3rd Edition NABH Guidebook 2012 New PDF
3rd Edition NABH Guidebook 2012 New PDF
3rd Edition NABH Guidebook 2012 New PDF
Introduction
This is the 3rd edition of NABH standards for hospital accreditation. This supersedes
the previous editions. This is the result of the effort put in by the members of the
Technical Committee. A lot of standards were debated for their relevance and
linkages to the evolution.
The guiding principles for finalisation of the standards have been the experience of
members as assessors on one end and drivers of quality in their role in their own
respective organisations on the other end. In addition, the feedback and inputs
obtained formally and informally from various stakeholders during the revision
exercise formed a very important and major contributory factor for the revision of
various standards. Emphasis was laid on referring to best practices in various
countries with regard to accreditation standards, national and international
guidelines on key areas like infection control, patient safety and quality
improvement.
An utmost effort has been put in to be objective and pragmatic in revising the
standards, keeping an eye on raising the bar. However, formulation and thereafter
revision of the standards, is an on-going and never-ending exercise. Culmination of
a revision exercise is only a step towards evolution to the next level.
There is one major difference in this edition as compared to the previous editions:
the guidebook has been done away with. The interpretation and remark(s) follow
every objective element. It is felt that this would enable hospitals and assessors in
removing any ambiguities with regard to the essence of the standard and/or its
objective elements.
Wherever there are references to documented requirements, it must be clearly
understood that such documentation shall be established, reviewed, controlled and
evidenced to be effectively implemented.
The attention of users of this guideline is drawn to those points identified as
'mandatory'. These shall be identified; data gathered, analysed and interpreted with
the aim of improving the quality system of a hospital. Wherever the word
shall/should is used it is imperative that the organisation implement the same. When
the phrase can/could/preferable is used the organisation would use its discretion and
implement it according to the practicability of the proposed guidance.
In general, the organisation will need to identify, meet requirements of and provide
objective evidence of compliance with the following issues:
1.
2.
3.
4.
5.
Patient related: monitoring safety, treatment standards and quality of care. This
would include effectively meeting the expectation of patients and their
attendants, families and visitors.
Employee related: monitoring competence, on-going training, awareness of
patient requirements and employee satisfaction.
Regulatory related: identifying, complying with and monitoring the effective
implementation of meeting legal, statutory and regulatory requirements.
Organisation policies related: defining, promoting awareness of and ensuring
implementation of, the policies and procedures laid down by the organisation,
amongst staffs, patients and interested parties including visiting medical
consultants.
NABH standards related: identification of how the organisation meets the
NABH standards and the objective elements. Where a part of an element, an
element or a standard cannot be applied in a particular organisation, adequate
explanation and justification must be provided to NABH and its team of
assessors to enable exclusion of applicability. In particular, it must be ensured
that the intent of each chapter of standards is applied.
The accreditation standard is divided into 10 chapters, which have been further
divided into 102 standards and these standards have been further divided into 636
objective elements. Objective elements are measurable components. Objective
elements are required to be met in order to meet the requirement of a particular
standard. Similarly, standards are required to be met in order to meet the
requirement of a particular chapter. Finally, all chapters are deciding factor to say
whether a hospital is meeting the requirements of the Accreditation Standard. In the
beginning of each chapter, intent is given to highlight the summary of the chapter.
The intent statement provides a brief explanation of a chapters rationale, meaning,
and significance. Intent statements may contain detailed expectations of the chapter
that are evaluated in the on-site assessment process. For most of the objective
elements, interpretation is provided just after each one of these. Also, a remark is
given to further elaborate on how that objective element can be met.
These standards are equally applicable to government and private hospitals, and are
applicable to whole organisation. Standards are dynamic and would be under
constant review process. Comments and suggestions for improvement are
appreciated. We seek your support in keeping these standards adequate to the need
of industry.
Dr. Girdhar J Gyani
Secretary General
Quality
Council
of
India
Table of Contents
Sr. No.
Particulars
Page No.
Patient-Centred Standards
01.
05 29
02.
30 63
03.
64 82
04.
83 95
05.
96 111
Organisation-Centred Standards
06.
112 130
07.
131 142
08.
143 159
09.
160 173
10.
174 187
Essential Documentation
188 189
Glossary
190 203
204 205
206 213
214 215
216 252
Summary of Standards
AAC.1. The organisation defines and displays the services that it can provide. AAC.2.
The organisation has a well-defined registration and admission process. AAC.3.
There is an appropriate mechanism for transfer (in and out) or referral of
patients.
AAC.4. Patients cared for by the organisation undergo an established initial
assessment.
AAC.5. Patients cared for by the organisation undergo a regular reassessment.
AAC.6. Laboratory services are provided as per the scope of services of the
organisation.
AAC.7. There is an established laboratory-quality assurance programme.
AAC.8. There is an established laboratory-safety programme.
AAC.9. Imaging services are provided as per the scope of services of the
organisation.
AAC.10.There is an established quality-assurance programme for imaging services.
AAC.11.There is an established radiation-safety programme.
AAC.12.Patient care is continuous and multidisciplinary in nature.
AAC.13.The organisation has a documented discharge process.
AAC.14.Organisation defines the content of the discharge summary.
*
This
implies
that
this
objective
element
requires
documentation.
Standard
National Accreditation Board for Hospitals and Healthcare Providers
Documented policies and procedures are used for registering and admitting
patients. *
Interpretation: Organisation shall prepare document(s) detailing the policies
and procedures for registration and admission of patients which should also
include unidentified patients.
All patients who are assessed in the hospital shall be registered.
Remark(s): All admissions must be authorised by a doctor.
Standard
AAC.3. There is an appropriate mechanism for transfer (in and out) or referral of
patients.
Objective Elements
a. Documented policies and procedures guide the transfer-in of patients to the
organisation. *
Interpretation: This shall address both planned and unplanned transfers.
Remark(s): For unplanned transfers and in case of suspected unstable
patients, the organisation could send a trained ACLS person with the
ambulance. However, this shall be guided by the information received.
b. Documented policies and procedures guide the transfer-out/referral of unstable
patients to another facility in an appropriate manner. *
National Accreditation Board for Hospitals and Healthcare Providers
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11
Remark(s): This shall include patients being transferred both for diagnostic
and/or therapeutic purposes.
Standard
AAC.4. Patients cared for by the organisation undergo an established initial
assessment.
Objective Elements
a. The organisation defines and documents the content of the initial assessment for
the outpatients, in-patients and emergency patients. *
Interpretation: The organisation shall have a format using which a
standardised initial assessment of patients is done in the OPD, emergency
and in-patients. The initial assessment could be standardised across the
hospital or it could be modified depending on the need of the department.
However, it shall be the same in that particular area, e.g. in paediatric OPD
the weight and height may be a must, whereas it may not be so for
orthopaedics OPD. In emergency department, this shall include recording the
vital parameters.
The format shall be designed to ensure that the laid-down parameters are
captured.
Remark(s): Every initial assessment shall contain the presenting complaints,
vital signs (temperature, pulse, BP and respiratory rate) and salient
examination findings (especially of the system concerned).
This shall incorporate initial assessment by doctors and nursing staff in case
of in-patients.
Refer AAC 4e
b. The organisation determines who can perform the initial assessment. *
Interpretation: The assessment could be done by various categories of staff.
The organisation determines who can do what assessment and it should be
the same across the organisation. Assessments are performed by each
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discipline within its scope of practice, registration and applicable laws and
regulations. Only doctors/nurses shall conduct the assessments.
Remark(s): Also refer to HRM 9a.
c. The organisation defines the time frame within which the initial assessment is
completed based on patients needs. *
Interpretation: The organisation has defined and documented the time frame
within which the initial assessment is to be completed with respect to OPD/
emergency/ indoor patients. The time frame shall be from the time that the
patient has registered (or in case of emergency: come to the emergency) till
the time that the initial assessment is documented by the treating consultant.
Remark(s): The time frame shall be reasonable and match with the
organisational resources and patient load. In case of out-patients there could
be a separate timeframe for patients coming with appointment and for walkin patients.
Patients needs mean the condition of the patient.
d. The initial assessment for in-patients is documented within 24 hours or earlier as
per the patients condition as defined in the organisations policy. *
Interpretation: This should cover history, examination including vital signs
and documentation of any drug allergies. It should mention the provisional
diagnosis.
Remark(s): For an admitted patient, if a detailed assessment has been done
earlier (either in OPD within the past seven days or emergency), it need not
be written in detail again. However, there shall be a comment linking the
assessment to the earlier assessment and the findings of all
such
13
Interpretation: This shall identify the nursing needs and also help identify any
special needs of the patient. It shall be completed within a defined time frame.
This assessment shall help in identifying the nursing needs of the patient.
Remark(s): A checklist or template could be used for the same.
f. Initial assessment includes screening for nutritional needs.
Interpretation: The protocol for patients initial assessment should cover
his/her nutritional needs. This is only a screening for nutritional needs and not
a complete assessment. A detailed nutritional assessment shall be done
wherever necessary.
Remark(s): This could be done by the treating doctor/nurse/ dietician.
Questionnaires could be used for the same.
Nutritional screening shall be done for all stable patients including OP and IP.
Where appropriate the organisation could consider providing a nutritional
assessment for out- patients also.
g. The initial assessment results in a documented plan of care.
Interpretation: This shall be documented by the treating doctor or by a
member of his team in the patient record.
Remark(s): For definition of "plan of care" refer to glossary. This is applicable
only for day-care and in-patients.
h. The plan of care also includes preventive aspects of the care where appropriate.
Interpretation: The documented plan of care should cover preventive actions
as necessary in the case and could include diet, drugs etc. In conditions
where it is not possible to incorporate this at the time of assessment (e.g.
diagnosis not made/unclear) the same shall be done as soon as a definite
diagnosis is arrived at.
Remark(s): This could also be done through booklets/patient information
leaflets etc. e.g. diabetes, hypertension.
i. The plan of care is countersigned by the clinician in-charge of the patient within
24 hours.
14
Standard
AAC.5. Patients cared for by the organisation undergo a regular reassessment.
Objective Elements
a. Patients are reassessed at appropriate intervals.
Interpretation: After the initial assessment, the patient is reassessed
periodically and this is documented in the case sheet. The frequency may be
different for different areas based on the setting and the patient's condition,
e.g. patients in ICU need to be reassessed more frequently compared to a
patient in the ward. Reassessments shall also be done in response to
significant changes in patients condition.
Remark(s): Every patient shall be reassessed at least once every day by the
treating doctor.
Reassessments shall also be done for day-care patients (before discharging)
or patients awaiting admission/bed.
b. Out-patients are informed of their next follow-up, where appropriate.
Interpretation: Self-explanatory.
The reassessment notes shall reflect the patients response to treatment and
at a minimum capture the symptoms (change or fresh) and vital signs.
Remark(s): This would not be applicable in cases where patient has come for
just an opinion or the patients condition does not warrant repeat visits.
15
c. For in-patients during reassessment the plan of care is monitored and modified,
where found necessary.
Interpretation: The plan of care shall be dynamic and modified where
necessary by the treating doctor according to the patients condition.
d. Staff involved in direct clinical care document reassessments.
Interpretation: Actions taken under reassessment are documented. The staff
could be the treating doctor or any member of the team as per their domain of
responsibility of care.
At a minimum, the documentation shall include vitals, systemic examination
findings and medication orders.
Remark(s): The nursing staff can document patients vitals.
Only phrases like patient well; condition better would not be acceptable.
e. Patients are reassessed to determine their response to treatment and to plan
further treatment or discharge.
Interpretation: Self-explanatory.
Standard
AAC.6. Laboratory services are provided as per the scope of services of the
organisation.
Objective Elements
a. Scope of the laboratory services are commensurate to the services provided by
the organisation.
Interpretation: The organisation should ensure availability of laboratory
services commensurate to the healthcare services offered by it either by
providing the same in house or by outsourcing. The organisation shall ensure
that these services are available round the clock and patient care does not
suffer.
16
handling,
disposal of specimens, to ensure safety of the specimen till the tests and
retests (if required) are completed. The organisation shall ensure that the
unique identification number is used for identification of the patient. In
addition, it could use another number (for example, lab number) to identify the
sample.
Remark(s): This should be in line with standard precautions. The disposal of
waste shall be as per the statutory requirements (Bio-medical waste
management and handling rules, 1998.)
e. Laboratory results are available within a defined time frame. *
National Accreditation Board for Hospitals and Healthcare Providers
17
Interpretation: The organisation shall define the turnaround time for all tests.
The organisation should ensure availability of adequate staff, materials and
equipment to make the laboratory results available within the defined time
frame.
Remark(s): The turnaround time could be different for different tests and
could be decided based on the nature of test, criticality of test and urgency of
test result (as desired by the treating doctor).
f. Critical results are intimated immediately to the personnel concerned. *
Interpretation: The laboratory shall establish its biological reference intervals
for different tests. The laboratory shall establish and document critical limits
for tests which require immediate attention for patient management and the
same shall be documented. The critical test results shall be communicated to
the personnel concerned and this shall be documented.
Remark(s): If it is not practical to establish the biological reference interval for
a particular analysis the laboratory should carefully evaluate the published
data for its own reference intervals.
g. Results are reported in a standardised manner.
Interpretation: At a minimum, the report shall include the name of the
organisation (or in case of outsourced laboratory, the name of the same), the
patients name, the unique identification number, reference range of the test
(where applicable) and the name and signature of the person reporting the
test result.
Remark(s): All reports from the outsourced laboratory shall incorporate these
features and the organisation shall not alter/modify anything in the report.
In case of outsourced test results, the same shall be on that labs letterhead.
h. Laboratory
tests
not
available
in
the
organisation
are
outsourced
to
18
ii.
of specimens
and
completing
of tests
as
per
iv.
Standard
AAC.7. There is an established laboratory quality assurance programme.
Objective Elements
a. The laboratory quality assurance programme is documented. *
Interpretation: The organisation has a documented quality assurance
programme (preferably as per ISO 15189 Medical laboratories Particular
requirements for quality and competence).
Remark(s): Quality assurance includes internal quality control, external
quality assurance, pre-analytic phase, test standardisation, post-analytic
phase, management and organisation.
The laboratory shall participate in external quality assurance programme
when available. When such programmes are not available, the laboratory
could exchange samples with another laboratory for purposes of peer
comparison.
b. The programme addresses verification and/or validation of test methods. *
Interpretation:
19
Standard
National Accreditation Board for Hospitals and Healthcare Providers
20
Health and
Safety
21
Standard
AAC.9. Imaging services are provided as per the scope of services of the
organisation.
Objective Elements
a. Imaging services comply with legal and other requirements.
Interpretation: The organisation is aware of the legal and other requirements
of imaging services and the same are documented for information and
compliance by all concerned in the organisation. The organisation maintains
and updates its compliance status of legal and other requirements in a regular
manner.
Remark(s): All the statutory requirements are met with such as BARC
clearance, dosimeters, lead sheets, lead aprons, signage, display as per
PNDT act, reports to competent authority, etc.
The organisation shall have an RSO (of appropriate level).
b. Scope of the imaging services is commensurate to the services provided by the
organisation.
Interpretation: Self-explanatory.
Remark(s): For example, a neuro-science centre shall have CT and MRI.
c. The infrastructure (physical and manpower) is adequate to provide for its defined
scope of services.
Interpretation: The equipment available and manpower should be able to
effectively deliver its imaging services.
Remark(s): Reports should not get delayed due to lack of adequate
equipment or manpower (including people authorised to report results).
d. Adequately qualified and trained personnel perform, supervise and interpret the
investigations.
Interpretation: As per AERB guidelines.
National Accreditation Board for Hospitals and Healthcare Providers
22
23
ii.
iii.
iv.
Standard
AAC.10.There is an established quality assurance programme for imaging services.
Objective Elements
a. The quality assurance programme for imaging services is documented. *
Interpretation: Refer to AERB guidelines.
Remark(s): Some examples include congruence of optical and radiation field,
focal spot size, output consistency, leakage rate, etc.
b. The programme addresses verification and/or validation of imaging methods.
Interpretation: This holds true for any in-house developed methods.
c. The programme addresses surveillance of imaging results. *
Interpretation: The head of the department shall periodically assess the
imaging results. This shall be done in a structured manner. The organisation
shall specify the frequency and the sample size that it shall use for the
surveillance.
d. The programme includes periodic calibration and maintenance of all equipment. *
Interpretation: Calibration and maintenance of all equipment shall be carried
out by competent persons.
National Accreditation Board for Hospitals and Healthcare Providers
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25
Standard
AAC.12.Patient care is continuous and multidisciplinary in nature.
Objective Elements
a. During all phases of care, there is a qualified individual identified as responsible
for the patients care.
Interpretation: The organisation shall ensure that the care of patients is
always given by appropriately-qualified medical personnel (resident doctor,
consultant and/or nurse).
Remark(s): Although care may be provided by a team, the hospital record
shall identify a doctor as being responsible for patient care.
b. Care of patients is coordinated in all care settings within the organisation.
Interpretation: Care of patients is co-ordinated among various care-providers
in a given setting viz OPD, emergency, IP, ICU, etc. The organisation shall
26
2)
transfer summary.
e. Transfers between departments/units are done in a safe manner.
Interpretation: The organisation shall ensure that intra-organisation transfers
are done adhering to safe practices. The patients shall be transported in a
safe manner and a proper handover and takeover shall be documented.
f. The patients record(s) is available to the authorised care-providers to facilitate
the exchange of information.
Interpretation: Self-explanatory.
Remark(s): The record could be kept in the nursing station for that area.
g. Documented
procedures
guide
the
referral
of
patients
to
other
departments/specialities. *
Interpretation: The organisation has clearly defined and documented the
procedures to be adopted to guide the personnel dealing with referral of
patients to other departments or specialties
The organisation shall ensure that where appropriate a multi-disciplinary team
shall provide care.
National Accreditation Board for Hospitals and Healthcare Providers
27
Established
criteria
or
policies
should
be
used
to
determine
the
Standard
AAC.13.The organisation has a documented discharge process.
Objective Elements
a. The patients discharge process is planned in consultation with the patient and/or
family.
Interpretation: The patient's treating doctor determines the readiness for
discharge during regular reassessments. The same is discussed with the
patient and family.
b. Documented procedures exist for coordination of various departments and
agencies involved in the discharge process (including medico-legal and
absconded cases). *
Interpretation: The discharge procedures are documented to ensure
coordination amongst various departments including accounts so that the
discharge papers are complete well within time. For MLC the organisation
shall ensure that the police are informed.
Remark(s): In case of discharges not happening on a particular day, the
discharges are planned keeping this in mind.
c. Documented policies and procedures are in place for patients leaving against
medical advice and patients being discharged on request. *
28
Standard
AAC.14.Organisation defines the content of the discharge summary.
Objective Elements
a. Discharge summary is provided to the patients at the time of discharge.
Interpretation: Self-explanatory.
Remark(s): The discharge summary shall be signed by the treating doctor or
a member of his/her team.
b. Discharge summary contains the patients name, unique identification number,
date of admission and date of discharge.
Interpretation: Self-explanatory.
c. Discharge summary contains the reasons for admission, significant findings and
diagnosis and the patients condition at the time of discharge.
Interpretation: Self-explanatory.
d. Discharge summary contains information regarding investigation results, any
procedure performed, medication administered and other treatment given.
Interpretation: Self-explanatory.
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30
31
Summary of Standards
COP 1: Uniform care to patients is provided in all settings of the organisation and is
guided by the applicable laws, regulations and guidelines.
COP 2: Emergency services are guided by documented policies, procedures and
applicable laws and regulations.
COP 3: The ambulance services are commensurate with the scope of the services
provided by the organisation.
COP 4: Documented policies and procedures guide the care of patients requiring
cardio-pulmonary resuscitation.
COP 5: Documented policies and procedures guide nursing care.
COP 6: Documented procedures guide the performance of various procedures.
COP 7: Documented policies and procedures define rational use of blood and blood
products.
COP 8: Documented policies and procedures guide the care of patients in the
Intensive care and high dependency units.
COP 9: Documented policies and procedures guide the care of vulnerable patients
(elderly, physically and/or mentally-challenged and children).
COP 10: Documented policies and procedures guide obstetric care.
COP 11: Documented policies and procedures guide paediatric services.
COP 12: Documented policies and procedures guide the care of patients undergoing
moderate sedation.
COP 13: Documented policies and procedures guide the administration of
anaesthesia.
COP 14: Documented policies and procedures guide the care of patients undergoing
surgical procedures.
National Accreditation Board for Hospitals and Healthcare Providers
32
COP 15: Documented policies and procedures guide the care of patients under
restraints.
COP 16: Documented policies and procedures guide appropriate pain management.
COP 17: Documented policies and procedures guide appropriate rehabilitative
services.
COP 18: Documented policies and procedures guide all research activities.
COP 19: Documented policies and procedures guide nutritional therapy.
COP 20: Documented policies and procedures guide the end of life care.
* This implies that this objective element requires documentation.
33
adopts evidence-based
medicine
and
clinical
practice
34
Standard
COP 2: Emergency services are guided by documented policies, procedures,
applicable laws and regulations.
Objective Elements
a. Policies and procedures for emergency care are documented and are in
consonance with statutory requirements. *
Interpretation: These could include SoPs/protocols to provide either general
emergency care or management of specific conditions, e.g. poisoning.
It shall address both adult and paediatric patients. The procedure shall
incorporate at a minimum identification, assessment and provision of care.
Remark(s): Also refer to AAC 4a. Objective elements b, d shall be
addressed.
All patients coming to the hospital shall be provided basic medical care/
stabilised before transferring them to another centre.
b. This also addresses handling of medico-legal cases. *
Interpretation: The policy shall be in line with statutory requirements w.r.t.
documentation and intimation to police. The organisation shall also define as
to what constitutes an MLC (in accordance with statutory rules).
c. The patients receive care in consonance with the policies.
Interpretation: Self-explanatory.
Remark(s): Poisoning cases, road-traffic accidents, patients with coronary
disease, etc. shall be dealt as per hospital policies and procedures.
d. Documented policies and procedures guide the triage of patients for initiation of
appropriate care. *
Interpretation:
Self-explanatory.
Triage
shall
be
done
only
by
qualified/trained individuals.
Remark(s): This should be based on good clinical practices. For triage refer
to glossary.
35
e. Staff is familiar with the policies and trained on the procedures for care of
emergency patients.
Interpretation: All the staff working in the area should be oriented to the
policies and practices through training/documents. Staff should be trained in
BLS and preferably be trained/well versed in ACLS also.
f. Admission or discharge to home or transfer to another organisation is also
documented.
Interpretation: Self-explanatory.
g. In case of discharge to home or transfer to another organisation a discharge note
shall be given to the patient.
Interpretation: Self-explanatory.
Remark(s): Also refer to AAC 13 and 14. The discharge note shall
incorporate salient features of investigations done and treatment.
Standard
COP 3: The ambulance services are commensurate with the scope of the
services provided by the organisation.
Objective Elements
a. There is adequate access and space for the ambulance(s).
Interpretation: The organisation shall demarcate a proper space for
ambulance(s).This shall be demarcated keeping in mind easy accessibility for
receiving patients and to enable the ambulance(s) to turn around/exit quickly.
b. The ambulance adheres to statutory requirements.
Interpretation: Self-explanatory.
Remark(s): This is in the context of Motor Vehicle Act.
c. Ambulance(s) are appropriately equipped.
Interpretation: This shall be done based on the organisations scope.
36
The
ambulance
shall
be
connected
with
Standard
37
the
COP 4: Documented policies and procedures guide the care of patients requiring
cardio-pulmonary resuscitation.
Objective Elements
a. Documented policies and procedures guide the uniform use of resuscitation
throughout the organisation. *
Interpretation: The organisation shall document the procedure for same.
This shall be in consonance with accepted practices. Where appropriate, it
shall address adult, paediatric and neonatal patients.
The organisation shall ensure that adequate and appropriate resources (both
men and material) are provided.
Remark(s): The protocols could be displayed prominently in critical areas
such as emergency, ICU, OT, etc.
b. Staff providing direct patient care is trained and periodically updated in cardiopulmonary resuscitation.
Interpretation: These aspects shall be covered by hands on training. If the
organisation has a CPR team (e.g. code blue team) it shall ensure that it is
trained in ACLS and is present in all shifts.
Remark(s): All doctors, rehabilitation staff and nursing staff must at least be
trained to provide BLS.
All doctors and nurses working in intensive care/high dependency units
should undergo appropriate training (ACLS or PALS or NALS).
c. The events during a cardio-pulmonary resuscitation are recorded.
Interpretation: In the actual event of a CPR or a mock drill of the same, all
the activities along with the personnel attended should be recorded.
Remark(s): This could be done using the pre-defined procedural checklist
and by monitoring if the prescribed activity has been performed properly and
in the right sequence.
d. A post-event analysis of all cardio-pulmonary resuscitations is done by a
multidisciplinary committee.
National Accreditation Board for Hospitals and Healthcare Providers
38
as
possible)
and
include
at
least
one
physician/cardiologist,
anaesthesiologist, one member from the code blue team and nurse.
Remark(s): Analysis should be completed within a defined time frame.
e. Corrective and preventive measures are taken based on the post-event analysis.
Interpretation: Self-explanatory.
Remark(s): Corrective and preventive measures should be completed within
a defined time frame.
During subsequent resuscitations it is preferable that implementation of these
actions is noted and training be modified, if necessary.
Standard
COP 5: Documented policies and procedures guide nursing care.
Objective Elements
a. There are documented policies and procedures for all activities of the nursing
services. *
Interpretation: Self-explanatory.
Remark(s): This could be in the form of a nursing manual incorporating all
nursing procedures.
b. These reflect current standards of nursing services and practice, relevant
regulations and purposes of the services.
Interpretation: Nursing practice is in accordance with nationally accepted
standards and shall include:
i.
ii.
iii.
iv.
39
v.
Standard
COP 6: Documented procedures guide the performance of various procedures.
Objective Elements
a. Documented procedures are used to guide the performance of various clinical
procedures. *
National Accreditation Board for Hospitals and Healthcare Providers
40
in performing
procedures.
Interpretation: Self-explanatory.
Remark(s): The organisation could conduct a clinical audit of various
procedures especially w.r.t. indications.
c. Documented procedures exist to prevent adverse events like wrong site, wrong
patient and wrong procedure. *
Interpretation: The unique hospital ID shall be used for identifying patients.
In addition, the organisation should have a procedure to identify the side of
procedure, where appropriate.
d. Informed consent is taken by the personnel performing the procedure, where
applicable.
Interpretation: Self-explanatory.
The consent shall be taken by the person performing the procedure or a
member of his/her team. In case the procedure is being done by a person in
training, it shall specify the same. All such procedures shall be supervised by
the treating doctor.
e. Adherence to standard precautions and asepsis is adhered to during the conduct
of the procedure.
Interpretation: Self-explanatory.
Remark(s): In case the organisation has a policy of re-using single use
devices it shall ensure that they are properly sterilised. Further, the integrity of
the devices shall be checked. It shall define the number of times it will be reused and develop a mechanism to monitor the same.
f. Patients are appropriately monitored during and after the procedure.
Interpretation: Self-explanatory.
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Standard
COP 7: Documented policies and procedures define rational use of blood and
blood products.
Objective Elements
a. Documented policies and procedures are used to guide rational use of blood and
blood products. *
Interpretation: This shall address the conditions where blood and blood
products can be used. It shall also address inventory and ordering schedules
(planned and unplanned).
b. Documented procedures govern transfusion of blood and blood products. *
Interpretation: This shall at a minimum include how the orders are written
including pre-medications if any (rate needs to be mentioned for paediatric
patients), transport of blood, how the blood/blood product is verified prior to
transfusion, how the patient is identified and how the patient is monitored.
Remark(s): This shall include procedure for availability and transfusion of
blood/blood components for emergency use/in emergency.
A good reference guide is the NABH standards for blood banks.
In case the organisation does not have a blood bank, it shall have an MoU
with a blood bank/organisation having a blood bank and ensure that patient
care does not suffer. Verification, transportation, cold chain and delivery at
42
the right source should be taken care of. Blood shall be transported from the
external blood bank in a safe and proper manner.
c. The transfusion services are governed by the applicable laws and regulations.
Interpretation: Self-explanatory.
Remark(s): Refer to Drugs and Cosmetics Act.
d. Informed consent is obtained for donation and transfusion of blood and blood
products.
Interpretation: Consent should be taken for every transfusion. However, with
the same consent you can give multiple transfusions in the same sitting. For
example, two pints of blood may be transfused serially using the same
consent. However, if the same is given over two days or hours apart, then a
separate consent is required.
Remark(s): Also refer to PRE4 d.
In case of patients who are transfusion dependent (e.g. haemophilia,
thalassemia etc.) the consent can be taken once in six months. However,
before every transfusion a verbal approval shall be taken.
e. Informed consent also includes patient and family education about donation.
Interpretation: Self-explanatory.
Remark(s): This could be in the form of a booklet/leaflet. This has to be given
with the consent form.
f. The organisation defines the process for availability and transfusion of
blood/blood components for use in emergency.*
Interpretation: The organisation shall define as to what constitutes use in
emergency and accordingly develop procedures.
Remark(s): This is applicable even if the organisation doesnt have the blood
bank facility in-house.
It is preferable that the organisation also define the time frame within which
blood must be available for use in emergency.
Use in emergency includes both for emergency use (stand-by) and in
emergency.
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g. Post-transfusion form is collected, reactions if any identified and are analysed for
preventive and corrective actions.
Interpretation: The organisation shall ensure that any transfusion reaction is
reported. It is preferable that the organisation capture feedback regarding
every transfusion (including the ones without reaction) as this would enable it
to capture all transfusion reactions. These are then analysed (by individual/
committee as decided by the organisation) and appropriate corrective/
preventive action is taken. The organisation shall maintain a record of
transfusion reactions.
Remark(s): For transfusion reactions refer to glossary.
h. Staff is trained to implement the policies.
Interpretation: This shall include doctors and can be done either by training
and/or by providing written instructions.
Remark(s): Records of the same should be available.
Standard
COP 8: Documented policies and procedures guide the care of patients in the
intensive care and high dependency units.
Objective Elements
a. Documented policies and procedures are used to guide the care of patients in
the intensive care and high dependency units. *
Interpretation: At a minimum this should include as to how care is organised,
how patients are monitored and the nurse-patient ratio.
Remark(s): This could also incorporate objective elements b, f, g, h.
b. The organisation has documented admission and discharge criteria for its
intensive care and high dependency units. *
Interpretation: The organisation should develop criteria based on physiologic
parameters and adhere to it.
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Standard
National Accreditation Board for Hospitals and Healthcare Providers
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management in these patients and monitoring of these patients (at least twice
a day).
All these patients shall be assessed for risk of falls and the same
documented.
Remark(s): Refer to disability act, mental act.
b. Care is organised and delivered in accordance with the policies and procedures.
Interpretation: Organisation develops SoPs for delivery of care.
c. The organisation provides for a safe and secure environment for this vulnerable
group.
Interpretation: The organisation shall provide proper environment taking into
account the requirement of the vulnerable group.
Remark(s): For example, playroom for children, anti-skid tiles for elderly,
ramps with railings for disabled, etc.
d. A documented procedure exists for obtaining informed consent from the
appropriate legal representative. *
Interpretation: The informed consent for this group of people should be
obtained from their family or legal representative.
Remark(s): Refer to PRE 3e.
e. Staff is trained to care for this vulnerable group.
Interpretation: All staff involved in the care of this group shall be adequately
trained in identifying and meeting their needs.
National Accreditation Board for Hospitals and Healthcare Providers
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Standards
COP 10: Documented policies and procedures guide obstetric care.
Objective Elements
a. There is a documented policy and procedure for obstetric services. *
Interpretation: At a minimum, this shall include assessment of these patients
including nutrition, immunisations and education.
Remark(s): It could include prenatal safety guidelines such as monitoring
standards, labour augmentation bundle, etc.
b. The organisation defines and displays whether high-risk obstetric cases can be
cared for or not.
Interpretation: The organisation shall define as to what constitutes high-risk
obstetric case in consonance with best clinical practices.
Remark(s): The display should be in a prominent location (either near the
entrance or registration counter or near the OPD). This is applicable only if it
cares for such patients.
The organisation caring for high-risk obstetric cases has the facilities to take
care of such mothers.
Refer to AAC 1b also.
c. Persons caring for high-risk obstetric cases are competent.
Interpretation: These shall not just be doctors but shall include nursing staff
also. The competency shall be based on qualification, experience and
training.
Remark(s): It is preferable that persons caring for high-risk obstetric cases
either have adequate experience or additional training for taking care of such
patients.
d. Documented procedures guide provision of ante-natal services. *
Interpretation: This shall at a minimum include assessment, immunisation,
diet counselling and frequency of visits.
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Standard
COP 11: Documented policies and procedures guide paediatric services.
Objective Elements
a. There is a documented policy and procedure for paediatric services. *
Interpretation: At a minimum this shall include assessment of these patients,
organisation of care and addressing special needs.
Remark(s): This could include objective element also.
b. The organisation defines and displays the scope of its paediatric services.
Interpretation: The scope shall also include neonatal services, if any.
Remark(s): The display should be in a prominent location (either near the
entrance or registration counter or near the OPD). Refer to AAC 1b also.
c. The policy for care of neonatal patients is in consonance with the national/
international guidelines. *
Interpretation: Self-explanatory.
Remark(s): There are national and international guidelines available for the
case of neonates by WHO, etc. The hospital should take them into account.
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Standard
National Accreditation Board for Hospitals and Healthcare Providers
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COP 12: Documented policies and procedures guide the care of patients
undergoing moderate sedation.
Objective Elements
a. Documented procedures guide the administration of moderate sedation. *
Interpretation: At a minimum, this shall include identification of procedures
where this is required, the mechanism for writing orders, the pre-procedure
assessment,
monitoring
during
and
after
the
procedure
and
the
50
and
documented
by the
Standard
COP 13: Documented policies and procedures guide the administration of
anaesthesia.
Objective Elements
a. There is a documented policy and procedure for the administration of
anaesthesia. *
Interpretation: Organisation shall document on the indications, the type of
anaesthesia and procedure for the same.
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anaesthesiologist.
Interpretation: Self-explanatory.
52
The patient and/or, family are educated on the risks, benefits, and alternatives
of anaesthesia by the anaesthesiologist.
Remark(s): This shall be separate from the surgery consent.
Also refer to PRE 4d.
f. During anaesthesia monitoring includes regular recording of temperature, heart
rate, cardiac rhythm, respiratory rate, blood pressure, oxygen saturation and end
tidal carbon dioxide.
Interpretation: Self-explanatory.
The same should be documented.
In case of regional anaesthesia instead of end tidal carbon dioxide the
adequacy of ventilation shall be evaluated by continual observation of
qualitative clinical signs.
Anaesthesiologist shall be present throughout the procedure.
Remark(s): In addition, certain other parameters may be monitored on a
case-to-case basis.
The cardiac rhythm may be monitored on a monitor during the procedure and
the same need not be documented. However, in case of rhythm abnormalities
the same shall be documented.
g. Patients post-anaesthesia status is monitored and documented.
Interpretation: This shall be done in the recovery area/OT and at least
include monitoring of vitals till the patient recovers completely from
anaesthesia and shall be done by an anaesthesiologist. If the patients
condition is unstable and he/she requires ICU care the same shall be
monitored there.
h. The anaesthesiologist applies defined criteria to transfer the patient from the
recovery area. *
Interpretation: The organisation documents these criteria which should be
based on physiologic parameters and in consonance with good clinical
practices.
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Standard
COP 14: Documented policies and procedures guide the care of patients
undergoing surgical procedures.
Objective Elements
a. The policies and procedures are documented. *
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55
Interpretation:
This note
provides
information
about the
procedure
are available in
56
Standard
COP 15: Documented policies and procedures guide the care of patients under
restraints (physical and/or chemical).
Objective Elements
a. Documented policies and procedures guide the care of patients under restraints.
Interpretation: This shall clearly state the conditions/circumstances under
which restraints shall be used. It shall also specify as to who can authorise
the use of restraints, the frequency of monitoring these patients and the
validity of restraint orders.
b. These include both physical and chemical restraint measures.
Interpretation: Physical restraints include boxer's bandage, use of cuffs, etc.
Chemical restraints include sedatives.
c. These include documentation of reasons for restraints.
Interpretation: Self-explanatory.
d. These patients are more frequently monitored.
Interpretation: The organisation shall specify the parameters and frequency
of monitoring and accordingly implement the same.
e. Staff receives training and periodic updating in control and restraint techniques.
Interpretation: Self-explanatory.
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policies
appropriate
pain
management.
Objective Elements
a. Documented policies and procedures guide the management of pain. *
Interpretation: It shall include as to how patients are screened for pain, the
mechanism to ensure that a detailed pain assessment is done (when
necessary), pain mitigation techniques and monitoring.
b. All patients are screened for pain.
Interpretation: Every patient entering the hospital shall be screened for pain.
Pain shall be considered the fifth vital sign.
Remark(s): This could be done by incorporating a sub-heading in the initial
assessment for pain.
c. Patients with pain undergo detailed assessment and periodic re-assessment.
Interpretation: A detailed pain assessment is done when pain is the
predominant (or one of the main) symptom(s). It shall be done for all postoperative patients.
The pain assessment shall include intensity of pain (can be done using a
pain-rating scale), pain character, frequency, location, duration and referral
and/or radiation.
The assessment should be done in an objective manner so that it facilitates
regular reassessment.
Remark(s): For example, cancer pain, neuralgia and arthralgia.
This does not include chest pain due to angina or where the aetiology of pain
is physiological like labour pain.
d. The organisation respects and supports management of pain for such patients.
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Interpretation: Self-explanatory.
In case the hospital does not have facilities for pain management it could
refer such patients to centres specialising in pain management.
Remark(s): Pain management includes medical, surgical and anaesthetic
techniques.
e. Patient and family are educated on various pain management techniques, where
appropriate.
Interpretation: Self-explanatory.
Remark(s): This could be done only for patients who are likely to have longterm pain in view of the underlying condition not being treatable.
Standard
COP 17: Documented policies and procedures guide appropriate rehabilitative
services.
Objective Elements
a. Documented policies and procedures guide the provision of rehabilitative
services. *
Interpretation: Self-explanatory.
Remark(s): This includes physiotherapy, occupational therapy and speech
therapy.
b. These services are commensurate with the organisational requirements.
Interpretation: The scope of the departments is in consonance with the
scope of the hospital.
Remark(s): For example, provision of ante-natal and post-natal exercises
could form a part of obstetric rehabilitation programme.
c. Care is guided by functional assessment and periodic re-assessment which is
done and documented by qualified individual(s).
National Accreditation Board for Hospitals and Healthcare Providers
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Standard
COP 18: Documented policies and procedures guide all research activities.
Objective Elements
a. Documented policies and procedures guide all research activities in compliance
with national and international guidelines. *
Interpretation: Self-explanatory.
Any research undertaken in the hospital falls under its ambit. This includes
both funded and non-funded and also student studies.
Remark(s): For example, International Conference on Harmonisation (ICH) of
Good Clinical Practice (GCP) and Declaration of Helsinki Somerset (1996)
and Ethical Guidelines for Biomedical Research on Human Subjects (ICMR2000).
b. The organisation has an ethics committee to oversee all research activities.
60
Standard
COP 19: Documented policies and procedures guide nutritional therapy.
Objective Elements
a. Documented
reassessment. *
61
ii.
iii.
iv.
62
v.
vi.
measures are in place to ensure that flies do not come in contact with
prepared/stored food;
vii.
appropriate food service trolleys (hot food kept hot and cold food kept
cold).
Standard
COP 20: Documented policies and procedures guide the end of life care.
Objective Elements
a. Documented policies and procedures guide the end of life care. *
Interpretation: The organisation has a documented policy and procedure for
providing end of life care to terminally ill-admitted patients. This shall include:
i.
ii.
iii.
iv.
v.
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64
65
66
Summary of Standards
MOM 1: Documented policies and procedures guide the organisation of pharmacy
services and usage of medication.
MOM 2: There is a hospital formulary.
MOM 3: Documented policies and procedures exist for storage of medication.
MOM 4: Documented policies and procedures guide the safe and rational
prescription of medications.
MOM 5: Documented policies and procedures guide the safe dispensing of
medications.
MOM 6: There are documented policies procedures for medication management.
MOM 7: Patients are monitored after medication administration.
MOM 8: Near misses, medication errors and adverse drug events are reported and
analysed.
MOM 9: Documented procedures guide the use of narcotic drugs and psychotropic
substances.
MOM
10:
Documented
policies
and
procedures
guide
the
usage
of
chemotherapeutic agents.
MOM 11: Documented policies and procedures govern usage of radioactive drugs.
MOM 12: Documented policies and procedures guide the use of implantable
prosthesis and medical devices.
MOM 13: Documented policies and procedures guide the use of medical supplies
and consumables.
*
This
implies
that
this
objective
element
requires
documentation.
67
68
Standard
MOM 2: There is a hospital formulary.
Objective Elements
a. A list of medications appropriate for the patients and as per the scope of the
organisations clinical services is developed. *
Interpretation: The organisations formulary shall be prepared and be
preferably updated at regular intervals.
Remark(s): The formulary could be prepared keeping in mind the National
List of Essential Medicines and WHO Model List of Essential Medicines.
Please note that implants also come under drugs. The organisation could look
at the possibility of having department-wise formulary.
b. The list is developed and updated collaboratively by the multidisciplinary
committee.
Interpretation: Self-explanatory.
Remark(s): Refer to MOM 1c.
c. The formulary is available for clinicians to refer and adhere to.
Interpretation: The formulary shall be made available to all treating doctors
of the organisation.
The organisation shall ensure that the prescriptions are as per the formulary.
It shall monitor the frequency of prescriptions being rejected because it
contained non-formulary drugs.
Remark(s): The formulary could be made available in either physical or
electronic form.
d. There is a defined process for acquisition of these medications. *
Interpretation: The process should address the issues of vendor selection,
vendor evaluation, indenting process, generation of purchase order and
receipt of goods.
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Standards
MOM 3: Documented policies and procedures guide the storage of medication.
Objective Elements
a. Documented policies and procedures exist for storage of medication. *
Interpretation: These should address issues pertaining to temperature
(refrigeration), light, ventilation, preventing entry of pests/rodents and vermin. b.
Medications are stored in a clean, safe and secure environment; and
incorporating manufacturers recommendation(s).
Interpretation: The organisation
shall
70
Standard
MOM 4: Documented policies and procedures guide the safe and rational
prescription of medications.
Objective Elements
a. Documented policies and procedures exist for prescription of medications. *
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Interpretation: Self-explanatory.
Remark(s): Refer to MOM 1a. It could also incorporate objective elements
b, f and h.
b. These incorporate inclusion of good practices/guidelines for rational prescription
of medications.
Interpretation: Self-explanatory.
The organisation shall ensure that the clinicians are trained/sensitised on the
rational prescription of medications.
Remark(s): WHO states: Rational use of medicines requires that patients
receive medications appropriate to their clinical needs, in doses that meet
their own individual requirements, for an adequate period of time, and at the
lowest cost to them and their community."
c. The organisation determines the minimum requirements of a prescription. *
Interpretation: Self-explanatory.
This shall adhere to national/international guidelines where appropriate.
At a minimum, the prescription shall have the name of the patient; unique
hospital number; name of the drug, dose, route and frequency of
administration of the medicine; name, signature and registration number of
the prescribing doctor.
Remark(s): A good reference is the Drugs and Cosmetics Act and Code of
Medical Ethics.
d. Known drug allergies are ascertained before prescribing.
Interpretation: Self-explanatory.
Remark(s): It is a good practice to document drug allergies in a prominent
manner in the medical record, both in OP and IP.
e. The organisation determines who can write orders. *
Interpretation: This shall be done by a doctor who at a minimum holds a
MBBS qualification.
Remark(s): The orders written by the treating doctor on the case sheet could
be transcribed by another person onto the indent slip (physical/electronic).
72
international
abbreviations
shall
be used.
Dangerous
In
case
of
medicine
having
two
or
more
drugs
73
ii.
iii.
iv.
v.
74
Interpretation: Self-explanatory.
Standard
MOM 5: Documented policies and procedures guide the safe dispensing of
medications.
Objective Elements
a. Documented policies and procedures guide the safe dispensing of medications. *
Interpretation: Clear policies to be laid down for dispensing of medication,
e.g. route of administration, dosage, rate of administration, expiry date, etc.
Remark(s): This shall include both bulk and retail pharmacy.
Physician samples shall not be sold.
b. The procedure addresses medication recall. *
Interpretation: Recall may result based on letters from regulatory authorities
or internal feedback (e.g. visible contaminant in IV fluid bottle).
c. Expiry dates are checked prior to dispensing.
Interpretation: Self-explanatory.
Remark(s): This shall be done at all levels, e.g. pharmacy, ward, etc.
d. There is a procedure for near expiry medications. *
Interpretation: This procedure shall ensure that near expiry drugs are
withdrawn and that no beyond expiry date medication is available.
Remark(s): The organisation could define as to what constitutes near
expiry. For example, three months prior to the expiry date.
e. Labelling requirements are documented and implemented by the organisation. *
Interpretation: At a minimum, labels must include the drug name, strength,
frequency of administration (in a language the patient understands) and
expiry dates.
Remark(s): This is applicable to all dispensing areas wherein medicines are
dispensed either as cut strips or from bulk containers. It shall also be
applicable where drugs are diluted viz chemotherapy.
National Accreditation Board for Hospitals and Healthcare Providers
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Standard
MOM 6: There
are documented
policies
and
procedures
for
medication
management.
Objective Elements
a. Medications are administered by those who are permitted by law to do so.
Interpretation: Self-explanatory.
Remark(s): Refer to statutory requirements. In addition to doctors, nursing
staff may also administer.
This does not apply to topical administration.
b. Prepared medication is labelled prior to preparation of a second drug.
Interpretation: Self-explanatory.
Remark(s): Applicable only for parenteral drugs, especially for anaesthetic
drug preparation in OTs.
c. Patient is identified prior to administration.
Interpretation: Self-explanatory. Identification shall be done by unique
identification number (e.g. hospital number/IP number, etc.) and/or name.
d. Medication is verified from the order prior to administration.
Interpretation: Staff administering medications should go through the
treatment orders before administration of the medication and then only
administer them. It is preferable that they also check the general appearance
of the medication (e.g. melting, clumping etc.) before dispensing.
Remark(s): If any of the parameters with respect to an order namely name,
dose, route or frequency/time are missing/incomplete
the medication
76
not suffer a verbal order may be got from the treating doctor followed by
ratification of the same (refer to MOM 4i).
In case of high risk medication(s), the verification shall be done by at least
two staff (nurse-nurse or nurse-doctor) independently and documented.
e. Dosage is verified from the order prior to administration.
Interpretation: Self-explanatory.
f. Route is verified from the order prior to administration.
Interpretation: Self-explanatory.
Remark(s): Where applicable the site of administration shall also be verified.
g. Timing is verified from the order prior to administration.
Interpretation: Self-explanatory.
Remark(s): The organisation needs to define the timing of administration of
medications. For example, o.d, b.i.d, t.i.d, q.i.d, h.s.
h. Medication administration is documented.
Interpretation: The organisation shall ensure that this is done in a uniform
location and it shall include the name of the medication, dosage, route of
administration, timing and the name and signature of the person who has
administered the medication.
In case of infusions, it shall capture the start time, the rate of infusion and end
time.
Remark(s): The records shall reflect the actual administration. For example, if
brand Y was given in place of brand X (same generically) the documentation
shall be of brand Y. Similarly, if the order was for a tablet of 250 mg but the
administration was a tablet of 500 mg the latter shall be documented.
i. Documented policies and procedures govern patients self-administration of
medications. *
Interpretation: At the outset the organisation could define if it would permit
self- administration of medications. In case the organisation permits then the
policy shall include the medications which the patient can self-administer. It is
preferable that the organisation also incorporates a method to ensure that the
National Accreditation Board for Hospitals and Healthcare Providers
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Standard
MOM 7: Patients are monitored after medication administration.
Objective Elements
a. Documented policies and procedures guide the monitoring of patients after
medication administration. *
Interpretation: Self-explanatory.
Remark(s): The purpose of monitoring is to verify that the medicine is having
its intended effect. In addition this would help identify near misses, medication
errors and adverse drug events.
b. The organisation defines those situations where close monitoring is required.*
Interpretation: Self-explanatory.
Remark(s): For example, administration of high-risk medicines, concentrated
electrolytes, chemotherapeutic drugs.
c. Monitoring is done in a collaborative manner.
Interpretation: This shall be done by the clinician and nurse.
Remark(s): A clinical pharmacist may also be involved.
d. Medications are changed where appropriate based on the monitoring.
Interpretation: Self-explanatory.
Remark(s): This also includes dose adjustment.
78
Standard
MOM 8: Near misses, medication errors and adverse drug events are reported and
analysed.
Objective Elements
a. Documented procedure exists to capture near miss, medication error and
adverse drug event. *
Interpretation: This shall outline the process for identifying, capturing,
reporting, analysing and taking action.
b. Near miss, medication error and adverse drug event are defined. *
Interpretation: The organisation shall define as to what constitutes these.
This shall be in consonance with best practices.
Remark(s): Refer to glossary for near miss, medication error and adverse
drug event.
c. These are reported within a specified time frame. *
Interpretation: Self-explanatory.
The organisation shall define the time frame for reporting once any of this has
occurred.
d. They are collected and analysed.
Interpretation: All these incidents are analysed regularly by the multidisciplinary committee (refer to MOM 1c).
Remark(s): The analysis shall be completed in a defined time frame.
e. Corrective and/or preventive action(s) are taken based on the analysis where
appropriate.
Interpretation: Self-explanatory.
Standard
79
MOM 9: Documented procedures guide the use of narcotic drugs and psychotropic
substances.
Objective Elements
a. Documented procedures guide the use of narcotic drugs and psychotropic
substances which are in consonance with local and national regulations. *
Interpretation: Self-explanatory.
Refer to MOM 1a.
Remark(s): This is in the context of Narcotic Drugs and Psychotropic
Substances Act.
b. These drugs are stored in a secure manner.
Interpretation: They shall be stored under lock and key with a designated
person being responsible for the same.
c. A proper record is kept of the usage, administration and disposal of these drugs.
Interpretation:
These
shall
be
kept
in
accordance
with
statutory
requirements.
Remark(s): A very strict inventory control shall be kept for these drugs.
d. These drugs are handled by appropriate personnel in accordance with the
documented procedure.
Interpretation: Self-explanatory.
Standard
MOM
10:
Documented
policies
and
procedures
guide
the
usage
of
chemotherapeutic agents.
Objective Elements
a. Documented policies and procedures guide the usage of chemotherapeutic
agents. *
Interpretation: Self-explanatory.
National Accreditation Board for Hospitals and Healthcare Providers
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Remark(s): This could incorporate all the objective elements of this standard.
b. Chemotherapy is prescribed by those who have the knowledge to monitor and
treat the adverse effect of chemotherapy.
Interpretation: This shall preferably be a medical oncologist or a person who
has been trained and has achieved competency in the same.
c. Chemotherapy is prepared in a proper and safe manner and administered by
qualified personnel.
Interpretation: This shall preferably be staff, who has received special
training in preparing and administration.
Remark(s): Where appropriate, a bio-safety cabinet shall be used for
preparing/mixing chemotherapeutic drugs.
d. Chemotherapy drugs are disposed of in accordance with legal requirements.
Interpretation: These shall be disposed of according to BMW management
and handling rules 1998 or manufacturer's recommendation.
Standard
MOM 11: Documented policies and procedures govern usage of radioactive drugs.
Objective Elements
a. Documented policies and procedures govern usage of radioactive drugs. *
Interpretation: Self-explanatory.
Remark(s): The documentation shall include documentation for objective
element c and shall adhere to objective element b.
b. These policies and procedures are in consonance with laws and regulations.
Interpretation: Self-explanatory.
Remark(s): Refer to AERB guidelines.
c. The policies and procedures include the safe storage, preparation, handling,
distribution and disposal of radioactive drugs.
Interpretation: Self-explanatory.
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81
Standard
MOM 12: Documented policies and procedures guide the use of implantable
prosthesis and medical devices.
Objective Elements
a. Usage of implantable prosthesis and medical devices is guided by scientific
criteria
for
each
individual
item
and
national/international
recognised
82
d. The batch and serial number of the implantable prosthesis and medical devices
are recorded in the patients medical record and the master logbook.
Interpretation: Self-explanatory.
Standard
MOM 13: Documented policies and procedures guide the use of medical supplies
and consumables.
Objective Elements
a.
b.
c.
Medical supplies and consumables are stored in a clean, safe and secure
environment; and incorporating manufacturers recommendation(s).
Interpretation: The organisation shall ensure that the storage requirements
are as specified by the manufacturer as are adhered to. This shall be
applicable to all areas where these are stored including wards. They shall be
protected from loss or theft. Overall cleanliness of the storage area shall be
maintained.
d.
83
84
85
Summary of Standards
PRE.1. The organisation protects patient and family rights and informs them about
their responsibilities during care.
PRE.2. Patient rights support individual beliefs, values and involve the patient and
family in decision-making processes.
PRE.3. The patient and/or family members are educated to make informed
decisions and are involved in the care-planning and delivery process.
PRE.4. A documented procedure for obtaining patient and/or familys consent exists
for informed decision making about their care.
PRE.5. Patient and families have a right to information and education about their
healthcare needs.
PRE.6. Patient and families have a right to information on expected costs.
PRE.7. Organisation has a complaint redressal procedure.
* This implies that this objective element requires documentation.
86
87
e. Violation
of
patient
and
family
rights
is
recorded,
rights
have
reviewed
and
Where
patients'
been
infringed
upon,
feedback
form (by
incorporating
patient rights
worded
Standard
PRE.2. Patient rights support individual beliefs, values and involve the patient and
family in decision-making processes.
Objective Elements
a. Patients and family rights include respecting any special preferences, spiritual
and cultural needs.
Interpretation:
This
could
include
dietary
preferences
and
worship
requirements.
b. Patient rights include respect for personal dignity and privacy during examination,
procedures and treatment.
Interpretation: During all stages of patient care, be it in examination or
carrying out a procedure, hospital staff shall ensure that patients privacy and
dignity is maintained. The organisation shall develop the necessary guidelines
for the same.
88
89
PRE.3. The patient and/or family members are educated to make informed
decisions and are involved in the care planning and delivery process.
Objective Elements
a. The patient and/or family members are explained about the proposed care
including the risks, alternatives and benefits.
Interpretation: The plan of care as decided by the doctor on duty or the
patient management team (as the case may be) is to be discussed with the
patient and/or family members. This should be done in a language the
patient/attendant can understand. The above information is to be documented
and signed by the doctor concerned.
b. The patient and/or family members are explained about the expected results.
Interpretation: The patients and/or family members are explained in detail by
the treating physicians or his/her team about the outcomes of such treatment.
National Accreditation Board for Hospitals and Healthcare Providers
90
are explained
complications.
Interpretation: Possible complications of the treatment, if any, are clearly
communicated to the patient and/or family members.
d. The care plan is prepared and modified in consultation with patient and/or family
members.
Interpretation: Self-explanatory.
During the preparation of the care plan the patient and/or family members are
explained about the various treatment options, risks and benefits.
Remark(s): The organisation could develop a structured mechanism to
capture this. The feedback for this could be got at the time of admission and
during the re-assessments.
e. The care plan respects and where possible incorporates patient and/or family
concerns and requests.
Interpretation: The religious, cultural and spiritual views of the patient and/or
family shall be considered during the process of care delivery.
Remark(s): Incorporating patient and/or family requests shall be limited by
the statutory requirements.
f. The patient and/or family members are informed about the results of diagnostic
tests and the diagnosis.
Interpretation: Self-explanatory.
Remark(s): Confidential information like HIV test result shall only be revealed
to the patient.
g. The patient and/or family members are explained about any change in the
patients condition.
Interpretation: Self-explanatory.
Remark(s): This includes improvement, deterioration or occurrence of
complications.
91
Standard
PRE.4. A documented procedure for obtaining patient and/or familys consent exists
for informed decision making about their care.
Objective Elements
a. Documented procedure incorporates the list of situations where informed consent
is required and the process for taking informed consent. *
Interpretation: The process for taking informed consent shall specify the
various steps involved with the responsibility.
A list of procedures should be made for which informed consent should be
taken.
This shall be prepared keeping in mind the requirements of this standard and
statutory requirement. For example, some statutory requirements are MTP
Act, PNDT Act and Organ Transplantation Act.
Remark(s): The policy for HIV testing should follow the national policy on HIV
testing (NACO).
b. General consent for treatment is obtained when the patient enters the
organisation.
Interpretation: Self-explanatory.
c. Patient and/or his family members are informed of the scope of such general
consent.
Interpretation: The organisation shall define as to what is the scope of this
consent and the same shall be communicated to the patient and/or his family
members.
Remark(s): This cannot include consent for invasive procedures or other
procedures for which a specific consent is required as per this standard.
d. Informed consent includes information regarding the procedure, risks, benefits,
alternatives and as to who will perform the requisite procedure in a language that
they can understand.
National Accreditation Board for Hospitals and Healthcare Providers
92
Interpretation: The consent shall have the name of the doctor performing the
procedure. If it is a doctor under training the same shall be specified,
however the name of the qualified doctor supervising the procedure shall also
be mentioned. Consent form shall be in the language that the patient
understands.
e. The procedure describes who can give consent when patient is incapable of
independent decision making. *
Interpretation: The organisation shall take into consideration the statutory
norms. This would include next of kin/legal guardian. The order of preference
is spouse,
son, daughter/brother/sister/parents.
However,
in case
of
taking consent before the procedure (either on the day or the previous
day);
ii.
iii.
taking consent every time (especially for procedures which the patient
has to undergo lifelong;
iv.
taking a fresh consent (for the new procedure) in case the procedure
has to be changed mid-way.
93
Remark(s): In case the patient has to undergo a procedure for a long time
(e.g. dialysis) a fresh consent shall be taken every time. However, this
consent could be verbal. Once in every six months (at a minimum) or
whenever there is fresh information to be provided to the patient a fresh
written informed consent shall be taken.
h. Staff is aware of the informed consent procedure.
Interpretation: Self-explanatory.
It shall be aware of the conditions which require informed consent and the
process for taking informed consent.
Standard
PRE.5. Patient and families have a right to information and education about their
healthcare needs.
Objective Elements
a. Patient and/or family are educated about the safe and effective use of medication
and the potential side effects of the medication, when appropriate.
Interpretation: The organisation shall make a list of such drugs and
accordingly educate, e.g. digoxin. This could also include education regarding
the importance of taking a drug at a specific time, e.g. sustained release
medications.
b. Patient and/or family are educated about food-drug interactions.
Interpretation: Patient and family should be counselled about their diet
during medication, e.g. no alcohol when taking metronidazale.
c. Patient and/or family are educated about diet and nutrition.
Interpretation: Self-explanatory.
d. Patient and/or family are educated about immunisations.
Interpretation: Self-explanatory.
More applicable for paediatric population. In adults it could be for influenza,
Streptococcus pneumonia, typhoid, hepatitis B, Neisseria meningitides, etc.
National Accreditation Board for Hospitals and Healthcare Providers
94
e. Patient and/or family are educated about organ donation, when appropriate.
Interpretation: They should be educated in a very sensitive and courteous
manner.
f. Patient and/or family are educated about their specific disease process,
complications and prevention strategies.
Interpretation: Self-explanatory.
This could also be done through patient education booklets/videos/leaflets,
etc.
This shall include information on lifestyle modifications, diet changes and
immunisations where appropriate.
Remark(s): This is more relevant for chronic conditions.
g. Patient and/or family are educated about preventing healthcare associated
infections.
Interpretation: Self-explanatory.
Remark(s): For example, hand washing and avoiding overcrowding near the
patient.
h. Patient and/or family are educated in a language and format that they can
understand.
Interpretation: Self-explanatory.
Standard
PRE.6. Patient and families have a right to information on expected costs.
Objective elements
a. There is uniform pricing policy in a given setting (out-patient and ward category).
Interpretation: There should be a billing policy which defines the charges to
be levied for various activities.
b. The tariff list is available to patients.
95
Standard
PRE.7. Organisation has a complaint redressal procedure.
Objective elements
a. The organisation has a documented complaint redressal procedure. *
Interpretation: This shall incorporate the mechanism for lodging complaints
(including verbal or telephonic complaints), method of compiling them,
analysing complaints including the time frame, the person(s) responsible and
documenting the action taken.
Remark(s): It is for the organisation to decide if it wants to give credence to
anonymous complaints.
96
b. Patient and/or family members are made aware of the procedure for lodging
complaints.
Interpretation: Self-explanatory. This shall be either by display or providing
written information.
Remark(s): It is important that the organisation creates an environment of
trust wherein the patient would be comfortable to air his/her views.
c. All complaints are analysed.
Interpretation: The entire process shall be documented.
Remark(s): Where appropriate the patient and/or family could be involved in
the discussions and also informed regarding the outcome.
d. Corrective and/or preventive action(s) are taken based on the analysis where
appropriate.
Interpretation: Self-explanatory.
97
98
Summary of Standards
HIC.1. The organisation has a well-designed, comprehensive and coordinated
Hospital Infection Prevention and Control (HIC) programme aimed at
reducing/eliminating risks to patients, visitors and providers of care.
HIC.2. The organisation implements the policies and procedures laid down in the
Infection Control Manual.
HIC.3. The organisation performs surveillance activities to capture and monitor
infection prevention and control data.
HIC.4. The organisation
takes actions
provides
resources for
outbreaks of infections.
HIC.7. There are documented policies and procedures for sterilisation activities in
the organisation.
HIC.8. Bio-medical waste (BMW) is handled in an appropriate and safe manner.
HIC.9. The infection control programme is supported by the management and
includes training of staff and employee health.
*
This
implies
that
this
objective
element
requires
documentation.
99
Objective Elements
a. The hospital infection prevention and control programme is documented which
aims at preventing and reducing risk of healthcare associated infections. *
Interpretation: Self-explanatory.
This shall be based on current scientific knowledge, guidelines from
international/national and professional bodies and statutory requirements,
wherever applicable.
Remark(s): Reference documents could include WHO guidelines, CDC
Guidelines and Manual for Control of Hospital Associated Infections,
Standard Operative Procedures by NACO, Ministry of Health and Family
Welfare, Govt. of India.
b. The infection prevention and control programme is a continuous process and
updated at least once in a year.
Interpretation: The updation shall be done based on newer literature on
infection prevention and outbreak prevention mechanisms, infection trends
and outcomes of the audit processes.
c. The hospital has a multi-disciplinary infection control committee, which coordinates all infection prevention and control activities.
Interpretation:
This
shall
preferably
have
Hospital
Administrator,
100
The committee shall lay down the policies and procedures to guide the
implementation.
Remark(s): The composition, frequency of meetings, minimum quorum
required and the minutes of the meeting shall be documented.
d. The hospital has an infection control team, which coordinates implementation of
all infection prevention and control activities.
Interpretation: The team is responsible for day-to-day functioning of infection
control programme. It shall support surveillance process and detect
outbreaks. It shall also participate in audit activity and in infection prevention
and control on a day-to-day basis.
Remark(s): For the composition of the team refer to WHO, APIC and CDC
guidelines.
The committee and the team shall not be the same. However, the team shall
be represented in the committee.
e. The hospital has designated infection control officer as part of the infection
control team.
Interpretation: This shall be a doctor.
Remark(s): It is preferable that he/she is an infectious diseases specialist.
f. The hospital has designated infection control nurse(s) as part of the infection
control team.
Interpretation: The criteria for designating shall be either by qualification or
based on training.
Remark(s): It is preferable for them to have undergone a short-term training
programme on infection control nursing by a recognised institute.
Standard
HIC.2.
The organisation implements the policies and procedures laid down in the
Infection Control Manual.
101
Objective Elements
a. The organisation identifies the various high-risk areas and procedures and
implements policies and/or procedures to prevent infection in these areas. *
Interpretation: The manual should clearly identify the high-risk areas of the
hospital, e.g. ICU, HDU, OT, post-operative ward, blood bank, CSSD, etc.
Similarly, all high-risk procedures should be identified from infection control
point of view, for example, cardiac catheterisation, endoscopies, surgery
lasting more than two hours, BMT, etc.
The policies and procedures shall be directed at prevention of infection in
these areas and include monitoring.
Remark(s): At a minimum, the manual shall incorporate all the requirements
of this chapter.
b. The organisation adheres to standard precautions at all times. *
Interpretation: Self-explanatory.
Remark(s): Refer to glossary for standard precautions.
c. The organisation adheres to hand-hygiene guidelines. *
Interpretation: The organisation
102
of linen including
blankets (where
applicable).
Remark(s): If outsourced, the organisation shall ensure that it establishes
adequate controls to ensure infection prevention and control.
i. The organisation adheres to kitchen sanitation and food-handling issues. *
Interpretation: Self-explanatory.
This shall be applicable even if this activity is outsourced.
103
(ISO
to architectural
Standard
HIC.3.
Objective Elements
a. Surveillance activities are appropriately directed towards the identified high-risk
areas and procedures.
104
surveillance
system
should
be
appropriate
and
adhering
to
national/international guidelines.
Surveillance activities include areas where demolition, construction or repairs
are undertaken, especially in high-risk areas.
Remark(s): The organisation should use a judicious mix of active and passive
surveillance.
The organisation could lay down the parameters that need to be captured and
the process for reporting.
b. Collection of surveillance data is an on-going process.
Interpretation: The organisation shall ensure that it has a process in place to
collect surveillance data and also to ensure that it is able to capture all such
data.
c. Verification of data is done on a regular basis by the infection control team.
Interpretation: The data collected shall be authenticated by the infection
control team by going through every data or by using random sampling so
that the process can be validated. The team shall preferably verify every
serious infection (as defined by the organisation) report.
d. Scope of surveillance activities incorporates tracking and analysing of infection
risks, rates and trends.
Interpretation: This shall be done at regular intervals (maybe monthly and
consolidated into an annual report) and the organisation shall take suitable
steps based on the analysis.
Remark(s): A simple calculation of infected patients (numerator) provides
only limited information which would be difficult to interpret. Risk factor
analysis would require information for both infected and non-infected patients,
in order to calculate infection and risk-adjusted rates.
105
Standard
106
HIC.4.
Objective Elements
a. The organisation takes action to prevent urinary tract infections.
Interpretation: Self-explanatory.
Remark(s): A good reference is the CDC/WHO/SHEA guidelines.
b. The organisation takes action to prevent respiratory tract infections.
Interpretation: Self-explanatory.
This is especially so for Ventilator Associated Pneumonia.
Remark(s): A good reference is the CDC/WHO/SHEA guidelines.
c. The organisation takes action to prevent intra-vascular device infections.
Interpretation: Self-explanatory.
Remark(s): A good reference is the CDC/WHO/SHEA guidelines.
d. The organisation takes action to prevent surgical site infections.
Interpretation: Self-explanatory.
Remark(s): A good reference is the CDC/WHO/SHEA guidelines.
Standard
HIC.5.
Objective Elements
a. Adequate
and
appropriate
personal
protective
equipment,
soaps,
and
Gloves,
107
ii.
iii.
mask,
iv.
apron,
v.
gown,
vi.
vii.
cap/hair cover.
b. Adequate and appropriate facilities for hand hygiene in all patient-care areas are
accessible to healthcare providers.
Interpretation: The organisation shall ensure that it provides necessary
infrastructure to carry out the same.
Remark(s): Optimal hand-hygiene requirements include large washbasins,
hands-free control, soap and facility for drying hands without contamination.
c. Isolation/barrier nursing facilities are available.
Interpretation: The organisation shall define the conditions where isolation is
required and the conditions wherein barrier nursing or both are required. The
same shall be carried out. The organisation shall ensure that it provides the
necessary resources to carry out the activity (e.g. clothing, masks, gloves,
etc.).
Remark(s): Refer to glossary for isolation/barrier nursing.
Ideally patients requiring isolation (contact, droplet and airborne) should be
placed in isolation rooms and droplet cases be kept in negative pressure
rooms. An air-conditioned single room with an exhaust or a well-ventilated
room is an adequate option for healthcare facilities without negative
pressure rooms. If an air-conditioned single room is not available, a fan can
be placed in the room to direct airflow towards an outside window. The door/s
to the aisle or other rooms should be kept closed at all times. Appropriate
signage shall be used/displayed.
d. Appropriate pre- and post-exposure prophylaxis is provided to all staff members
concerned.
Interpretation: Self-explanatory.
108
Standard
HIC.6.
Objective Elements
a. Organisation has a documented procedure for identifying an outbreak. *
Interpretation: Standard case definitions shall include a unit of time and
place along with specific biological and/or clinical criteria.
Remark(s): To define as to what constitutes an outbreak the organisation
should have baseline rates.
b. Organisation has a documented procedure for handling such outbreaks. *
Interpretation: Organisation shall investigate outbreaks according to the laiddown procedures. This shall be in accordance with good clinical practices.
c. This procedure is implemented during outbreaks.
Interpretation: The organisation should be able to identify the outbreak,
describe the outbreak by developing a case definition, designing a data
collection form, collecting data from the affected, constructing an epidemic
curve.
d. After the outbreak is over appropriate corrective actions are taken to prevent
recurrence.
Interpretation: The organisation should be
109
Standard
HIC.7.
Objective Elements
a. The organisation provides
adequate
zoning for
sterilisation activities.
Interpretation: Adequacy of space refers to the CSSD, which should have
suitable location, proper layout (unidirectional flow, zoning) and separation of
clean and dirty areas.
Sufficient space shall be available to ensure that the activities can be
performed properly.
Remark(s): The organisation shall provide for the same in all areas where
sterilisation activities are carried out. It is preferable to have separate areas
for receiving, washing, cleaning, packing, sterilisation, sterile storage and
issue.
A good reference is Hospital Infection Society India and HTM 2010
guidelines.
b. Documented procedure guides the cleaning, packing, disinfection and/or
sterilisation, storing and issue of items. *
Interpretation: Self-explanatory.
Remark(s): The sterilised/disinfected equipment/sets shall be stored in an
appropriate manner across the organisation and not just in CSSD.
A good reference is CDC Guideline for Disinfection and Sterilisation in
Healthcare Facilities, 2008. Other references include ISO 17665, Health
Technical Memorandum (HTM) 2010 on Sterilisation and Hospital Infection
Society India guidelines.
Objective element c shall also be incorporated in the documentation.
c. Reprocessing of instruments and equipment is covered.
110
Standard
HIC.8.
Objective Elements
a. The organisation adheres to statutory provisions with regard to biomedical waste.
Interpretation: The organisation shall be authorised by the prescribed
authority for management and handling of biomedical waste. The occupier
shall apply in the prescribed form and get approval from the prescribed
authority, e.g. pollution control board/committee.
Remark(s): It shall adhere to the various requirements specified in the biomedical waste management rules.
111
b. Proper segregation and collection of biomedical waste from all patient-care areas
of the hospital is implemented and monitored.
Interpretation: Wastes to be segregated and collected in different colour
coded bags and containers as per statutory provisions. Monitoring shall be
done by members of the infection control committee/team. Biomedical waste
shall be handled in the proper manner.
c. The organisation ensures that biomedical waste is stored and transported to the
site of treatment and disposal in proper covered vehicles within stipulated time
limits in a secure manner.
Interpretation: The waste is transported to the pre-defined site at definite
time intervals (maximum within 48 hours) through proper transport vehicles in
a safe manner.
Remark(s): If this activity is outsourced, the organisation shall ensure that it
is done through an authorised contractor. Monitoring of this activity should be
done by an infection control team.
d. Biomedical waste treatment facility is managed as per statutory provisions (if inhouse) or outsourced to authorised contractor(s).
Interpretation: If the hospital has waste treatment facility within its premises
then it has to be in accordance with statutory provisions or it can outsource it
to a central facility.
Remark(s): Outsourced facility shall be visited by the organisation at least
once in six months to ensure waste disposal according to the BWM rules.
e. Appropriate personal protective measures are used by all categories of staff
handling biomedical waste.
Interpretation: Self-explanatory.
Remark(s): For example, gloves and masks, protective glasses, gowns, etc.
Standard
112
HIC.9.
Objective Elements
a. The management makes available resources required for the infection control
programme.
Interpretation: The organisation shall ensure that the resources required by
the personnel should be available in a sustained manner. This includes both
men and materials.
b. The organisation earmarks adequate funds from its annual budget in this regard.
Interpretation: There shall be a separate budget demarcated for HIC activity.
This shall be prepared taking into consideration the scope of the activity and
previous years experience.
c. The organisation conducts induction training for all staff.
Interpretation: There must be a documented evidence of induction training
for all categories of staff before joining department(s) concerned. It should
include the policies, procedures and practices of the infection control
programme.
Remark(s): Doctors also need to be trained.
d. The organisation conducts appropriate in-service training sessions for all staff
at least once in a year.
Interpretation: Self-explanatory.
113
114
Summary of Standards
CQI.1. There is a structured quality improvement and continuous monitoring
programme in the organisation.
CQI.2. There is a structured patient-safety programme in the organisation.
CQI.3. The organisation identifies key indicators to monitor the clinical structures,
processes
and
outcomes
which
are used
as tools
for continual
improvement.
CQI.4. The organisation identifies key indicators to monitor the managerial
structures, processes and outcomes, which are used as tools for continual
improvement.
CQI.5. The quality improvement programme is supported by the management.
CQI.6. There is an established system for clinical audit.
CQI.7. Incidents, complaints and feedback are collected and analysed to ensure
continual quality improvement.
CQI.8. Sentinel events are intensively analysed.
*
This
implies
that
this
objective
element
requires
documentation.
115
Objective Elements
a. The quality improvement programme is developed, implemented and maintained
by a multi-disciplinary committee.
Interpretation: This committee shall have representation from management,
various clinical and support departments of the organisation. This programme
shall be developed, implemented and maintained in a structured manner.
Remark(s): For example, core committee, quality improvement committee,
etc.
b. The quality improvement programme is documented. *
Interpretation: This should be documented as a manual. The manual shall
incorporate the mission, vision, quality policy, quality objectives, service
standards, important indicators as identified, etc. The manual could be standalone but shall have cross linkages with other manuals.
Remark(s): Refer to AAC 7, AAC 10, COP 8 and COP 14 also.
c. This should be documented keeping in mind requirements of objective elements
d, f, g and i. It should also incorporate the various indicators as required by CQI
3 and 4.There is a designated individual for coordinating and implementing the
quality-improvement programme.
Interpretation: This should preferably be a person having a good knowledge
of
accreditation
standards,
statutory
requirements,
hospital
quality
116
117
The inputs for updation could be based on the review carried out by the
quality improvement committee.
h. Audits are conducted at regular intervals as a means of continuous monitoring.
Interpretation: This audit shall be done by a multi-disciplinary team
(preferably trained in NABH standards) including all the applicable standards
and objective elements. All the areas of the organisation shall be covered. At
the end of the audit, there shall be a formal meeting to summarise the
findings and corrective and preventive measures shall be taken and
documented.
Remark(s): The assessors shall be either trained internally or externally in
NABH standards. They shall assess areas independent of their area of work.
All audits shall be documented.
i. There is an established process in the organisation to monitor and improve
quality of nursing and complete patient care.
Interpretation: Self-explanatory.
Remark(s): This could be done through clinical audits.
CQI.2.
Objective Elements
a. The patient-safety programme is developed, implemented and maintained by a
multi-disciplinary committee.
Interpretation: This committee shall have representation from management,
various clinical and support departments of the organisation. This programme
shall be developed, implemented and maintained in a structured manner.
Remark(s): This committee could be called safety committee.
This committee could have a mix of administrators, engineers, doctors and
nurses.
Refer to glossary for definition of "safety programme".
b. The patient-safety programme is documented. *
118
119
Standard
CQI.3.
improvement.
Objective Elements
National Accreditation Board for Hospitals and Healthcare Providers
120
ii.
iii.
iv.
ii.
Percentage of re-dos.
iii.
iv.
121
ii.
iii.
iv.
ii.
iii.
iv.
122
ii.
iii.
iv.
ii.
iii.
iv.
ii.
Pneumonia rate.
iii.
iv.
123
Mortality rate.
ii.
iii.
iv.
Re-intubation rate.
ii.
iii.
iv.
124
Remark(s): For example, once the reasons for "re-dos have been analysed
and preventive and corrective measures undertaken then data can be
collected to confirm that reductions have occurred in the incidence of "re-dos"
Standard
CQI.4.
Objective Elements
a. Monitoring includes procurement of medication essential to meet patient needs.
Interpretation: The organisation shall develop appropriate key performance
indicators suitable to it. The following is, however, mandatory:
i.
ii.
iii.
iv.
ii.
Incidence of falls.
iii.
iv.
125
ii.
iii.
iv.
Remark(s): Any equipment the failure of which could impede patient care
shall be considered critical. Some examples are ventilators, cardiac monitors
and pulse-oximeter. However, every organisation shall identify its list of
critical equipment and accordingly capture the indicator. The downtime has to
be captured irrespective of whether it has a backup or not.
d. Monitoring includes patient satisfaction which also incorporates waiting time for
services.
Interpretation: The organisation shall develop appropriate key performance
indicators suitable to it. The following is, however, mandatory:
i.
ii.
iii.
and out-patient
consultation.
iv.
Remark(s): Waiting time implies the time taken from the time that the patient
registers to the time taken for assessment to be done by the doctor/
diagnostic procedure to be performed.
Time taken for discharge implies the time from which the doctor writes for
discharge to the time for final clearance.
e. Monitoring includes employee satisfaction.
Interpretation: The organisation shall develop appropriate key performance
indicators suitable to it. The following is, however, mandatory:
i.
ii.
iii.
126
iv.
employee rights,
ii.
iii.
iv.
ii.
iii.
iv.
Remark(s): Missing records include records within the retention time only.
h. Monitoring includes data collection to support further improvements.
Interpretation: The data could be collected at pre-defined intervals, e.g.
monthly/quarterly. This data is analysed for improvement opportunities and
the same are carried out. Also refer to CQI 1f.
Remark(s): For example, waiting time in OPD.
i. Monitoring includes data collection to support evaluation of these improvements.
Interpretation: All improvement activities carried out by the organisation shall
have an evaluable outcome. The same shall be captured and analysed.
Standard
CQI.5.
127
Objective Elements
a. The management makes available adequate resources required for quality
improvement programme.
Interpretation: This shall include the men, material, machine and method.
These should be in steady supply so as to ensure that the programme
functions smoothly.
b. Organisation earmarks adequate funds from its annual budget in this regard.
Interpretation: Appropriate fund allocation is done by the organisation for the
smooth functioning of the programme.
Remark(s): The budget could be earmarked based on previous year's
spending. If no data is available the organisation could make a beginning by
earmarking a budget but reviewing it at the end of six months to make any
necessary modifications.
c. The management identifies organisational performance improvement targets.
Interpretation: The management shall identify organisation and department
level quality objectives, set targets, monitor them (at least once in four
months) and modify the target (at least annually).
Remark(s): The targets should be shared with the faculty and staff and
regular feedback taken.
d. The management
supports
and implements
use of appropriate
quality
Standard
CQI.6.
128
Objective Elements
a. Medical and nursing staff participates in this system.
Interpretation: The organisation shall identify such personnel. It could be a
mix of clinicians, administrators and nurses.
Remark(s): These could be members of the
core
committee/quality
129
Standard
CQI.7.
Objective Elements
a. The organisation has an incident reporting system. *
Interpretation: The incident reporting system includes:
i.
identification
ii.
reporting
iii.
review
iv.
action on incidents
130
At
minimum,
patient
satisfaction
levels
shall
be
Standard
CQI.8.
Objective Elements
a. The organisation has defined sentinel events. *
Interpretation: The sentinel events relating to system or process deficiencies
that are relevant and important to the organisation must be clearly defined.
The list of the identified and relevant sentinel events shall be documented.
Remark(s): Refer to glossary for definition of "sentinel events".
b. The organisation has established processes for intense analysis of such events.
Interpretation: The established processes should include reporting the
occurrence of such events on standardised incident report forms.
c. Sentinel events are intensively analysed when they occur.
Interpretation: Root-cause analysis of all such events should be carried out
by
multi-disciplinary
committee
taking
inputs
from
the
units/
discipline/departments concerned.
Remark(s): All sentinel events shall be analysed within 24-working hours of
occurrence.
d. Corrective and preventive actions are taken based on the findings of such
analysis.
131
132
133
Summary of Standards
ROM 1: The responsibilities of those responsible for governance are defined.
ROM 2: The organisation complies with the laid-down and applicable legislations
and regulations.
ROM 3: The services provided by each department are documented.
ROM 4: The organisation is managed by the leaders in an ethical manner.
ROM 5: The organisation displays professionalism in management of affairs.
ROM 6: Management ensures that patient-safety aspects and risk-management
issues are an integral part of patient care and hospital management.
* This implies that this objective element requires documentation.
134
Organogram
is
transparent
and
is
disseminated
to all
135
Interpretation: Self-explanatory.
Remark(s): Senior leaders include the first two rungs of the organogram.
Appointment of senior leaders shall be through selection committee.
f. Those responsible for governance support safety initiatives and qualityimprovement plans.
Interpretation: Self-explanatory.
All risk assessment and risk reduction is known and measures to reduce are
discussed for corrective actions.
g. Those responsible for governance support research activities.
Interpretation: Self-explanatory.
Support in research shall include providing resource, budget, following ethical
and legal norms.
h. Those
responsible
for
governance
address
the
organisations
social
responsibility.
Interpretation: The governing board and head of the organisation shall
willfully develop social responsibility policy and accordingly address it.
Remark(s): For example, free camps, outreach programmes, adoption of
villages, PHCs, etc.
i. Those responsible for governance inform the public of the quality and
performance of services.
Interpretation: Self-explanatory.
Remark(s): This could be done in the form of displays or brochures.
This could include results of surveys done by independent third parties and
results of benchmarking done by professional bodies.
Standards
ROM 2: The organisation complies with the laid-down and applicable legislations
and regulations.
Objective Elements
National Accreditation Board for Hospitals and Healthcare Providers
136
a. The management is conversant with the laws and regulations and knows their
applicability to the organisation.
Interpretation: Self -explanatory.
This shall include central legislations (e.g. Drugs and Cosmetics act and MTP
act, PNDT Act, 1996), Bio Medical Waste Act, Air (Prevention and Control of
Pollution) Act, 1981, Atomic Energy Regulatory Body Approvals, License
under Bio-medical Management and Handling Rules, 1998, respective of
state legislations (Maharashtra Maintenance of Clinical Records act, Clinical
establishment of West Bengal) and local regulations (e.g. building byelaws).
Remark(s): A designated management functionary could be given the
responsibility to enlist the laws and regulation as applicable to the
organisation. This functionary in turn could identify the appropriate personnel
in the organisation who are supposed to implement the respective laws and
regulations.
Refer annexure for an indicative list of various statutory requirements.
b. The management ensures implementation of these requirements.
Interpretation: Self-explanatory.
All relevant clauses under the rules and acts are abided by the organisation.
c. Management regularly updates any amendments in the prevailing laws of the
land.
Interpretation: Self-explanatory.
d. There is a mechanism to regularly update licenses/registrations/certifications.
Interpretation: Self-explanatory.
Remark(s): For example, license for lifts, DG sets, etc.
The organisation could develop a tracker sheet for this purpose.
Standards
ROM 3: The services provided by each department are documented.
Objective Elements
National Accreditation Board for Hospitals and Healthcare Providers
137
This
shall
include all
administrative
procedures
like
Standards
ROM 4: The organisation is managed by the leaders in an ethical manner.
Objective Elements
a. The leaders make public the vision, mission and values of the organisation.
National Accreditation Board for Hospitals and Healthcare Providers
138
139
Standard
ROM 5: The organisation displays professionalism in management of affairs.
Objective elements
a. The person heading the organisation has requisite and appropriate administrative
qualifications.
Interpretation: Self-explanatory.
Remark(s): This implies to the individual looking after the day-to-day
operations and not to the chairman of the Board of Governors. Appropriate
implies qualification in hospital management/administration.
b. The person heading the organisation has requisite and appropriate administrative
experience.
Interpretation: Self-explanatory.
Remark(s): Appropriate implies administrative experience in a hospital.
c. The organisation prepares the strategic and operational plans including long-term
and short-term goals commensurate to the organisations vision, mission and
values in consultation with the various stakeholders.
Interpretation: The leader(s) shall define and develop the process for
strategic and operation plans so as to achieve the organisational vision and
mission statement and adhere to the values. It shall be discussed with all
stakeholders.
One of the inputs that should be considered while finalising these plans shall
be the findings of the risk-management plan (refer to ROM 6a).
This shall at least be done on an annual basis.
Remark(s): Refer to glossary for strategic and operational plans.
National Accreditation Board for Hospitals and Healthcare Providers
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141
Standard
ROM 6: Management ensures that patient-safety aspects and risk-management
issues are an integral part of patient care and hospital management.
National Accreditation Board for Hospitals and Healthcare Providers
142
Objective elements
a. Management ensures proactive risk management across the organisation.
Interpretation: This shall include clinical and non-clinical (strategic, financial,
operational and hazard) risks.
It shall include risk identification, prioritisation and risk alleviation. This shall
be documented as a risk management plan. It shall include the various risks
identified, the action taken for risk alleviation of each of these risks and the
mechanism for informing staff regarding the same.
Further, the risk management plan shall be monitored and reviewed for
continued effectiveness at least annually. The results of the review shall be
communicated to the relevant stakeholders in the organisation.
Remark(s): This could be done using a matrix.
Clinical-risk assessment could include:
i.
ii.
iii.
b. Management provides resources for proactive risk assessment and riskreduction activities.
Interpretation: There shall be sufficient resources kept as contingency to
address the risk reduction activities as and when the leaders proactively
suggest.
The end-result of these shall result in preventive actions.
Remark(s): Refer to glossary for definition of risk assessment and risk
reduction.
c. Management ensures implementation of systems for internal and external
reporting of system and process failures. *
143
144
145
Summary of Standards
FMS.1.
FMS.2.
FMS.3.
FMS.4.
The
organisation
has
programme
for
bio-medical
equipment
management.
FMS.5.
FMS.6.
The organisation has plans for fire and non-fire emergencies within the
facilities.
FMS.7.
FMS.8.
implies
This
that
this
objective
element
requires
documentation.
146
where
devices, etc.
c. The organisation is a non-smoking area.
Interpretation: Self-explanatory.
Remark(s): The organisation shall adhere to statutory requirements.
National Accreditation Board for Hospitals and Healthcare Providers
147
d. Facility inspection rounds to ensure safety are conducted at least twice in a year
in patient-care areas and at least once in a year in non-patient-care areas.
Interpretation: Rounds to be carried out by safety committee.
The organisation plans and budgets for upgrading or replacing key systems,
buildings, or components based on the facility inspection, in keeping with laws
and regulations.
Remark(s): During these rounds potential safety risks are identified. This
could be carried out using a checklist incorporating some of the more
common safety hazards.
e. Inspection reports are documented and corrective and preventive measures are
undertaken.
Interpretation: Self-explanatory.
Remark(s): Before and after evidence may be maintained.
f. There is a safety education programme for staff.
Interpretation: Self-explanatory.
Standard
FMS.2. The organisations environment and facilities operate to ensure safety of
patients, their families, staff and visitors.
Objective Elements
a. Facilities are appropriate to the scope of services of the organisation.
Interpretation: Self-explanatory.
Remark(s): The basis of appropriateness will be the best practices/national
/international guidelines.
b. Up-to-date drawings are maintained which detail the site layout, floor plans and
fire-escape routes.
Interpretation: A designated person maintains the drawings.
148
(Indian
or international
standards)
and directives
from
government agencies.
Interpretation: Self-explanatory.
Remark(s): For example, Indian standards (IS 12433) formulated by Bureau
of Indian Standards (for 30 and 100-bedded hospitals and other standards),
IS 10905 for basic requirements for general hospital buildings, IPHS
standards and various international standards.
e. Potable water and electricity are available round the clock.
Interpretation:
149
operational
and maintenance
(preventive and
breakdown) plan. *
Interpretation: Self-explanatory.
This shall include facility/building/installations.
Remark(s): Refer to glossary for definition of "preventive maintenance and
breakdown maintenance".
j. Maintenance staff is contactable round the clock for emergency repairs.
Interpretation: Self-explanatory.
150
Standard
FMS.3. The organisation has a programme for engineering support services.
Objective Elements
a.
b.
c.
151
Remark(s):
Where
applicable,
the
relevant
quality
conformance
Qualified
and
trained
personnel
operate
and
maintain
There
is
documented
operational
and
maintenance
g.
h.
152
Interpretation: This shall include chiller unit, AHU, FCU and various airconditioners.
Remark(s): This shall adhere to manufacturers recommendations and good
infection-control practice requirement. This includes timely cleaning and/or
replacement of filters.
i.
Standard
FMS.4. The organisation has a programme for bio-medical equipment management.
Objective Elements
a. The organisation plans for equipment in accordance with its services and
strategic plan.
Interpretation: Self-explanatory.
This shall also take into consideration future requirements.
The equipment shall be appropriate to its scope of services.
Remark(s): A good reference for minimum equipment is the IPHS guideline.
b. Equipment are selected, rented, updated or upgraded by a collaborative
process.
Interpretation: Collaborative process implies that during equipment selection
there is involvement of end-user, management, finance, engineering and biomedical departments.
153
or
instrumentation engineer/technician
with
operational
and maintenance
(preventive and
breakdown) plan. *
Interpretation: The manufacturer's instruction manual for equipment exists.
The operator is trained in handling the equipment. There shall be a planned
preventive maintenance tracker.
g. There is a documented procedure for equipment replacement and disposal. *
154
Interpretation: The organisation shall plan for this keeping in mind the
strategic plans, upgrade/update path and the equipment log.
Organisation shall condemn (dispose) equipment in a systematic manner.
Standard
FMS.5. The organisation has a programme for medical gases, vacuum and
compressed air.
Objective Elements
a. Documented procedures govern procurement, handling, storage, distribution,
usage and replenishment of medical gases. *
Interpretation: This shall be applicable to all gases used in the organisation.
It shall also address the issue of statutory requirements and approvals
wherever applicable. It shall follow a uniform colour coding system.
Remark(s): A good reference is HTM 2022 or NFPAs Medical Gas and
Vacuum Systems Installation Handbook (NFPA's new NFPA 99C solution).
Proper signage are kept for used, full, empty cylinders.
The organisation shall adhere to statutory requirements under the provisions
of Indian Explosives Act, Gas Cylinder rules and Static and Mobile Pressure
Vessel (unfired) rules.
The documentation shall cover objective element b also.
b. Medical gases are handled, stored, distributed and used in a safe manner.
Interpretation: Self-explanatory.
Remark(s): Standardised colour coding of the cylinders and pipelines should
be maintained.
A good reference for medical gas systems are HTM 2022, ISO 7396-1:2007
(Medical gas pipeline systems -- Part 1: Pipeline systems for compressed
medical gases and vacuum), ISO 7396-2:2007 (Medical gas pipeline systems
-- Part 2: Anaesthetic gas scavenging disposal systems), ISO 9170-1:2008
(Terminal units for medical gas pipeline systems -- Part 1: Terminal units for
National Accreditation Board for Hospitals and Healthcare Providers
155
(Flow-metering
devices
for
156
Standard
FMS.6. The organisation has plans for fire and non-fire emergencies within the
facilities.
Objective Elements
a. The organisation has plans and provisions for early detection, abatement and
containment of fire and non-fire emergencies. *
Interpretation: The organisation shall:
i.
ii.
iii.
acquire adequate fire fighting equipment for this and records are kept
up-to-date;
iv.
v.
vi.
vii.
viii.
terrorist attack,
ii.
iii.
earthquake,
iv.
v.
viii.
157
ix.
x.
xi.
fall
passageway,
xii.
xiii.
bursting of pipelines,
xiv.
xv.
xvi.
The organisation shall establish liaison with civil and police authorities and fire
brigade as required by law for enlisting their help and support in case of an
emergency.
Remark(s): The National Building Code is a good reference guide.
b. The organisation has a documented safe-exit plan in case of fire and non-fire
emergencies.
Interpretation: Fire-exit plan shall be displayed on each floor particularly
close to the lifts. Exit doors should remain open all the time.
Remark(s): The signage of fire exits shall be as per the National Building
Code and/or respective statutory body (for example, fire service).
c. Staff is trained for its role in case of such emergencies.
Interpretation: In case of fire, a designated person is assigned a particular
work.
Remark(s): The training shall include various classes of fire, information and
demonstration on how to use a fire extinguisher and the procedure to be
followed in case of fire and non-fire emergencies.
d. Mock drills are held at least twice a year.
Interpretation: Self-explanatory.
158
This
shall
test
all
the
components
of
the
plan
and
not
just
This
shall
adhere
to
manufacturers
and/or
statutory
recommendations.
Standard
FMS.7. The organisation plans for handling community emergencies, epidemics and
other disasters.
Objective Elements
a. The organisation identifies potential emergencies. *
Interpretation: The organisation has a documented plan and procedure for
handling the situations like sudden rush of victims of
i.
earthquake,
ii.
flood,
iii.
train accident,
iv.
v.
vi.
materials,
identified-trained
personnel,
transportation
aids,
159
Resource
availability
should
be
according
to
threat
perception.
Remark(s): Quantity of resources, i.e. medical stores, etc,. to be crosschecked with expected workload.
d. Staff is trained in the hospitals disaster management plan.
Interpretation: Self-explanatory.
Remark(s): The training shall include the various elements of the disaster
plan.
e. The plan is tested at least twice a year.
Interpretation: Self-explanatory.
This shall test all the components of the plan and not just awareness.
Simulated patients (not real) shall be used.
Remark(s): This is only the minimum frequency and this may be increased.
At the conclusion of every mock drill, the variations are identified, reason for
the same is analysed, debriefing of the drill conducted and where appropriate
the necessary corrective and/or preventive actions are taken.
Standard
FMS.8. The organisation has a plan for management of hazardous materials.
Objective Elements
a. Hazardous materials are identified within the organisation. *
National Accreditation Board for Hospitals and Healthcare Providers
160
The
organisation has the requisite training need identification for material handling
and those trainings are included in the organisations training calendar.
c. Requisite regulatory requirements are met in respect of radioactive materials.
Interpretation: The appropriate personnel in the organisation are aware
about the rules and regulations such as the Atomic Energy Act, the norms
issued by Atomic Energy Regulatory Board (AERB) and the directives from
the Health Physics Division of Bhaba Atomic Research Centre (BARC).
d. There is a plan for managing spills of hazardous materials. *
Interpretation: Self-explanatory.
Remark(s): The organisation could have a HAZMAT kit(s) for handling spills.
National Accreditation Board for Hospitals and Healthcare Providers
161
162
163
Summary of Standards
HRM.1.
HRM.2.
HRM.3.
There
is
an ongoing
programme
for professional
training
and
HRM.5.
HRM.6.
HRM.7.
HRM.8.
HRM.9.
is a process
for credentialing
and
privileging of nursing
This
implies
that
this
objective
element
requires
documentation.
164
Objective Elements
a. Human resource planning supports the organisations current and future ability to
meet the care, treatment and service needs of the patient. *
Interpretation: This shall be done in a structured manner keeping in mind the
scope of services, mission and the healthcare needs of the community that it
serves. It shall use recognised methods for determining levels of staffing.
Remark(s): It shall match the strategic and operational plan of the
organisation.
b. The organisation maintains an adequate number and mix of staff to meet the
care, treatment and service needs of the patient.
Interpretation: The staff should be commensurate with the workload and the
clinical requirement of the patients.
Remark(s): A good reference could be the MCI and INC guidelines.
c. The required job specification and job description are well defined for each
category of staff. *
Interpretation: The content of each job should be well defined and the
qualifications, skills and experience required for performing the job should be
clearly laid down. The job description should be commensurate with the
qualification.
Remark(s): Refer to glossary for definition of "job description and job
specification". For a job which requires the skills of a doctor or a nurse the
minimum qualification shall be an MBBS and GNM degree respectively.
d. The organisation verifies the antecedents of the potential employee with regards
to criminal/negligence background.
National Accreditation Board for Hospitals and Healthcare Providers
165
Interpretation: Self-explanatory.
Remark(s): This report can be obtained from the district magistrates office of
the district where the employee has served earlier and/or from the previous
employer. In case of fresh graduates, the same could be obtained from the
last institution attended.
In case of a doctor or a nurse, a good standing certificate may be obtained
from the regulatory body.
Standard
HRM.2.
Objective Elements
a. There is a documented procedure for recruitment. *
Interpretation: The recruitment process ensures an adequate number and
skill mix of staff to provide the organisations services. The procedure shall
ensure that the staff has the necessary registration, qualifications, skills and
experience to perform its work.
Remark(s): Recruitment is undertaken in
requirements, where applicable.
accordance
with
statutory
166
The contents of this training could be provided to every staff in the form of a
booklet.
There can be separate induction training at the organisational level and for
the respective departments.
d. The induction training includes orientation to the organisations vision, mission
and values.
Interpretation: The organisation's staff including the outsourced staff should
be aware and should correctly interpret the vision, mission and values of the
organisation.
e. The
induction
training
includes
awareness
on
employee
rights
and
responsibilities.
Interpretation: Self-explanatory.
f. The induction training includes awareness on patients rights and responsibilities.
Interpretation: The employees should be able to identify and report violation
of patient rights as and when it occurs.
Remark(s): For patient rights refer to PRE 2.
g. The induction training includes orientation to the service standards of the
organisation.
Interpretation: Self-explanatory.
Remark(s): The employees should be trained to implement the service
standards of the organisation.
h. Every staff member is made aware of organisations wide policies and
procedures as well as relevant department/unit/service/programmes policies and
procedures.
Interpretation: The organisation's staff including the outsourced staff should
be aware and should correctly interpret the policies and operating procedures
of the organisation as well as that of the department/ unit/ service in which he
is performing the requisite duties.
National Accreditation Board for Hospitals and Healthcare Providers
167
Standard
HRM.3.
Objective Elements
a. A documented training and development policy exists for the staff. *
Interpretation:
training
manual
incorporating
the
procedure
for
168
Interpretation: This shall include both internal and external training. For
external training, it could be done either by the organisation itself or by the
external agency, which imparted the training. Impact of training at user level
should also be documented.
Standard
HRM.4.
Objective Elements
a. Staff is trained on the risks within the organisations environment.
Interpretation: The organisation shall define such risks that shall include
patient, visitors and employee-related risks.
Remark(s): For example, fire and non-fire emergency, needle stick injury,
etc.
b. Staff members can demonstrate and take actions to report, eliminate/minimise
risks.
Interpretation: Self-explanatory.
Remark(s): Staff should be able to practically demonstrate actions like taking
care of blood spills, medication errors and other adverse event reporting
systems.
c. Staff members are made aware of procedures to follow in the event of an
incident.
Interpretation: Self-explanatory.
Remark(s): The staff should be able to intimate the sequence of events that
they will undertake in the eventuality of occurrence of any adverse event.
d. Staff is trained on occupational safety aspects.
Interpretation: This shall include making them aware of the possible risks
involved and preventive actions to avoid risks.
Remark(s): Some examples are: Needle Stick Injury and Blood/Body Fluid
Exposure.
National Accreditation Board for Hospitals and Healthcare Providers
169
Standard
HRM.5.
Objective Elements
a. A documented performance appraisal system exists in the organisation. *
Interpretation: Self-explanatory.
This shall be done for all categories of employees starting from the person
heading the organisation and including doctors who are employees.
Remark(s): For definition of "performance appraisal" refer to glossary.
b. The employees are made aware of the system of appraisal at the time of
induction.
Interpretation: Self-explanatory.
Remark(s): This could be incorporated in the service booklet and included in
the induction training.
c. Performance is evaluated based on the pre-determined criteria.
Interpretation: Self-explanatory.
d. The appraisal system is used as a tool for further development.
Interpretation: Self-explanatory.
This can be done by identifying training requirements and accordingly
providing for the same (wherever possible).
Remark(s): Key result areas are identified for each staff and training need
assessment is also done.
e. Performance appraisal is carried out at pre-defined intervals and is documented.
Interpretation: Self-explanatory.
Remark(s): This shall be done at least once a year.
Standard
National Accreditation Board for Hospitals and Healthcare Providers
170
HRM.6.
Objective Elements
a. Documented policies and procedures exist. *
Interpretation: Self-explanatory.
Remark(s): For definition of "disciplinary procedure" and "grievance handling"
refer to glossary.
The documentation shall be done keeping in mind objective elements c, d
and e.
b. The policies and procedures are known to all categories of staff of the
organisation.
Interpretation: Self-explanatory.
All the staff should be aware of the disciplinary procedure and the process to
be followed in case they feel aggrieved.
c. The disciplinary policy and procedure is based on the principles of natural justice.
Interpretation: This implies that both parties (employee and employer) are
given an opportunity to present their case and decision is taken accordingly.
d. The disciplinary procedure is in consonance with the prevailing laws.
Interpretation: Self-explanatory.
Remark(s): Refer to relevant labour laws and CCS (CCA) rules. Anti-sexual
harassment committee should also be established in the organisation.
e. There is a provision for appeals in all disciplinary cases.
Interpretation: The organisation shall designate an appellate authority to
consider appeals in disciplinary cases.
Remark(s): Appellate authority should be higher than the disciplinary
authority.
f. The redress procedure addresses the grievance.
Interpretation: Self-explanatory.
g. Actions are taken to redress the grievance.
National Accreditation Board for Hospitals and Healthcare Providers
171
Interpretation: Self-explanatory.
This shall be documented and communicated to the aggrieved staff.
s
Standard
HRM.7.
Objective Elements
a. A pre-employment medical examination is conducted on all the employees.
Interpretation: Self-explanatory.
This shall, however, be in consonance with the law of the land.
Remark(s): For example, performing pre-employment HIV testing without
consent is illegal.
b. Health problems of the employees are taken care of in accordance with the
organisations policy.
Interpretation: Self-explanatory.
This shall be in consonance with the law of the land and good clinical
practices.
Remark(s): For example, employee health and safety policy.
c. Regular health checks of staff dealing with direct patient care are done at least
once a year and the findings/results are documented.
Interpretation: Self-explanatory.
The results should be documented in the personal file.
Remark(s): The organisation could define the parameters and it could be
different for different categories of personnel. The organisation could also
identify competent individuals to perform the same.
The staff member shall not be charged for this health check.
d. Occupational health hazards are adequately addressed.
Interpretation: Self-explanatory.
Appropriate personal
172
Standard
HRM.8.
Objective Elements
a. Personal files are maintained in respect of all staff.
Interpretation: Self-explanatory.
b. The personal files contain personal information regarding the employees
qualification, disciplinary background and health status.
Interpretation: Self-explanatory.
c. All records of in-service training and education are contained in the personal
files.
Interpretation: Self-explanatory.
Remark(s): In case of internal trainings the organisation could file a summary
of all trainings attended by the employee on an annual basis. However, there
shall be a supporting document to verify that the employee has actually
attended the training.
d. Personal files contain results of all evaluations.
Interpretation: Evaluations would include performance appraisals, training
assessment and outcome of health checks.
Standard
HRM.9.
There
is a process
for credentialing
and privileging
of medical
173
174
Standard
HRM.10. There
is a
process
for credentialing
and
privileging
of nursing
175
176
177
178
Summary of Standards
IMS.1.
IMS.2.
IMS.3.
The organisation has a complete and accurate medical record for every
patient.
IMS.4.
IMS.5.
IMS.6.
IMS.7.
implies
This
that
this
objective
element
requires
documentation.
179
Standard
IMS.1.
Objective Elements
a. The information needs of the organisation are identified and are appropriate to the
scope of the services being provided by the organisation. *
Interpretation: The organisation has manual and/or electronic hospital
information system and/or management information system which provide
relevant information to all stakeholders concerned.
This shall include the information needs of care providers, management and
external agencies/governmental bodies.
Remark(s): For example, daily census report, utilisation rates, etc. Also refer
to CQI 3 and CQI 4.
The identified information needs shall be documented.
b. Documented policies and procedures to meet the information needs exist. *
Interpretation: A policy document is available where the HIS/MIS is
described.
This shall also specify the frequency of data collection and the person(s)
responsible.
c. These policies and procedures are in compliance with the prevailing laws and
regulations.
Interpretation: Self-explanatory.
Remark(s): Some of these include: IT Act 2000 for computer-based records,
PNDT Act for relevant details of all patients undergoing ultrasound, Code of
Medical Ethics, 2002, RTI Act 2005, etc. Relevant state legislation, e.g.
Maintenance of Clinical Records Act (MOCRA) in Maharashtra.
180
as
requirements
and
future
necessities.
Remark(s): The organisation shall ensure that it has the necessary license
for software.
e. The organisation contributes to external databases in accordance with the law
and regulations.
Interpretation: The organisation shall define the system of releasing the
relevant information to the authority as per statutory norms.
Remark(s): For example, sending birth and death statistics, notifiable
diseases (refer to glossary) and acute flaccid paralysis reporting.
Standard
IMS.2.
Objective Elements
a. Formats for data collection are standardised.
Interpretation: MIS/HIS data are collected in standardised format from all
areas/services in the organisation.
Remark(s): This is in the context of frequency of capturing data, namely
daily, weekly, monthly, quarterly, yearly etc. (Statistical bulletin).
b. Necessary resources are available for analysing data.
Interpretation: The organisation shall make available men, material, space
and budget.
181
c. Documented procedures are laid down for timely and accurate dissemination of
data. *
Interpretation: Self-explanatory.
All timely feedback is given to relevant stakeholders after data generation and
analysis.
Remark(s): The organisation could decide on which data needs to be shared
with whom and also the modalities (e.g. memos, circulars, etc.) for
dissemination of such data.
d. Documented procedures exist for storing and retrieving data. *
Interpretation: The organisation shall define data management policy and
ensure adequate safeguards for protection of data, wherever physical or
electronic data is stored.
Remark(s): Storage could be physical or electronic. Wherever electronic
storage is done the organisation shall ensure that there are adequate
safeguards for protection of data.
e. Appropriate clinical and managerial staff participates in selecting, integrating and
using data.
Interpretation: They are responsible for the appropriate selection of
indicators, measurement of trends and initiating action, wherever required.
Remark(s): This could be done by a multi-disciplinary committee.
Standard
IMS.3.
The organisation has a complete and accurate medical record for every
patient.
Objective Elements
a. Every medical record has a unique identifier.
Interpretation: This shall also apply to records on digital media.
National Accreditation Board for Hospitals and Healthcare Providers
182
Every sheet in the medical record shall have this unique identifier. In case of
electronic records, all entries for one unique identifier shall be available in one
place.
Remark(s): For example, CR number, UHID, hospital number, etc.
b. Organisation policy identifies those authorised to make entries in medical record.
Interpretation: Organisation shall have a written policy authorising who can
make entries and the content of entries.
Remark(s): This could be different category of personnel for different entries,
but it shall be uniform across the organisation, e.g. progress record by doctor
and medication administration chart by nurse.
c. Entry in the medical record is named, signed, dated and timed.
Interpretation: Self-explanatory.
All entries should be documented immediately but no later than one hour of
completion of the assessment/procedure.
Remark(s): For records on electronic media it is preferable that the date and
time is automatically generated by the system.
d. The author of the entry can be identified.
Interpretation: This could be by writing the full name or by mentioning the
employee code number, with the help of stamp, etc. In case of electronicbased records, authorised e-signature provision as per statutory requirements
must be kept.
e. The contents of medical record are identified and documented. *
Interpretation: The organisation identifies which documents form part of the
medical records, documents and implements the same.
Remark(s): For example, admission orders, face sheet, IP sheet, discharge
summary, doctor's order sheet, TPR chart, consent form, etc.
f. The record provides a complete, up-to-date and chronological account of patient
care.
Interpretation: Every medical record has all the identified sheets filed in the
proper order.
National Accreditation Board for Hospitals and Healthcare Providers
183
The organisation shall decide the format for maintaining the continuity in the
medical records.
Remark(s): It shall ensure that all medico-legal case records have the
mandatory information.
In case a particular sheet is missing a note to that effect would be put in the
medical record.
g. Provision is made for 24-hour availability of the patients record to healthcare
providers to ensure continuity of care.
Interpretation: Self-explanatory.
In case of physical records when the MRD is not open, there should be a
system in place by which authorised personnel can open the MRD and
retrieve the record.
Remark(s): For all existing hospital patients coming to the emergency room
medical records shall be easily retrieved.
Standard
IMS.4.
Objective Elements
a. The medical record contains information regarding reasons for admission,
diagnosis and plan of care.
Interpretation: Self-explanatory.
The final diagnosis (IP) must be documented by the treating doctor in all
records. This could preferably be as per ICD (latest edition). However, in the
medical records department all such diagnoses shall be codified as per ICD
(latest edition).
Remark(s): For definition of "plan of care" refer to glossary.
b. The medical record contains the results of tests carried out and the care
provided.
National Accreditation Board for Hospitals and Healthcare Providers
184
Interpretation: Self-explanatory.
Remark(s): It is preferable that the medical record also reflects any delay in
tests and treatment planned or provided for the patient. This could be taken
up for clinical audit.
c. Operative and other procedures performed are incorporated in the medical
record.
Interpretation: Self-explanatory.
Remark(s): Also refer to COP 14f.
d. When patient is transferred to another hospital, the medical record contains the
date of transfer, the reason for the transfer and the name of the receiving
hospital.
Interpretation: Self-explanatory.
It is mandatory to mention the clinical condition of the patient before transfer
is effected.
Remark(s): If the patient has been transferred at his/her request, a note may
be added to that effect. In such instances, the name of the receiving hospital
could be the name the patient desires to go to. However, if the patient has
been transferred by the organisation, it shall have an acknowledgement from
the receiving hospital.
Any element of care carried out during the patient transfer is documented,
where appropriate.
e. The medical record contains a copy of the discharge summary duly signed by
appropriate and qualified personnel.
Interpretation: Self-explanatory.
Remark(s): Also refer to AAC 14.
f. In case of death, the medical record contains a copy of the cause of death
certificate.
Interpretation: Self-explanatory.
185
This shall mention the cause, date and time of death The organisation
provides the death certificate as per the International Form of Medical
Certificate of Cause of Death (W HO).
Remark(s): Also refer to AAC 14 g.
Cardiac and respiratory arrest is an event of death and not the cause of
death.
g. Whenever a clinical autopsy is carried out, the medical record contains a copy of
the report of the same.
Interpretation: Self-explanatory.
Remark(s): For definition of "autopsy" refer to glossary.
h. Care providers have access to current and past medical record.
Interpretation: The organisation provides access to medical records to
designated healthcare providers (those who are involved in the care of that
patient).
Remark(s): For electronic medical record system, every faculty shall have a
user ID and a password.
Standard
IMS.5.
Objective Elements
a. Documented policies and procedures exist for maintaining confidentiality,
security and integrity of records, data and information. *
Interpretation: The organisation shall control the accessibility to the MRD
and to its Hospital Information System. For physical records, it shall ensure
the usage of tracer card for movement of the file in and out of the MRD.
It shall have a system in place to ensure that only the relevant care providers
have access to the patients record. Similarly for data and information, it shall
ensure that records and data are not taken out from the areas where they are
National Accreditation Board for Hospitals and Healthcare Providers
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187
Standard
IMS.6.
Objective Elements
188
Standard
IMS.7.
Objective Elements
a. The medical records are reviewed periodically.
Interpretation: Self-explanatory.
Remark(s): The organisation could define the periodicity. A standardised
checklist can be used for this purpose.
b. The review uses a representative sample based on statistical principles.
National Accreditation Board for Hospitals and Healthcare Providers
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190
Essential Documentation
Like all quality management systems documentation is an essential component of
NABH accreditation. NABH standards require documentation. It is suggested that
the organisation prepare an apex manual (quality manual) incorporating the various
standards and objective elements and providing appropriate linkages. The apex
manual could be distributed to all individuals in the first rung of the organogram. It is
preferable that procedures and processes (refer to glossary for definition) are not
incorporated in the apex manual (only linkages to be provided). The policies (refer to
glossary for definition) for various objective elements could be incorporated in the
apex manual. The procedures and processes have to be distributed to all areas
where the activities concerned are taking place. Wherever, the organisation feels
that only a policy would not suffice it can instead document a procedure.
It is essential that document control be followed during documentation and
distribution.
A suggested content is given below.
For example, for AAC 2a which states that Documented policies and procedures
are used for registering and admitting patients the organisation could mention its
policy for admission in the apex manual and for procedure in the apex manual just
mention as Refer to AAC/SOP/01.
National Accreditation Board for Hospitals and Healthcare Providers
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In addition to the apex manual, the organisation needs to have the following
manuals:
Scope/Aim/Objective
Definition
Applicable areas
Responsibility
Contents/explanations/detailing or various processes
Monitoring and analysis/indicators
References
The minimum documentation required by NABH 3rd edition has been mentioned in
the previous pages. A * mark has been placed for the objective elements which
require documentation.
Document control shall be adhered to for all documentation.
192
Glossary
The commonly-used terminologies in the NABH standards are briefly described and
explained herein to remove any ambiguity regarding their comprehension. The
definitions narrated have been taken from various authentic sources as stated,
wherever possible. Notwithstanding the accuracy of the explanations given, in the
event of any discrepancy with a legal requirement enshrined in the law of the land,
the provisions of the latter shall apply.
Accreditation
Advance life
support
Adverse drug
event
drug
193
Ambulance
Anaesthesia
Assessment
Autopsy
Barrier nursing
194
patient and other patients and staff in the hospital, and thence to
the outside world. The nurses wear gowns, masks, and gloves,
and they observe strict rules that minimise the risk of passing on
infectious agents.
Basic life
support
Basic life support (BLS) is the level of medical care which is used
for patients with life-threatening illnesses or injuries until the
patient can be given full medical care.
Breakdown
maintenance
Activities which are associated with the repair and servicing of site
infrastructure, buildings, plant or equipment within the sites
agreed building capacity allocation which have become inoperable
or unusable because of the failure of component parts.
Bylaws
Clinical audit
Clinical practice
guidelines
Competence
Confidentiality
Consent
195
Data
Discharge
summary
Disciplinary
proceedings
Employees
End of life
Ethics
Evidence-based
medicine
Family
Formulary
196
Grievancehandling
procedures
Hazardous
materials
Hazardous
waste
Healthcareassociated
infection
Healthcare
organisation
Highdependency
unit
In service
education/
training
197
Indicator
Information
Intent
Inventory
control
Isolation
Job description
Job
specification
Laws
Maintenance
198
Medication
error
Mission
Monitoring
Multidisciplinary
Near-miss
No harm
199
adverse event does not occur. The distinction between the two is
important and is best exemplified by reactions to administered
drugs in allergic patients. A prophylactic injection of cephalosporin
may be stopped in time because it suddenly transpires that the
patient is known to be allergic to penicillin (near-miss). If this vital
piece of information is overlooked and the cephalosporin
administered, the patient may fortunately not develop an
anaphylactic reaction (no harm event).
Notifiable
disease
Smallpox
(b)
(c)
(d)
In India the following diseases are also notifiable and may vary
from state to state:
(a) Polio
(b) Influenza
(c) Malaria
(d) Rabies
(e) HIV/AIDS
(f) Louse-borne typhus
(g) Tuberculosis
(h) Leprosy
(i) Leptospirosis
(j) Viral hepatitis
(k) Dengue fever
The various diseases notifiable under the factories act lead
poisoning, byssinosis, anthrax, asbestosis and silicosis.
Objective
Objective
element
200
the standard.
Occupational
health hazard
Operational
plan
Organogram
A graphic representation
organisation.
Outsourcing
Patient-care
setting
Patient record/
medical record/
clinical record
Performance
appraisal
Plan of care
A plan that identifies patient care needs, lists the strategy to meet
those needs, documents treatment goals and objectives, outlines
the criteria for ending interventions, and documents the
individuals progress in meeting specified goals and objectives.
The format of the plan may be guided by specific policies and
procedures, protocols, practice guidelines or a combination of
these. It includes preventive, promotive, curative and rehabilitative
of
reporting
relationship
in
201
an
aspects of care.
Policies
Preventive
maintenance
Privileging
Procedure
1.
2.
Process
Programme
Protocol
Quality
Quality
assurance
Quality
improvement
202
Re-assessment
Resources
Restraints
Risk
assessment
Risk
management
Risk reduction
Safety
Safety
programme
Scope of
services
Security
Sedation
203
Social
responsibility
Staff
Standard
precautions
1.
2.
204
Sterilisation
Strategic plan
Surveillance
Transfusion
reaction
Triage
Unstable
patient
Validation
205
Values
Vision
Vulnerable
patient
206
2.
Surgical events
Anesthesia-related event
3.
the use or function of a device in a manner other than the devices intended
use
207
4.
5.
Environmental events
Patient death or serious disability while being cared for in a healthcare facility
associated with:
a burn incurred from any source
an electric shock
6.
omission error
dosage error
dose-preparation error
wrong-time error
wrong-patient error
Criminal events
Any instance of care ordered by or provided by an individual impersonating
a clinical member of staff
Abduction of a patient
208
209
A fault-finding mission
A punitive action
MS/Coordinator/Hospital Administrator
Nursing representatives
210
How to audit?
The Audit Cycle
Measure baseline
Review standard
if required
Set standards
Evaluate
change
Measure practice
through data
collection and
analysis
Implement
change
Assessment of
performance against
standard
Suggest change
Identify opportunity
for improvement
Methodology
1. Selection of Topic
a. Should be common because it is common or high risk or bears high cost.
b. Should be having local clinical concern or known wide variance in clinical
practice.
c. Topic should be well defined, focused and amenable to standard setting.
Some topics
a.
b.
c.
d.
e.
2. Setting of standard
a. To be set prior to the study
National Accreditation Board for Hospitals and Healthcare Providers
211
Process
Criteria
Staffing of ICU
BT
surgery
Target
Outcome
Not to exceed
0.1 per cent for
specified
procedures
e. Objective criteria are explicit but clinical judgment can be used to answer
the question: Was the management of this case satisfactory? This is an
implicit criterion.
f. Use of explicit criteria should be preferred. The problem with implicit
criteria is that important deficiencies in care may be overlooked and rates
may differ in their assessments of the acceptability of management.
National Accreditation Board for Hospitals and Healthcare Providers
212
4. Tabulation of evaluation
5. Interpretations
a. Deficiency of care recognised
b. Specific solutions are proposed. They may not be possible every time.
E.g. a study of the way cervical screening is organised identified
deficiencies but concluded only that other schemes needed to be
examined
c. Education impact is appreciated
6. Effecting change
a.
b.
c.
d.
Q)
Why audit?
213
Professional
Social
Pragmatic
Legal
A diagrammatic representation of the motives is given below
Professional Motives
Social Motives
a) To ensure safety of
public
b) To present patient
from inappropriate
or suboptimal care
a) To identify
deficiencies
b) Educational need
c) Self-correction &
self-regulation
Pragmatic Motives
To reduce patients
suffering
Legal Motives
CPA
Q)
Q)
Negligence
Malpractice
What are the key questions to be asked while doing clinical audit?
What do we do?
How we improve?
Professional benefits
-
214
(b)
Q)
Q)
teamwork
Increase in workload
Restriction of clinical feedback
Professional threat
Q)
Q)
Lack of resources
Lack of expertise in design and analysis
Lack of an overall plan for audit
Relationships problem
Organisational impediments disputes between views of clinicians and
managers
2.
215
3.
Importance of planning
4.
5.
6.
7.
Checklist
Question
Criteria
1.
2.
3.
4.
What next?
216
Conclusion
Audit appears deceptively simple. Current care is observed so that it can be
compared with standards and the necessary charges in patient care are
implemented.
In practice
Topics for audit need to be chosen with care and refined to make them
suitable.
Standard setting requires clarity of thought and careful definition.
Data collection to observe practice can consume endless time and money.
Lasting change is notoriously difficult to achieve.
Notwithstanding the above, once audit is understood and planned, it is one of the
best ways to check quality of care being rendered, to bring about changes for
improving care, to improve patient and employee satisfaction and for professional
development.
217
Provide complete and accurate information including full name, address and
other information.
To ask questions when he/she does not understand what the doctor or other
member of the healthcare team tells about diagnosis or treatment. He/she
should also inform the doctor if he/she anticipates problems in following
prescribed treatment or considering alternative therapies.
Comply with the visitor policies to ensure the rights and comfort of all
patients. Be considerate of noise levels, privacy, and safety. Weapons are
prohibited on premises.
Treat hospital staff, other patients, and visitors with courtesy and respect.
Provide complete and accurate information for insurance claims and work with
the hospital and physician billing offices to make payment arrangements.
To pay for services billed for in a timely manner as per the hospital policies.
To respect that some other patients medical condition may be more urgent than
yours and accept that your doctor may need to attend them first.
To respect that admitted patient and patients requiring emergency care take
priority for your doctor.
To follow the prescribed treatment plan and carefully comply with the
instructions given.
218
To accept the measures taken by the hospital to ensure personal privacy and
confidentiality of medical records.
Not to take any medications without the knowledge of doctor and healthcare
professionals.
219
Standard Indicator
Definition
1.
CQI 3a
Formula
Remarks**
In case of emergency
the time shall begin
from the time the
patient has come to
the door of the
emergency till the
time that the initial
assessment is
completed
by
a
doctor.
Sample size*
The
outliers:
those
taking more than 20% of
the average time shall
be audited.
220
2.
3.
Percentage of
cases
(inpatients)
wherein care
plan
with
desired
is
outcomes
documented
and countersigned by the
clinician.
Desired
outcome
includes
curative,
preventive,
rehabilitative etc.
Percentage of
cases
(inpatients)
wherein
screening for
nutritional
needs
has
been done.
Number
of
X 100
discharges and
deaths
Number of inpatient
case
records
wherein
the
nutritional
assessment
has
been X 100
documented
Number
Number of inpatient
case
records
the
wherein
care plan with
desired
outcomes has
been
documented
of
221
4.
Percentage of
cases
(inpatients)
wherein
the
nursing care
plan
is
documented.
discharges and
deaths
hospital.
For hospitals with
>
50 However,
immediate
admissions/day:
correction isto
be
20%
initiated, when gaps are
seen on a real time
basis.
Number of inpatient
case
records
the
wherein
nursing
care
plan has been
documented
X 100
Number
of
discharges and
deaths
5.
CQI 3b
Number
of Reporting
errors
reporting
include those picked
up before and after
errors/1000
Number
reporting
errors
of
Not applicable
X 1000
222
6.
7.
investigations
dispatch.
It
shall
include transcription
errors.
Percentage of
re-dos.
This
shall
also
include
tests
repeated
before
release of the result
(to
confirm
the
finding).
Number of redos
Co-relation
means
that the test results
should match either
the
diagnosis
or
differential diagnosis
writtenin
the
requisition form.
Number
reports
relating
clinical
diagnosis
Percentage of
reports
corelating
with
clinical
diagnosis.
Number
tests
performed
of
Not applicable
X 100
Number of tests
performed
223
month: 20%
For hospitals with
>
500
tests/
month: 15%
8.
9.
CQI 3c
Percentage
adherence
safety
precautions
employees
working
diagnostics.
of
to
by
Incidence
of A medication error is
in
Number
employees
adhering
safety
precautions
of
Number
employees
sampled
of
to
Total number of
In addition to incident
reporting,
to
detect
medication
errors
any
preventable
event that may cause
to
or
lead
inappropriate
medication use or
harm to a patient
(US-FDA).
medication
errors
Number
patient days
occupancy < 50
patients /day: 10%
of patients/day
of
include,
Examples
but are not limited to:
Errors
in
the
prescribing,
transcribing,
dispensing,
administering,
and monitoring of
medications;
Wrong
drug,
wrong strength, or
wrong
dose
errors;
Wrong
errors;
Wrong route
administration
patient
of
For hospitals with
225
errors; and
10.
11.
Calculation
preparation
errors.
average
occupancy > 1000
patients
/day:
0.5%
of
patients/day
or
Percentage of
admissions
with adverse
drug reaction
(s)
Refer to glossary
Percentage of
medication
charts
with
prone
error
abbreviations
Number
adverse
reactions
of
drug
Not applicable
Number
of X 100
discharges and
deaths
Number
of
medication
charts
with
prone
error
abbreviations
Not applicable
X 100
Number
of
medication
charts reviewed
12.
Number
patients
receiving
of
high
226
13.
14.
CQI 3d
risk
medications
developing
adverse drug
event.
percentage
of
medication errors or
sentinel events and
medications
that
carry a high risk for
abuse, error, or other
adverse outcomes.
A good reference for
this is the ISMPs
List of High-Alert
Medications.
risk medications
who have an X 100
adverse
drug
event
Percentage of
modification of
anaesthesia
plan
Number
of
patients
in
whom
the
anaesthesia
plan
was
modified
Percentage of
unplanned
ventilation
following
Number
of
patients
receiving
high
risk medications
Not applicable
The
modification
is
anaesthesia plan could
be
captured
in
a
register/system
before
the patient is shifted out
of the OT.
Not applicable
X 100
Number
of
patients
who
underwent
anaesthesia
Number
patients
requiring
unplanned
of
X 100
227
anaesthesia
ventilation
following
anaesthesia
Number
of
patients
who
underwent
anaesthesia
15.
16.
Percentage of
adverse
anaesthesia
events
Anaesthesia
related
mortality rate
Adverse anaesthesia
event
is
any
untoward
medical
occurrence that may
present
during
treatment with an
anaesthetic product
but which does not
necessarily have a
causal
relationship
with this treatment.
Number
of
patients
who
developed
adverse
anaesthesia
event
Number
of
patients
who
died due to
anaesthesia
Not applicable
of
Number
patients
who X 100
underwent
anaesthesia
Not applicable
X 100
Number
of
patients
who
underwent
228
anaesthesia
17.
CQI 3e
Percentage of
unplanned
return to OT
Number
of
unplanned
return to OT
Not applicable
X 100
Number
patients
operated
18.
19.
Percentage of
re-scheduling
of surgeries
Re-scheduling
of
patients
includes
cancellation
and
postponement
(beyond 4 hours) of
the surgery.
Percentage of
cases where
the
organisations
procedure to
prevent
adverse
events
like
wrong
site,
wrong patient
and
wrong
of
Number
cases
scheduled
of
re-
Number
surgeries
performed
of
X 100
Number
of
cases
where
the procedure
not
was
followed
Number
surgeries
performed
Not applicable
Not applicable
X 100
of
229
surgery have
been adhered
to
20.
21.
Percentage of
cases
who
received
appropriate
prophylactic
antibiotics
the
within
specified time
frame
CQI 3f
Percentage of
transfusion
reactions
Number
of
patients
who
did not receive
prophylactic
antibiotic (s)
A systemic response
by the body to the
administration
of
blood
incompatible
with that of the
recipient. The causes
include red blood cell
incompatibility;
allergic sensitivity to
the
leukocytes,
platelets,
plasma
protein components
Number
surgeries
performed
of
Number
transfusion
reactions
of
Not applicable
X 100
It is equally important
that the antibiotic should
have been given not
more than two hours
prior to the incision.
This indicator could be
captured
in
a
register/system before the
patient enters the OT.
Not applicable
X 100
Number
of
transfusions
230
of the transfused
blood; or potassium
or
citrate
preservatives in the
banked blood.
22.
Percentage of
wastage
of
blood
and
blood products
Number
of
blood and blood
products used
Not applicable
Number
of X 100
blood and blood
products issued
from the blood
bank
231
Percentage of
blood
component
usage
24.
25.
Turnaround
time for issue
of blood and
blood
components
CQI 3g
Number
components
used
Not applicable
X 100
Number
of
blood and blood
products used
The time shall begin Not applicable
from the time that the
order is raised to
blood/blood
component reaching
the clinical unit.
Number
urinary
catheter
associated
UTIs
in
month
Not applicable.
of
Not applicable.
a
X 1000
Number
of
urinary
catheter days
in that month
National Accreditation Board for Hospitals and Healthcare Providers
232
26.
Pneumonia
rate
Number
of
pneumonias in
a month
Not applicable.
X 1000
Number
of
ventilator days
in that month
27.
Bloodstream
infection rate
Number
of
central
line
associated
blood stream
infections in a
month
Number
central
days in
month
28.
Surgical site
infection rate
of X 1000
line
that
Number
of
surgical
site
infections in a
given month
Number
surgeries
performed
Not applicable.
Not applicable.
X 100
of
in
233
that month
29.
CQI 3h
Mortality rate
Number
deaths
of
Number
of
discharges and
deaths
30.
Return to ICU
within
48
hours
Not applicable.
X 100
Number
of
returns to ICU
within 48 hours
Not applicable.
Number
of X 100
discharges/tran
sfers
and
deaths in the
ICU
31.
Return to the
emergency
department
72
within
with
hours
similar
presenting
complaints
Number
of
returns
to
emergency
within 72 hours
similar
with
presenting
X 100
complaints
Number
patients
of
who
234
Not applicable.
have come to
the emergency
32.
Re-intubation
rate
Number of reintubations
within 48 hours
of extubation
Not applicable.
X 100
Number
intubations
33.
CQI 3i
Percentage of
research
activities
approved by
Ethics
committee
Number
research
activities
approved
ethics
committee
Number
research
protocols
submitted
ethics
committee
34.
Percentage of
patients
withdrawing
from the study
of
Not applicable.
Not applicable.
by
of
X 100
to
Number
of
patients
who
X 100
have withdrawn
from all on235
going studies
Number
of
patients
enrolled in all
on-going
studies
35.
Percentage of
protocol
violations/
deviations
reported
Number
protocol
violations/
deviations
reported
of
Not applicable.
X 100
Number
of
protocol
violations/
deviations that
have occurred
36.
Percentage of
The
timeframe
for
Number
of
236
37.
CQI 4a
serious
adverse
events (which
have occurred
in
the
organisation)
reported to the
ethics
committee
the
within
defined
timeframe.
reporting shall be as
per ICMR guidelines
or as laid down by
the sponsor.
serious adverse
events reported
Percentage of
drugs
and
consumables
procured
by
local purchase
Number
of
items
by
purchased
local purchase
captured on a quarterly
basis.
Number
of X 100
serious adverse
events reported
within
and
outside
the
defined
timeframe
Number
drugs listed
Not applicable
of
X 100
in
hospital
formulary and
hospital
consumables
list
237
such
events
captured.
38.
39.
40.
Percentage of
stock
outs
including
emergency
drugs
A stock out is an
event which occurs
when an item in a
pharmacy
or
consumable store is
temporarily unable to
provide
for
an
intended patient.
Number
outs
Percentage of
drugs
and
consumables
rejected
before
preparation of
Goods
Receipt Note
Total quantity
rejected
Percentage of
variations from
the
procurement
process
Total number of
variations from
the
usual X 100
procurement
process
stock
Not applicable
To
capture
this,
organisation
should
maintain a register in the
pharmacyand
stores
(and also if necessary in
the wards) wherein all
such
events
are
captured.
Not applicable
X 100
Number
of
drugs listed in
hospital
formulary and
hospital
consumables
list
Total quantity
received before
GRN
X 100
238
are
Not applicable
authorized, agencies,
wholesalers/distribut
ors.
41.
42.
CQI 4b
Total number of
items procured
Number
variations
observed
mock drills
of Mock drill
is a Total number of
simulation exercise variations in a mock drill
in of preparedness for
any type of event. It
could be event or
disaster.
This
is
basically a dry run or
preparedness
drill.
fire
For example,
mock drill, disaster
drill, Code Blue Drill.
Not applicable
Incidence
falls
of The US Department
of Veteran Affairs
National Centre for
Patient
Safety
defines fall as
Not applicable
Number of falls
Number
of X 100
discharges and
deaths
Loss
of
upright
position that results
in landing on the
floor, ground or an
object or furniture or
a
sudden,
239
at different levels
i.e., from one level to
ground level e.g.
from
beds,
wheelchairs or down
stairs
on the same level
as
a
result
of
slipping, tripping, or
stumbling, or from a
uncontrolled,
unintentional,
nonpurposeful,
downward
displacement of the
to
the
body
floor/ground or hitting
another object like a
chair or stair.
collision, pushing, or
shoving, by or with
another
person
below ground level,
i.e. into a hole or
other opening
in
surface
All types of falls are to
be included whether
from
they
result
physiological
reasons
(fainting)
or
environmental reasons.
Assisted falls (when
another person attempts
to minimize the impact of
the fall by assisting the
patients descent to the
floor)
should
be
included.
(NDNQI, 2005)
It is an event that
results in a person
coming
to
rest
inadvertently on the
ground or floor or
other lower level.
43.
Incidence
of
bed
sores
after
admission
A pressure ulcer is
localized injury to the
skin
and/or
underlying
tissue
usually over a bony
Number
of
patients
who
develop
new
/worsening
of
pressure ulcer
Not applicable
240
prominence, as a
result of pressure, or
pressure
in
combination
with
shear and/or friction.
44.
45.
Percentage of
employees
provided preexposure
prophylaxis
CQI 4c
Bed
occupancy
and
rate
average
length of stay
Pre-exposure
prophylaxis is any
medical or public
health
procedure
used
before
exposure
to
the
disease
causing
agent, its purpose is
to prevent, rather
than treat or cure a
disease. (Wikipedia)
Number
of
employees who
were provided
pre- exposure
prophylaxis
(Basic
statistics for health
Number
inpatient
in
a
month
Number
of X 100
discharges and
deaths
Number
of
employees who
were due to be
provided
preexposure
prophylaxis
Number
available
days in
month
Not applicable
The denominatorshall
include new employees
(working in patient care
areas)
and
existing
employees
whose
booster dose is due in
that month.
X 100
of
days
given
Not applicable
of X 100
bed
that
241
information
management
technology By Carol
Osborn)
E.
The occupancy rate
is a calculation used
to show the actual
utilisation
of
an
inpatient
health
facility for a given
time period.
Number of inpatient
days in a given month
242
Not applicable
calculated
by
subtracting day of
admission from day
of
discharge.
However,
persons
entering and leaving
a hospital on the
a
same dayhave
length of stay of one
46.
OT and ICU
utilisation rate
Number of discharges
and deaths in that
month
OT
utilisation
is OT utilisation rate =
Total population
defined
as
the
utilisation
quotient of hours of OT
time
in
hours
OT time actually
used during elective
X 100
Resource hours
resource hours and
the total number of ICU
elective
resource
hours available for Equipment utilisation =
use.
Number
of
of equipment
The
degree
X 100
utilisation depicts the utilized days
average utilisation of
Number of
inpatient
days-It is a sum of daily
inpatient census.
Equipment
243
Critical
equipment
down time
X 100
244
Not applicable
Check
list
of
all
equipment should be
updated in the unit on
daily basis to monitor
equipment utilisation and
downtime.
duration refers to a
period of time that a
system
fails
to
provide or perform its
primary function
48.
Nurse-patient
ratio for ICUs
and wards
Number
of staff/
Number of shifts
Number of beds
The
HCOs
should
calculate the staffing
patterns separately for
ICUs and for the wards.
The in-charge/supervisor
of the area shall not be
included for calculating
the number of staff.
For example, if in the
ICU there are a total of
15 nurses who work in 3
shifts the numerator will
5 (15/3) and if there are
5 beds the ratio is 1:1.
Similarly for wards.
It is preferable that in
case
of
ICU
the
organisation capture the
245
CQI 4d
Out
patient
satisfaction
index
Patient Satisfaction is
defined in terms of
the degree to which
the
patients
are
expectations
fulfilled. It is an
expression of the gap
between
the
expected
and
perceived
characteristics of a
(Lochoro,
service
2004).
Score achieved
Maximum
possible score
In
patient
satisfaction
index
Score achieved
Maximum
possible score
the
various
Waiting time
for
services
including
diagnostics
outand
patient
consultation
A waiting time is a
length of time which
one must wait in
order for a specific
action to occur, after
that
action
is
requested
or
mandated.
247
Not applicable
Waiting
time
for
diagnostics is applicable
only for out-patients.
Waiting
time
for
diagnostics is the
time from which the
patient has come to
the
diagnostic
(requisition
service
has
been
form
presented to the
counter) till the time
that the test is
initiated.
Number of patients
reported
in
OPD/
Diagnostics
248
assessment.
52.
53.
CQI 4e
Employee
satisfaction
index
Employee
satisfaction index is
an index to measure
satisfaction
of
employee
in
an
organisation
Not applicable
Number of patients
discharged
Score achieved
Maximum
possible score
X 100
249
(Selection of staff
will be stratified, to
enable
comprehensive
overview)
54.
55.
Employee
attrition rate
Employee
absenteeism
rate
Number
of
employees who
have left
Absenteeism
in
employment law is
the state of not being
Number
of
employees who
are
on
Not applicable
Number
of X 100
employees
at
the beginning of
month + newly
joined staff
Not applicable
250
56.
Percentage of
employees
who are aware
of employee
rights,
responsibilities
welfare
and
schemes
unauthorised
absence
Employee awareness
is the
state or
condition of being
aware;
having
knowledge;
consciousness about
employee
rights,
responsibilities and
welfare schemes.
Number
of
employees who
are aware of
employee
rights,
responsibilities
welfare
and
schemes
X 100
Number
employees
Number
employees
interviewed
X 100
of
of
57.
CQI 4f
Number
of Refer to glossary
Number
of
Not applicable
251
If there is deviation in
either
reporting/
sentinel
events
reported,
collected and
analysed
the
within
defined
timeframe
58.
Percentage of
near misses
sentinel events
reported,
collected and
analysed within
the
defined
timeframe
Number
of
sentinel events
reported,
collected and
analysed
A near miss is an
unplanned event that
did not result in
injury,
illness,
or
damage but had
the potential to do so.
(Wikipedia)
Number of near
misses reported
it
collecting/analysis
shall not be included in
the numerator.
X 100
Not applicable
X 100
Number
of
incident reports
Organisations
should
consider
using
a
portfolio
of
toolsincluding
incident
reporting, medical record
review, and analysis of
patient claims-to gain a
comprehensive picture
of sentinel events.
252
59.
60.
Incidence
of
blood
body
fluid
exposures
An exposure is when
blood,
blood
components or other
potentially infectious
materials come in
contact with a staffs
eyes,
mucous
membranes,
nonintact skin or mouth.
(Adopted from Joan
Viteri Memorial Clinic
PEP
Post
Exposure
Prophylaxis)
Incidence
of Needle stick injury is
needle
stick a penetrating stab
injuries
wound from a needle
(or
other
sharp
that
may
object)
result in exposure to
blood or other body
fluids.
Number
of
blood body fluid
X 100
exposures
All
exposures
to
blood/body fluids should
be assessed on a caseby-case basis.
Not applicable
Parenteral
exposure
means injury due to any
sharp.
Number
parenteral
exposures
of
Not applicable
253
accidentally puncture
the skin.
injury
trends.
Data
from
injury
reporting
should
be
compiled and assessed
to
identify:
(1) where, how, with
what devices, and when
injuries are occurring
and
(2) the groups of health
care
workers
being
injured.
CQI 4g
Percentage of
medical
A
discharge
summary is the part
Number
of
medical records
Not applicable
254
records
not
having
discharge
summary
of a patient record
that summarizes the
reasons
for
admission, significant
clinical
findings,
procedures
performed, treatment
patients
rendered,
condition
on
discharge and any
specific instructions
given to the patient
or
family
(for
example
follow-up
medications).
not
having
discharge
summary
Number
of
X 100
discharges and
deaths
It is a summary of the
patients
stay
in
hospital written by
the attending doctor.
62.
Percentage of
medical
records
not
having
codification as
Number
of
medical records
not
having
codification as
per
per
International
Classification
of
Diseases
(ICD)
63.
Percentage of
medical
records having
incomplete
epidemiological,
many
health
management
purposes and clinical
use. These include
the analysis of the
health
general
situation
of
population
groups
and monitoring of the
incidence
and
prevalence
of
diseases and other
health problems in
relation
to
other
variables such as the
characteristics
and
circumstances of the
individuals affected,
reimbursement,
resource allocation,
and
quality
guidelines (W HO).
International
Classification of
Diseases (ICD)
Consent
is
the
willingness
of
a
patient to undergo
examination/procedu
Number
of
medical records
medical records
having
Number
of
discharges and
deaths
/day: 50%
For hospitals with
X 100 51-100 discharges
/day: 20%
For hospitals with
> 100 discharges
/day: 10%
Not applicable
256
and/or
improper
consent
re/ treatment by a
health care provider.
Informed consent is a
type of consent in
which the health care
provider has a duty
to inform
his/her
patient about the
procedure,
its
potential risk and
benefits, alternative
procedure with their
risk and benefits so
as to enable the
patient to take an
informed decision of
his/her health care.
incomplete and/
or
improper
consent
Number
of
X 100
discharges and
deaths
257
person/consent
obtained by wrong
person etc.) it is
considered
as
improper.
64.
Percentage of
missing
records
A medical record is
considered
as
missing when the
record could not be
found out from the
MRD after the 72nd
hour of the record
request.
Number
of
missing record
Number
records
Not applicable
X 100
of
258