing
areas and observe donning and
doffing practices before and after
patient transport.
3.5. Transport and movement Look for signs limiting patient
of patients outside the movement. Check if the facility has
isolation area are limited to a SOP for transmission-based
medically necessary purposes precautions and if it entails how
(e.g., operation procedures) patients in isolation are transported.

3.6. Frequently touched Check cleaning checklists and

surfaces (e.g., bed rails, over- visual observations for cleanliness.
bed tables, bedside
commodes, lavatory surfaces
in patient bathrooms,
doorknobs) and equipment in
the immediate vicinity of the
patient are cleaned and
disinfected twice daily and
when visibly soiled.

13-35
 3.7. Toilets are cleaned twice Review the checklist and observe
daily and when visibly for a visibly soiled toilet.
soiled.

3.8. There is no equipment or Observe

practice in the patient room
that could exacerbate any
environmental
contamination.

3.9. Contaminated, reusable, Ask and observe how bed sheets

non-critical patient-care and patient pajamas works too.
equipment is placed in a
plastic bag for transport to a
soiled utility area for
reprocessing.

3.10. The facility has policies Check if:

and a system for triaging • Coughing patients are triaged
coughing patients to prevent separately; • Coughing
airborne or droplet patients should be separated by at
transmission at OPDs. least one meter.
• Coughing patients are given
priority in que
3.11. The facility ensures the Observe patients in waiting area
wearing of facemasks by and TB clinic for wearing of mask
coughing clients and other
symptomatic persons upon
entry to the facility
(including providing
facemasks for coughing
patients with no mask).

3.12. The facility has posted Observe the posted signage and
signs on respiratory hygiene posters.
(covering mouth /nose with
tissues while coughing or
sneezing, perform hand
hygiene after touching
respiratory secretions) for
individuals with symptoms of
respiratory infection
Domain score Total score for ‘Y’, ‘N’ and ‘N/A’

Domain percentage score

13-36
4 Instrume 4.1. The facility has a Check for availability of CSSD
nt designated Central with a responsible person assigned
Reproces Sterilization Services with a letter; signage is posted to
sing Department (CSSD). restrict entry to the CSSD room;
CSSD has a separate entrance and
exit gate for unidirectional flow of
traffic; and CSSD has a zonal
partition to delimit the placement of
contaminated and sterilized items.

4.2. Reprocessing of Observe the reprocessing process,

contaminated medical SOP availability, water availability
instruments follows the at the point of use cleaning site, and
updated national standard at least three different wards:-
(point-of-use cleaning). --->
(thorough cleaning) ---> •
(high-level disinfection or Point of care cleaning
sterilization) • Thorough cleaning
• Sterilization

4.3. Critical medical devices Check how instruments are

(e.g., forceps, scissors) are sterilized. Check if chemical
sterilized as indicated per sterilizing agents are available
standard (glutaraldehyde (2-4%), peracetic
acid 0.3%, hydrogen peroxide
8.3%, or mixed H2O2).

4.4. The Facility has clear Observe utility rooms in care units
separation of clean and and sterilizing areas in CSR,
contaminated medical Zonning
equipment.
4.5. The facility has a Check the availability of CSR and
dedicated area for cleaning the presence of a unidirectional
and sterilizing medical flow of traffic in CSR.
devices.

4.6. Reprocessed medical Observe storage

equipment (sterilized or
HLD) is safely stored in a
designated and safe area (free
from moisture, dust, insects,
rodents, etc.).

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 4.7. Sterilization machine Check out the document:
preventive and corrective • Daily preventive maintenance
maintenance and calibration • Corrective maintenance as needed
are conducted regularly. • Calibration based on manufacturer
instructions

Domain score Total score for ‘Y’, ‘N’ and ‘N/A’

Domain percentage score

5 Environ 5.1. Environmental cleaning Locate the cleaning forms or

mental follow-up monitoring checklists and check if they are
Cleaning systems are available and completed, the frequency of
completed at the time of this completion, and how frequently
assessment. they are completed.

5.2. Cleaning and Ask for the schedule and check

disinfection of wards/rooms SOPs.
occurs twice daily and when
visibly soiled.

5.3.Frequently touched Ask for the schedule and check

surfaces in SOPs and verification by visual
consultation/examination inspection/ fluorescent marker.
areas are cleaned and
disinfected at least twice
daily.

5.4. Walls, windows, ceilings, Check cleaning checklists and

and doors should be spot visual observations for cleanliness.
cleaned with a towel,
detergent, and water (specify
rooms observed).

5.5. Toilets and latrines Check cleaning checklists and

should be cleaned with a visual observations for cleanliness;
dedicated mop, cloth, or check if cleaning equipment is
brush and a disinfectant stored separately.
solution.

5.6. Instructions on making Observe the poster or instructions

solutions for disinfection are posted.
posted where the solution is
prepared.

5.7. Required cleaning Check for the availability of

supplies (a bucket, mop, cleaning supplies and equipment;
cleaning cloths, and check for the availability of a
disinfectant solution, e.g., cleaning supply stock monitoring

13-38
 bleach) are all available. tool or mechanism.

5.8. Rooms are terminally Check cleaning checklists and

cleaned and disinfected after visual observations for cleanliness.
patient discharge, including
floors, sinks, toilets, ceilings,
walls, and any material in the
room (sinks and toilets after
use).

5.9. The drainage system Observe

within and around hospital
building(s), e.g., gutters,
pipes, etc., should be free
from any obstructions, e.g.,
vegetation.
5.10. Cleaning campaigns Check for the availability schedule,
should be conducted every pictures, and report.
month.

5.11. The dedicated utility Check cleaning checklists and

room for the storage of visual observations for cleanliness.
cleaning equipment
5.12. Stairs, steps, and lifts, Observe
internal and external,
including all component
parts, are visibly clean and
well-maintained.
Domain score Total score for ‘Y’, ‘N’ and ‘N/A’
Domain percentage score

6 Adheren 6.1. Proper HH, using Observe at least three HCWs` per
ce with alcohol-based hand rub ward performing HH.
Injection (ABHR) or soap and water, is
Safety performed prior to preparing,
Practices during the administration of
medications, and after the
procedure.

6.2.Injections are prepared Observe at least three HCWs per

using aseptic technique in a ward practicing injection
clean area free from procedures.
contamination or contact

13-39
 with blood, body fluids, or
contaminated equipment.

6.3. Needles and syringes are Observe at least three HCWs per
used for only one patient ward.
(this includes manufactured
prefilled syringes and
cartridge devices such as
insulin pens).

6.4.HCWs dispose of needles Observe at least 3 HCWs doing

appropriately (i.e., needles injection procedures per ward and
are discarded after single use check the availability of a safety
and are not recapped, bent, or box in the hand-accessible area.
broken prior to disposal in a
sharps container).

6.5. The rubber septum on a Observe during the injection

medication vial is disinfected procedure.
with alcohol prior to piercing

6.6. Medication vials are Observe Interview HCP

entered with a new needle
and a new syringe, even
when obtaining additional
doses for the same patient
6.7. Single-dose or single-use Observe Interview HCP
medication vials, ampoules,
and bags or bottles of
intravenous solution are used
for only one patient

6.8. Medication Observe during medication

administration tubing and administration
connectors are used for only
one patient.

6.9. Multi-dose vials are Observe. This is different from the

dated when they are first expiration date printed on the vial.
opened and discarded within (Interview HCP)
28 days, unless the
manufacturer specifies a
different (shorter or longer)
date for that opened vial.

6.10.Multi-dose vials are Check if multi-dose vials are used

dedicated to individual for a patient (Interview HCP)

13-40
 patients whenever possible.

6.11. Multi-dose vials used Observe. If multi-dose vials enter

for more than one patient are the immediate patient treatment
kept in a centralized area, they should be dedicated for
medication area and do not single-patient use and discarded
enter the immediate patient immediately after use.
treatment area (e.g.,
operating room, patient
room/cubicle).

Domain score Total score for ‘Y’, ‘N’ and ‘N/A’

Domain percentage score

7 Facility 7.1. The facility has a policy Observe

Design to access hospital premises
and and manage traffic flow.
Patient
Flow 7.1.1. Visiting hours for Check and verify
Manage clients, including time for • Facility visitor hour’s protocol
ment rounds, cleaning , patient • Visitor hours are posted at the
meals, and the number of hospital gate.
attendants per patient, are • Visiting hours, round time, meal
determined. delivery time, and the number of
allowed attendants are posted
clearly in each ward.
7.1.2. Triage and Observe the triage services and
appointment systems should appointment system at Liason,
be established in the hospital. IPDs, and OPDs and check if the
block-hour appointment system is
followed.

7.1.3. Patient waiting areas Observe waiting areas, adequate

are well ventilated and not seating based on patient load, and
crowded. natural or artificial ventilation.

7.1.4. The facility has Observe traffic flow management at

assigned a dedicated person the facility. Check if appropriate
to handle traffic flow at all signage and physical barriers are
service delivery points. used in restricted areas.

7.1.5. The facility practices Check the OR, ICU, labour ward,
regarding zoning restrictions CSD, Kitcken, etc.
at different high-risk
departments

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 7.2. The hospital compound Observe and check that the waiting
is safe for patients, visitors, areas, garden, cafeteria, and
and staff walkways are free and safe for
patient transport.
7.3. The hospital regulates Check service areas randomly for
the flow of visitors, patients, signage, reminders, and physical
and staff using signs (such as barriers.
authorized personnel only,
reminders, and physical
barriers, e.g., closed doors) in
designated areas.

Domain score Total score for ‘Y’, ‘N’ and ‘N/A’

Domain percentage score

8 Processi 8.1.The facility has a Check that the laundry has separate
ng functional laundry service. areas for segregation, collection of
reusable soiling linens, washing, drying,
textiles ironing, and storing clean linen.
and
laundry 8.2. The facility has Check cleaned/washed linens
services physically separated storage observed separately from soiled
areas for cleaned/washed linen.
linens and for soiled linens
with sufficient ventilation
and light.

8.3. Appropriate PPE is Observe laundry staff wearing

utilized by laundry personnel appropriate PPE.
at all times

8.4. The laundry has Observe the availability of water by

uninterrupted water opening the pipe and checking that
availability for 24 hours a the laundry has a hot water source.
day, 7 days a week.

8.5. The laundry has a well- Check the number of functional

maintained sewage system. windows and doors and the
availability of artificial ventilation.
Check that sewage is not spilled on
the floor.

8.6.The laundry has a Observe the availability of

continuous electric supply electricity 24/7 with backup source.
(24 hours per day, 7 days per
week) with a backup source.

13-42
 8.7. The laundry has Check the number of functional
adequate natural or artificial windows and doors and the
ventilation. availability of artificial ventilation.

8.8. Hand washing sinks are Observe the presence of a

available in the laundry functional sink with soap.

8.9. consistent and sufficient Check for SOPs on disinfectant and

supply of detergents and detergent, and ask the laundry head
chemicals for for a consistent supply.
washing/disinfecting linen.

8.10. Separate physical Observe the containers/trolleys

storage areas and different used for transporting clean, washed,
trolleys and waterproof and dirty/contaminated linens.
containers are used for
transporting clean, washed,
and dirty/contaminated
linens.

8.11. Appropriate waste Observe the availability and

disposal containers are cleanliness of color-coded waste
available in the laundry for containers.
high- and low-risk waste.

8.12. Laundry machines in Observe the functionality of the

the facility are regularly machine and the maintenance
maintained schedule

8.13. The laundry keeps Observe records

records of receiving and
distributing linens.

Domain score Total score for ‘Y’, ‘N’ and ‘N/A’

Domain percentage score

9 Food 9.1. Food handlers are Ask food handlers whether they are
and educated and trained in food trained in food handling and safety
Water safety and good food procedures; check their names at
Safety handling procedures the training office and their
certificate.
9.2. The kitchen has a hot Observe whether the kitchen has
water source for washing three compartments and a hot water
kitchen utensils, with at least source.
three compartments for
washing.

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 9.3.After each use, kitchen Observe the cleaning practice
utensils are cleaned and/or
disinfected (if necessary)

9.4. The facility provide Observe at least 3 food handlers

necessary and suitable PPE wearing appropriate PPE (e.g.,
for kitchen staff aprons, face masks, hair covers)

9.5. Prepared food Observe whether food is

transported to the patient transported using clean and covered
room using a clean and carts
covered cart
9.6.The facility has separate Observe whether raw food storage
storage areas for perishable is separate for perishable and non-
and non-perishable raw perishable foods.
foods.

9.7. Food handlers undergo Ask for and observe the medical
medical examinations for certificates of food handlers.
foodborne transmittable
infections at least every three
months.

9.8. The kitchen has Observe the availability of sinks (at

dedicated and adequate sinks least one).
with running water and soap
at all times for hand washing

9.9. The Kitchen is well Check for washable floors, walls,

maintained and has a posted and ceilings free of dirt and debris.
cleaning schedule. Check the posted cleaning
schedule.

9.10. The Kitchen checks and Observe refrigerator temperature

documents the temperatures monitoring mechanisms
of the refrigerator and cold (documentation, temperature gauge
rooms regularly. up to the requirement), and check
the functionality of the refrigerator.

9.11. The facility has Check waste containers

washable, leak-proof garbage
containers with tight-fitting
lids, and garbage is collected
daily.
9.12. The facility has a Check that water quality is tested
regular Physicochemical and every three months (Check
bacteriological water quality documentation).

13-44
 monitoring system.

9.13.The kitchen has a policy Observe the policy and check for
to limit the traffic of relevant signage and posters.
unauthorized individuals into
the food preparation area.

9.14. The kitchen cleanliness Check whether there is an assigned

and personal hygiene of the professional to monitor the
food handlers are monitored cleanliness and hygiene of the
regularly by a knowledgeable kitchen and food handlers.
and responsible professional.

9.15.A responsible person or Observe the signed document and

team is assigned to ensure the ask the kitchen store head
quality of food entering the
kitchen. (Meat, vegetables,
and milk).
9.16. There is a system for Check the documentation from the
the management of food kitchen coordinator (Treated
handlers’ illnesses. properly; sick leave was given and
rescreened before return to the
work place).

Domain score Total score for ‘Y’, ‘N’ and ‘N/A’

Domain percentage score

1 Waste 10.1. Waste collection Observe that all waste bins are
1 Manage containers for non-infectious clearly marked to indicate the type
ment and (general), infectious, and of waste (e.g., colour-coding or
Sharps sharps waste are available at labeling to indicate the type of
Disposal each clinical area. waste) and available at each clinical
area.

10.2. Waste is correctly Observe the segregation practice at

segregated into general, the point of generation.
infectious waste, and sharps
at the point of generation

10.3. Waste segregation Observe availability of posters

posters (including sharp
containers) are displayed
above all waste bins
10.4. Each waste bin and Observe the dust bins and safety
sharp container is filled less boxes at least at three points of use.
than its ¾th volume.

13-45
 10.5. No sharps or needles Observe the floor
were observed on the floor at
the time of this assessment.

10.6. Bins and bags are Ask about and observe waste
transported upright in carts or transportation practices to the
trolleys to a central waste disposal site.
storage site, burial pit, waste
dump, or municipal pick-up
area.

10.7. The facility has a Observe the storage site (e.g.,

designated waste storage temporary storage).
area.

10.8.The facility has a Observe the incinerator plant

designated and fenced
incinerator for both solid
waste and sharps.

10.9. The facility has a Observe the disposal practice

designated waste disposal
area.

10.10.The facility has an Observe the availability of liquid

appropriate liquid waste waste treatment plants.
management system.

10.11. Janitors and Check the schedule /attendance

transporters are available 24 sheet.
hours a day, 7 days a week.
Domain score Total score for ‘Y’, ‘N’ and ‘N/A’

Domain percentage score

1 Healthca 11.1. The facility has policies Ask for the policy and reporting
1 re and a reporting structure for structure, and check if they are
Workers occupational exposure and available for all wards.
Safety management.
11.2. All HCWs and waste Check vaccination records or
handlers are vaccinated reports. If not all, specify the
against Hepatitis B. percentage of vaccinated staff in the
notes.

11.3. HCWs are aware of Ask for a reporting register or form

management procedures and reporting lines.
following exposure to blood
or body fluids.

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 11.4. The facility has a plan Ask about the plan and reports for
in place for monitoring monitoring HCWs.
HCWs exposed to patients
with respiratory illnesses,
including TB, COVID-19,
and other infectious diseases.

11.5. Healthcare workers Specify the specific plan in the

receive post-exposure notes
counseling and PEP

Domain score Total score for ‘Y’, ‘N’ and ‘N/A’

Domain percentage score
1 IPC in 12.1.The facility has SOPs Observe updated SOPs.
2 Mortuar for handling dead bodies,
y including those with highly
contagious diseases.
12.2.The facility has a Observe the availability of
functional dead body freezer functional refrigerators.
(refrigerator).

12.3. The staff working in the Observe the document/ask the care
mortuary are trained for dead providers
body management and care.
12.4. Appropriate PPE is Check the availability of PPE and
used by care providers, observe whether all wear
relatives, or other individuals appropriate PPE during the
involved in the handling of handling of dead bodies.
dead bodies.

12.5. A proper dead body Check the availability of plastic

plastic bag (cadaver pouch) bags
should be used when
necessary.

Domain score Total score for ‘Y’, ‘N’ and ‘N/A’

Domain percentage score

1 Outbreak 13.1.The facility has a Check the meeting note, TOR, and
3 Prepared functional Outbreak response Letter of Assignment of Taskforce.
ness and committee or task force.
Respons
e 13.2. Outbreak preparedness Check the plan.
and response plans are in
place.

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 13.3. The facility has a SOP Check the availability of the plan.
for managing contact tracing.

13.4. Determined maximum Committee meeting notes and

capacity in the event of a action points
surge (availability of physical
space, human resources,
intensive care capabilities,
ventilator support, etc.) for an
outbreak.

13.5.Developed a plan to stop Check availability SOP

non-essential services (e.g.,
elective or non-urgent
procedures) in the event of a
surge.

13.6. Identified additional Check the plan

space that can be used to
expand the number of
patients that can be treated
(assuming adequate human
resources, supplies, etc. are
available).
13.7. Developed a plan to Check the plan in the planning
move non-critical patients document.
elsewhere (e.g., for home-
based care) to increase
capacity in the event of a
surge.
13.8. The facility has clear Check the plan
communication and reporting
mechanisms in the event of a
surge.

13.9. The facility has a Check the inventory report.

procedure for estimating
consumption rates for critical
supplies, including PPE, in
the context of a surge
scenario.

Domain score Total score for ‘Y’, ‘N’ and ‘N/A’

Domain percentage score

13-48
1 Environ 14.1. The facility has a fence Fences are strong enough to restrict
4 mental that surrounds all the hospital the entrance of Pets and other
cleanline grounds and will not allow animals. There are at least two
ss and the entrance of pets and other separate gates for the entry and exit
safety animals without a functional of both pedestrians and vehicles. A
gate, or at least two gates. separate gate for staff. Gates are
spacious enough to accommodate
emergency scenarios.

14.2. The hospital's external Observe the hospital external

ground (at least 5–20 m from ground.
the fence) is free from any
hospital or community-
generated waste.
14.3. The hospital has a good Check the availability of green
Internal compound areas with seats and walkways.
appearance (Designated Check their cleanliness and
social green areas or parks tidiness.
with seating facilities) and
tidiness.

14.4. The Hospital has Check the activity report and

established a certification.
system/mechanism for pest
and rodent control
(outsourced or trained and
assigned personnel).

Domain score Total score for ‘Y’, ‘N’ and ‘N/A’

Domain percentage score

Section Grand Total

Section Grand Total

percentage

13-49
Source Documents

National Infection Prevention and Control Reference Manual, MoH- Ethiopia third edition; 2023
Interim Practical Manual supporting national implementation of the WHO Guidelines on Core
Components of Infection Prevention and Control Programmes. Geneva: World Health Organization;
2017. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at
http://apps.who.int/iris
Guidelines on core components of infection prevention and control programmes at the national and acute
health care facility level. Geneva: World Health Organization; 2016. Licence: CC BY-NC-SA 3.0 IGO.
Minimum requirements for infection prevention and control. Geneva: World Health Organization; 2019.
Licence: CC BY-NC-SA 3.0 IGO.

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13-51
 Chapter 17:

TEACHING AND
AFFILIATED HOSPITALS
SERVICES MANAGEMENT

13-1
Chapter Outline

Section 1 Introduction

Section 2 Operational Standards

Section 3 Implementation Guidance

3.1. Teaching and Affiliated Hospitals' Management and Governance Structure

3.2. Principles of Quality Service, Teaching and Research in Teaching and Affiliated Hospitals

3.3 Students/Interns/Residents' Orientation

3.4 Ward Round and Bedside Student Teaching Related to Patients' Dignity and Quality of Care

3.4.1 Protecting Confidentiality and Dignity

3.4.2 Use of Skills Lab and Simulator Centers

3.4.3 Ward Rounds/Bedside Teaching and Quality of Care

3.4.4 Multidisciplinary Morning Meeting Sessions

3.4.5 Record Keeping

3.5 Community Practice and Field Visits

3.6 Regular Clinical Audit of Patient Care Provided by Students/Interns and Residents

Section 4: Source Documents

13-2
Abbreviations

ADD - Academic and Development Director

CAD - Chief Administrative and Development Director

CARD - Chief Academic and Research Director

CCD - Chief Clinical Director

CED - Chief Executive Director

EHSTG - Ethiopian Hospital Service Transformation Guidelines

FMOE - Federal Ministry of Education

FMOH - Federal Ministry of Health

HCF - Health Care Financing

HMIS - Health Management Information System

HSTP - Health Sector Transformation Plan

JD - Job Description

KPI - Key Performance Indicator

M&E - Monitoring and Evaluation

MCC – Motivated, Competent, Compassionate

MDT - Multidisciplinary Team

MoU - Memorandum of Understanding

QI - Quality Improvement

SBFR - Strategic Budget and Fiscal Reform

SMT - Senior Management Team

ToR - Terms of Reference

13-3
Section 1 Introduction

Teaching and affiliated hospitals have the potential to provide exceptional care to patients, in
addition to medical education and training for current and future healthcare professionals, as well
as serving as research centers to improve healthcare delivery. However, recent findings show that
care provided at major teaching hospitals results in better patient outcomes across a wide range
of common medical and surgical conditions and severity levels compared to non-teaching
hospitals (Medical et al., 2018).

Managing teaching and affiliated hospital services introduces novel challenges. The delivery of
healthcare and teaching in these hospital settings is complex, involving multifaceted learning
approaches. Bedside teachings and ward rounds have historically formed the foundation of
clinical education for health professionals. Currently, the lack of integration between top
management and shared activities between care delivery, teaching, and research remain key
challenges. Similarly, prolonged bedside and ward teachings combined with inappropriate ward
layouts, overcrowded spaces, and high student-to-bed ratios contribute to these challenges.

To address these challenges, the Ministry of Health has developed and proposed various
guidelines, promoting a model of full organizational integration where patient care, teaching, and
research collectively function under the leadership of a single Chief Executive Director (CED)
and a common governing board. However, the anticipated integration, teamwork, coordination to
ensure proper implementation of patient care, teaching, and research activities to improve care
quality, patient safety, engagement, develop high-performing teams and use resources efficiently
in teaching hospitals, have fallen short of expectations, resulting in poor performance.

Therefore, this chapter aims to facilitate comprehensive integration of services, education,

research, and community endeavors to ensure quality patient care and optimize the management
efficiency and effectiveness of teaching and affiliated hospitals.

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Section 2: Operational Standards

1. The hospital has established a functional management and governance structure

integrating medical education, health services, research, and community health priorities.

(Optional for affiliated hospitals)

2. The teaching and affiliated hospital has established functional management procedures

directing all teaching processes, student attachments, and community field activities.

3. The hospital develops and implements an orientation protocol for

students/interns/residents on hospital and national reforms before clinical attachments.

4. The teaching and affiliated hospital conducts regular clinical audits of patient care

provided by students/interns/residents and develops quality improvement projects based

on audit findings.

5. The teaching and affiliated hospital has established a system to ensure care provided and

student practices maintain patient confidentiality and privacy at all times.

6. The hospital has functional Library, skill labs and simulation centers.

7. The teaching and affiliated hospital has established protocols/policies and procedures for

ward rounds and bedside student teachings to maximize patient benefit.

8. The teaching and affiliated hospital ensures student/intern/resident patient care is

supervised by their respective teachers/hospital-based instructors at all times.

9. The teaching and affiliated hospital has established guidelines, memoranda of

understanding and procedures for affiliating with other teaching institutions, communities

and field activities.

13-5
Section 3 Implementation guidance
3.1. Teaching and Affiliated Hospitals’ management and governance structure

The Ministry of Health currently promotes a full organizational integration model where patient
care, teaching and research collectively function under the leadership of a Chief Executive
Director (CED) and a common governing board. Under this model, integration requires a shared
vision, collaborative strategic planning, and transparency between clinical and academic
components within a teaching hospital.

Full organizational integration under unified leadership and governance is advantageous for
several reasons. First and foremost, it facilitates strategic focus. Without such focus and
discipline, patient care, teaching and research activities may pursue divergent interests and
engage in initiatives that benefit one component but do not optimally advance the shared
mission. Secondly, it enables efficient utilization of financial and human resources. Third, it
allows researchers to focus on local health problems so that patients and the community can
benefit from research outcomes.

Teaching and affiliated hospitals should establish a governing board aligned with the FMOH and
FMOE’s “Guidelines for the Management of Federal Hospitals in Ethiopia.”

The teaching Hospital shall have:

 A governing board
 A Chief Executive Director nominated by the board and appointed by the Minister of
Health or relevant university president.
 Chief Directors for Clinical and practical teaching services, Academic and Research
affairs, Administration and Business affairs
 An Executive management committee under the CED and composed of all chief Directors
 A Senior Management team composed of clinical directors and relevant departments
 An academic commission organized based on relevant regulations

Affiliated Hospitals can continue to use their existing structures.

13-6
The roles, responsibilities, and procedures for the Chief Executive Director (CED), Chief
Academic and Research Director (CARD), Chief Clinical Director (CCD), Chief Administrative
and Development Director (CADD), Clinical Services Directors, Departments, Student rights
and duties, Consultant Staff, Residents and Interns are detailed in the “Guidelines for the
Management of Federal Hospitals in Ethiopia.” Teaching and affiliated hospitals should adhere
to and implement these guidelines.

3.2 Principles of Quality Service, Teaching and Research in Teaching and Affiliated
Hospitals:

 Complete integration of patient care, medical education and research under one
institution and management produces optimal results.
 Teaching and affiliated hospitals need to be led by boards overseeing the core activities
of the institutions.
 The functions of teaching and affiliated hospitals must be patient- and student-centered.
 All legislation needs to accommodate the unique aspects of teaching and affiliated
hospitals, with necessary modifications made.
 “Departments” are the basic functional units of teaching and affiliated hospitals for
patient services, medical education and research.
 Teams are the core groups running activities at all levels and need to be empowered.
 Teaching and affiliated hospital boards should be adequately represented in Federal
Hospital boards.
 Teaching and affiliated hospital boards shall include change agents, entrepreneurs,
community and civil society representatives, and be transparent, representative of all
stakeholders.
 All teaching and affiliated hospital appointments will involve participation, transparency
and be merit-based.
 All department members are jointly and individually responsible and accountable for the
three functions of medical care, teaching and research.

13-7
  Performance-based evaluation and evidence-based practice are fundamental to teaching
and affiliated hospital activities.
 Physician engagement, participation and leadership at all levels ensure ownership,
responsibility and accountability.
 Developing management and leadership capabilities among staff and trainees is essential
for teaching and affiliated hospital productivity.

3.3. Students/interns/residents’ orientation

All new students/interns/residents should receive an orientation on hospital improvement
initiatives, policies and procedures before any clinical attachment. The orientation should cover
the hospital’s organizational structure, accountability arrangements, policies and procedures to
help new students/interns/residents become acquainted with the overall organization and their
attachment areas and departments. The hospitals have developed an orientation guideline as a
reference for newly enrolled students/interns/residents. The orientation guide should include
updated information on:

 Infection prevention and control

 Patient information documentation and management/EMR use
 Communication with patients and staff
 Patient confidentiality, privacy, safety practices
 Hospital reforms like:
o EHSTG, Clinical audit, designing quality improvement projects
o Clinical Leadership Improvement Program/CLIP/
o SBFR
o HSTP-II
o HCF etc.
o National Quality and Safety Strategy
 Professional codes of conduct and other relevant knowledge and skills.
 Using the hospital knowledge repository
 MCC

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 All students/interns/residents are expected to comply with relevant hospital policies and
procedures at all times. The hospital should implement established new
student/intern/resident orientation guidelines.

3.4 Ward round and bedside student teaching related patients’ dignity and quality of care

The hospital should develop and implement a written protocol/policy for ward rounds and
bedside teachings to ensure these activities are patient-centered. All healthcare providers should
practice and provide care, teaching and research while maintaining patient dignity,
confidentiality, privacy, and quality care for optimal clinical outcomes. The protocol should also
include information on patient/family/caregiver involvement and access to details about their
care, including assessments, testing, care planning, implementation, and evaluating the
effectiveness of interventions.

3.4.1 Protecting confidentiality and dignity

In addition to medical knowledge and skills, healthcare professionals should demonstrate

psychosocial and humanistic qualities like caring, empathy, humility, compassion, social
responsibility, and sensitivity to cultural beliefs. Respecting patient trust in healthcare implies
adhering to values like acting in the patient's best interests while upholding the highest standards
of medical practice. Confidentiality and dignity are heavily influenced by ward layout and
available space. All ward team members should be aware of the environment when conducting
bedside teachings and rounds. Below are recommended guidelines to ensure patient
confidentiality and dignity:

 Use language that sets the tone for partnership.

 Common courtesy: Ask the patient for permission, introduce teachers/learners, explain the
proposed activity.

 Perform and practice examinations/procedures with appropriate explanation to the patient

and family/caregiver.
 Engage the patient in three-way dialogue with teacher and learners.

13-9
 Ask for patient feedback on clinician communication, clinical skills, attitude, and bedside
manner.
 Ask if the patient has questions since sensitive issues may have been raised.
 Ensure students respect patient information confidentiality.
 Use bedside curtains fully drawn before examinations to protect visual privacy. Auditory
privacy must also be respected during discussions.
 Establish policy on student-to-patient ratios to ensure patient comfort and effective student
learning.

3.4.2 Use of Skills Lab and Simulator Centers

Skills labs and simulation centers provide a safe way to acquaint healthcare students, especially
medical and nursing students, with clinical skills before application on actual patients. The
simulation prepares students to acquire skills prior to clinical practice.

3.4.3 Ward rounds/bedside teaching and quality of care

Ward rounds and bedside teachings are integral components of inpatient care, enabling the
clinical team to coordinate ongoing care planning, implementation, and evaluation. Quality care,
positive patient experience, and safety should be central to all ward rounds. Mistakes are more
likely in complex, chaotic teaching hospital wards, but a systematic human factors approach to
identify omissions and mistakes can reduce errors. Establishing, promoting and sustaining
cultural change around ward rounds and bedside teaching requires robust clinical leadership and
commitment from all healthcare professionals. Below are the recommended guidelines for ward
rounds/bedside teachings:

 Maximum ONE hour bedside teaching/ward rounds per patient. Extra time should be
justified and patient permission obtained.
 In the absence of teaching rounds, the ward specialist/medical officer should conduct
DAILY rounds for ALL inpatients.
 Findings, treatment changes, complaints in medical records during rounds should be
documented.

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  Ensure implementation of consultant recommendations/treatment regimens from rounds
as detailed in patient notes.
 On-duty medical officer should see ALL inpatients at least ONCE EVERY shift, and as
needed.
 Critically ill patients should be routinely monitored by the on-duty doctor, and seen by
the specialist at least ONCE per shift whenever there is a change in condition.
 Inpatient medication changes should ONLY be made after consulting the on-duty doctor,
apart from documented standing orders.
 Attend immediately to emergencies, discuss critical situations with the on-duty doctor as
early as possible, prioritizing patient stabilization.
 Communicate all referrals and consultations to the on-duty doctor, specialist, and
document in records.
 Ensure accurate, legible documentation.

3.4.4 Multidisciplinary Morning Meeting Sessions

Multidisciplinary morning meetings enable the multidisciplinary team (MDT) -

under/postgraduates, interns, clinicians, nurses, pharmacists, laboratory staff, radiographers, etc.
- to briefly review patient cases before starting routine activities on weekdays, excluding
weekends and holidays. The MDT uses the meetings to discuss care for critically ill patients and
propose alternative effective treatments. The meetings also discuss emerging administrative
issues.

A drawback is that prolonged meetings increase patient waiting times to see physicians, a major
source of complaints and dissatisfaction. Meeting durations should not exceed 30 minutes.

3.4.5 Record keeping

Ward rounds should include holistic patient assessments. Reviews and decisions need proper
documentation for care continuity and to address any medico-legal issues. Records should be
maintained in wards or medical records rooms. All documents should be legible with the name,
designation and signature of the documenter.

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  Patient records should be centralized to enable effective communication and teamwork.
 Clearly document all key ward round decisions and actions.

3.5 Community practice and field visits

Community practice and field visits are important teaching and learning activities conducted in
health facilities or the community. When students are placed in other health facilities or
communities, the teaching hospital should sign a memorandum of understanding with the
receiving/host facility and relevant community health authority.

Recommended guidelines include:

a) Students should always be accompanied by their instructors.

b) Orient students on community roles and responsibilities.

c) Provide relevant information on socio-cultural structure, values before deployment. Staff and
students should respect local cultures, values, social structures.

d) Hospital staff and students should not replace regular host facility activities.

3.6 Regular clinical audit of patient care provided by students/interns and residents.

Regular clinical audits of care provided by students/interns and residents are crucial for teaching
and affiliated hospitals to ensure care delivery adheres to standards without compromising
training and teaching activities.

Hospitals should develop a protocol to monitor and evaluate regular clinical audits of
student/intern/resident-provided care. The primary goal of this clinical audit protocol is to instill
a culture of systematic evaluation in teaching and affiliated hospitals and improve care and
learning processes.

The Clinical Audit Implementation Guide manual developed by the Ministry of Health provides
detailed guidance on implementing clinical audits in hospitals.

13-12
Section 4: Source Documents

1. Health, M. of (2021) National Clinical Leadership Improvement Program guidlin .

2. Medical Services, D.G. office (2019a) Final-National Clinical Audit Implementation
Guide.
3. Medical Services, D.G. office (2019b) Health Sector Transformation in Quality: A
guideline to support implementation of health service quality improvement activities in
Ethiopian health facilities, First edition.
4. Medical, W. et al. (2018) “Investment in Teaching Hospitals Benefits All: Mortality
Outcomes,” (September). doi:10.1001/jama.2017.5702.2.Burke.
5. Medical, W. et al. (2018) “Investment in Teaching Hospitals Benefits All: Mortality
Outcomes,” (September). doi:10.1001/jama.2017.5702.2.Burke.
6. Sector, H. and Plan, T. (2021) “Hstp ii,” 25(February).
 Chapter 18
Healthcare Technology
Management
Table of content

Contents
Table of content 14
List of table 16
List of figure 16
Abbreviations 16
Section 1 Introduction 18
Section 2 Operational Standards for Medical Equipment Management 19
Section 3 Implementation Guidance 20
3.1. Healthcare technology Management Unit/Directorate/Department 20
3.2 Medical Device Advisory committee (MDAC) 22
3.3. Medical Device Management information System (MDMiS). 24
3.4. Medical device maintenance and training workshop 30
3.5. Oxygen Devices Management 31
3.6. Cold chain management system 32
3.7. Good medical devices and spare parts storage practice 33
3.8. Acquisition/Procurement of medical devices 34
3.9. Medical devices installation and commissioning practice 40
3.10. Medical Device Maintenance Practice 44
3.11. Capacity building for users and Biomedical on proper utilization, safety and maintenance of
medical devices 53
3.12. Decommissioning and disposal of medical equipment 57
Section 4 operational standards with implementation checklist Error! Bookmark not defined.
Section 5 Indicators Error! Bookmark not defined.
5.1. Percentage of medical equipment Repaired Error! Bookmark not defined.
5.2. Availability of standardized biomedical workshop Error! Bookmark not defined.
5.3. Percentage of medical equipment installation 58
5.4. Percentage of MDMiS implementation Error! Bookmark not defined.
5.5. Percentage of Health Facilities with Functional Medical Device Advisory Committee (MDAC)
Error! Bookmark not defined.
5.6. Percentage of Medical Equipment Functionality Error! Bookmark not defined.
Annexes 59
Annex A: Inventory form 60
Annex B Performance test checklist 60
 Annex C PPM check list 61
Annex D Biomedical Equipment Maintenance workshop layout For General and Referral Hospital
63
Annex E Sample User Training Verification Form 63
Annex F - Work Order Form 64
Annex G Corrective Maintenance form 65
Annex H Good Practice Checklist for Corrective Maintenance 65
Annex I PPM Log Sheet 68
Annex J Sample Bin Card for Spare Parts 68
Annex L Sample Acceptance Test Log Sheet 70
Annex M calibration and testing tools 75

List of table
Table 1 Advantages and Disadvantages of Leasing/Leasing Type Arrangements ....................... 39
Table 2 Maintenance related definitions .................................................................................... 49
Table 3 operational standard with implementation checklist ........ Error! Bookmark not defined.
Table 4 Percentage of medical equipment Repaired ..................... Error! Bookmark not defined.
Table 5 Availability of standardized biomedical workshop .......... Error! Bookmark not defined.
Table 6 Percentage of medical equipment installation ................. Error! Bookmark not defined.
Table 7 Percentage of MDMiS implementation ........................... Error! Bookmark not defined.
Table 8 Percentage of Health Facilities with Functional Medical Device Advisory Committee
(MDAC) ..................................................................................... Error! Bookmark not defined.
Table 9 Percentage of Medical Equipment Functionality ............. Error! Bookmark not defined.

List of figure
Figure 1 healthcare technology management cycle .................................................................... 22
Figure 2 organogram for hospital HTMU .................................................................................. 22
Figure 3 components of maintenance program .......................................................................... 45

Abbreviations
BME/T – Biomedical Engineer/Technician
CCE – Cold chain equipment
CM – Corrective Maintenance
CMMS – Computerised Maintenance Management System
DiCOM – Digital imaging and Communication in Medicine
EFDA – Ethiopian Food and Drug Administration
EHSTG – Ethiopian Health Sector Transformation Guide
EPSS – Ethiopian Pharmaceutical Supply Service
FMOH – Federal Ministry of Health
HM7 – Health Level 7
HSTP- Health Sector Transformation Program
HTM – Healthcare Technology Management
HTMU - Healthcare Technology Management Unit
IPM – Inspection and Preventive Maintenance
JD – Job Description
LCD – Liquid Crystal Display
MD - Medical device
MDAC – Medical Device Advisory Committee
MDM – Medical Device Management
MDMiS – Medical Device Management Information System
MDDP – Medical Device Development Plan
PM – Preventive Maintenance
PPM – Planned Preventive Maintenance
SOP – Standard Operating Procedure
TOR – Terms of Reference
Section 1 Introduction

There is recognition that healthcare technology management (HTM), including medical Devices,
are among areas included in the Healthcare Sector Transformation plan (HSTPII and HSTPIII).
Specific areas that require improvement in the coming years include the development of local
innovative healthcare technologies through technology transfer and increased local production
capabilities. In Ethiopia, lack of proper management of Healthcare Technology has limited the
capacity of health institutions to deliver adequate health care. It is estimated that only 75% of
medical equipment found in Addis Ababa public hospitals that are functional and 50% in some
regional hospitals.
The rising number of this non-functional equipment is due to Poor equipment handling and
utilization, frequent power surges, the age of the equipment, the four lack (lack of operator
training, lack of preventive maintenance, lack of spare parts, lack of maintenance capacity), no
medical device policy and minimal knowledge regarding sophisticated equipment, factors which
also contribute to equipment breakdown. Beside all this existing problems because of lack of
representative data on medical device availability and functionality makes it, difficult to deploy
appropriate and skilled professionals.
As healthcare delivery continues to expand and improve in Ethiopia, and an increasing number
of sophisticated high-tech medical devices are being introduced, a system capable of supporting
and managing these medical technologies must be in place. It is very crucial to implement
Medical Devices Management operational standards in the hospitals using its cycle which
includes planning and assessment of needs, procurement, training, operation, maintenance,
decommissioning and disposal. Ensuring the interoperability of the Medical software and the
clinical application should be uses HL7 protocol and DiCOM supported. Additionally, activities
that ensure the successful management of resources and patient related risks in a healthcare
facility need to be implemented.
To improve healthcare technology management across all hospitals, the FMOH has introduced
and implemented EHSTG for the past decade.
This chapter outlines procedures that a hospital should undertake to appropriately implement the
Healthcare Technology management that allowing for the extension of services while ensuring
the safety of its patients.
Section 2
Operational Standards for Medical Equipment Management

The Hospital has in-house biomedical Engineering department or directorate or unit to oversee
the entire Medical Equipment Management system that has operational plan as well as a
necessary structure and staff.

1. The hospital has organized Healthcare Technology Management (HTM) Structure

2. The hospital has HTM committee (HTMC) from multi-disciplinary team
3. The hospital has a functional HTM information system
4. The hospital has standard medical device maintenance workshop
5. The hospital has medical oxygen devices management system
6. The hospital has cold chain equipment (CCE) management system
7. The hospital has separate medical device and spare part store
8. The hospital has appropriate acquisition system for medical devices
9. The hospital has proper medical devices installation and commissioning practice
10. The hospital has a proper medical device maintenance practice
11. The hospital conducts capacity building for users and BME/T on proper utilization,
safety, and maintenance of medical devices
12. The hospital has a proper decommissioning and disposal system
Section 3 Implementation Guidance

3.1. Healthcare technology Management Unit/Directorate/Department

Each hospital should establish a Medical Equipment Management Unit/Directorate/Department
that is appropriately staffed and led by trained biomedical personnel, which oversee the entire
health care technology/Medical device Management system with the following activities;

 The HTMU should have internal structure with JD for each Biomedical staffs within
hospitals according to Hospital level.
 The HTMU ensures the hospital recruit biomedical work forces as per the hospital
organogram.
 The HTMU should have Medical Device Strategic and Operational plan for Procurement,
Maintenance and Training of medical device.
 The HTMU ensures the hospital allocate sufficient budget for operational, maintenance
and spare part for Medical devices.
 Assuring quality and safety of patients, operators and Doctors while using medical
device.
 Arrange continuous training for all users by certified trainers on medical device
 The HTMU head should be part of the hospital management team.
 The HTMU should conduct preventive and corrective maintenance for medical device
 The HTMU should follow Medical Equipment after sales contract management as per
procurement agreement.
 The HTMU should develop a written procedure describing the processes for managing
risk, improving safety and quality of utilization
 The HTMU establishes automated and centralized documentation system that tracks all
equipment and spare parts for planning, budgeting, acquisition, reporting and other
purposes.
 The HTMU participates on equipment planning, purchase, installation, maintenance,
troubleshooting, and technical support
 The HTMU works towards national and international service accreditations.
 Figure healthcare technology management cycle

Healthcare technology management cycle

The Healthcare Technology Management (HTM) cycle involves a systematic approach to
effectively manage and optimize healthcare technology within a healthcare facility. It begins with
the with planning and need assessment with appropriate budgeting and financing which enable
to the identification of technology needs, followed by the process of planning and procurement
to fulfil the necessary devices. Once acquired, the next step involves installation and
commissioning, ensuring proper integration and functionality. Regular maintenance and
calibration ensure the equipment's sustained performance and reliability, while training and
education ensure that healthcare professionals can effectively and safely utilize the technology.
Eventually, the technology may reach the end-of-life stage, where strategies for
decommissioning and disposal are determined. Overall, this cycle ensures a comprehensive and
efficient approach to managing healthcare technology, ultimately contributing to improved
patient care and outcomes.
Budgeting and financing
Budgeting and financing of medical devices management activities involve planning and
managing the financial aspects of acquiring and maintaining medical equipment. The budgeting
process typically involves estimating the costs of various medical devices, including their
purchase prices, installation expenses, maintenance and repair costs, and ongoing operational
expenses. It's important for healthcare facilities to assess their needs, prioritize their medical
device requirements, and allocate proper resources accordingly.

Organogram for Hospital HTMU/department/directorate/team

CEO/CED

HTMU/D/T

Warehouse Oxygen
Maintenance Managment managment
and training case
Work shop Team/Focal

Imaging and
Radiation Laboratoy Other HTM HTA & MD Data
Case case case Management case OR & ICU case
team/focal team/focal team/focal team/focal
Team/Focal

Figure 9 organogram for hospital HTMU

3.2 Healthcare Technology Management Committee (HTMC)

Health technology management committee is a multidisciplinary team that has an advisory role
on medical device management system. Medical device management is not a standalone task and
needs involvement of multidiscipline within hospital. Each hospital should establish a medical
device advisory committee (HTMC) that has an advisory role in management of medical device
in the facility.

Organization of Healthcare Technology Management Committee

The health technology advisory committee should be organized from clinical, administrative, and
finance, and other relevant hospital departments. The committee will be chaired by the clinical
director of the hospital and the head of HTM will be a secretary. Members will be assigned from
different departments and should comprises, as a minimum:-
 Chief Clinical officer/ Medical director/ Chief executive director/ Chief executive officer
(Chairperson)
 Head/Director of health technology management (Secretary)
 Head of Pharmacy (member)
 Head of laboratory department (member)
 Head of Nursing - midwifery service (Matron) (member)
 Head/representatives of major clinical departments (internal medicine, surgery,
pediatrics, gyn-Obs, etc.) (members)
 Head of finance department (member)
 Head of imaging department
 Representative from medical oxygen management unit (if oxygen plant available)
 Representative from other services as deemed necessary (member)
All members should be assigned with official letter and defined role and responsibilities.
Depending on the equipment being discussed by the HTMC, specialists from the associated
department/case team may also participate. The selection of members of the HTMC should be a
clear and transparent process. The Committee should prepare terms of reference (TOR) that
clearly outline the roles and responsibilities of the committee members and should conduct
regular meeting (at least every two months) and as needed in urgent situations. Meeting minutes
should be documented properly. The committee will prepare action plan and monitor, review, and
report its performance to the management.

The advisory committee should regularly assess the hospital’s medical device management
system performance and take intervention strategies accordingly.
Role of HTM committee
 Oversee the medical device management system
 Develop a model medical device list
o The hospital should develop and maintain a model medical device list that
comprises types of equipment required by the hospital. The model device list is
prioritized to provide each service.
o National standards for medical equipment for each type of service or hospital
(Primary, General and Specialized), where these exist, should be the minimum
requirements of the model list, but these may be expanded upon as determined by
the multi-disciplinary team.
o The model medical device list should be approved and revised annually by the
advisory committee.
 Monitor the implementation of policies, standards and guidelines developed for effective
medical device management
o Planning and procurement of medical equipment
o donation of medical equipment
o Disposal of medical equipment
o Review incident reports related to medical equipment
 Monitor establishment of a medical equipment inventory system
 Ensure proper utilization of medical device within the health facility
 Conduct medical device utilization, safety, and need assessment and propose intervention
strategy

3.3. Healthcare technology management (HTM) information system

Healthcare technology management (HTM) information system is hardware or software products
intended to transfer, store, convert formats, and display medical device information.
The major category of information about medical device are:
 Medical device Inventory
 Bin and stock card
 Medical device History file,
 Risk classification system
 Spare parts and accessories inventory management
Medical device inventory
Medical device information recording and archiving begins on the day the device is
commissioned and overhanded to the health facility. Medical device inventory is a list of the
technology on hand, including details of the type and quantity of equipment and the current
operating status, preventive maintenance schedules, Accessories, consumables and spare parts
The inventory provides the basis for effective asset management, including facilitating
scheduling of preventive maintenance and tracking of maintenance, repairs, alerts and recalls.
The inventory can provide financial information to support economic and budget assessments.
The inventory is the foundation needed to organize an effective MDM department. Items such as
equipment history files and logbooks, operating and service manuals, testing and quality
assurance procedures and indicators are created, managed and maintained under the umbrella of
the device inventory. Furthermore, accessories, consumables and spare parts inventories are
directly correlated with the main medical equipment inventory.
 Conduct once and must be continually maintained and updated to reflect the current
status of each Medical equipment.
 Depending on the level of the hospital and its Medical device, different details are tracked
and updated as changes occur
Each hospital should establish an inventory of all medical device following the inclusion and
exclusion criteria described in the Medical Equipment guidelines and definition.
 A small team should be established to set up the initial inventory of medical equipment.
 The team should be led by the Head of Medical device management who is ultimately
responsible to establish and maintain the equipment inventory.
 Medical device maintenance personnel or other staff assigned by hospital management
should also form part of the inventory team.
 Additionally, one or more department/case team representatives should participate in the
inventory of their respective department/case team.
 The inventory team is responsible to visit every department and record every item of
medical equipment.
 A sample Inventory Data Collection Form is presented in annex A.
 Items that are obsolete, that cannot be repaired or that are not of use to the hospital should
be removed and transferred to a storage area at the time of the inventory and the formal
disposal process should be started.
 An inventory code number should be assigned to each piece of equipment. This can be
done sequentially from number one (1) upwards. Each new item is assigned the next
number, with no regard to type of device, location etc. Alternatively, a ‘speaking
numbers’ inventory system can be used.
 This system indicates the location, the type of equipment and the individual number of
the equipment. With a ‘speaking number’ system each room/department in the hospital is
assigned a location code and each type of equipment is assigned an equipment type code
– for example “T1 99 02” where T1 is Theatre number 1 in the operating suite, 99
indicates the item is suction pump and 02 is the individual number of machine.
 Although the ‘speaking numbers’ inventory system is more complex to establish, it has
the advantage that it is easy to identify the location of each item and to organize the
equipment inventory by each department.
 An inventory database should be established to record and manage all items of
equipment. This can be paper based or computerized, with paper back up. The following
should be documented in the inventory for each item of equipment:
 Information gathered as part of the inventory of medical equipment should be included in
the overall fixed asset inventory of the hospital.
 The inventory should be reviewed and checked annually, with regular updates during the
year when new equipment arrives or is removed from service.
 Additional inventory checks may be conducted at regular time intervals throughout the
year, as determined by the HTMC and hospital management.
 When an item is discarded it should be removed from the Inventory Database. A record
should be kept in a separate file of all discarded equipment for future reference and audit
purposes. All equipment should be labelled with its inventory number preferably using a
water proof Poly Vinyl Chloride (PVC) sticker. Hospital policy should prohibit use of
medical equipment without inventory tags/stickers. This is to ensure that all equipment in
use has undergone ‘acceptance testing’ and receives regular preventive maintenance,
hence minimizing risks to patients and staff from faulty equipment.
 Uses MEMIS website for computer based medical devices, Spare parts inventory and
Maintenance system
 Upload the develop and maintain Equipment History Files for all Equipment and
uploaded in MEMIS
 Upload the establish SOPs for equipment use, safety, PPM and Troubleshooting
procedures and using MEMIS
 Upload the establish PPM schedules using MEMIS
 Track history file
Items included in an inventory
 The hospital medical device inventory includes medical equipment’s;
 Can be based on function (2-10 pts), risk level (1-5 pts) and maintenance requirement (1-
5 pts) criteria whose formula is given by:-
 𝑫𝒆𝒗𝒊𝒄𝒆 𝒎𝒂𝒏𝒂𝒈𝒆𝒎𝒆𝒏𝒕=𝑭𝒖𝒏𝒄𝒕𝒊𝒐𝒏+𝑹𝒊𝒔𝒌+𝑴𝒂𝒊𝒏𝒕𝒆𝒏𝒂𝒏𝒄𝒆 𝑹𝒆𝒒𝒖𝒊𝒓𝒎𝒆𝒏𝒕
 Items with score <12 are excluded from inventory
 In addition to this include the medical equipment’s by definition.
 Main medical equipment inventory Data included in Hospital medical equipment
inventory information:
o Inventory identification number based on available nomenclature system
o Type of equipment/item
o Brief description of item
o Manufacturer
o Model/part number
o Serial number
o Power requirement
o Physical location within facility
o Condition/operating status
o Operation/service requirements
o Date inventory updated
o Maintenance service provider
o Purchase supplier
o Year of Manufacturing and purchased
 o Equipment risk classification
o Estimated life span
o Availability of trained user and technicians
o Other information as needed
 Before establishing a medical equipment inventory the MDAC/HTMU should determine
which items should and should not be included in the inventory and medical equipment
management program based on standard inclusion and exclusion criteria. However, the
MDAC/HTMU may decide to exclude smaller, less expensive and easily replaceable
items from the medical equipment inventory and program (for example
sphygmomanometers, stethoscopes, etc.) since the effort required to record, maintain and
repair these smaller items may not be worth the required

Equipment History File

An individual file/folder should be established for each item of equipment. This file should be
held in the equipment maintenance department. The file should contain:
 Inventory Data Collection Form (Appendix xx)
 The address of the manufacturer
 The address of the supplier and local agents
 Details of any maintenance contract and maintenance contractor (if relevant)
 Copy of warranty (if relevant)
 Price paid/Copy of invoice
 Medical device manual or location of the manual
 List of consumables required to run machine and recommended spare parts
 Acceptance test log sheet (Appendix H)
 Medical device Risk Assessment Form (Appendix C)
 SOPs for operation and maintenance of the item
 Planned preventive maintenance schedule
 Corrective maintenance reports (Appendix K)
Operator, service and other relevant manuals for all equipment items should be stored in the
workshop library. Copies should be made and distributed to users and other interested parties as
necessary
Medical device Risk Classification
As part of establishing an inventory an assessment should be undertaken to classify each item of
equipment as ‘high’, ‘medium’ or ‘low’ risk. This level of risk determines the priority with which
equipment should be repaired and maintained or replaced if no longer operable. For example if a
‘high risk’ item (such as an anesthesia machine) is broken this should generally be repaired
before a ‘low risk’ item even if the ‘low risk’ item has been broken for longer, except under
special circumstances. Additionally, when implementing the guidance in this chapter (such as
developing standard operating procedures (SOPs), setting maintenance schedules, training staff
in equipment use etc.) the ‘high risk’ items should be dealt with first.
The assessment of risk should be done based on:
 Function of the equipment: For example whether the equipment is used for life support,
routine treatment, diagnosis or monitoring Risk which may associated with equipment
failure
 Preventive maintenance requirements: The frequency with which preventive maintenance
is required to minimize breakdown and ensure safety
 Main area of equipment use: For example use in anesthesia or surgical areas, use in
general care areas etc.
 Likelihood of equipment failure: This is measured as the ‘mean time between failures’
calculated from previous use or service records. A Medical Equipment Risk Assessment
Form should be completed for all items in the equipment inventory. The risk category
should be entered on the Inventory Index Card, and the Risk Assessment Form should be
fled in the medical device history file. Any new item of equipment should be assigned a
‘risk category’ when it is received by the hospital and entered into the inventory.
Spare Parts and accessories Inventory
The medical device maintenance department should maintain a stock of the most commonly
replaceable spare parts for the different types of equipment in the hospital. Items should be kept
in a locked room with a stock control system in place. Spare parts should be stored according to
manufacturer’s instructions and should not be used beyond the expiration date. The inventory of
spare parts should be managed using a ‘stock and bin card’ system.
3.4. Medical device maintenance and training workshop

The hospital should have a medical devices Training and maintenance workshop separately from
the general maintenance workshop equipped with the necessary testing, calibration, measuring
instruments, maintenance tools, personal protective equipment, computer, printers, reference
books, operator and service manuals, SOPs and internet access needed to carry out the overall
medical devices management services.

Hospitals should establish a medical equipment maintenance workshop based on their level (see
the Appendix D Workshop Minimum standard layout) that consists of the following:
Maintenance workshop including space for:

 Standard medical device and training workshop layout - Hospitals based on their
service level and standard should establish medical device workshop as per the minimum
standard of MOH. The hospital should have all the necessary facility rooms, well
ventilated utilities, easy access for loading and unloading.
 Administration offices - Hospital medical device workshop as of any department in the
hospital shall have administrative office for department head as well as for their staff and
well furnish with the necessary office equipment (furniture, computers, and internet).
 Electrical/Electronic Work Area
 Biomechanical Work Area
 Test, Measuring equipment, Tools, Spare parts - Medical device of the hospital
Workshop shall have standard test, measuring, calibration, and maintenance tools based
on the number of staff available in the workshop. The minimum standard list of medical
device workshop test, calibration, and maintenance tools are annexed M.
 Personal Protective Equipment(PPE) – such as safety shoes, eye goggle, mask, gloves,
rubber sheet/apron and others
 Spare part and consumable mini- Store - Hospital medical device workshop shall have
a mini- store for storing fast moving consumable’s Spare part. This mini- store should
have a shelf to put all items in their proper order and easy to apply a good storage
practice and using bin card.
 Mini- library - Workshop must have a mini- library facility which is help full to access
equipment users and service manuals, maintenance SOPs, reference books
  Training Room - The hospital medical device should have a well-equipped (with LCD
projector and chair) training room which is appropriate to conduct frequently equipment
users ( clinicians) training on newly arrived equipment and also train a new clinical staffs
about the equipment they are going to use and proper handling
 Duty room - Medical device Workshop should have a duty room for their staffs those
who assigned for night duty activity.
 Rest room (toilet) - Hospital medical device workshop should have a functional and
separate for male and female rest room with shower and change room services

3.5. Medical Oxygen Devices Management

Hospitals that have medical gas systems plan (medical Oxygen plant) and pipeline system they
shall have oxygen device management team under the HTMU. The team may be composed of
biomedical and electromechanical engineer professionals as required.

Medical Oxygen plant

The health facilities should conduct oxygen production quality assurance activities through
periodic check using the proper instrument. It is also important to verify that the quality and
capacity of each oxygen sources/plants production maintained (m3 per hour) as per the
manufacturer’s manual. Furthermore, it is important to ensure the continuous production and
supply. To ensure continuity of production it is advisable to use duplex or triplex pant system
instead of single use.
Consumption & production Record
The health facilities BME/T should record the daily, monthly and annual oxygen consumption to
facilitate proper quantification, budgeting and to ensure access to patient treatment and there by
avoid mortality due to oxygen scarcity.
Availability of testing and measuring devices
To monitor the quality and production capacity of oxygen production plants /devices the
availability of testing and measuring with appropriate oxygen analyzer is mandatory. To maintain
quality of work analyzers needs to be calibrated and documented periodically.
Oxygen Cylinders
The health facilities BME/T team need to ensure the implementation of standard color code and
use medical grade oxygen cylinders. There must be a separate storage compartment for filled and
empty cylinders. It is also important to have storage space to keep distance between each
cylinder. During transportation and storage, ensure that all cylinders are kept up right position
with safety cup on them. In order to avoid accidents due to oxygen explosion and valve damage
proper care must be taken on loading and un-loading cylinders. Inspection for each cylinder
should be done to identify if there is a damaged valve. The use of proper transportation trolley
should be a usual habit by all oxygen cylinder transporters.
Oxygen cylinder Refilling
During refilling oxygen Cylinders, the BME/T should inspect to ensure whether the cylinder is
properly filled and compressed (appr…150 bar). It is also important to ensure the cleanness of
cylinders every six months and document the certificate. Leak and purity (oxygen concentration
93 ± 3) test have to be performed using relevant instrument or other methods such as soap foam
and so on.
Health facility Medical gas distribution system
Medical Gas Distribution System is a central supply system to supply a medical gas (O 2, N2O,
and N2), medical air, and medical vacuum to each ward of hospital safely and conveniently
through a central supply piping from medical gas supply sources. The system has a thorough
going color coordination according to the kind of gas.
Oxygen devices, Consumables & Accessories as per the annexed list
The health facilities should ensure/ confirm the availability of relevant oxygen devices,
consumables, accessories and other relevant equipment’s needed for the production, distribution,
delivery and monitoring of medical gas for safe treatment of patients. (List of oxygen devices are
annexed).

3.6. Cold chain management system

As immunization programs is one of the hospital critical service, Vaccines, some pharmaceutical,
Laboratory reagents and blood products must be kept in appropriate cold chain system. For this
purpose equipment needed to move and store vaccines, reagents, and blood products at the ideal
temperature range. By implementing the following best practices—planning with program needs
in mind; committing to cold chain equipment maintenance; and developing good recordkeeping,
reporting, to maintain a strategic cold chain and lower risk to the vaccine, pharmaceuticals, and
blood products. To separate cold chain equipment’s based on their functionality status is very
crucial.

The preservation of cold chain products, including vaccines, is indeed vital in the healthcare
industry. Cold chain products are temperature-sensitive and must be stored, managed, and
transported within a limited temperature range to maintain their potency. Temperature
monitoring devices play a crucial role in ensuring that proper storage conditions are maintained
throughout the cold chain. These devices measure and record the temperature of the environment
in which the products are stored or transported. By using temperature monitoring devices, the
risk of spoilage and quality degradation is reduced, regulatory compliance is improved, and
proactive measures can be taken to prevent product loss. It is also important for biomedical
engineers/technicians to calibrate temperature monitoring devices, regularly document
temperature readings, and store vaccines according to the manufacturer's instructions.
Additionally, during the loading and unloading process, vaccines should be carefully packed into
refrigerated containers or trucks to maintain the required temperature range. Vaccines sensitive
to freezing should be stored within a specific temperature range of 2°C to 8°C.

3.7. Good medical devices and spare parts storage practice

The procured medical device and spare parts shall be received by the store manager. Before
receiving established procedure for each incoming items against the relevant documentation
(specification, ordered quantity, required manuals) to ensure that the correct product is delivered.
Once confirmed that these medical device and spare parts fulfill the minimum requirements, the
store manager should receive using Model 19.
If there is any discrepancy, it should be noted and informed to EPSS or the supplier. The received
medical device and spare parts should be stored at separate store from pharmaceutical store until
they are issued to service delivery units of the hospital. The medical device and spare parts store
manager should properly store medical device and spare parts following guidelines/ SOP for
good storage practices for medical device and spare parts. The stored items must have proper
management (zoning for medical device, spare part) and labelling of items including the
following information (item name, part number, model).
The store manager also determines the available warehouse space before ordering medical
device and spare part for the next procurement period according to Storage Guideline/ SOP. Both
manual and electronic-based inventory management system shall be implemented. Effective
inventory management is underpinned by a Medical Equipment Management Information
System (MEMIS). The purpose of MEMIS is to support the management of all medical device
and spare part by collecting, organizing and reporting information to other levels in the system.
Standardized forms for inventory management are described below:
Bin Card: A Bin Card should be prepared for each product in the medical device and spare part
Store. The Bin Card should be kept with each product inside the store. All transactions of the
product to or from the store should be recorded on the Bin Card. The Bin Card should also
include a column for the loss/adjustment of stock and a column for the stock balance. The stock
balance should be updated after each and every transaction or adjustment.
Stock Record Card: The Stock Record Card is similar to the Bin Card but is used to track stock
based on issuing and receiving orders. It should be kept in the Medical Device Management
Unit. The totals on the Stock Record Card should be checked against those on the Bin Card and
the results of the physical count. Any discrepancies should be investigated. A combined
Bin/Stock Card System provides a measure of internal control that helps to minimize leakages of
stock due to theft or loss. Paper based or electronic systems can be used.

3.8. Acquisition/Procurement of medical devices

Any new equipment acquired must be suitable for the hospital’s mission and improve access to
quality healthcare. The HTMU also needs to ensure that equipment operators have the ability
and capacity to absorb, support, and use any technologies procured. Procurement activity is part
of the broader acquisition phase of healthcare technology management, which also includes
planning, need assessment, selection, financing and budgeting.

Purchasing refers to the acquisition of goods or services in return for money or equivalent
payment whereas Procurement is a wider term and refers to the process of obtaining goods and
services in any way, such as through purchase, donation, loan or hire. However, the use of the
terms ‘procurement’ and ‘purchasing’ interchangeably to mean ‘procurement’ is a common and
accepted practice

Planning and need assessment

Planning and need assessment requires establishment of Multi-disciplinary Team/HTMC, data
gathering and definition of strategic areas, development of list of required devices, quantities and
specifications and specifying of site requirements.

Need assessment is the identification and definition of prioritized requirements with regard to
medical devices. A thorough needs assessment is indeed essential before purchasing medical
equipment. It involves evaluating the potential impact on the performance of medical equipment
users and the delivery of services within the context of the health system's capabilities and
service delivery priorities. This assessment considers factors such as the overall objectives of the
institution, existing facilities and infrastructure, long-term usage plans, and human resources
development. The general approach to conducting a needs assessment is to assess the current
availability of medical equipment in the facility and compare it with what should be available
based on the specific demands and situations of the catchment area or target group. This helps
identify any gaps and determine the necessary medical devices that need to be procured. During
the procurement process of medical devices and technical evaluation, the involvement of
biomedical engineers and related disciplines is crucial. Their expertise ensures the procurement
of quality and appropriate medical devices that meet the requirements of the institution and can
be effectively utilized by the healthcare professionals.

Medical Devices Development Plan

The Medical Device Development Plan (MDDP) is aimed to define goals for acquisition,
maintenance, and replacement of equipment in the short term and long term. It should be
developed taking into consideration the current devices inventory and the ‘model medical device
list’.

The medical devices development plan (MDDP) brings attention to:

● Current stock and condition of equipment: which pieces need to be replaced or

rehabilitated or to be disposed
● Shortfalls in equipment: missing equipment that needs to be purchased
● What action is needed to rehabilitate, replace or purchase equipment
● Short-term (1 year) and long-term (2-5 year) goals to ensure that the hospital has all
necessary equipment for current and future services.
The MDDP should be developed by the HTMU and approved by hospital management. The plan
is the basis for the annual equipment budget .The Head HTMU is responsible to implement the
plan, with the assistance of other departments where relevant (for example administration and
finance). The HTMU should quantify spare parts and device consumables together with the
equipment.

Medical device Specification

The specification is the most important document for both the purchaser and for the potential
supplier, since it sets out precisely what characteristics are required of the products or services
sought. Often, this is the only chance to detail the selection criteria including requirements for
certain levels of technology, quality, safety, appropriateness, consumable inputs, training, and
technical support. This is especially the case if the hospital is using a tendering process when it is
not legal to introduce additional terms and conditions after the tender bids have been received.
Therefore any preferences made in these areas must be highlighted within the initial
specification.

The HTMU should write medical device specifications, so that whoever is procuring/ providing
the goods can conform to the hospital’s requirements. The specifications provide the detailed
technical description of each type of equipment on the Model Equipment List. HTMU may
require specialists to help with writing such specifications.

Having drawn up Model Equipment Lists and Acquisition policies follows the process of
acquisition. Whether we are carrying out procurement on our own behalf, or have enlisted the
help of an external support agency to do it, purchase orders or requests for tenders/quotations
have to be prepared. A clear specification includes;

 A detailed description of the equipment

 The ‘package of inputs’ needed to keep the equipment going through its lifetime
(including consumables, installation, training and after-sales support)
 The quantities required

Medical device Procurement

Obtaining equipment is intensive work, both in terms of time and resources. It is therefore
required to consider a number of factors before committing to buying, accepting donations, or
hiring equipment. Before carrying out any equipment procurement (through purchases, donations
or rentals), the hospital should already have

● an up-to-date equipment inventory

● a vision for health service delivery
● purchasing, donations, replacement, and disposal policies
● Model Equipment Lists

Ideally, all procurement should be for those items laid out in the Device Development Plan for
the current year, plus occasional additional items required to cover contingencies (emergencies
and unplanned events).

The acquisition/procurement of medical equipment should be under taken in accordance with the
Ethiopian government/ MOFED/ directives. Once we know the equipment we need, there are
several ways to obtain it:

Choosing purchase methods

Whenever the hospital purchases medical equipment, it is needed to decide the best model of
procurement to use (for example, whether to purchase by ourselves or collectively). It is needed
to decide upon the most appropriate purchasing method and the types of suppliers to approach.
Such planning will enable to make efficient use of resources, and ensure that any equipment
bought is appropriate to the need and is of the right quality. It will also enable to work within the
appropriate timescales. There are various ways of purchasing equipment. It is important to know
the different options available, so that each time the equipment is bought; the most appropriate
options are selected.

 Centralized procurement – procurement takes place centrally, for example at the national
level
 Group procurement – joint procurement by different health facilities, health authorities
(district, regional) or health service provider organizations (public or private)
  Decentralized procurement – health facilities or health authorities to which authority has
been decentralized procure equipment themselves, or health facilities and health
authorities with independent funds undertake their own procurement.
 Mixed procurement – a combination of centralization and decentralization, whereby
some parts of the procurement process are undertaken centrally and others at district or
facility level.
 Using procurement agents – private companies being hired to handle procurement.

Leasing and Renting Medical Equipment

Leasing and renting are terms commonly associated with acquiring the temporary use of a
property or asset, but they have some fundamental differences.

If the hospital do not wish to buy equipment using the capital budget, it may choose some form
of leasing arrangement, which uses funds from the recurrent budget instead. When doing this, it
is necessary to weigh up carefully the costs and benefit and also check whether such
arrangements are legal and approved by national authorities or the central management body.

Renting, on the other hand, typically involves shorter-term agreements, often month-to-month or
on a yearly basis. Renting usually involves paying regular rent to the landlord for the use of a
property or asset. Apartments, houses, and equipment rentals are common examples of renting
arrangements.

In the case, the leasing organization retains ownership of the item and is also responsible for the
maintenance, repair, and updating of the equipment. The lessee (in this case, the hospital) has
possession and use of the equipment until such time as the lease contract runs out.

In summary, the key difference between leasing and renting lies in the duration and flexibility of
the agreement. Leasing usually involves a long-term commitment, while renting tends to be more
short-term and flexible.

Advantages and Disadvantages of Leasing/Leasing Type Arrangements

Advantages Disadvantages

Provides certainty as costs are known in A fixed obligation is created to pay rental from
advance your recurrent funds

Reduces the need to tie up capital funds in The flexibility to dispose of obsolete
fixed assets equipment before the end of the lease may be
reduced.

Enables the suitability of equipment to be Doesn’t provide ownership.

assessed over a pre-determined trial period

Sometimes enables you to obtain equipment or Agreements are one-sided. When leasing, if
material that is hard to purchase something goes wrong most risks are
transferred to the lessee (for example, loaned
items must be replaced if damaged). Under
leasing type arrangements, although most of
the risk remains with the owner of the
equipment this has to be paid for in the rental
price, and additional costs will be incurred,
depending on the contract terms, if a leased
item is misused or otherwise damaged.

Table 6 Advantages and Disadvantages of Leasing/Leasing Type Arrangements

Medical Device Donation

The hospital should strictly follow National Medical Devices Donation Directive for the receipt
of donated medical devices. The directive describes the conditions under which donated medical
devices will be accepted by the hospital. For example:
 ● Donated equipment must be in good working order
● Equipment will only be accepted if the item is needed by the hospital and is described in
the Model Devices List and associated annual medical device management plan
● Instruction manuals, in English, should be supplied with the donation
● Supplies, consumables and spare parts for the equipment should be readily available in
Ethiopia. If that is not possible, at least 1 to 2 years of needed consumables and spare
parts should be supplied by the donor with the donated equipment
● Expertise for the maintenance and repair of the equipment should be available in Ethiopia
● The equipment must be compatible with other medical equipment system in the hospital
● The equipment must not require any special storage or operating conditions that the
hospital cannot provide (for example air conditioning, humidity control etc.)
● The donor should provide training in the regular use and preventive maintenance of the
equipment, if relevant, and
● The donor should provide follow up support regarding use of the equipment, where
necessary
● When items are donated the hospital and donor must agree who is responsible for
customs clearance, including approval of the item by the regulatory authority if
necessary.
All equipment donations should be reviewed by HTMU and approved by the hospital
management before acceptance.

3.9. Medical devices installation and commissioning practice

Healthcare and patient management have changed dramatically in recent years and continue to
do so, mainly as a result of the advances in healthcare technology. Healthcare technology plays
an extremely important role in everyday clinical and public health work. Therefore the hospital
senior management in-collaboration with medical device management unit shall in place proper
medical device installation and commissioning procedure/protocol or other guiding documents.

When an order has been placed to purchase a new item of equipment, or a donation has been
accepted, preparations must be made for receipt of the item. Receive equipment on site check
according to given logistics specifications and confirm there is no visible damages. This is to
ensure quick and efficient installation, commissioning, training, acceptance testing and
eventually placement into service.

Installation of medical devices is “the process of fixing equipment into place” related processes
are the delivery, storage and placement of procured goods in the desired location and should
completed contract awards or purchase orders, specified materials and well defined delivery
requirements.

Pre-installation work involves:

 Preparing the site ready for equipment when it arrives

 Organizing any lifting equipment
 Organizing any warehouse (storage) space
 Confirming installation and commissioning details
 Confirming training details.

Site Preparation - Site preparation is often required to ensure that the location where the new
equipment to be installed is suitable. This may require sufficient room/place, door entry sizes,
elevator capacity, and new connections for electricity, water, drainage, gas or waste piping and
may even require construction work.

Site preparation tasks may include:

 Disposing of the existing item that is to be replaced

 Extending pipelines and supply connections to the site
 Upgrading the type of supply, such as increasing voltage or pipeline diameters
 Providing new surfaces, such as laying concrete or providing new worktops
 Creating the correct installation site, such as digging trenches, building a transformer
house or a compressor building

Lifting Equipment - Large or heavy items will need to be lifted and moved upon arrival. Plans
should be made ahead of time to arrange proper lifting/ moving equipment before the new
equipment arrives.

Warehouse (storage)
If goods need to be stored before they can be unpacked or installed, space should be made
available for these items before they arrive.

Acceptance testing - Depending on the complexity of the equipment, installation can range from
simply plugging the equipment into an electrical socket to building it into the fabric of the room.
All medical equipment, purchased or donated, should be inspected upon delivery and tested prior
to initial use. This is known as acceptance testing and ensures that delivered medical equipment
is complete, undamaged, in good operating condition, accompanied by manuals and spare parts,
satisfies safety criteria, and meets specifications of the purchase order. A competent individual
must assess the functionality of the equipment to prevent any harm to the operator or patient
upon use. Guidance for unpacking and inspecting equipment is presented within the package.

The main steps in the Acceptance Testing process are described below:

 How complex is the equipment? The more complex the device, the more likely the
manufacturer will need to be involved.
 Do the hospital staffs have the necessary technical skills? If the staff cannot perform
the job, then an outside vendor should be contracted.
 Does the purchase is single item or in bulk? If purchasing in bulk, it is often
worthwhile to contract the manufacturer to perform this process on all the equipment. For
a single unit, the in-house staff may be able to manage with guidance from the
manufacturer.

Commissioning is performing a series of tests and adjustments that will check whether the new
equipment is functioning correctly and safely, and ensuring that any adjustments are made,
before the equipment is accepted.

Preparation for User Training: The details of training should already have been decided when
drawing up the purchase contract or donation acceptance document. During delivery time, any
preparations that need to be made (including preparation of training materials, training space,
equipment, etc.) should be finalized in order to ensure training can commence when the
equipment is delivered.
Isolate the equipment until it has undergone acceptance testing Once equipment arrives, set it
aside by isolating the equipment in a special holding area and by labeling it as “not for use” to
ensure that the equipment will not be used. The only exception is for large items that may be
delivered to where they will be installed but should still be clearly marked as “not for use” until
the acceptance process is completed.

Undertake acceptance testing and complete Acceptance Test Log Sheet (see Appendix L)

Acceptance testing should include:

 Checking the delivered equipment matches as per the details of the purchasing order
(model, vendor, quantity, technical requirements, etc)
 Checking the equipment is accompanied by operation and service manuals and necessary
paperwork (e.g. warranty, if applicable) as per the purchase order.
 Checking that appropriate spare parts and consumables are included as per the purchase
order
 Installation and commissioning of the equipment. Installation is the process of fixing the
equipment into place. Depending on the complexity of the equipment, this can range
from simply plugging the equipment into an electrical socket to building it into the fabric
of the room. Commissioning is performing a series of tests and adjustments that will
check whether the new equipment is functioning correctly and safely, and ensuring that
any adjustments are made, before the equipment is accepted.

If the equipment passes the safety, calibration and function tests and commissioned then the
hospital can officially accept the equipment and establish equipment history file which includes
Inventory form, Standard Operating Procedure, risk classification and Preventive maintenance
schedule.
Provide training for equipment users and maintainers as appropriate.
This will ideally occur immediately but sometimes, due to availability of trainers (in-house,
vendor, other), training may occur at a later date. In this case the HTMU will have to decide if it
is safe to hand over the equipment before training the staff. Placing the equipment into operation
without training should only be done when the equipment type has been used before and the
staffs are familiar with proper operation. Installation and commissioning should be carried out in
the presence of the user as well as engineering support team. Demonstration of the device
indicating all its functions should be carried out to the satisfaction of the user and biomedical
engineering team. Training on operation and maintenance should be included in specifications
indicating the type, duration, location (on-site/off-site, local/overseas), target personnel i.e.
doctors, nurses, maintenance personnel, since differing types and levels of training needs to be
provided for each staff category. User training should be provided by an application specialist,
especially training for sophisticated or complex devices.

3.10. Medical Device Maintenance Practice

Medical devices may cause life threatening problem if it is not managed properly. Therefore, it is
important to have a well-planned and managed maintenance practice to ensure medical device
are reliable, safe and available all time when it is needed for diagnostic procedures, therapy,
treatments and monitoring of patients. In addition, such activities lengthen the useful life of the
device and minimize the repair related cost of device.

Medical device maintenance practice is the strategy and the procedure which consists adequate
planning, management and implementation. Planning considers the financial, physical and
human resources required to adequately implement the maintenance activities. Once the program
has been defined, financial, personnel and operational aspects are continually examined and
managed to ensure the program continues uninterrupted and improves as necessary. Ultimately,
proper implementation of the program is key to ensuring optimal equipment functionality.

Medical device maintenance practice can be divided in to corrective maintenance and inspection
and preventive maintenance (IPM) which includes performance testing, functional testing and
calibration after corrective, preventive maintenance and before applying to the patient.

Components of a maintenance program

 Maintenance

Inspection and
Corrective
Preventive
maintenance
maintenance

Planned functional and

Inspection Preventive performance
maintenance test

Figure 10 components of maintenance program

IPM includes all scheduled activities that ensure equipment functionality and prevent
breakdowns or failures. Performance, calibration and safety inspections are straightforward
procedures that verify proper functionality and safe use of a device. Preventive maintenance
(PM) refers to scheduled activities performed to extend the life of a device and prevent failure
(i.e. by calibration, part replacement, lubrication, cleaning, etc.). Inspection can be conducted as
a stand-alone activity and in conjunction with PM to ensure functionality; this is important as
PM can be fairly invasive in that components are removed, cleaned or replaced. Corrective
maintenance is performed whenever medical equipment breaks down.

Tags and labels: It is good practice to label each piece of medical equipment with a unique
identification number. This number will be used by the users to communicate with the medical
equipment maintenance department so there is no confusion about which specific piece of
equipment is being reported.

Maintenance related definitions:

Name Description
Acceptance testing The initial inspection performed on a piece of medical equipment
prior to it being put into service. When the device first arrives in the
health-care facility, it is checked to ensure it matches the purchase
order, it is functioning as specified, the training for users has been
arranged and it is installed correctly. If a computerized maintenance
 management system (CMMS) is available, it is registered into the
CMMS.
Corrective maintenance A process used to restore the physical integrity, safety and/or
(CM) performance of a device after failure. Corrective maintenance and
unscheduled maintenance are regarded as equivalent to the term
repair. This document uses these terms interchangeably.
Inspection and IPM refers to all the scheduled activity necessary to ensure a piece of
preventive maintenance medical equipment is functioning correctly and is well maintained.
(IPM) IPM therefore includes inspection and preventive maintenance (PM).
Inspection Inspection refers to scheduled activities necessary to ensure a piece of
medical equipment is functioning correctly. It includes both
performance inspections and safety inspections. These occur in
conjunction with preventive maintenance, corrective maintenance, or
calibration but can also be completed as a stand-alone activity
scheduled at specific intervals.
Calibration Some medical equipment, particularly those with therapeutic energy
output (e.g. defibrillators, electrosurgical units, physical therapy
stimulators, etc.), needs to be calibrated periodically. This means that
energy levels are to be measured and if there is a discrepancy from
the indicated levels, adjustments must be made until the device
functions within specifications. Devices that take measurements (e.g.
electrocardiographs, laboratory equipment, patient scales, pulmonary
function analyzers, etc.) also require periodic calibration to ensure
accuracy compared to known standards.
Performance test These activities are designed to test the operating status of a medical
device. Tests compare the performance of the device to technical
specifications established by the manufacturer in their maintenance or
service manual. These inspections are not meant to extend the life of
equipment, but merely to assess its current condition. Performance
inspections are sometimes referred to as ‘performance assurance
inspections’. Evaluation of the device parameter by comparing
 measured output and true value by using different analyzers such as
electrical safety analyzer, radiation analyzers, oxygen analyzer,
pressure analyzer, patient simulator, defibrillator analyzers etc.
Failure The condition of not meeting intended performance or safety
requirements, and/or a breach of physical integrity. A failure is
corrected by repair and/or calibration.
Preventive maintenance PM involves maintenance performed to extend the life of the device
(PM) and prevent failure. PM is usually scheduled at specific intervals and
includes specific maintenance activities such as lubrication, cleaning
(e.g. filters) or replacing parts that are expected to wear (e.g.
bearings) or which have a finite life (e.g. tubing). The procedures and
intervals are usually established by the manufacturer. In special cases
the user may change the frequency to accommodate local
environmental conditions. Preventive maintenance is sometimes
referred to as ‘planned maintenance’ or ‘scheduled maintenance’.
This document uses these terms interchangeably. The maintenance
plan and schedule should be developed collaboratively between the
HTMU and the Head of the Department/Case Team where the item is
located. The maintenance plan, schedule and log sheet should be
attached or kept adjacent to the equipment item. A copy of the plan and
schedule should be kept in the Equipment History y File that is held in
the Equipment Maintenance department.
 A description of and guidelines for the tasks to be
conducted including
 Care and cleaning
 Safety procedures
 Functional and performance checks
 Calibration testing
 Preventive maintenance checks
Repair A process used to restore the physical integrity, safety, and/or
performance of a device after a failure. Used interchangeably with
 corrective maintenance.

Safety inspections These are performed to ensure the device is electrically and
mechanically safe. These inspections may also include checks for
radiation safety or dangerous gas or chemical pollutants. When these
inspections are done, the results are compared to country or regional
standards as well as to manufacturer’s specifications. The frequency
of safety inspections may be different than planned maintenance and
performance inspections, and are usually based on regulatory
requirements.
Work Orders and Whenever an item of equipment is faulty this should be reported
Reports immediately to the medical equipment maintenance department using
a Service Request/Work Order Form. Requests for maintenance to
be under taken by technicians should also be documented on a Work
Order Form. In urgent cases the request for repair can be made by a
telephone call or other verbal means of reporting, however this must
always be backed up with a written request on the Work Order Form. .
Outsourcing of When the HTMU is unable to perform PPM or corrective
Technical Services maintenance of a par titular item of equipment, support from external
maintenance contractors will be required. Work may be outsourced
to the National Scientific Equipment Centre, the manufacturer’s local
agent, the manufacturer, private maintenance companies, individuals
such as electricians or plumbers or the Ethiopian Public Health
Institute for laboratory y equipment. The Ethiopian Biomedical
Engineers/Technicians Association could be a good source for finding
qualified individuals or companies. Support may also be provided by
the relevant Regional Health Bureau.
Equipment History Medical Equipment History Files for each equipment that consists of
file schedule for Inspection, performance testing, and preventive
maintenance, corrective maintenance, SOP, and inventory data
collection form and risk assessment form.

Table 7 Maintenance related definitions

Prioritization of maintenance work

Prioritize medical device for maintenance is important. Prioritization will be done based on the
following criteria:

 Risk-based prioritization: One method used to prioritize medical equipment IPM is

based on assigning the highest priority to equipment with the highest likelihood of
causing patient injury if it fails.
 Resource-based prioritization: This is a combination with knowledge about the staffing
and resource levels of the particular facility or region, in order to define maintenance
priorities.
 Mission-based prioritization: This methodology is based on the question: Which
devices are most important to us in providing the majority of our patient care? For
example, if the hospital’s priorities were caring for people living with HIV and caring for
pregnant women and their children, the equipment used in this type of care would
become the priority. The second priority after this work is completed would then be those
devices with the highest risk.

CM performance measures

In addition to the measures already mentioned, there are certain measures that may be recorded
to specifically monitor CM performance. For example:

 Mean time between failures. The average time elapsed between failures.
 Repeated failures.
 The number of failures within a specified period of time
Troubleshooting and repair Identification of a device failure occurs when a device user has
reported a problem with the device. As mentioned earlier, it may also occur when a technician in
the biomedical engineering department finds that a device is not performing as expected during
IPM.

This corrective maintenance may be accomplished at various levels:

 Component level: Component-level troubleshooting and repair isolates the failure to a

single, replaceable component
 Board level: it is common to isolate failures to a particular circuit board and to replace
the entire circuit board rather than a given electronic component.
 Device or system level: In some cases even board-level troubleshooting and repair is too
difficult or time consuming. In such cases it can be more cost-effective to replace the
entire device or subsystem

Work order

Three copies of the Work Order Form should be prepared (using carbon copy paper):

 The first copy should be kept by the user department and filed in a ‘Maintenance Pending
File’. This file is best organized by date submitted, with the most recent request at the
top. The ‘Maintenance Pending File’ should be checked regularly by the Head of
Department/Case Team to ensure that Work Orders are being carried out in a timely
manner. When the work is completed and the item is returned to service the Work Order
Form should be signed by the user (Department/Case Team Head or representative) and
the Work Order Form should be transferred to a ‘Maintenance Completed File’.
 The second two copies of the Work Order Form should be submitted to the HTMU
together with the broken item (if it is feasible to move the item). Whenever a Work Order
is received by HTMU it should be reviewed by the Department Head and the duty should
be assigned to the appropriate individual (or outside service provider). The name of the
person who is assigned to undertake the repair should be written on both copies of the
Work Order Form. In the event that several items required repair at the same time then
‘High priority’ equipment should be repaired before ‘Medium ‘or ‘Low Priority’
equipment.
  Within the HTMU one copy of the Work Order should be entered into a ‘Work Order
Pending’ File held by the Head of Equipment Maintenance. This file is best organized by
date submitted, with the most recent request at the top. When the work is completed the
Work Order should be transferred to a ‘Work Order Completed’ File and kept as a
permanent record of the work under taken.
The final copy of the Work Order Form should be given to the responsible medical
equipment technician who is assigned to undertake the repair. Upon completion of the
task the final section of the Work Order Form and a Corrective Maintenance Log should
be completed. The item should be returned to the user. The completed Work Order Form
and Corrective Maintenance Log should be filed together in the Equipment History File.

Out-sourcing for technical service

When making the decision to outsource a service, the hospital must consider the task at hand and
the qualifications needed to perform the task. In order to do this, the Medical Device Advisory
Committee should register all potential individuals and companies that they would consider as a
supplier of maintenance services. The HTMU should prepare a list of requirements that each
company should meet in order to be contracted by the hospital and a team of suitable staff chosen
to visit these registered suppliers when possible to ensure that the suppliers meets the
requirements and are qualified to provide the services they offer.

Once the appropriate companies or individuals have been identified and registered, the MEMU
should determine the type of arrangement they would like to have with the par titular
organization. The arrangement used depends on the sophistication of the equipment and the
number of maintenance options available.

The most common arrangements encountered are:

1. Agents’ Maintenance Contracts – typically for sophisticated equipment that is covered by a

warranty for a certain period of time. The contract would be for service post-warranty and
negotiated at the time of equipment purchase.

2. Annual Contracts – for particular types or groups of equipment that can be maintained by
an external company for a period of one year. A formal tendering process should take place
to select the best company to provide these service.
 3. Annual Standby Registration – these companies or individuals can be called upon as
needed to provide maintenance services for certain equipment although they must submit
tenders at the time a job becomes available

4. One-off Jobs – in this case, the expertise needed may not be on the registered list and the
HTMU must look for individuals or companies that might be able to undertake this one-
time only task.

Having such arrangements allows the hospital to gain from the benefits of bulk purchasing (e.g.
one company can cover many different maintenance jobs), gain from the benefit of fixed period
contracts; ensure that appropriate contractors are chosen and that the quality of work is high.
Therefore, when a repair requiring external support t becomes necessary, the Head of the
biomedical engineering department can refer to the registered list of companies and/or contracts
to outsource the work.

The HTMU should follow national guidelines for the use of outside contractors including:

 Staff from the biomedical engineering directorate/department/unit/case team must

accompany outside consultants at all time
 Contractor must provide feedback on progress of job
 Contractor must sign-out after each service visit
 Contractor will provide a report t at the completion of the service to be placed in the
equipment file

Hospitals may also collaborate together to enter joint service contracts in order to minimize
costs and benefit from bulk purchasing.

Reporting

For IPM and CM activities, the technician typically has a detailed checklist to follow in order to
record the results. Having such a checklist also serves as a reminder of each step in the IPM
process and thus helps avoid skipping or overlooking specific steps. Recording measurements
and documenting the final results (either as ‘pass/fail’ or numeric values) aids in the execution of
future maintenance work, including repairs
 Safety

There are various safety aspects to consider when implementing a successful and effective
maintenance program, such as the safety of technical personnel while performing maintenance,
safety of the user following maintenance, and general infection control.

3.11. Capacity building for users and Bio-medicals

Proper utilization of medical device is essential to maintain optimal performance, sustainable

functionality, and quality of care and preserve the safety of patients as well as the staff operating
the devices. Building the capacity of biomedical engineers, technologists, and technicians is
always one of the major activities of the HTMU. This can be realized through regular short -term
training programs, Supplier Company’s training, and formal credit programs in higher education
institutions, local and abroad. All such training programs are accompanied by certifications. The
hospital plans annually at least one-week long in-house refresher training program for its staff.
Participation in such refresher programs is mandatory and is part of the annual performance
evaluation.
Given the differences in the technical characteristics of medical equipment, hospital biomedical
engineers and technicians, or suppliers during new equipment installation and commissioning,
should provide training for all clinical staff working on the devices how to operate and handle
each medical device that they use. The hospital should prepare long and short-term training plan
to capacitate and equip the man-power of biomedical engineers/technicians on all Medical
devices to operate, perform preventive maintenance, corrective maintenance and calibration. The
HTMU is responsible for coordinating and overseeing all user and biomedical
engineers/technicians pre and post training for medical devices, whether in-service or conducted
by suppliers/external parties.
Training should be conducted at various times throughout a staff member’s career:
 Induction training – when staff are newly placed in post, move to a new department or
facility, or to a new location with different responsibilities
 Training at the commissioning of Medical devices – when new MDs first arrives and
installed
 Refresher training – to update and renew skills throughout the working life of staff
 User training should cover Guideline, policy, SOP and other related documents
Equipment capabilities and technology
 Purpose and capabilities of device
 Awareness of different models and operational differences
 Awareness of the expected life of medical device and need for replacement
 Knowledge of where/how to access user manuals and receive equipment updates
Operating procedures
 How to connect the device with its accessories
 How to operate the device effectively and safely
 How to link device to patient safely, causing minimal discomfort to patient
 How to set/change controls
Protocol for equipment failure
 How to recognize malfunction (or correct if possible)
 Who to contact to report damage and adverse incidents and to do so promptly
Proper handling and safety procedures
 How to proper handling of the devices
 How to safely shut down/disassemble
 How to clean/decontaminate device and maintain equipment in good operating condition
 Basic safety protocol:
 Always visually inspect equipment before each use.
- Check for signs of damage or incorrect settings
- Make sure all necessary p a r t s are in place
Preventive maintenance procedures
 How to perform basic preventive and routine maintenance (if applicable)
 How to request maintenance work order
 How to keep track of accessories, consumables and reorder when necessary

Biomedical engineer and technicians training should cover:-

 Medical device supply chain management

  Health care technology management
 Company, facility, regional and federal level
 Healthcare technology assessment
 Biomedical equipment maintenance workshop tool, calibration devices, and analyzers.
 Trainer (professionally trained expert in use, maintenance, and repair of medical
equipment)
 Training materials specific to the piece of medical equipment
 Adequate space to conduct the training
 Sample equipment and supplies to practice/conduct the training
 Test and calibration instruments to test performance and safety
 Spare parts for maintenance training
 User and service manuals
 Formal method of testing and method of certifying trainees (e.g. give exam and issue
certificate)
 Cold chain equipment
 Medical Oxygen plant and device management
Steps to Develop an Equipment Training Plan
Assess training needs:

The first step in developing a medical devices training program is to identify and assess needs
and gaps. User and biomedical engineering and technicians training needs may be in the areas of
– management, planning, procurement, logistics, basic handling, operation, application, care and
cleaning, safety, user PPM, PPM and repair for maintainers, associated skills. These gaps should
be identified, prioritized, and turned into training objectives for the organization.

Set organizational training objectives:

The ultimate goal is to bridge the knowledge, skill, and attitude gap that has to improve supply
chain management, medical device functionality, utilization, preventive and corrective
maintenance, calibration, safety, and handling at the facility level in order to provide safe,
quality, and effective services.

Create training action plan:

The next step is to create a comprehensive action plan that includes development of training
manuals, materials and other training elements needed for medical devices training. Resources
and training delivery methods should be detailed in the context of medical devices. While
developing the program, the level of training and participants’ learning styles need to consider
user and biomedical engineers/technician. The hospital should implement a pilot training and
gather feedback to make adjustments well before launching the training to the hospital.

Implement training initiatives:

The implementation phase is where the training program comes to life. The hospital management
needs to decide whether training will be delivered in-house or externally coordinated. The
training implementation should include schedule of training activities and any related resources.
The training is then officially launched, promoted and conducted. During training, participant
progress should be monitored and evaluated to ensure that the program is effective.

Post training monitoring

The hospital should monitor the training continually and evaluate to determine if it was
successful and met training objectives.

The Human Resource Department and HTMU are responsible for keeping records of all user
trainings. Training records should specify the name of the person trained, the trainer, the date of
the training, the medical device for which training was conducted, its manufacturer and model. If
possible, the content of the training should be appended or briefly described in the user training
form. A sample User Training Verification Form is presented in annex E.

Medical Equipment Incident Reporting

Definition of Incident
An incident is an event that causes, or has the potential to cause, unexpected or unwanted effects
involving the health and safety of patients, users or other people.
Incidents in medical devices may arise due to:
 Shortcomings in the design or manufacture of the device itself
 Inadequate instructions for use
 Inadequate servicing and maintenance
  locally initiated modifications or adjustments
 inappropriate user practice
 Inappropriate management procedures
 inappropriate environment in which a device is used or stored
 selection of the incorrect device for the purpose

The aim of incident reporting is to improve the protection of health and safety of patients, users
and others by reducing the likelihood of the same type of incident being repeated in different
places at different times.
The hospital should establish a process to report and investigate all critical incidents, including
incidents that arise from the use of medical equipment. An Incident Officer should be assigned to
investigate all incidents and to ensure that any required follow up action is implemented. Further
guidance on Incident Reporting and a sample Incident Report Form are presented in Clinical
Governance and Quality Improvement Chapter.

3.12. Decommissioning and disposal of medical equipment

Decommissioning is the process of removing a medical device from service in a health care
facility following a decision to disinvest. Disposal is process of remove medical devices from the
health facility through donation, transfer, sale, destruction, and incineration which undertaken
with local and international standards at minimum risk and financial cost.
Health facilities are obligated to use medical device safely, rationally and efficiently to improve
the healthcare delivery. The hospital should establish Medical Equipment Disposal Committee to
oversee the disposal of all medical equipment that are no longer required medical equipment in
the health facility. Items may be decommissioned and disposed when they are no longer required
by the hospital, cannot be repaired, or have reached the end of their useful lifespan or surplus. A
Functional policy for the decommissioning and disposal of medical devices should be developed
as per national and international standards and regulations by the hospital HTMC and approved
by hospital management.
When medical equipment is decided to decommission and disposal the hospital Biomedical
engineering team perform a technical assessment and verify it for decommissioning and the
hospital HTMC approved the decommissioning and disposal. The equipment should be removed
from service in a safe manner and stored in a secure warehouse until it is disposed of. And
remove all data, especially confidential or identifiable data, from the equipment. Following the
committee's decision to dispose, the item should be removed from the hospital inventory and
record should be entered into the Equipment History File to indicate that the item has been
disposed. The medical device History File should then be moved to a separate storage location
for ‘inactive’ equipment items. Further guidance on the disposal of medical devices refer
Ethiopian Food and Drug Authority (EFDA) Guideline for Decommissioning and Disposal of
Medical Devices.
Source Documents
1. Abington Memorial Hospital Department of Biomedical Engineering, Medical Equipment
Management Program.Abington Memorial Hospital Policy and Procedure for Biomedical
Equipment Class/Risk Classification.
2. Association for the Advancement of Medical Instrumentation. AAMI Equipment Management
Committee. (1999). ANSI/AAMI EQ56: 1999. Recommended practice for a medical equipment
management program. Arlington, VA.
3. The Australian Council on Healthcare Standards.EQuIP Standards, 3rd Edition. Safe Practice
and Environment, pp. 4.
4. Baldinger, P. and Ratterman, W.(2008). Powering Health. Options for Improving Energy
Services at Health Facilities in Ethiopia. Washington DC: United States Agency for International
Aid.
5. Bekele, H. (2008, August). Assessment on Medical Equipment Conditions. Ethiopian Science
and Technology Agency. National Scientific Equipment Centre
6. Egyptian Ministry of Health and Partners for Health Reformplus. (2004, December). Egyptian
Hospital Accreditation Program: Standards. 6. Environmental Safety, pp. 31.
7. Hospital Standards for Accreditation for Afghanistan. Section 5: Administration and
Management. Maintenance of Hospital Facilities and Equipment.
8. Joint Commission International. Joint Commission International Accreditation Standards for
Hospitals, 2nd Edition. Facility Management and Safety. pp. 135, 140-1.
9. Mavalankar, D., Raman, P., Dwivedi, H., Jain, M.L. (2004). Managing Equipment for
Emergency Obstetric Care in Rural Hospitals. International Journal of Gynecology and
Obstetrics. (87): 88-97.
10. Temple-Bird, C., KaurManjit, LenelAndreas,andWilliKawohl. (2005). Guide 1: How to
Organize a System of Healthcare Technology Management. In ‘How to Manage’ Series for
Healthcare Technology. Hertfordshire, UK: TALC.
11. Temple-Bird, C., KaurManjit, LenelAndreas,andWilliKawohl. (2005). Guide 2: How to Plan
and Budget for your Healthcare Technology. In ‘How to Manage’ Series for Healthcare
Technology. Hertfordshire, UK: TALC.
12. Temple-Bird, C., KaurManjit, Lenel Andreas, TrondFagerli, and WilliKawohl. (2005). Guide
3: How to Procure and Commission Your Healthcare Technology. In‘How to Manage’ Series for
Healthcare Technology. Hertfordshire, UK: TALC.
13. Temple-Bird, C., KaurManjit, Lenel Andreas, and WilliKawohl. (2005). Guide 4: How to
operate your healthcare technology effectively and safely. Management Procedures for Health
Facilities and District Authorities. In‘How to Manage’ Series for Healthcare Technology.
Hertfordshire, UK: TALC.
Annexes
Annex A: Inventory form
Inventory #: __________________________________________________________________
Type of Equipment: ____________________________________________________________
Manufacturer: _________________________________________________________________

Model: ____________________________ Serial no. _______________________________

Country of Origin: ____________________ Year of Manufacture: _______________________

Power Requirement: 220V 110V
Current State/Condition:

Operable and in service

Operable and out of service

Reason out of service;
Needs maintenance
Not repairable
Needs to be discarded? Yes No
Spare parts available? Yes No
If yes, what, how many, and where are they located?__________________________________

Manuals Available:

User manual # of copies _______ Location ________________________

Service manual # of copies _______ Location _____________________
Equipment Users:
Doctors Nurses Lab Technicians Students
Equipment owner (department), if any: ___________________________________________
Contact Person and Telephone numbers: __________________________________________
Current location of equipment: __________________________________________________
Will it move from here? No Yes If so, where? _____________________

Annex B Performance test checklist

Description Set Measured Pass Fail N/A
 UOM values values Limit/Tolerance
( ) ( ) ( )
( ) ( ) ( )
( ) ( ) ( )
( ) ( ) ( )
( ) ( ) ( )

( ) ( ) ( )
( ) ( ) ( )
( ) ( ) ( )
( ) ( ) ( )
( ) ( ) ( )

UOM = UNIT OF MEASUREMENT

Remarks/ Status: ( Performance report)

Test Equipment Used

Test Device : Test Device:
Model : Model:
Serial No: Serial No:

Annex C PPM check list

Pass
Planned Preventive Maintenance (PPM) Checklist Fail Not Available
Physically
Inspection
Examine for cleanliness and general physical
1. Chassis/Housing condition.
Examine for mount/fastener general physical
2. Mount/Fastener condition.
Examine for caster/breaks general physical
3. Caster/Brakes condition.
4. AC plug Examine AC plug physical condition

5. Line Cord Examine for line cord physical condition.

Examine the strain relief at both ends of the line
6. Strain relief cords.
7. Fuse Check correct value fuse rating is use.
8. Cables Inspect the patient cable and leads and strain relief.
Examine for connectors physical condition and
9. Fitting/Connectors smooth Movement between male female contacts.
10.Pump Check for pump physical condition.
11. Examine for controls and switches physical condition
Control/Switches. and free movement
12. Indicator/Display Examine for indicator/Display operational
Check audible alarm for indicator/Display
13. Alarm operational

14. Label Check label legibility.

Internal Inspection
15. Cleanliness Clean interior and exterior of the equipment.
16. Lubricate Lubricate paper drive and recorder mechanism.
Check internal battery.(Replace according
17. Battery manufacture requirement )
Performance
18. Lubricate Lubricate paper drive and recorder mechanism.
19. Battery Check main external battery.(Replace if required)
Safety Test &
Performance
Electrical Safety Perform EST as stated and required in IEC
20. Test 60601.01(refer to EST report).
Test according to Hospital Engineering Planned
21 Performance Preventive
Planned Preventive Maintenance (PPM) Results:
No safety relevant defects Defect which require repair and removed from service.
Defects corrected immediately Significant defects, this unit beyond feasible repair.
Remarks/ Status: (Physical Inspection) Notes:

Evidence Attachment: (Physical Defect) If needed for exception of incident.

Evidence Pic 1 Evidence Pic 3

Evidence Pic 2 Evidence Pic 4

Notes:
Annex D Biomedical Equipment Maintenance workshop layout For General and
Referral Hospital

Annex E Sample User Training Verification Form

Name: _____________________ Position: ___________________________
Department __________________ date employment commenced ____________
Assessment/Review
Ma nufacturer/

Date of training
Medical Device

Trained By

Comments
Supplier

Model

date
Annex F - Work Order Form
Note: this is a triplicate form
· 1st sheet is the User File copy
· 2nd sheet is the Maintenance Progress File copy

· 3rd sheet is the Equipment History File copy

SECTION A: To be completed by user

Equipment Type: Inventory Number:

Item Location:

Name of person making request: Date:

Description of Problem:

Troubleshooting performed (if relevant):

SECTION B: To be completed by Head of Equipment Maintenance

Date request received: Work order number:

Priority of task (high/medium or low): Task allocated to:

SECTION C: To be completed by Maintenance Technician

Was item repaired?

Yes No

If Yes, complete Maintenance Report Form. If No, state reason work not Return Item to User. completed and
return Work Order Form to Head of
Equipment returned Equipment Maintenance for to follow up and completion
of Work Order (by assigning an-
Date returned other technician or outsourc- ing):
Name of Maintenance Technician Signature:
After corrective maintenance is completed the Work Order Form and Corrective Maintenance Log Form should be
filed together in the Equipment History File.

Annex G Corrective Maintenance form

Work order number:
Equipment type Inventory Number

Model Serial No.

Description of equipment failure

Cause of equipment failure (if known)

Part of machine / equipment to be maintained

Corrective action
Time required
Spare parts replaced
1. 2. 3.

4. 5. 6.

Engineer 1 Signature 1 Date

Engineer 2 Signature 2 Date
User comments

Date Signature Date

Annex H Good Practice Checklist for Corrective Maintenance

Step 1 Resist the temptation to dive straight in. Do not immediately open up the machine and
plunge in with a screwdriver.
Step 2 Listen to the equipment users. Talk to the user – they can help you to discover the
symptoms of the fault. Ask the users lots of questions – they often don’t realize how much
they know.
Step 3 Look up the equipment’s service history. Each individual piece of equipment should
have a record of its service history. Use this to make yourself aware of the particular
machine’s past fault.
Step 4 Check the main incoming supply. Ensure that the electricity/gas/water supply is
reaching the wall outlet/socket – if it isn’t, check the relevant main circuit breakers/valves/taps
controlling the service supply.
Step 5 Inspect the main incoming connection. Check the plug, connector, and mains/ incoming
lead to see if electricity (or other supply) is reaching the machine.
Step 6 Inspect the machine’s external supply connection point. Check the main external
fuses/taps/regulators for the machine.
Step 7 Refer to the operator’s manual. Familiarize yourself with the instructions on how the
equipment is meant to work.
Step 8 Check the accessories. Ensure that the correct accessories are attached to the correct
inlets
Step 9 Watch the machine in operation. Ask the users to describe what steps they usually take
to put the machine through a normal operational cycle. Watch them do this, and observe what
happens
Step 10 Refer to local sources of advice. Consult the service manual, training resources, PPM
schedules and any other technical personnel. Take note of any possibility of remote
diagnostics where, for complex equipment such as CT scanners, the manufacturer’s computer
may be able to log into the equipment and diagnose the fault.
Step 11 Only at this point, consider opening the machine. Decide whether it is best to take the
machine back to the workshop before opening it.
Step 12 Inspect the machine’s internal supply connection points. Check the main internal
fuses/taps/valves for the machine, and then check the on/off switch.
Step 13 Go through the troubleshooting or fault-finding steps provided in the service manual.
BEWARE: It is very common for maintainers to guess the problem and act on it without
verification. This leads to frustration when the diagnosis turns out to be incorrect. Thus,
always take steps in the following order:
1. Determine the problem to a high degree of certainty by testing
- Alter and adjust the equipment as little as possible during this stage
- Never guess a problem or make an alteration that cannot be reversed
- Always record adjustments as the work progresses (for example, on a notepad)
2. Correct the problem
Step 14 Contact more experienced colleagues. Ask the in-house team of another health service
provider (for example at a neighboring public or private hospital), or ask the national service
provider (National Scientific Equipment Center).
Step 15 Ask the manufacturer or their representative for help. Contact them for discussions
and fault-finding by phone, fax or email. Email is the cheapest and often the most effective
way to get in contact with the manufacturer. Try to get some hints, but be sure to clarify
whether you are being charged for this advice.
Step 16 Call in support from the private sector when the work is beyond your capabilities. Call
in the private maintenance contractor, if there is one, for faults that cannot be handled by the
in-house team. Ensure that the hospital management or Medical Equipment Service has the
funds to cover this.
Step 17 If the work is within your capabilities, only at this point consider taking corrective
action. When a fault is found that the in-house team has the skills and authority to pursue,
follow the corrective action or parts replacement steps provided in the service manual.
Step 18 Use the correct materials. Select only the correct maintenance materials and spare
parts relevant to the machine.
Work carefully. Handle the spare parts and maintenance materials carefully so as not to
damage them or the machine
Step 20 Make a record of your work. Fill in the Work Order form to record the problem
reported, fault found, corrective action taken, parts used, time taken, etc.
Step 21 Ensure the equipment is safe to use. Always safety test the equipment with the correct
test equipment before returning it to the users.
Step 22 Repeat step 9. Ensure that the operators can make the equipment function properly
during a normal operational cycle.
Step 23 Reduce the likelihood of problems in the future. Ensure in the future that planned
preventive maintenance (PPM) is carried out on the equipment.
Annex I PPM Log Sheet
Equipment: Inventory #: Location: Month:

Task 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Daily Tasks
Daily Task 1
Daily Task 2
Daily Task 3
Daily Task 4
Daily Task 5
Weekly Tasks
Weekly Task 1
Weekly Task 2
Monthly Tasks
Monthly Task 1
Monthly Task 2
Quarterly Tasks
Quarterly Task 1
Quarterly Technical PM
Semi-Annual Tasks
Semi-Annual Technical
PM
Annual Tasks
Annual Technical PM

Annex J Sample Bin Card for Spare Parts

Item Description: ___________________ Item Code Number:_________________________
Received from or Issued to

Quantity
Doc. No. (Receiving or

Expiry Date
Issuing)

Remarks
Batch No.
Date

Loss/Adj
Received

Balance
Issued
Annex K Site preparation steps for installation of medical equipment
Step Activity
· Study the manufacturer’s site preparation instruction
Review technicalneeds
· Use experience and common sense

· Cut supply connections and remove the existingitem

Remove existingequipment
· Cannibalize the existing item for parts

· Build any special construction required, such as a transformer housing, lead

screening, room extension

Construct or alterbuilding · Make any special modifications necessary, such as enlarging the doorway, or
building a worktop
· Remove any scrap or other items from the room

Undertake the work required to provide (as necessary):

· A new transformer
· A new or upgraded generator

Provide electrical · A single phase or three-phase supply at the site ofinstallation

requirements · A special circuit breaker
· A special socket outlet
· An electrical circuit with sufficient capacity

Undertake:
Ensure the electricity
· An exercise to ensure that all relevant electricalinstallations are properly
installationis safe grounded and tested
· Any remedial works as required
Undertake the work required to provide (as necessary):
· Adequate water pressure
· Water treatment
Provide water and
drainage requirements · Increased pipeline diameter
· Proper drainage
· Appropriate connection points
 Undertake the work required to provide (as necessary):
· A steam supply at the proposed site
· Increased pipeline diameter
Provide steam sup- ply
requirements · A boiler which can accommodation the increased load
· Appropriate connection points
Undertake the work required to provide (as necessary):
Provide gas supply · Relevant gas supplies at the proposed site
requirements
· Appropriate connection points

Depending on specific guidelines for certain types of equip- ment (as detailed by the
equipment supplier), provide:
Provide extra specific · Bolts in the ceiling for attaching operating lights in the- atres
requirements for · Trenches for supply lines to dental suites
installing the equipment
· Trenches for waste water for washing machines, etc.
Provide any associated items as necessary for the equip- ment or installation, such as:
Provide any additional · An uninterruptible power supply (UPS)
equipment needs
· A water pump

Annex L Sample Acceptance Test Log Sheet

Only when this form has been satisfactorily completed should the Registration Box be filled in
by the Head of Medical Equipment Maintenance.

ALLOCATED INVENTORY NUMBER _____________________________________________________________

EQUIPMENT TYPE ________________________________________________________________________________________
DESTINATION LOCATION_______________________________________________________________________________
ACCEPTANCE DATE _____________________________________________________________________________________
MAINTENANCE CONTRACT WITH _____________________________________________________________

HEALTH FACILITY ___________________________________________________________________________________________

NAME OF EQUIPMENT _______________________________________________________________________________________

TYPE/MODEL ________________________________________________________________________________________________

ORDER NUMBER _________________________________ SERIAL NUMBER ____________________________

COST__________________________________ DATE RECEIVED _______________________________________

MANUFACTURER ________________________________ SUPPLIER/AGENT ________________________________________

ADDRESS _______________________________________ ADDRESS _________________________________________________

PHONE . . . . . . . . . . . . . . . . . . . . . . . PHONE . . . . . . . . . . . . . . . . . . . . . .

DETAILS OF ALL ACCESSORIES, CONSUMABLES, SPARE PARTS AND MANUALS

RECEIVED ARE LISTED ON THE FOLLOWING PAGE OF THIS FORM
ACCEPTANCE CHECKS
1. DELIVERY
Undertaken by______________________________________________________________
Witnessed by: Name ________________________ Position _________________________
Date _________________________
Correctedif
No/not
Yes/done applicable
done

a) Representative of supplier present?

b) Correct number of boxes received?
c) After unloading, visible damage to theboxes?

d) If damaged, has this been stated onthe delivery

Note and senior management informed?

2. UNPACKING (refer to invoices and shipping documents)

Undertaken by: _________________________________________________________________
Witnessed by: Name ______________________ Position ____________________________
.. Date ____________________________
Yes/done No/not Corrected if
done applicable
a) Visible damage to the equipment?
b) Equipment complete as ordered?
c) User/operator manual as ordered?
d) Service/technical manual as ordered?

e) Accessories as ordered?
f) Consumables as ordered?
g) Spare parts as ordered?

3. ASSEMBLY (refer to manuals)

 Yes/done No/not done Corrected if
applicable

a) Are all parts available?

b) Do they fit together?

c) Mains lead with plug included?

d) Do all the accessories fit?

e) Are markings and labels OK?

f) Any damage?

4. INSTALLATION (refer to manuals)

Yes/ done No/not done Corrected if
applicable

a) Was the work carried out satisfactorily?

b) Were technical staff present as learners?

5. COMMISSIONING/TESTING (refer to manuals)

Corrected if
Yes/done No/not done
applicable

a) Were electrical, mechanical, gas, radiation safety tests

and performance checks carried out inaccordance with
the test sheets on pages 7 to 9 of this
Form?

...... ...... ......

b) Was the work carried out satisfactorily? ...... ...... ......
c) Were technical staff present as learners? ...... ...... ......
d) Were operators present as learners? ...... ...... ......

6. ACCEPTANCE – to be certified by the Head of Equipment Maintenance only

 Yes/done No/not done Corrected if
applicable
a) Is the equipment accepted?
b) If rejected, have the shortcoming- been summarized
on page 10 of this form

c) If so, has a report gone to senior management

and formal complaints procedures started?

d) Should payment be withheldpending

corrections?
e) Is payment approved?

7. TRAINING
Yes/ done No/not done Corrected if applicable

a) Were the expected training courses given?

b) Were the training courses satisfactory?

c) Were suitable operators present?

d) Were suitable technical staff present?

8. REGISTRATION – to be undertaken by the Head of Medical Equipment Maintenance

Yes/ done No/not Corrected if
done applicable
a) If accepted, has an inventory number been allocated?

b) Has the Registration Box on Page1 of this form been filled

in?
c) Has the Stores Controller beenprovided with the
location for the equipment and all necessary data, so that
the Stores Receiving Procedure canbe followed and a
Goods Received Note completed?
d) Have the accessories, consumables, spare parts, and
manuals all been issued to the correct holding
authorities?

ACCESSORIES RECEIVED
1. 2.
3. 4.
5. 6.
7. 8.

CONSUMABLES RECEIVED
1. 2.
3. 4.
5. 6.
7. 8.

SPARE PARTS RECEIVED

1. 2.
3. 4.
5. 6.
7. 8.

COMMISSIONING/TESTING PROCEDURES (see manuals)

ELECTRICAL INTEGRITY TESTS
Yes/done No/not Corrected if
done applicable

Mains Connection
a) Are cables and plugs intact?
b) Is cable color code correctly connected?
c) Are connectors intact?
d) Are the fuses correct?
e) Is equipment protection correct?
f) Is voltage setting correct?
g) Is there an earth terminal?

Electrical Measurements with Safety Tester

a) Is protective earth continuity correct?
b) Is insulation resistance correct?
c) Are the leakage currents correct?
d) Is the voltage measurement correct?
GAS INTEGRITY TESTS
Yes/ No/not Corrected if
done done applicable
a) Are the cylinders full?
b) Are appropriate gauges available?
c) Is there a cylinder key?
d) Is the pressure reading correct?
e) Is the cylinder colour code correct?
f) Are the hoses and fittings correct?
g) Is the system leaking?

RADIATION INTEGRITY TESTS

Yes/ No/not Corrected if
done done applicable
a) Is the kV calibration correct?
b) Is the mAs calibrated correctly?
c) Was the line voltage compensation per-formed?

d) Was the exposure test correct?

e) Were the step wedge test results correct?

f) Were the small and large focus calibrations done?

PERFORMANCE TESTS
Yes/done No/notdone Corrected if
applicable
Note: carry out all operational tests as specified by the manufacturer
a) Are the function verification tests correct?

b) Is the equipment calibration acceptable?

Annex M calibration and testing tools

Defibrillator analyzers Ultrasound meters

Electrosurgical analyzers Ventilator Taste

Infusion pump analyzers Gas Flow Analyzers

NIBP analyzers Temperature / Humidity Calibration
 Annex N criteria for standard biomedical work shop
s.no Standard criteria for biomedical work shop Met Unmet
1 Presence of well-equipped staff office with mini
library (e - library ) at the workshop
2 Presence of mini- store(for spare part and
accessories) in the medical device workshop
3 Presence of maintenance, calibration & testing tools,
appropriate gases (e.g. Acetylene, oxygen) & other
tools
4 Availability of equipped maintenance training
workshop capable of mechanical & electrical
activities
5 Presence of appropriate and adequate space for
loading and unloading of medical devices
6 Rest room
7
 Chapter 19
Infrastructure and Asset
Management
Chapter outline sections
1. Introduction

2. Operational standards

3. Implementation Guidance

3.1. Organizations

3.1.1. Organization of Hospital Infrastructure and Asset Management Services

3.1.2. Buildings
3.1.3. Landscape and Garden
3.2.Asset Management
3.2.1. Asset Procurement and Delivery

3.3.Utilities and Sewerage

3.3.1. Electricity
3.3.2. Water supply
3.3.3. Sewerage
3.3.4. Plumbing
3.3.5. Boiler/steam supply
3.3.6. Heating, ventilation, and air conditioning (HVAC)
3.3.7. Energy efficiency
3.3.8. Pet, pest, and rodent control
3.4. Vehicle Management
3.4.1. Vehicle Management and Transport Services
3.5.Hospital Security
3.5.1. The Security (Guard) department
3.5.2. Control of entry and exit to and from the hospital
3.5.3. Security plan
3.6.Hospital Safety
3.6.1. Hazardous materials
3.6.2. Fire safety
3.6.3. Other safety measures

1
 3.7.Major Incident Planning and Management
3.7.1. Major Incident Committee
3.7.2. Roles of the Major Incident Commander and Deputy Major Incident Commanders
3.7.3. Incident control room
3.7.4. Command and control arrangements in a major incident
3.7.5. The Major Incident Plan
3.7.6. Management of a Major Incident
3.7.7. Testing the Major Incident Plan
4. Annex
5. Reference

2
 Section 1:- Introduction

Facility and Asset Management is a systematic approach to the governance and realization of all values
for which a group or entity is responsible. It may apply both to tangible assets (physical objects such
as complex processes or manufacturing plants, infrastructure, buildings, or equipment) and to
intangible assets (such as intellectual property and goodwill) is a systematic process of developing,
operating, maintaining, upgrading, and disposing of assets in the most cost-effective manner (including
all costs, risks, and performance attributes).1

Adequate facility and asset management has several benefits, which include Improving patient care and
safety; Allowing staff to quickly and easily locate medical equipment in real-time and increase staff
efficiency; recording assets actual value; ensuring accurate asset usage and performance data; safety
disposes medical waste, and to create efficient use of physical space and organized equipment storage. 2
As well as overseeing cleaning, transportation, landscape and gardening, hospital security service, and
asset management.

1
Wikipedia, the free encyclopedia
2
Asset Management Software

3
Section 2:- Operational Standards

1. The hospital has a functional Basic Service and Asset Management Executive office to plan,
execute, coordinate, and monitor hospital infrastructure and Asset Management activities.

2. The hospital complies with relevant laws, regulations, Guidelines, SOPs

3. The hospital grounds are regularly inspected maintained, for their basic services and ensured
cleanliness for safety of patients, visitors & staff.

4. The hospital has included its infrastructure, asset procurement, and maintenance plan in its
long-term and annual plans
5. The hospital has a maintenance workshop with technical personnel, sufficient space, and
adequate ventilation.
6. The hospital has a transport policy for using and accessing hospital vehicles.
7. The hospital has a safety and security policy.
8. The hospital has a plan for responding to likely incidences in the hospital and other disasters.
9. The hospital stock management system is in place, and disposal is done in compliance with
the relevant laws and guidelines.
10. The hospital conducts an annual inventory.
11. The hospital has allocated a budget for procuring and maintaining medical and non-medical
devices, buildings, vehicles &utilities from retained revenue.

4
Section 3:-Implementation Guidance

3.1 organization

3.1.1. Organization of Hospital Infrastructure and Asset Management Services

Each hospital should have a fictional Basic Services and Asset Management Executive office to lead
and manage infrastructure and asset management activities. The executive office should have assigned
full-time workers to carry out activities based on their job description effectively. The Basic Services
and Asset Management Executive office is responsible for the following:

 Cleaning and janitorial services

 Vehicle management and transport services
 Landscape and Gardening
 Hospital security services
 Laundry and Kitchen services
 Pets, pest, and rodent control
 Planning, procuring, and maintenance of Asset management.
The Executive office is also responsible for the management of:

 Buildings organization, construction, layout, maintenance/renovation

 Hospital infrastructure Master plan preparation and implementation

 Utilities (electrical, water, incinerator, placenta pit) and sewerage

 Safety (Fire, Hazardous materials, and other environmental safety)

 Major incident planning and response

In addition, each hospital must have an asset management policy and Asset Management strategy to enhance
the efficient use of its resources for the ultimate attainment of improved healthcare services. For that purpose,
any hospital should employ evidence-based planning and budgeting. Asset management tasks start with
identifying the asset need of the hospital. Therefore, each hospital should conduct a comprehensive need
assessment to identify and fulfill its asset needs step-by-step. To that end, the hospital has to set clear
objectives and priorities, as the asset need might not be met at once due to resource constraints.

The hospital’s Asset Management strategy must be based on the hospital’s set objectives and priorities.
Furthermore, each hospital has to include the asset plan in its long-term and annual plans. In doing so, the
most urgent assets have to get precedence over those assets, which can be gradually fulfilled. The Asset
Management plan has to be detailed enough and should include the following:

 Asset set to be acquired

5
  Utilization
 Maintenance
 Dispose/replace

 The hospital's assets must be appropriately registered when received, utilized, and
disposed of in line with the public asset management rules and regulations.
Furthermore, the hospital’s asset procurement must align with the Government Asset Procurement Guidelines.
3
The assets must be appropriately registered when received, when issued, at the time of use, and finally, be
disposed of in line with the public asset management rules and regulations. The hospital can procure assets
from the treasury or its approved retained revenue budget. It is to be remembered that the procurement of
hospital assets is in the first category of the positive list to be covered with the retained revenue of the
hospitals. 4

3.1.2. Buildings
3.1.2.1.Buildings layout
The buildings are the most fundamental component of a hospital, and their layout and design contribute
significantly to the smooth operation of patient services and other activities. The use of buildings
should be organized to:

 Minimize the travel distance between frequently used spaces,

 Streamline the movement of patients between care teams/units,

 Allow for patients to be easily visible to staff for supervision purposes,

 Include all the needed clinical and non-clinical areas, avoiding unnecessary
redundancies and making efficient use of space,
 Provide an efficient system for the handling of food, storage of supplies, and the
removal ofwaste, and
 Enhance the safety and security of patients, visitors, staff, and hospital assets.

3
Please refer to the Government Procurement Guideline.
4
Please refer to the Revised HCF Implementation Manual.

6
 3.1.2.2.The layout of patient services

The hospital should be organized so that patient services are easily accessible and located nearby.

The Emergency Department should be easily accessed from the adjacent main road and have a separate
entrance labeled in a way visible from the street.

The Outpatient Department (OPD) should also be easily accessed from the main road and have enough
space and seating for the expected daily arrivals.

The hospital triages (central and emergency) should be clearly labeled and easily accessible.

Inpatient wards should be easily accessible from elevators, ramps, and stairways. Sufficient seating
space should be provided for visitors, caregivers, and guests.

Toilets and showers should be provided for patients. Ideally, these should be located adjacent to each
ward, but if this is not possible, they should be signposted, and a covered walkway should be used to
link the ward to the facilities.

Administrative offices, such as medical records and payment offices, should be in a location that is
easily accessible to patients and visitors and clearly labeled.

All public areas should be kept clear of large objects and clean. Hazards such as wet floors should be
clearly labeled to prevent injury.

Hospitals with more than one story should have elevators or ramps to transport wheelchair- or bed-
bound patients. If elevators are in use, they should provide access to all levels of the hospital.
Elevators should be large enough to accommodate patient beds. Floors should be labeled at elevator
exit points and stair landings for easy identification for guests. Stairs and corridors should not be used
as storage areas and must be kept clear to allow easy access to patients, staff, and visitors.

Areas restricted only to staff should be clearly marked with "No entry" or "Restricted entry" signs to
prevent unwanted visitors from entering.

7
 3.1.2.3.The layout of staff services

Staff services should be organized to provide easy access and mobility. Toilets should be available within
proximity to all staff working areas. Where necessary, changing rooms with lockable lockers should be
provided to staff without their own office (such as operating theatre, delivery suite, laundry, kitchen,
maintenance staff, and security personnel). Showers should be provided to workers exposed to dirt,
hazardous materials, or body fluids during their duty shift.

Health workers should be provided with adequate space for meals. A canteen or café should be available
for staff to purchase food or beverages. Drinking water should be available at all times.

Staff working ‘on duty’ should have access to duty rooms with beds for resting when not actively working.
Duty rooms should be located near regular work areas and equipped with telephones or other
communication access in case the worker is needed.

Facilities should provide meals/refreshments during duty hours. Health workers, residents, and visiting
students should have access to a study area or library with various educational resources, including internet
access.

3.1.3. Hospital site map

A map of the hospital campus should be displayed at all entry points to the hospital to provide
straightforward, easy navigation for patients and visitors. All hospital buildings should be clearly
labeled, and signs should be used to guide patients or visitors to each service area.

3.1.4. Building maintenance

Buildings are generally the most significant investment in the facility and should be well-maintained to
prolong their lifespan and minimize the need for expensive repairs or renovation. Inspections of all
hospital buildings should be conducted regularly to ensure that facilities are in good condition and
should be performed by professional, certified staff (for example, masons, painters, carpenters, etc.)
with access to appropriate tools, equipment, and machinery. Preventive maintenance and repairs
shouldbe undertaken whenever necessary. In particular:

 Windows should be replaced when cracked or broken.

 Windows should be able to open to allow for ventilation.

 Windows should have a functioning lock to prevent theft or unwanted intruders.

 Doors should be able to open and close quickly.

8
  Doors should have a functioning lock so doors may be opened as needed.

 The roof should not have any source of leakage into the facility.

 The walls should be repaired as necessary.

 Rain drainage systems should be working correctly and efficiently. Water from
drainage systems should be diverted to a location that eliminates considerable flooding
in locations around the building, and

 Mold growth should be prevented or removed if discovered to prevent building

damage.
 Sagging and broken beds should be fixed.
 Broken patient or visitor chairs, tables, etc., should be repaired as soon as the
problem isreported.
 Regular walkthroughs should be conducted to assess the hospital facilities'conditon.These
should be done at least once a month.

The hospital should ensure that reasonable stocks of building maintenance materials are held at all
times and that these form part of recurrent budgets. Basic building maintenance materials include
cement, paint, metal, wood, glass, etc. A system should be in place that prompts for re-order when
stocks of building maintenance materials run low.

A construction plan for the buildings, including civil engineering drawings, should be available and
kept within the office of the section head and should be updated when modifications are made.

3.1.4.1.Buildings maintenance workshop

The hospital should have a maintenance workshop with skilled personnel and equipment to maintain
hospital buildings and non-medical equipment. Some maintenance services may be outsourced if
necessary (for example, electrical engineering, etc.). The hospital should also have skilled personnel
and equipment to maintain and repair medical equipment (See Chapter 9, Medical Equipment
Management). A hospital maintenance workshop should have the following:

 Appropriate workforce,
 Adequate workspace,
 Essential tools,
 Adequate, safe, and secure storage space for tools, equipment, and
hazardous materials,

9
  Maintenance/repair manuals and literature,
 Protective clothing for maintenance staff (ex., Gloves, overalls/overcoat,
goggles, boots),
 Proper disposal guidelines and methods for maintenance waste, and
 Dedicated disinfection room or area for disinfecting equipment before
maintenance isperformed.
The layout of the workshop can vary according to the size of the maintenance team; the design
should allocate space for:

 Different work areas are designated for different maintenance work,

 Adequate work benches and stools to meet the needs of each work area,

 Storeroom with cabinets and shelves,

 Office space (for workshop manager’s desk and filing space),
 Changing room with toilet, lockers, wash basin, and shower,
 Shaded outdoor area for large maintenance/repair jobs and handling of
hazardous materials,
 Secure outdoor storage area for bottled gases and equipment to be
discarded,
 Vehicle access, and
 Technical library.
A library of reference materials is essential for ongoing staff education and should also be included in
the workshop's design. The library should include operation and service manuals, general textbooks on
engineering and related disciplines, journals, instruction booklets, updated hazard reports, and other
reference material. A sample layout of a workshop for a 300-bed hospital is presented in Annex A.

10
 3.1.4.2.Workshop tools

The maintenance team should identify essential tools (either by maintenance needs or technician roles)
required to perform their work and procure them based on quality. Poor tools may break if not strong
enough, fail earlier than expected, rub, corrode, or damage other machine parts. It is recommended
that higher-quality tools and test instruments be purchased for repairs on critical equipment. Lower-
quality tools may be acceptable for less critical items, but the cost of early replacement of such tools
should be considered before purchase. Sample lists of suggested maintenance tools and safety
calibration testing instruments are presented in Appendices B and C.

The maintenance team should have a tool inventory, either paper-based or computerized, that lists all
test and bench instruments and the contents of all tool kits. Tool usage should be monitored by
keeping a tool ledger in which each item is 'signed out' and 'signed in' when used by a technician. A
sample format for a tool’s ledger is presented in Appendix D.

3.1.4.3. Fault reporting and work order

Procedures should be in place, so staff, patients, or visitors can report any problems identified with
the hospital building or facilities so that repair can be undertaken promptly.

The Facility Maintenance Team should be informed of building maintenance needs (e.g., a broken
window or sink). The work request should be submitted in written form to enable tracking of service
requests. Telephone calls or other verbal means of reporting may be acceptable in times of emergency;
however, a service request/work order should be submitted to provide a written record of the reported
fault. A sample Facilities Maintenance Work Order Form is presented in Appendix E. Follow-up
should be conducted on all service requests to ensure the work has been completed. Service
requests/work orders should be filed.

3.1.4.4.Planning for new construction or renovation

The services provided by a hospital and the number of patients attending a hospital are rarely static. To
accommodate changes in services or patient load, it may be necessary to undertake significant
renovation of existing buildings, construct new buildings, and/or redesign the layout and functions of
the hospital.

Adequate planning for new constructions must be carefully performed to ensure good results.
Planning is best carried out through a dedicated committee, with members from various backgrounds,

11
including staff well-versed in the new service. Technical staff with sufficient knowledge of existing
facilities must be included in the planning to interface with already-existing systems, such as
electricity, plumbing, sanitation, etc.

Adequate consideration should be given to the effects of the construction process on existing services.
Factors that may interrupt regular facility operation include noise, vibrations, water or electricity needs
or interruptions, access to large equipment or machinery, storage of construction materials, facilities for
construction staff, excess dust, etc. Construction activities should be planned to minimize the effect on
daily facility operations.

To ensure that any construction or renovation is fit for purpose, it is essential to involve multiple
personnel in the planning process and to follow critical steps as described in Table 1 below.

Table 1:- Steps to be taken for planning construction or renovation

Step Description
One Establish the need for renovation or construction:
 What services will be provided?
 What is the demand and/or population health need for those services?
 Can these services be provided using existing buildings, or is a renovation
or new construction required?
At this stage, stakeholders such as woreda, zonal, regional, or federal health
offices, hospital staff,and the community should be involved.
Two Preparation of a Design Brief.
 The Design Brief is a basic framework for the design of the building or
facility and should provide sufficient detail for construction engineers to
prepare construction plans.

At this stage, stakeholders such as woreda, zonal, regional, or federal health

offices, hospital staff,and the community should be involved.

A “Sample Format and Checklist for a Typical Design Brief” is presented in

Appendix F.
Three Tender announcement and consideration of bids received
 The Design Brief should be put to a competitive tender

12
  Bids received should be considered by the planning committee
 Explicit criteria should be used to assess or score each bid received.
Criteria could include:
o Cost of construction
o Time to completion
o The closeness of Plan to Design Brief
Four Construction of the building or facility.
Construction activities should be planned to minimize the effect on daily facility
operations.
Five Purchase of all furniture, equipment, and supplies needed for the building or
facility and Appointment and training of all staff

3.1.3. Landscape and Garden

Patient and community perceptions of a hospital and staff satisfaction with their workplace can be
enhanced by clean and pleasant hospital grounds. Buildings should be linked by covered and paved
walkways. Recreation areas should be established, including areas for sitting and for walking. Grass,
trees, and flowers should be planted wherever possible and unique features such as fountains may be
installed as a focal point. Hospital grounds may also be used to grow crops, vegetables, or fruit in the
hospital kitchen.

Hospital grounds should be free from litter, including old equipment or construction materials, and
regularly inspected to ensure a safe and comfortable environment for patients, visitors, and staff.

Grounds keeping staff should have access to all necessary tools, equipment, and machinery necessary
to maintain and enhance the hospital ground. These materials should be budgeted to ensure a
consistent supply of materials.

13
 3.2. Asset Management
The hospital should establish a robust Asset Management (AM) system to ensure the availability,
efficient use, and replacement of asset sets.

3.2.1. Asset Procurement and Delivery

 Procuring any asset must comply with the country's public procurement law.
 Once procured, the hospital must ensure that the asset set is delivered to the hospital with
(Model 19)
 The hospital should also deliver any donated asset with Model 19.
 The hospital should establish a database for fixed assets that details the history of the asset
sets, such as the name of the fixed asset set, its manufacturing time, lifespan, and actual or
estimated cost asset.
 The wear and tear of significant hospital assets must be appropriately registered and annually
updated.
 The hospital also needs to ensure assets are stored in the right place and under optimal
temperatures depending on the nature of asset assets.
 The hospital also must ensure that significant assets have been issued to pertinent
departments with Model 22
 The hospital must also compile with the rules and protocols of the government to dispose of
any significant hospital asset.

3.3. Utilities and Sewerage

3.3.1. Electricity

A reliable source of electricity is essential for every hospital. As regular supplies may be erratic,
every healthcare facility must have a backup system, such as a diesel generator. Suppose a generator is
the preferred backup system. In that case, a dedicated individual must ensure the proper functioning of
the generator, including a sufficient supply of diesel, charged batteries (for start-up), and regular
maintenance. Alternatively, solar panels might be a more cost-effective backup option. Regular
inspections of the backup electricity system should be conducted, with particular attention given to
potential causes of malfunction. Hospitals should have access to a professionally qualified technician
with appropriate training, tools, and equipment to perform maintenance and repair electrical backup
installations. Up-to-date plans and manuals should be kept by each facility to ensure easy access when
troubleshooting or maintaining the equipment.

14
The hospital should ensure that a reasonable stock of spare parts for the backup electrical system(s) is
always held and that these form part of recurrent budgets. A system should be in place that prompts for
re-order when spareparts or diesel stocks run low.

The backup supply can be used to provide power to the entire hospital or may be used to provide
electricity to selected critical areas or critical equipment. Suppose the backup supply does not provide
electricity for the whole facility. In that case, an assessment should be made to identify those essential
areas that must be provided with uninterrupted supply, for example, the operating room, emergency
room, labor and delivery room, patient wards, laboratories, refrigerators for drugs, reagents, and blood
products, etc. The backup system must be able to maintain all the critical functions identified. Ideally,
the backup supply should start automatically during mains interruption. If this is not possible, a trained
individual must be available on-site to start the generator or alternative power source immediately
when a power failure occurs.

Standard electricity in Ethiopia runs at 220V and 50-60 Hz. However, medical and hospital
equipment originating abroad may require a different operating voltage. For example, equipment
originating from the United States operates on 110V. The donor should be asked to modify the
equipment to operate on a 220V supply if possible. If this is not possible, a step-down transformer is
necessary. Staff must be educated on when to use such step-down transformers, as plugging the
machine into the 220V supply will damage the equipment. Other large equipment, such as X-ray
machines, may require a 3-phase electricity supply, generally at 380V. Facilities need to prepare
accordingly if such electricity is needed. Medical equipment may be affected by fluctuations in
supplied voltage or power loss. Even in facilities with backup generators, there may be a brief period
(20-30 seconds) of electricity loss while the generator powers up. Any equipment damaged by power
fluctuations or interruptions must have a backup Uninterruptible Power Supply (UPS) that lasts at least
30 minutes, providing sufficient time for the generator to start up or for the equipment to be switched
off safely. The UPS will also protect the item from a power surge when the main power returns.

Electrical hazards may pose serious fire and shock hazards to patients, staff, and visitors. Electrical
safety should be ensured at all times. Regular inspections should be conducted, and electrical fire
hazards, such as frayed cords and compromised electrical sockets, should be identified and corrected
immediately. Electrical power strips (dividers) should be used cautiously and inspected regularly.

Hospitals should have access to a professionally qualified electrician with appropriate training, tools, and
equipment to perform maintenance and repair of electrical installations. To guarantee safety, they must:

 Test for grounding,

 Test for circuit connectivity,

15
  Test for loose connections,

 Perform insulation tests,

 Test switch leaks,

 Test for power,

 Check for the correct rating, and

 Check whether wiring regulations were followed during installation.

Each facility should keep up-to-date plans of electrical installations to ensure easy access when
troubleshooting or maintaining the electrical system.

The hospital must ensure that reasonable stocks of electrical maintenance materials are always held and
that these form part of recurrent budgets. Basic electrical maintenance materials include wires,
sockets, switches, fluorescent light components, fuses, circuit breakers, etc. A system should be in
place that prompts for re-order when stocks of electrical maintenance materials run low.

3.3.2. Water supply

All hospitals should have access to a safe and reliable water supply. Water in hospitals must be:

 Free of disease-causing organisms and any other hazardous substances,

 Transparent, colorless, odorless, and tasteless,
 Not too highly concentrated with calcium, magnesium, manganese, iron, or carbonates,
 Without any corrosive substances, and
 At a relatively low temperature.

Regular (at least every 6 months) microbiological checks should be conducted on the water supply.
Checks should be conducted on water outlets (faucets) and storage tanks.

A backup water supply such as water tanks, a reservoir, or a dedicated well should be available if the
main supply is interrupted. Water tanks should hold sufficient water to supply the hospital for at least
one or three days. Backup supplies should be cleaned regularly and water checked to ensure the
quality and safety of the water being brought to the facility. A mesh filter can prevent large debris
from entering the water supply. Filters must be cleaned regularly, as they get clogged with dirt or mud.

If, for any reason, the water supply is lost, every effort must be made to ensure that water is supplied to
all essential areas. The cause of the water interruption should be investigated, and the potential length

16
of the interruption should be estimated. The hospital should prepare a contingency plan that identifies
the areas to which water must be provided in order of priority. If the interruption is likely prolonged
and the backup supply is limited, then only the most essential services should be provided with water.

The contingency plan should include systems for transporting water throughout the building and
coordinating alternative plans for food preparation and laundry services. When the main supply is not
functioning, staff, patients, and visitors should be reminded to close faucets to prevent water wastage
and flooding when the water supply resumes. If the hospital cannot continue patient services due to
prolonged interruption to the water supply, then arrangements should be made to transfer patients to
other facilities. Such arrangements should be described in the contingency plan.

Water should be available in all toilets and clinical areas (wards, treatment rooms, outpatient
department, emergency room, laboratory, pharmacy etc). Ideally, piped water and faucets should be
provided in the above areas. If this is not possible covered water containers should be installed and
regularly filled. Such containers may be static or mobile so they can be taken on ward rounds, etc.

Additionally, all staff should have access to hand washing facilities near their workstation. Drinking
water should be available to patients and staff at all times. Water should be tested to ensurethat it is
potable. If water is treated with chlorine, regular chlorination tests should be performedto ensure the
water is safe for drinking.

3.3.3. Sewerage
Proper sewage facilities are essential to any healthcare facility to ensure cleanliness and minimize the
spread of infections. Flushing toilets should be available wherever possible and when adequate water
is available 4, ideally adjacent to each ward and clinical area. Otherwise, pit latrines are
recommended. Covered walkways should be used to link hospital buildings to any external toilet
facilities.

Flushable toilets should be inspected regularly to ensure the flushing mechanism is functional and
practical. Drainage systems should be inspected and maintained to eliminate leaks and system back-
ups. Patients, staff, and visitors must be instructed to keep large solid waste out of the sewage system
since these may cause blockages. Signs with written and visual messages indicating what can and
cannot be deposited in the sewage system should be used to minimize system misuse.

Where available, hospital sewage systems should connect to the municipal sewage system. Hospital
sewage should be pre-treated before entering the municipal system. Where municipal sewage systems

17
are not available, septic tanks may be used. Hospitals should install biogas systems where possible to
minimize sewage build-up and provide an efficient energy source. All hospital sewage should be
regarded as a hazardous material, and appropriate safety and infection prevention measures, including
personal protective equipment, should be followed when handling sewage or undertaking repairs on
any sewage systems (pipes, drains, toilets, septic tanks, etc.).

Hospitals should have access to a professional qualified plumber with appropriate training, tools, and
equipment to perform maintenance and repair of sewage installations. Up-to-date plans of sewage
installations should be kept by each facility to ensure easy access when troubleshooting or maintaining
the sewage system.

4
Federal Ministry of Health. Site Selection Criteria, 1998.

The hospital must ensure that reasonable stocks of sewage maintenance materials are always held
and that these form part of recurrent budgets. Basic sewage maintenance materials include pipes,
elbows, de-clogging snakes, and personal protective equipment for workers (such as boots,
gloves, and face masks). A system should be in place that prompts for re-order when stocks of
sewage maintenance materials run low. The disposal of pharmaceutical and laboratory products
and infectious waste are considered further in Chapter 4 Pharmacy Services, Chapter 5
Laboratory Services, and Chapter 7 Infection Prevention.

3.3.4. Plumbing

Hospital plumbing should be checked regularly to ensure that all components are functional and there
are no leaks in the system. Unnecessary water loss (due to leaks, running toilets, etc.) can be costly and
can cause damage to a building or equipment if left unattended. If present, water pumps should be
regularly checked and maintained per the manufacturer’s recommendations.

Plumbing hazards may pose various risks to hospital facilities, patients, staff, and visitors. Hazards
include flooding, slippery floors, and water damage. Regular inspections should be conducted, and
possible causes for leakage should be identified and corrected immediately. Hospitals should have
access to a professionally qualified plumber with appropriate training, tools, and equipment to install,
maintain, and repair plumbing installations. The plumber may be a regular employee of the hospital or
may be hired on a contract basis, depending on the size and needsof the hospital. Each facility should
keep up-to-date plans of plumbing installations to ensure easy access when troubleshooting or
maintaining the plumbing system.

18
The hospital must ensure that reasonable stocks of plumbing maintenance materials are always held
and that these form part of recurrent budgets. Basic plumbing maintenance materials include pipes,
faucets, toilet and sink fixtures, valves, flexible tubing, etc. There should be a system in place that
prompts for re-order when stocks of plumbing maintenance materials run low.

3.3.5. Boiler/steam supply

The hospital may use a boiler where a regular steam supply is needed. While running, boilers should
be constantly supervised by a dedicated boiler technician. Regular inspections should be performed to
ensure the boiler is running as expected; results of these inspections should be recorded, and corrective
action should be performed immediately. A functional backup boiler should be available for
emergency use when steam from boilers is used to provide essential services, such as autoclave
sterilization. The boiler technician should be qualified and have access to appropriate tools and
equipment to install, maintain, and repair boilers and associated steam pipe installations. The boiler
technician may be a regular employee of the hospital or may be hired ona contract basis, depending on
the size and needs of the hospital. Up-to-date plans of steam plumbing installations should be kept by
each facility to ensure easy access when troubleshooting or maintainingthe steam piping system.

The hospital must ensure that reasonable stocks of boiler and steam plumbing and piping maintenance
materials are held at all times and that these form part of recurrent budgets. This includes heavy oil or
other oil used to fuel the boiler. Basic steam piping maintenance materials include copper pipes, steam
traps, release valves, steam valves, etc. There should be a system in place that prompts for re-order
when stocks of boiler and steam plumbing maintenance materials run low.

3.3.6. Heating, ventilation, and air conditioning (HVAC)

Hospitals in Ethiopia generally do not require heating systems. If installed, they should be inspected
and maintained regularly to ensure they function correctly and do not pose a hazard. Where
appropriate, carbon monoxide detectors should be used to eliminate the risk ofinhalation. Additionally,
“space heaters” or other small heaters must be regularly checked for damage to eliminate the risk of
fire or other hazards.

Air conditioning systems are generally not used in Ethiopian hospitals but may be necessary under
certain conditions. For example, specific medical equipment may require rooms to remain within a
specific room temperature range that may only be achieved through air conditioning systems. If

19
present, air conditioning systems must be inspected and maintained regularly to ensure correct
operation.

Adequate ventilation is essential in a hospital environment to help prevent the spread of infectious
diseases and to minimize health risks due to harsh chemicals or other pollutants. Ventilation is also
needed to reduce mold or other fungus growth in areas of high humidity, such as the kitchen, laundry,
and any other areas with steam, water, or sewage pipes running through. Workshops where welding,
soldering, burning, or other smoke-producing activities occur, or exposure to harsh chemicals (such as
paint or epoxies) must also be adequately ventilated. Natural ventilation (opening windows) can be a
low-cost alternative when artificial ventilation methods are unavailable. This method should not be
used if the external environment is polluted or excessively noisy.

Hospitals should have access to a professionally qualified HVAC technician with appropriate training,
tools, and equipment to perform maintenance and repair of HVAC installations. Up-to-date plans of
HVAC installations should be kept by each facility to ensure easy access when troubleshooting or
maintaining the HVAC system.

The hospital must ensure that reasonable stocks of HVAC maintenance materials are always held and
that these form part of recurrent budgets. Basic HVAC maintenance materials include vent ducts, fans,
air filters, etc. A system should be in place that prompts for re-order when inventory of HVAC
maintenance materials runs low.

3.3.7. Energy efficiency

Hospitals should maximize energy efficiency to minimize costs and environmental pollution. Ways to
increase energy efficiency include:

 The use of natural ventilation:

o Open windows (should only be done if the external environment is free of

pollution, smog, industrial gases, and excessive noise). Screens can be installed
to protect from insects while allowing maximum airflow,

o Provide vents in the ceiling and roof to allow hotter air to escape,
 Construct windows to be as tall as possible to let in the maximum amount of natural
light,
 Provide comprehensive roof coverage to protect windows from direct sunlight and

20
 hence keep buildingscool,
 Provide reflective materials on windows to redirect the rays of the sun,

 Plant trees to provide shade to buildings, especially outside windows, in hot climate areas,

 Ensure doors and windows close correctly to maintain internal heat in cold climate areas,

 Use solar panels for heating water, powering lights, etc.,

 Install biogas systems as an alternative source of energy, and
 For new buildings, orient the building to decrease sun exposure or take advantage
of prevailing winds.

21
 3.3.8. Pet, pest, and rodent control
Rodents and insects can spread disease and cause damage to buildings and equipment, for example, by
chewing electrical wires and soft tubing. Pests and rodents can be minimized by keeping the facility
clean and free from waste materials. The following steps help to eliminate pets and rodents and are
particularly important in storage areas:

 Design or modify storerooms to facilitate cleaning and prevent moisture.

 Regularly clean floors and shelves.

 Do not store or leave food uncovered/unsealed in any storage areas.

 Keep the interior of the building as dry as possible.

 Properly varnish or paint wooden furniture as needed.

 Use pallets and shelving; do not keep products directly on the floor.

 Regularly inspect and clean the outside premises of the storage facility, especially
areas where garbage is stored. Make sure that garbage and other wastes are stored in
covered containers.
 Check for still or stagnant pools of water in and around the premises, and ensure there
areno buckets, old tires, or items holding water.

 Treat wood frame facilities with water sealant, as required.

 The fine wire mesh should protect the facility from birds or bats and cover any open
space between the roof and the ceiling.

 To protect the facility from flying pests, keep all doors and windows closed or put fine
wire mesh on all windows to ensure no holes in the ceiling, walls, or floors.
 Using Insect Electrocuting Light Bulb (hanging electric grids that attract flying insects
via a bright fluorescent or ultraviolet light) may be the appropriate solution if available
at a reasonable price.
 Using noisemakers and keeping the outside of the facility clear of long grasses and
bushes can protect the facility from the different snake species.
 All patient bed sheets and blankets should be washed and ironed regularly to eliminate
flees or similar insects. Mattresses, pillows, and other items that do not get laundered
should be disinfected with appropriate chemicals regularly, especially before the bed
is occupied bya new patient.
 Animals in Health care may have direct contact (Bites), Direct or indirect contact,

22
 Fecal-oral, and Droplet vector born. This may cause selected diseases transmission
like Rabies, Staphylococcus aureus infection, Giardiasis (Giardia duodenalis), and
Ticks (dogs passively carry ticks to humans; disease not transmitted directly from dog
to human).
 The role of animals in transmitting zoonotic pathogens and cross-transmitting human
pathogens in these settings may affect the Service provider and the clients. So it is
mandatory to use standardized infection prevention and control measures to prevent
animal-to-human transmission in Hospital settings.
 Inspections should be performed regularly to detect the presence of rats, rodents, or other
pests, paying particular attention to store rooms and the kitchen. Proper extermination methods
should be undertaken when pests are suspected. Extermination techniques should be
performed by local rules. Patients and staff should be temporarily removed from areas if there
is a risk of exposure to toxic chemicals or substances.

3.4. Vehicle Management

3.4.1. Vehicle Management and Transport Services

Hospitals may have one or more vehicles, including ambulances, depending on the size and location of
the facility. Such vehicles should be organized within a transport department of drivers anddepartment
heads. All drivers must have valid driving licenses for the vehicle type and be sufficiently trained to
undertake essential repairs (for example, burst tires, overheating, etc.). All vehicles should be
equipped with at least one spare tire and preferably two for vehicles used in remote locations, and these
should be checked regularly to ensure they are intact and filled with air. All vehicles should be fitted
with functioning seat belts in both front and back seats, which should be used by drivers and passengers
at all times. All vehicles must be insured against accident and theft.

Routine services should be undertaken for each vehicle by the manufacturer’s recommendations.
Routine and repair services should only be undertaken by a qualified mechanic.

A logbook describing the mileage undertaken and maintenance record should be kept for each vehicle.

A transport policy should be established that specifies the following:

 The appropriate use of ambulances and regular vehicles,

 The process by which vehicles are issued for use,

 Control of vehicle keys,

23
  Storage of vehicles,

 Fuel consumption policy,

 Use of seatbelts,

 Use of mobile telephone by the driver,

 Use of alcohol, chat, or other substances by the driver,

 Action to be taken in the event of an accident or breakdown, and

 Action to be taken in the event of misuse of the vehicle.

3.5. Hospital Security

3.5.1. The Security (Guard) department
Security for the staff, patients, property, and information located within the hospital is critical.
Potential security threats include theft – by an employee or visitor and threats against patients or staff.

Security personnel play a vital role in ensuring the hospital is welcoming and accessible and a safe
environment for patients, visitors, and staff. Security personnel need a thorough knowledge of the
premises to protect buildings and valuable equipment. Security personnel should know when and how
to diffuse potentially difficult situations and should be able to react appropriately in an emergency.

A head of security should be appointed to manage all security officers. The security department
should provide 24-hour coverage, with security officers stationed at all hospital entry and exit points.
The security staff also should conduct regular rounds of the premises. Security staff should be
issued with appropriate communication devices, such as walkie-talkies or mobile telephones to ensure
communication in an emergency. If firearms are to be held by security staff, then appropriate
training must be given to ensure their appropriate use. The local police department may provide such
training on request. There should always be a security focal person on the premises who will be the
first point of contact in a security incident (such as a fire or theft) and will be in charge of deploying
guards to the incident area to diffuse the situation. Security personnel should be fit and in good health
and issued uniforms and ID badges to be identified as security staff easily.

3.5.2. Control of entry and exit to and from the hospital

The hospital should have a policy to control access to the hospital addressing the areas outlined below.

Access to the hospital should be limited to staff, patients, caregivers, and visitors with legitimate
business.

24
All staff should wear ID badges which they must present upon entry to the facility. In addition, staff
should wear uniforms appropriate for their positions at all times within the hospital. A policy should
be established for the number of caregivers permitted for each patient (for example, one caregiver per
patient except for critical and pediatric cases). The policy should be displayed in the hospital and
explained to all patients and caregivers whenever a patient is admitted. Caregiver ID badges should be
issued for caregivers, indicating the ward and bed number of the patient they are attending. (For further
information on 'traffic control,' please see Section 3.4.5 of Chapter 7, Infection Prevention).

Fixed visiting hours should be established and displayed at all hospital entry points and within each
ward. These should be strictly enforced. The number of visitors to each bed should be limited to
prevent crowding. Visitor ID badges should be issued for patient visitors, indicating the ward and bed
number of the patient they are visiting.

All other visitors to the hospital attending for other purposes, such as providing supplies, and
administrative or supervisory functions, should also be issued visitor ID badges.

Patients attending the outpatient department or emergency room should be directed to the appropriate
department and not enter ward areas unless attending for clinical assessment or treatment. All staff,
mainly security personnel, should ensure that patients, caregivers, and visitors remain within the area
wher e they have legitimate business and do not wander around other clinical areas or hospital
premises unnecessarily.

Staff, visitors, patients, and vehicles should be searched when they enter the premises to detect
dangerous weapons or other security threats, and a search should be undertaken of all individuals and
vehicles on exit from the premises to prevent theft.

Visitor and caregiver ID cards should be returned to security personnel when the individual leaves the
premises.

3.5.3. Security plan

A security assessment should be undertaken at least once a year to identify security vulnerabilities,
including the location of essential or expensive equipment or supplies. A security plan should be
designed based on the findings of this assessment. The security plan should address areas such as:

 Control of access points, entry and exit to premises,

 Security rounds,
 Action to be taken in the event of security threat,

 Use of communication devices,

 Use of firearms (if permitted),

25
 Control of assets entering or leaving premises, and
 Induction and training of new security personnel.

3.6. Hospital Safety

3.6.1. Hazardous materials
Exposure to hazardous chemicals can produce a wide range of adverse health effects. The likelihood
of an adverse health effect occurring and the severity of the effect is dependent on the toxicity of the
chemical, the route of exposure, and the nature and extent of exposure to that substance.

Toxic chemicals often produce injuries at the site at which they come into contact with the body. For
example, irritant gases, such as chlorine and ammonia, can produce a localized toxic effect in the
respiratory tract; corrosive acids and bases can damage the skin. In addition, a toxic chemical may be
absorbed into the bloodstream and distributed to other body parts. These chemicals may then produce
systemic effects. There are three main routes of chemical exposure: inhalation, skin contact, and
ingestion.

26
Table 2. Recommended protection against some chemical hazards

Chemical Exposure Routes Symptoms First Aid Personal

Protection
Glutaraldehyde Inhalation, skin Irritation of eyes, Eye: irrigate Wear eye- protection,
(commonly used as absorption, skin, respiratory immediately. Skin: protective clothing,
ahigh level ingestion, skin system; dermatitis; Water flush gloves, and a mask
disinfectants and/or and/or eye contact cough, asthma; immediately Good ventilation
sterilizers for some nausea, vomiting Breathing: Respiratory and easy access to
medical equipment supportSwallow: Medical water
that does not resist attention
heat)
immediately

Ammonia Inhalation, Irritation of eyes, Eye: irrigate immediately Wear eye- protection,
(used in the ingestion, skin nose, throat; Skin: Water flush protective clothing,
laboratory and and/or eye contact dyspnoea, immediately. gloves, and a mask
some cleaning wheezing, chest Breathing: Good ventilation
solutions) pain; pulmonary Respiratory support and easy access to
oedema; skin burns water
Swallow: Medical
attention immediately

Formalin or Inhalation, skin, Irritation of eyes, Eye: irrigate immediately Wear eye- protection,
formaldehyde and/or eye contact nose, throat, Skin: Water flush protective clothing,
(commonly used as respiratory system; immediately. gloves, and a mask
a high-level lacrimation; cough; Breathing: Good ventilation
disinfectant or wheezing Respiratory support and easy access to
sterilizer for some water
medical equipment
that do not resist
heat)
Chlorine Inhalation, skin, Burning eyes, nose, Eye: irrigate immediately Wear eye- protection,
(used for and/or eye contact mouth; lacrimation, Skin: Water flush protective clothing,
decontamination, rhinorrhea; cough; immediately. gloves, and a mask
cleaning, and chocking; nausea, Breathing: Good ventilation
disinfection) vomiting; headache, Respiratory support and easy access to
dizziness; syncope; water
pulmonary oedema,
pneumonitis;
dermatitis
Mercury Inhalation, Burning eyes, nose, Eye: irrigate immediately Wear eye- protection,
ingestion, skin mouth, skin Skin: Water flush protective clothing,
and/or eye contact irritation; damage to immediately gloves, and a mask
the nervous system Good ventilation
and easy access to
water

27
 Source: Adapted from NIOSH Pocket Guide to Chemical Hazards. Draft Workplace Safety &
Health Guidelines for Health

Workers (2007).

Material safety data sheets (MSDSs) should be available for all chemicals found at the hospital. These
should include information about the substance, safe handling, precautions, first aid, etc. MSDSs
should be held at all sites where hazardous materials are stored or utilized, and a complete set of all
MSDSs should be held by personnel in the materials management/central supply department and
hospital management. An example of MSDS is presented in Appendix G.

The hospital should ensure that reasonable stocks of personal protective equipment are held at all times
and that these form part of recurrent budgets. Essential personal protective equipment includes gloves,
masks, eye protection, protective clothing, etc. A system should be in place that prompts for re-order
when stocks of personal protective equipment run low (For further information on personal protective
equipment, please refer to section 3.2.2 of Chapter 7, Infection Prevention).

3.6.2. Fire safety

A fire in a health facility risks patients' and providers' safety, health, and lives. Hospitals should have a
fire safety plan that addresses the prevention of and response to fires.

A. Fire prevention
The following safety measures minimize the risk of fire:

 Electrical safety: All appliances, instruments, and installations should be tested before use
to determine compliance with grounding, current leakage, and other device safety
requirements. A routine maintenance program should be enforced to ensure that all
electrical receptacles, plugs, wires, and connectors are safe. An earth leakage (grounding)
system should be used, and start and stop switches must be identified.
 Flammable storage: Specifically designated areas for storage of flammables (e.g., diesel,
alcohol, oxygen) should be identified. These items should be stored properl y and
located in restricted areas protected from sources of excessive heat, fire, or electrical
discharge and away from patient care areas. Minimum quantities of flammables should be
kept at workstations.
 Smoking/open flame restrictions: The facility should adopt strict rules governing

28
 smoking within the hospital, which should be made known to hospital personnel, patients,
and visitors. These rules should include at least the following: smoking must be prohibited
within the facility and in any room or compartment where flammable liquid, combustible
gas, or oxygen is being used or stored and in any other hazardous hospital area. These
areas must be posted with clear ''NO SMOKING'' signs. Open fires (e.g., waste burning,
kitchens) must not be allowed near explosive storage areas. All open fires should be
monitored until wholly extinguished.
 Fire inspections: In localities where fire departments exist, health facilities should request
an annual inspection by the local fire department that includes verification of fire
prevention measures and response readiness assessment (access to the building, current
floor plan, storage places of flammable and explosive gases, sources of water, firefighting
equipment, patient rooms, exits, and evacuation plans).
B. Response to a fire
The action taken in response to a fire can minimize injury and the damage caused to buildings
andequipment. Fire response measures should include the following:

 Fire warning system: Ideally, every building should have a fire alarm system installed
(automatic and/or manually activated) to allow the early identification of fires. If this is
not possible, a large handbell may be used as an alert signal.
 Emergency notification: The facility should have a fire emergency notification
system for the local fire department using the most direct, fast, and reliable
communication.
 Firefighting equipment: All buildings should have portable extinguishers appropriate to
the different hazards, properly tagged, and easily accessible in all building areas.
Extinguishers should be periodically checked according to regulations to ensure they are
operable. If hydrants and hoses exist within the facility, they should be conveniently
distributed throughout the building to allow water to reach all potential fire points
effectively. Hydrants and hoses should also be regularly checked to ensure functionality.
 Water sources: Adequate water sources must be available in the facility for fire control.
If the public water supply system is non-existent or unreliable, water supply should be
guaranteed by elevated tanks or electric pumps. In the latter case, an emergency energy
source should be available.
 Access to the building: Access to the building for firefighters should be marked and
freeof obstacles. Established routes must allow access to all parts of the building.

29
 Evacuation: All facilities must have evacuation plans for patients and staff. Evacuation
routes can be horizontal or vertical. Evacuation routes must be marked, built of fire-
resistant materials if possible, free of obstacles, well-lit, and ventilated to avoid smoke
accumulation. They must not pass through or be close to explosive storage areas.
Evacuation routes should direct patients and staff to a safe place outside of the building or
to a designated safe area in the building (behind fire doors if they exist). Elevators must
not be used for vertical evacuation. Evacuation should be done systematically by first
moving all patients and personnel closest to the danger. Doors into patient rooms should
not be locked when the patient is alone. Exit doors should be easily opened from the
inside.
Referrals: After a fire, it may be necessary to relocate patients to other facilities. Health
facilities must have an emergency referral plan that includes all health services, public or
private, in their geographical area, including the identification of transportation means.

All employees should be trained in fire prevention and response and familiar with the fire safety
plan. Training should include the operation of firefighting equipment, evacuation, and the specific
responsibilities of each staff member. Update training should be conducted at least annually.

A' Fire and Evacuation Drill' should be conducted annually to test the fire and safety plan and
ensure that staff is familiar with their responsibilities. These drills should be planned and
implemented to:

 Ensure that all personnel on all shifts are trained to perform assigned duties in case of a fire,

 Ensure that all personnel on all shifts are familiar with the use and operation of the fire-
fightingequipment in the hospital,
 Enable hospital management to evaluate the effectiveness of the plan,

 Check the feasibility of a prompt and orderly discharge or transfer of patients already in
thehospital who can be safely moved without jeopardy,

 Verify security measures to keep unauthorized persons out of the emergency area.

3.6.3. Other safety measures

All hazards (such as wet floors, spills, broken glass, etc.) should be clearly labeled to prevent injury.
All public areas should be kept clean and free of large objects. Stairwells and corridors should be kept
clear and not used as storage areas. When cleaning is conducted, only half of the area of corridors and
stairwells should be wet cleaned at a time to have a dry and safe path available for use. Further

30
occupational health and safety guidance is presented in Section 3.13 of Chapter 11, Human Resource
Management.

3.7. Major Incident Planning and Management

A significant incident is any event whose impact cannot be handled within routine service
arrangements. This may arise when:

 The numbers or type of casualties overwhelm or threaten to overwhelm r o u t i n e

services, and special arrangements are needed to deal with them; or
 An incident poses a serious threat to the health of the community; or

 There is the potential for the hospital itself to suffer severe internal disruption.

Major incident planning aims to ensure that the hospital can respond to major incidents of any scale in
a way that delivers optimum care and assistance to victims, minimizes the consequential disruption to
healthcare services, and brings about a speedy return to normal activity levels. Box A outlines ways in
which a major incident may present. It is the nature of major incidents that they are unpredictable, and
each will present a unique set of challenges. The task is not to anticipate each major incident in detail
but to have a set of expertise available and to have developed a set of core processes to handle the
uncertainty and unpredictability of whatever happens.

Box A: Presentation of a Major Incident

Major incidents may present in several ways:

 The big bang

 The rising tide
 The cloud on the horizon
 Headline news
 Internal incidents
 Deliberate release of chimerical or biological materials
A. The 'Big Bang'- A major health service incident is classically triggered by a sudden
primary transport or industrial accident. In this case, the police service or emergency
room may be the first to be aware of and respond to the incident.
B. 'Rising Tide'- This problem creeps up gradually, as occurs with an infectious disease
epidemic. There is no clear starting point for the major incident, and the point at which
an outbreak becomes ‘major’ may only be apparent retrospectively.
C. ‘Cloud on the horizon

31
 An incident in one place may affect others following the incident, for example, a
major incident in another health facility or an epidemic arising elsewhere.

D. ‘Headline news’-A wave of public or media alarm over a health issue as a reaction to a
perceived threat may create a major incident for the health service even if fears prove
unfounded. For example, a perceived risk of bird flu or swine flu may cause mass
attendance at the facility, even if the risk to the population is minimal. It is the urgent
need to manage information that creates the major incident. If well handled, it may not
become a major incident; if mishandled, it probably will.
E. ‘Internal incidents’-The hospital itself may be affected by fire, breakdown of utilities,
major equipment failure, hospital-acquired infection, hazardous material spill, etc. If
such incidents are mishandled, the morale of staff and public confidence in the facility
may be eroded in the long term.

F. ‘Deliberate release of chemical or biological materials

The hospital's role in such incidents is to deal with emergency cases that present to the
facility. The overall response to such incidents requires close coordination between the
hospital and government agencies such as police, military, and woreda/zonal/regional
health bureaus.

The essentials of major incident planning are:

 establishing a Major Incident Committee,

 establishing an Incident Control Room,

 preparing a Major Incident Plan (MIP),

 establishing appropriate command and control arrangements,

 implementing the MIP through training, exercising, and testing, and

 I am validating the MIP through a system of regular reviews and updates.

32
 3.7.1. Major Incident Committee

All hospitals should have a Major Incident Committee (MIC) responsible for supervising and
coordinating emergency planning. The MIC should be led by a Major Incident Commander. Major
Incident planning leads should be identified in all clinical and non-clinical case teams/departments, and
each should be a member of the MIC.

Roles of the MIC include:

 To consider all possible types of major incidents that could affect the local population,

 To undertake a risk analysis of the facility and identify risks that should be
addressed in the Major Incident Plan. A sample Facility Risk Analysis Template is
presented in Appendix H,

 To produce and update annually the Major Incident Plan (see below),

 To determine membership and terms of reference of the Incident Response Team,

 To develop Action Cards that describe the responsibilities and reporting

arrangements of allkey personnel in the event of a major incident,

 To establish an emergency communication system including both internal

communication andexternal communication with external parties,
 To ensure staff receive training in emergency preparedness,

 To conduct emergency drills and tabletop exercises to test the Major Incident Plan, and

 To evaluate the response to any major incidents and take action to address any
problems identified.

3.7.2. Roles of the Major Incident Commander and Deputy Major Incident
Commanders
All hospitals should have a Major Incident Commander, who should be the Chair of the MIC. This role
could be filled by the CEO, the Head of Finance and Procurement, or another individual with an
excellent working knowledge of the facility, staff, and services provided. The Major Incident
Commander authorizes MIP activation and communication to all hospital personnel. Other MIC
members may be assigned as Deputy Major Incident Commanders who can authorize activation of the
MIP if the Major Incident Commander is unavailable. The Major Incident Commander and Deputies
must operate a rota system with 24-hour coverage each day, 365 days a year, and this duty schedule
should beavailable to all staff. Ideally, a dedicated mobile telephone number or pager should be carried

33
bythe duty Major Incident Commander or Deputy known to external agencies and hospital staff so that
the duty Commander may be contacted directly and immediately in the event of a major incident.

The Major Incident Commander or Deputy is also responsible for deactivating the MIP after a proper
emergency assessment.

3.7.3. Incident control room

All hospitals should have an Incident Control Room (ICR) activated as a post to manage
emergency/disaster response activities. This may be an existing office or meeting room that can be
used as the ICR in an emergency. Keys for the ICR should be kept with the Major Incident
Commander or the Deputy on duty. The ICR serves as the assembly point where duties are assigned
and personnel report activities in the event of a major incident. The ICR should contain the following:

 Desks and chairs

 Telephone

 Fax

 Stationary

 Action Cards

 Copies of the Major Incident Plan

3.7.4. Command and control arrangements in a major incident

An Incident Response Team (IRT) should be formed in a Major Incident. The IRT should gather in the
Incident Response Room, where all activities will be coordinated.

Members of the IRT should include:

 Major Incident Command Officer

 Major Incident Command Deputies

 Chief Executive Officer

 Director of Facility Services (or equivalent)

 Director of Human Resources

 Director of Outpatient Services

 Director of Inpatient Services

34
  Director of Emergency Services

 Chief Nursing Officer (or equivalent)

 Liaison and Referral Officer

 Others, as determined by the facility

Sample terms of reference of an IRT are presented in Box B.

Box B Terms of Reference of Incident Response Team

 To oversee the response to the incident, issuing Action Cards and receiving
update reports from key personnel
 To make an initial assessment of the situation and determine the critical
organizations with which to establish communication
 To put in place adequate measures to ensure communications with
the appropriate organizations during the incident
 To put in place adequate measures to ensure communication with
relatives and the community during the incident
 To assess the internal resources required to deal with the incident and to
ensure that these are put in place (for example, calling additional staff onto
duty, mobilizing medical supplies)
 To seek expert advice where the expertise does not exist within the
hospital (for example,from Public Health Laboratory Service)
 To prepare staff for the execution of the response plan and to monitor implementation.
 To prepare a plan for the long-term follow-up of the incident if necessary
 To prepare, if necessary, regular press statements or other means of public communication
 To decide when the incident should be declared over and inform any
necessary external agencies that this has been done
 To organize the re-entry of staff, patients, and visitors
 To identify and complete appropriate reports of any damage that occurred
to buildings or equipment
 To carry out a debriefing, including a review of the Major Incident Plan and
recommendations for modification
 To prepare a report for the Hospital Governing Board and other agencies on the incident

35
 The membership, contact details, and terms of reference of the IRT should be described in the Major
Incident Plan (see section 3.9.5 below).

In addition to the IRT, the MIP should describe command and control arrangements showing who is
accountable to whom in the event of a major incident. The command and control arrangements can be
supported by ‘Action Cards’ that specify the responsibilities of each individual in the event of a Major
Incident and state who that individual should report (see section 3.9.6 below). Sample Major Incident
Action Cards are presented in Appendix I.

All staff should be familiar with the command-and-control arrangements and their particular
responsibilities and reporting arrangements described in their Action Card.

3.7.5. The Major Incident Plan

All hospitals should have a Major Incident Plan approved by the Senior Management Team. The MIP
should be distributed to all staff, and copies should be readily available in all case teams/departments.
The MIP should be updated annually.

The MIP should include:

 Basic hospital information, e.g., location of facility, number of beds, services provided

 An outline plan of the hospital identifying:

o Emergency room areas

o Patient flow plan
All fire extinguishers and fire alarms
o Exit routes (doors, windows, stairways, etc.)
o Assembly points

o Emergency supply storage

 Contact information for:

o Key facility personnel (for example, MIC and IRT members, hospital
management, caseteam leaders, and medical staff)

o External agencies (for example, police, fire brigade, water and electricity
suppliers, woreda/zonal/regional health offices, FmoH, and local media)

 Clear alerting and activating procedures for the MIP

36
 The essential functions and critical personnel needed to continue health facility
operations in caseof an emergency

 A communications cascade by which all key personnel will be contacted

 Precise arrangements for establishing an Incident Response Team

 Clear statements on the roles/responsibilities of essential staff/functions

 Action cards for key personnel involved in a Major Incident that describe staff
roles/responsibilities and reporting arrangements (see section 3.9.6 below)
 Department/Case Team specific action plans and checklists that establish the different
courses of action for each department in an emergency

 Clear identification of resources required for the response and how these will be
accessed (for example, emergency drug store)
 A plan outlining coordination with all suppliers/providers to deliver needed supplies
during an emergency (for example, food, drugs, water, electricity, laundry services,
additional personnel, etc.)

 A communications plan with all local emergency agencies. All local emergency
agencies should have a copy of the hospital's MIP.

 Evacuation protocol includes:

o All possible evacuation routes and assembly points for staff, patients, and
visitors to convene. This emergency should be marked throughout the facility.

o Description of situations requiring evacuation such as:

 Fire/Smoke

 Hazardous fumes and/or hazardous material spill

 Area contamination by toxic agents

 Radiation

 Loss of critical support services (this could simply require a partial

evacuationof patients from one department to another)

 Explosion

 Police action

 Armed/dangerous visitor

 Natural disasters (ex., flooding, earthquakes)

37
  Fire safety plan

 Arrangements for creating additional space/capacity within the hospital

 Arrangements with other healthcare providers for an alternative care site for patients if
the facility exceeds its capacity

 Communication plan to manage communication and information for families of

casualties and other visitors. A communications Centre should be established to
provide information about casualties' status. The center should collect visitors' names
and patient associations to help staff locate visitors needing to be escorted to the patient.

3.7.6. Management of a Major Incident

The steps to be taken in the management of a major incident include the following:

1. Incident alert: Any staff member may identify a potential incident and should notify
their case team/department head immediately or the Major Incident Commander,
depending on the situation's nature and the event's time. An external event may come
to the attention of staff in the emergency room via the local police, fire service, or
health bureaus. Such external agencies should be instructed to notify the Hospital
Major Incident Commander immediately should a potential major incident occur.
2. Assessment of the situation by Major Incident Commander. The Major Incident
Commander should complete an Incident Alert Log (Appendix J) and decide if the MIP
is to be activated.
3. Activate communications cascade (Appendix K). The Major Incident Commander
should contact the Incident Response Team, who is responsible for contacting directly
or arranging for the contact of all key personnel as described in the Communications
Cascade.
4. Establish Incident Response Room and Incident Response Team. The Incident
Response Room should be opened by the Major Incident Commander, and all members
of the IRT should report there immediately or as soon as they reach the facility. The
Major Incident Commander shall brief team members on the situation.
5. Assign Action Cards: All essential post holders/managers should have a card that
briefly details the actions they should take in an emergency. The cards should be
laminated and carried by each individual at all times. Copies should be kept in the
Incident Response Room and included in the MIP.

38
 6. Proceed as instructed in the action cards

7. Manage Incident

8. Step down when an incident is over

Management of a Major incident

Inform Major Incident Commander orDeputy

Incident alert: Internal event (e.g., Incident alert: External event (e.g.,
fire,chemical spill) roadaccident, disease epidemic)

The department staff provides Emergency Rooms or external agencies

an initialresponse such as the police provide an initial
response.

Assess situation. Compete Incident Alert Log

Activate communications cascade

Review responses and revise

IncidentManagement Plans
accordingly.
Establish Incident Control Room and
Incident Control Team

3.7.7. Testing the Major Incident Plan

All staff should be trained in major incident preparedness, including personal roles and responsibilities

Take action cards

Proceed as instructed

39
Manage incident
Step down when an incident is over.
 in the case of a major incident.

The MIP should be tested at least once every year, and modifications made to the plan based on lessons
learned from the drill. The drill can be either a simulated exercise involving mock victims or a 'desk
top' exercise involving establishing the IRT, activating the cascade system, issuing action cards,and
testing each department/case team's response. A MIP Drill Plan and Drill Evaluation Form are
presented in Appendices L and M. The Drill Evaluation should be carried out by one or more
observers.

Source Documents

1. Agency for Healthcare Research and Quality. Emergency Management Principles and
Practices for Health Care Systems: Unit 3 – Healthcare System Emergency Response and
Recovery. Retrieved from:-http://www.ahrq.gov/research/hospdrills/predrill.htm;
http://www.ahrq.gov/research/hospdrills/triage.htm;
http://www.ahrq.gov/research/hospdrills/tx.htm.

2. California Hospital Association. (2008, Nov 20). Hospital Emergency Management

ProgramChecklist.

3. Carr, R.F. The National Institute of Building Sciences – Whole Building Design Guide:
Hospital. Retrieved from: http://wbdg.org/design/hospital.php.

4. Claude Moore Health Sciences Library. (Revised August 2008). Emergency

Preparedness andResponse Plan.

5. Federal Democratic Republic of Ethiopia Ministry of Health. Planning and Project

Department. Architectural and Engineering Team. (1998, May). Site Selection Criteria.
Addis Ababa, Ethiopia.

6. Griffith, J. R. and. White, K. R. The Well-Managed Healthcare Organization: Sixth Edition.

7. Ministry of Finance and Economic Development. (2007, December). Government

Owned FixedAssets Management Manual.

8. Ugandan Ministry of Health. Prepared by Necochea, E. and Bossemeyer, D. Jhpiego. (2007).

Ugandan Ministry of Health Draft Workplace Safety and Health Guidelines for Health Workers.

9. Mississippi Depart of Health: Office of Emergency Planning and Response. Hospital

EmergencyPreparedness Planning Template (August 2005).

40
10. Mississippi Department of Health: Office of Emergency Planning and Response. (2005, April)
Clinical Emergency Planning Template.

11. National Association of Community Health Centers. Retrieved from:

http://www.nachc.com/EM-Planning. cfm.

12. New York Centers for Terrorism Preparedness and Planning. (2006 March). Draft
HospitalEvacuation Protocol.

13. New York Centers for Terrorism Preparedness and Planning. (2006 July).
Draft MassCasualty/Trauma Event Protocol.

14. Quality Improvement Support Services. Departmental Emergency Preparedness Plan.

15. U.S. Department of Health and Human Services: Agency for Healthcare Research and
Quality. Retrieved from: http://www.ahrq.gov/research/hospdrills/introduction.htm.

16. United Nations Development Programme, India. Guidelines for Hospital Emergency
PreparednessPlanning. GOE-UNDP DRM Programme (2002-2008).

17. Washington University in St. Louis: Disaster and Business Continuity Planning Committee.
Department Emergency Guides.

18. Wisconsin Department of Health Services. Hospital Disaster Plan.

Retrieved from:
http://dhs.wisconsin.gov/rl_DSL/Hospital/HospitalDisastrPlng.htm.

41
19. World Health Organization-Regional Office for the Western Pacific. "District
Health Facilities-Guidelines for Development and Operations. Risks, Emergencies,
and Disasters," Planning and Design. WHO Regional Publications. Western
Pacific Series No. 22. 1998. Retrieved from:
http://www.wpro.who.int/internet/files/pub/297/part1_1.6.pdf.

20. Yale-New Haven Health System. Disaster Critique Follow-up and Resolution Form.

21. Yale-New Haven Hospital. (2009). Emergency Management Plan.

42
 Chapter 12
Human Resource
Management and
Development

1
Outline
Section 1 Introduction

Section 2 Operational Standards for Human Resource Management and

Development
Section 3 Implementation Guidance
Section 4 Annexes
Section 5 References

2
Section 1 Introduction
The most important asset of a hospital is the people who work there. Employees, whether they
are the hospital’s technical or admin wing staff, all individually and as a group, are responsible
for and have valuable contribution in carrying out the hospital’s duty to care for patients. A well-
performing health workforce is one that works in ways that are responsive, fair and efficient to
achieve the best health outcomes possible, given available resources and circumstances (i.e. there
are sufficient in number, with required mix, fairly distributed; they are competent,
compassionate, caring, responsive and productive).
The main objective of the Human Resource management and Development
Department/Directorate(HRMD) function is to ensure that the facility attracts, develops, retains,
and motivates qualified employees who are critical for achieving the organization’s objectives of
delivering high quality and safe patient care by creating conducive working environment for the
staff (Capacity building on different initiatives including MCC,QI concepts, strong support and
monitoring at all level with regular feedback, engagement of clinicians in L/P, performance
based evaluation and recognition).
The HRMD Directorate/Department does this by designing organizational structure that shows
clear vertical and horizontal communications, and roles and responsibilities, establishing policies
and procedures for the work environment and the effective management and development of
employee workplace issues to the mutual benefit of the individual employee , the hospital and
the clients.

The benefits of a well-functioning HRMD system include:

 Develop hospital-based HR development plan which address professional mix, education
level category
 Continuous professional development CPD through ongoing training (onsite, short- and
long-term training to maximize employee performance, skills and knowledge, satisfaction
 Implement scope-based practices and assess competency
 Create conducive learning platform for the hospital staff (face to face, online courses,
etc.)
 Prepare Skill lab/simulation centre for staff capacity building

3
  The hospital should clearly define and create awareness on employee roles and
responsibilities
 Improved relationships between employees and management,
 Efficient use of HR to improved effectiveness and productivity.
 Regularly monitor staff adherence to rules and regulations, Ethics, performance with
improvement plan and level of staff satisfaction
 Set a recognition mechanism for individual and service areas based on well-defined
recognition mechanism.
This chapter sets standards and provides guidance for the establishment of a human resource
functions that contributes to the advancement of the vision, mission and guiding principles of the
hospital.

4
Section 2 Operational Standards for Human Resource Management and Development
1. The hospital has a Human Resources Management Directorate/Department/ which lead and
manage the HR management and development of the hospital
2. The hospital has a human resource development plan.
3. The hospital established a transparent and accountable system of staff acquisition
4. The hospital has the number and professional mix in accordance with the regional/national
standards.
5. The HRMD Directorate/Department maintains each personnel file and fully implement HRIS
6. The Human Resource Directorate/Department creates conducive work environment to motivate
health work force.
7. The hospital strengthens a system to have Motivated, Competent, and Compassionate (MCC)
human resource for the hospital.
8. The hospital has a performance evaluation management system and reward policies to formally
and objectively evaluate all the employees.
9. The hospital has occupational health and safety policies, plan, and procedures
10. The hospital’s HRMD directorate/department enhances Productivity and working hours
management of the hospital
11. HRM&D directorate/department prepares an Employee Handbook that contains policies and
procedures to help ensure consistency in service delivery.
12. The hospital regularly conducts a staff job satisfaction survey and exit interview.

5
Section 3 Implementation Guidance
3.1 Human Resource Department

The Human Resource Management and Development (HRMD) Directorate/Department/ Support Process
is responsible for the planning, recruitment, placement, performance appraisal, development, motivation
and retention of employees, and for establishing policies and procedures to manage employee/employer
relations. The HR Directorate/Department/ Support Process should be led by a competent individual who
possesses management skills and experience dealing with HR issues. He/she should be a member of the
hospital’s Senior Management Team (SMT). Additional HR staff includes recruitment and promotion,
training and development, employee services and benefits, occupational safety and health, and HRIS.

The HR Directorate/Department/ Support Process should have sufficient space to store personnel files
securely, and should have an area/room where confidential discussions can be held between the HR Head
and individual employees should the need arise.

3.2 Human Resource Policies

The HR Directorate/Department/ Support Process is responsible to establish policies to manage employee

activities and employee/employer relationships. Once developed, these policies should be communicated
to all employees to ensure they are aware of the policies that guide their workday. Policies should be
collated into an ‘Employee Hand Book that is distributed to all

6
existing and new staff. Preferably the Employee Hand Book should be in a ring binder format to allow for
the addition of new policies or insertion of revised policies as the need arises. The Employee Hand Book
should be revised and updated regularly (for example every 3 years).

Policies should address the following areas:

A) Recruitment, Promotion and Transfer Procedures

1) Recruitment: vacancy announcement, screening of applicants
2) Job applicant interviews
3) Reference checks
4) Employment offers
5) New staff induction/Orientation
6) Promotion, secondments and transfers
B) Remuneration/ Compensation, Benefits and Reward
1) Salary scales
2) Salary review policy
3) Paydays
4) Duty/Overtime
5) Salary increment/adjustment
6) Severance pay/lay off/retrenched
7) Services and Benefits
7.1 Types of available benefits
7.2 Eligibility

7
 7.3 Medical and disability payments
7.4 Private wing opportunities
7.5 Staff canteens
7.6 Private wing opportunities
7.7 Transport facilities
C) Occupational health and safety
1) Medical assessment and immunizations
2) Safety risks and protection measures
3) Work-related injuries and compensation policies

D) Work schedule
1) Work days and working hours
2) Overtime and duty work
3) Annual leave, unused leave (carry over)
4) Sick leave
5) Maternity, paternity leave
6) Nuptial leave
7) Exam leave
8) Special leave (with or without pay)

E) Performance Appraisal procedures

1) Performance appraisal process

2) Performance improvement plans

8
 3) Uses of performance evaluation results
4) Recognition/award schemes

F) Training and Development

G) Continuing Professional Development
H) Disciplinary and Grievance procedures
I) Termination of employment (exit interview)
J) Staff Code of Conduct
1) Employee Code of Conduct (see Appendix B)
2) Employee rights and responsibilities (See Appendix C)
3) Timekeeping
4) Dress code (ID badges and uniform to be worn at all times)
5) Smoking policy (not permitted on hospital premises)
6) Use of alcohol, chat or other substances (not permitted in hospital premises, employee
should not be under the influence when attending for duty)

7) Mobile phone use (no personal calls while on duty or with patients)
8) Photography, video camera, audio-recording (not permitted without permission of
management and patient)

9) Gift policy (personal gifts should not be accepted from patients or caregivers since this
could be interpreted as an attempt to gain preferential favour. If a patient wishes to offer a
gift he/she should be encouraged to make a donation for the benefit of the whole hospital
or staff, e.g. a financial or equipment donation after care has been completed.)

9
3.3 Human Resource Acquisition Plan

Human resource acquisition planning enables the hospital to forecast its human resource needs, to
acquire human resources in the right number and type, and to develop and properly utilize available
resources.

All hospitals should have a human resource acquisition plan which is the foundation for the recruitment
and placement of staff both in the short term and long term. The human resource acquisition plan should
give due consideration to skill mix, competence and staff adequacy, and should be developed taking into
consideration the hospital’s ‘Essential Services Package’ (See Section 3.6 of Chapter 1 Hospital
Leadership and Governance), WHO and FMHACA standards.

Steps to develop a human resource acquisition plan:

Step 1: Define the Essential Services Package (See Section 3.6 of Chapter 1 Hospital Leadership
and Governance).

Step 2: Estimate patient load based on past trends of utilization and, for new services, estimatedneed for
the service

Step 3 Identify any plans to ‘outsource’ non-clinical services and/or to clinical serviceareas

Step 4: Determine ‘ideal’ skill mix and minimum staff to patient ratios or minimum staffnumbers in each
service area

Step 5: Compare current staff pattern with ‘ideal’ staff pattern and identify the gaps

Step 7: Describe actions to address the gaps, for example:

 Training of current staff

 Transfer/reassignment/lay-offs of existing staff to better match ‘ideal workforce’

 Recruitment of new staff: number, type

 Revision of organizational structure, if necessary

10
Step 8: Estimate budget for implementation of the HR acquisition plan. Budget should includesalaries,
and all corresponding benefits and allowances.

A sample data collection tools that can be used develop the human resource acquisition plan are
presented in Appendix A.

Figure 1: Human Resource Planning Model

SUPPLY ANALYSIS

 Workforce analysis and trends

 Employee knowledge, skills, SOLUTION ANALYSIS
abilities GAP ANALYSIS
 Planning workforce
 Workforce demographics  Comparison of current transition
 Current Workload Analysis workforce skills with  Employee development
future needs and re-training
 Analysis of how workforce  Changes in staffing
DEMAND ANALYSIS demographics will change patterns
 Identification of areas in  Determine budget needs
 Workforce knowledge, skills, which management action
abilities to meet project need will be needed to reach
 Staffing patterns workforce objectives
 Anticipated program and
workload changes

Source: Adapted from: ww.hhs.gov/ohr/workforce/wfpmodel.gif.

The human resource acquisition plan and budget should be approved by the hospital SMT and should be
updated annually. The human resource acquisition plan should be the foundation for the hire of new staff
or transfer of a staff member from one service area to another. New employees may be hired to fill gaps in
the workforce or to fill vacancies that arise due to employee resignation or retirement.

3.4 Workload Indicators of Staffing Need (WISN)

Hospitals can use Workload Indicators of Staffing Need (WISN) to determine their staff requirements.
The WISN method is a human resource management tool that calculates a staff

11
requirement based on workload for a particular staff category and type of health facility. Thistool can
be applied nationally, regionally, or only for a single health facility or even a unit/ward at a hospital,
provided relevant service statistics are available.

The steps of the WISN method are:

i. Determining the priority cadre(s) and work unit/service area(s) for applying the WISN
method.
ii. Estimating available working time, defined as the time a health worker has available in
one year to do their work, given authorized and unauthorized absences for leave,
sickness, and so on.
iii. Defining workload components, consisting of both health service activities and those
supporting these activities (such as recording, reporting, and management meetings).
iv. Setting activity standards, defined as the time necessary to perform an activity to
acceptable professional standards in the local circumstances.
v. Establishing standard workloads (that is, the amount of work within a health service
component that one health worker can do in a year).
vi. Calculating allowance factors in order to take account of the staff requirement of support
activities performed by all or some of the staff for which there are no service statistics.
vii. Determining staff requirements based on WISN by calculating the total staff required to
cover both health service activities and activities supporting the services.
viii. Analyzing and interpreting the WISN results.

An analysis of WISN results provides two different measures: (1) the difference between current and
required number of staff, and (2) the WISN ratio (current staff divided by required staff).The WISN ratio
is a proxy measure for the daily workload pressure on the staff. Examining both the gap or excess in
staffing and the WISN ratio is important in determining how to improve staffing equity; a staffing gap of
the same size has a much bigger impact on workload stress in a health facility with only a few staff than
in one with a large staff.

Illustrations of the Steps of WISN Method

Step I. Determining Priority Cadre(s)

1. List all work units/ service areas and the main staff categories working in the hospital

2. Determine which staff categories/ cadres have most difficult staffing problems cadres
3. Decide which staff category (or categories) should have highest priority 17-9

4. If sufficient resources are available, incorporate the second and the third highest priorities
in the WISN process
 Step II: Estimating Available Working Time

Available working time (AWT): The time a health worker has available in one year to do his orher
work, taking into account authorized and unauthorized absences.

S. Category Average Weeks Average days in Average Hours

N. in
one year in one year
one year
1 Working weeks, days and 52 260 2080
hours in one year
2 Annual leave 3.6 25 200
3 Sick leave 2.1 15 120
4 Public holidays 1.7 12 96
6 Other leaves (training, personal 2. 15 120
1
leave)
7 Maternity leave 1.4 10 80
8 Weeks, days & hrs. not Worked 11 67 616
in one year
9 Available Working 41 193 1544
Weeks, Days & Hours in one
year

*Available working days per year = 52 weeks in a year – (public holidays + annual leave + sickleave +
other leave). This applies for doctors, nurses and midwives and other health workforces.

*Available working hours per year = available working days per year x number of working hoursin a day.

Step III: Defining workload components

Workload Components:

1. Health service activities: Performed by all members of the staff category & Regular statistics are collected
on them
2. Support activities: Performed by all members of the cadre, but regular statistics are not collected on them
3. Additional activities: Performed only by certain (not all) members of the cadre Regular statistics are not
collected on them
 The workload components that the hospital define should be the most important activities in a health
workers daily schedule. Each component has its own, separate demand for time. For example, antenatal
care and deliveries are two different workload components of a health centre midwife. Each requires a
certain portion of the midwife’s time, because she cannot provide antenatal care while attending to a
delivery. This is why each important workload component must be listed separately.

Table: Example of Defining Workload Components

Staff category: Midwife in x Hospital

Workload group Workload component
Health service activities of all midwives Antenatal care
Postnatal care (including care of a newborn)
Deliveries
Family planning
Support activities of all midwives Recording and reporting

Meetings
Additional activities of certain midwives Supervision of midwifery students
Attending continuing education sessions
General administration

Step 4: Setting activity standards

Types of Activity Standards:

1. Service Standards: A service standard is an activity standard for health service activities
2. Allowance Standards: Performed by all members of the cadre, but regular statistics are not
collected on them
 Service standards and allowance standards must be considered separately, because they will beused
differently in calculating the final staff requirement based on WISN.

4.1 How to Calculate Service Standards for health service activities

A service standard is an activity standard for health service activities, this can be expressed intwo
ways, as a unit time or as rate of working.

A) Unit time: This is the average time that a health worker needs to perform the activity

E.g. Service standards for antenatal care by a health centre midwife can be shown as“10
minutes per pregnant woman”

B) Rate of Working: This is the average number of activities completed within a defined
time period.
E.g. Service standards for antenatal care by a health centre midwife can be expressed as“18
pregnant women seen during a three-hour antenatal clinic”

Example of setting service standards

Staff Category: Midwife in X Hospital

Health service activity Unit time or rate of working
Antenatal care 20 minutes per client
Postnatal care (including care of newborns) 6 clients in a 4-hour postnatal clinic
Deliveries 8 hours per client
Family planning 30 minutes per client

4.2 Allowance standards for support activities and additional activities

An allowance standard is an activity standard for support and additional activities. There are two types of
allowance standards: Category allowance standards (CAS) and individual allowance standards (IAS)

A) Category allowance standards: are determined for support activities that all members of a
staff category perform.
E.g. all midwifes in a hospital spend time in recording and reporting
 B) Individual allowance standards (IAS) are set for additional activities that only certain
cadre members perform.
E.g. only two hospital midwives spend time supervising midwifery students.

Category Allowance Standards can be expressed either as actual working time or as a percentage of
working time. For example, an allowance standard for “recording and reporting” can be shown
either as “one hour per working day” or as“14% of working time.

Individual Allowance Standards: to calculate how much time the additional activities of certainstaff
members require.

 Write down the number of staff members who perform each activity and the time it
takes them.
 Multiply the number of staff members by the time the activity requires in one year

 Do this for each workload component.

 Add the results together to calculate the total individual allowance standard (IAS) in a
year.
Step 5: Establishing standard workloads

Example of standard workload calculation

Staff Category: Midwife

Available Work Time (AWT) in a Year:
1544
Health Service Activity Unit Time or Rate of Standard Work Load

Working
Antenatal care 20 minutes per client 4632 clients (1544 x 3)
(equivalent to 3 clients per
hour, or 60 / 20)
Postnatal care 6 clients in a four-hour postnatal 2316 clients (1544 x 1.5)
(includingcare of clinic (equivalent to
newborns) 1.5 clients per hour, or 6 / 4)
Deliveries 8 hours per client 193 clients (1544 / 8)
Family planning 30 minutes per client 3088 clients (1544 x 2)
(equivalent to 2 clients per
hour, or 60 / 30)

A standard workload is the amount of work within a health service workload component that one health
worker can do in a year. The formula to calculate a standard workload depends on whether the service
standard is expressed as unit time or as rate of working.

Use this formula when the service standard is shown as unit time:

Standard workload = AWT in a year divided by unit time

Use this formula when the service standard is expressed as rate of working:

Standard workload = AWT in a year multiplied by rate of working.

Step 6: Calculating allowance factors
Having established standard workloads will help the hospital management to know how much work a
health worker can do in a year within all health service activities. These are the workload components for
which routine statistics are collected and available annually. But health workers are also required to
undertake other important activities for which routine data are not collected. These are the support and
additional activities of health workers. The following calculation shows how to take account of the
time that such activities take.

To take into account the two types of allowance standards calculated in step 4 (Category allowance
standards & Individual allowance standards) the hospital management need to convert the allowance
standards into allowance factors as follows.

The category allowance factor (CAF) is a multiplier that is used to calculate the total number of health
workers required for both health service and support activities.

CAF= 1/[1-(Total CAS/100)]

The individual allowance factor (IAF) is the staff requirement to cover additional activities of certain
cadre members of activity group. The IAF shows how many full-time equivalent staff members (or what
proportion of such a staff member time) are needed to cover the time commitment of certain cadre
members to additional activities. The IAF is not a multiplier. Instead, it is added to the total required
number of staff members in the final WISN step.

IAF = annual total individual allowance standard (IAS) divided by the available
Working time (AWT)
Step7. Determining staff requirements based on WISN

To determine how many health workers are required to cope with all the workload components of your
WISN cadre(s) we need the annual service statistics for the previous year. We need these data for each
health service activity for which a standard workload is calculated. The total required number of staffs
must be calculated separately for the three different workload groups

Health service activities: Divide a health facility’s annual workload for each workload component (from
annual service statistics) by its respective standard workload. This gives the
number of health workers that is required for the activity in this health facility. By Adding the
requirements of all workload components together we will get is the total staff requirement for all
health service activities.

Support activities: done by all members of the staff category can be calculated by multiplying the staff
requirement of health service activities by the category allowance factor. This gives the number of health
workers required for all health service activities and support activities.

Additional activities of certain cadre members: Add the individual allowance factor to the
above staff requirement.

Components of workload Activity standards Standard workload

Outpatients 10 minutes/patient 11,232 patients/year

Home visits 12 minutes/visit 9,360 homes/year
Category allowance

Standard
Travelling 1.5 hours/day 18.75 per cent
Individual allowance

Standard
Administration, 1 CHW 15 per cent 15 per cent

Step 8: Analyzing and interpreting WISN results

The WISN results are analyzed in two ways. The first analysis looks at the difference between the
current and required number of staff. The second analysis examines the ratio of these two numbers. The
two analyses will help to examine different aspects of the staffing situation in a given facility

Difference: By comparing the difference between current and required staffing levels, we can identify the
health facilities that are relatively understaffed or overstaffed.
3.5 Employee Job Description

Job description is a short statement that includes information about an employee’s assigned duties or
responsibilities. It details the position’s objectives, the skills, training and education necessary to perform
the position. These statements define the performance standards or obligation of the employee to the
health facility. For the health facility, a job description defines the type of employee desired for the
position and what is expected of the employee. It provides the facility with guidance for hiring, salary
structure, performance appraisal and supervision.

A job description should be developed for every position in the hospital. Template job descriptions may
be available from the FMOH or Regional Health Bureaus (RHBs). However, each hospital should adapt
these job descriptions to reflect the hospital’s needs and to define the duties and responsibilities of the
position. Job descriptions should be developed in collaboration with the Human Resources Department
and head of the department/case team in which the position is located. The job description should be
explained to each new employee when he/she commences employment and he/she should sign on the job
description to indicate their understanding of and agreement with the duties and responsibilities therein.

Two copies of the job description should be prepared. The first copy should be kept by the post holder
and the second copy should be filed in his/her personnel file.

The job description should be kept under review and amended if the need arises, for example if duties or
supervisory responsibilities are added to or removed from the post. At the time of Performance Based
Evaluation (PBE), the employee and supervisor should consider whether the job description is still an
accurate description of the post and should amend if necessary.

If an employee is promoted or transferred to another position then a new job description should be given
and signed for the new position. The date on the new job description will indicate the date at which the
employee changed position.

A job description should contain the following components:

Job Title: The title of the position

Reporting to: The position of the immediate supervisor to whom the post

holder will report

Department: The department within which the position is located

Full-time, part-time, contract, consultancy, temporary

Employment type:
position, or otherwise.

Job Summary: Provides a 2-3 sentence description of the job

Essential Duties and A detailed explanation of the position’s tasks

Responsibilities:

Supervisory
responsibilities: Statement that outlines which staff will be supervised by the
post holder, and the specific tasks associated with
supervision (e.g. conduct PBE etc)
Educational
The minimum educational requirement for the position
Qualifications

Certificates, Licenses, All minimum required credentials and equivalents should be

Registrations: outlined here.

Experience The minimum work experience required for the position

Other required skills Any other required skills/competence. For example language
skills, IT skills, mathematical or statistical skills; reasoning
skills (such as ability to define problems, collect data,
establish facts, and draw valid conclusions) planning and
organization skills etc

Physical Demands If the position requires heavy lifting, high level of physical
activity, or exposure to natural elements such as outdoors in
weather conditions, it should be noted here.
Description of job site This contains specific information about the work
and work environment environment, including a description of surrounding areas,
building layout, and other information relevant to the work
atmosphere including environmental hazards.

Occupational Exposure If the employee will be exposed to a known risk for an

extended period of time, it should be noted on the job
description.

Salary and Benefits The specific salary or salary range. This information may or
may not be included in the job description. Instead, a
hospital may use a job-grade system, which rates each job
and assigns a job grade number that correlates to a wage
range.
Employee Name and
Signature

Date

A sample Job Description for the position of Laboratory Technologist is presented in Appendix D.

3.6 Recruitment
Recruitment involves searching for and attracting prospective employees, either from outside or inside of
the hospital. The Federal and Regional Civil Service Proclamations and Directives establish criteria for
recruitment as follows:

The candidate should have no prior criminal record,

No one terminated for a disciplinary offence can be rehired by a public facility within
five years,

Preferential consideration should be given to female candidates, candidates with

disabilities, and members of nationalities/ethnicities comparatively less represented in the
 hospital, having equal or not more than 3% score (if the difference is 3%) to other
candidates, and

Candidates should not be discriminated against on the grounds of ethnic origin, religion,
political outlook, disability, sex, HIV/AIDS status or any other grounds.

3.6.1 Recruiting and Staff Request Procedures

To fill a vacant position the Head of the requesting department or work unit and the HRDepartment should
follow the following steps.

 Departments/work units fill staff request/recruitment form and submit to HR

Directorate/Department/Support Process.
 HR Management Directorate/Department/Support Process check the availability of
approved and budgeted position/s
 HR and requesting department review the qualification requirements of the vacant
position/s
 The job description for the post should be reviewed by the requesting department/work
unit and the HR Department to confirm that it is still suitable for the position.
Amendments should be made if necessary.
 HR Management Directorate/Department/Support Process advertise the vacant position/s
A sample Personnel Recruiting and Posting Request Form is presented in Appendix E.

3.6.2 Vacancy Announcement

A job announcement should be made for any vacancies that arise stating as a minimum:

 name and address of the hospital

 place of work and department

 position, grade and salary

 number of vacant positions to be filled

  minimum qualification requirements for the position

 knowledge, skills, competence and other essential requirements

 specification of documents that should be submitted

 nature of the work including travel, duty or overtime requirements if relevant

 application closing date and time

 Place where candidates can get more information about the position and from where they
can collect an application form.

Ethiopian Federal Civil Service Directives specify that for positions up to grade VIII and below hospitals
can advertise external recruitment in their premises or notice boards. However, the hospital can advertise
these vacant positions through the mass media to attract adequate pool of applicants. For grade IX and
above positions the vacancy position announcement should always be posted externally through mass
media outlets such as newspapers, television, internet etc. (NB: internal candidates may still apply but
will be screened and assessed against the same criteria as external candidates).

A sample Vacancy Notice Form is presented in Appendix F.

3.6.3 Application process

A standardized application form should be completed by all applicants for the position. The form should
include candidate’s personal information, education, language proficiency, training, work history, and
licenses (if required). A sample Application Form is presented in Appendix G.

3.6.4 Selection process

A selection team should be established to shortlist candidates. The procedures may have slight differences
between regions but according to the federal recruitment and promotion directives the selection team
members include:

 Head of the directorate/department/ Case Team where the post will be located (Chair)
 HR directorate/department/support process Head or Representative

 HR Professional assigned by HR directorate/department/support process (Secretary)

The selection team should screen all applications and to assess whether candidates fulfil essential and
desirable qualifications and experience that are described in the vacancy announcement. Candidates that
best meet the criteria should be invited for interview and or written exam/practical test.

NB: Federal Civil Service Directives specify that at least three candidates must compete for a vacancy
before a final candidate is selected unless the hospital can evidence that the level of professional skills
and training required are scarce in the market, in which case, less than three candidates may be allowed to
enter into competition. It may be necessary to advertise the position for a second time, or more widely, if
there are insufficient applicants following the first vacancy announcement.

3.6.5 Competitive Assessment

Short listed candidates should be assessed against each other by interview. The hospital may also conduct
a written examination or practical test for positions that require technical knowledge andskills.

Interviews should be conducted by the selection team. The role of each interviewer should vary. For
example, the immediate supervisor should evaluate the candidate’s technical knowledge while the HR
representative should investigate more general skills and behaviours.

The following techniques may be useful for the interviewers when conducting an interview:

 Be familiar with the job description,

 Ask the applicant questions that draw information from him/her

 Describe hypothetical situations that might occur on the job and ask how they would handle
them
 Use how, what, why and when questions as open ended questions that elicit answers that
reveal the candidate’s interests, attitudes and approach to work
 Describe the job, and

 Answer any questions the applicant may have

A scoring system and comparative assessment form may be used to compare candidates and toselect
the top applicant. A sample Candidate Assessment Form is given in Appendix H.
All candidates should be notified of the outcome of their interviews/written exams/practical test by the
HR Department in as short a time as possible, ideally no more than 5-10 days following interview/written
exams/practical test. At the time of interview candidates should be informed both how and when they will
be notified their results.

3.6.6 Reference Checking

Prior to employment the credentials and employment history of the selected candidate should be verified.
The candidate should submit original ESLCE/certificate/diploma/degree documents (as appropriate) for
verification by the HR department. Photocopies of the original(s) should be taken and filed in the
employee file. A minimum of two professional work references should be obtained. References can be
verified by telephone or in writing. A standardized form should be used to obtain references. A sample
Reference Check Form is given in Appendix I.

3.6.7 Appointment and Probation

Prior to appointment the candidate should submit a medical certificate (except HIV test) to demonstrate
his/her fitness for service. The assessment for the medical certificate can be done either at the hiring
Hospital or at another health facility. The medical certificate should include a history of any current or
previous illnesses and a full physical examination. The candidate should also provide written testimony
from policy to prove that he/she does not have a criminal record. A clearance letter from the previous
employer should also be submitted.

The first six months of employment of any new employee will be a probationary period. A probation
period appointment letter should be issued to the selected candidate. This letter should stipulate, at
minimum, the following:

 employee name

 position and department/case team where located

 position identification number

 salary and benefits

 job grade

 starting date
  employment status: temporary or permanent

 full time or part time position

A copy of the job description should be included with the letter.

At the end of the six months a performance evaluation should be conducted. If the performance of the
employee in probation period is satisfactory, a letter of permanent employment should be issued. If the
evaluation is unsatisfactory, the employee should be instructed on his/her shortcomings and provided with
training/orientation as necessary. The probation period can be extended for a further three months. If the
work performance remains unsatisfactory the employment can be terminated.

3.6.8 Promotion

In accordance with federal and regional directives, hospitals should consider employees for promotion.
The hospital should post an internal vacancy announcement for each post that may be filled by promotion
of an internal candidate. The vacancy notice should describe the post and essential education, work
experience, knowledge and skills required. A ‘promotion selection team’ should be established to review
all applicants for promotion. The procedures may have slight differences between regions but according
to the federal recruitment and promotion directives the team should be comprised of;

1. Head of the directorate/department/ Case Team where the post will be located (Chair)

2. HR directorate/department/support process Head or Representative

3. HR Professional assigned by HR directorate/department/support process (Secretary)

The following criteria should be considered when assessing a candidate(s) for promotion:

1. Permanent employee who has completed his/her probation period

2. Should fulfil the essential qualification requirements for the vacant position

3. Must have attained a satisfactory or above performance evaluation result in 2 subsequent

performance appraisal.
 4. Must not be under any current rigorous disciplinary measure (for example demotion or
salary suspension)
5. Should be no less than 3 months before retirement age.

Health Professionals career promotion should follow the health professionals career ladder andqualification
requirement procedures.

3.6.9 Transfers

An employee may be transferred from one position to another of similar grade and salary whenthe need
arises. Employees may be transferred when:

1. An emergency situation arises and there is a need to fill any gaps in a service. This is a
temporary transfer and should not last more than a year
2. An employee has been deemed unfit to carry the functions of his current post by a
medical authority
3. The current position of an employee has been abolished

An employee may also be transferred from one government institution to another when needed and upon
agreement of the employee, recipient and sender institutions. The transfer of the employee should be to a
position of equal grade and salary as their current position.

3.7 Orientation
3.7.1 New Hire Orientation/Induction
New-hire orientation training should be provided to all new employees (see Table 1 below). The
orientation provides information about the hospital’s mission, vision and values – and helps build the
employee’s sense of identification with the organization. The orientation enables the new employee to
become familiar with the entire organization as well as his/her own work area and department. The
orientation should include an overview of the job expectations and performance skills needed to perform
the job functions and an explanation of reporting structures and mechanisms. The Employee Code of
Conduct and Statement of Employee Rights and Responsibilities should be introduced to the worker at
this stage (see Appendices B and C). Training should also be provided on any equipment or specific
documents/forms that are used in the position.
A copy of the Employee Hand Book should be given to the employee when his/her employment begins
and he/she should be given opportunity to raise questions or discuss this with his/her supervisor or the HR
Directorate/Department/Support Process during the time of orientation.

Table 1 New Hire Orientation

Hospital-  Overview of the hospital

wide o Mission, vision and core values of the facility
information
o Services offered

o Organizational structure

o Hospital layout

 General overview of each department’s functions

 HR policies, including benefits

 Safety guidelines (e.g., standard precautions, fire safety, and

disaster preparedness plan)
 Performance Appraisal Procedures

 Employee Code of Conduct

 Employee Rights and Responsibilities

Job specific  Specific responsibilities of their job (job description)

 Performance expectations

 Reporting mechanisms

3.7.2 In-service/Refresher Orientation

In addition to orientation for new employees, the HR Case Team should also provide recurring
orientations to all staff in order to:

 orient existing staff who may not have received new hire orientations

 introduce new HR policies and procedures to staff

  provide employees with a forum to discuss issues with the HR department

Hospitals should provide updated orientations to all staff at least once a year. The training should be on
site, and preferably should not exceed one day in duration. The orientation should cover both general HR
policies and department specific policies and hence may be provided on a Case Team by Case Team
basis. It may be necessary to provide the orientation on more than one occasion to ensure that all staff can
participate.

3.8 Salary and benefits

An important component of Human Resources for the hospital is effective remuneration administration.
While the hospital may be required to work within government-directed protocols and/or regulations for
salaries and fringe benefits, the compensation system will directly affect the organization’s ability to
attract and retain quailed employees.

3.8.1 Compensation system factors

Equity in pay between jobs is the foundation of a sound compensation system. This involves
consideration of three factors:

1. Internal equity: How does the pay of various jobs compare? What should a nurse
earn compared to a dietary worker or physician? To achieve internal equity, job
requirements must be identified and their complexity evaluated. This evaluation can
be reduced to a numerical factor or rating, so that jobs can be compared.

2. External equity: How does the hospital’s pay for jobs compare with that at a
competing organization? As supply and demand affects the marketplace for workers,
external equity becomes more important. Shortages of a certain type of staff can
create “wage wars.”

3. Philosophy: How does the hospital see itself as an employer – one that targets its
wages at the midpoint of the market so that it stays competitive in the marketplace or
one that targets its wages near the top of the market so it can attract the best
candidates?
3.8.2 Benefits

In addition to the basic salary, employees may be provided with additional benefits as determined by
hospital management. Benefits may be in the form of medical benefits, pension, housing, vehicles,
vacations, holidays, or sick time. These forms of compensation add to the overall cost of labour for the
hospital, so decisions regarding fringe benefits must be evaluated to maximize employee satisfaction and
minimize costs.

Some benefits will be common to all employees (e.g. medical benefit). In addition to these
universal benefits, hospitals should seek to develop and implement a benefit system that:

 Motivates staff to improve performance,

 Incentivizes staff to remain with the hospital, and

 Attracts new employees to the hospital.

Benefits that hospitals may consider include:

1) Medical benefit

2) Pension

3) ‘Top up’ allowance: This is particularly useful to attract skilled employees to remote
locations where the living conditions are less convenient than in larger towns.

4) Housing allowance: as above.

5) Transport allowance: as above

6) Duty allowance: Payments made for employees who work evening or night hours
7) Risk and Hazard allowance: A specified amount of money to be paid to employees whose
positions expose them to risks. For example, an incinerator operator or X-ray technician.

8) Telephone allowance: allowance given to employees (senior positions) for work related calls
made outside of working hours or when using personal telephone.

9) Travel allowance: allowance given to employees who use a non-hospital vehicle for transport
to work-related activity.

10) Uniforms allowance: provision of uniforms to employees in accordance with the Federal
Civil Service directive

11) Bereavement allowance: payment given to the family if an employee dies.

12) Training opportunities/allowance: The hospital should ensure that all workers have the skills,
knowledge and competence to perform their required duties and should provide all necessary
trainings to ensure that essential job functions can be fulfilled. However in addition to this,
hospitals may give opportunities for staff to participate in additional ‘career development’
trainings that will enhance their opportunities for promotion within the hospital, or enhance
their chance to obtain a higher position within another organization in the course of time.
Training may be provided ‘in house’ or by an external agency (either on-site or off-site).

13) Participation in private wing activities: Staff who provide services in a private wing are
entitled to a share of the profit made by the service. The opportunity to participate in private
wing activities may be offered preferentially to candidates with good work performance and
acts an incentive for employees to improve their performance. (For more information about
private wing establishment and activities please see Chapter 10 Financial Management).

14) Access to recreational services such as:

a. Cafeteria

b. Break room (equipped with a television and other recreational equipment)

c. Green area

d. Library (equipped with books and computers with internet connectivity)

e. Quiet rooms for prayer (multi-purpose prayer room)

15) Rewards for high performers (see section 3.10.4 Employee Recognition)

3.9 Performance Management

Performance management is an on-going process focused on reinforcing high performance or improving
substandard performance to enhance the knowledge, skills and behaviors of all employees in order to
achieve organizational goals. Performance management has three main components: supportive
supervision, performance-based evaluation and performance improvement.
3.9.1 Supportive Supervision
Supportive supervision is a continuous and participatory process, where a supervisor or manager accepts
shared responsibility for an employee’s professional development in order to get the best possible
performance from the employee. Performance can be enhanced through managers working directly with
their staff to set clear goals, standards and expectations. This includes mentoring staff, providing
constructive feedback and open and two-way communication.

The intended result of supportive supervision is that employees develop a supportive link with their
supervisors, marked by open communication to address concerns and share ideas. There should be a
process for mentoring and coaching staff, including developing performance plans inadvance so that there
is clarity in terms of job/performance expectations; a feedback mechanism on performance; and support
for staff through training or skill development, as needed. In order to achieve this, the hospital should
prepare a supervision policy, which clearly spells out procedures, rules, responsibilities and authority of
managers.

3.9.2 Performance Based Evaluation

Performance-based evaluation (PBE) is the practice of periodic review and evaluation of an individual’s
or team’s performance against specified goals or expectations. The first step in performance evaluation is
to determine the performance objectives of each employee. The goals and expectations may be described
in an individual’s job description. Alternatively, goals and expectations may be described in an alternative
performance framework - for example the ‘Balanced Scorecard’ (see Chapter 13 Monitoring and
Reporting) - and an individual or team may undergo evaluation against these criteria. The advantage of
the Balanced Scorecard approach is that the hospital’s vision, mission and plans can be cascaded down to
department/team level and subsequently to the level of the individual, ensuring that individual and team
actions contribute to the overall goals of the hospital. Whichever performance criteria are used, there must
be a clear understanding from the outset between the supervisor andindividual/team on the specific goals
and expectations that the employee(s) will be evaluated against. In PBE the supervisor assesses how well
the individual is fulfilling the roles and responsibilities outlined in his/her performance plan (i.e. job
description, and/or BSC) and
whether remedial action is necessary. A sample job description and related PBE framework are presented
in Appendices D and J.

Performance evaluation should be conducted by the immediate supervisor of each employee. PBE
should be conducted at the end of the probation period and semi-annually thereafter, or more
frequently if poor performance is identified and corrective action is necessary.

To be effective, PBE must be linked to both positive reinforcement (recognition, benefits or rewards) for
good performance and to performance improvement processes when areas of poor performance are
identified.

Positive reinforcement

Employees who obtain a satisfactory or above satisfactory result on performance evaluation are entitled to
a periodic salary increment as specified in Federal/Regional Civil Service Legislation. Additionally,
hospitals should devise rewards for good performance such as ‘Employee of the Month’ recognition, or
opportunities for further training or participation in Private Wing activities for those employees who
demonstrate good performance. For further discussion onstaff motivation and benefits see Section 3.10
below.

3.9.3 Performance Improvement Process (PIP)

The Performance Improvement Process is designed to identify, communicate, and intervene when job
performance is below expected standards. Performance improvement interventions should be initiated as
soon as it becomes apparent that an employee is not meeting expected performance standards.
Supervisors should not wait until the end of the review period to communicate the need to improve
performance if the need to improve is identified earlier in the period.

Performance improvement should begin with coaching/counselling or specific training to address

identified gaps, and should proceed to more formal oral or written warnings if performance does not
improve as a result. Finally, where performance does not improve despite remedial action, it may be
necessary to terminate the employment of the individual. The duration of each step of the Performance
Improvement Process (Coaching/Counselling, Oral Warning, and Written Warning)
will vary depending on the performance issue and on the employee's progress. Normally, each step would
last from 30 to 90 days. No matter what the stated duration of the step, additional action may be taken
before the stated end of the step if the performance continues to decline noticeably or the employee does
not make a good faith effort to meet expectations. By acting promptly and decisively, the organization can
avoid long-term problems.

Coaching and Counseling

In many cases, informal coaching and counseling will be all that is necessary to facilitate improved
performance. The objective of coaching is to help the employee recognize – and solve

– the problem early on. When a problem occurs or begins to develop regarding work
performance, the supervisor should discuss the situation with the employee before it becomes
serious. During such a discussion, the supervisor should explain exactly what the performance
expectation is and specifically how the employee is failing to meet it. Once the employee agrees
(or at least understands) that he or she is accountable for meeting expectations, the employee and
supervisor should jointly explore steps the employee might take to ensure he or she meets
expectations in the future. Ideally, the employee and supervisor will agree on the approach that
will be taken to solve the problem. If agreement cannot be reached, it is the supervisor’s
responsibility to ensure that the employee understands what he or she must do to solve the
problem and the consequences for the employee if the problem is not resolved. The supervisor
also needs to tell the employee how and when he or she will follow up to provide additional
feedback on progress against the agreement.

If the employee’s performance does not improve with coaching/counseling or it is apparent that the
employee is not sufficiently trying to improve his/her performance then it may be necessary to take
Disciplinary Action as described in Section 3.10.5 below.

In all cases of poor performance, the supervisor should consult with the HR Department and other senior
management as necessary for advice and decision making about any actions necessary.

All PBE results and any Performance Improvement measures should be documented in the employee
personnel file for follow up and future reference.

A sample Performance Improvement Process Form is presented in Appendix K.

3.10 Training and development
Federal Legislation stipulates that all public hospital employees are entitled to training to improve his/her
capability, or prepare him/her for increased responsibility based on career development. Staff training
includes both short and long-term training and educational opportunities.

Staff training benefits the hospital by:

Creating a pool of readily available and adequate replacements for personnel who may
leave or move up in the organization
Ensuring adequate human resources for expansion into new programs

Enhancing the hospital's ability to adopt and use advances in technology because of a
sufficiently knowledgeable staff
Improving staff morale which in turn enhances performance and reduces employee
turnover
Attracting staff to the facility

Reducing the need for supervision

Plans for staff training should be included in the human resource development plan. Training plans should
take into consideration the needs of the organization as a whole and the needs of individual workers. The
HR department should conduct a training needs assessment to identify:

Knowledge, Skills and attitude gaps

Performance gaps at institution, work unit and individual levels

Who needs to be trained? (All staff, selected departments/case teams?)

What types of trainings should be offered to staff?

The hospital’s training plan should also include an estimate of cost and budget needs. The HR department
should communicate budget needs to the SMT to ensure that budget is secured for planned training needs.
The frequency of training programs should be based on the level of need and the level of importance to
improving performance or quality of care. For example, infection
prevention and nursing process trainings could be conducted at least 2-3 times a year, as both arekey areas
relating to patient outcomes. In addition to trainings that improve employees’ technical skills, the hospital
should also organize trainings to develop the management skills of employees.

All trainings can be provided either ‘in house’ or through external trainings. Clear selection criteria
should be set to determine who is selected to attend a specific training. This will ensure transparency of
the process and allow for equity in the distribution of trainings among staff.

As part of staff development each hospital should have a core set of trainings that are provided tostaff on
a regular basis. For example, trainings should be provided to all staff on fire safety, the major incident
plan, occupational health and safety risks and infection prevention practices.

The main objective of training is to instil a new or renewed behaviour or practice to a specific area of
work. Therefore, trainings do not end when the training modules conclude but rather when the impact
of the training is assessed and the desired outcome is achieved. All trainings should be evaluated to assess
whether the desired outcomes (knowledge or skills have been achieved) and their impact on employee
performance. If the objectives have not been attained additional training, using different methods may be
necessary.

Staff development (medium- and long-term trainings/education) should be based on workforce plan. Staff
development plans are aimed at creating pool of leadership successors and competent manpower for key
positions.

3.11 Continuing Professional Development (CPD)

FMHACA’s Continuing Professional Development (CPD) Guideline for Health Professionals define
Continuing Professional Development (CPD) ‘as a range of learning activities through which health
professionals maintain and develop throughout their career to ensure that they retain their capacity to
practice safely, effectively and legally within their evolving scope of practice’. This definition emphasizes
the need for health professionals to maintain, update and enhance their knowledge, skills and attitude in
order to adequately deliver quality health care.
Health professionals need to cope up with the changing disease pattern in which diseases that had
been eradicated are now reemerging, as well as an increase on non-communicable diseases. CPD helps to
maintain professional competence in an environment of numerous challenges, rapid organizational
changes, information technology, increasing public expectation and demand for quality and greater
accountability.

CPD is an ethical obligation for all health professionals to ensure their professional practice is up- to-
date and can contribute to improving patient outcomes and quality of care. It is also a mandatory for
health professionals practicing in Ethiopia. Health professionals should accumulate the mandatory credit
hours or certificates of training attendance for relicensing their profession every five years.

According to the FMHACA’s Continuing Professional Development (CPD) Guideline for Health
Professionals, some of the features of CPD applicable to the context of hospitals are:

Continuing professional development refers to all activities health professionals

undertake formally so as to maintain, update and develop their knowledge, skills and
attitudes in response to the health service needs of the public
Continuing professional development denotes to the period of education and training of
health professionals commencing after completion of basic or post graduate health
professional training

Continuing professional development is a broad concept referring to the continuing

development of the multi-faceted competencies inherent in health services covering wider
domains of professionalism needed for high quality professional performance. It aims to
maintain and develop competencies of individual health professionals essential for
meeting the changing needs of patients and the health service system and responding to
the new challenges of scientific development
Continuing professional development must serve the purpose of enhancing the
professional development (what is relevant to current practice and the future profession)
of health professionals
 Continuing professional development should occur when; 1) there is a clear need, 2)
learning is based on the identified need, and 3) there is follow up to reinforce the learning
is accomplished
The challenges or barriers of accessing CPD trainings and activities are costs, time, lack of motivation
or incentives and geographical distances. Hospitals need to recognize the importance of CPD and
enable all health professionals to undertake CPD suitable to their needs and interests by identifying
and tackling the barriers for accessing CPD. Hospitals should:

Looking at barriers and incentives to following CPD, the need for systemic and organizational
support to professionals, in terms of allocating time for CPD in workplace and staff planning and in
ensuring costs of CPD are not prohibitive, is identified as shared responsibility, in which employers,
professional organizations and the ministries of health have a role to play, alongside the professional.
It is also recommended to make use of flexible learning tools and ensure CPD is relevant to health
professionals’ daily practice, soas to improve access and motivation.

1. Undertake CPD need assessment for their workforce and communicate the result to
training or accreditation institutions
2. Allocate CPD time in workplace and staff planning, and avail CPD activities to their
employees CPD activities
3. Make use of flexible learning tools and ensure CPD is relevant to health professionals’
daily practice, so as to improve access and motivation.
4. Ensure costs are not prohibitive for accessing CPD by taking shared responsibilities with
other stakeholder in soliciting fund for their employees’ CPD activities
3.12 Employee Relations

The HR Directorate/Department/Support Process should strive to establish employer-employee

relationships that contribute to satisfactory productivity, motivation and morale. Employee relations are
directed toward preventing and resolving problems involving individuals that arise out of or affect work
situations. The hospital should create conducive work environment and conduct periodic work climate
assessment, and develop work climate improvement plans.
The hospital should provide services for staff including toilets, showers, safe drinking water, a canteen
and library facilities. For further discussion on staff services please see Section 3.2.1 of Chapter 8
Facilities Management.

3.12.1 Employee Code of Conduct and Professional Ethics

Each hospital should devise a set of standards that governs employee conduct and ethics. The standards
should include what is expected from the employee in their work, their interactions with patients,
caregivers, visitor and other staff. These standards/principles should be made known to all employees and
packaged in a code of conduct. A sample of code of conduct is presented in Appendix B. Outlined below
are core areas that should be covered in an employee code of conduct and ethics.

Guidelines for employees to follow when offered gifts: Employees should refuse any gifts, favours or
hospitality that might be interpreted as an attempt to gain preferential treatment, not ask for or accept
loans from anyone under their care or anyone close to them and must establish and actively maintain clear
boundaries at all times with patients, their families and caregivers.

Patient care: Patients have the right to fair and equal access to care from all staff, according to their
needs. All employees should care for all patients equally and without prejudice to age, gender, and
economic, social, political, ethnicity, religious or other status and irrespective of personal circumstances.
They should demonstrate a personal and professional commitment to equality and diversity in caring for
patients and ensure that their professional judgment is not influenced by any commercial or preferential
considerations.

Confidentiality: All patients have the right to expect that any information they disclose in the course if
their care is confidential between themselves and their treatment team. Hospitals should ensure that there
is a written hospital information management policy which sets out how the hospital ensures that
information held by the hospital on patients, their families and staff is handled confidentially.

Respect for persons: Health care practitioners should respect patients as persons, and acknowledge their
intrinsic worth, dignity, and sense of value.
Best interests or well-being: Health care practitioners should not harm or act against the best interests of
patients, even when the interests of the latter conflict with their own self-interest. Health care practitioners
should also act in the best interests of patients even when the interests of the latter conflict with their own
personal self-interest.

Compassion: Health care practitioners should be sensitive to, and empathize with, the individual and
social needs of their patients and seek to create mechanisms for providing comfort and support where
appropriate and possible.

Integrity: Health care practitioners should incorporate these core ethical values and standards as the
foundation for their character and practice as responsible health care professionals.

Tolerance: Health care practitioners should respect the rights of people to have different ethical beliefs as
these may arise from deeply held personal, religious or cultural convictions.

Dress Code and Identification: The Hospital should have guidelines which clearly and strictly define
dress codes for all employees. Such guidelines should explicitly list each article of clothing, the colour,
and condition which is acceptable in hospital settings. The hospital should have colour-coded system–
one which clearly and easily allows patients to distinguish between staff. The hospital should also have a
policy to ensure that all staff wear their identification badges at all times.

Community: Health care practitioners should strive to contribute to the betterment of society in
accordance with their professional abilities and standing in the community.

Professional competence and self-improvement: Health care practitioners should

continuallyendeavour to attain the highest level of knowledge and skills required within their
area of practice.

3.12.2 Employee Motivation

Employees who are motivated tend to work harder and stay longer with their employer. To “motivate” is
to stimulate the employee’s enthusiasm and factors that harness their driving force. What motivates
employees? Each hospital employee brings his/her own personal goals and what they hope to gain. These
might include:
 1) To get a good job and keep it

2) To earn money and help support the family

3) To advance professionally

4) To improve their financial situation

5) To have a job that is pleasant, secure, and offers opportunity for improvement

6) To have fair and consistent supervision – free from discrimination or harassment

7) To receive recognition, praise or other rewards for a job well done

8) To help people and contribute to society

9) To work in a good work environment and

3.12.3 Job satisfaction

Job satisfaction is another component of employee relations. Job satisfaction depends on the employee’s
evaluation of the job and the environment surrounding it. The employee evaluates their actual experience
in the job – remuneration, supervision and the work conditions – when assessing their job satisfaction.

1) Remuneration: Ideally, the compensation for the job should be deemed equitable by
the employees. If, instead, the employee believes the wages paid are substandard in
the market, then the hospital is at risk for unwanted turnover, low staffing ratios,
higher overtime costs and lower productivity by employees.
2) Supervision: Supervision of the employee should be fair and consistent, following
established policies and procedures that are applied consistently across the
organization. The supervisor communicates clearly to the employee the expectations
 for the job and any necessary performance improvements that must be undertaken to
meet expectations.
3) Work conditions: Work conditions relates to the climate in which the work takes place

– do supervisors and co-workers have mutual respect, are there positive interactions, shared
problem solving, investment in improving quality outcomes and an interest in

employee work life quality? Hospitals should provide a safe and comfortable working
environment for staff, including accessible toilets, showers and changing facilities (where
relevant). Staff should also have access to refreshments and meals, to a library with internet
access and to private recreational areas (such as garden or canteen).

3.12.4 Employee Recognition

Staff motivation and performance may be enhanced by a recognition/reward scheme that acknowledges
outstanding individuals or teams.

Employee recognition can be in the form of a certificate or letter from hospital management to the
individual/team, or through an ‘Employee of the Month’ program where the hospital identifies employees
who evidence the hospital’s vision, mission and core principles in their everyday work. Recognition can
also be coupled with a reward (for example additional vacation days, gift, or financial reward). Ideally
recognition should be public, for example announcements could be made in the hospital bulletin or posted
on the hospital notice board etc. In addition, the hospital can also organize all staff gatherings to
recognize the contribution of the entire hospital workforce.

The hospital should set clear criteria for the selection of staff for recognition or reward. The selection and
reward process should be transparent and made known to all staff. Any recognition should be filed in the
employee file as evidence of good performance and should be referenced when evaluating an individual
for further opportunities for advancement and benefits, such as training opportunities.

3.12.5 Health Workforce Productivity

Hospitals should ensure that their health workers perform well and deliver effective, quality health
services to the communities they serve. In addition to developing long-term strategies for increased
motivation and retention of health workers hospitals should also strengthen the productivity and
performance of the workforce so as to get the best possible results and the highest impact with existing
resources. Hospitals expect to conduct workforce productivity measurement, identify the underlying
causes for health workforce productivity problems and potential intervention areas for health workforce
productivity improvements.
 1. How to Measure Health Workforce productivity

Health workforce productivity measures the amount of health services produced by

health workers in a given period of time. While the issue of productivity applies to all levels
of the health system, (i.e., national, regional, zone/Woreda, and facility levels) health
workforce productivity can often be best analyzed and understood at the facility level.

Health workforce productivity is calculated by taking the ratio of the service delivery outputs
produced over the human resource inputs used. The calculation assumes that all other health
systems inputs are constant among the facilities whose health workforce productivity is
being measured.

The denominator, or the human resource inputs in the productivity ratio, is the health
workers’ salary, which represents the time and effort of the health workers who contribute
to health services deliveries in which the productivity ratio measures.

Health workforce productivity can be improved either by increasing outputs for a given
number of inputs or by reducing the use of inputs for a given level of
outputs. Productivity analysis can help inform if the level of outputs is acceptable given the
present input use. If productivity is low, the analysis can help managers and supervisors
identify what they can do to enhance productivity at their health facilities.

Some examples of service delivery areas and the indicators commonly used to represent the
numerator, or service delivery outputs, in the productivity ratio include the following:

Health Service Area Out Put Indicator Weight

Outpatient care Number of outpatient

Consultations
Inpatient care Number of inpatient days
Antenatal care (ANC) Number of ANC consultations
Labor and delivery care Number of institutional
deliveries
Family planning (FP) Number of FP consultations
Child immunizations Number of
immunizations

Administered

(Source: Vujicic, Addai, and Bosomprah 2009,)

To calculate total health workforce productivity, the single health service outputs are combined
into an aggregate output measure. Total service provision is not simply the sum of the
individual services because not all the services are of equal value in terms of time, effort, and
impact. Therefore, weights are assigned to each health service. It is recommend using service
weights that represent the relative human resources costs of producing the services.

Several different categories of health workers contribute to the provision of health services. The
decision of which of the health workers to include in the input calculation should be guided by
the set of health services included in the output calculation. All categories of staff that
contribute to the provision of the
relevant health services should be included in the input calculation. Therefore, typically, it
will be appropriate to include all categories of staff except in rare cases when the service
unit is very narrow (e.g., surgical ward). Staffing categories should be defined according to
the categories used in the unit of analysis. In general, these will include: Medical, Nursing,
Specialties (e.g., surgery), Laboratory, Pharmacy, Diagnostics, Support Staff, and
Administration.

Generally, hospitals can apply the following steps to generate a measure of

workforce productivity
Step 1 – Define the Service Unit

Measuring the Aggregate Facility-level health workforce productivity would be of great interest to
compare the productivity level of all hospitals. In addition to the aggregate health workforce productivity
the facility may decide to measure Special Service Area Productivity Level.

Step 2 – Define the Categories of Health Services to Include as Outputs in the Numerator

In practice, two of the broadest indicators of health care services commonly used to measure aggregate
workforce productivity are inpatient days (IPD) and outpatient visits (OPD). These are often used because
they are comprehensive measures of health care service delivery and are relatively easy to construct from
HMIS databases. In order to measure departmental level/ special service productivity, the availability of
data on the utilization of that specific service shall be considered.

Step 3 – Determine a Method of Aggregating Different Categories of Health Services into a

Composite Service Indicator

A simple method of aggregating health services into a single Composite Service Indicator (CSI) is to
take a weighted sum of the volume of various categories of services produced in a service unit:

Composite Service Indicator= Summation of the volume of service Z in service unit Yx Weight assigned to
service Z

Step 4 – Define the Categories of Human Resources to Include as Inputs in the Denominator
Several different categories of health workers contribute to the provision of health services. All
categories of staff that contribute to the provision of the relevant health services should be
included in the input calculation. Therefore, typically, it will be appropriate to include allcategories of
staff except in rare cases when the service unit is very narrow (e.g. surgical ward). Staffing categories
should be defined according to the categories used in the unit of analysis. Ingeneral, these will include:
Medical, Nursing, Specialties (e.g. surgery), Laboratory, Pharmacy,Diagnostics, Support Staff, and
Administration.

Data Sources and analysis

The data need to measures aggregate productivity as well as especial service productivity shall be
extracted from the routine health management information system. The data for this consist of clinical
service data (i.e. outpatient visits, inpatient days), public health service data (i.e. antenatal care,
supervised delivery, and immunization), and human resource data (i.e. staffing, and wages).

There are several approaches in selecting weights, again with implicit value judgments. Different
weighting schemes have a large impact on the composite service indicator measure of service output as
well as composite staffing indicator measure of service input. Specifically, the relative performance of
facilities will be affected by the choice of weights. Thus, both weighting scheme shall be drawn through a
consultative process involving, clinicians, hospital managers, Quality team, and M&E professionals.

3.12.6 Discipline Management

In cases where an employee demonstrates behavior that is unacceptable or in conflict with the hospital’s
Code of Conduct, or where an employee persistently performs poorly despite opportunities for
improvement, it may be necessary to take disciplinary action. Disciplinary measures should be governed
by two principles:

 the employee must be clearly informed by his/her immediate supervisor as to the source of
dissatisfaction, and
 Except in limited circumstances (such as serious professional misconduct or corruption)
the employee should be given the opportunity to correct the problem. A Disciplinary
Committee should be established to investigate all disciplinary charges and to determine
 the appropriate disciplinary measure. The Committee should be chaired by the HR Department
Head. Additional membership should be determined by the hospital CEO. Each hospital should
establish a Policy for Discipline Management that describes the behaviour or performance issues
for which should be brought to the discipline committee, the range of disciplinary measures, the
process by which disciplinary action is taken and the appeals process by which an employee may
appeal against any disciplinary measures. The Policy should be included in the Employee
Handbook.

Civil Service Regulations stipulate six types of disciplinary measures:

1. Oral warning
2. Written warning
3. Fine up to one month’s salary
4. Fine up to three month’s salary
5. Downgrading of position for up to two years
6. Dismissal
The first three categories are considered as ‘simple disciplinary penalties’ while the latter three categories
are considered as ‘rigorous disciplinary penalties’. Examples of behaviour that might result in a ‘rigorous
disciplinary penalty’ are presented in Appendix L. Evidence of rigorous penalties should remain in the
employee record for 5 years while simple penalties should remain in the employee file for 2 years.

In general, disciplinary action should not come as a surprise to the employee and any concerns

with an employee 17-45

Guidance for Supervisors

It can be very difficult to advise an employee that you have concerns with his/her behavior or
performance. However, to enable the employee to improve it is essential to be honest, frank
and precise about the problem and to be clear about your future expectations of the
employee. Vagueness and generalities, or glossing over the situation, are likely to leave the
employee uneasy and feeling that something is wrong but unable to correct his/her behavior or
performance. Criticism should be related to work related matters only. Wherever possible,
guidance on how to improve should also be given.
performance or behavior should be addressed at an early stage to avoid the need for ‘rigorous’
disciplinary measures. It is the responsibility of the employee’s immediate supervisor to explainto the
employee those areas in which he/she is expected to improve, to make suggestions about how to improve,
and to allow time for the employee to make improvements. It is usually only in instances of serious
misconduct that the more severe penalties, including termination of employment, should be considered.

3.12.7 Grievance Management

A grievance is a concern, problem or complaint that an employee has about his/her job, for example
his/her employment terms and conditions, work environment, contractual or statutory rights or the way
he/she is being treated at work.

Grievances can often be avoided by good communication between employees and senior managers such
that problems are identified and corrective action taken at an early stage. Grievances are more likely
when employees feel that their views are not being heard or their concerns are not being addressed.
Grievances are more likely to be settled when employees perceive that the process is transparent, fair and
without retribution for the employee.

Each hospital should establish a Grievance Policy that describes the steps that could be taken by an
employee should he/she have any concerns or complaints about the work environment or their work
situation. A Grievance Committee should be established that is responsible to investigate employee
complaints about, and make recommendations in relation to:

 Interpretation and implementation of laws and directives

 Protection of rights and benefits

 Occupational health and safety

 Placement and promotion

 Performance appraisal

 Undue influence exerted by supervisors

 Disciplinary measures

 Other issues related to conditions of service

The Grievance Committee should be chaired by the Head of the HR Department, with other
members determined by the CEO.
Any employee with a complaint about their work situation should first try to resolve the issue with their
immediate supervisor. If this is not possible a Grievance Form should be completed and submitted to the
Grievance Committee. A sample Grievance Form is presented in Appendix

M. All grievances should be responded to promptly and a written response should be given to the
complainant following the investigation. A copy of the Grievance Form and written response should be
kept in the employee file.

All grievances should be kept confidential unless required to disclose to senior management or higher
authorities (based on severity).

The HR Department should maintain an anonymous record of Grievances received and should monitor
these on a monthly basis, identifying any trends or common themes that might require further
investigation or action by senior hospital management.

3.12.8 Staff Survey

Each hospital should regularly (for example biannually) conduct a staff survey to assess staff satisfaction
with the workplace and suggestions for improvement. Summary results should be presented to the SMT
and Governing Board.

3.13 HR Audit
A Human Resources Audit is a comprehensive method (or means) to review current human resources
policies, procedures, documentation and systems to identify needs for improvement and enhancement of
the HR function as well as to assess compliance with ever-changing rules and regulations. An Audit
involves systematically reviewing all aspects of human resources, usually in a checklist fashion. The
purpose of an HR Audit is to recognize strengths and identify any needs for improvement in the human
resources function. A properly executed Audit will reveal problem areas and provide recommendations
and suggestions for the remedy of these problems. The hospital is expected to conduct periodic(annually)
HR Audit by establishing an HR Audit committee comprising people from Internal Audit, Legal Service
and HR Department.The areas to be covered by the HR Audit include;

Hiring, promotion and transfer processes

 Compensation and benefits

Performance evaluation process

Medium- and long-term training opportunity processes

Job descriptions

Employee orientations

Safety trainings

Disciple and employee grievance handling processes

Personnel files

Termination process and exit interviews

3.14 Termination of employment
A worker’s employment may end through retirement, resignation, termination by the employer or death.
Whenever an employee leaves the workplace an exit interview should be conducted to gather information
about the employee’s experience and any lessons that could be learned for future employees. A sample
Exit Interview Form is presented in Appendix N. The exit interview should be reviewed by the Head of
HR to identify areas for follow up action, and thereafter should be filed in the employee’s Personnel
Record.

3.15 Personnel Records

For organizational and legal purposes, hospitals should maintain and regularly update a file on each
employee that includes information such as credentials for hiring, ongoing performance evaluations, and
any documentation concerning performance improvement action. Hospitals may need to share employee
data between departments – Nursing and Human Resources, for example

– and files are an ideal way to facilitate this function. Employee files are also the repository of
documents defining the mutual understanding between the employee and employer concerning
workplace policies and performance expectations.
3.15.1 Organization of Personnel Records
Employee Records should be filed by employee name. Within each individual file, papers should be
organized by category - Hiring Documents, New Hire Orientation, Education and Trainings,
Performance Management, Exit of Employment, Other. Within each category, documents should be
organized by date.

Standardized Forms should be used for all documents maintained in each Personnel File, for example
application form, performance evaluation, disciplinary action etc. All forms should include the following
basic information:

 Employee name, position/job title,

 Date of action(s) taken

 What action is being taken, and

 Signatures of all involved, signed when the form is completed.

3.15.2 What to maintain in the Personnel Record
All-important job-related documents should go in the file, including:

1) Hiring documents:

a) job description for the position,

b) job application and/or resume,

c) offer of employment,

d) references checked in the hiring process,

e) any contract, written agreement, receipt, or acknowledgment between the employee and
the employer (such as an employment contract, or an agreement relating to a hospital-
provided car), and
f) Payroll/wage information.

2) New employee orientation:

a) receipt or signed acknowledgment of having received the employee handbook,

b) forms relating to employee benefits,

c) forms providing next of kin and emergency contacts,

d) forms related to beneficiary designation and

e) Documentation of completion of new hire orientation.

3) Growth and development: Any document that evidences an employee’s advancement in

 skills or knowledge should be kept here, for example

a) Record/certificate of all trainings completed

b) Copies of educational program completion (certificates, diplomas or degrees)

4) Performance management and improvement documents:

a) all performance evaluation documents

b) awards or citations for excellent performance

c) recognition letters from patients or caregivers regarding the employee

d) complaints from customers and/or co-workers

e) disciplinary documents

5) Exit of employment: This should contain any documents relating to the worker's
departure from the hospital including:
a) Exit interview

b) Documentation of return of all hospital-issued property or items

6) Other forms that should be maintained in the employee file include:

a) Leave forms (including annual leave, maternity, paternity and sick leave)

b) Health examination forms/fitness for duty verification

c) Disciplinary action

d) Grievances filed

e) Any change or update to employee information

3.15.3 Keeping the Personnel Record Up to Date
The HR Department should periodically review each employee's personnel file to ensure that all
information remains accurate, up to date and complete. For example this could be done when the
employee’s evaluation is conducted. Questions to consider include:

1. Does the file reflect all of the employee's raises, promotions, and commendations?

2. Is there a current copy of the employee’s job description that reflects changes made to
the original job description?
3. Does the file contain every written evaluation of the employee?
 4. Does the file show every warning or other performance improvement/disciplinary
action taken against the employee?

5. If the employee was on a performance improvement plan, a probationary or training

period, or other temporary status, has it ended? Has the file been updated to reflect
the employee's current status?
6. If the employee hand book has been updated since the employee started working for
the hospital, does the file contain a receipt or acknowledgment for the most recent
version?
7. Does the file contain current versions of every contract or other agreement between
the hospital and the employee?

3.15.4 Computerized Personnel Records

Hospitals may choose to install a computerized database to manage selected human resource information
for example employee hire date, transfers, promotions, benefits, annual leave requests and approval etc.
Computerized systems provide easy retrieval of information for audit and planning purposes (for example
calculation of vacancy rates, staff turnover rates, average performance evaluation scores etc). However, if
a computerized system is installed a complete paper-based personnel file should still be maintained for
every employee.

3.15.5 Confidentiality of Personnel Records

Employee records are private and confidential. All employees should have access to their own employee
record, but they cannot add to their employee record without authorization of the HR Department Head.
Employees are not authorized to remove anything from their personnel file, nor should employees be able
to access records other than his/her own. If an employee wants to look at their personnel file, they should
first get permission from the Head of the HR department. The employee should look at the file in the
presence of a representative from the HR department.

3.16 Occupational Health and Safety

Each hospital should assign an Occupational Health and Safety Officer (OHSO) who is accountable to the
HR Department head or HR team leader.

Responsibilities of the OHSO include:

1. To meet with all new employees and review the following:

a. Medical certificate submitted– see section 3.13.2 below

 b. Immunization status – see section 3.13.3 below

2. Conducts site visits to identify, in collaboration with case team staff, workplace risks and
actions to be taken to address those risks, as well as personal protective equipment needs.
(see section 3.13.1 below)
3. In collaboration with the hospital Incident Officer to investigate reports of employee
accidents or injuries in the workplace. (See section 3.1.1 of Chapter 19 Quality Management
and Patient Safety.
4. Facilitate access to treatment for employee’s who have been injured in the work place.
Maintaining a safe work environment for hospital employees is essential for the provision of quality care
and for promoting staff satisfaction.

Both the hospital and employees play a role in ensuring occupational health and safety. The hospital
should:

 ensure that the work place does not cause hazards to the health and safety of employees

 provide workers with protective materials and equipment needed to protect them from
potential hazards
 provide training/orientation to workers which includes safety risks, risk minimization
methods and occupational health and safety services available.
It is also the responsibility of all workers to observe safety rules and procedures, as issued by the facility.
Employees once trained and provided with necessary information, should properly use safety devices and
materials, and report any problems or defects of materials/equipment, as well as report any situation
which they feel presents a hazard at the facility.

3.16.1 Risk Assessment

In order to provide appropriate occupational health and safety services, the hospital should assessthe
safety risks that might occur. When assessing safety risks areas that should be considered include but are
not limited to:

 Needle stick
  Slips, trips and falls

 Manual handing

 Violence and aggression (from patients and/or other staff)

 Hazardous substances (chemicals, drugs etc)

 Harassment (from patients and/or other staff)

 Stress

Safety risks can be identified through workplace inspections and reviewing reports of workplace
accidents and injuries. Hospitals should establish processes to regularly assess and take steps to minimize
risk arising in the workplace. Some potential risks and possible solutions for thoserisks are described
in Table 2 below. Further guidance on risk assessment is presented in Section

3.1.1 of Chapter 19 Quality Management and Patient Safety.

Additionally, hospitals should establish a process for reporting and investigating workplace injuries or
accidents. An Incident Officer should be assigned to receive reports of all incidents that involve patient or
worker safety. He/she should inform the OHSO and jointly investigate with the OHSO any incidents that
involve injury to a hospital employee. The OHSO should keep a register of all occupational incidents. A
sample register is presented in Appendix O.

Table 2 Examples of Risks and Suggested Solutions

Potential Hazard Example Potential Solution

Lifting, Dressing, bathing, Minimizing manual lifting of patients in all
handling, feeding, and toileting cases and eliminating lifting when possible.
transferring
patients
Needlestick Injections, inserting IVs Provide workers with auto disable syringes.
injuries etc Establish syringe usage and disposal procedures
and ensure that staff are trained on injection
safety procedures.
Transferri Transferring Place equipment on a rolling device, if possible,
ng equipment like IV to allow for easier transport, or have wheels
equipmen poles, wheelchairs, attached to the equipment. Push rather than pull
t oxygen canisters, equipment when possible. Keep arms close to
respiratory equipment, your body and push with your whole body not
x- ray machines, or just your arms. Assure that passageways are
multiple
items at the same time
 unobstructed. Attach handles to equipment to
help with the transfer process. Get help moving
heavy or bulky equipment or equipment that you
can't see over. Don't transport multiple items
alone; for example, if moving a patient in a
wheelchair as well as an IV pole and/or other
equipment get help, don't overexert yourself.
Reaching into Washing dishes, Placing an object such as a plastic basin in the
deep sinks or laundry, or working in bottom of the sink to raise the surface up while
containers maintenance areas and washing items in the sink or remove objects to be
using a deep sink washed into a smaller container on the counter
for scrubbing or soaking and then replace back
in the sink for final rinse.
Source: Adapted from the US Department of Labor, Occupational Safety and Health
Administration, Health Care Wide Hazards Module.

3.16.2 Medical screenings and Health Promotion

All employees should undergo a health screening prior to employment at the hospital. The health
screening can either be done at the hiring hospital or at another health facility. The candidate should
submit a medical certificate (except HIV results) prior to employment to show fitness for service. The
medical certificate should include a history of current and previous illnesses and a full physical
examination.

The OHSO should review the medical certificate of each new employee to identify any special needs of
the employee in relation to the workplace or work duties.

Any employee who has completed his/her probationary period is eligible to receive medical services at
any government medical facility, free of cost. Through the OHSO the hospital should provide health
promotion and disease prevention services for employees and prompt access to medical assessment for
workers who have any symptoms of illness. In particular the OHSO should educate employees about
signs and symptoms of common diseases (such as TB or malaria) and encourage workers to seek early
medical advice should they have signs and symptoms of these diseases. This is especially important for
those diseases that may be
transmitted to co-workers or patients (e.g. TB, hepatitis). Health promotion programs dealing with issues
such as smoking, substance abuse, stress, and reproductive health at the workplace should be made
available to staff.

Voluntary counselling and testing for HIV should be encouraged and made available to all workers.

3.16.3 Immunizations

Many health care workers are at risk for exposure to and possible transmission of vaccine- preventable
diseases such as TB, hepatitis B, influenza, measles, mumps, rubella, and varicella. Maintenance of
immunity is an essential part of prevention and infection control programs for health care workers.

The OHSO should review the immunization history of each new hospital employee. For those whose
vaccination status is incomplete, the hospital should provide all routine childhood immunizations, in
accordance with the current national immunization policy. Additionally, ‘booster’ doses should be
provided if necessary (e.g. tetanus booster).

The OHSO must assess the need for vaccination on an individual employee basis, taking into
consideration any co-morbidities and/or pregnancy status. Some vaccines are contraindicated in cases of
pregnant workers (varicella, MMR) and workers with HIV infection (varicella), or AIDS.

3.16.4 Workplace Injuries

As specified in Federal Legislation, any worker who incurs accident, injury or disease as a direct result of
their employment is entitled to receive free general and special medical treatment and surgical care
expenses; hospital and pharmaceutical care expenses; an all necessary prosthetic or orthopaedic expenses.
Additionally, employees are entitled to injury leave with pay, or will be provided with benefits should
s/he be (due to a permanent disability) unable to return to work.

Hospitals should seek to reinstate workers who suffer an accident or injury by making adjustments to
accommodate the injury/disability. Examples include:
 Rearrangement of working hours

 Modified tasks and jobs, including modifications in the case of HIV-positive workers who
may be at risk (e.g. avoiding exposing them to infectious TB patients, particularly MDR TB)
or pose a risk to patients by virtue of their performing invasive procedures (this precaution
may also apply to workers with other infections such hepatitis B)
 Adapted working equipment and environment

 Provision of rest periods and adequate refreshment facilities

 Granting time-off for medical appointments

 Flexible sick leave

 Part-time work and flexible return-to-work arrangements

3.16.5 Occupational Health and Safety Trainings

The hospital should conduct promotional activities to raise the awareness and strengthen decision-making
skills of workers related to infectious exposures and other hazards.

Basic information on infectious exposures and other hazards must be provided to every new health
worker within the first week of employment as part of the new employee orientation. Refresher
orientation sessions can also be provided to other staff annually. Facilities must have appropriate written
informational materials through which updated information on infectious exposures and other hazards is
communicated.

The information provided should include:

 identification of potential hazards and infectious and other exposures in the health
workplace

 provide information about infection transmission mechanisms and how to reduce the risk
of such transmission

 instruct workers on the utilization of safe work practices and standard precautions

 workplace health and safety services

 workers’ responsibilities regarding workplace safety and health

 promote the implementation of periodic health screening for health
workers including the promotion of voluntary counseling and testing for
HIV/AIDS

 provide information on the signs and symptoms of the most frequent

illnesses at the workplace, including TB, HIV, malaria, hypertension, and
diabetes and instruct workers to report promptly for evaluation should
these develop
 disseminate health workers’ rights and responsibilities with regard to
workplace safety and health, including the right to confidentiality (See
Statement of Workers’RightsandResponsibilities,inAppendix
Section 6 Annexes
1. HRMD Implementation Manual
2. HRMD Training Module
3. Staff competency assessment score tool
4. Staff satisfaction score tool
Section 7 Reference
1. HSTP II
2. HRD Strategy
3. Health Service Delivery and Administration Legal Framework
4. National regulatory standards for HR by hospitals level

59
 Chapter 21
Managing Health Financing

60
Chapter outline
1. Introduction

2. Operational standards

3. Implementation Guidance
3.1.The hospital has a functional finance structure with trained finance personnel and
technology.
3.2.The hospital has a strategic and operational financial plan in alignment with its
overall plan.
3.3.The hospital increases internal revenue collection and its allocation for quality
improvement.
3.4.The hospital establishes systems and practices for improving its resource utilization.
3.5.The hospital has put in place a reimbursement mechanism for HI and other services
given on credit basis.
3.6.The hospital has established a system to implement outsourcing of services
3.7.The hospital has opened up a private wing in accordance with the provisions of the
federal or regional regulation
3.8.The hospital fully complies with the government finance rules and regulations

61
Section 1: Introduction
Health Financing Concept
According to the World Health Organization (WHO), healthcare financing is one the functions of
the health system that deals with how resources are mobilized, pooled and health services are
purchased. It refers to the “function of a health system which is concerned with the mobilization,
accumulation, and allocation of money to cover the health needs of the people, individually and
collectively, in the health system. The purpose of health financing is to make funding available,
as well as to set the right financial incentives to providers, to ensure that all individuals have
access to effective public health and personal health care” (WHO 2000).

Without the necessary funds, no health workforce would be employed, no medicines would be
available, and no health promotion, prevention or rehabilitation would occur. Hence, Health
Financing is far more than generating funds- it drives other health system components to provide
improved and sustained health services.

Health Financing Reforms in Ethiopia

The Ethiopian health delivery system and financing mechanisms have been evolving over time.
In 1998, the Government of Ethiopia approved a comprehensive healthcare financing strategy
with primary policy objectives of:

 Increasing resources to the health sector.

 Enhancing efficiency in the use of available resources.
 Improving the quality and coverage of health services.
 Ensuring equity and promoting sustainability.

The government has also lunched Health Insurance System to improve financial protection
through risk pooling and foster prepayment, improve quality of healthcare services, and raise
revenues to accelerate progress towards Universal Health Coverage (UHC)

The healthcare financing strategy in Ethiopia aims to contribute to the realization of progress
towards universal health coverage by enhancing risk protection mechanisms and protecting all
indigents. Additionally, the strategy seeks to increase domestic sources and to gradually reduce
aid dependency. It also emphasizes the importance of investing in essential health services in a

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sustained manner that is allocating adequate resources to ensure the availability and accessibility
of key healthcare services to improve the overall health outcomes.
Every hospital has a critical role in effectively implementing health financing reforms. As some
health financing components, such as the health facility governing board, have stand-alone
chapters independently, the fee-waiver system component is being replaced by health insurance
programs; and the fee revision component is majorly beyond the mandates of the hospital, the
chapter guides the remaining health financing components, namely, revenue retention and
utilization, Private Wing, Outsourcing, Exempted Health Services, and Health Insurance as well
as compliance of the hospitals to the government financial rules and regulations to ensure
financial sustainability for sustained improvement of the health outcome.

Section 2: Operational Standards for Health Financing

1. The hospital has a functional finance structure with trained finance personnel and
technology.
2. The hospital has a strategic and annual financial plan in alignment with the hospital’s overall
plan.
3. The hospital increases retained revenue collection and its allocation for quality improvement.
4. The hospital establishes systems and practices for improving its resource utilization.
5. The hospital has put in place a reimbursement mechanism for HI and other services given on
credit basis.
6. The hospital has established a system to implement outsourcing of services
7. The hospital has opened up a private wing to the provisions and requirements of the federal
or regional regulation
8. The hospital fully complies with government finance rules and regulations

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Section 3: Implementation Guidance

3.1. The hospital has a functional finance structure equipped with trained finance
personnel and technology
Every hospital should have a functional finance structure approved by the civil service
commission. The finance directorate of the hospital is a member of the management committee.
The finance structure needs to be equipped with skilled finance personnel who can effectively
run the hospital's financial activities. Though the number of staff may vary from hospital to
hospital depending on the level of a hospital, the presence of the Finance Directorate, senior and
junior accountants, cashiers, and daily cash collectors is mandatory for the proper execution of
financial activities.

Hospital Organizational structure of finance support process:

Each hospital should establish a finances support process with, a minimum of the following
personnel:
 Finance Head

 Senior finance officer

 Finance officers

 Assistant finance officer/ Cashier

 Daily Cash Collector/s

 Archive staff
The finance support process contributes to the provision improved service in several ways:
 Increasing revenue,

 Reducing unnecessary costs and assisting in ensuring that all resources are used
appropriately, efficiently, and effectively, and

 improving the quality of services and in providing decision-makers by providing them

with timely, accurate, and reliable program and financial information.

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Duties and responsibilities of the key finance personnel will be as per job descriptions elaborated
by the human resource unit of the hospital.

Besides, the hospital's finance department must have relevant financial laws, regulations,
directives, implementation manuals, vouchers, and financial formats printed by the Ministry of
Finance or Finance Bureau or its finance structure. Every hospital should also have a safe box(s)
to help ensure its financial security.

Furthermore, the hospital should provide periodic financial training on financial management,
Budgeting, and Reimbursement for its finance staff to improve the staff's skills and knowledge
and continuously improve the hospital's financial operation.

3.2. The Hospital has a strategic and Operational Financial Plan in alignment with its
overall plan

Hospitals must have financial strategic and operation plan that aligned with the overall
development plan of the hospital. Hospitals should also prepare evidence-based planning by
taking into account key considerations such as make expenditure projection by identifying
expenditures financed from treasury and retained revenue, community priority needs, etc.;
national/regional health sector plans and initiatives, reforms, map resources during plan
preparation to avoid duplications.
Evidence-based planning has been implemented in a decentralized fiscal setting to ensure
resources are invested in high-impact, low-cost interventions to enhance effectiveness and
efficiency. Efforts have also been exerted to encourage private partners to establish healthcare
facilities equipped with high-end technologies and enhance local production of medical
technologies and products.
With the growing demands to improve health care quality, coverage, and outcomes, health sector
decision-makers not only face the challenge of allocating resources to the highest priorities but
also of ensuring that those resources are put to good use, deliver "value for money," and achieve
the intended outcomes or impact. For that reason improving a hospital's budgeting ability and
control of the flow of finances is extremely important.

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The hospitals’ financial plan needs to be based on the needs of all the departments of the hospital
and the initial proposal is prepared by the finance directorate and then reviewed by the
management committee and submitted to the governing board for approval. The hospital board
is required to critically review the budget proposal submitted to it by the Management
Committee. In reviewing the financial plan, the governing board is expected to have clear
information on the budget allocated for the hospital from the government treasury and from the
internal revenue sources. Furthermore, the Governing board should know the amount of the
retained revenue allocated for quality improvement activities. By successfully implementing
performance-based program budgeting capabilities, hospitals are to be attained greater financial
control to effectively utilize resources, and maintain spending limits related to expected targets
and results. Improved financial flows and procurement processes within a hospital also create
greater efficiency and use of human resource. Hospital budgets should be prepared, approved,
and appropriated following procedures established by BOFED/MOFED. Procedures for
planning and budgeting are necessary to ensure that financial resources within the hospital are
spent with proper accountability and promptly according to expenditure guidelines established
by the BOFED/MOFED.

Plan and Budget Preparation:

The budget plan preparation is done in a decentralized setting and the budget cycle has
three stages:
• Budget planning
• Budget preparation and request
• Procedures for budget approval and to complete the budget cycle
A budget estimates is the maximum level of resources (financial, human, material, time)
available to spend to achieve desired set of outcomes. Decentralized planning and budgeting
pass through the following stages; a) Budget planning (preparing work plans, review of work
plans, estimation of revenue, allocation of revenue, estimation of capital and recurrent budget,
budget call, budget request), b) budget preparation, c) budget hearing and recommendation, d)
budget consolidation, e) budget approval, f) budget appropriation, g) budget notification, h)
budget allocation, and I) budget implementation, monitoring and reporting. These stages are

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described below. ( further details of each stage can be found in the Budget Preparation and
Management Manual.)

Budget Planning:
A. Preparation of work plans: The Hospital Management, with the active participation of the
staff, prepares a work program considering overall health sector objectives, catchment area
activities, improvement of service quality, and envisaged projects. The annual plans should
include the requirements for outsourcing non-clinical services, procurement of goods and
services etc. The finance bodies (MOFED/BOFED) issue guidelines regarding the direction and
priorities that public bodies should incorporate in their annual work plans. Although health
facilities are not public bodies, this guidance equally applies to them.

B. review of work plans: After getting the approval of their respective) Boards, Hospitals
submit their work plans to FMOH/RHB for review. Federal Ministry of Health/Regional Health
Bureaus consolidates the work plans and submits them to finance bodies at their respective
levels. The work plans include both recurrent and capital components. Past performances are
taken into consideration during the review of work plans.

Planning and Budgeting for Retained Revenue:

As part of the budget planning process, the hospital should estimate the retained revenue it
anticipates collecting from different sources in the coming year. Health facilities shall forecast
the amount of retained revenues they expect to collect from different sources in the budget year
(from July eight to July seven), including expected changes in user fees, expected improvement
in the quality of health services, and the resulting inflow of patients, etc.
Retained revenue can be estimated based on past revenue collection trends made from each
source of revenue item-Total, number of visitors, and collected revenue from each item of
revenue (examination/card, drugs, x-rays, lab tests, etc.), Estimated number of service seekers
and average collections, and changes in the amount of user fee and expected facility visitors.
The retained revenue estimate should be included in the budget proposal.

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 Note: Expenditure of retained revenue should be budgeted separately from expenditures made
from other revenue sources.
All revenue must be appropriated before use. The hospital should declare any unutilized
retained revenue at the end of every fiscal year to be proclaimed and utilized with the collections
of the following budget year and the appropriated block budget. Sources of retained revenue
include:
 Block budget appropriated by the government
 Fees collected from health care and diagnostic services
 Sale of drugs and medical supplies
 Revenue collected from third parties.
 Fees collected from consultancy, trainings and research activities
 Income from non-medical services and goods
 Direct aid in cash and in kind
Government source: main sources of revenue for health facilities includes what they get from
WOFED/BOFED/MOFED in the form of budget allocations from government treasury and
foreign sources. There is no direct allocation for primary hospitals from
WOFED/BOFED/MOFED. Instead, they are notified of their ceilings based on what WOFED
/BOFED allocates to the health sector.
Budget adjustments: There are two types of budget adjustments permitted by law:
a) Budget transfers-- moving budgeted funds from one item of expenditure to another (in so far
as it is permissible by the law) after the annual budget process is finalized.
b) Supplementary budget-- adding an increment to the authorized budget with approval of
OFED/BOFED and appropriation by the respective council. Finance bodies notify the public by
Form Ma/BeMa6 (for recurrent) and Ka/BeMa6 (for capital).
For budget transfers from government subsidies, the Hospital Manager must seek the approval of
BOFED/MOFED before the funds have been spent, using The request should be made using
Form BeMA1 and should specify from which item(s) in the approved initial budget funds will be
taken and for what new expenditure categories they will be used.
The Hospital Management must approve budget transfers from retained revenues for Hospitals.
Transferring and using the budget for those categorized as 'negative list'

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Budget Execution: Budget execution refers to the activities undertaken to utilize the appropriated
budget for the intended purposes. Hospitals and Health Centers shall submit a monthly
disbursement request to the respective finance office, either by filling out the required form or by
writing a letter to BOFED/MOFED according to the existing procedures provided by MOFED/
BOFED.
Monitoring and evaluation: The budgets are monitored and evaluated through monthly and
quarterly execution reports, audits, supervision, etc.

Financial management

Financial management means planning, organizing, directing, and controlling financial activities
such as the utilization of funds of an organization. Finding adequate resources to finance health
systems has become a real challenge for countries worldwide. This challenge is exacerbated in
developing countries that need more funds to meet their populations' essential health. Increasing
public resources for health—or more precisely, expanding "fiscal space" for health—does not
necessarily need to come from more significant tax revenue or larger budgets. Often, it is not the
amount of health spending but the efficiency with which those funds are used that matters most.
Efficiency improvements in the health sector, even slight efficiency, can yield considerable cost
savings and even facilitate the expansion of services for the community. Public Financial
Management (PFM) is about ensuring that public money is used well and is made to stretch as
far as possible. It provides leaders and managers with information to make decisions and know
if they use resources effectively. Managing finances in the public sector is about much more
than accountancy – it is integral to bringing services to people.
Accounting Practices:
Accounting is concerned with recording, analyzing, and interpreting financial data. Hospitals
require qualified financial officers to provide information for the regular evaluation of business
performance and for periodic appraisal of the business's 'value' or 'net worth.' Accounting
information is necessary to prepare business plans, analyze business efficiency and costs of
services, and make policy decisions. Detailed guidance on accounting systems for hospitals is
provided in the financial management Manual of the relevant Government bodies, with
additional guidance in the Healthcare Finance Reform Implementation Manual. Each hospital

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should follow an Accounting Manual which establishes all policies and procedures relating to
financial management. The hospital's financial practices should comply with the accounting
system as described in the manual, using approved, standardized vouchers and forms. The
following section gives a brief overview of significant accounting practices for hospitals by the
procedures established in the financial management Manual.

Cash Collection Procedures

General issues:
 The Health Care and Finance Legislation makes the following stipulations:
 Hospitals should only charge payments at the user fee or bypass fee set by the
 respective government authority
 Bilingual fee posters should be placed next to each departmental reception desk, in all
waiting areas, and
 At all cash points; the hospitals are highly encouraged to indicate the estimated fee for
illiterate patients.
 Each poster should show the fees & exemptions and should advise patients to obtain & keep
 Receipts for all payments,
 Collection points should be readily accessible for all patient services
 Cash should be collected only by personnel who the hospital authorizes,
 Except in emergency cases, the services fees should be collected after the treatment has been
ordered and its availability confirmed, but before the treatment is administered,
 In emergency cases, treatment should be administered when needed, and the question of
payment should be handled when the emergency is under control
 Revenue can be collected as cash, cheque, or bank transfer. When a cheque is received, the
following issues should be considered:
 Cheques must be made payable to the health facility;
 Personal or company cheques must be certified by the drawer's bank;
 Government agency cheques are acceptable without certification;
 No employee has the authority to cash any cheque made payable to the health facility;
 Post-dated cheques shall not be accepted as revenue, and

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  Bank transfers must be evidenced by a bank deposit slip or bank advice

Cash Receipt Vouchers

Cash Collectors should collect payments from clients/patients and others by issuing a Cash
Receipt Voucher. The Cash Receipt Voucher should be used to acknowledge and evidence the
receipt of cash, cheques, the direct deposit of cash into the bank, and bank transfers. Only pre-
printed sequentially prenumbered official Receipt Vouchers issued by BOFED (MOFED for
Federal Hospitals) should be used. The Cash Receipt Vouchers should be distributed as follows:
 Original copy to the payer as an acknowledgment of the cash receipt;
 Second copy to the main Cashier; and
 Third copy is retained in the pad
Daily, each Cash Collector should submit all cash receipt vouchers and cash collected to the
principal Cashier/assistant finance officer.
Summary Receipt Voucher
The principal Cashier/assistant finance officer uses the Summary Receipt Voucher to summarize
the cash collected and cash vouchers received from each Cash Collector. Upon receipt of the
cash receipt vouchers, the main Cashier should summarize these on a pre-numbered Summary
Receipt Voucher. The Summary Receipt Voucher is prepared in triplicate:
 Original copy is given to the daily Cash Collector when the collected cash is remitted;
 Second copy is sent to the financial officer, attaching the Receipt Vouchers & deposit
slips;
 Third copy is kept in the pad.
Receipt Voucher Summary by Revenue Code.
The Receipt Voucher Summary by Revenue Code is a spreadsheet prepared by daily Cash
Collectors to summarize receipt vouchers by revenue account code. Daily, each Cash Collector
should complete a Receipt Voucher Summary by Revenue Code and submit this to the main
Cashier with the issued receipt vouchers and cash collected. The total amount shown on the

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Receipt Voucher Summary by Revenue Code should be checked with the total amount shown on
the Summary Receipt Voucher to ensure that the two amounts are the same.
A copy of the Receipt Voucher Summary by Revenue Code should be submitted to the financial
officer together with the Summary Receipt Voucher and supporting Receipt Vouchers.
Deposit Receipt Voucher
This is used to acknowledge and evidence the receipt of cash or cheques as a deposit/advance
payment from inpatients. The Deposit Receipt Voucher should be prepared by the Cash
Collector and submitted to the main Cashier with the funds deposited.
The daily Cash Collector should summarize all deposit payments in a Deposit Cash Book.
At the end of the patient's stay, the total service charge should be calculated as follows:
A. If the service charge equals the deposited amount, then a Cash Receipt Voucher should
be prepared. A copy should be given to the payee, and the second copy should be
attached to the Deposit Receipt Voucher and submitted to the financial officer.
B. If the service charge is greater than the deposit, then the payee should pay the difference,
and a Cash Receipt Voucher should be prepared for the total sum, with a copy given to
the payee and a second copy attached to the Deposit Receipt Voucher and submitted to
the financial officer.
C. If the service charge is less than the deposited amount, a Cash Receipt Voucher should be
prepared for the total service charge. The balance should be remitted to the payee using a
Payment Voucher. A copy of the Cash Receipt Voucher and Payment Voucher should be
attached to the Deposit Receipt Voucher and submitted to the financial officer.

Cash Register

A Cash Register should be established to record the cash collected daily and the sum deposited in
the bank. The Cash Register should be completed by the main Cashier.

Collections from Credit Services

Hospitals may provide services on a credit basis. A Credit Agreement should be entered
between the hospital and each Institution which would like to subscribe to health services on a
credit basis. The Credit Agreement should describe the reimbursement collection procedure and

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schedule. Credit should be granted for a maximum period of three months. Institutions with a
Credit Agreement with the hospital may deposit money in the hospital's account in advance.
That sum can be replenished whenever it is used up. The hospital financial officer should prepare
a monthly report for the Hospital Management with details of credit granted, credit repaid, and
balance outstanding.
Handling Cash
In monetary terms, 'cash' refers to currency, cheques, drafts, cash payment orders, and bank
remittances. Cash in hand should be kept in a locked safe box under the responsibility of the
main Cashier or the daily Cash Collector. The cash safe box must be used only for those assets
belonging to the hospital. Personal property should not be kept in the cash safe box.
Wherever a cash safe box has double or triple keys, the reserve keys should be safely kept in a
sealed envelope. The sealed envelope should be signed by the Cashier, the Auditor, the financial
officer, and the Finance Head of the Hospital. When the Cashier requires the reserve key, the
sealed envelope should be opened with two or three signatory persons.
Cheque books
When checkbooks are received from the bank, the Cashier should make sure that the leaves of
the checkbooks are correct and that each leaf in the cheque is stamped. A Register should be
used to record all new checkbooks received and checkbooks issued. Partly used checkbooks
should be kept with the financial officer.
Deposit Procedures
All cash and cheques received should be deposited into the hospital bank account on the date of
collection or the next working day if it is not possible to deposit on the same day. The amount of
cash 18-25 kept overnight in the safe box should be, at most, the limits set by BOFED. Daily
collections should not be mixed up with petty cash funds when revenue is deposited; the Cashier
should obtain two copies of the deposit slip – one should be submitted to the financial officer,
and the other should remain with the Cashier as evidence. In direct deposits by a third party, the
financial officer should collect copies of deposit slips from the bank.

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Bank Accounts

Hospital bank accounts can only be opened or closed with the approval of BOFED/MOFED.
Hospital management should assign, in writing, three named individuals as signatories of each
bank account. The bank and BOFED/MOFED should be notified of any signatory changes.
Each hospital should have a particular bank account specifically for retained revenue. Health
facilities' retained revenue bank account shall be allowed at the end of the financial year. To
open the bank account, the hospital should apply in writing to BOFED/MOFED.
The hospital should establish a bankbook or bank register record for each bank account that
shows the movement of funds, indicating the beginning balance, deposits, withdrawals, and
ending balance at any given time. Every month the Finance officer should prepare Bank
Reconciliation for every bank account and pass any necessary correcting entries. Correcting
entries must be evidenced by the Finance officer's signature and verified by separate persons by
the government Budget and Accounts Manual.
Petty Cash
Petty cash is a fund from which small cash payments can be made. Petty cash funds should be
authorized by the CEO and established under the custody of cashiers. Depending on the size of
the hospital, the CEO may approve more than one petty cash fund.
The CEO, in consultation with the Finance Head and Finance officer, should determine the
magnitude of the petty cash fund. Generally, this should not exceed ETB 30,000.
The number and magnitude of petty cash funds should be approved from /BOFED/MOFED. A
change in the size of the petty cash fund within a limit of ETB 30,000 can be made with the
approval of the CEO. However, if a change in the size of the petty cash fund exceeds Birr
30,000, approval of the BOFED/MOFED is required.
The petty cash fund should be kept separately from other collections and funds.
Petty cash funds should be replenished when the remaining cash reaches a minimum level. The
Cashier should submit all paid petty cash vouchers and a request form for replenishment to the
Finance officer. The Finance officer should verify the vouchers and sum requested and should
18-26 prepare a Payment Voucher and cheque for the total expended amount in the name of the
Cashier. This cheque should be handed over to the Cashier against their signature on the
Payment Voucher.

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A petty cash book should be established to track the cash balance for each petty cash fund. At
the end of every month, a cash count should be conducted by someone other than the Cashier,
with a third employee as a witness. Additional 'surprise' cash counts may be conducted. At the
end of the budget year, the remaining balance of petty cash funds should be deposited into the
appropriate bank account.
Disbursement Procedures
The Finance Head should prepare a cash flow program each month and quarter detailing income
and expenditure for each significant budget heading. This should be submitted to the CEO for
review and approval. A sample Format for Cash Flow Forecast is presented in Appendix.
Requests for disbursement (payments) should be made to the hospital Finance officer, who will
prepare a payment voucher and submit it and supporting documents to the Head of Finance. The
Head of Finance should review and approve the disbursement, considering the available funds,
providing the payment amount is within the limits of BOFED/MOFED.
The Finance officer will prepare a cheque and submit it for signature. For cash disbursements,
the approved voucher should be submitted to the Cashier who will effect payment. Withdrawals
from the bank should be recorded sequentially in the transaction register. Facilities should
present disbursement requests to respective BOFED/MOFED for operating expenses of all
eligible expenditures from the government block grant. Requests for monthly salary will also
follow appropriate BOFED/MOFED guidelines.
Recording/Accounting
The accounting system of Hospitals should follow the Federal/regional government accounting
system and should utilize the printed payment voucher for expenses as a detailed financial
management Manual. The following are some of the recording procedures that need to be
followed:
A. The hospital shall establish registers for cash collected, and the Cashier shall enter
daily cash collections into the Cash Receipts Register Book.
B. The Finance officer shall prepare a Daily Cash Receipt Summary.
C. The Cashier shall keep a record of all cash received and deposited in the bank and
record it in a Cash Transaction Register Book as described in the Accounts Manual.
The Finance officer will prepare a cash receipt summary at the end of the day.

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 D. The Finance officer shall record all cash received and deposited in the bank accounts
and records it in the Cash Receipts Registration Book. The Receipt A voucher is the
source document to record a receipt of cash in the Cash Receipts Register Book.
E. When the services provided or delivered for a particular purpose are entered into
transaction register at health facilities, debit payable account, and credit cash at bank
by utilized amounts.
F. When a health facility utilizes the fund appropriated to it, it will debit the related
expenditure account and credit its bank account.
G. Outstanding bills at the end of the financial year are paid within the grace the period
by federal/regional financial proclamations, regulations and financial management
manual.
H. Health facilities shall make monthly reconciliations of accounting records with
related statements.
I. As each month ends, a reconciliation statement of the balances of the Health facility
ledger and bank statements should be prepared for all bank accounts. Reconciling
items should be shown in sufficient detail and should be cleared timely.

Reporting

Each hospital shall maintain books of accounts and formats. This will provide complete and
adequate monthly information on how funds allocated have been utilized as prescribed in the
regional financial proclamation and regulation and shall report to the respective Health and
Finance Office at all levels. RHB, zone health office, Woreda Health office , in collaboration
with the respective Finance office, will assist Hospitals in establishing proper systems for
accounting and in submitting disbursement requests and reporting.

3.3 The hospital increases internal revenue collection and its allocation for quality
improvement
Ethiopia has a tradition of paying for health services dates back to the introduction of the modern
health service delivery system. Ethiopia follows a consolidated revenue collection and
budgeting system in which all public institutions are supposed to channel their collected revenue

76
to the central treasury and receive operational funding through a government budget. Similarly,
in the health sector, health facilities used to channel all revenue they have been generating to the
treasury. This caused a lack of sense of ownership by health facility staff.
On the other hand, health facilities faced a severe shortage of resources to cover their operational
costs, and, in most cases, their non-salary operational budget was depleted by the end of the first
quarter, making it difficult to provide quality health services. In response to this challenge, a
healthcare financing strategy was prepared and approved by the Council of Ministers, which
allows, among other things, the retention and utilization of revenue by health facilities following
the approval of the strategy. The federal and respective regional laws were approved, which
mandate health facilities to retain and use their revenue for improving the quality of health
services. Sources of retained revenue of hospitals include:
 Fees collected from health care and diagnostic services, as well as beds and other services
related to medical treatment,

 Sale of drugs and medical supplies,

 Revenue collected from third parties in connection with waiver and health insurance
schemes,

 Fees collected from consultancy, teaching-learning activities, training, and research

activities,

 Income from non-medical services and goods such as lease of facilities and other similar
activities,

 Direct aid in cash and in-kind obtained from domestic and outside sources, and

 Other similar revenue sources.

Utilization of Revenues
Positive Lists
To ensure hospitals should use retained revenue judiciously to improve the quality of healthcare
services, activities for which RRU should be used are identified as positive lists while activities
that should not be undertaken by RRU are listed as negative lists to guide implementation.
Whereas retained revenue can generally be used for set activities which positively impact quality
of healthcare services such as:
 Improve the services provided under the referral system,

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  Improve the supply of drugs, medical equipment, and supplies,
 Conduct procurement and carry out construction works to improve the health care
services of the hospital,
 Develop health care information systems and manuals and improve procedures,
 Conduct on-the-job training programs and other similar health-related problem-solving
research so as to improve the efficiency of employees,
 Strengthen health education activities and undertake disease control and preventive
activities,
 Undertake other similar revenue utilization activities in line with the objectives
designated by the hospital management committee.
positive lists can be further divided into three categories based on their level of importance to
quality improvement. Hospitals therefore can set priorities based on their needs. The general
categorization is:
First level priorities
• For purchase of drugs, medical equipment and supplies.
• To develop health facility infrastructure,
• Activities that improve cleanness of the health facilities
• For purchase of generator
• First level priorities
• For purchase of drugs, medical equipment and supplies.
• To develop health facility infrastructure,
• Activities that improve cleanness of the health facilities
• For purchase of generator
Second level priorities
• To finance activities required to improve health management information system (HMIS)
• To finance construction of additional rooms/wards to improve services to patients
• To finance activities that improve financial and pharmaceutical management of health
facility

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Third level priorities
• To finance training cost on computer operation skill, office administration, procurement
management, etc.
• Purchase and transportation of office furniture
• Vehicle purchase such as ambulance and transportation for health facility staff, etc.
Negative List
Retained revenue should not be used for activities which include:
 Any kind of foreign trip and training,
 Long-term domestic training program of more than three months,
 Any kind of subsidy given to a third party,
 Revenue utilization other than those activities designed to meet the objectives therein, nor
 There is no approved budget for any expenditure code in the positive list.
(Please refer to the revised HCF implementation Manuals of MOH for detailed information)

3.4. The hospital establishes a system and practice for improving its resource utilization

Ensuring adequate resources to finance health systems has become a real challenge for countries
worldwide. This challenge is exacerbated in developing countries that lack sufficient funds to
meet their populations' essential health services. Increasing public resources for health—or more
precisely, expanding "fiscal space" for health—does not necessarily need to come from more
significant tax revenue or larger budgets. Often, it is not only the magnitude health spending but
the efficiency with which those funds are used that matters most. Efficiency improvements in
the health sector, even in small amounts, can yield considerable cost savings and even facilitate
the expansion of services for the community.
Public hospitals are mandated to retain and use internal revenue from different sources, including
consultation fees, sales of drugs, and different non-medical income-generating activities.

The hospital’s health financial system strictly follows government financial rules and
regulations. That means the hospital should fully adhere to the public financial system in
generating, managing cash, and utilizing financial resources. For instance, the hospital should
use receipt vouchers printed by the Ministry of Finance or Finance Bureau. The hospital should

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also not utilize retained revenue before appropriation even though it has revenue collected at
hand. Therefore, utilizing retained revenue before it is appropriated is strictly prohibited, as
doing so would breach the government's financial rules and regulations.

In line with the above, the hospital governing board needs to monitor the hospital's adherence to
the government's financial rules and regulations. In this connection, the governing board is
expected to give direction for the hospital to strengthen its financial management system.
Public Financial Management (PFM) means planning, organizing, directing, and controlling
financial activities such as the utilization of funds of an organization. It is about ensuring that
public money is used well and is made to stretch as far as possible. It provides leaders and
managers with information to make decisions and know if they use resources effectively.
Managing finances in the public hospital is much more than accountancy – it is integral to
bringing health services to people.

3.5. The hospital has put in place a reimbursement mechanism for HI and other services
provided on credit
Health Insurance (HI) is a formal arrangement where insured persons are protected from the cost
of medical services that are covered by the insurance plan. Health Insurance provides for the
unforeseen medical bills that would otherwise be a burden on the hard-earned savings of
individuals/HHs. It is an agreement between an insurance scheme/company and the individual
or groups where the insurer agrees to pay some or all medical expenses in exchange for a
monthly or annual contribution/premium payment. HI can cover a range of medical services,
including hospitalization, doctor visits, medication, and medical procedures. With health
insurance, a person can access quality health services from healthcare providers without
worrying about the financial impact of medical expenses. In other words; HI is a formal
arrangement where insured persons are protected from the cost of medical services covered by
the insurance plan. Health Insurance covers unforeseen medical bills that would otherwise
burden hard-earned savings.
Types of Health Insurance

SHI: a mandatory, non-for-profit Health Insurance program for formal sector employees and
financed by earmarked payroll/pension contributions (from employees and employers).

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CBHI: Not-for-profit insurance scheme aimed primarily at the informal sector and formed on the
basis of a collective pooling of health risks, and in which the members participate in its
management.
Private HI: refers to insurance schemes that are financed through individual (group) private
health premiums, which are often voluntary, and risk rated and funds managed by ‘For-profit’
insurance companies
The government of Ethiopia has launched two types of health insurance programs, namely,
Social Health Insurance (SHI) and Community Based Health Insurance (CBHI), with objectives
of alleviating financial barriers, mobilizing additional resources to the health sector, encouraging
community participation, and ultimately improving health service utilization and health status of
the population.
Social health insurance covers the population engaged in the formal sector, including civil
servants, NGO employees, private sector employees, pensioners, and police forces while the
CBHI program is designed to address populations engaged in the informal sector- i.e., the rural
population, self-employed and people engaged in petty trade in urban settings.
Hospital is one of the critical stakeholders that have a significant role in the successful
implementation of the programs. They are expected to provide quality health services included
in the benefit package. The benefit package covers outpatient and inpatient services, delivery
services, surgical services, and provision of generic drugs included in the health insurance drug
list and diagnostic services at the hospital level. Insurance beneficiaries should not pay any out-
of-pocket payment when accessing care, apart from the copayment and bypass fee, if any.
Not all services may be covered by the benefit package, and some services such as diagnosis and
treatment abroad, cosmetics surgeries, and dialysis, except acute renal failure, in vitro
fertilization, organ transplantation, hip replacement, traffic accidents, etc., excluded for various
reasons.
Services included in the benefits package, including supply of drugs, laboratory, and diagnostic
services per the terms and procedures indicated in the contractual agreement, the hospital should
submit timely, complete, and accurate payment requests using agreed-upon formats and follows
up on the reimbursement.
Whereas user fees were majorly paid by patients and clients for the hospital at a point of service
for long, this trend has been changing, especially with the commencement of the CBHI program.

81
Furthermore, these days public hospitals are covering the cost of Exempted Health Services,
which have to be covered from the government budget and/or from donner funding in financial
and non-financial form/in-kind, expecting the reimbursement of the costs they incurred for the
exempted health services.
Nevertheless, the hospitals are depleting their internal revenue, which must be allocated to
prioritized high-quality impacting activities such as the purchase of drugs, medical equipment &
utility payments, as they are not reimbursed by the government partners or the treasury budget.
Implementing health insurance programs requires active involvement of different stakeholders
with their distinct roles and responsibilities.
For that reason, hospitals should hospital keep records of all services provided to eligible healt h
insurance beneficiaries and related financial information as appropriate, and the information
must be compiled into reports. These include: -
 service utilization reports,
 cost of services provided
 hospital fee schedules issued by the authorized body,
 standard treatment guidelines, and
 contract documents.
Apart from HMIS data capturing and reporting formats, the hospital utilizes formats
developed by health insurance schemes/service purchaser to record and document health
insurance activities.

Exempted Health Services

Exempted health services refer to those services that are rendered free of charge to all
irrespective of the level of income, because they are of public health nature that widely affects
the general public and improves the health-seeking behavior of society. Exempted services are
generally those of a public health nature, such as:
 Immunization of mothers and children against eight child illnesses;
 Prenatal, delivery, and postnatal services
 Family planning services in health care units;
 HIV Voluntary Counseling and Testing (VCT);

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  Diagnosis, treatment, and follow-up of TB;
 Leprosy management
 Epidemic follow-up and control;
 Obstetric Fistula management
 Immunization and treatment of health professionals to reduce risk related to occupational
hazards
 Other services are to be provided free of charge for future endorsement by the
government.

Federal Ministry of Health and each Regional Government will approve the list of exempted
services for Federal and Regional Hospitals, respectively. Each hospital should provide
exempted services by the relevant Legislation and display a list of exempted services at
appropriate locations throughout the hospital to inform patients, staff, and the public.
The budget for exempted health services should be covered by the treasury budget and/or by
development partners. However, most hospitals are forced to cover the cost of exempted health
services from their retained revenue, which depletes internal resources dedicated to improving
the general quality of health services. The cost of the services should be financed from the
appropriated government budget or from donations. For that to happen, the hospital must
strengthen its data capturing system, especially data on the cost of exempted health services, to
reimburse the cost expended on exempted health services from their internal revenue.

Overview of Provider Payment Mechanisms

The ways providers are organized and paid is central to the structure of any health insurance
system. The payment mechanisms used to reimburse providers have essential effects on system-
wide costs and efficiency. Some payment mechanisms encourage the over-provision of services,
while others run the risk of causing providers to restrict the provision of services that are
necessary. The provider payment system influences the quantity of services provided and rate of
user fees.

83
The provider payment mechanism used by the health insurance system must be evaluated against
its effects on the quality of health care service, cost containment, and administrative simplicity.
The widely used provider's payment systems are:
Fee-For-Service: Fee-for-service payment systems can be completely open but are often based
on an established fee schedule. The drawback of this payment mechanism is that hospitals can
maximize their income under a fee-for-service reimbursement scheme by increasing the number
of services provided or by reducing quality of service's.

Diagnosis-Related Groups (DRG)/ Case Payment: The most widely-known case classification
system is the "diagnosis-related groups" (DRG) system, which classifies conditions into
approximately 470 diagnostic groups. DRG or case-based payment systems are most commonly
used to pay hospitals for inpatient treatment. Hospitals must examine the resources used
(operating theatre, supplies, technology, drugs, medical staff, and bed days) to treat a patient with
a given diagnosis. Because a fixed fee is received per case, the hospital faces incentives to
minimize costs and to increase income. On the other hand, providers also face incentives to code
the diagnosis into a more generously reimbursed diagnostic group. This tendency, called "DRG
creep," requires an elaborate monitoring system to control. As the health insurance authority has
no prior experience with the DRG payment mechanism and also since sufficient data has to be
available to define the DRGs, the social health insurance system may initially use a less
complicated form of case payment mechanism known as Departmental Based Grouping (DBG)
for all inpatient services.

Capitation payment: Capitation payments are made to health plans that receive a fixed monthly
payment per member to provide a defined benefits package. The health insurance may contract
health centers and hospitals to provide part of the benefits package and may pay those provider
groups by capitation payment. If designed and appropriately implemented, capitation payment
systems have many desirable qualities. For a capitation payment system to be effective, there
must be a large base of enrollees to spread the financial risk. With few enrollees and a
comprehensive package, few very sick enrollees could bankrupt the provider. It is essential for
members to have the opportunity to choose among competing capitated plans. Competition to

84
attract members should cause quality to increase, and the pressure to provide a defined package
of benefits for a fixed premium should result in controlled costs.
Because capitation payment is for a range of benefits, providers and health insurance schemes
have incentives to rethink the structure and organization of the delivery system. Capitation
payments encourage a systemic focus compared to fee-for-service payment, which encourages a
focus on individual procedures or diagnoses. Administrative costs of capitation payment
methods are low compared with fee-for-service reimbursement systems.

3.6. The hospital has established a system to implement outsourcing of services

Outsourcing is the agreement between a health facility as a purchaser and a third–party provider
of services as a vendor, under which the vendor provides to the health facility certain defined
services formerly performed by the health facility itself. It has the potential to become a core
business strategy for health facilities. By leveraging the contractors' core abilities, the health
facilities can maximize their options to, for example, expand additional services by gaining
access to the state–of–the–art technologies without investing directly in the development of such
technologies. Thus, by allowing the contractor to deal with services that are the core
competency of that contractor, the health facilities can focus their efforts on their core clinical
competencies.
Box B. Rationale for Outsourcing:

 improve quality
 Help hospitals to focus their efforts on core clinical competencies.
 Access specialized skills/expertise that are not available in the facilities.
 Cost reduction and/or
 Gain efficiency and effectiveness

Outsourcing allows health facilities to leverage the contractor's knowledge of services and
abilities. It provides health facilities with access to individuals with specialized skills who might

85
otherwise be expensive and difficult for the facilities to hire/attract. Although the current practice
focuses on outsourcing non-clinical services, there is a strong need for outsourcing selected
clinical services such as Radiology and Imaging. It is to be noted that hospitals have to pay
particular attention to undertaking preparatory activities, including conducting feasibility
assessments and preparing clear bid documents before they outsource services.
Through outsourcing, hospitals can gain access to the experience of the contractor, which may,
through its provision of the outsourced services, improve the work pattern or processes of the
facilities. This may, in turn, improve the quality of services provided by the facilities. It allows
health facilities to benefit from the ability of the contractors to provide these services at rates that
reflect economies of scale.
The international experience shows that, while outsourcing of clinical services, public facilities
have faced challenges in the proposal design, decision-making, implementation, and monitoring
stages. Some challenges at the designing stage include changing priorities, setting unrealistic
expectations, neglecting to realize the cost of outsourcing, and failing to strategize an exit
procedure. Similarly, the challenges encountered during the implementation phase were
permitting the outsourced service to get out of control and pressures from the internal
constituent. It has also been reported that there were weak monitoring mechanisms, poor
capacity to monitor contracts at each level, and poorly defined monitoring indicators. To resolve
these challenges, they took several actions, including creating an enabling political environment,
designing legal frameworks and strategies, building the facility's capacity to manage to
outsource, and establishing independent sources of monitoring information. The Federal Ministry
of Health (FMOH) recognizes the potential of the private for-profit and private not-for-profit in
expanding health development.
3.7 The hospital has opened a private wing in accordance with the Provisions of the federal
or regional regulation

Ethiopian public hospitals cannot meet increasing financial demands solely using the budgeted
funds allocated by the government. This has deteriorated the quality of services provided in
public hospitals, decreased staff motivation and morale, and increased the movement of health
workers from public to private hospitals in Ethiopia and abroad. This brain drain has been
exacerbated under the free-market economy that Ethiopia currently follows, which promotes the

86
attractiveness of the private sector. The health policy of Ethiopia encourages hospitals to look
for new sources of revenue to supplement the grants they receive from the government to
expand, organize, support, and strengthen the services they provide. Furthermore, the policy
encourages upper-income people to pay for healthcare services and, thus, help to support those
who do not have the financial capacity to gain equitable access.
Therefore, the hospital may establish a private wing to motivate the health workforce and retain
senior health professionals by enabling them to earn additional income by working in the wing
during off hours, weekends, and holidays. The establishment of the private wing also lessons
overcrowding and enhances the provision of services in the regular service as the private wing
provides alternatives for clients who choose to be served by their preferred health professionals
and at their preferred time.
A private wing is an official arrangement for public hospitals where clinical services are
provided based on a service fee. Hospitals may establish a private wing to benefit patients, staff,
and the hospital (see Box C). Fees charged to patients in the private wing should be set based on
cost recovery and higher than those charged in the regular hospital.
Income raised by the private wing should be shared between the hospital and the professionals
providing the private wing services. The income distribution should be approved by the
Governing Board based on the federal and respective regional guidelines. The hospital should
receive its share from the private wing income.

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Box C Benefits of a private wing

Benefits for the patient include:

 A higher level of amenities and customer service
 A cleaner, more comfortable, and secure environment
 More convenient appointment times
 Personal choice of doctors
Benefits for the staff include:
 A better work environment
 Caring for people with an increased level of patient satisfaction
 For eligible employees, a potential to increase earning
Benefits for the Hospital include:
 Help to retain qualified staff
 Increase revenue for institutional improvement – upgraded equipment, computer
system,
 Clinical services, additional investment in staff training, etc
 Establish and role model a higher standard of non-clinical services throughout the
facility
Improve patient satisfaction
Improve reputation

Care should be taken to establish a pirate wing. The establishment of the private wing must be
based on national/regional regulations and implementation guidelines. Yet, preparatory activities
must be undertaken, and a comprehensive plan must be prepared to guide the establishment and
implementation of the private wing. The preparatory activities include:
 Conducting a feasibility analysis and gathering information, among other things, on the
need for private room services,
 Willingness of the hospital staff
 Availability of working space
 Establishment of the technical committee

88
  Preparation of the private wing guideline
 Review and approval of the establishment proposal by the board.
The hospital management should ensure that the opening of a private wing does not negatively
affect the quality and regular operations of the general hospital services and should ensure that
the quality of clinical care provided in the private wing is no different from the quality of care
provided to other patients.
The hospital management should ensure that the opening of a private wing does not negatively
affect the quality and regular operations of the hospital services and should ensure that the
quality of clinical care provided in the private wing is no different from the quality of services
provided during regular working hours.
Step 1
Public Private Partnerships in Hospitals (PPPH)

Public Private Partnership (PPP) is an arrangement between the public and private sectors that
aims to join forces to meet public needs through the most appropriate allocation of resources,
risks, and rewards.
The country's current stage of health development calls for engaging the private sector in Public
Private Partnership in Health (PPPH), particularly in providing secondary and tertiary level
health services, manufacturing indigenous health products, alleviating human resource
constraints, and nurturing the existing PPPH. With the objective to encourage the private sector
for high-end diagnostic services (laboratory and imaging services), high-end clinical services
such as hemodialysis, radiotherapy, neurosurgery and rehabilitation medical services, and other
unmet need driven PPP projects in the premises of the public health facilities; To guide
outsourcing of non-clinical services, as appropriate (management service, building, and
equipment maintenance to the private operators; guide the existing partnership to fully
complement government public health programs regarding coverage, standardization, ensuring
transparency and accountability, service quality, public safety, and sustainability.
Currently, some hospitals have contract with the private sector for clinical services - diagnostic
services. The existing PPPH has contributed significantly to improving the efficiency and
quality of service delivery, availing the private sector expertise, building the health professionals'
capacity, and creating a conducive environment for private sector collaboration.

89
The expansion of Non-Communicable Diseases (NCD) and the growth of the citizens' income
put more pressure on the demand for high-tech diagnostic and imaging services. Under the
existing condition, many public hospitals cannot meet this increasing demand due to financial
and technical reasons. For that reason, many patients are compelled to travel abroad for medical
treatment or get treatment in quite a few private facilities where some of these technologies are
available, and the user fees are too expensive to afford for many of them. Evidence from
international experience suggests that these gaps are met through public facilities that can
mediate by outsourcing clinical services. There are several reasons why many countries
outsourced the clinical services previously provided at public hospitals as indicated under
outsourcing improving access, quality, and efficiency to engage the private sector in the health
service delivery system, leveraging the advanced medical technology available in the private
sector, and reducing the cost of foreign treatment were significant reasons for outsourcing
clinical services.

3.8. The hospital fully complies with the government finance rules and regulations

Ensuring full adherence of the hospital's operations to the government rules, regulations, and
standards is one of the primary responsibilities of the Hospital Governing Board (HGB) and
management committee (MC). Hence, the hospital governing board should provide due attention
to ensuring the management and use of the public finance and assets as per the government rules
and regulations, use different mechanisms to validate the rules, and ensure the regulations are
fully implemented in the hospital. And undertaking financial, pharmaceuticals, and financial
enteral and external audits are among the mechanisms employed to ascertain full adherence of
the hospital. Hence, the hospital board needs to give guidance and support for the
implementation of the following audits: Internal financial audit regularly to guard against
breaches of the hospital's finance rules and make on-spot corrections.
Internal drugs and supply audit for mini stores every quarter and annually for leading stores
Annual external audit on financial performance, assets, and pharmaceuticals
Notably, the HGB and MC should review the internal and external audit findings and make
corrective actions for future improvement without delay.

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The audit is derived from a Latin word meaning "He hears." In ancient times, the accounts of an
estate, domain, or manor were checked by having them called out to those in authority by those
who had compiled them. Currently, auditing can be defined as the process by which a
competent, independent person accumulates and evaluates evidence about quantifiable
information related to a specific economic entity to determine and report on the degree of
correspondence between the quantifiable information and established criteria.

Types of audits

Auditing can be grouped into four types: -

1. Financial audit: involves verification of financial data to express an opinion on their
validity and reliability
2. Compliance audit: involves verifying adherence to policies, plans, procedures, laws, and
regulations
3. Value for money (performance) audit: is a forward-looking evaluation of operations to
identify areas in which economy, efficiency, and effectiveness (the three E's) may be
improved or to evaluate compliance with and the adequacy of operational policies, plans,
and procedures. It involves the evaluation of inputs, processes, and outputs. Other names
that describe this type of audit include Operational, Management, and Three E.
4. Environmental audit: is an audit that confirms the degree of compliance with both
internally and externally determined emission and pollution standards.

Pre audits and Post audits

Auditing takes two forms, especially in government offices, commonly called "pre-audit" and
"post-audit." Pre-audit is the examination of transactions before payment. It is the more
traditional audit function. Post-audit represents an after-the-fact examination and is more recent
in origin.
Scope and concept of pre-audit
The pre-audit, perhaps more accurately described as a prepayment audit, is generally an integral
part of the central accounting and payment process. The primary objectives of pre-audit are to

91
ensure that; Expenditures are not unreasonable or extravagant; sufficient funds are available to
enable payment of the invoice, and there has been compliance with government proclamations,
regulations, directives, and procedural and budgetary requirements. It may include an
examination of contracts before approval and encumbrance, scrutiny of all invoices, and all
payrolls before payment.

Scope of post audit

The scope of post-audit may be grouped into two general categories:
 Financial accountability and legality – the verification of accounting records and review
of internal controls;
 Value for money – the examination of the efficiency, effectiveness, and economy of
operations, including the broad examination of the extent to which objectives are
accomplished.

These categories tend to overlap, but they help demonstrate the changing auditing concepts. The
primary limitation of the post-audit is that it concentrates on detecting irregularities rather than
preventing their occurrence. Each hospital should appoint an Internal Auditor responsible for
conducting regular internal audits as described in the government Internal Audit Manual.

The hospital accounts should be closed on the last day of the financial year. The external audit
should be conducted by external auditors from the Office of the Auditor General (Federal or
regional Audit office) or other authorized private auditors, approved by the Governing Board,
within six months of closing the accounts. The audit should consider the recording and
bookkeeping system and the hospital's annual retained revenue and expenditure. Audit reports
should be submitted to the CEO, who will present them to the Governing Board for taking
corrective actions.

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Annexes

Box A Decentralized planning and budgeting

Decentralized budgeting and planning decentralization transfers authority and responsibility for public
functions from the central government to lower-level tiers. It involves the transfer of authority for
decision-making to local governments on expenditure assignment, i.e., performing public functions,
including the provision of services, and revenue assignment, i.e., generating own revenues and having
independent authority in making investment decisions. Fiscal decentralization is a core component of
decentralization. It refers to the situation where lower levels of government are entitled to collect and
spend their revenues and share some revenue with a higher level of government authority. The
principle of fiscal decentralization suggests that assigning expenditure responsibilities and decision-
making powers to the lower levels of government can substantially improve a state's ability to ident ify
and address its citizens' needs effectively. In light of this, the government has introduced fiscal
decentralization and essential planning and budgeting procedures. The purpose of planning and
budgeting is to ensure that financial resources at the facility level are spent with proper accountability
promptly according to expenditure guidelines established by the MOFED/BOFED.

Source: Implementation Manual for Health Care Finance Reform. FMOH, 1995

93
Box B: Components of Health Financing

 Revenue retention and utilization, which is mainly aimed at increasing health sector
resources to be dedicated to improving the quality of healthcare

 Facility Governing Board -is the legitimate authority to provide strategic leadership for
the attainment of the overall objectives of the hospital.

 Private wing -helps to provide an alternative health service for those who can afford to
pay and to retain senior health professionals in public health facilities.

 Outsourcing of non-clinical services -contract out selected non-clinical services for the
third party to enhance efficiency. It helps health professionals to focus on their core
business and to provide an enhanced service.

 Exempted Health Services-provision of selected health services for all eligibles for free
irrespective of ability to pay.

 The fee waiver system aims to improve equitable health services provision by providing
exceptional support for citizens who cannot afford health services. Currently, this
component is majorly being implemented under Health Insurance programs.

 User fee revision – refers to the periodic revision of user fees, considering the
population's ability and willingness to pay.

 Community-Based Health Insurance aims to remove catastrophic out-of-pocket health

expenditures and improve health service utilization of citizens engaged in the informal
sector without exposing them to financial hardship.

 Social Health Insurance aims to remove catastrophic out-of-pocket health expenditure

and improve health service utilization of citizens engaged in the formal sector without
exposing them to financial hardship.

Source: MoH, Health Care Financing Strategy

94
References

1. The Federal Democratic Republic of Ethiopia. (1988). Health Care Financing Strategy, Addis
Ababa.

2. The Federal Democratic Republic of Ethiopia. (2006, January). User's Guide for Procurement
of Goods (For National Competitive Bidding).

3. Federal Democratic Republic of Ethiopia. (2006, January). User's Guide for Standard
Bidding Document for the Procurement of Works (For International Competitive Bidding).

4. Federal Democratic Republic of Ethiopia Ministry of Finance and Economic Development.

(1998 E.C.). Internal Auditor Standard, Ethical Conduct Guidance, and Internal Auditing
Manual. Addis Ababa: Ministry of Finance and Economic Development.

5. Federal Democratic Republic of Ethiopia Ministry of Finance and Economic Development.

Procurement Manual.

6. Federal Democratic Republic of Ethiopia Ministry of Finance and Economic Development.

Federal Government of Ethiopia Accounting System Volume I Accounting for Modified Cash

Transaction Version 1.1. Addis Ababa: Ministry of Finance and Economic Development.

7. Federal Democratic Republic of Ethiopia Ministry of Finance and Economic Development.

Federal Government of Ethiopia Accounting System Volume II Chart 7 Accounting Version

8. Federal Democratic Republic of Ethiopia Ministry of Finance and Economic Development.

Federal Government of Ethiopia Accounting system Volume III Accounting for Other Assets and
Liabilities version 1.1. Addis Ababa: Ministry of Finance and Economic Development.

10. Federal Democratic Republic of Ethiopia Ministry of Finance and Economic Development.
(2007, 12 January).
11. Revised Federal Budget Manual (Draft). Addis Ababa: Ministry of Finance and Economic
Development.
12. Federal Democratic Republic of Ethiopia Ministry of Finance and Economic Development.

95
(2005, 05 July). Federal, Public Government Procurement Directive. Addis Ababa: Ministry of
Finance and Economic Development.

13. Federal Democratic Republic of Ethiopia Ministry of Health. (2005, 14 November).

Implementation Manual for Healthcare Financing Reforms Final Document (Revised).
14. Federal Democratic Republic of Ethiopia Ministry of Finance and Economic Development.
(2007, December). Government Owned Fixed Assets Management Manual. Addis Ababa:
Ministry of Finance and Economic Development.
15. Office of Public Management NSW Premier's Department SYDNEY NSW 2000.
16. Proclamation No. 57/1996. Federal Government of Ethiopia Financial Administration Addis

Ababa: Federal Negarit Gazeta.

17. Proclamation No. 430/2005: Determining Procedures of Public Procurement and Establishing
its Supervisory Agency. (2005, 12 January). Addis Ababa: Federal Negarit Gazeta.
18. Proclamation No.553/2007: The Ethiopian Federal Government Procurement and Property

Administration Proclamation. (2009, 09 September). Addis Ababa: Federal Negarit Gazeta.

19. South Nations Nationalities and People's Regional Government and Health Bureau. (2006,
May). Implementation Manual for Healthcare Financing Reforms

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1
Chapter Outline
Section 1: Introduction
Section 2: Operational standards
Section 3 Implementation Guidance
3.1 Organizational structure for
3.1.1 Roles and responsibilities of

3.2 Clinical audit

3.3 Quality improvement projects
3.3.1 Quality improvement models
3.3.2 Implementing improvement cycle
3.3.3 Measuring change, communicating findings, documenting and recognizing achievements
3.3.4 Conclusion - Quality Improvement Project
3.4 Clinical Risk Management
3.5 Patient Focused Care
3.6 Benchmarking and experience sharing platforms
Source Documents/References

2
Appendices
Abbreviations
ANC - Antenatal Care
CEO - Chief Executive Director/Officer
CED - Chief Executive Director
EHAQ - Ethiopian Hospital Alliance for Quality
ER - Emergency Room
FMOH - Federal Ministry of Health
GB - Governing Board
GP - General Practitioner
HMIS - Health Management Information System
HO - Health Officer
HSQ - Health Service Quality
IPD - Inpatient Department
MPH - Master of Public Health
OPD - Out Patient Department
PDSA - Plan, Do, Study, Act
PPE - Personal Protective Equipment
QI - Quality Improvement
RHB - Regional Health Bureau
SMT - Senior Management Team
TB - Tuberculosis
TOR - Terms of Reference
WHO - World Health Organization PDSA Plan, Do, Study, Act
QI Quality Improvement
RHB Regional Health Bureau
WHO World Health Organization

3
Section 1 Introduction
As per the national quality and safety strategy of Ethiopia, quality is defined as comprehensive
and integrated care that is measurably safe, effective, people-centered, and uniformly delivered
in a timely manner that is affordable to the Ethiopian population and appropriately utilizes
resources and services efficiently. It encompasses seven generally accepted dimensions:
Table 1: Quality Dimensions
Quality dimensions Definitions
Avoiding injuries to patients from the care that is intended to help them; the
Safe WHO defines “patient safety” as the prevention of errors and adverse effects
to patients associated with healthcare.
The care is based on evidence-based knowledge and evidence-based
Effective
guidelines.
It must consider the people’s needs, preferences and values while delivering
health care, characterized by respect and dignity of the users. People-
People-centered
centeredness shifts the power from the health care system
and providers to patients/users of the system.
Reducing waits and sometimes harmful delays for both those who receive
Timely
and provide care.
Efficient Avoiding waste, including waste of equipment, supplies, ideas, and energy.
Providing care that does not vary in quality because of personal
Equitable characteristics such as gender, ethnicity, geographic location, and
socioeconomic status.
Care provided to the patients is coordinated across the health care platform
Integrated and
individual providers.

Quality management in healthcare needs three core components (Juran Trilogy): Quality
Planning, Quality Control and Quality Improvement. Quality care is achieved not by one aspect.
As part of the health system, information about quality care can be drawn from integration of
structure, process and outcomes. SMT and GB should ensure that health service quality is in
place and should monitor their effectiveness. All staff should participate in health service quality
activities specific to their work area.

4
Quality improvement (QI) is a continuous process whereby organizations iteratively test and
measure changes in work routines, set and achieve ambitious aims, shift whole system
performance, and spread best practices rapidly for uptake at a larger scale to address specific
issues set to improve. The content in these operational standards is organized to include health
service quality organizations, all quality dimensions, clinical audits and regulatory accreditation
concepts.

5
Section 2: Operational Standards

1. The hospital has an established Health Service Quality Directorate/Office.

2. The hospital has functional Health Service Quality council/committee
3. The hospital coordinates health service reform activities and integrates into the existing
system.
4. The hospital has established a system to manage health care delivery related risks.
5. The hospital has functional clinical audit program
6. The hospital actively participates in collaborative learning and experience sharing
platforms.
7. There is regular Hospital to health center support system
8. The hospital develops a system to insure patient preference and value.
9. The hospital regularly conducts patient satisfaction surveys.
10. The hospital has established a health literacy desk.
11. The hospital identifies priority problems in service delivery areas and implements QI
projects.
12. The hospital ensures equitable service delivery.
13. The hospital establishes a system to ensure timeliness of care.
14. The hospital establishes a system to control efficiency of healthcare delivery.

6
 Section 3 Implementation Guidance
3.1 Organizational structure for Health Service Quality

A Health Service Quality Directorate/Office requires a clear and standard structure and
framework. The structure includes the organization's human, physical, and financial resources,
such as buildings, staff, equipment, plan and policies. These structures and serve to:

 Encourage the participation of all staff in continuous Health Service Quality

processes.
 Assign responsibility for Health Service Quality processes.
 Ensure activities proceed as planned per the annual plan.
 Maximize quality, effectiveness and efficiency of services.

The hospital should establish a Health Service Quality Directorate/Office reporting to the Chief
Executive Director/Officer (CEO/CED) or relevant body based on hospital level. This unit
should be led by an assigned senior physician, general practitioner, or holder of a Master of
Public Health degree or other equivalent professional. This person will be the Health Service
Quality Director/Head. The director/head should be selected using the following criteria:

 Good clinical leadership capability

 Excellent clinical skills
 Excellent analytic and research skills
 Commitment
 Good understanding of systems thinking and systems change
 Good data-use culture
 Innovative/ creative and able to offer solutions
 Team player

Each clinical department should establish its own QI team, led by the department/case team
head, to undertake HSQ activities. Department heads are responsible for ensuring quality
activities occur and reporting them to the HSQ Directorate/Office. Each department should
regularly audit its performance.

7
3.1.1 Roles and responsibilities of Health
As outlined above, hospitals should establish an HSQ Directorate/Office to oversee all hospital
QI functions. The HSQ Directorate/Office should comprise a director/head and Quality Officers.
It should be multidisciplinary, with members from different clinical and administrative
backgrounds. The HSQ Directorate/Office head should be a member of the hospital senior
management team and accountable to the CEO/CED. The HSQ director and officers should serve
full-time in their HSQ roles.

CEO/CED. The HSQ director and Directorate/Officers should be full time in their role for HSQ
activities.

HSQ Unit Roles include:

a) Develop the HSQ strategy and present to the Senior Management Team for approval,
b) Develop an HSQ strategy implementation plan and monitor execution,
c) Ensure HSQ activities relate to the hospital's vision and mission, aligned with strategic and
annual plans,
d) Coordinate all HSQ activities,
e) Promote and support staff participation in HSQ activities,
f) Receive and analyze feedback from patients, staff and visitors,
g) Receive clinical audit reports and maintain records of all clinical audit activities,
h) Review selected hospital deaths as part of death audit committee,
i) Work closely with the HMIS Office to monitor performance
j) Conduct peer review in response to specific quality and safety concerns and take appropriate
action and follow-up when deficiencies are identified,
k) Build capacity of hospital staff on QI activities and findings.

This unit should collaborate closely with the Medical Director as activities are closely related.

Departmental Quality Improvement team/taskforce

Irrespective of the workload, the hospital should establish a departmental/case team level QI
team/taskforce to undertake some of the above functions. Each departmental QI team should be
chaired by the department/case team director/head that provides regular update reports to the
HSQ office.

8
3.2 Clinical Audit and Death Audit

A. Clinical Audit
Clinical audit is defined as a quality improvement process seeking to improve patient care and
outcomes through systematic review of care against explicit criteria and implementation of
change. It involves assessing structure, process, and outcomes against agreed standards and
introducing changes based on identified gaps with further monitoring to ascertain improvements.

Hospitals should establish and implement a clinical audit program with identifiable service areas.
Clinical audit involves 5 main steps:

i. Audit planning
for successful clinical audit, adequate preparation is very important. Planning involves
three essential components:
 Identifying stakeholders - those involved in the audited activity including service
providers and users. Including the unit head will be beneficial.
 Identifying the audit topic - it is necessary to decide the topic in advance. With several
topics, the team should prioritize resources efficiently.
 Planning the audit field work - the audit objective should be clearly understood by all
stakeholders, required skills and personnel identified, appropriate training and briefing
conducted on roles, and a comprehensive proposal developed with adequate resources
and timetable.

ii. Develop standards/criteria for clinical care in the selected area

Standards/criteria may include:
 National or international drug treatment guidelines,
 National or international diagnostic and treatment guidelines,
 ‘Best practice evidence’ from literature reviews
 National clinical audit guideline as a reference.

iii. Assess current practice against standards

9
 This can be done through retrospective or prospective case note review, direct
observation, surveys or interviews.

iv. Take action to address identified deficits in clinical care (Conduct QI activities)
If the audit identifies suboptimal care, reasons should be investigated using qualitative
methods like those in Table 1. Investigation should involve relevant stakeholders to
address the problem comprehensively. Findings should inform recommendations for
practice change.

Table 2. Summary of qualitative study methods

METHOD ADVANTAGES DISADVANTAGES

Focus Group Discussion  Inexpensive  Groups may not represent

 < 2-hour recorded discussion  Quick the larger population

 6–10 non-random respondents  Easy to organize  Successful outcome depends heavily

 2–4 discussions for each  Identifies range of on moderator skills

significant target population beliefs  Recorders may inhibit participants.
 Moderator leads discussion
Respondents have similar
characteristics e.g. age, gender,
social status
 Discussion topics pre-defined
 Informal, relaxed, ambient
 Reveals beliefs, opinions and
motives
In-depth Interviews  Can reveal significant  May generate difficult to manage of
 One-to-one extended interview but unsought data data
 Questions are pre-  Time-consuming and expensive
determined butopen-ended  Bias due to respondent pleasing
 Often covers up to 30 topics interviewer

Corrective measures will vary but may involve staff training, providing aide-memoires,
developing and implementing guidelines, or ensuring availability of appropriate drugs or
diagnostics.

10
 v. Re-assess practices against standards (Sustain improvements)

The audit should be repeated after corrective interventions to measure impact and identify if
further action is needed.

Clinical audit enables participation of all clinical staff in QI activities and is an ideal mechanism
for multidisciplinary teams or department staff to improve performance collaboratively. Ideally
all clinical staff should participate in at least one clinical audit project annually and findings
should be shared across the hospital. All staff should be encouraged to identify potential audits
based on observed clinical activity and outcomes. Similarly, hospital management may
recommend an audit in response to reported outcome measures. For example, a high or
increasing postoperative infection rate may prompt an audit of prophylactic antibiotic use for
surgeries, to identify adherence to guidelines.

The HSQ Directorate/Office should receive all Clinical Audit Reports and maintain a record of
audits undertaken. Participation in clinical audit could be a performance measure for staff
undergoing evaluation, or when assessing department contributions to hospital strategic plans.

If possible, the hospital should appoint a clinical audit officer to support activities, including
helping design protocols and tools, data entry and analysis alongside clinical staff. If this is not
feasible, hospital management should ensure necessary equipment and supplies are available to
audit staff.

The HSQ Directorate/Office should ensure clinical audits occur in the hospital. The Governing
Board may include completed audits as an indicator on the Balanced Scorecard for monitoring
performance.

B. Death Audit

The death audit committee, led by the Chief Clinical Officer (CCO), should consist of members
from the quality unit and other relevant departments. The audits should be conducted regularly,
with deaths being audited at the departmental level. Additionally, it is essential to prioritize the

11
audit of all maternal deaths, given their unique considerations and the need for specialized care.
By following these guidelines, healthcare organizations can effectively identify areas for
improvement and implement necessary changes to enhance patient safety and healthcare
outcomes.

3.3. Quality Improvement Projects

Quality improvement projects in healthcare are systematic, data-driven initiatives to enhance

efficiency, effectiveness, and safety of care delivery processes, ultimately improving patient
outcomes and satisfaction. They involve identifying areas for improvement, implementing
evidence-based interventions, continuously monitoring and evaluating results to ensure sustained
progress.

3.3.1 Quality improvement models

The two selected QI Models to be used in the Ethiopian healthcare are:

1. Kaizen: Engine driving improvement or entry point of all QI activities

2. Model for Improvement: Vehicle that provides structure for improvement

KAIZEN

Focuses on improving efficiency and lowering costs.

Key feature is big results from small changes accumulated over
time.

Implementation steps
5S establishes an ideal workplace for continuous improvement. It is a philosophy and way of
organizing and managing workspace and workflow to improve work efficiency. 5S shall be
conducted systematically with staff participation.

12
 Figure 1: Kaizen/5S

1. Sort: remove unused stuff from working area by:

• Categorizing and color code the items.
• Developing inventory list of categorized items.
• Storing “may be needed” items.
• Regularly sorting of unused items.
• Developing a culture of returning items where they belong.
2. Set in order: organize necessary items in proper order for
easy serviceprovision:
• Labeling/numbering cabinets
• Keeping items in respective areas and labeling them
• Directional arrows to services areas.
• Labeling service rooms.
• Updating equipment/stock inventories.
Note: Rules and regulations must be written and known to all staff

3. Shine: maintain high cleanness standards:

13
 • Routine cleaning and mass cleaning campaigns
• Clean behind and under furniture/equipment
• Clean and attractive environment appreciated by clients
4. Standardize: the first three components set the stage for to
develop and implement standard operating procedures to maintain
good work environment.
• Set up the sort, set and shine as a norm in all sections
• Work instructions
• Standard operating procedures (SOPs)
• Standards and regulations for administrative and technical staff
5. Sustain: train and maintain discipline of engaged staff through
consistent 5S practice:
• Train and maintain staff discipline
• Apply regular self-assessment.

THE MODEL FOR IMPROVEMENT

The model of improvement asks three fundamental questions:

• What are we trying to accomplish?

• What change can we make that will result in improvement?
• How will we know a change is an improvement?

What are we trying to accomplish?

This encourages clear aim-setting. The aim should be:
• Specific – described clearly and precisely, identifying
beneficiaries and achievements
• Measurable – progress can be tracked using data
• Ambitious - may not know how to achieve initially but
shouldn't limit bold targets if aligned with customer
needs/expectations and achievable
• Relevant – meaningful to others if requiring resources or
support

14
 • Time-bound – clear timeframe for achievement

“What change can we make that will result in improvement?”

This prompts thinking about changes that may help achieve the aim - change ideas. Change is
required for improvement, but not all changes result in improvement. Many techniques and tools
can identify successful changes like:

• Benchmarking against better performers to identify differences

• Consulting experts to determine best practices
• Using root cause analysis tools like 5 whys and fishbone
diagrams
• Applying creativity tools such as provocations and random
words to think innovatively
• Checking lists of change concepts to generate ideas
• Mapping key process steps to identify potential improvements

“How will we know the change is an improvement?”

Measurement question means finding a way to demonstrate the aim is achieved - the outcome measure.
Before making changes, the current outcome measure provides a baseline. Observing what happens to the
outcome measure with different changes then shows if there is improvement correlated to the
intervention. A process measure related to the change provides insight into how well it is being
implemented.

Combined with the Plan-Do-Study-Act (PDSA) test cycle, the Model for Improvement is the
foundational framework for successful improvement activities.

15
 Figure 2: The PDSA Cycle, a model for Quality Improvement

Plan – Do – Study – Act cycle (Deming cycle)

Step 1: Plan
• Plan the test, including data collection.
• State the test objective.
• Make predictions about what will happen and why.
• Develop a test plan. (Who? What? When? Where? What data
to collect?)

Step 2: Do
• Try the test on a small scale.
• Carry out the test.
• Document problems and unexpected observations.
• Begin data analysis.

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Step 3: Study
• Refine the change based on learning.
• Compare data to predictions.
• Summarize learning.

Step 4: Act
• Refine the change, based on what was learned from the test.
• Determine modifications needed.
• Prepare next test plan.

PRINCIPLES OF IMPROVEMENT
Fundamental to the success of any improvement effort is the understanding that improvement
requires change - altering how work is done to produce visible, positive differences relative to
goals with lasting impact. Not all changes result in improvement, some just reset things. Doing
more of the same does not necessarily bring change.

TYPES OF CHANGES

Reactive change: needed to maintain current performance

Fundamental change: required to create new performance systems through

redesign and fundamentally altering how the system works.

Fundamental changes that result in improvement

• Alter how work or activities are done

• Produce visible, positive difference relative to historical norms
• Have lasting impact

17
 Improvement is characterized by being faster, easier, more efficient,
effective, less expensive, safer, cleaner, etc. The extent relates directly to the
nature of implemented changes.

DRIVERS OF IMPROVEMENT IN HEALTH CARE

The drivers of Improvement are:

• Will: Desire to change current state to better state.

• Ideas: Developing ideas to improve processes and outcomes.
• Execution: Applying QI theories, tools and techniques
enabling idea implementation.

Figure 3: Drivers of quality improvement in health care

QUALITY PLANNING AND MONITORING

Successful quality improvement programs include four key elements:

1. The Problem
• In-depth understanding of the problem

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 • System-wide buy-in for the initiative and targeted problem
2. The Goal
• Targeted improvements based on a return on investment (ROI) and cost-
benefit analyses
• Key questions when defining goals:
o How does this tie into strategic improvement objectives?
o What will have the biggest patient impact?
o What areas have largest variation?
o What will have the biggest cost impact?
3. The Aim
 Breaks up goal achievement into manageable pieces.
4. The Measures
 Measuring baselines and actuals
 Determining if and how the improvement correlates to
the intervention

3.3.2 Implementing improvement cycle

Health center performance and quality need continuous improvement. The cycle
involves:

19
 Step 6 – Monitor
action plan
Step 1 – Review
progress and
performance and
expected
quality
achievements

Step 5 – Prepare Step 2 –

detailed action plan Identify and
to implement
prioritize
intervention
problems

Step 4 – Select Step 3 – Conduct

interventions root-cause analysis
addressing root-
causes

20
 Figure 4: Quality improvement implementation cycle

Identify the problems and prioritize

From the indicator and issue review in Step 1, list problems needing improvement. Select a
manageable number as monthly priorities. Improving all areas simultaneously may not be possible, so
the facility should choose priority areas for the timeframe before taking improvement actions.

First priority should be problems solved with few resources, followed by more complex, expensive
ones. However, more difficult areas may need addressing first if impact is significant. Performances
related to national & regional priority areas (TB, Malaria, HIV, Maternal and Child health) should be
priority considerations.

Conduct root-cause analysis of the problem

Understanding the causes helps develop appropriate interventions. Targeting changes to causes
enables sustainable improvement versus superficial solutions. Fishbone analysis and flowcharting are
common techniques for identifying root causes.

Fishbone analysis steps

1. Place the problem to be analyzed and improved in a box at the end of a horizontal arrow
2. Categorize major cause areas (policy, process, people, environment, infrastructure) and
connect them to the backbone with diagonal arrows
3. To find secondary, tertiary, etc causes ask "why did this happen?" under each category
4. Repeat until reaching the root cause

Figure 5 illustrates a fishbone diagram analyzing causes of “Low skilled birth attendance in our area”

21
 Figure 5: Fishbone analysis of root causes in quality problems

Flow chart steps

1. Decide beginning and end points of the process to chart
2. Identify process steps
3. Link steps with directional arrows. May also use symbols:

Begin or End

Step Decision

Flow Lines

Connectors

Delays

22
Select interventions that address the root-cause

Following root cause analysis, design an intervention addressing the root cause directly for sustainable
problem-solving versus superficial fixes. When selecting interventions, consider cost and
implementation feasibility.

Prepare detailed action plan, implement the intervention, monitor the progress and expected
achievements

Here, the team prepares an action plan to implement selected interventions and collect relevant
monitoring data using the PDSA cycle. The team should discuss implementation status and evaluate if
the intervention is leading to improvement or requires continuation, modification, or discontinuation.
The cycle then continues.

3.3.3 Measuring change, communicating findings, documenting and recognizing achievements

Along with implementing quality improvement strategies, the care quality level needs continuous
measurement against set goals to track changes. Findings from quality measurement, after analysis,
provide advocacy tools to take further improvement actions - mobilizing resources, creating
competitiveness among providers, and increasing user awareness.

3.3.4 Conclusion - Quality Improvement Project

The above steps may result in a quality improvement project to address specific facility deficiencies
through a strategic approach. The QI project process involves: quality assessment comparing
performance to expectations/standards/goals; identifying gaps and root causes; designing and
implementing best interventions within available resources; and continuous monitoring and evaluation
of outcomes.

3.4 Clinical Risk Management

Risk is the likelihood, from low to high, of somebody or something experiencing harm from an
unwanted event or incident, multiplied by the severity of potential harm. Clinical risk management is
an approach to improving the quality and safety of care by emphasizing identifying circumstances
putting staff/patients at risk of harm and acting to control those risks.

Risk management involves assessing the environment for potential patient and staff risks, then taking
action to minimize identified risks. The risk management process seeks to answer four related
questions:

How bad?

Is there a need for

What can go
action?
wrong?

How often?

Figure 6: Risk management

Risk management proactively reduces identified risks to an acceptable level by creating a culture
founded upon assessment and prevention culture, rather than reaction and remedy. Risk assessment
examines:
 Hazards – situations with potential for cause harm; and
 Risks - defined as the probability a specific adverse event will occur in a timeframe or because of a
situation.

Risk assessment involves 5 steps:

Step 1 Identify hazards (what could go wrong) - Consider past incidents and near misses. Walk around
and discuss with patients and staff. Map/describe the assessed activity. A multidisciplinary team may
be needed.

Step 2 Decide who may be harmed and how (what can go wrong, who is exposed)

Step 3 Evaluate risks (severity, likelihood) and precautions needed - Use a risk matrix like Table 3.

Step 4 Record findings, proposed actions and responsible persons

Step 5 Review and update the risk assessment as needed

Table 3 Risk Assessment Matrix

Catastrophic Yellow Orange Red Red Red

Major Yellow Orange Orange Red Red
Consequence

Moderate Green Yellow Orange Orange Red

Minor Green Yellow Yellow Orange Orange
Negligible Green Green Green Yellow Yellow
Rare Unlikely Possible Likely Almost
certain
Likelihood

Low risk (green) – quick, easy measures should be implemented immediately and
furtheraction planned when resources permit.

Moderate risk (yellow) – actions should be implemented as soon as

possible, but no laterthan one year.

High risk (orange) – actions should be implemented as soon as possible, but no

later thansix months.

Extreme risk (red) – action should be taken immediately.

Hospitals should establish systems for regular risk assessment from healthcare provision and delivery,
ensuring steps are taken to minimize risk. Each department should regularly (quarterly) conduct risk
assessment and identify risk minimization actions. The whole team should be involved in an open,
learning environment. Areas for consideration include, but are not limited to:

 Physical environment – clean, safe, hazard-free?

 Emergency exits clearly labeled and unobstructed?
 Infection prevention policies and procedures adequately implemented?
 Hazardous materials safely and securely stored?
 Equipment in good working order with maintenance minimizing errors and breakdowns?
 Medication administration policies implemented to reduce errors?
 Laboratory policies ensuring correct samples from patients, accurate timely results?
 Clinical guidelines adhered to for evidence-based practice?
A ‘Safety Walk-Round’ is another Risk Management approach. A leadership/quality team visits areas
asking frontline staff about events, contributing factors, near misses, potential problems and solutions.
Issues are then prioritized for the department to develop solutions. This often embeds solutions in the
descriptions, enabling prompt care and safety improvements. It can lead to culture change as frontline
concerns are addressed through ongoing hazard observation and discussion with leadership. Safety
Walk-Rounds are a low-cost way to identify frontline staff concerns and make needed changes without
additional resources.

3.5. Patient focused care

Patient-centered care includes care quality - the compassion, dignity and respect shown. Every patient
wants to be treated as an individual and has rights to courtesy, privacy and confidentiality, and full
information about their condition, investigations and treatments. Patient-centered care involves
planning and delivering quality care in partnership between staff, patients and caregivers. Effective care
balances:
 Consideration
 Talking and Listening

Hospitals should adopt a Patient Rights and Responsibilities Statement readily available to patients like
posting in outpatient/inpatient areas. All staff should be aware of the Statement to treat patients
accordingly.

Patient-centered care also includes quality of hotel services like housekeeping, food services, etc. The
hospital should ensure high standards of these services within the budget by outsourcing to improve
quality and cost-efficiency.

Patient-centered care is improved by analyzing patient satisfaction. Hospital management and

Governing Board should monitor patient perspectives on care through Patient Satisfaction Surveys.
Appendices F and G contain validated Inpatient and Outpatient Satisfaction Surveys. Surveys should be
conducted quarterly with summary results reported to the Board, analyzed, and acted upon through
detailed action plans or linked to QI projects. Results can be included in the hospital’s Balanced
Scorecard. Additionally, staff attitudes and relationships with patients and caregivers should be a
component of performance evaluation. (refer Human Resource Management chapter).
Patient and public involvement in healthcare planning and implementation
Services should be tailored to population needs and expectations. Patient and public perspectives help
identify what works and doesn't in service delivery. Before involvement, important considerations are:
 What information is needed,
 Why their views are needed,
 How their views will be used, and
 What patients/services will gain from this involvement.

Involvement can occur through:

 Informing: where people passively receive information,

 Consulting: where the users of a service are asked to give information or advice, or

 Partnership: involving the public in decision-making.

The involvement level will influence who is involved and the approach. For example, informing the
public about diarrhea management may use posters at the hospital/community or lectures. Establishing
a new child clinic may involve focus groups, surveys or public meetings. Each situation requires
tailored involvement for the purpose. Using multiple approaches gives more people chances to
participate. All approaches have strengths/weaknesses and may overlap.

Health Literacy Desk

Health literacy is understanding and using health information to make informed care decisions.
Hospital health literacy desks significantly help clients learn about their health and make informed care
decisions.

Hospitals should establish a Health Literacy Desk coordinated by an assigned health education focal
point, with additional professionals as needed based on hospital tier. The unit should maintain a register
with patient details like name, address, diagnosis, information provided, contact number, etc.
Preferably, leaflets/posters should be in local languages. Audiovisual materials are also recommended.

3.6. Benchmarking and experience sharing platforms

In 2012 GC, Ethiopia launched the Ethiopian Hospital Alliance for Quality (EHAQ) clustering
hospitals nationwide. Purposes include learning, experience sharing, support, mentoring, resource
sharing and synergy towards improvement.
EHAQ hospitals are evaluated against requirements through self-then external assessment by trained
auditors authorized by the Ministry/Regional Health Bureau. The audit tools introduced in each EHAQ
cycle can be used for training, mentoring and supportive supervision. The national EHAQ audit team
supports hospitals and conducts audits and recognition. EHAQ provides a learning opportunity for
continuous healthcare quality improvement and an ideal mechanism for efficient and effective resource
management.

Additionally, as part of the health system, hospitals should support health centers technically,
materially, and with human resources to improve quality of care.
Source Documents
1. Federal Ministry of Health, Ethiopia. National quality strategy review document; 2021-2025.
2. Department of Health. (2000). An Organisation with a Memory. London, England: Her Majesty’s
Stationary Office.
3. Donabedian, A. (1980). Explorations in Quality Assessment and Monitoring. The Definition of
Quality and Approaches to its Assessment. Vol. I.Ann Arbor, MI: HealthAdministration Press.
4. Federal Democratic Republic of Ethiopia Ministry of Health. (2008, January). Health Management
Information System/Monitoring and Evaluation. Strategic Plan for the Ethiopian Health Sector.
Addis Ababa, Ethiopia.
5. Federal Democratic Republic of Ethiopia Ministry of Health. (2008, August). Performance
Monitoring and Quality Improvement Guideline for the Ethiopian Health Sector. Addis Ababa,
Ethiopia.
6. Haynes AB, et al. A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global
Population. New England Journal of Medicine, 2009; 360:491-9.
7. Institute of Medicine. (1999). To Err is Human. Building a Safer Health System. Washington, DC:
National Academy Press.
8. NHS Quality Improvement Scotland. (2005). National Standards. Clinical Governance and Risk
Management: Achieving Safe, Effective, Patient-Focused Care and Services.
9. Standards Australia and Standards New Zealand. (2004). AS/NZS 4360:2004. Risk Management.
Sydney, NSW. ISBN 0 7337 5904 1.
10. World Health Organization. World Alliance for Patient Safety. (2005). WHO Draft Guidelines for
Adverse Event Reporting and Learning Systems. From information toaction. . Retrieved
from:http://www.who.int/patientsafety/events/05/Reporting_Guidelines.pdf.
11. World Health Organization. Patient Safety, World Alliance for Safer Healthcare.(2009).
Implementation Manual Safe Surgery Checklist 2009. Retrieved
from:http://whqlibdoc.who.int/publications/2009/9789241598590_eng.pdf.
12. World Health Organization. (2009) WHO Guidelines for Safe Surgery 2009: SafeSurgery Saves
Lives. Retrieved from: http://whqlibdoc.who.int/publications/2009/9789241598552_eng.pdf.
Appendices

Appendix A Sample Risk Assessment Template

Date of Risk Assessment: dd/mm/yy

Case Team/Service Area: Example- Operating Theatres

Participants who took part in Risk Assessment: (list names and positions)

Risk Assessment Matrix:

Catastrophic Yellow Orange Red Red Red

Major Yellow Orange Orange Red Red
Consequence

Moderate Green Yellow Orange Orange Red

Minor Green Yellow Yellow Orange Orange
Negligible Green Green Green Yellow Yellow
Rare Unlikely Possible Likely Almost
certain
Likelihood
Hazard identified Consequence(negligibl Likelihood(rare, Category(green, Action to be Responsible Date for
e, minor, moderate, unlikely, possible, yellow, orange, taken person completion of
major, catastrophic) likely, almost red) action
certain)

1. Old broken equipment in Moderate Likely ORANGE Remove Head of Case Within one week
corridor and potential that equipment to Team(name) by dd/mm/yy
patients or staff may trip and maintenance
fall, or injure themselves on department
the items

2.No sharp boxes available Major Likely RED Install sharp Senior Within two days
and potential to cause boxes Nurse(name) by dd/mm/yy
needle-stick injury to staff or
patients

3.Interrupted electrical Catastrophic Possible RED Back-up CEO As soon as

supply potential for failure generator to be possible, no later
of lights, anaesthesia installed than 3 months
machine during surgical dd/mm/yy
procedure and hence patient
harm

4.Shortage of nursing staff Catastrophic Possible ORANGE Add more Case Team Head Within three
to monitor patients in nursing staff to and Head of months, i.e. by
‘recovery’ area and potential department or Human Resource dd/mm/yy
harm due to poor monitoring change skill mix Department
and clinical care of existing staff

5.Lack of pre-surgical Major Possible ORANGE Prepare pre- Senior Within two
checklist and potential for surgical checklist Surgeon(name) months, i.e. by
cancelled surgery because and train ward dd/mm/yy
patient not prepared staff in its use
adequately
Appendix B Sample Statement of Patients’ Rights and Responsibilities

Your Rights and Responsibilities as a Hospital Patient

We consider you a partner in your hospital care. When you are well-informed, participate in treatment
decisions, and communicate openly with your doctor, nurse and other hospital staff, you help make
your care as effective as possible. This hospital encourages respect for the personal preferences and
values of each individual.

While you are a patient in our hospital, your rights include the following:

1. You have the right to considerate, respectful and safe care.

2. You have the right to be well informed about your illness, possible treatments, likely
outcomes and unexpected outcomes and to discuss this information with your doctor.
3. You have the right to know the names and roles of people treating you.
4. You have the right to consent to or refuse a treatment, as permitted by law, throughout
your hospital stay. If you refuse a recommended treatment, you will receive other needed
and available care.
5. You have the right to have an advance directive, such as a living will or health care
proxy. These documents express your choices about your future care or name someone to
decide if you cannot speak for yourself. If you have a written advance directive, you
should provide a copy to the hospital, your family, and your doctor.
6. You have the right to privacy. The hospital, your doctor and others caring for you will
protect your privacy as much as possible.
7. You have the right to expect that treatment records are confidential unless you have given
permission to release information or reporting is required or permitted by law. When the
hospital releases records to others, such as lawyers or insurers, it emphasizes that the
records are confidential.
8. You have the right to review your medical records and to have the information explained,
except when restricted by law.
9. You have the right to expect that the hospital will give you necessary health services to
the best of its ability. Treatment, referral, or transfer may be recommended. If transfer is
recommended or requested, you will be informed of risks, benefits, and alternatives. You
will not be transferred until the other institution agrees to accept you.
10. You have the right to know if this hospital has relationships with outside parties that may
influence your treatment and care. These relationships may be with educational
institutions, other health care providers, or insurers.
11. You have the right to consent or decline to take part in research affecting your care. If
you choose not to take part, you will receive the most effective care the hospital
otherwise provides.
 12. You have the right to be told of realistic care alternatives when hospital care is no longer
appropriate.
13. You have the right to know about hospital rules that affect you and your treatment and
about charges and payment methods. You have the right to know about hospital
resources, such as social and religious services, or ethics committees, that can help you
resolve problems and questions about your hospital stay and care.
14. You have the right to have an autopsy done by a physician who is not affiliated with this
hospital and/or to have it done at an unaffiliated institution. Any person authorized to
give consent for an autopsy will receive this information before signing the consent or
giving consent by telephone.
15. You have the right to be free from all forms of abuse or harassment.

You have responsibilities as a patient.

1. You are responsible for providing information about your health, including past illnesses,
hospital stays, and use of medicine. You are responsible for asking questions when you
do not understand information or instructions. If you believe you can’t follow through
with your treatment, you are responsible for telling your doctor.

2. This hospital works to provide care efficiently and fairly to all patients and the
community. You and your visitors are responsible for being considerate of the needs of
other patients, staff, and the hospital.

3. You are responsible for providing information for insurance and for working with the
hospital to arrange payment, when needed.

4. Your health depends not just on your hospital care but, in the long term, on the decisions
you make in your daily life. You are responsible for recognizing the effect of life-style on
your personal health.

5. A hospital serves many purposes. Hospitals work to improve people’s health; treat people
with injury and disease; educate doctors, health professionals, patients, and community
members; and improve understanding of health and disease. In carrying out these activities,
this institution works to respect your values and dignity.

You have the right to be free from restraints of any form (physical or chemical) and/or seclusionthat are
not medically necessary.
A restraint can only be used if needed to improve your well-being and when less restrictive
interventions have been determined to be ineffective. A restraint may be used to ensure your safety
and/or that of others.

There must be an order for restraints, and that order should never be written as standing or asneeded.
This order must:

be followed by consultation with the treating physician as soon as possible if not ordered
by the treating physician
be in accordance with a written modification to the plan of care
be implemented in the least restrictive manner possible
be in accordance with safe and appropriate restraining techniques
end at the earliest possible time

Your condition must be continually assessed, monitored and revaluated. Staff

involved must have ongoing restraint education and training.

Seclusion is the involuntary confinement of a person where the person is physically prevented from
leaving. A physician or other Licensed Medical Practitioner (LMP) must see and evaluate the need for
the restraint or seclusion within one hour after its initiation.

Time limits exist for which orders for restraint or seclusion are valid, depending upon your age. After
the order expires, the physician or LMP must see and assess you before issuing a new order.

A restraint and seclusion may not be used simultaneously, except in certain situations. For

more information about your rights regarding restraint or seclusion, please contact
………………. (Hospital state the contact person and details here).

Complaints and Grievances

We would like to resolve any concern you might have as soon as possible. Please first discuss it with the
staff looking after you; you may also request to speak to the nurse in charge, assistant manager or
manager. If you are not satisfied with the results, you may contact the …… (Hospitalto specify here).
 Appendix C Sample Patient Satisfaction Survey Tools

Outpatient Assessment of Health Care (O-PAHC) Survey

Survey No. Health Facility Name:

Age Ethiopian Date (DD/MM/YYYY):

Male 1 Female 2

Morning/Afternoon Department:

Strongly
Strongly Disagree Disagree Agree
Agree
1. During this visit, nurses treated me with
1 2 3 4
courtesy and respect.
2. During this visit, nurses listened carefully to me. 1 2 3 4

3. During this visit, nurses explained things in a

1 2 3 4
way I could understand.
4. During this visit, doctors/health officers treated
1 2 3 4
me with courtesy and respect.
5. During this visit, doctors/health officers listened
1 2 3 4
carefully to me.
6. During visit, doctors/health officers explained
1 2 3 4
things in a way I could understand.
7. I could distinguish between doctors/health
1 Yes 2 No
officers and nurses.
8. The outpatient department was clean. 1 2 3 4

9. The bathrooms/latrines were clean (leave blank

1 2 3 4
if not applicable).
10. I was prescribed new medication at this visit. 1 Yes 2 No, Skip Q11, 12, & 13
11 The staff told me what the medication was for. 1 Yes 2 No
12 The staff described the medications possible
1 Yes 2 No
side effects in a way I could understand.
13 All the medications I needed were available at
1 Yes 2 No
the drug dispensary here.
14 Someone discussed with me what symptoms to
1 Yes 2 No
look out for after I left the health facility.
15. It was easy for me to find my way around the
1 Yes 2 No
facility.

16. On a scale of 0-10 (0 being the worst facility,

10 being the best facility), how would you rate this 0 1 2 3 4 5 6 7 8 9 10
health facility?
Worst… ............................................................................... Best
17. I would recommend this outpatient 1 2 3 4
department/clinic to my friends and family. Definitely no Probably no Probably yes Definitely yes
18. I had to pay for this outpatient visit. 1 Yes 2 No, Skip Q19
19. I consider this outpatient visit too expensive. 1 Yes 2 No
Inpatient Assessment of Health Care (I-PAHC) Survey

Survey # Health Facility Name Department Ward:

Ethiopian Date (DD/MM/YYYY): Age:

Male 1 Female 2

Never Sometimes Usually Always

1. During this health facility stay, how often did nurses treat you
1 2 3 4
with courtesy and respect?
2. During this health facility stay, how often did nurses listen
1 2 3 4
carefully to you?
3. During this health facility stay, how often did nurses explain
1 2 3 4
things in a way you could understand?
4. During this health facility stay, how often did doctors/health
1 2 3 4
officers treat you with courtesy and respect?
5. During this health facility stay, how often did doctors/health
1 2 3 4
officers listen carefully to you?
6. During this health facility stay, how often did doctors/health
1 2 3 4
officers explain things in a way you could understand?
7. I could distinguish between doctors/health officers and nurses. 1 2 3 4

8. During this health facility stay, how often was the room you
1 2 3 4
were sleeping in kept clean?
9. During this health facility stay, how often was the area around
1 2 3 4
you quiet at night?
10. During this health facility stay, how often did you have
1 2 3 4
enough personal privacy?
11. During this health facility stay, did you experience any pain? 1 Yes 2 No, Skip 12 & 13
12. During this health facility stay, how often was your pain well
1 2 3 4
controlled?
13. During this health facility stay, how often did staff do
1 2 3 4
everything they could to help you with your pain?
14. During this health facility stay, were you given any
1 Yes 2 No, Skip 15 & 16
medication that you had not taken before?
15. Before giving you any new medication, how often did staff
1 2 3 4
tell you what the medicine was for?
16. Before giving you any new medication, how often did staff
1 2 3 4
describe possible side effects in a way you could understand?
17. Did anyone discuss with you what symptoms to look out for
1 Yes 2 No
after you left the health facility?
18. Was it easy to find your way around the health facility? 1 Yes 2 No

0 1 2 3 4 5 6 7 8 9
19. On a scale of 0-10 (0 being the worst facility, 10 being the 10
best facility), how would you rate this health facility? Worst
facility................................................ Best
facility
1 2 3 4
20. Would you recommend this health facility to your friends and
Definitely Probably Probably Definitely
family?
no no yes yes
21. Did you have to pay for this health facility stay? 1 Yes 2 No, Skip Q22

22. Do you consider this health facility stay too expensive? 1 Yes 2 No
Appendix D Sample Complaints Management Procedure

Introduction

Any hospital complaint management process tries to answer the following questions:

 How easy is it for patients to make complaints?

 Are patients’ complaints analyzed systematically?
 Do changes occur to the way patients are cared for and treated as a result?
 How are staff trained and supported in patient (customer) care? Communication skills?
Confidentiality issues? Complaints handling?
 Is there recognized customer care practice e.g. codes of conduct?
It is important that all hospitals have an effective complaint management process (referred to as ‘the
complaints system’ in this guide) in place for identifying, receiving, handling and responding
appropriately to complaints and comments patients/service users or persons acting ontheir behalf make in
relation to a service/s or care received.

Even hospitals in high income countries do receive complaints from their service users and
complaints are a fact of hospitals’ business- from minor staff behavioral issues to serious
accusations of incompetence or misconduct.

Patient/client feedback comes in three forms: compliments, comments and complaints. All threeare
worth recording as they act as pointers to what’s going right or wrong within your hospital.

Everybody hears and remembers compliments-although they sometimes seem rarer than comments and
complaints! However, even the negative comments worth your attention too as they can be useful early
warnings of dissatisfaction or a weakness in the hospital delivery servicesystem. Ignoring a negative
comment may lead to a full-blown complaint and take up much of your time and energy.

It is important to remember that whoever receives a complaint is the patient’s or client’s first point of
contact. You will win points both for yourself and the hospital if you seem genuinelyconcerned and
interested in helping to resolve the matter

This guide is designed to help all hospital staff deal with complaints as quickly and effectively aspossible.
It is split into two parts: Section I is for front line staff and contains general tips for all hospital staff
dealing with complaints; Section II deals with general advice for those responsible for hospital policies
and procedures. We hope this guide will help you in handling complaints from the unhappy
patients/clients/service users.
Section I: Dos and don’ts in handling complaints
What is a complaint?

A complaint is a clear expression of dissatisfaction with a given hospital service and it may be:

 A verbal comment serious enough to demand a direct response

 A letter from a client/patient
 A letter on behalf of a patient/client
The must dos at hospital level

For the purposes of assessing, preventing or reducing the impact of unsafe or inappropriatehospital
care, the hospital must:

 Bring the complaints system to the attention of service users and persons acting on their
behalf in a suitable manner and format(including notice/leaflets);
 Provide support to service users and persons acting on their behalf on how to bring a
complaint or make a comment, where such assistance is necessary;
 Ensure that any complaint made is fully investigated and ,so far as reasonably
practicable, resolved to the satisfaction of the service user and person acting on their
behalf and;
 Take appropriate steps to coordinate a response to a complaint where that complaint
relates to care or treatment provided to a service user, and share or notify the appropriate
regulatory body where patient safety has been compromised through professional
misconduct/incompetence/negligence.

Top tips for those handling hospital complaints

Listening to a complaint

The most important thing is to make sure the complainant feel you’re really listening, if you cantake the
time and space to listen properly first time around when a client/patient/family member/friend
complaints to you in person or by phone. It will save a lot of extra time and trouble later on! Here are
some useful tips to bear in mind:
 Stay calm
 Take the client/patient/complainant to a private , seated area or take their call in a quiet
zone
 Thank the client or complainant for bringing the matter to your attention
 Ask them to tell you the full story from the beginning, just listen and keep listening-don’t
interrupt or argue
  Empathize-but it is generally better to avoid phrases such as “I know how you feel”(you
can’t)
 Pick up on key words, e.g., ‘You must have been very worried about x (etc.…)”
 Take notes- and check that the complainant agrees with what you’ve written
 Summarize for the complainant what has been said to make sure you haven’t
misunderstood or missed anything.

Say sorry and mean it

Once you’ve listened carefully, express regret that the complainant is dissatisfied. This is oftenall the
complainant needs, but it must sound genuine. So…
 Be sincere- the person you’re talking to will detect and resent an automatic response
 Remember, an expression of regret will make the complainant feel heard and understood.
It doesn’t mean you are admitting liability-it simply means you are acknowledging the
upset and are ‘sorry that something has happened’, not ‘ sorry it was caused by anyone’s
fault’
 Try not to make apologies on behalf of someone else-or let someone else apologize for
you. The complainant may feel put off and could end up unhappier than before!
 Get the complainant on your side by saying things like, ‘How can we solve the problem?’

Explain quickly and clearly

A prompt and thorough explanation can work wonders too. Here are some key points that might help,
most of which apply to written explanations too:

 Focus on the key issues the complainant is concerned about- and ask in what order they’d
like you to cover them
 Use clear language and explain any health jargon
 Encourage the complainant to ask questions throughout
 Check they have understood, e.g., ‘I’m not sure I’ve put that clearly. Did that make
sense?’
 Ask the complainant if your explanation has answered their concerns
 Reassure them that the matter will be dealt with promptly and that you’ll keep them
informed of progress
 To identity the specific issues of a complaint, it may be helpful to ask the
client/patient/relative to put something in writing
 Never blame other members of staff.
What to do next?

Refer any clinical problems to the hospital medical director or equivalent for university hospitalsas soon
as possible

 Ask the complainant what they’d like you to do at this stage and if possible do it
 If the complaint is now satisfied, record the complaint and how you resolved it and send a
copy to the CG&QI Unit.

What if the complainant isn’t satisfied?

 If the complainant isn’t satisfied, ask if they wish to take the complaint further and
explain the ‘Hospital’s Complaints Procedure’. Give them a copy of the hospital’s
complaints’ leaflet
 Agree a plan within the hospital of what action will be taken by whom and by when
 Look at the root causes of the problem and see if there are any changes you could make
to stop it happening again, e.g.:
- Bringing a policy on what to say when a patient’s appointment has been cancelled
- Putting up a notice in the waiting areas inviting patients and visitors to make comments
on a new change in service, etc.
- Displaying information sheets or TV programs on standard treatments or procedures.
 Tell the complainant which member of the hospital service/case team is going to deal
with the complaint and by when.

How to respond in writing

First send out an immediate, brief letter of acknowledgment (see appendix G for a sample
acknowledgement letter) when you receive a written complaint from a complainant. This shouldinform
the complaint who is going to deal with the complaint and by when.

Remember to respond within 24 hours on receipt of a written complaint and within 28 days toprovide
a full response in writing after a full investigation has been carried out.
Appendix E: A sample hospital’s acknowledgement letter to a complaint

[Complainant name]
[Address 1]
[Address 2]
[Address 3][

[Date]

Dear [Salutation]

RE:

Thank you for the information you have shared with us about < service name> that we receivedon
<date>.

The first step is for <name and position of hospital staff> to look at what you have told us. Wewill
then write to you within <insert date/working days> to inform you about how we will respond to this
information.

A leaflet is enclosed that gives you information about what the Hospital’s Complaint Procedure.

<Additional closing information if appropriate>

Yours sincerely

<Name>
<Job Title>

Encl: Hospital’s Complaint Procedure

Appendix F Hospital’s Complaint Procedure

Most issues can be resolved without you having to make a formal complaint. Try having an
informal chat with your doctor or a member of staff first.
A formal complaint takes time and minor issues are resolved quicker if you just speak to a person on
site. For example, if you are worried about something during your hospital outpatientappointment talk
to one of the nurses or the team leader.
The Federal Ministry of Health calls this informal process 'local resolution' and urges everyoneto see if
things can be solved there and then before they escalate to a real problem.
However, if despite everything this doesn’t solve your problem, or even if it does but you wouldstill like
to make a formal complaint, you should follow the ‘Hospital’s Complaints Procedure’ as described
below.

Giving feedback and comments

Not all issues have to end up with a complaint. Sometimes it is enough to give feedback or leavea
comment. All hospitals do welcome feedback as it will help improve the quality of their services.

You can give feedback about the hospital service or staff in person or in writing and the hospitalmay
respond to your comments.

Stage one: Thinking of making a complaint

If you don't feel like you can solve issues informally then you should make a formal complaint tothe
hospital directly. If you cannot make a complaint yourself, then you can ask someone else to do it for
you.

Every hospital has a complaints procedure. To find out about it, ask a member of staff, look on
the hospital’s noticeboards or website, or contact the “Clinical Governance and Quality
Improvement Unit” for more information. Each hospital has this unit.

What to consider before making a complaint

If you decide to make a complaint it's important to consider what you want to happen. For
example:
 Are you content with an apology?
 Do you want action to be taken against a member of staff?
 Do you want a change to the system?
Whatever action you're seeking, make this clear. Before you make your complaint, make a noteof:

 The relevant events;

 Dates
 Times
  Names and conversations, and include all necessary details.
Your notes will also help you to remember all the details in the future. Processing a complaintcan take
a while, and you might be asked to verify some information at a later stage.

Whether you decide to complain orally or in writing, try to make your explanations as short andclear as
possible. Focus on the main issues, and leave out irrelevant details.

If you can, talk through what you want to say with someone else, or ask them to read whatyou've
written before you send it.

If you complain in writing, keep a copy of everything you give to the hospital, and make a noteof when
you sent it.

Who can help you make a complaint?

Making a complaint can be daunting, but help is available. Ask a hospital staff to show you where the
“Clinical Governance and Quality Improvement Unit” is and they will offer confidential advice, support
and information on health-related matters to patients, their familiesand their carers.

What happens if you are not happy with the hospital response or reply to your written complaint?

If you have already complained to the Case Team Leader/Department Leader/Service Head of the
hospital and you are still unhappy with their response, then contact the hospital manager (address to be
included here). You should provide as much information as possible to allow yourCEO to investigate
your complaint, such as:
 Your name and contact details
 A clear description of your complaint and any relevant times and dates
 Details of any relevant hospital staff or services
 Any relevant correspondence, if applicable
When should I complain?

As soon as possible. Complaints should normally be made within 12 months of the date of theevent
that you're complaining about, or as soon as the matter first came to your attention.
The time limit can sometimes be extended (so long as it's still possible to investigate the complaint). An
extension might be possible, for instance in situations where it would have been difficult for you to
complain earlier, for example, when you were grieving or undergoing trauma.

If you made your complaint to the hospital manager you will receive the findings of the investigation
together with an appropriate apology and the changes or learning that have takenplace as a result of the
investigation.
Stage two: I am not happy with the outcome of my complaint

If you are unhappy with the outcome of your complaint you can refer the matter to the Health
Service Ombudsman, who is independent of the healthcare system and the address is:

………
………

Include the following details in your complaint:

 Your name, address and telephone number
 Name and contact details of anyone helping you with the complaint
 Name and contact details of the hospital you wish to complain about
 The factual details of your complaint (listing the main events and when they
happened)
 Why you think your previous complaint wasn’t resolved to your satisfaction,
and howthis has caused you injustice
 Details of the complaints you've already made to the hospital and the outcome
of their investigations
 Copies of any relevant documents (it's usually helpful to number these and
provide a list)Keep copies of everything you post, and make a note of when you send it.
The Health Service Ombudsman’s decision is final but this does not take away your
human rights to pursue a civil law suit.

How long will it take to complete an enquiry?

We will aim to complete our enquiry within 20 working days. If we are not able to do this, we
will keep you informed of what is happening.

Contact details
Our contact details are –

<Hospital’s contact details>

45
 Chapter 23
Hospital Performance
Monitoring and Reporting

1
Section 1 Introduction
Information Revolution is crosscutting agenda described in Health Sector Transformation Plan II

(HSTP II), which mainly deals with improving culture of data use at all levels of the health
system; to digitalize priority Health Information System (HIS) to improve access and quality of
service, to improve HIS governance.

Health Information System refers to system that captures, stores, manages or transmits
information related to the health of individuals or the activities of organizations, which will
improve health care management decisions at all levels of the health system (WHO, 2017).
Health Information System provides the underpinnings for decision making and improves health
care management decisions at all levels of the health system. The components of HIS are Data
production, compilation, analysis, synthesis, communication and use. Health Information system
serves multiple users and data from different sources are used for multiple purposes at different
levels of the health system.

A well-functioning health information system is one that ensures the production, analysis,
dissemination and use of reliable and timely information on health determinants, health systems
performance and health status. Availability and use of quality information on health
determinants, health systems performance and health status.

Hospital management and Governing Boards play a pivotal role in ensuring the effective
monitoring and reporting of hospital performance. Monitoring, defined as the systematic and
continual collection, analysis, interpretation, and use of data on key aspects of an intervention
and its expected results, serves as a fundamental process in healthcare management. Regular
tracking and reporting of performance are essential to ensure that activities are executed as
planned, contributing to the achievement of national health sector targets and objectives.

The objectives of monitoring encompass various critical aspects:

1. Ensuring Planned Implementation: To verify that activities are progressing as intended

and on schedule, ensuring the faithful execution of annual plans.

2
 2. Maximizing Service Quality, Effectiveness, and Efficiency: To enhance the quality,
effectiveness, and efficiency of healthcare services provided by the hospital.
3. Ensuring Financial Viability: To monitor and ensure the financial viability of the
hospital, contributing to its sustainability.
4. Contribution to National Targets: To guarantee that the hospital aligns its efforts with
national health sector targets and objectives.

This chapter emphasizes the role of the Health Management Information System (HMIS) as a
valuable tool for internal monitoring of hospital performance. It highlights the HMIS's
significance in providing data for hospital management and external oversight by Regional
Health Bureaus (RHBs) and the Federal Ministry of Health (FMOH). Furthermore, the chapter
underscores the pivotal role of the hospital Governing Board in monitoring performance. It
introduces a tool and a set of indicators, the Balanced Scorecard, designed to aid Governing
Boards in effectively fulfilling their monitoring responsibilities. This integrated approach aims to
optimize hospital performance, promote transparency, and contribute to the broader goals of the
national health sector.

3
Section 2: Operational Standards for Monitoring and Reporting
1. The hospital has established Performances Monitoring and Reporting Structure
2. The hospital has a functional Performances Monitoring Committee
3. The Hospitals has daily EMR data monitoring system or equivalent dashboard to track
key clinical and administrative data.
4. The hospital conducts integrated -interdepartmental performance assessment
5. The hospital has regular mechanism to ensure data quality
6. The hospital submits standard complete monthly, quarterly and annual reports to the
relevant higher office within the agreed timelines.
7. The hospital has regular data driven decision making practice
8. Hospital regularly perform HMIS and KPIs capacity building for staff
9. The hospital SMT and GB regularly evaluate HMIS and KPI reports

4
Section 3: Implementation Guidance
3.1 Hospital Monitoring and Reporting with HMIS:

Health Management Information System (HMIS) is the routine collection, aggregation, analysis,
presentation and utilization of health and health related data for evidence based decisions for
health workers, managers, policy makers and others.
Purposes of HMIS
 Availing accurate, timely and complete data to support decision making at each level of
the health system
 Strengthening the use of locally generated data for evidence based decision making

Components of HMIS

1. Information management

Data collection: Recording of health data using individual and family folder, registers, tally
and reporting formats

Data processing: is a process of cleaning, entering and aggregation of data.

Data analysis and presentation: is a process of interpretation and comparison of generated

information in the form of sentence, tables and graphs.

2. Using information for management purposes

Problem identification: identifying problems using key indicators

Prioritizing problems and decision making: Problems identified should be prioritized and
decide what types of actions need to be taken.

Action taking: Implementing the agreed action.

Result monitoring: Assessing the desired result has been achieved.

Establishment of HMIS Unit: Hospitals undertaking the critical task of systematic monitoring
and reporting should first establish a dedicated Health Management Information System (HMIS)
unit. This unit serves as the nerve center for the collection, analysis, and reporting of essential
healthcare data. The establishment of this unit demonstrates a commitment to harnessing the
power of data for performance enhancement.

5
Assignment of HMIS Focal Officer: An equally vital step involves the appointment of an
HMIS focal officer equipped with a clearly defined Job Description (JD). This designated
individual should not only serve as a pivotal member of the Senior Management Team (SMT)
but also be directly accountable to the hospital's Chief Executive Officer (CEO) or Chief
Executive Director (CED). This strategic positioning ensures seamless integration with top-level
leadership.

Infrastructure and Resources: The infrastructure supporting the HMIS unit is critical for its
effective functioning. This includes ensuring the presence of a dedicated or integrated room,
equipped with necessary office furniture, computers, printers, UPS systems, and reliable internet
access. These resources are fundamental to facilitating the seamless operation of the HMIS unit.

Regular Weekly Meetings and Planning: To maintain a structured and proactive approach to
performance monitoring, hospitals should instigate regular weekly meetings among case team
members. These meetings serve as a platform to discuss ongoing monitoring activities and
ensure alignment with the hospital's annual, quarterly, and monthly plans.

HMIS Indicators Implementation: For a successful HMIS implementation, it is imperative to

familiarize hospital staff with the 122 indicators outlined in the system. These indicators span
various categories, including Access to Health Services, Quality of Health Services, and Human
Capital. Furthermore, staff should undergo comprehensive training to ensure proficiency in
HMIS procedures and reporting formats.

By following this comprehensive guide, hospitals can not only establish a robust HMIS
infrastructure but also integrate it into their monitoring and reporting mechanisms. This approach
sets the stage for data-driven decision-making, continuous improvement, and enhanced
healthcare delivery.

3.2 Performance Monitoring Committee (PMC)

A critical component of hospital governance and performance oversight is the establishment of a

functional Performance Monitoring Committee (PMC). The PMC plays a vital role in
systematically monitoring and addressing the hospital's performance to ensure it aligns with set

6
standards and objectives. To assess the effectiveness of the PMC, several key elements should be
considered. Firstly, the presence of an assignment letter and Terms of Reference (TOR) is
crucial, as it defines the committee's responsibilities and scope of activities. These foundational
documents serve as a guiding framework for the PMC's role in monitoring the hospital's
performance.

Additionally, the examination of minutes from consecutive monthly Performance Review Team
(PRT) meetings over the last three months provides insight into the committee's ongoing
activities. These minutes reveal discussions, decisions, and actions taken by the PMC in response
to identified performance issues. A well-documented activity plan demonstrates the committee's
proactive approach to addressing performance challenges, while evidence of implemented
corrective measures signifies the committee's commitment to driving positive changes within the
hospital. In essence, a robust PMC, supported by clear documentation and effective actions,
contributes significantly to the hospital's continuous improvement and adherence to quality
standards.

3.3 Electronic Medical Record (EMR)

Implementing an Electronic Medical Record (EMR) system in hospitals holds paramount

importance in enhancing healthcare delivery, patient safety, and overall operational efficiency.
EMR systems enable real-time data monitoring, ensuring that clinical and administrative
information is readily accessible and up-to-date. This not only streamlines the healthcare
workflow but also contributes to improved patient care through accurate and timely information.
Monitoring and reporting within a hospital become more efficient with the integration of an
EMR system, allowing for quick identification of trends, performance metrics, and areas that
require attention or improvement.

The guiding document for implementing an EMR system in hospitals includes a comprehensive
data monitoring protocol. This protocol outlines the procedures and standards for monitoring and
reporting clinical and administrative data using the EMR system. Access privileges, especially
self-reporting capabilities, are critical aspects to examine, ensuring that relevant personnel have
the appropriate access rights. Verification of the presence of a dashboard dedicated to monitoring
daily service area and administrative data is also crucial. Lastly, collaborative meetings involving

7
the Medical Record Unit, Hospital Service Quality, and Performance Monitoring and Reporting
Unit create a platform for aligning goals, sharing insights, and collectively leveraging the
benefits of the EMR system for enhanced hospital performance.

In essence, the implementation of an EMR system with a robust monitoring and reporting
infrastructure not only modernizes healthcare practices but also fosters a data-driven approach to
hospital management, ultimately leading to improved patient outcomes and operational
excellence.

3.4 Integrated Departmental Performance Assessment

The hospital's commitment to conducting integrated-interdepartmental performance assessments

reflects a proactive approach to ensuring comprehensive and cohesive healthcare services. To
assess the effectiveness of this initiative, it is essential to review three copies of integrated-
interdepartmental assessment reports. These reports serve as a tangible representation of the
hospital's commitment to evaluating its overall performance. During the examination, particular
attention should be paid to verifying whether the assessment reports contain HMIS indicators, as
well as any additional local indicators determined by hospital management. This ensures that the
assessment process aligns with both national standards and the hospital's specific objectives,
capturing a holistic view of performance.

Equally important is the examination of the action measures taken on identified gaps within the
assessment reports. The implementation of strategic actions in response to identified weaknesses
or gaps demonstrates the hospital's dedication to continuous improvement. The effectiveness of
these action measures directly contributes to the hospital's ability to address challenges promptly
and enhance its overall performance. Therefore, assessing the integration of HMIS indicators,
local indicators, and the subsequent action measures is pivotal in gauging the hospital's
commitment to achieving excellence through performance assessments

3.5 Ensuring Data Quality in Hospital Management

Ensuring the quality of data is fundamental to a hospital's commitment to accuracy and reliability
in healthcare information. The regular conduct of Data Quality Assurance (DQA) and Lot
Quality Assurance Sample (LQAS) on a monthly basis serves as a robust mechanism to validate

8
the accuracy and consistency of the collected data. This commitment to data quality should be
evident in the minutes of Performance Monitoring Team (PMT) meetings, highlighting its
integration into the hospital's monitoring and evaluation framework.

During the evaluation, it is crucial to confirm that the LQAS percentage consistently exceeds
85%, indicating a high level of accuracy and reliability in the reported data. This benchmark
serves as a crucial indicator for acceptable data quality, ensuring that the hospital's information is
trustworthy for decision-making processes. Investigating the availability of a protocol for the
triangulation of selected data and corresponding triangulation reports illustrates the hospital's
systematic approach to cross-validating data from different sources, enhancing overall data
quality assurance practices. Additionally, regular supportive supervision of the HMIS
unit/department affirms the hospital's commitment to providing continuous guidance and
oversight to maintain high standards of data quality.

Dimensions of Data Quality and Importance:

Data quality is the state of completeness, validity, consistency, timeliness, accuracy, integrity,
and confidentiality that makes the data appropriate for specific use. Accurate and reliable data
are essential for making informed, evidence-based decisions and modifying healthcare delivery.
Inaccurate data can lead to erroneous understanding and inappropriate decisions, hindering
service improvement. The dimensions of data quality assessment include accuracy, timeliness,
completeness, precision, integrity, reliability, and confidentiality. These dimensions ensure that
data are measured consistently, are timely, complete, precise, and secure, providing a holistic
view of service delivery in the hospital.

Types of Data Quality Assurance Tools and Methodology:

Various data quality assurance tools are available, with Lot Quality Assurance (LQAS), Routine
Data Quality Assurance (RDQA), and Performance of Routine Information System Management
(PRISM) being common. Hospitals are recommended to conduct Lot Quality Assurance (LQAS)
for data quality assurance, with the performance monitoring team, HMIS focal or team, and the
CG&QI team jointly involved in this activity. LQAS, originating as a low-cost quality
assessment methodology, has been applied to assess the quality of health services, including data

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quality. The methodology involves estimating the level of quality based on a small sample size,
ensuring the accuracy and reliability of monthly data reports and subsequent decision-making
processes.

Steps to do Lot Quality Assurance Sample (LQAS):

The Lot Quality Assurance Sample (LQAS) process for estimating the quality of HMIS data
involves several key steps:

1. Identification of Data Elements: Begin by randomly selecting 12 data elements from

different sections of the monthly report form. This random selection ensures a
representative sample, offering an equal opportunity for all data elements to be assessed

2. Data Accuracy Check Sheet: Create a data accuracy check sheet with three columns. In
the first column, record the selected data elements. In the second column, note the figures
from the monthly report form related to these data elements.

Table 1 Data Accuracy Check Sheet

Week for which data accuracy is checked______________
Randomly Selected Data Elements from the monthly Figures from Figures Do figures, from
reporting form the Monthly counted from columns 2 & 3
report form (2) registers Match?
&tallies (3) YES NO
1. Disease cases for a single disease / age / gender group
2. OPD attendance for a single age / gender group
3. Family planning monthly report section
4. Maternal health monthly report section
5. Child health
6. EPI monthly report section
7. Logistics
8. TB (if service provided)
9. HIV/AIDS (if service provided)
TOTAL

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3. Verification from Registers: Retrieve the registers or tally sheets containing the selected data
elements. Count the actual entries in the register or tally for each specific data element and record
these figures in the third column of the check sheet.
4. Comparison and Verification: Compare the figures from the monthly report form (column 2) with
the figures from the registers (column 3). If the numbers match, mark "YES" in the fourth column;
if they don't match, mark "NO."
5. Calculation of Totals: Count the total number of "YES" and "NO" marks. Ensure that the sum of
both totals equals the sample size of 12, verifying the consistency of the comparison process

Table 2: LQAS Decision

Interpretation: the interpretation of the "Yes" column in the Lot Quality Assurance Sample
(LQAS) table is crucial for understanding the accuracy level of Health Management Information
System (HMIS) data. The total number of "Yes" marks directly corresponds to the percentage of
data accuracy, as indicated in the LQAS table. For instance, if the total number of "Yes" marks is
2, it implies that the accuracy level is within the range of 30-35%. Similarly, if the total number
of "Yes" marks is 7, the accuracy level falls within the range of 65-70%.

Setting achievable targets for data accuracy becomes instrumental in monitoring progress over
time. By establishing goals for improvement within a specified period, organizations can track
the monthly increase in correct match numbers, as demonstrated in the LQAS table. The
relationship between the correct match number and the monthly improvement reflects the
ongoing enhancement in the level of data accuracy.

Furthermore, achieving a data accuracy level of 95% is considered a high standard and signifies
a commendable level of precision. Sustaining this high level of accuracy is essential,
emphasizing the need for continuous efforts to maintain the integrity and reliability of HMIS
data.

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It's essential to note that, given a sample size of 12 data elements, the data accuracy ranges
within a +15% margin. For example, if the data accuracy is 30%, the acceptable range extends
from 15% to 45%. This acknowledgment underscores the need for a nuanced understanding of
the data accuracy level, considering the inherent variability within the defined margin.

3.6 HMIS data registration, aggregation and reporting

The Federal Ministry of Health (FMOH) has developed standardized registers, tally sheets,
abstract and reporting formats. An integrated data collection and reporting system provides the
foundation for harmonizing the requirements of information consumers need within and outside
the FMOH. It creates the basis for the harmonization concept (one report).
Used to compile and compare health information in an integrated comparable fashion nationally
and internationally. Hospitals are expected to report disease according to Ethiopian Simplified
Version of International Classification of Diseases, now 11th revision (ESV ICD 11). These
enables standardization and integration of health data specially disease reports. it also Provides
the basis for compiling national mortality and morbidity statistics. The health sector play a key
role in providing statistical information on key health variables to the civil registry and national
statistics office

Ethiopia is among countries to legalize community- and facility-level birth and death notification
and cause of death reporting, under the proclamation number 720/2012 and 1049/2017 of the
Federal Negarit Gazette. These proclamations gives the responsibility to the health sector to
notify birth and death, and cause of death that happen both in the health facilities and
community.

According to the proclamation, if the event happen in the health facility, the physician who
attained the birth and death is responsible to give notification paper for the family who is
responsible to register the event. If the event happen outside the health facility, the lower health
administrative level is responsible to fill birth and death notification paper and give the copy to
respective keble civil registration office. It is also expected that the health sector to print and
distribute birth and death notification materials and follow the performance routinely.

These registries and reporting formats should be correctly filed in order to have quality data at all
levels of the health system. Inappropriate use of the registries will lead to erroneous data entry,
aggregation into reporting formats and poor data quality, unhelpful for planning, decision making
and process improvement. Therefore, correct and appropriate use of the registers and reporting
formats is crucial in maintaining data integrity and quality. The HMIS is designed to generate
different types of reports that can capture important data elements required to monitor and
evaluate health programs in Ethiopia.

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Types of reports by period: Weekly, Monthly, Quarterly, Annual

 Last date of report time for frontline (data owner) is 22

 Last date of report time for HMIS focal through DHIS2 is 26

Types of reports by content:

 OPD disease IPD morbidity and mortality

 Service PHEM

3.7 Promoting Data-Driven Decision-Making in Hospitals

Ensuring the hospital's commitment to data-driven decision-making is pivotal for informed and
effective healthcare management. Several key indicators can be assessed to verify the adoption
of this practice:

1. Regular Trend Analysis:

o Check for the availability of regular trend analyses at each service delivery area
within the hospital. This involves scrutinizing whether the hospital conducts
systematic assessments of trends in various healthcare metrics. Such analyses
provide valuable insights into the performance and effectiveness of different
services over time.
2. Encouragement of Evidence Generation:
o Investigate whether there is a mechanism in place to encourage evidence
generation, particularly through gap-oriented research. This entails assessing the
hospital's commitment to fostering research activities that aim to fill knowledge
gaps and address specific challenges in healthcare delivery.
3. Institutional Quality Improvement (QI) Projects:
o Verify if the hospital has devised institutional Quality Improvement (QI) projects
based on data findings. This involves examining whether the hospital actively
identifies areas for improvement through data analysis and subsequently
implements structured QI initiatives to enhance overall healthcare quality and
outcomes.
4. Linkage of Annual Plan to Historical Performance Data:

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 o Check for the linkage of the hospital's annual plan to facility-specific historical
performance data. This involves assessing whether the hospital's strategic
planning takes into account historical data on performance metrics. This linkage
ensures that the annual plan is informed by past experiences and is aligned with
continuous improvement goals.

In summary, the hospital's commitment to data-driven decision-making can be confirmed by

evaluating the presence of regular trend analyses, mechanisms for evidence generation,
institutional QI projects based on data, and the linkage of the annual plan to historical
performance data. These practices collectively contribute to a culture of continuous improvement
and informed decision-making in healthcare management.

3.8 Ensuring Staff Orientation on HMIS and KPIs in Hospitals

To guarantee that hospital staff are well-versed in Health Management Information System
(HMIS) and Key Performance Indicators (KPIs), several key verification steps can be taken:

1. Staff Awareness of KPIs:

o Check and verify with selected staff regarding their awareness of Key
Performance Indicators (KPIs). This involves assessing whether the hospital staff,
especially those directly involved in service delivery, is knowledgeable about the
specific KPIs relevant to their roles.
2. Availability of Data Owners:
o Check for the availability of designated data owners from each case team or
service area. Data owners are individuals responsible for overseeing and
managing the data related to specific performance indicators. Their presence
ensures accountability and accurate data management.
3. Indicator Determination by Case Teams/Departments:
o Verify whether case teams or departments within the hospital are actively
involved in determining indicators relevant to their areas. The utilization of a
process improvement model can be assessed to ensure that teams are engaged in
selecting, monitoring, and improving performance indicators based on their
unique responsibilities.

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 4. Review of Reports/Minutes:
o View reports and minutes of case team meetings to assess the utilization of
performance data. This involves scrutinizing documented evidence of how case
teams or departments are using performance data during their meetings for
decision-making, improvement planning, and overall performance management.

By conducting these verification steps, the hospital can ensure that staff orientation on HMIS and
KPIs is comprehensive and effective. This, in turn, contributes to a data-driven culture within the
hospital, where staff are not only aware of key indicators but also actively engaged in utilizing
data for continuous improvement in healthcare services.

3.9 Performance evaluation

Effective collaboration between the hospital's Performance Monitoring and Reporting (PMR)
unit and the Governing Board (GB) through the CEO is crucial for informed decision-making
and strategic planning. Regular presentations of core and selected Health Management
Information System (HMIS) and Key Performance Indicators (KPIs) ensure that the Governing
Board is well-informed about the hospital's overall performance. Monthly reports to the hospital
Senior Management Team (SMT) contribute to continuous monitoring and allow for timely
interventions. Furthermore, the presentation of core indicators in a 'user-friendly' manner as a
Balanced Scorecard (BSC) to the Governing Board on a quarterly basis enhances transparency
and facilitates the understanding of complex data. This strategic alignment fosters a shared
understanding of hospital performance, promotes accountability, and empowers the Governing
Board to make well-informed decisions that positively impact patient care and organizational
efficiency.

The implementation of this collaborative reporting process involves establishing a systematic

approach for the PMR unit to present comprehensive HMIS and KPI reports to the hospital SMT
on a monthly basis. This requires a well-defined communication channel and reporting schedule.
Additionally, the identification and presentation of core indicators in a Balanced Scorecard
format for the Governing Board demand careful consideration of the indicators' relevance and
significance. The PMR unit should ensure that the presentation is tailored to the Governing
Board's needs, providing a clear snapshot of performance trends. This may involve the use of

15
visual aids, concise summaries, and comparisons against benchmarks. Regular training sessions
for the PMR unit and relevant hospital staff can enhance the effectiveness of this reporting
mechanism, ensuring that data is not only accurate but also communicated in a manner that
facilitates strategic decision-making at the governance level.

3.9.1 Role of the Governing Board to monitor hospital performance

The hospital Governing Board is responsible to direct and supervise the overall activities of the
hospital, to provide proper financial oversight, to ensure adequate resources for hospital
operations, and to ensure that the hospital provides services to the highest possible standard in an
environment that is safe for patients, staff and visitors.
As described in Chapter 1 Hospital Leadership, Management and Governance the Governing
Board Fulfils these functions by establishing corporate strategies, plans and policies and by
overseeing the performance of the CEO who is responsible for implementation of these.
The Governing Board cannot and should not monitor day-to-day activities of the hospital.
Similarly, it is not feasible for the Governing Board to review and monitor the full set of HMIS
Indicators for the hospital. None-the-less, the Board must have sufficient information to assure
itself that the hospital is performing to a high standard and that proper mechanisms are in place
to deliver safe, efficient and high quality services. One means to achieve this is to monitor a core
set of indicators of hospital performance.

Ideally, the number of indicators should be small and should be presented in a ‘user friendly’
format that aids understanding. The Balanced Scorecard is a tool that can be used by Governing
Boards to achieve this.

3.9.2 The Balanced Scorecard

The Balanced Scorecard (BSC) is a planning, monitoring and evaluation tool that considers
performance in four key areas:
 Customer perspective
 Finance perspective
 Internal processes
 Learning and growth of the organization
The BSC is recommended by the FMOH as a management and measurement tool for all levels of
the health sector. The use of the BSC as a monitoring tool assists Governing Boards to oversee

16
the performance of the hospital. The indicators within the BSC provide only a summary of
hospital performance. The Governing Board should review each BSC report, identifying areas of
good performance and areas of concern and should discuss these with the CEO, seeking
clarification or further information where necessary.
Governing Boards should determine selected indicators within each of the four key areas and
should receive quarterly reports from hospital management on these indicators. (NB Patient
surveys may be conducted on a bi-annual basis, but all other indicators within the BSC should be
reported to the Governing Board as a minimum every quarter). A sample BSC for a hospital
Governing Board is presented in Figure 1 below. In the figure, the additional domain of ‘safety
and quality’ has been added to highlight the importance of patient safety and quality of services
provided. A definition of each indicator presented in Figure 1 is given in Appendix D. An
assessment tool measuring the attainment of the Operational Standards of the Ethiopian Hospital
Transformation Guidelines is presented in tool is presented in the Assessment Handbook.
The BSC can also act as a tool to orient staff to the objectives of the hospital and strengthen staff
engagement with hospital improvement efforts. To achieve this, hospital staff should be oriented
to the BSC and in particular should be familiar with the BSC indicators that will be reviewed by
the Governing Board. The Governing Board may choose to consult with hospital staff when
defining the core set of indicators that will be monitored on the BSC. Staff should understand the
purpose of each indicator and method of data collection in order to strengthen the completeness
and accuracy of the data.
Additionally, each Case Team/Department should set its own objectives (in consultation with
Senior Management) and should monitor its own performance using defined indicators. In this
way, the activities of each Case Team can be aligned with the objectives of the hospital and each
Case Team can be encouraged to improve its own performance.
Hospital management should ensure that there is a monitoring process for all HMIS indicators
but it is not necessary for the Governing Board to review each and every HMIS indicator.
Additionally, the BSC contains indicators that are not part of the HMIS data set but that would be
useful to the Governing Board to effectively govern the hospital.

3.5 Integrated Health Information platform

Integrated health information platform is about enabling data visualization, reporting and
charting across multiple information sources so that data might be used for planning,

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identification and prioritization of problems, performance monitoring, and providing feedback
reports to support transformative and sustainable evidence-based decision making.
No single source can provide sufficient information for monitoring service delivery. Thus, a
service delivery monitoring system relies on multiple sources of data brought together for
analysis and decision-making. Data from routine health facility reporting systems needs to be
supplemented with data from health facility assessments, etc. In addition, data generated through
facility assessments should be complemented or cross-checked with data from other sources,
such as the databases of health workers, infrastructures, equipment, and procurement, which are
often available in various departments of the hospital. This can serve as complementary or
benchmarking material for data on service delivery generated through the routine HMIS.
Health information is often not available to those who are best placed to use it to improve
performance of the health system. Hence, data visibility refers to analysing the health and health-
related data and making accessible different data presentation techniques from display charts in
the health institutions to stakeholders and mass media.
Major Activities that should be exercised to bring data comparability and synthesis practice
across multiple information sources are:
 Improve advanced analytical skill (in depth analysis, data mining)
 Conduct regular self-assessment (PMT establishment & functionality)
 Enhance accountability scorecard system and Pool health and health-related
 Strengthen the decision support system and Improve data triangulation mechanisms
 Implement an integrated platform
 Develop data access protocols for users

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Annex
Appendix A- HMIS indicators by level and frequency of collection

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Appendix B HMIS / M&E Implementation Roles and Responsibilities at Hospitals
1. Obtain sanction for HMIS, Hospital Information System (HIS), and card room posts and hire
staff.
 Optimal
a) HMIS / HIS
a. One person/ 150 patients/clients/ day
b. Professional background: Diploma in HMIS or Medical Records or Statistics
c. Card room: 5 minimum + 1/100 patients/clients/ day
b) Required to begin implementation
a. Minimum 1 full time HMIS professional person.
b. Card room: 5 minimum
2. Establish an HMIS implementation team.
a) Composed of Medical Director (team leader), Medical Administrator, Matron, HMIS staff,
and at least one Disease Prevention and Control and Family Health specialist (MD, HO, or
senior nurse).
b) Prepare Hospital HMIS implementation plan. In the plan, care should be taken to ensure that
all reengineering and personnel requirements are fulfilled before training begins at the
Hospital.
c) Monitor execution of implementation plan and provide guidance and support as necessary.
d) Assist woreda / sub city, regional and FMOH training teams in training and follow-up
supervision.
e) Provide orientation / sensitization to other public sector and civil society organizations as
required.
3. Training.
a) Assist woreda / sub city, regional, and FMOH training team to train all hospital staff.
b) Provide post-training follow-up supervision, in collaboration with regional and federal
training teams, to ensure that training is put into practice.
4. Resource mobilization for all.
a. HMIS and medical statistics staff and their office furnishings, including ICT, if any,
and an HMIS storage area including space for archives and storage of stationery.
b. Budget for hospital HMIS work – stationery, office supplies, and, if appropriate, ICT
consumables (paper, ink cartridges, CDs, etc) and ICT maintenance.

31
 c. Estimate costs, if any, for reengineering card room for integrated medical records
folder and fast track. Estimate costs for additional card room staff needed, if any.
Higher level hospitals request funds from RHB; district hospitals from woreda.
5. Establish a performance monitoring team, as specified in HMIS Information Use Guidelines.
Include HMIS implementation progress on regular management agenda during preparation
phase and monthly / quarterly performance monitoring when the HMIS has been installed.
Conduct meetings with other groups as specified in Harmonization manual.
6. Specific responsibilities of HMIS officer.
a. In collaboration with clinical staff, supervise recording of client/patient information
on cards and registers according to standard.
b. Perform monthly data quality checks
c. Ensure that HMIS reports are completed in a timely fashion
d. Provide tables and charts as needed for performance monitoring team
e. Ensure that display charts, worksheets, and performance monitoring team meeting
minutes are maintained.
f. Establish mechanism for ensuring a supply of HMIS reporting and recording formats.

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Appendix C – Sample BSC for Governing Board and Emergency Room

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Reference
1. Federal Democratic Republic of Ethiopia Ministry of Health (2008, July). Business Process
Reengineering: Policy, Planning and Monitoring & Evaluation Core Process
2. Federal Democratic Republic of Ethiopia Ministry of Health (2008, January). HMIS/M&E.
Strategic Plan for Ethiopian Health Sector
3. Federal Democratic Republic of Ethiopia Ministry of Health (2008, January). HMIS/M&E.
Indicator Definitions. HMIS/M&E Technical Standards Area 1.
4. Federal Democratic Republic of Ethiopia Ministry of Health (2007, May). HMIS/M&E.
Disease Classification for National Reporting. Technical Standards Area 2.
5. Federal Democratic Republic of Ethiopia Ministry of Health. (2008, January). HMIS
Procedures Manual: Data Recording and Reporting Procedures. HMIS/M&E Technical
Standards Area 3. HMIS/M&E.
6. Federal Democratic Republic of Ethiopia Ministry of Health. (2008, January). HMIS/M&E.
Information Use Guidelines and Display Tools. HMIS/M&E Technical Standards Area 4.
7. Federal Democratic Republic of Ethiopia Ministry of Health. (2008, August). Performance
Monitoring and Quality Improvement Guideline for the Ethiopian Health Sector.
8. Federal Democratic Republic of Ethiopia Ministry of Health (2009, June). Performance
Monitoring and Quality Improvement Guideline for the Ethiopian Health Sector. FMOH.

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