Punjab Healthcare Commission: CG-09RM-Ed2
Punjab Healthcare Commission: CG-09RM-Ed2
Punjab Healthcare Commission: CG-09RM-Ed2
In the year 2014, the Commission initiated developing MSDS for different kinds of Category-III HCEs offering
out-patient basis. This includes MSDS for Basic Health Units (BHUs) in the public sector and the clinics of general
practitioners/family physicians, dental clinics, clinical laboratories, radiological diagnostic centers, as well as for
homeopathic clinics and matabs providing services under the Unani Ayurvedic and Homeopathic Practitioners
Act 1965. The MSDS primarily focus on quality and safety of services and are based on the approved basic
framework which covers the ten functional areas of organizational management and patient care. These
include inter-alia, care of patients, management of medication, continuous quality improvement, information
management systems and infection control, etc., in accordance with the range and scope of services at the
particular type of HCE.
Accordingly, the MSDS for Dental Clinics mainly operated in the private sector, have been developed in line with
their scope of services and cater to the specialized practices at these HCEs. All relevant stakeholders, including
the Health Department and dental surgeons from all regions of Punjab, both from the public and private
sectors, were consulted during nalization of the MSDS which comprises of 23 standards and 69 indicators. The
document also provides the survey process, compliance requirements and scoring methodology at the end of
each area to facilitate implementation and assessment of compliance.
I would like to thank the PHC team, led by the Chief Executive Officer, who undertook the revision of earlier
version of MSDS in a thorough professional manner. My thanks are also due to the experts and stakeholders
who provided valuable inputs in compilation of this document. Although staying up to date with the regulatory
requirements requires constant vigilance and seems time-consuming, remaining current on the same is critical
as for safeguarding patients, care providers, the practices and the environment. The document in hand is the
2nd Edition of the MSDS for dental practices that has been reviewed and amended in the light of the
implementation experiences and incorporates other contemporary legal and operational developments.
Lastly, I am grateful to the fellow Commissioners on the PHC Board for their continuous guidance and support in
carrying forward the mandate of the Commission.
I sincerely hope that the nalization of this document would mark another step towards achieving the
mandated objectives of the PHC to improve the quality of healthcare service delivery in Punjab.
Table of Contents
List of Acronyms and Abbreviations 5
1 Introduction 7
1.1 Development Methodology 10
1.2 Reference Manual MSDS Dental Clinics 10
Standard 1. ROM-1: The clinic is identi able as an entity and is easily accessible Indicators 13
Ind 1. The clinic is identi able with name and registration/license numbers on the sign board/s 13
Ind 2. The patient/client has easy access to the clinic 13
Ind 3. The dental clinic is registered/licensed with the PHC 14
Ind 4. Door plate/s clearly display name and quali cation/s of the dental surgeon 14
Ind 5. The staff on duty uses identity badge/s 15
Ind 6. Consultation hours are displayed 15
Standard 2. ROM-2: The manager and the healthcare service provider/s at the clinic is/are suitably 19
quali ed
Ind 7. The clinic manager is duly designated and has requisite quali cations 19
Ind 8. PMC Registration Certi cate of the dental surgeon is displayed 19
Standard 7. HRM-1: There is documented personnel record of dental surgeon/s and staff 47
Ind 23. The Personnel record and credentials of all staff of the clinic are maintained 47
Standard 8. HRM-2: The employees joining the dental clinic/practice are oriented to the environment, 49
respective sections and their individual jobs
Ind 24. Each regular/part time employee trainee and voluntary worker is Ind 24. appropriately oriented to 49
the overall environment of the dental clinic/relevant section service and programme policies and
procedures
Ind 25. Each regular/part time employee is made aware of the job description 49
Ind 26. Performance evaluations are based on the JDs 50
Ind 27. Each regular/part time employee is made aware of his/her rights and responsibilities and patient 50
rights and responsibilities
Standard 10. QA-1: The dental clinic has Quality Assurance / Improvement System in place 60
Ind 32. Service provision is as per portrayal 60
Ind 33. A quality improvement system is practiced 60
Standard 11. QA-2: The clinic identi es key indicators to monitor the inputs processes and outcomes 63
which are used as tools for continual improvement
Ind 34. Monitoring includes appropriate patient assessment 63
Ind 35. Monitoring includes safety and quality control programmes of the diagnostic services 63
Ind 36. Monitoring includes ALL invasive procedures and equipment 64
Ind 37. Monitoring includes use of anesthetics 64
Ind 38. Monitoring includes availability and content of the clinic records 65
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Standard 14. COP-1: The clinic has a well-established patient management system 79
Ind 47. The clinic has an established registration and guidance process 79
Ind 48 Standard/Ethical practice is evident from the patient record 79
Ind 49. The clinic has referral SOPs 80
Standard 15. COP-2: The clinic has essential arrangements for providing care to emergency cases 84
Ind 50. The clinic has essential arrangements to cater for emergency care 84
Standard 18. PRE-1: There is a system for awareness/education of patients and others regarding the 96
Charter of Rights and Responsibilities for compliance
Ind 57. The Charter of Rights and Responsibilities are displayed and patients/families and staff are guided on it 96
Standard 19. PRE-2: There is a system for obtaining consent for treatment 98
Ind 58. The dental surgeon obtains consent from a patient before examination 98
Ind 59. The clinic has listed those situations where speci c informed consent is required from a patient or 98
family and the consent is taken accordingly
Standard 20. PRE-3: Patients and families have a right to information about expected costs 102
Ind 60. The patient/family is informed about the cost of treatment 102
Standard 22. IPC-1: The clinic has a well-designed, comprehensive and coordinated infection 108
prevention and control system aimed at reducing/ eliminating risks to patients,
visitors and care providers
Ind 63. The infection prevention and control plan is documented which aims at preventing and reducing 108
risk of nosocomial/cross-infection
Ind 64. The clinic has designated staff and de ned responsibilities for infection control and waste 109
management activities
Ind 65. The clinic has appropriate consumables, collection and handling systems, equipment and facilities 109
for control of infection
Ind 66. ALL staff involved in the creation, handling and disposal of dental/clinical waste shall receive 110
regular training and ongoing education in the infection control and safe handling of waste
Standard 23. IPC-2: There are documented procedures for sterilization activities in the clinic 122
Ind 67. There is adequate space available for sterilization activities 122
Ind 68. Regular validation tests for sterilization are carried out and documented 122
Ind 69. There is an established procedure for recall in case of breakdown in the sterilization system 123
3 ANNEXURES 131
ANNEXURE. A: Health Related Legislation 132
ANNEXURE. B: Equipment History Sheet 134
ANNEXURE. C: Sample Equipment Service History Form 135
ANNEXURE. D: Equipment Log Book 136
ANNEXURE. E: Orientation Guideline 137
ANNEXURE. F: Statement of Ethics 139
ANNEXURE. G: Template of JD 140
ANNEXURE. H: PHC Charters 144
ANNEXURE. I: Weeding of Old Record 148
ANNEXURE. J: Sample Authorized Personnel List 149
ANNEXURE. K: Sample Client Satisfaction Form 150
ANNEXURE. L: HCE Performance Measuring Checklist for In-charge 151
ANNEXURE. M: Actions Taken for Improvement of Services 152
ANNEXURE. N: Specimen Authorization of Professionals to Administerthe Drugs/Medications 153
ANNEXURE. O: Consent Form 154
ANNEXURE. P: Complaints Management 155
ANNEXURE. Q-I: First Consultation - 8 Dec, 2015 158
ANNEXURE. Q-II: Second Consultation - 22 Dec, 2015 160
ANNEXURE. Q-III: Field TestMSDS/RM - March 30-31, 2018 162
ANNEXURE. R: Development Team 164
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PART 1
INTRODUCTION
1. Introduction
The Government of Punjab promulgated the Punjab Healthcare Commission Act 2010 to establish the Punjab
Healthcare Commission (PHC) as a regulatory body with the prime objective to improve delivery of healthcare
services and ban quackery in Punjab in all its forms and manifestations and perform other functions
connected thereto. The PHC is legally mandated to regulate all healthcare establishments (HCEs) providing
services in public and private sectors through registration and enforcement of minimum service delivery
standards (MSDS) for all categories of healthcare services and to grant license to the HCEs on the basis of
implementation of these MSDS.1 To carry forward its mandate, the Commission prioritized its work regarding
development of MSDS for three recognized systems of treatment; allopathy, homeopathy and tibb. The PHC, in
the rst phase developed and enforced implementation of MSDS for Category-I HCEs i.e. above 50 bedded
hospitals followed by the MSDS for Category-II HCEs which generally cover all types of hospitals related to
allopathic system of treatment having less than 50 beds. Later, the PHC also completed the development of
MSDS for Category-III HCEs; including Homeopathic Clinics, Basic Health Units (BHUs), Matabs, Clinical
Laboratories, Radiological Diagnostic Centers and clinics of General Practitioners (GPs)/Family Physicians,
which have been approved and are being implemented. This was followed by nalizing the document in hand,
the MSDS for Dental Clinics covering small to large scale dental practices.
Setting service delivery standards and indicators for their assessment is an established international practice
for incessantly improving the quality of delivery of healthcare services across the health sector. The primary
objective of developing MSDS for dental practices is to set yard sticks for the clinics of dentists to become
eligible for grant of license by the PHC. These standards are primarily designed to regulate the premises for
streamlining the delivery of healthcare services at the dental clinics even at the lowest level. Issuance of
Certi cate of Registration to the Dentists/ Dental Practitioners to practice however, remains the responsibility
of the PMC in accordance with the provisions of the PMC which was previously the domain of the erstwhile
PMDC established under the PMDC Ordinance 1962 amended through the PMC (Amendment) Act 2012.
An outline for Draft MSDS was prepared by the PHC team by taking on board a core group of experts in
practicing dentistry at various scales. In addition, the professionals working at government healthcare facilities,
at clinical and management positions, members of faculty from dental colleges/universities, representatives of
the PMDC now PMC and the College of Physicians and Surgeons Pakistan, and members of various medical/
dental associations were also consulted.
The draft MSDS prepared by the CG&OS team was shared and thoroughly discussed with the entire technical
team of the PHC, including a skill mix of senior and mid-level practicing doctors, hospital managers, public
health professionals, pharmacists and quality assurance experts, for seeking their views. After incorporating
inputs of the PHC technical team, the draft was shared with the key stakeholders. After seeking comments of the
core group, a broad-based consultative workshop for stakeholders was organized, which was attended by
experts from the Health Department, senior dental surgeons working in the public sector hospitals, public and
private teaching institutions and independently working dental surgeons from across the province. The draft
was thoroughly reviewed and consensus based recommendations were incorporated. The draft reviewed by
the Subcommittee of the Technical Advisory Committee on Standardization and Accreditation, was presented
to the Board of Commissioners of the PHC for approval. The BOC reviewed the MSDS and accorded approval to
forward the same to the Government for formal approval and noti cation before implementation.
The MSDS Reference Manual for Dental Clinics comprises of 23 basic standards and 69 associated indicators, out
of which 48 indicators require 100% compliance (ascribed red), while 21 (ascribed yellow) are acceptable even
with partial compliance at least to the extent of 80%. The following scoring scale shall be used by HCE staff for
self- assessment to ensure 100% implementation.
0 1 2 3 4 5 6 7 8 9 10
An Implementation Assessment Scoring Matrix has been provided at the end of each set of standards and
indicators for self-assessment practice by the HCE Staff, whereas additional details are provided for the PHC
assessors. It is highly desirable to achieve 100% scoring in all areas as these standards only prescribe the lowest
acceptable benchmark of quality, which HCEs are expected to follow. The revised version of MSDS will yet, be a
dynamic document for subsequent improvement on the bases of implementation experience and other
developments in the eld.
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PART 2
These standards provide the structure to help the managers and care provider's effectively work together to
enhance organizational performance. Many dental clinics have grown from single man practices to more
complex businesses with a higher number of employees. Thus adding administrative duties to practitioners.
Therefore, dentists particularly the clinic owners need to have management skills besides expertise in dental
practices.
A dental clinic owner is inter-alia responsible for managing staff, coordinating marketing activities, practices
overseeing the budget, purchases, and managing patient's appointments, besides clinical activities. All these
tasks needs to be performed in an efficient yet pro table way to guarantee the success of the clinic.
To meet these obligations, leaders/managers, care providers/ practitioners must collaborate and work together
as a team to achieve a common objective. The leaders/managers are responsible to develop the mission, vision
and goals of the organization; encourage honest and open communication and address con icts of interest so
that good relationships can thrive which enable the achievement of the stated goals.
The standards related to the responsibilities of management entail creating a culture that fosters safety as a
priority, planning and providing services that meet patients' needs and ensuring availability of physical,
infrastructure and human resources necessary to provide care. The management is also responsible to engage
all managers and clinicians in performance improvement. The standards make clear that performing
management functions is the direct responsibility of all leaders and that a coherent working relationship
amongst different tiers enhances the quality of care provided to the patients. In the small scale practices
however, the management functions and responsibilities will be according to the scope of services provided at
the particular HCE.
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Survey Process:
Observe that access to the dental clinic for patients/relatives, particularly for disabled/elderly persons, is easy. In
case the entry/exit is not on a level ground, it should have steps and ramps/slopes for a wheel chair/stretcher
etc. and the ramps/slopes should be non-slippery. The entry/exit of the clinic and the washroom door/s (if
applicable) are wide enough to allow easy passage for a wheel chair.
Compliance Requirements:
i. Non slippery steps and/or,
ii. Non slippery ramp/slope for wheel chair and/or,
iii. Facilitation for patient access,
iv. Entry and exit of clinic and washroom doors (if applicable) are wide enough to allow easy passage of
wheel chairs.
2- The requirement to display PMC/PHC Registration number on the main sign board is relaxed for initial one year during which the Registration Number should be displayed at a prominent place inside the
clinic.
Survey Process:
The surveyor is required to verify Registration Certi cate and the License issued under the PHC Act 2010 or an
evidence of having applied for the License. PHC Registration Certi cate/License is to be displayed at a
prominent place inside the dental clinic.
Compliance Requirements:
i. PHC Registration Certi cate/License is available and displayed inside the clinic OR
ii. In case is yet in the process of acquiring license or if the license is expired, there is evidence of initiating
the process of obataining registration or renewal.
Scoring:
If the dental clinic has a Registration Certi cate/License from PHC and it is displayed as described above,
then score as fully met.
OR if the dental clinic has; i. registration Certi cate of the PHC which is displayed and ii. evidence of
having applied for the grant of License or renewal, from the PHC. Thereof also score as fully met.
If the dental clinic has no certi cation as above, then score as not met.
Ind 4. Door plate/s clearly display name and quali cation/s of the dental surgeon
Survey Process:
Observe the placement of the door plate/s displaying quali cation/s and having text in accordance with PMC/
PMDC Code of Ethics of Practice for Medical and Dental Practitioners3 prescribed under the PMC Act 2020/
PMDC Ordinance 1962 and the PMC (Amendment) Act 2012 as amended from time to time.
Compliance Requirements:
i. Door plate/s xed with name and quali cation/s
ii. Door plate/s text according to the PMC/ PMDC Code of Ethics for the Medical and Dental Practitioners
iii. Door plate/s size is according to the PMC/ PMDC Code of Ethics (not exceeding 4x10 inches)
Note: PMC Code of Ethics prohibits suffixing of any degree/diploma with the name of practitioners which
are not registered with PMC
Scoring:
If the door plate/s is/are as above, then score as fully met.
If the door plate/s is/are present but full information is not displayed as above, then score as partially met.
If the door plate/s does/do not exist, or it displays super uous information then score as not met.
3- Provision 7 (1) No person shall practice modern system of medicine or surgery unless that person is a doctor or dentist having registered quali cation and valid registration with PMC, 8 (1) refers to display
of valid registration of PMC at the clinic and writing of registration number on prescriptions, Certi cate and money receipts to patients and 8 (2) prohibits suffixing of degrees/diplomas with their names
which are not registered with PMC.
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Survey Process:
The essence of the indicator is to ascertain that every employee of the dental clinic⁵ who is on duty and
providing services can be identi ed by means of an identity badge, having clearly written name/designation
and specialty/discipline, where applicable.
Compliance Requirements:
i. Identity badge/s issued to staff by the administrator/in-charge of the dental clinic
ii. Staff on duty is identi ed with badges
iii. Badge/s have clearly written name/designation/discipline
Scoring:
If the staff is using identi cation badge/s as above, then score as fully met.
If the identi cation badge/s are not in use or there are non-conformities to the above, then score as not met.
Survey Process:
The dental clinic should function only when the dental surgeon is physically available to provide consultation/
services as per consultation hours prominently displayed outside and inside the clinic.
Compliance Requirements:
i. Consultation/Practice hours are displayed inside and outside the clinic
ii. Dental surgeon/s is/are physically present during consultation/practice hours
Scoring:
If the timings/consultation/practice hours are displayed and followed, then score as fully met.
If the timings/consultation/practice hours are NOT displayed or not followed, then score as not met.
Guidelines
Identi cation of the Dental Clinic
It is essential for every dental clinic to be clearly identi ed by its name, specialty, registration of the care
provider with the PMC and status of registration/license of the HCE from PHC to depict its status of being a
legitimate healthcare establishment/service provider while excluding those who are not
quali ed/authorized to practice independently.
Dental clinics are required to install appropriate boards taking into consideration safety measures and
ful lling the regulations/by laws of municipal authorities:
i. Size of the board in relation to the dental clinic building
ii. Location and tting strength of the board in view of the wind pressure
iii. Clear visibility from the approach road
4- Means a full identity card with photo and signatures of the staff and issued under the signatures of the administrator/in-charge of dental clinic.
5- For female staff, like dental nurse, female dental assistant or receptionist etc, who may not like their names/photos to be displayed, a modi ed system having designation only may be devised.
Those dental clinics where more than one dental surgeon provides services, the timings in terms of their
days and hours must be clearly mentioned. If a practitioner provides services at more than one clinic, his/her
name and authorised quali cation with working hours and days must be displayed accordingly.
In case a consultant dental surgeon is just on call to provide services as required, his/her name and
quali cation/s are to be displayed with the words 'ON CALL'.
The HCEs have to apply for registration/license on a prescribed form along with necessary documents. In
response to this application, PHC will issue a Registration Certi cate/Provisional License, which has to be
displayed in the dental clinic at a prominent place and its copy must be available in the clinic's record.
No dental clinic can provide dental services without being registered/licensed with PHC and the
Registration/License Certi cate prominently displayed at the place of practice.
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Staff Identity
Identi cation of the staff on duty at the dental clinic is essential because
i. Patients/relatives have a right to know as to who is providing care to the patient
ii. For seeking follow up of treatment
iii. To provide feedback regarding quality of care
Clinic Name
Employee No:_______________________
Standard 1. ROM-1: The clinic is identi able as an entity and easily accessible
Total 60
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
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Ind 7. The clinic manager is duly designated and has requisite quali cations
Survey Process:
Review the roles and responsibilities of the individual/s managing the dental clinic and/or providing clinical
services and assess if their credentials match the assigned role/portrayed services⁷.
Compliance Requirements:
i. Clinical services are managed/supervised by a dental practitioner registered with the PMC
ii. Support services are managed by a dental practitioner or any other designated person
iii. Evidence of staff credentials (quali cation, experience, training, etc.) is available
Scoring:
Score fully met, unless the survey team identi es signi cant de ciencies in the credentials.
Survey Process:
A photo copy of the valid Registration Certi cate issued by the PMC to the dental surgeon is displayed at a
prominent place and the original is made available when demanded by the inspection team. The validity of the
PMC registration certi cate can be veri ed from the PMC, if so needed.
Compliance Requirements:
i. Photocopy or original valid PMC Registration is displayed inside the clinic
ii. Evidence of initiating renewal process of registration (if applicable) is provided
Scoring:
If copy of the valid PMC Registration Certi cate is prominently displayed in the clinic or the original is
available when demanded by the inspection team, then score as fully met.
If copy of the PMC Registration Certi cate is displayed in the clinic, but is expired, and there is evidence
of having applied for its renewal, then score as partially met.
If copy of the Registration Certi cate is not available at the clinic or it is expired and the process for
renewal has not been initiated, then score as not met.
6- The practitioner/care provider has to be quali ed and registered as per the PMDC Ordinance 1962 and the PMDC (Amendment) Act 2012 or as amended from time to time.
7- The dentist registered with the PMC can be the owner/manager of the practice/clinic himself/herself. In case the clinic is owned by a person other than the dental surgeon himself/herself, then the technical
management shall lie with the dental surgeon who should not allow anyone else to practice in his/her absence, while general administrative issues may be handled by the owner/administrator/manager as the
case may be.
In case the clinic is owned by a non-doctor, the owner shall only manage the general administrative matters,
while all technical matters related to provision of dental care shall be the responsibility of the quali ed
doctor.
In case the clinic is owned/run by more than one practitioner, the person in charge has to be designated,
clearly de ning the following responsibilities as in-charge/manager of the clinic:
i. Provision of services at the clinic according to the PMC rules, regulations and Code of Ethics,
ensuring that only admissible dental services are portrayed and provided at the clinic.
ii. Regular maintenance and repair of physical infrastructure and putting in place the building safety
requirements.
iii. Maintain high standards of general hygiene and a positive approach to patient handling and
facilitation by the support staff.
iv. Maintain discipline amongst the staff and displaying the practice hours.
v. Ensure that medication is dispensed according to standard procedures.
vi. Ensure that all records are maintained with required information and are periodically reviewed and
kept in safe custody with declared responsibility.
vii. Arrange requisite facilities and trained staff to deal with emergency care and referrals.
viii. Establish a complaints redressing system.
ix. Ensure compliance of SOPs on infection control, etc.
x. Maintain all the equipment of the clinic in functioning order.
xi. Responsibility for all kinds of nancial requirements of the clinic.
xii. Responsibility for the training of the staff, like dental assistants, receptionists, etc.
xiii. Ensure that the PMC registration of the dentist/s providing services is valid and copies, along with
the PHC Registration Certi cate are displayed in the clinic and the original certi cates are produced
when asked by the surveyors.
xiv. Ensure that there is a process for renewal of PMC registration/PHC License on regular basis, the
process for renewal is initiated well before expiry and the receipt of application is kept in the record.
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Standard 2. ROM-2: The manager and the healthcare service provider/s at the clinic is/
are suitably quali ed
Total 20
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
Indicators (9-11):
Survey Process:
Observe that the dental clinic has the minimum required space for reception, a sitting/ waiting for patients⁸,
consultation/procedures on a dental chair (dental unit), an X-ray unit (portable/stand mounted or separately
installed/mounted on wall), autoclave and cabinets for instruments and for the dental materials used during
the procedures.
Compliance Requirements:
i. Premises has allocated space for the following:
a. Reception desk
b. Sitting arrangement for at least three patients at one given time
c. Dental chair with essential components and support systems (dental unit) for consultation and
procedures
d. Dental X-ray unit mobile or separately installed (as the case may be)
e. Autoclave
f. Labelled cabinet/s and drawer/s for instruments
g. Labelled cabinet for essential dental materials
Scoring:
If the dental clinic ful lls the requirements as described above, then score as fully met.
If the premises of the dental clinic is as above, but there is no reception desk then score as partially met.
If the premises of the dental clinic is not as above or the sitting arrangement is not sufficient to even
accommodate three patients at a time, then score as not met.
Ind 10. The dental clinic has adequate facilities for the comfort of the patients
Survey Process:
The surveyors should observe the presence of the following during a visit to a dental clinic.
Compliance Requirements:
i. Sitting arrangement/ waiting area
ii. Alternate arrangements of electricity, having at least a backup time of one hour for keeping all the
essential equipment operational and at least three emergency lights
iii. Appropriate waste containers in the consultation/procedure room as well as the patients' waiting
area and places where technicians work
iv. Proper ventilation/air conditioning
v. Clean drinking water
vi. Mosquito and y proo ng (wire gauze)⁹
vii. Toilet (available/accessible)
8- Comfortable sitting means arrangement for at least three to ve patients sitting with comfortable posture at one given time, depending on the size of the practice.
9- Essential to safeguard against diseases transmitted through mosquitos e.g. malaria, dengue, etc. and other infectious diseases spread by ies.
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Scoring:
If the dental clinic has all the seven facilities ( i to vii) mentioned above, then score as fully met.
If the dental clinic has rst six facilities (i to vi) mentioned above, then score as partially met.
If the dental clinic lacks any one of the rst six facilities listed above, then score as not met.
The dental clinic has adequate arrangements for the privacy of patients
Ind 11.
during consultation/examination/procedures
Survey Process:
Observe if arrangements for patient's privacy during consultation/examination, as applicable, are available and
privacy is respected ⁰ .
Compliance Requirements:
i. Arrangements for patient's privacy as per the PMC Code of Ethics:
a. Curtain
b. Cabin/Wooden partition
ii. Evidence that privacy is respected as per the PMC Code of Ethics.
Scoring:
If the Dental Clinic has arrangements for patients' privacy as de ned above and evidence that the
privacy is respected, then score as fully met.
If privacy arrangement is not available in the Dental Clinic, then score as not met.
Guidelines
The Premises
The size and premises of the dental clinic are important for proper delivery of proper healthcare. The clinic
should be designed keeping in mind the comfort of both patients and care providers. Dental clinics are
recommended to have sufficient space designed to cater for basic needs as follows:
i. Patient reception and waiting area for three to ve patients sitting in a comfortable posture at one
given time. The waiting area/room needs to be appropriately furnished with chairs, settee/s, sofa/s
or benches, depending upon affordability and the number of clients to accommodate at least three
to ve patients and attendants at a given time, allowing movement without hindrance. The furniture
should be comfortable and should preferably also have a center-table and magazine rack
depending on the available space and budget. The waiting area can also have a pin-board for
posting articles, appointments or general information for patients.
ii. Approximately 80 sq. ft. space to accommodate a dentist, patient and one to two attendants for
initial consultation and nal prescription writing after performing procedure separately or as part of
the dental procedure room.
iii. In dental procedure room/s, it is ideal to have one dental chair in one room. However, if separate
rooms for more than one dental chair are not available then two chairs may be xed in one larger
room with a mobile screen/ xed partition between the two for performing minor procedures only.
For difficult procedures and where surgery is performed, only one patient shall be managed at one
time. There should be sufficient space around each dental chair for free movement of the dentist and
the assistant/s. There should be sufficient space to accommodate purpose built cabinets/drawers for
10- Privacy of all patients during history taking/examination is important and cannot be ignored. Female patients and minors are not examined alone by the male practitioners. In such an event, the accompanying
attendant, preferably a female, should be requested to remain present. The PMC Code of Ethics for Medical and Dental Practitioners and PHC Charters for Patients and others are relevant.
Practice can be started at a place, having minimum space as described above. However, availability of
further space for possible expansion must be kept in mind with an increase in the number of patients.
White ceilings and light colors should be used on walls and furniture to provide an overall bright
ambience and clean environment.
Privacy of Patient
The script from the Hippocratic Oath signi es the entire concept of the privacy of the patient as follows:
“………I will respect the privacy of my patients, for their problems are not disclosed to me that the world may
know……….”.
Respecting privacy and con dentiality of the patients during examination is an integral part of the PMC /
PMDC Code of Ethics reproduced below:
Section 17. Examination, consultation or procedures on a female patient
(1) A female patient shall be given consultation either by a female dental practitioner or shall be examined in
the presence of a female attendant by a male doctor.
11- As per the Hospital Waste Management Rules 2014 prescribed under the Environment Protection Act 2012 and as amended from time to time.
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MSDS Reference Manual Dental Clinics
i. The medical or dental practitioner cannot seek to gain from information received in a con dential
context (such as a paper sent for review) until that information is publicly available;
iii. The professional medical record of a patient shall not be handed over to any person without the
consent of the patient or his/her legal representative. No one has a right to demand information
from the doctor about his patient, save when the noti cation is required under a statutory or legal
obligation and when in doubt, the medical or dental practitioner or a dentist may consult a legal
advisor;
iv. Con dence concerning individual or domestic life entrusted by patients to a medical or dental
practitioner and defects in the disposition or character of patients observed during medical
attendance shall never be revealed unless their revelation is required by law;
v. A medical or dental practitioner who gains access to medical records or other information without
consent shall be guilty of invasion of privacy; and
vi. The medical or dental practitioner who grants access of an information of a patient to a third person
except, law enforcing agencies, without consent shall be guilty of breach of con dentiality, but
where a medical or dental practitioner is of the opinion to determine it his duty to society requiring
him to employ knowledge about a patient obtained through con dence as a medical or dental
practitioner, to protect a healthy person against a communicable disease to which he is about to be
exposed, the medical or dental practitioner shall give out information to concerned quarters.
Total 30
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
26 CG-09RM-Ed2-141021
MSDS Reference Manual Dental Clinics
Indicators (12-13):
The dental clinic management intimates any change in scope or portrayal
Ind 12.
of services, the location of the HCE or the service provider/s etc. to the PHC
Survey Process:
Review the records and check whether any change in the ownership, managerial staff, portrayal/scope of
services and any change in the location of the clinic within a building or relocation at another site if carried out
has been intimated to PHC or not.
Compliance Requirements:
i. Electronic/documented evidence of intimation to the PHC of any above mentioned changes as
applicable
Scoring:
If there is evidence of intimation to the PHC of the above mentioned changes, if carried out, then score as
fully met.
If there is no evidence of intimation to the PHC of any above mentioned changes , if carried out, then
score as not met.
Survey Process:
Look for evidence which demonstrates that the dental clinic management is aware and has shown sensitivity
towards its community's healthcare needs and is promoting community dentistry. Look for any voluntary ‘out-
reach’ or ‘on-site’ activities catering for community's health needs such as awareness campaigns regarding
dental hygiene, dental camps and/or providing aid to people hit by calamities, etc., if applicable. The evidence
can be in the form of pamphlets/banners/posters/record of patients seen or educated during such awareness
campaigns.
Compliance Requirements:
i. Evidence of any one or more activities such as awareness campaigns regarding dental hygiene, dental
camps and/or providing aid to people hit by calamities, etc.
Scoring:
If there is evidence that the dental clinic is sensitive and catering to social responsibilities as
mentioned above, then score as fully met.
If there is no evidence that the dental clinic is sensitive to social responsibilities as mentioned above,
then score as not met.
Private sector dental clinics are also expected to provide lifesaving/emergency care, particularly to those
who fall prey to accidents/emergencies in the proximity of the private dental clinic, or arranging referral of a
serious patient to a public sector HCE for want of free treatment, etc. The expected social responsibility of a
dental clinic would be limited to providing basic life support (BLS) or a dentistry speci c aid, documenting
the lifesaving/emergency measures taken and referring the patient to the appropriate health facility. This
will also require arrangements for providing rst aid to deal with common emergencies as further explained
under the relevant indicator.
Dental clinics are expected to use the potential of CSOs/NGOs, as they are always willing to contribute in
such activities.
28 CG-09RM-Ed2-141021
MSDS Reference Manual Dental Clinics
Total 20
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
A dental clinic serves the dental care needs of the community and therefore, it needs to undertake regular
maintenance of the infrastructure to ensure functional and safe optimal services. It is imperative that all dental
equipment and support services at the dental clinic remain in prime working condition so that
procedures/surgeries are performed with highest level of precision. It is, therefore, desirable that quali ed
professionals handle and maintain these facilities in accordance with the relevant standards for ensuring
reliability, professionalism and sustaining the reputation of the practice/clinic.
In order to ensure, so that the services and maintenance needs are responded to quickly and efficiently, the
clinic should maintain and implement a preventive maintenance schedule in order to provide un-interrupted
services in a clean, healthy and safe environment. The standards under the functional area of FMS envisage that
the clinic staff is capable of identifying and managing re related accidents and has a provision of safe escape of
the visitors in case there is re emergency.
30 CG-09RM-Ed2-141021
MSDS Reference Manual Dental Clinics
Standard 5. FMS-1: The dental clinic staff is aware of, and complies with, the
relevant laws, rules, regulations, bylaws and facility
inspection requirements under the applicable codes
Indicators (14-19):
Ind 14. The clinic management is conversant with the relevant laws and regulations
Survey Process:
The clinic staff should be knowledgeable about the extent of applicability of the laws/regulations and codes
e.g. pertaining to building safety, re safety requirements, codes related to maintenance of lifts/elevators,
boilers, compressors and generator/s etc to ensure uninterrupted provision of services including power supply
and ventilation. The management/clinic staff also needs to know the laws governing the procurement of safe
pharmaceuticals, etc., supply of clean water12 and have effective contingency plans in the event of primary
system failures for ensuring smooth functioning of the clinic.
Compliance Requirements:
i. Staff is conversant with the relevant laws/regulations/codes and inspection requirements
ii. Effective contingency plans in the event of primary system failures
Scoring:
If there is clear evidence that the managerial and operational staff is aware of the relevant laws and their
applicability/requirements, then score as fully met.
If either there is evidence that the managerial staff is not aware of the relevant laws and their
applicability or operational staff is not aware of the relevant requirements, then score as not met.
Survey Process:
Directly observe and note the availability of updated/current laws that are applicable to the clinic .
Compliance Requirements:
i. Availability of copies of updated/current laws which are applicable to the clinic.
Scoring:
If a full range of updated/current laws that are applicable to the clinic is available, then score as fully met.
If even one of the applicable laws is either not updated/current or not available, then score as not met.
Compliance Requirements:
i. Valid registration certi cates/licenses including certi cation of dental X-ray unit available (as applicable)
ii. Documented evidence of mechanism to regularly update the certi cations/ licenses etc.
Scoring:
If there is a full range of current compliance documents, and there is mechanism to regularly update the
above then score as fully met.
If even one of the current compliance documents is not available, then score as not met.
The staff has the knowledge about early detection and containment of
Ind 18.
re and non- re emergencies
Survey Process:
The surveyors shall ask the staff (dental surgeon as well as the support staff ) of the clinic regarding knowledge
about the system/process for early detection and containment of re and non- re emergencies.
Compliance Requirements:
i. Evidence of awareness about detection and containment by interviewing the staff
ii. Evidence of re ghting drills by the staff e.g. attendance sheet available in record
13- Early detection at a small scale means to quickly check in person the extra ordinary smoke/burning smells, etc. non- re emergencies: earthquake/building collapse, oods, etc.
32 CG-09RM-Ed2-141021
MSDS Reference Manual Dental Clinics
Scoring:
If the staff has knowledge about the system/process of early detection and containment of re and
non- re emergencies, then score as fully met.
If the staff has no knowledge, then score as not met.
Compliance Requirements:
i. Documented re and non- re safety plan
ii. Fire ghting equipment/other arrangements available
iii. Staff aware about the re ghting system/non- re emergency combat system/process
Scoring:
If the arrangements to combat re and non- re emergencies are available and the staff is aware of
and knows how to use those, then score as fully met.
If the arrangements to combat re and non- re emergencies are available but the staff is not aware
of and does not know how to use those, then score as partially met.
If the arrangements to combat re and non- re emergencies are not available, then score as not met.
Guidelines
Applicability of Laws and Regulations to Dental Clinic/Surgery
A list of the relevant laws applicable to the health sector/healthcare service delivery, with the links to
download, is provided at Annexure-A.
The basic design of a dental clinic/surgery is required to support its functions, including the following:
i. Waiting/reception area
ii. Care of patients including consultation, procedures / treatment and emergency services etc.
iii Diagnostic facilities e.g. x-rays
iv. Research and training
v. Pharmacy services if portrayed (usually in case of polyclinics)
vi. Administrative/Facility management services
vii. Support and supply services
viii. Parking areas, etc.
The legal aspect is the most signi cant consideration in planning and designing the clinic and the
architects, engineers, and allied professionals must have working knowledge of the applicable laws, rules
and regulations and relevant codes of practice.
In the public sector, the Communication and Works Department (C&W) is the responsible agency for
planning and designing hospital and clinic buildings with an architect section headed by the Chief
Architect.
14- Equipment/arrangement suitable for the dental clinic/surgery like, bucket of water/sand, spade and/or re extinguisher, etc., as applicable.
1. Zoning Regulations
i. Access and accessibility
ii. Volumetric dimensional limits of the building in terms of site coverage
iii. Building height
iv. Easements and rights of way, if any
These considerations establish the criteria that help to evolve a clinic design which is safe and consistent
with the overall plan for the community, without disturbing the local ethos and environment.
2. Building Code
The following provision of Building Code are considered to achieve maximum safety to ensure structural
stability, so that construction can withstand powerful earthquakes and other calamities:
i. Types of construction
ii. Light and ventilation
iii. Labour safety and welfare during construction
iv. Sanitation
v. Electrical and mechanical regulations
vi. Protection from ionizing radiation from X-ray equipment
vii. Permits and inspection requirements
viii. Any other applicable code
3. Fire Code
The Fire Code is provided by the Rescue Department, which requires complying with the following
provisions in order to minimize injury, death and loss to the staff, patients and families and also to curtail
damages to the hospital infrastructure:
i. General precautions against re
ii. Principles of re safety in buildings/structures
iii. Fire protection appliances
iv. Maintenance of re exits.
v. Suppression control in hazardous areas
vi. Specifying smoking areas as per provisions of relevant law/rules
vii. Management and use of combustible materials
4. Other codes
Other relevant bylaws, regulations and codes include sanitation codes, environmental protection
laws and water codes. These vary in form and content according to the requirements and need of the
clinic and ensure that.
34 CG-09RM-Ed2-141021
MSDS Reference Manual Dental Clinics
i. Design is consistent with the national/international standards for public health and safety.
ii. The permits and licenses necessary for establishing the clinics, related to the above
mentioned codes, are obtained.
iii. Occupational safety and protection against health hazards is ensured.
Risk Management
Every organization, depending on its size, is required to designate individual/s to provide oversight for
effective, consistent and continuous implementation of all aspects of the risk management program,
including inter-alia the following:
i. Planning and implementing the program
ii. Educating the staff
iii. Testing and monitoring the program
iv. Periodical review and revision
v. Annual reports to the governing body/board on the effectiveness of the program
vi. Providing consistent and continuous management support
i. The oors of beams of egress shall be illuminated at all points including angles and intersections of
corridors and passageways, landings of stairs and exit doors with bulbs of not less than one
thousandth (0.001) lumens per square centimeter.
ii. Lighting source is of reasonably assessed reliability, such as public utility electric service.
iii. Emergency lighting facilities maintain the speci ed degree of illumination in the event of failure of
the normal lighting for a period of at least one hour.
iv. Illuminated 'EXIT' signs – distinctive in color, reliable source – ve thousandth lumens (0.005) per
square centimeters.
v. Size of signs – plainly legible letters not less than fteen centimeters high with the principal strokes
of letters not less than nineteen millimeters wide.
vi. Provide luminous directional exit signs located one foot or below oor level.
vii. There should be separate ingress and egress routes.
viii. Corridors, hallways and aisles must be 2.4 meters in width.
ix. Use of ramps as access to second and higher oors.
x. Stairways with safe and adequately secured railings.
xi. Stairway must be at least 112 cm. wide and made of concrete.
xii. Any opening in wall/s shall be protected by re doors or xed wire glass windows and must have
protection for vertical openings also.
xiii. Any door in a stairway, ramp, elevator shaft, stairway enclosure or light and ventilation shaft or
chute, shall be self-closing, and shall normally be kept closed.
36 CG-09RM-Ed2-141021
MSDS Reference Manual Dental Clinics
Standard 5. FMS-1: The dental clinic staff is aware of, and complies with, the relevant
laws, rules, regulations, bylaws and facility inspection requirements
under the applicable codes
Total 60
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
Ind 20. The clinic plans has an equipment in accordance with its scope of services
Survey Process:
Review at the least; i. the inventory of all dental equipment in the clinic and review the documentation to
seethat the minimum required equipment to support basic dental care services and specialized equipment, as
applicable, is listed on the clinic's inventory. ii. Evidence of testing prior to use.
Compliance Requirements:
i. An inventory of all dental equipment in the clinic (minimum required equipment to support the basic
dental care services and specialized equipment, as applicable)
ii. A written plan /SOPs for:
a. Testing prior to use
Scoring:
If there is a plan covering the above aspects and evidence that it is being implemented, then score as
fully met.
If the plan exists but it does not include testing prior to use, or there are inadequate skills and resources
for implementation, then score as partially met.
If there is no equipment plan or if it does not include the Sops for testing prior to use or if there is no
inventory of dental equipment, then score as not met.
Ind 21. Quali ed and trained personnel operate and maintain15 the equipment
Survey Process:
To determine if appropriate personnel operate and maintain the equipment correctly (up to user maintenance
level de ned by the equipment manufacturer), look for documented training for use and maintenance as a user
and any data that identi es ‘user error’.16 Also, review the job descriptions of personnel deputed to operate
and/or for maintenance of dental equipment and their personal record to verify that they have the required
quali cations17, knowledge and experience.
Compliance Requirements:
i. Equipment maintenance protocols are followed
ii. Appropriate personnel operate and maintain the equipment correctly (up to user maintenance level
de ned by the equipment manufacturer)
iv. Evidence of training for use and maintenance as a user and any data that identi es'user error'
v. Job descriptions of personnel deputed to operate and/or for maintenance of dental equipment
vi. Personal record for verifying that the staff have the required quali cations, knowledge and experience
15- Servicing and planned preventive maintenance can be outsourced to appropriately quali ed technicians if required, or a combination of in-house and outsourced maintenance and servicing would be ne.
16- Equipment failures due to incorrect use.
17- As prescribed by the PMF or any other certifying authority.
38 CG-09RM-Ed2-141021
MSDS Reference Manual Dental Clinics
Scoring:
If the staff are adequately quali ed and experienced and trained to operate and maintain all equipment
within the scope of their ability as described above, beyond which equipment is serviced by contracted
experts, then score as fully met.
If the staff are less quali ed and experienced but trained to operate and maintain all equipment within
the scope of their ability as described above, beyond which equipment is serviced by contracted
experts, then score as partially met.
If staff are less quali ed and less experienced and their competence to operate and maintain the
equipment within the scope of their ability is also questionable and contracted service experts are also
not available, then score as not met.
Survey Process:
There should be a written schedule of inspection, calibration and documented operational preventive
maintenance plan) based at least on manufacturer's recommendations. The inspection, calibration (if needed),
and maintenance must be documented18. The surveyors should review this documentation.
Compliance Requirement:
i. Written schedule of inspection, calibration and periodic preventive maintenance based at least on
manufacturer's recommendations
ii. Documentary evidence of inspection, calibration (if needed), and maintenance carried out
iii. Certi cate by the end user that the; i. the equipment is in working order, and ii. it is being periodically
serviced/calibrated
Scoring:
If ALL the above requirements are implemented and documented, then score as fully met.
Since this is a signi cant patient safety issue, if any of the requirements are not documented, then score
as not met.
Guidelines
Procurement Planning
While selection and procurement of the type and number of various equipment for the dental clinic/
surgery, and nalizing speci cations, the following must be taken into consideration:
i. Scope of services to be provided
ii. Future expansion/up graduation requirements
The SOPs regarding equipment selection and procurement should be periodically reviewed and revised.
18- The log book and history sheet etc. for each equipment should clarify that the inspection, calibration and maintenance is done in accordance with the preventive maintenance schedule detailed in the
Guidelines. The end user/specialist to certify that; i. the equipment is in working order, and ii. it is being periodically serviced.
The dental clinic shall ensure that the record regarding purchase and maintenance of equipment and
machinery is properly maintained. The facilities shall ensure that no equipment is non-functional/out of use
merely for want of minor repairs, preventive maintenance, lack of essential spares, electrical faults, etc.
Important factors resulting into gross equipment wastage may also include the following:
i. Mishandling of equipment
ii. Use by untrained and unskilled staff
iii. Purchase of highly sophisticated equipment without competent personnel to handle it
iv. Purchase of excess equipment without a justi able demand
This calls for an efficient system for equipment management by introducing an Equipment Audit,
particularly in larger setups, for periodic evaluation of the quality of performance of the equipment which
has the following advantages:
40 CG-09RM-Ed2-141021
MSDS Reference Manual Dental Clinics
Equipment Audit
Equipment audit is the periodic evaluation of the quality of performance of the HCE equipment.
OR
It may cover a retrospective evaluation of quality of performance of equipment by an Equipment Audit
Committee comprising of the head of clinic and end use based on documented records of the equipment
at the time of purchase and its subsequent maintenance.
The Equipment Audit Committee shall meet once in three months and assign tasks to the members
Maintenance of the history sheet and its subsequent write-up is sine-qua-non for performance of the
equipment audit by the committee. A format of the History Sheet and Log Book is given as Annexure-B and C:
The following parameters may be considered in the equipment audit procedure in the larger setups
Procurement
i. Was the equipment required?
ii. Were the technical speci cations worked out and provided by the user department and
speci ed in the purchase order ?
iii. Was the receipt of equipment as per the speci cations of the supply order?
iv. Was availability of spares, after sale services and training of staff incorporated/speci ed in
the contract to ensure uninterrupted functioning?
Performance
Periodic scienti c evaluation of the quality of performance of the equipment is carried out by using the
history sheet and log book. The process of equipment audit is an indispensable tool in formulating
speci cations and establishing benchmarks for medical equipment .
Planned preventive maintenance is a regular, periodic activity carried out to keep equipment in good
working order and to optimize its efficiency and accuracy. This involves regular, routine cleaning,
lubricating, testing, calibrating and adjusting, checking for wear and tear and replacing worn out
components to avoid breakdown. Productive preventive maintenance refers to proper selection of
equipment to be included in planned preventive maintenance and taking decisions on what to include and
to reduce costs making the procurement and maintenance cost-effective.
An important aspect of planned preventive maintenance is the participation of the user who is responsible
for bulk of the work. The task must be performed daily involving the end user and a technician/engineer at
the end of the week. Highly technical repairs, are the responsibility of the engineering section/engineer and
may be scheduled every six months or on a need basis.
1. Equipment Inventory
All relevant information about the equipment must be entered, including its location, records of
repair and maintenance, and the manufacturer's speci cations/ details.
The schedules presented in the guidelines can be modi ed to conform to the manufacturers'
speci cations. A record card will be included with each schedule for recording measurements and
the engineer/technician should also note on the record card any item that needs to be replaced, if
work is to be carried out later, and whether or not the same engineer is to carry out the work.
42 CG-09RM-Ed2-141021
MSDS Reference Manual Dental Clinics
Standard 6. FMS-2: The clinic has a program for management of dental and support
service equipment
Total 30
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
One pervasive issue impacting the management of the human resource (HR) function in a dental practice is that
despite years of medical education, dentists often are not educated in management and planning aspects.
The objective of the standards under the human resource management (HRM) is to ensure that the
quali cations and competency for the staff positions is determined to match the patient care needs and the
stated goals and mission of the organization. The dental clinic must employ the right number of quali ed staff to
meet the portrayed patient care requirements. The dental clinic also needs to have a system for assessing,
maintaining and improving staff capability and promoting continuous professional development and learning.
44 CG-09RM-Ed2-141021
MSDS Reference Manual Dental Clinics
Ind 23. The Personnel record and credentials of all staff of the clinic are maintained
Survey Process:
20
Review the personal record of the dental surgeon/s, dental technician/s , dental nurse, dental assistant/s,
dental hygienist/s and other staff (as applicable) to verify the credentials including professional quali cations,
registration with the concerned councils/authorities, validity of registration, experience certi cates, trainings,
current medical tness status, character certi cate/references,21 etc. and job descriptions (JDs) duly signed by
the employer and the employee as applicable.
Compliance Requirements:
i. Availability of personal les of staff including certi ed copies of the following:
a. Credentials (quali cation, experience and training)
b. Valid registration certi cate from concerned authorities
c. CNIC
d. Medical tness
e. Character certi cates / reference veri cation(if applicable)
f. Jds
g. Performance appraisal if applicable
Scoring:
If all reviewed records have documented information regarding professional quali cations/credentials
as above, then score as fully met.
If all the above record of the staff is not available , then score as not met.
Guidelines
Personal Files
The personal les provide an updated record of employees and should be maintained because:
i. It makes good business sense to have accurate information in an organized manner to be
use it for an official purpose.
ii. Immediate supervisors will eventually encounter the need to produce documentation about
employee performance and work history.
iii. Some employee records are required by the federal or provincial government/other agencies and
must be kept in the personal les.
iv. Organizing the record of employees in a proper manner facilitates the access for all legitimate
The personal le of each employee is very con dential and access to it is restricted and only allowed after
the approval from a competent authority. Access to information about employees should be strictly limited
to those people in the dental clinic who need to use it for official purposes.
46 CG-09RM-Ed2-141021
MSDS Reference Manual Dental Clinics
10
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
Ind 25. Each regular/part time employee is made aware of the job description
Survey Process:
The essence of the indicator is to emphasize the importance of developing job descriptions (JDs) of all the
employees and making them aware about the JD/s for effectively performing assigned duties. Each individual
employee is provided a detailed JD and is made fully aware of requirements given therein. The record bears the
signatures of the concerned employees certifying that it has been read and fully understood.
Compliance Requirements:
i. Documented JDs in respect of each employee duly signed by the employee/s and the employer
ii. Evidence that the employee is made aware of JD
Scoring:
If the JDs are available and signed by all employees23, then score as fully met.
If the JDs are available but not signed by any one employee, then score as not met.
22- Employees include all full time/regular or part time/visiting consultants/employees and staff members.
23- The Job Descriptions and Performance Evaluation Criteria for Medical, Nursing and Paramedical Staff 2008-09 developed by the PDSSP and noti ed by the Government of Punjab can be used as a guideline
/adapted for developing JDs for all appointments as required.
48 CG-09RM-Ed2-141021
MSDS Reference Manual Dental Clinics
Survey Process:
Review the system for performance evaluation of the staff (quarterly/yearly, as prescribed) and see if the
performance evaluations are based on the respective JDs.
Compliance Requirements:
i. Record/Documented periodic performance appraisal system of the staff
ii. Evidence that performance appraisals are carried out as per the appraisal system and these are based on
the respective JDs
Scoring:
If the performance evaluation system prescribed and record of periodic performance evaluations of the
staff is maintained as above, then score as fully met.
If the performance evaluation system is prescribed and record of periodic performance evaluations of
the staff is maintained but is de cient by 20% only, then score as partially met.
If either there is no performance evaluation system or the record of periodic performance evaluations of
the staff is not maintained as above, then score as not met.
Survey Process:
This indicator would require that written job descriptions (JDs)24 of each staff member points to his/her
responsibilities towards patients and others as well as his/her rights. Staff members rights are detailed in the
human resource/employee manual or other such documentation maintained by the clinic. . The Charter for
Patients, Carers and Others and Charter for HCEs providing detailed rights and responsibilities are available on
the PHC website as downloadable documents for information and compliance. The evidence should exist that
the employee has been made aware of these.
Compliance Requirements:
i. Written JDs of each staff member entails his/her responsibilities towards patients and others as well as
his/her rights
ii. The Charter for Patients and Charter for HCEs providing detailed rights and responsibilities are
available/ displayed
iii. All staff members are made aware of the Charters
Scoring:
If there is evidence of orientation of each staff member as above , then score as fully met.
If evidence of orientation of any of the staff member as above is lacking, then score as not met.
24- Mention job description as in Ind 26 & 27 to include responsibilities, particularly towards patients.
Once the selection process is completed, the new employee must be oriented in order to improve his/her
ability to perform the job and also to satisfy the personal desire and feeling that he/she is contributing for
the organization. Supervisors, in coordination with the human resource (HR) department, complete the
orientation by introducing the new employee to the co-workers. Every dental clinic should recognize that
its success and the quality of care provided depends upon the capacities of its staff and shall design a
comprehensive induction orientation programme as an integral component of their capacity building. The
induction and orientation processes will provide the information, guidance and support required for staff to
undertake their assigned responsibilities. This will be achieved by familiarizing the new staff with the
policies, systems, procedures, governance structure and the work location, and encouraging commitment
to the vision, mission and values of the HCE.
Performance management systems of the organization must be explained to the employees at the
induction, in order to align their daily activities with the overall organizational goals (the mission). The new
employee should be briefed about past achievements, in terms of services provided, future objectives,
plans and targets so as to create a positive image about the organization. General responsibilities towards
the institution and as to what the staff will be required to do, should be explained in the detailed guideline
regarding orientation as per format.
50 CG-09RM-Ed2-141021
MSDS Reference Manual Dental Clinics
Standard 8. HRM-2: The employees joining the dental clinic/practice are oriented to the
environment, respective sections and their individual jobs
Total 40
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
The exchange of relevant patient data, such as patient's medical/dental history, laboratory reports, and
prescribed medications, between dental and medical clinics has the potential to break down the barriers
between medical and dental practitioners communication. It also allows for better cooperation between
medical and dental clinics, to provide dependable and reliable data regarding patient's overall health. Quick
and timely access to a patient's updated dental history and any pre-existing medical condition allows more
thorough assessments in less time.
The standards pertaining to information management system (IMS) highlight the fact that patient care is highly
dependent upon accurate and correct information. The standards also signify that the work of dental surgeons
and staff in the clinic must be facilitated by timely information to provide coordinated and integrated care. In
addition, it is important to protect the con dentiality of the data/patient information collected during the
course of treatment by limiting unauthorized access.
Medical/dental records serve many functions, primarily to support quality patient care and better outcome.
Although, currently there is a great trend to computerize medical/dental records. The desired bene t of
providing better patient care however only be achieved once the quality of manual records is improved. The
onus for improving medical records lies with individual health professionals as well as the management of the
HCE/practice. Structuring the record can bring direct bene ts by improving patient care, treatment outcomes
and health system performance and ensure safety of services.
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Indicators (28-31):
Every patient's medical records has a unique identi er and particulars for
Ind 28.
identi cation
Survey Process:
Check that a system of maintaining medical record that should contain information including serial number,
date, name, parentage/husband name, age, gender, address, etc. computerized / manual is in place. This
symptoms/provisional diagnosis, treatment/procedures provided/performed and referrals (if any) as per the
25
prescribed format . CNIC and contact number of the patient may be noted as a routine if convenient and will be
mandatory when a patient is referred/transferred or is a medico legal case. Patient record should be maintained
in the clinic at least for one year for general records and 12 years for medico legal cases26 (if applicable).
Compliance Requirements:
i. The medical record(computerized or manual) covering the following parameters is maintained:
a. Serial number
b. Date
c. Name
d. Parentage/Husband name
e. Age
f. Gender
g. CNIC/Contact number (mandatory when a patient is referred/transferred or is a medico legal case)
h. Address
ii. Evidence that Patient record is maintained in the clinic at least for one year for general records and 12
years or longer as required for medico legal cases
Scoring:
If the patient record is maintained as above, then score as fully met.
If the patient record is maintained but the information is de cient by about 20% only, then score as
partially met.
If no record is maintained or the de ciency is more than 20%, then score as not met.
Survey Process:
If a person other than the dental surgeon is delegated to make entries in the record of the patients, he/she
should be duly authorized in writing to do so and the entries in the record are traceable/identi able when
required. Name and designation of the dental surgeon writing the prescriptions and the person making entries
in other records must be mentioned , in pen or by stamp and signed.27
25- Detailed format given in the Guidelines as well as in the DHIS of the Health Department.
26- As explained in the guidelines, retention of the record for a longer period may become applicable if some other statutes so require.
27- As per details given in the guidelines, the dental surgeon himself in case of single man clinic is responsible for making entries in the record, as such under his/her signatures. The person responsible to
prescribe and perform the required procedure etc. should write full name or use stamp under signatures.
Survey Process:
Correct recording of time of arrival of a patient at a clinic and the time at which he/she is attended and leaves, is
very important as the same may be required to be produced as an evidence. Focus attention on timing of
patient's arrival, clinical notes including patient's complaints, oral examination, investigations, type of
anesthesia (if applicable), treatment provided/procedure performed, materials used and medication
prescribed/dispensed, etc. Any emergent situation attended or referral is also documented. This can be
evaluated during the review of the previously selected records.
Compliance Requirements
i. Record of clinical notes as stated above
Scoring:
If all entries are dated, timed and signed as above, then score as fully met.
If all entries are dated and signed, but some entries are not timed, then score as partially met.
If any entry is not dated or signed, then score as not met.
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Guidelines
Unique Patient Identi ers
All patients record must be consistently labelled with at least one unique identi er so that it can be veri ed
that it correspond to particular patients. Computer generated unique ID number is the easiest and correct
identi cation method. The patient's medical record always becomes a focal point whenever there is a
question regarding the care and treatment rendered. It is important that entries in the medical record are
documented timely and accurately. The medical record serves three primary purposes: i. to provide
evidence of the patient's course of illness and treatment; and ii.to facilitate review of the record/ treatment
provided iii. To ensure quality of patient care.
It is often perceived that the medical record is a means of protection or a defense action against medical
malpractice. However, the purpose of the medical record is not only to protect or to provide a defense, it also
preserve the truth. A complete and accurate medical record will protect the legal interests of the patient, the
hospital and the practitioner provide a justi able defense.
Accurate identi cation of the patient is pivotal for an effective and efficient medical record system. Correct
identi cation is needed to positively identify the patient and ensure that each patient has one medical
record number and one medical record and no duplicates. In order to identify patients, we need a UNIQUE
PATIENT CHARACTERISTIC. The type and number of unique patient characteristics will change from one
setting to another and are de ned as below.
Accurate date and time recording is important whenever it is needed to be produced the as a proof of
certain timely action. It is also a valuable source of data for coding, health research and source of evidence
and rationale for resource management.
Minimum Requirements for Patients' Medical Records. ⁹ Upon completion, medical records for
outpatients shall contain, at a minimum, the documents as speci ed below. Records for patients at the
hospital for other specialized services, such as emergency services or surgical services, shall contain such
additional documentation as required for those services.
Records for patients at the hospital for other specialized care, such as emergency services or surgical
services, shall contain such additional documentation as required for those services.
29- Authority O.C.G.A. Sec. 31-7-2.1. History. Original Rule entitled “Medical Records” adopted. F. Nov. 22, 2002; eff. Dec. 12, 2002.
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Ind 29. Only authorized person/s make entries in the record 10 80%
Ind 30. Every record entry is dated, timed and signed 10 80%
Total 40
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
Quality assurance is a systemic approach for assessing the quality of care, implementing and evaluating
changes in the patient care to maintain continually improve the quality of care. Each service area in the of
minimum service delivery standards is an integral to the quality assurance system. Quality assurance is a
sequence of actions that lead to performance enhancement. Although QA & QI is relatively a newer concept,
protocols produce encouraging results towards furthering quality in dental practice. Quality assurance is in fact
an on-going evaluation system that focuses on overall patterns of behavior rather than on isolated instances of
behavior.
Continuous Quality Improvement entails the entire systems and process that assure safety for patients and staff
and allowing provision of consistent highest quality care at the lowest justi able cost.
QA/QI requires the participation and input of entire staff working in the clinic and is best implemented through
coordinated activities. Dental team consist of dentist , manager, staff nurse, or any designated person
responsible for maintaining and improving quality. Compliance of these indicators must be ensured by an
internal monitoring conducted on monthly or quarterly basis. While some processes need to be monitored on a
regular basis (e.g., daily, weekly), all functions of the clinic should be reviewed at least annually to ensure that
they are performed according to QA/QI plans, and other organizational objectives.
The standards under the continuous quality improvement/ quality assurance primarily focus on a systematic
approach of using data to measure/ assess the current performance against the set benchmark of quality,
identify gaps and take measures to improve the quality and care in the dental clinic. It is a continuous process
that focuses on outcomes of care, patient safety and satisfaction in terms of health care delivery and must
include reducing actual and potential risks to patient safety. To achieve this goal, the standards emphasize on
the processes, systems and individual behaviors that reduce the likelihood of unanticipated adverse events as
well as near misses.
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Standard 10. QA-1: The dental clinic has Quality Assurance / Improvement
System in place
Indicators (32-33):
Survey Process:
The indicator focusses on ascertaining that services provided by the clinic staff to the patients are as per the
facilities portrayed and scope de ned in the application for registering/licensing with PHC. There should be no
super uous displays/ portrayals.
Compliance Requirements
i. There is evidence that services are provided as per portrayal essential equipment is available
ii. There are no super uous displays
Scoring:
If the dental services provided are in accordance with those listed in the application form for registration
/licensing with PHC and there is no super uous display, then score as fully met.
If either the dental services provided are not in accordance with those listed in the application for
registration/licensing with PHC or there is/are super uous display/s, then score as not met.
Survey Process:
This indicator is to demonstrate actions taken by the dental surgeon/administrator/manager to make
improvements in the quality of care based on the observations as recorded during his/her monitoring/
evaluations.
The clinic in-charge should periodically check how the patients are being received and seated while waiting
and that the facilities for the comfort of patients like sitting arrangements, drinking water, ventilation, etc. are
available/intact. The clinic in-charge shall use a quality assurance checklist 3 0 for checking on
daily/weekly/monthly/yearly basis that the services provided at the clinic conform to the minimum standards.
The duties assigned to the staff should be included in the JDs and evaluated on the basis of the checklist which
shall be dated and signed and kept in record.
Compliance Requirements
i. Checklist developed and monitored by the clinic In-charge regularly.
ii. Evidence regarding any improvement made by dental surgeon/ in charge /administrator based on
the observations documented during periodic evaluations/inspections
Scoring:
If there is a written record of actions taken as above, then score as fully met.
If monitoring based on the checklist and quality improvement/Quality Assurance is demonstrated but
there is no written record of actions taken a above then score as partially met.
If neither a quality improvement system is demonstrated nor there is record of actions taken then score
as not met.
30- Format of the Checklist provided in the Guidelines can be adapted as per requirement of the clinic.
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Standard 10. QA-1: The dental clinic has a quality assurance/improvement system in
place
Total 20
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
Survey Process:
When surveying the clinic, review the document that covers i, complete history with initial examination ii,
planned course of treatment, iii, modi cation of treatment on patient medical condition/ demands/ needs,
treatment outcomes. iv, all information is recorded in the clinical records. A carbonized prescription cum
procedure record is also acceptable.
Compliance Requirements
i. Impact of CQI is re ected by the record that includes:
a. Complete history with Initial examination.
b. Planned course of the treatment.
c. Modi cation of treatment on the basis of the patient medical condition andthe needs / demands
and /treatment outcomes.
ii. All information recorded and maintained in the clinical records.
Note: A carbonized prescription cum procedure of maintaining record will be acceptable. eg in the
record of the patients.
Scoring:
If there is documented evidence that patient assessment has been monitored and examples can be
seen as a result of the QI program, then score as fully met.
If not, then score as not met.
Compliance Requirements
i. Documented SOPs for use of diagnostic equipment
ii. Documented OH&S protocols
iii. Documented training of staff on SOPs and OH&S protocols
iv. Reference testing/calibration as per OEM guidelines to ensure accuracy
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Scoring:
If there is documented evidence of the above, then score as fully met.
If there is no evidence of the above, then score as not met.
Survey Process:
Review the documentation along with the equipment and check that during invasive procedures, any adverse
31
occurrences has been reported such as return to dental surgery within 24 hours and re-doing the procedure
within 24 hours, and that such reporting is included in the CQI programme. All the dental equipment is required
to be checked for maintenance, validation and accuracy at least once a month.
Compliance Requirements
i. Documentary evidence of reporting all adverse occurrences.
ii. Documented occupational health and safety (OH&S) protocols for the dental equipment e.g,
maintenance, validation, and accuracy of autoclave, dental compressor, dental unit, dental handpieces,
endomotors, high speed scalers etc.
iii. Reference testing/caliberation of equipment to ensure accuracy
Scoring:
If there is documented evidence that all invasive procedures has been monitored as above, then score as
fully met.
If there is no evidence as above, then score as not met.
Survey Process:
Review the documentation and observe for reporting of adverse occurrence from use of anesthetics and
adequate follow up.
Compliance Requirements
i. Documentary evidence of reporting adverse occurrences during or soon after administration of
anesthetics
ii. Evidence of adequate management/follow up of the adverse occurrence.
Scoring:
If there is documented evidence that adverse occurrences from use of anesthetics have been monitored
and adequately followed up, then score as fully met.
If there is no evidence of the above, then score as not met.
Survey Process:
Review the documentation to check that monitoring the quality of the clinic records has been monitored. Also
check for compliance monitoring and performance monitoring:
Ÿ Compliance monitoring: a regular exercise to check conformity with the Act and standards
Ÿ Performance monitoring: monitoring of employe's performance monitors from top to bottom for increasing
patient satisfaction and achieving treatment goals. This also covers regular and integrated monitoring of
32
record keeping system and the processes
Compliance Requirements
i. Measuring and monitoring the record keeping performance for planning and improvement purposes
ii. Roles and responsibilities for monitoring are outlined
iii. Requirements and timelines for monitoring activities
iv. Evidence of review of the clinic records by the dental surgeon.
Scoring:
If there is evidence of the review of the clinic records as above, then score as fully met.
If there is no evidence of the review as above, then score as not met.
Guidelines
32- Integrated notes involve all care providers writing in the notes in a chronological order and in the same section of the notes. Details added in the Guidelines.
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Ÿ Ensure that only fully validated load con gurations and cycle parameters are documented in the
relevant operational SOPs.
Ÿ Prepare, approve and execute protocols in Quality Assurance
Ÿ Ensure compliance with this SOPs with speci c regard to installation, operational and performance
and re-validation activities.
Ÿ Ensure compliance with current corporate policy and regulatory requirements.
Ÿ Quality Control
Ÿ Review and approve validation protocols and test documentation.
Ÿ To ensure SOPs contain only current and accurate load patterns and associated autoclave cycles
Ÿ To generate change controls for autoclave cycle/load additions/changes
Ÿ Perform Biological Indicator (BI) analysis.
Ÿ Ensure compliance with this SOP with speci c regards to maintenance, calibration and change
controls.
Ÿ Ensure that autoclave equipment utilities and sensors are compliant with operating limits
Ÿ Ensure autoclave cycle programs, PLCs and chart recorders are up to date, correct and operational
Ÿ Review and approve validation protocols and test documentation
Ÿ Provide access to equipment and resources for carrying out validation work .
Invasive procedures
It is important to understand the difference between invasive and non-invasive procedures as invasive dental
procedures are not recommended when blood cell counts are below certain levels.
Monitoring
Compliance monitoring is the quality assurance testing carried out over the day to day activities of the
business. In the corporate setting, the compliance monitoring team usually sits as an independent function in
the second line of defence and provides assurance to the board that the rm is operating within a compliant
framework.
Performance monitoring may be de ned as the process of appraising an environment of continuous learning
and development. It will be done by maintaining the employee's performance, enhancing individual
competencies to make them more productive for the organization.
Standard 11. QA-2: The clinic identi es key indicators to monitor the inputs, processes
and outcomes which are used as tools for continual improvement
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
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Indicators (39-39):
Ind 39. The clinic has enlisted the Sentinel Events to be analyzed and managed
Survey Process:
Surveyor asks for list of possible 'Sentinel Events', record of any sentinel event analyzed and managed in the last
33
12 months and results used for Quality Assurance/Improvement.
Compliance Requirements
I. List of possible 'Sentinel Events.
ii. Documentary evidence if any sentinel event analyzed and managed in the last 12 months.
Evidence of using results of analysis for Quality Assurance/Improvement.
Scoring:
If there is a list of possible sentinel events and evidence of occurrence of a sentinel event that was
analyzed and managed as above, then score as fully met.
OR if there is no evidence of having a sentinel event but the system is in place to manage if one occurs,
then also score as fully met.
If there is no system in place to manage the sentinel events, or the one that occurred was not analyzed
and managed then score as not met.
Guidelines
Sentinel Events
A sentinel event is de ned as “An unexpected occurrence involving death or serious Physical or
Psychological Injury, or the Risk thereof". Serious Injury speci cally includes Jaw fracture during tooth
extraction. Loss of function of nerve/nerve injury due to complicated extraction or wrong technique of
anaesthesia or tuberosity fracture in upper third molar extraction are also considered as serious injuries.
The phrase, 'or risk thereof' includes any process variation for which a recurrence carries a signi cant chance
of a serious adverse outcome.”
Such events are called "SENTINEL" because they necessitate immediate investigation and response.
Most of these medical mistakes are preventable and they are most often caused by systems that break down
and don't support the highly quali ed and dedicated hospital/clinic or care providers the way they should
perform.
While signi cant and attracting attention, medication errors aren't the only types of medical errors that
need attention of the hospitals/clinic.
Sentinel events also include the following, even if the outcome is not death or major permanent loss of
function:
i. Wrong tooth extraction/treatment
ii. Surgery on the wrong individual or wrong side of patient.
33- Unforeseen event like severe drug aggravation, wrong prescription, wrong patient, wrong tooth extraction, jaw fracture during tooth extraction, needle breakage while injecting anesthesia, reamers/ les
breakage during RCT, any foreign object swallowed (arti cial crown/endodontic instrument/dental implant or its abutment etc), patient violence against clinic staff, violence against patients, etc. as detailed in the
guidelines.
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Total 10
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
Continuity of care can be de ned as the extent to which a person experiences an ongoing relationship with a
clinical team or member of a clinical team and the coordinated clinical care that progresses smoothly as the
patient moves between different parts of the health service/ healthcare service provider.
As patients health care needs can only rarely be met by a single professional, multidimensional models of
continuity have had to be developed to accommodate the possibility of achieving both ideals access and
continuity of care simultaneously. Continuity of care may, therefore, be viewed from the perspective of either
patient or provider. Continuity in the experience of care relates conceptually to patients' satisfaction with both
the interpersonal aspects of care and the coordination of that care. Experienced continuity may be valued in its
own right. In contrast, continuity in the delivery of care cannot be evaluated solely through patients'
experiences, and is related to important aspects of services such as 'case-management' and 'multidisciplinary
team work.
A dental clinic should consider the care it provides as part of an integrated system of services, healthcare
practitioners/ professionals and levels of care which make up a continuum of care. The goal is to correctly match
the patient's healthcare needs with the services available, to coordinate the services provided to the patient in
the organization/ clinic, and then to plan for reception, registration, management, disposal and follow-up. The
result is improved patient care outcomes and more efficient use of available resources.
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Ind 40. The services being provided at the clinic are displayed as per Code of Ethics
Survey Process:
There should be a board clearly displaying the scope of services provided at the clinic that are in consonance
with the ethical provisions. This means that only those services are to be offered for which the particular
registered dental practitioner is quali ed and competent to provide. ⁴
Compliance Requirements
i. A board, clearly displaying the scope of services provided at the clinic, in consonance with the legal/
ethical provisions
ii. Services provided at the clinic are in consonance with the legal/ethical provisions
Scoring:
If the displayed services are in compliance with the code of ethics, then score as fully met.
If there is super uous/misleading information or no information displayed, then score as not met.
Survey Process:
The indicator implies that the specialized services and specialized equipment based evaluation are consistent
with quali cation, training and experience of the care provider, in the portrayed eld as prescribed by the
respective councils/authority.
Compliance Requirements
i. The specialized consultations/ services are provided by the professionals who are accordingly quali ed
and registered with the council/authority
ii. The evaluations and procedures using specialized equipment are consistent with the quali cation/
training/experience of the Health care service provider (HCSP)
Scoring:
If the specialized services are in compliance with the above parameters, then score as fully met.
If the specialized services do not meet the above compliance requirements, then score as not met.
Survey Process:
The surveyor is required to look for the display of relevant dental health educational messages for prevention of
dental disease and promotion of oral health. IEC material and/or written instructions delivered to the patients
by the dental care provider should be relevant and as per approved guidelines.
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Compliance Requirements
i. IEC material including dental health educational messages for prevention of dental disease and
promotion of oral health are displayed
ii. Evidence that the written instructions delivered to the patients by the dental care provider are as per
approved guidelines and are relevant
Scoring:
If there is a display of relevant dental health educational messages/IEC material and consistent
evidence that patients are guided on it accordingly, then score as fully met.
If there is a display of relevant dental health educational messages/IEC material, but inconsistent
evidence of patients being guided on it, then score as partially met.
If there is neither a display of relevant dental health educational messages/IEC material, nor any
evidence that patients are accordingly guided on it, then score as not met.
Survey Process:
The surveyor is required to look for the display of a list of preventive services being provided, like prevention of
caries, etc. Specialized preventive services, if being provided, should conform to the relevant prescribed
guidelines.
Compliance Requirements
i. Preventive services are provided to patients as per guidelines
ii. Guidelines on preventive services are available/displayed
Scoring:
If the list of services being provided is displayed and the services being provided conform to the
prescribed guidelines, then score as fully met.
If the list of services being provided is not displayed or is not complete, but the services being provided
conform to the prescribed guidelines, then score as partially met.
If there is no list of services being provided or any one of the services provided does not conform to the
prescribed guidelines, then score as not met.
Guidelines
Portrayal of Services39
It is of immense importance for patients to be aware of the services available at a particular dental clinic. It
means that a BDS dental surgeon having valid registration with PMC should display only those services
which are related to general dentistry and for which he/she is trained and certi ed to provide.
Any specialized services provided, must be as per speci ed standards and the health care provider must
have requisite post graduate quali cation duly registered with the Council/ authority.
“Radiation doses that exceed a minimum (threshold) level can cause undesirable effects such as depression
of the blood cell-forming process (threshold dose = 500 mSv, 50 rem) or cataracts (threshold dose = 5,000
mSv, 500 rem)*. The scope and severity of these effects increases as the dose increases above the
corresponding threshold. Radiation also can cause an increase in the incidence, but not the severity, of
malignant disease (e.g., cancer). With this type of effect, the probability of occurrence increases with dose
rather than the severity. For radiation protection purposes it is assumed that any dose above zero can
increase the risk of radiation-induced cancer (i.e., there is no threshold). Epidemiologic studies have found
that the estimated lifetime risk of dying from cancer is greater by about 0.004% per mSv (0.04% per rem) of
radiation dose to the whole body (NRC, 1990).”
Dental radiology and diagnostic imaging services, may be provided within the dental clinic or by agreement
with another organization, or both. The contracted outside source selected by the dental clinic must have
PHC registration/license. The in house, as well as contracted radiology services, must comply with laws and
regulations and must provide safe services of acceptable quality standards in accordance with the de ned
time frame.
All the statutory requirements included in the Pakistan Nuclear Regulatory Authority (PNRA) regulations
e.g. use of dosimeters, lead sheets, lead aprons, thyroid guard, signage, and display etc. and applicable
provision of the Drug Regulatory Authority of Pakistan (DRAP), as amended from time to time, are to be
complied.
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Total 70
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
Improving patient care has become a priority for all health care providers with the overall objective of achieving
a high degree of patient satisfaction. Greater awareness among the public, increasing demand for better care,
increasing number of health care regulation, the rise in litigation against medical malpractice, and concern
about poor outcomes are factors that contribute to this change. The quality of patient care is essentially
determined by the quality of infrastructure, quality of training, competence of personnel and efficiency of
operational systems. The fundamental requirement is adoption of a 'patient orientated system of care
provision'.
The standards under the functional area 'Care of Patients' address essential principles and processes for the
clinical care of patients who come to a dental clinic for treatment, with excellent care being the overarching
goal. The standards further entail that comprehensive treatment shall be provided in the respective clinical
specialty, with strict compliance to the prescribed standard. Improvement of patient care is a dynamic process
and should be kept in minds by the medical care personnel. Development and sustenance of a patient-
sensitive system is most critical in achieving this objective. It is important to pay attention to quality in every
aspect of patient care, both medical and non-medical.
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Ind 47. The clinic has an established registration and guidance process⁴⁰
Survey Process:
Observe as well as check from the record that a reception, registration and guidance⁴ system is practiced to
facilitate the patients. Patients can comfortably reach the reception and communicate with the reception staff,
get registered and obtain token number/time for an appointment. The reception staff is polite and guides the
patients to wait for their turn/time for consultation/examination by the dental surgeon and/or explains such
other requirement/s.
Compliance Requirements
i. The reception, registration and guidance system to facilitate the patient is in place
ii. Patients should be able to comfortably access the reception/reception staff, get registered and obtain
token number/ time for appointment
iii. The reception staff is polite and guides the patients to wait for their turn/time for consultation/
examination by the dental surgeon and/or explains such other requirement/s
Scoring:
If the reception, registration and guidance provided to patients is evident as described above, then
score as fully met.
If there are non-conformances to the above, then score as not met.
Survey Process:
Observe and check that patients are assessed by the dental surgeon by taking history and vitals(as indicated)
oral examination and documenting the patient's complaints signs and symptoms, diagnosis/differential
diagnosis and relevant evaluations for every affected tooth, as applicable, with the objective of providing
42 43
quality dental care/treatment and follow up , in line with the prescribed Code of Ethics or for referral to the
44
higher level facility. Check documentary evidence of assessment, treatment or referral (as applicable), by
reviewing the representative sample of record of patients which can be a register/copies of prescription and/or
an elaborate record, depending on the scale /scope of practice.
40- Applicable for larger clinics and clinics providing a wider range of dental healthcare services where prior appointments may be necessary/desirable.
41- Direction/Guidance to patients regarding further actions in connection with their dental treatment needs and its management i.e. consultation/specialized testing on equipment/dispensing/referral etc. The
dental surgeon himself or the quali ed and authorized technician/assistant must explain the processes involved in safety/infection control/post op /post procedure complications etc. This requirement has to be
included in the JDs of relevant staff as further explained in the Guidelines.
42- Standard Clinical Methodology respecting patient's privacy is to be adopted while examining the patients.
43- PMDC Code of Ethics of Practice for Medical and Dental Practitioners published on http://www.pmdc.org.pk/Ethics/tabid/101/D efault.aspx#20, PHC Charters published on www.phc.org.pk links
(http://www.phc.org.pk/downloads/-Charter.pdf and as adapted by PMC
44- A dental surgeon is required to refer all those patients to an appropriate dental clinic/surgery, that cannot be/should not be managed at his/her clinic due to the limited scope of services, nature of their ailment or
due to an emergency or medico legal nature. This needs critical judgment and ethical decision by the dentist. Check the referral record to ascertain whether the required details such as serial number, name, son/
daughter of/wife of /address, contact no., symptoms/provisional diagnosis, prognosis, reasons for referral, date and time of referral, place of referral, etc. referred in past 12 months are available at the clinic.
Scoring:
If all checked records of the patients show documentation of patient's assessments and management as
above, then score as fully met.
If less than 20% of the record is de cient on the above, then score as partially met.
If the record shows more than 20% de ciency on the above, then score as not met.
Guidelines
Registration and Disposal
A well-functioning registration and disposal process is an important indicator of an established patient
management system. If the patients are received, registered and appropriately guided for further actions, it
con rms the satisfaction of the patients and other care providers. The following SOPs45 can be adopted and
used as guidelines by appropriate modi cation to suit a particular dental clinic/surgery.
i. Reception / Registration
a. Receptionist (s)/Computer Operator (s) to perform duty according to type of facility/workload
b. Information is provided to the patients both verbally and on telephone in a pleasant manner
c. Patient is sent/guided/ taken to the relevant section/department
d. Particulars of patients are entered in the register/computer and a form or slip is provided
after data entry
e. Minimum time is consumed up to this stage
45- Standard Operating Procedures (SOPs) for Primary and Secondary Healthcare Facilities by the PDSSP 2008-2009 noti ed by the Health Department Government of Punjab may also be consulted for more details.
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Guidelines
i. Reception / Registration
a. Receptionist (s)/Computer Operator (s) to perform duty according to type of facility/workload
b. Information is provided to the patients both verbally and on telephone in a pleasant manner
c. Patient is sent/guided/ taken to the relevant section/department
d. Particulars of patients are entered in the register/computer and a form or slip is provided
after data entry
e. Minimum time is consumed up to this stage
ii. Guidance of Patients/Visitors
a. Sign boards showing services available in a particular setup (menu of services) are clearly
displayed at the key point/s (gates), key turning points, reception, sections/areas so that
users are facilitated to know and access the services available in a particular facility
b. Sign boards with directional arrows, indicating the location of service areas/speci c
departments, are placed and maintained as required except in the settings which do not
require such directional boards
c. Services available at a particular service area should also be displayed within that area
d. Lea ets providing information about the services in simple language are prepared,
distributed/kept at key point/s to create awareness amongst the patients/visitors about the
available services in the facility
e. Services which are not available are not displayed
f. Use of close circuit TV and public address system may be considered for information and
education of clientele on health matters
At this stage, the patient shall either have a prescription if only medication is required, along with advised
tests,etc., or have had explained and obtained the consent about the dental procedure/surgery to be
undertaken, followed by post procedure/surgery advice in writing to be followed or referral to another
facility as applicable. The dental surgeon must follow the standardized dental protocols⁴⁶ when managing
any particular disease, at the same time using their own clinical acumen in treating and saving the patient's
oro-dental health.
46- Standardized Medical Protocols (SMPs) for Primary and Secondary Healthcare Facilities developed by the PDSSP for Primary and Secondary Healthcare Facilities of the Government of Punjab, a disease speci c
document may be consulted for guidance.
Both practitioners should discuss the referral treatment period and the return of the patient to the referring
dentist. This arrangement may be enhanced by an exchange of business cards, referral forms and patient
instructional materials. Availability for emergency treatment during the referral period should be discussed.
The dental clinic should display on a chart all the contact numbers of the local police station, re brigade,
rescue services, electricity complaint cell, ambulance service, etc. so that it is easy to contact these services
in an emergency situation.
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MSDS Reference Manual Dental Clinics
Standard 14. COP-1: The clinic has a well-established patient management system
Total 30
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
Guidelines
EMERGENCY SERVICE
Dentists shall make reasonable arrangements for the emergency care of their patients shall also be obliged,
when consulted in an emergency, to make reasonable arrangements for emergency care. If treatment is
provided, the dentist, upon completion of such treatment, is obliged to return the patient to his/her regular
dentist, unless the patient expressly reveals a different preference.
47- List of standard rst aid kits/boxes/trays/trollies with guidelines/SOPs and listing of the types of emergencies portrayed to be managed are included in the guidelines. Arrangements to manage; i. syncope, ii.
respiratory distress, iii. anaphylactic shock, iv. control of bleeding and v. fracture of mandible and other long bones for at least one patient at a time should be available at the clinic. Additional portrayal will be
checked accordingly as an optional binding of the service provider. This is to be linked with sentinel events (Ind 39).
82 CG-09RM-Ed2-141021
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Preparatory SOPs
FIVE steps to prepare and manage a medical emergency:
i. Medical history including history of allergy and drug history
ii. Assessment of patient's condition
iii. Resuscitation knowledge, training and practice
iv. Pro ciency in the use of emergency medications and devices
v. Calling for medical assistance
Essential Emergency Drugs
Drug Indication Initial Adult Dose
1. Oxygen Almost any medical emergency 100% inhalation
Anaphylaxis. Asthma 0.1mg IV or 0.3-0.5mg IM
2. Epinephrine Unresponsive to albuterol/ 0.1mg IV or 0.3-0.5mg IM
Salbutamol, Cadiac arrest. 0.1mg IV
3. Nitroglycerin Angina pain 0.3-0.4mg sublingual
4. Antihistamine (dephenhydramine
Allergic relations 25-50mg IV, IM. 10-20mg IV, IM
or chorpheniramine)
5. Albuterol/salbutamol Asthmatic broncho spasm 2 Sprays: Inhalation
6. Aspirin Myocardial infection 160-325mg
48- Readiness in terms of these SOPs/SMPs is considered essential for ensuring safety of patients.
Standard 15. COP-2: The clinic has essential arrangements for providing care to
emergency cases
Total 10
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
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MSDS Reference Manual Dental Clinics
Medication errors are one of the most common healthcare issues, with a number of preventable drug-related
mortalities/morbidities. Medication errors are also among the most frequently reported types of adverse events.
Medication management standards help support patient safety and improve the quality of care by creating a
system for selecting, procuring, storing, ordering, transcribing, preparing, labeling, dispensing, administering
and monitoring medications. The standards are designed to reduce practice variations, errors and misuse;
encourage monitoring of the efficiency, quality and safety of medication management processes; promote the
use of evidence-based good practices; and standardize processes in the dental clinic.
Managing medications effectively is a critical component of the dental clinic safety plan. Every attempt must be
made to maintain accurate records regarding a patient's medication use. . Antibiotics are widely used during
different dental treatments both for therapeutic and prophylactic reasons. In recent years the irrational use of
antibiotics has been rapid emergence of antimicrobial resistance. Antibiotics are often prescribed and used
unnecessarily and excessively, thus contributing to the development of resistant microbes.
There is a need of creating awareness amongst the providers as well as the recipients of can in order to increase
understanding of antibiotic resistance through education, communication and training.
Ind 52. Prescriptions are clear, legible, dated, timed, named/stamped and signed
Survey Process:
Surveyors are required to check that prescriptions are legible, dated, timed, named and signed by the dental
surgeon. Names of the medicines (trade or generic) are clearly written and there is no coding.
Compliance Requirements
i. Prescriptions are legible, dated, timed, named and signed by the dental surgeon
ii. Names of the medicines (trade or generic) are clearly written and there is no coding
Scoring:
If the representative sample of prescriptions are as described above, then score as fully met.
If only up to 20% prescriptions are not timed as above, then score as partially met.
If more than 20% prescriptions are not as above, then score as not met.
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Guidelines
SOPs on Prescription of Medications
In dental clinics/hospitals, only medical doctors and dental surgeons are authorized for prescription writing
in their own elds.
Directions must be clearly stated and should be quali ed e.g. 'Take one or two tablets for pain or headache'
cautioning'Not to be taken empty stomach'and/or'Take one Capsule every 6 hours for ve days'in case of an
antibiotic course for infection, etc. 'As directed' or 'when needed' must be avoided.
Every patient coming to the dental clinic and getting dental treatment must get a clearly written
prescription depicting the complaints, diagnoses, treatment/procedure performed, medication prescribed
and detail of post-op instructions. No verbal instructions regarding taking medications are acceptable.
Post-procedure written instructions in the form of pamphlet/lea et for the awareness of patients having
any surgical procedure, in addition to written speci c instructions, should be used, rather than to
communicate only verbally.
Total 30
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
88 CG-09RM-Ed2-141021
MSDS Reference Manual Dental Clinics
Indicators (54-56):
Survey Process:
The guidelines for safe storage include inter-alia⁵ ; i. proper stacking in groups to differentiate common drugs,
injections, anesthetics, look alike and sound alike medicines/cements/materials within the rack/cupboard; ii.
labeling; iii. ventilation; iv. temperature control/refrigerator for sensitive drugs/materials, etc.; v. protection of
high risk and narcotic drugs as the case may be, and vi. record of expiry dates.
Compliance Requirements
i. Proper stacking in groups to differentiate common drugs/materials, injections, look alike and sound
alike medicines/cements/materials within the rack/cupboard
ii. Labeling of drugs/materials etc.
iii. Ventilation
iv. Temperature control/refrigerator for sensitive drugs/materials, etc.
v. Protection/safe custody of high risk and narcotic drugs if applicable
vi. Record of expiry dates
Scoring:
If the medicines/materials are stored as per the above referred guidelines, then score as fully met.
If implementation of parameters at serial numbers i, ii and iii only is inconsistent, then score as partially met.
If implementation of any one of the parameters at serial numbers. iv, v and vi is inconsistent then score
as not met.
Survey Process:
Randomly selected medicines/dental materials/anesthetics are checked to make sure that these are within the
expiry limit.
Compliance Requirements
i. Items are within the expiry date printed on the label as per Drug Act/Rules
ii. Evidence that expiry dates are monitored / followed.
Scoring:
If all 5 randomly selected medicines/materials administered/used or to be administered/used are within
the expiry date, then score as fully met.
If any of the randomly selected medicines/materials administered/used or to be administered/used are
not within the expiry date, then score as not met.
Guidelines
Storage and Dispensing Policy
Storage of medicinal materials is an important aspect of the overall drug control system. Environmental
control (i.e., proper temperature, light, humidity, sanitation, ventilation, segregation, etc.) must be
maintained wherever drugs and supplied are stored. Storage areas must be secure; xtures and equipment
used to store drugs should be such that drugs are accessible only to designated and authorized personnel.
Safety is an important factor and proper consideration should be given to the safe storage of poisons and
ammable compounds. Medications meant for external use should be stored separately from those for
internal use. Temperature sensitive medications must be stored in a refrigerator containing only medicines,
and items other than drugs should be kept in a separate refrigerator, e.g; dental materials which need to be
stored in the refrigerator should have a separate storage arrangement.
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Guidelines
v. Reconstituted medications are properly labeled with expiry and preparation date.
vi. Illegible labels are replaced.
vii. Liquid bottles are clean and free of spills.
viii. Disinfectants and drugs for external use are stored separately from internal and injectable
medications.
ix. Medications requiring special environmental conditions for stability are properly stored.
x. Non-pharmaceuticals are stored separately.
xi. Expired medications are not stocked.
xii. Medications are not overstocked.
xiii. Medications required on emergency basis are readily available (emergency box, crash carts, etc.).
xiv. Medication room door/cart is locked when unsupervised.
Monitoring of Expiry Dates
All medication/dental materials should be examined to ensure their being in date at the time of use. The
pharmacy in-charge shall ensure implementation of the following SOPs for the monitoring of expiry dates;
i. Check the expiry dates on daily/monthly/quarterly/yearly basis.
ii. Once a drug is re-packaged in a separate container, there is a reduction in the shelf life of the product,
therefore, original expiry dates should not be used. It is the responsibility of the re- packaging
technician to inspect these products for date of manufacturing and then proposed expiry.
iii. Expired stock or products which expire within a month are pulled from the shelves and the
purchasing section noti ed of the need for additional stock.
iv. The pharmacists/pharmacy technicians in the dispensing areas are responsible for inspection of all
drugs in the working stock. Visual inspection to check deterioration and expiry date shall be a
normal practice.
v. Expired medicines/ material shall be pulled from the shelves and held in a segregated area clearly
marked for disposal.
Authorization to Administer the Drugs/Medications/Dental Materials
Administering medication to treat a patient requires speci c knowledge and experience. Each dental
clinic/surgery/hospital is responsible for identifying individuals with the requisite knowledge and
experience who are also permitted by,certi cation or regulations to administer medications (PMC Act2020,
Allopathic System (Prevention of Misuse) Ordinance No. Lxv of, 1962, relevant provision of PMDC
Amendment Act 2012 as retained under the PMC Act, PNC Ordinance, Pharmacy Council Act, Punjab
Medical Faculty Regulations, etc.). Dental assistant is to be trained by the dentist himself if he/she is not
quali ed/registerd by the concerned authority. Minimum requirement is that he/she is litrate and have a
command on written english and is able to understand doctor's handwriting.
Total 30
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
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The dental clinic/surgery shall de ne patient and family rights and responsibilities as per the guidelines
provided by the PHC. The staff is aware of these and is trained to protect patients' rights. Patients are informed of
their rights and educated about their responsibilities at the clinic. They are informed about the disease, the
possible outcomes and are involved in decision making. The treatment costs are explained in a clear manner to
the patient and/or family. Patients are educated about the mechanisms available for addressing
grievances/complaints.
The PHC charter for patients and others is relevant and should be displayed in the clinic.
Survey Process:
The surveyor is required to see that PHC Charter of Rights and Responsibilities for Patients, Carers and Others, is
displayed at a prominent place in the clinic, like the waiting area or main entrance, for awareness. Also, check
that clinic staff is well aware of the charters for compliance at their end and provide guidance to the patients on
above aspects as and when required.
Patient and others are expected to observe the social norms by waiting for their turn, avoid con ict situations,
following the instructions of the dental surgeon regarding re-visit date and time, etc.
Compliance Requirements
i. PHC Charters of Rights and Responsibilities for Patients and HCEs are displayed at a prominent place in
the clinic, like the waiting area or main entrance for awareness
ii. Clinic staff is well aware of the charters, compliance at their end and provide guidance to the patients on
the above aspects as and when required
Scoring:
If the Charters are displayed as required above and evidence that the patients/families are also guided
on the same, then score as fully met.
If the Charters are available but not displayed as required above but there is and evidence that the
patients/families are guided on the same, then score as partially met.
If the Charters are not available as required above and there is no evidence to the effect that the
patients/families are guided on the same, then score as not met.
Guidelines
The PHC Charter for Patients, Carers and Others and the Charter for HCEs have been provided before as
Annexure-H.
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Total 10
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
Ind 58. The dental surgeon obtains consent from a patient before examination⁵
Survey Process:
Dental surgeons are required to politely seek permission from the patient/parents/attendants before dental
54
examination. This should include the need/role of a chaperon if so required . The 'verbal consent' so'obtained'
is required to be documented on the prescription at the minimum as 'VCO'. To validate the 'VCO', the surveyors
are required to review the register/copy of prescriptions.
Compliance Requirements
i. Documentary evidence that the 'verbal consent obtained' is documented on the prescription at the
minimum as 'VCO'
Scoring:
If there is evidence of VCO, then score as fully met.
If there is evidence of VCO in up to 80% of cases, then score as partially met.
If there is no evidence of VCO as above, then score as not met.
The clinic has listed those situations where speci c informed consent55 is
Ind 59. 56
required from a patient or family and the consent is taken accordingly
Survey Process:
Review the listed conditions requiring informed consent. Then review records of patients from whom speci c
informed consent should have been taken. The informed consent includes providing information in a language
57
and detail that patient/attendant can understand on risks, bene ts, and alternatives and as to who will provide
the treatment or perform the procedure/investigation/test. Informed consent is also required for taking
photographs or making movies during the procedures either for record keeping/preservation of identity or
educational/research purposes, so to respect the individual's religious/social/cultural beliefs58.
Compliance Requirements
i. Procedures/conditions requiring informed consent listed
ii. Speci c informed consent taken as per list
iii. The format of speci c informed consent is available in local language
iv. Informed consent is also taken for taking photographs or making movies during the procedures either
for record keeping/preservation of identity or educational/research purposes.
Scoring:
If the situations requiring informed consent en listed, and the relevant records document an informed
consent accordingly, then score as fully met.
If neither the situation requiring informed consent enlisted nor the relevant records do not document
consent as above, then score as not met.
53- This is to maintain the privacy, respect, dignity and honor of the patients while examining intimately and providing care and to comply with the Patients Charters and the Code of Ethics.
54- ‘Intimate examinations and chaperones (2013)’ GMC Good Medical Practices.
55- This is important for informed decision making as well as patient & care provider's safety. See consent form in the Guidelines.
56- Family consent is required if the patient is not capable to give consent or is a minor. Family means; immediate relatives—mother, father, brother & sister, son & daughter, wife & husband.
57- Further explained in the Guidelines.
58- Refer to PHC Patient Charters.
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Guidelines
Scope of Informed Consent
Although the client's/patient's general consent is obtained for the proposed care or treatment, a written
consent is mandatory for any invasive procedures or operations and a prerequisite to carry out any surgical
intervention. The patient has the right to refuse or to halt the intervention.In different situations of health
care provision or involvement of the client in any research activity, the mode of consent and action will be as
follows:
i. When a patient is unable to express his or her will and a medical intervention is urgently needed, the
consent of the patient may be presumed, unless it is obvious from a previously declared 'Expression
of Will' that consent would be refused in the situation.
ii. When the consent of a legal representative is required and the proposed intervention is urgently
needed, the intervention may be made if it is not possible to obtain the representative's consent in time.
iii. When the consent of a legal representative is required, patients (whether minor or adult) must
nevertheless be involved in the decision-making process to the possible extent.
iv. If a legal representative refuses to give consent and the physician or other provider is of the opinion
that the intervention is in the interest of the patient, then in case of a non-emergency situation, the
decision must be referred to a court or some form of arbitration.
v. In all other situations where the patient is unable to give informed consent and where there is no
legal representative or representative designated by the patient for this purpose, appropriate
measures should be taken to provide for a substitute decision making process, taking into account
what is known and, to the greatest extent possible, what may be presumed about the wishes of the
patient.
vi. The consent of the patient is required for the preservation and use of all substances of the human
body. Consent may be presumed when the substances/body part are to be used in the current
course of diagnosis, treatment and care of the patient.
vii. The informed consent of the patient is needed for participation in clinical teaching.
viii. The informed consent of the patient is a prerequisite for participation in scienti c research. All
protocols must be submitted to a proper ethical review committee. Such research should not be
carried out on those who are unable to express their will, unless the consent of a legal representative
has been obtained and the research would likely be in the interest of the patient.
As an exception to the requirement of involvement being in the interest of the patient, an incapacitated
person may be involved in observational research which is not of direct bene t to his or her health provided
that, the person offers no objection, that the risk and burden is minimal, that the research is of signi cant
value and that no alternative methods and other research subjects are available.
Details regarding informed consent of the patient have been discussed in Section 2.9 covering Patient's
Rights and Education.
After giving information about diagnosis, management and follow-up, the healthcare service provider
should check to ensure that the client/patient has understood the advice. Obtaining this feedback is
important in assessing to what extent the instructions have been understood.
Treating clients/patients with respect, actively listening to them, asking questions about their
choices/preferences, praising, explaining diagnosis and management, describing the follow-up plan, and
taking feedback about their understanding of the given advice/choice are very important components of
health care delivery.
The person performing the procedure shall be responsible for the entire process of taking the consent
including providing explanation and taking the signature. A team member can take consent on behalf of
the person performing the procedure, but their name and designation must be clearly mentioned in the
chart.
When the patient does not speak or understand the predominant language of the community, efforts
should be made to ensure that proper interpretation is done.
For the informed consent process to the conformity to the norms include the following
i. Taking consent before the procedure.
ii. At least one independent witness signing the form.
iii. Taking a fresh consent (for the new procedure) in case the procedure has to be changed during
course of treatment/procedure.
iv. Appropriate information is provided to clients/patients and their families, in a way that they can
understand, on the proposed treatment, the costs, the risks and bene ts of the proposed treatment
or investigation, and the alternatives available.
v. Clients/Patients and their families are fully informed about the client's/patient's health status,
including the clinical facts about their condition, unless there is an explicit request not to disclose a
particular information to the patient Template of consent form is provided at Annexure-O.
98 CG-09RM-Ed2-141021
MSDS Reference Manual Dental Clinics
Standard 19. PRE-2: There is a system for obtaining consent for treatment
Total 20
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
Survey Process:
Customarily, the consultation fee is displayed or patients are informed about the fee, the charges for procedure,
etc. by the dentist personally, or by the staff at the reception desk (as applicable), and the cost list is shown if
requested.
Compliance Requirements
i. The consultation fee is displayed
ii. Patients are informed about the fee and the charges for medicines/procedures at the reception desk (as
applicable)
iii. Cost list is shown if requested
Scoring:
If there is evidence that the patients/families are informed about the treatment cost as above, then score
as fully met.
If the patients/relatives are not informed about the expected cost of treatment as above, then score as
not met.
Guidelines
Tariff List
Although customarily, the consultation fee is displayed or patients are informed about the fee and the
charges for medicines, etc., at the reception desk (as applicable), a detailed cost list is shown if requested.
There should be a general tariff/billing system which de nes the charges to be levied for the services
provided by the clinic which may include the following:
i. Consultation fee
ii. Cost of dental procedure/surgery
iii. Cost of investigations if required and carried out onsite
iv. Cost of medicines to be dispensed or to be purchased if prescribed (as applicable)
v. Costs of dentures, bridges, caps and implants, braces, etc., to be provided by the clinic as indicated
The above-mentioned service charges should be a part of the tariff/billing system and must be available in a
le maintained at the clinic. Sometimes, the consultation fee for the rst visit and for subsequent visits (for
new and old patients) may be different. It will be the duty of the receptionist, technician or doctor to inform
the patient of such tariff differences prior to the treatment. Patients/Families/Attendants should be given an
estimate of the expenses, particularly in case of prolonged treatment. It is preferable to provide this
information in writing. However, at minimum, tariff related to consultation fee (which is usually xed) must
be displayed at a prominent place, either at the reception or inside the consultation room.
100 CG-09RM-Ed2-141021
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Standard 20. PRE-3: Patients and families have a right to information about expected
costs
Total 10
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
Ind 61. Patients and families have a right to refuse the treatment
Survey Process:
Patient and families are expected to respect the instructions/medication orders prescribed by the dental
surgeon, but they have a right to refuse the treatment59 and seek advice from any other dentist of their choice60
as provided in the prescribed Code of Ethics and the PHC Charters61. This necessitates speci cally displaying the
right of refusal. In cases where patients refuse advice, procedures or treatment, it has to be recorded in the
patient's record.
Compliance Requirements
i. The right of refusal for treatment by the patient is displayed in PHC Charter for Patients
ii. The record of patient's refusal (if applicable) is available
Scoring:
Unless the surveyors have a reason to believe that the above provision of the Charters are not being
complied, the score should default to fully met.
Survey Process:
Patients and families have a right to complain and put forward their grievances/concerns. There is a mechanism
to handle the complaints effectively. The complaints can be lodged on the spot on occurrence, with some delay,
verbally, in writing or by any other means. A complaint box or a complaint register, display of PHC helpline/web
address and/or availability of a complaint form and le record are evidence of the system being in place.
Compliance Requirements
i. Functional Complaint Management System, evidenced by the following:
a. A complaint register
b. Display of PHC helpline/web address
c. Availability of complaint form
d. File record
ii. Evidence that the complaints are managed.
Scoring:
If there is a display which facilitates/guides the patients about their right of complaint and the system is
being followed as above (including zero report recording in the register), then score as fully met.
If there is no display to facilitate/guide the patients about their right of complaint and/or the system
described above is not being followed, then score as not met.
59- Provisions 12. ©, PMC Code of Ethics of Practice for Medical and Dental Practitioners allows refusal to treat a patient.
60- Provisions 12. (b) and 13., PMC Code of Ethics of Practice for Medical and Dental Practitioners allows independent additional opinions.
61- Annexure-H, also provided on PHC website: https://www.phc.org.pk
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Guidelines
Right to Express Concern or Complain
An institutionalized, accessible and transparent grievance redress mechanism must be in place. The
information as how to lodge a complaint must be clearly displayed in the local language at prominent
places.
A complaint is an expression of client dissatisfaction and a way to provide feedback on the quality of care
which needs a response. Every healthcare facility should inform the clients/patients about their right to
complain and the complaint handling procedures. A complaint may be written or verbal and be lodged by
the patient, his/her attendants or a legally authorized person. Various ways should be adopted, for example:
i. Display the message clearly in the local language at prominent places in the facility, such as
registration desk, waiting area, OPDs, main entrance, private rooms, etc. (Complaints form
Annexure-P).
ii. Pertinent information may be made available in the form of lea ets/brochures at
appropriate places.
iii. Client feedback/satisfaction must be sought on a prescribed but simple format at the
time of discharge (format attached previously as Annexure-J).
When the treatment plan has been made and discussed with the patient, then it is the
patient's right to agree with the whole treatment plan or disagree with any procedure. In that
case, the patient must be explained about the need or requirement of that speci c
procedure but in any case he/she should not be forced to undergo that procedure. If the
patient still refuses to get treatment, it must be documented in the patient's record.
Standard 21. PRE-4: Patients and families have a right to refuse treatment and lodge a
complaint
Total 20
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
104 CG-09RM-Ed2-141021
MSDS Reference Manual Dental Clinics
Prevention of healthcare associated infections (HAIs) represents one of the major safety initiatives a dental clinic
is required to undertake. The standards related to the infection prevention and control provide the framework
for dental surgeries to develop and implement plans to prevent and control infections by using an integrated
approach across all programme, services and settings. The standards call on healthcare establishments to
educate and collaborate with all members of the clinic, including support staff, to participate in the design and
implementation of an effective infection prevention and control programme.
Although the principles of infection prevention and control remain unchanged, new technologies, materials,
equipment and updated data require continuous evaluation of current infection control practices and
continuous education for the oral health team. It is the responsibility of dentists in charge of the practice/ clinic
to establish a protocol that prevents or limits the spread of infection in dental practice for the patients, the staff
and the practitioner himself.
Members of the oral health team are obliged to keep their knowledge and skills up to date with regard to the
diagnosis and management of infectious diseases that may be transmitted in the clinical setting, adhere to
standard precautions and where necessary transmission‐based precautions as set forth by the relevant
authorities and to take appropriate measures to protect their patients and themselves against infections.
Survey Process:
Check the written IPC Plan to verify that it covers the following aspects:
ü SOPs for Infection Prevention & Control
ü Arrangement for the Infection Prevention & Control Practices as under
i. HCSP Speci c including (but not limited to) the following:
Hand Hygiene
Respiratory Hygiene
PPE
Needle stick/Sharps Safety
Safe Injection Practice
Blood borne Pathogens/ OPIM Standard
Hazards Communication
Immunizations/Post exposure prophylaxis
Emergency Action Plan
Environmental Health & Safety
ii. Patient Speci c including (but not limited to) the following:
Universal Precautions
Sterilization
Surface Disinfection
Waste Disposal62
Dental Unit water decontamination
Suction care
62- In line with the Punjab Hospital Waste Management Rules 2014 issued by Environment Protection Department and as amended from time to time and applicable locally. Details provided in the Guidelines.
106 CG-09RM-Ed2-141021
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Scoring:
If there is a documented infection prevention and control plan that includes SOPs for infection control
and arrangements of infection control practices, surveillance activities, and de ned responsibilities and
authorities of an Infection Prevention & Control Team and evidence that the IPC plan is implemented,
then score as fully met.
If there is either no written plan, or it does not include any one of the above 4 requirements, then score as
not met.
The clinic has designated staff and de ned responsibilities for infection
Ind 64.
control and waste management activities
Survey Process:
Review the documentation regarding designation/appointment and assigned responsibilities (JDs) in that the
staff is assigned the role/s in writing to implement the Infection Prevention & Control Plan (IPC Plan) and clinical
waste management as stipulated in the relevant statutes updated from time to time.
Compliance Requirements
i. Staff designated and responsibilities in respect of infection control activities including medical waste
management as per HWM Rules 2014 (as amended from time to time) are de ned.
ii. JDs of Nurse/Technician/Dental Surgeon on Infection Prevention & Control available and match the
requirements of IPC Plan and PHWMR 2014.
Scoring:
If the quali cation/ credentials of the IPC nurse/(s) match the requirements in the job description, and
their number is adequate to manage the workload, then score as fully met.
If the credentials of the IPC nurse/(s) do not match the requirements in the job description, and or their
number is not adequate to manage the workload, then scored as not met.
Survey Process:
Observe and check that
i. Appropriate collection and handling of consumables is being carried out
ii. Equipment and facilities for control of infection are available, including
- Cleaning
- Disinfection
- Sterilization
63
ii. A full System of Clinical Waste Management is implemented including, the following components in
practice, from the point of generation to the point of destruction
- Segregation
- Collection
- Disposal
63- As per Punjab Hospital Waste Management Rules 2014 as amended from time to time.
Scoring:
If there is evidence of training of the staff on infection prevention and control including Clinical WM
System at induction and when the new System are introduced, or when new component, consumables
or equipment related to IPC and clinical waste management are employed, then score as fully met.
If there is no training at all or training material does not cover all the IPC activities OR if any one of the
above conditions are not ful lled, score as not met.
64- Staff means permanent, temporary or short term employees of the HCE/any third party.
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Guidelines
1. Hospital-acquired or nosocomial infections are infections that patients acquire during their stay or
treatment at a health centre. Such infections are easily transmitted during daily clinical practice if;
a. The instruments used during surgery are not free of micro organisms
b. The staff do not wash their hands properly before and after treating patients
c. The material used during the treatment is not free of micro organisms
d. Contaminated waste is not disposed of properly
2. Cross-infections are infections transmitted from one patient to another through contaminated
equipment, instruments and materials. Cross-infection is one of the major causes of nosocomial
diseases and has a huge impact on the patient.
Following different processes involved in minimizing cross infection and assure quality treatment go side
by side in a dental operatory.
1. Cleaning
The process of removing dirt and soils, that does not involve killing micro organisms and spores.
2. Disinfection
The process of destroying all pathogenic microorganisms, but not bacterial spores.
3. Sterilization
The process of destroying all forms of microbial life including bacterial spores on inanimate surfaces.
65- Pakistan National Infection Prevention & Control Guidelines, 2006 as updated from time to time.
For sustained effectiveness, the IPC programme will have to be comprehensive, include surveillance and
prevention activities and staff training. It must also be able to draw upon effective support at national and
regional levels.
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Standard Precautions
Treating all patients in the healthcare facility with the same basic level of “standard” precautions involves
work practices that are essential to provide high level of protection to patients, healthcare workers and
visitors. These include the following:
HAND HYGIENE
Hand washing and hand antisepsis with following speci c antiseptics
I. 2%-4% chlorhexidine
ii. 5%-7.5% povidone iodine
iii. 1% triclosan
iv. 70% alcoholic hand rubs. waterless, alcohol-based hand rubs: with antiseptic and emollient gel and
alcohol swabs, that can be applied to clean hands.
Hot water (80°C) is a useful and effective environmental cleaner. Bacteriological testing of the environment
is not recommended unless seeking a potential source of an outbreak. Any areas visibly contaminated with
blood or body uids should be cleaned immediately with detergent and water.
i. Airborne precautions
ii. Droplet precautions
iii. Contact precautions
Mechanical ventilation - reduces the risks of airborne spread by removing bacteria from the patient's
room and by excluding bacteria present in the outside air from the room.
The transfer of infection by the airborne route can be controlled either by con ning the affected patient in a
separate room or by rapidly removing the internal air by forced mechanical ventilation).
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The management of clinical contact surfaces in the dental setting is accomplished either by the use of
surface barriers or the process of cleaning and disinfecting the surfaces that are not barrier-protected. While
disinfection and application of surface barriers are both effective, some surfaces are easier to cover, while
disinfection may be the best method with other surfaces. The use of barrier protection or chemical
disinfection is largely a matter of practicality and personal choice. Effectively managing clinical contact
surfaces in the dental settings uses a combination of both approaches to reduce contamination.
Environmental Barriers
The purpose of surface barriers is to prevent contamination of the surface or equipment and reduce the
need to clean and disinfect that surface or equipment before reuse. Barrier protection is the most efficient
way to protect difficult-to-clean, electronic, and smaller surfaces. Surface barriers should be used on as
many surfaces as possible, particularly on surfaces that are difficult to disinfect or access, and that are
touched frequently by gloved hands during patient care and likely to become contaminated. A variety of
barrier materials are available, such as clear plastic wrap, bags, sheets, tubing, and plastic-backed paper. Any
barrier material chosen for use on clinical contact surfaces must be impervious to both moisture and uid.
Wrapping of aluminum foil around light handles, handpiece tubing, and on switches is easier to use than
many other barriers. After use, if the foil is not damaged or visibly contaminated, it may be cleaned,
disinfected, and autoclaved once more for use before discard. If surfaces are not covered by barriers, these
may be touched during the procedure using a barrier like cotton gauze or sterile paper, or plastic wrap. Once
used the gauze/paper/plastic should be discarded. Plastic/Cellophane over-gloves, worn over the latex
gloves, can also be used to touch non-sterile surfaces during a procedure.
Disinfectants
A surface barrier cannot effectively cover many surfaces in the dental treatment area. Clinical contact
surfaces that do not have a surface barrier, or become contaminated during removal of a barrier, should be
cleaned and disinfected after every patient contact.
An intermediate-level disinfectant is speci cally indicated when the surface is visibly contaminated with
blood, and a low-level disinfectant is not appropriate to be used on surfaces contaminated with blood.
Additionally, while low-level disinfectants may effectively inactivate blood- borne pathogens such as HIV
and HBV, they are not effective against more resistant organisms that would be inactivated with a
tuberculocidal product (an intermediate-level disinfectant). The use of a tuberculocidal agent that is
effective against nonenveloped viruses offers a broader spectrum of antimicrobial activity, a property that
is highly desirable for environmental surface disinfection in the dental practice.
Tuberculocidal Activity
Although tuberculosis is transmitted by airborne infective droplets and not transmitted by contaminated
environmental surfaces, the ability to kill Mycobacterium tuberculosis is used as a benchmark to measure
how effectively a disinfectant will kill microorganisms. Tuberculosis is a very difficult organism to kill; only
bacterial spores are more difficult to inactivate than Mycobacterium tuberculosis. Any chemical germicide
with a tuberculocidal claim (Intermediate-level disinfectant) is considered capable of inactivating a broad
spectrum of microorganisms of most concern in the dental setting, including less-resistant organisms such
as blood-borne pathogens e.g., hepatitis B and C viruses, HIV. More importantly, nonenveloped viruses such
as coxsackievirus and rhinovirus (the cause of many upper respiratory infections), human papillomavirus
(HPV, the cause of cervical and oropharyngeal cancer), and multiple species of fungi are inactivated only by
an intermediate-level disinfectant and but these organisms are not inactivated by low-level disinfectants.
Many hospital disinfectants are now available as presoaked wipes and the use of disinfectant wipes is
becoming more widespread in the health-care environment. These products offer a convenient option for
use of disinfectants and have a number of advantages. First, the wipe signi cantly limits the indiscriminate
application of any chemical agent and the chemical is only applied to the area that the wipe contacts. This
decreases human contact and the amount of chemical introduced into the environment. Wipes are also
easy to use and store. The ease of use of ready-to-use cleaning-disinfection products has the potential to
increase cleaning-disinfection compliance when compared to products that require daily preparation of
solutions.
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Pump spray bottles, in most instances, are an appropriate method of applying liquid germicides. An
advantage of a pump spray bottle is better penetration of the liquid germicide into crevices in the
equipment where wipes may not effectively contact.
Immunization against Viral hepatitis and Tetanus is recommended for all personnel handling waste and
infectious material with Hepatitis B vaccination/immunoglobulin if a clinic employee has not been
vaccinated against Hepatitis B
Hep. B results show insufficient antibodies, Hep. B immunoglobulin must be administered within 72 hours.
If sufficient antibodies are present, a Hep. B vaccination booster will only be required.
Atetanus injection will be required if not received within the last 5-10 years. HIV/Hepatitis C results must be
collected in person within 7 days.
ii. Hospital/Clinical waste in Punjab is regulated under the punjab Hospital Waste Management Rules,
2014. According to the rules, every clinic shall be responsible for the proper management of the
waste, through developing a 'Clinical Waste Management Plan'. The plan will be facility speci c,
containing a list of activities and quantity of required materials. Development of the plan is the
responsibility of Waste Management Officer (a designated member of the Clinic's Waste
Management Team (WMT). The plan will be reviewed and nalized by the clinic WMT and should aim to:
a. Protect public health and safety.
b. Provide a safer working environment.
c. Minimize waste generation and environmental impacts of waste treatment/disposal.
d. Ensure compliance with legislative requirements.
Yellow Bags
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A separate waste basket for household waste should also be present in the clinic next to the yellow
contaminated waste bin/basket for collection and disposal of Non-contaminated items.
Standard 22. IPC-1: The clinic has a well-designed, comprehensive and coordinated
infection control system aimed at reducing/eliminating risks to
patients, visitors and care providers
Total 40
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
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Ind 68. Regular validation tests for sterilization are carried out and documented
Survey Process:
This is an important patient safety issue. Review the procedure to validate that complete sterilization has
occurred. This should be uniformly done on each batch that is sterilized. There are several methods such as color
change strips etc. Whatever method is used, it must be effective and documented. Observe that the date of
sterilization and expiry are clearly indicated on the packaging.
Compliance Requirements
i. Complete sterilization process is documented for each batch that is sterilized that can be con rmed by
using color change strips etc.
ii. Date of sterilization and expiry are clearly indicated on the packaging.
Scoring:
If there is a procedure to verify that complete sterilization has occurred, it is used for ALL batches that are
sterilized, it is documented and sterilization and validity dates are indicated, then score as fully met.
If there is no procedure, or if it is rarely (once a day) used, which includes monitoring of autoclaving
through validation tests or if it is not documented, or dates are not indicated, then score as not met.
Guidelines
Documented Layout and Processes
The de nition of 'adequate' includes enough space (or at least physical barriers) to ensure separation/well
demarcated areas for handling of contaminated and non-contaminated instruments considering the
workload. The de ned Sterilization department/area should have provision to physically separate the areas
where instruments undergo different steps of sterilization. These include:
i. Sorting of instruments:
This step helps to identify the instruments cleaning technique that can be classi ed as;
a. Critical Instruments
Critical instruments are those used to penetrate soft tissue or bone, or enter into or contact
the bloodstream or other normally sterile tissue. They should be sterilized after each use.
Critical instruments include forceps, scalpels, bone chisels, scalers and surgical burs.
b. Semi-critical Instruments
Semi-critical instruments are those that do not penetrate soft tissues or bone but contact
mucous membranes or nonintact skin, such as mirrors, reusable impression trays and
amalgam condensers. These devices should also be sterilized after each use. In some cases,
however, sterilization is not feasible and, therefore, high-level disinfection is appropriate.
c. Non-Critical Instruments
Objects that are in contact with intact skin. Low-level disinfection is required. These items are
less likely to spread infections, except when contaminated with pathogens by the hands of
health-care personnel. They require rigorous cleaning, washing and disinfection, and hands
must be washed after handling them.
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iii. Disinfection:
Many disinfectants are present commercially and should be used with the given guidelines:
Disinfectant should be mixed with sterile water in proper ratio to ensure disinfection.
The contaminated instruments should be soaked in the solution for the prescribed time.
iv. Washing:
All disinfected instruments are washed carefully not leaving behind any debris.
v. Drying:
Drying can be either done by spreading instruments in rows on a towel or by drying it separately
with a piece of cloth. Wet instruments should not be packed.
vi. Packaging:
Different sizes of sterilization pouches are available commercially. Over-packing should be avoided
Pouches should be sealed properly.
Storing sterilized equipment in open environments, such as open shelves, resulted in faster
microbial penetration than storing in closed cabinets with dustcovers. It is recommended to store
sterilized packages in reserved closed cabinets. Storage environment may cause sterilization breach
and contamination of instruments.
Barrier efficiency of packaging material should be evaluated by visual evidence of compromised
packages through:
Ÿ Tears
Ÿ Holes
Ÿ Rupture of Seals and Closures
Ÿ Wetness
Ÿ Crushed Packages
Ÿ Storage conditions(Temperature and humidity control)
Autoclave efficacy is highly dependent on time, temperature, and pressure, and these parameters can be
manipulated and optimized to create speci c sterilization cycles for each application.
Monitoring of Sterilization:
Monitoring is a quality assurance procedure used to ensure that the autoclave reaches adequate
temperature for an adequate holding time to complete sterilization.
Each autoclave should be validated every 40 operating hours. See the “Cumulative Time” on the Autoclave
Operation Log to determine when validation is necessary.
Each time the autoclave is validated, the date of validation, pass/fail and other relevant information should
be noted on the Autoclave Validation Log.
When the cumulative time reaches 38-40 hours, a validation test must be performed.
The sterilization procedure should be monitored routinely by using a combination of mechanical, chemical,
and biological indicators to evaluate the sterilizing conditions and indirectly the microbiologic status of the
processed items.
Mechanical Indicators
The mechanical monitors for steam sterilization include the daily assessment of cycle time and temperature
by examining the temperature record chart (or computer printout) and an assessment of pressure via the
pressure gauge.
Chemical indicators
These indicators undergo a chemical change when exposed to ''Time – Steam – Temperature (TST)''.
Chemical indicators are convenient, inexpensive, and indicate that the item has been exposed to the
sterilization process. Chemical indicators should be used in conjunction with biological indicators, but
based on current studies should not replace them because they indicate sterilization at marginal
sterilization time Therefore, only a biological indicator consisting of resistant spores can measure the
microbial killing power of the sterilization process.
Chemical indicators usually are either heat-or chemical-sensitive inks that change colour when one or more
sterilization parameters are present.
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The Bowie-Dick test is performed to assess air removal efficiency in steam sterilizers used in pre-vacuum
sterilization cycles. It detects air leaks and inadequate air removal.
If the sterilizer fails the Bowie-Dick test, do not use it until it has been inspected by the maintenance
personnel and passes the Bowie-Dick test.
Biological indicators
Biological indicators are recognized by most authorities as being closest to the ideal monitors of the
sterilization process because they measure the sterilization process directly by using the most resistant
microorganisms (i.e., Bacillus spores), and not by merely testing the physical and chemical conditions
necessary for sterilization.
The use of biological monitors (spore tests) is the most reliable method to validate that the sterilizer is
functioning and that the sterilization of instruments is effective. These monitors consist of paper strips or
vials impregnated with bacterial spores that are speci cally resistant to the sterilization process. These tests
allow quick remediation and validate proper infection control procedures without a long lag time during
which the sterilization procedure may have become ineffective but is not known.
Breakdown Recall
Like all other healthcare settings, the Dental Clinic/Surgery should develop and maintain a written recall
procedure and the staff members should be trained on these procedures. The Dental Clinic shall ensure
that the sterilization procedure is regularly monitored and in the eventuality of a breakdown it has a
procedure for withdrawal of such items. A batch processing system with date and machine number for
effective recall should be in place. Whenever a breakdown in the sterilization system is noted, all packs
sterilized by the faulty machine should immediately be called back from the respective areas where the
sterile packs has been supplied and should be sent for re-sterilization using a proper machine/technique.
The IPC Team shall ensure that Clinical IPC policies are consistent with contemporary provincial/national
guidelines and shall conduct IPC audit periodically e.g., at least monthly in areas where materials are
reprocessed to ensure policy compliance. Any breaches in the policy should be documented and corrective
action instituted.
The shelf life of sterilized packaged instruments can be either date-related or event-related; both are
acceptable. Date-related shelf life refers to a rst-in rst-out policy, meaning that the items that are
sterilized rst are used rst, so long as the packages have maintained their integrity.
Event-related shelf life refers to an approach that recognizes that a package and its contents should remain
sterile until some event such as tearing or moisture penetration causes the package to become
contaminated. All packages should be inspected before use to verify barrier integrity and dryness.
Standards re ect the premise that contamination is "event-related" and not "time-related", and recognize
the hospital's expertise in maintaining and delivering sterile products.
Expiry dates vary with packaging materials, but a general guideline is 1 month from the date of sterilization.
Commercially available plastic dust covers will extend the shelf life to 6-12 months.
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Standard 23. IPC-2: There are documented procedures for sterilization activities in the
clinic
Total 30
Detailed remarks regarding non-compliance, partial compliance and assessors own impression:
Assessor Coordinator
Name:__________________________________ Name:__________________________________
Signature:_______________________________ Signature:_______________________________
Date:___________________________________ Date:___________________________________
TOTAL 690
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PART 3
12. THE PUNJAB HEPATITIS ACT 2018 (Act XII of 2018) http://punjablaws.gov.pk/laws/2704.html
13. The Punjab Environmental Protection Act 1997 http://punjablaws.gov.pk/laws/2192a.html
amended in 2009
https://epd.punjab.gov.pk/system/ les/Punjab%
14. Punjab Hospital Waste Management Rules 2014 20Hospital%20Waste%20Management%20Rules
%2C%202014.pdf
128 CG-09RM-Ed2-141021
MSDS Reference Manual Dental Clinics
http://www.fmu.gov.pk/docs/laws/Control%20of
20. Control of Narcotics Substance Act 1997 %20Narcotic%20Substances%20Act.pdf
http://www.punjablaws.punjab.gov.pk/public/dr
21. The Medical & Dental Degrees Ordinance 1982 /THE%20MEDICAL%20AND%20DENTAL%20
DEGREES%20ORDINANCE,%201982.doc.pdf
22. Provincial Employees Social Security http://punjablaws.gov.pk/laws/187.html
Ordinance1965
23. The Epidemic Diseases Act 1958 http://punjablaws.gov.pk/laws/90.html
http://punjablaws.punjab.gov.pk/public/dr/THE%
24. Boilers and Pressures Vessels Ordinance 2002 20BOILERS%20AND%20PRESSURE%20VESSELS%
20ORDINANCE,%202002.doc.pdf
HISTORY SHEET
S/no. Description
1. Name of Equipment
2. Date of Purchase
3. Cost of Equipment
4. Name and Address of Supplier
5. Date of Manufacture
6. Date of Installation
7. Department where Installed
8. Environmental Control*
9. Spare Parts Inventory
10. Technical Manual/Circuit Diagrams/Literature
11. After Sale Service Arrangement
12. Warranty Period
13. Life of Equipment
14. Depreciation per year
15. Charges of Tests**
16. Use Coefficient***
17. Down-time/Up Time
18. Cost of Maintenance
19. Date of Condemnation
20. Date of Replacement
21. Other Relevant Remarks
*Proper environment control in terms of temperature, lighting and ventilation should be ensured and
recorded, wherever applicable.
**Wherever applicable, charges of tests must be speci ed.
***Should be applied to assess the utilization of equipment.
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1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
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Once the selection process is completed, the new employee must be oriented in order to improve his/her
ability to perform the job and also to satisfy the personal desire and feeling that he/she is a productive
contributor and part of the organization's social fabric. Supervisors, in coordination with the human
resource (HR) department, complete the orientation by introducing the new employee to the co-workers.
Every dental clinic should recognize that its success and the quality of care provided by it depends upon the
capacities of its staff and shall design a comprehensive induction orientation program as an integral
component of their capacity building. The hospital's induction and orientation processes will provide the
information, guidance and support required for staff to undertake their assigned responsibilities and to
succeed in their new role. This will be achieved by familiarizing the new staff with the signi cant policies,
systems, procedures, governance structure and the work location, and encouraging commitment to the
vision, mission and values of the HCE.
The 'Balanced Score Card' (Corporate Finance, Treasury and Risk Management) approach is a good start
towards implementing performance management systems in any organization which must be explained to
the employees at the induction, in order to align their daily activities with the overall organizational goals
(the mission). The new employee should be briefed about past achievements, in terms of services provided,
future objectives, plans and targets so as to create a positive image about the organization. General
responsibilities towards the institution and as to what the staff will be required to do, should be explained to
the employee.
1. Policy
The aim of the policy is to specify a program to introduce new joiners to the organization, work
colleagues, its culture and environment. All new employees will go through an induction orientation
program designed by the HR Department, which should include the following:
i. The vision, mission, values, objectives and policies of the dental clinic/surgery
ii. Overview of the organizational structure, systems and key processes
iii. Brief on key processes of the relevant department
iv. Description of the dental clinic's specialty and target population
2. Procedure
At the time of joining the dental clinic, the employee will submit photocopies of his/her past
credentials to the designated HR representative who will complete the following necessary
documentation and will get signatures of the employee where necessary:
i. Appointment letter
ii. Joining report
iii. Statement of ethics (Annexure-D)
iv. Con dentiality agreement
v. Reference forms for at least two referees will be lled by the employee (referees must not be
blood relations)
vi. Employee will ll a Health Questionnaire Form
After orientation, the HR representative will issue an orientation checklist to be lled by the employee
giving feedback about the orientation. The checklist will be led into the record of the employee and
feedback will be used for required improvements in the orientation program.
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1) We do not make misleading claims for our services or criticize our competitors before clients. We only
believe in servicing our client's needs to the best of our efforts.
3) We avoid con icts of interest either of a nancial or personal nature; these could compromise the
objectivity and integrity of our work.
4) We exercise our professional judgment impartially while taking any decisions related to work, keeping
all pertinent facts, relevant experience and the advice of our management in mind.
5) We hold the affairs of our clients in the strictest con dence. We do not disclose personal information
during service provision or derive bene t from using information outside the clinic.
6) We act with courtesy and consideration towards all with whom we come into contact in the course of
our professional work.
7) We do not accept any favors, gifts or inducements, including undue hospitality and entertainment, from
the clients. The only expectations would be if the gifts are of promotional nature (diaries, calendars, etc.)
or of a nominal value, the indulgence of which would not damage the doctor's/clinics reputation.
8) We are fully committed to the principle of equality and non-discrimination on the grounds of disability,
gender, age, race, color, ethnicity, origin or marital status. We do not indulge in any intimidation and
harassment of any sort at work.
9) We will communicate with our clients and its representative in an effective and timely manner.
10) We would be perceived by clients and other thought leaders as setting the standards in client focus and
client service among professional service companies.
Declaration
I have read and understood the “Statements of Ethics” and stand committed to it.
Signature:
i. Job Code. It is a speci c number assigned to the document e.g. 001, 004, etc.
ii. Position Name. It is exactly the title which the employee will use and conveys the main function
of the job/position.
iii. Physical location and surroundings. This description provides information about the place where
a particular dental clinic/surgery is located and what are its surroundings and communication links.
iv. Reporting. Name of the authority to whom the employee has to report.
vi. Functions of the position. It provides details of what the job actually entails and can be quite
speci c. It should also provide any supervisory functions in addition to being as speci c as possible
while describing tasks the employee will face every day. This is also the best place to indicate
whether the person will deal with customers, the public or only internal employees. This section can
also be used to prioritize the activities.
vii. Attributes needed for the position. If the position involves the use of machinery (or computers),
spell out what type of machines or software the employee will use. Also detail any technical or
educational requirements that may be critical or desired. This will also provide an insight into the
type of work environment to be maintained.
viii. Reporting. Provide details on the reporting and organizational structure to help the employee
better understand how their activities t into the total organization.
ix. Compensation. Including a grade/range instead of a speci c gure will give you more exibility, but
most people will feel they should be at the top of the range. It is usually better to have a speci c
amount, especially when the job description is being given to the employee.
x. Evaluation criteria. This section will de ne what is most important for the organization as well as
the employee in speci c terms. The evaluation criteria of the position will promote the type of
activities to enhance the success of the business and will also provide details on when evaluations
will take place.
xi. Acknowledgment. This includes the signatures of the authorized person of the dental
clinic/surgery, who usually is Manager HR/HOD/MS/CEO, and the employee, to con rm that he/she
has read and is aware of the JD.
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JDs and Performance Evaluation Criteria - 2008-2009 for the employees in the Public Sector Hospitals of
Health Department Government of Punjab were developed by the PDSSP, taking into account the above
mentioned parameters and service package provided for the Primary and Secondary Healthcare in Punjab.
The JD of a senior dental surgeon at THQ Hospital is given below as a sample. JDs of all other categories of
hospital staff can be seen in the above referred and noti ed document ⁷ These JDs c n be used s guidelines
nd m di ed t suit the l c l requirements f the priv te sect r h spit ls clinics etc
BPS: 18
Recruitment: Initial/Transfer
Position Type: Full Time
Dress Code :
Jurisdiction : THQH
Reports to : MS
Job Summary
In-charge of the dental unit for deliverance of optimal standard of dental care. Scope of work includes
dental OPD, admission of patients needing indoor dental care, care of admitted patients and planned
procedures on speci c days (only applies to OMFS department).
Duties/Responsibilities
I. Curative/Clinical
a. Overall in charge of the dental OPD and admitted patients.
b. Conducts dental OPD regularly on noti ed days and time.
c. Reviews referrals by MOs/other specialists and from the lower facilities to establish
diagnosis and proper management.
d. Plans and performs procedures e.g. RCT, surgical extraction, IMF, etc. on speci ed days
and time as per hospital policy.
e. Performs emergency dental procedures on patients admitted through A&E.
Department as and when required.
f. Writes post procedural notes and instructions for each case.
ii. Preventive/Promotive
a. Ensures compliance of SOPs particularly on infection control and waste management
in the OPD, dental clinics and surgical wards.
b. Ensures that instruments/equipments being used in examinations and procedures are
properly sterilized.
c. Ensures that all staff participating in the procedures are physically well protected by
wearing of proper dress i.e. gowns, masks, caps, gloves and shoes.
d. Provides educational information about common diseases and ways to promote
physical health.
iii. Rehabilitative
a. Provides psychological, social and nutritional rehabilitative measures to patients if required.
b. Teaching/Supervision.
c. Trains dental, nursing and paramedical staff as per departmental/specialty
requirements/ protocols and work instructions.
iv. General
a. Checks the cleanliness and up keep of the unit.
b. Ensures that responsible staff regularly upkeeps and maintains electro-medical
equipment of the unit to ensure their functionality at all the time.
c. Ensures that responsible staff is regular in supply/replenishments of medicines and
stores.
d. Provides technical assistance to the management for purchase of new equipments/
instruments needed from time-to-time for the unit.
e. Ensures the preparation and implementation of the duty roster for his unit.
f. Checks that the subordinate staff performs their duties as per JDs, SOPs and SMPs.
g. Writes objective Performance Evaluation Reports of subordinate staff.
h. Performs outreach duties to lower facilities as required.
i. Performs any other professional duty assigned by higher authorities.
I have read and accept the job description. Signature of the incumbent:
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Using JDs helps a dental clinic to better understand the experience and skill base needed to improve service
delivery. They help in hiring, evaluation and termination of employees when required. Quite often, there is a
misunderstanding of what a position entails and in that case, a well-prepared job description can help both
sides share a common understanding.
I. Responsibilities
The HR Department must have well-de ned JDs for each category of staff, which will also be an
important component of the respective personal le duly signed by the employee.
ii. Rights
The rights of the staff member should be detailed in the employee manual maintained by the HR
department which should also be shared with the employee/s.
iii. Patients' Rights
The rights and responsibilities of the patients are available as Patient Charters (Section 2.9
PRE-Annexure-H).
The following points regarding the rights and responsibilities of employees are to be considered:
a. Staff members may have cultural, religious or personal con icts concerning their
involvement with speci c components in the care or treatment of patients. The dental
clinic shall provide a mechanism for employees' to submit their requests for review of work
assignments by their HoD. However, the continuum of patient care services shall be
ensured at all levels.
b. The HoD, manager or supervisor shall make every effort to accommodate the request and
maintain the duties referenced in the employees' JD.
c. The HoD, manager or supervisor shall reassign duties, if reasonable and possible, to
accommodate the request and meet the needs of the patient.
d. Response to all requests for reassignment of duties, whether approved or denied will be
provided in writing to the employee.
e. A record of all requests and actions taken shall be maintained in the employee's
departmental le.
f. If the request of the staff member cannot be granted, the employee may appeal to the next
higher authority to review the request. The decision of the human resources department
shall be nal to the extent of respective request.
Similarly, the staff is to be apprised about the rights and responsibilities of the patients and the dental clinic,
as provided as part of Annexure-H.
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19. Seek compensation if he has been harmed by, including but not limited to maladministration,
malpractice, negligent treatment, or failure on the part of a healthcare service provider or any
staff/employee or others rendering services at the Healthcare Establishment;
20. Be informed and to refuse to participate in research, or any project dealing with his disease, care and
treatment;
21. Be accompanied by a family member or carer, as the case may be, particularly in cases of
children, females, elderly and disabled. The healthcare service provider and/or the Healthcare
Establishment, as the case may be, are to ensure that in cases of children and females in the immediate
post anesthesia phase, a female staff shall be present until a family member or carer can join the
patient/client, The healthcare service provider and/or the Healthcare Establishment, as the case may be,
are also to ensure that in cases of children and females an authorized family member or a carer or if not
so possible, at least a female staff is present during physical examination and investigation procedures
where physical contact and or exposure of body part(s) is required.
22. Expect that the Healthcare service provider, the Healthcare Establishment, and/or such other person
rendering similar services, as the case may be, shall not misuse nor abuse their duciary position vis-à-
vis him or his carer(s) or family members, as the case may be, for undue favour(s) including but not
limited to sexual favour(s) or any other undue or uncalled for reward or privileges in terms of
professional fee or gifts etc;
23. Be informed as early as possible regarding cancellation and/or postponement of any appointment,
surgery, procedure, treatment or meeting, as the case may be;
24. Be made aware of the costs, fee and/or expenses, prior to the consultation, treatment or other services,
and/or operation/procedure, as the case may be, and receive payment receipt(s) for the same;
25. Be given written instructions regarding his treatment, including instructions at the time of discharge;
26. Examine and receive an explanation for the bill(s) regardless of the source of payment;
27. End of life care3;
Nothing in this Charter prevents any organization/healthcare service provider/healthcare
establishment from recognizing additional rights of the Patient/Client and/or the carer, as the case may
be. The purpose of this Charter is to inculcate and invigorate in the community the understanding and
recognition of the fact that health, care and/or treatment is a right of an individual even when he is
unborn and the same continues from his cradle to coffin. This document will be reviewed annually or
earlier, as deemed appropriate by the Punjab Healthcare Commission, in view of its experiences,
through a consultative process involving patients, former patients, family members, related
professionals, staff and other stakeholder groups.
Explanatory Notes
1. Gender includes male, female, transgender and intersex individuals.
2. Life, in the context of mental emergency, includes those of others.
3. End of Life Care includes healthcare, not only of patients in the nal hours or days of their lives,
but more broadly, care of all those with terminal illness or terminal condition that has become
advanced, progressive and incurable. Accordingly, it may so happen that no treatment may be
advisable and or given but the care should continue, keeping in view the ethics of the profession.
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10. Demand abstinence from the use of violent and disruptive behaviors or language abuse and take
appropriate legal action in case of breach;
11. Prohibit smoking and/or substance/drug abuse on the premises and take appropriate legal action in
case of breach;
12. Limit its liability for misplacement or theft of valuables and belongings of the patient/client, carer and
visitor;
13. Be paid for all services rendered to the patient/client, either personally or by the carer or through the
third party, e.g. insurance company.
14. Be noti ed of any change of contact, address and other details of the patient/client, as the case may be;
15. Ask for information from the patient/client regarding its services for the purposes of improving the
healthcare services/systems within the Healthcare Establishment;
16. Maintain and utilize the data collected from the patient/client, subject to the principles and law relating
to con dentiality, for the purposes of improving the healthcare services/systems within the Healthcare
Establishment;
17. Ensure that while using the available facilities and equipment, due care and caution is taken by the
patient/client and/or their carers and visitors, as the case may be.
The Punjab Healthcare Commission while recognizing the fact that each Healthcare Establishment is a “House
of Hope” where advice and treatment, including other services, are rendered to the public at large, has
developed this Charter of Rights for all Healthcare Establishments/Healthcare Service Providers in the Province
of Punjab. All these rights are to be exercised with a view to make better services available to the masses.
The Punjab Healthcare Commission further assures that it stands committed to the cause of the Healthcare
Establishments/Healthcare Service Providers in the exercise of these rights and shall always be ready and
willing to support in the implementation and enforcement of the rights envisaged herein. This document will
be reviewed annually or earlier, as deemed appropriate by the Punjab Healthcare Commission, in view of its
experiences, through a consultative process involving patients, former patients, and family members, related
professionals, Healthcare Establishments/Healthcare Service Providers, staff and other stakeholder groups.
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2. If YES, how? (You can circle more than one 1. Complete information provided
response and write below) 2. Services available when needed
3. Services are affordable
4. Convenient to reach the facility
5. Staff is courteous
6. Relevant staff is available
7. Privacy is observed
8. Female staff is available
9. My condition improved after treatment
10. Other (specify) _________________________
3. If NO, why? (You can circle more than one) 1. Issues of con dentiality
response and write below) 2. Issues of privacy
3. Lack of attention
4. Inadequate information provided
5. I was asked to come another time without
examination
6. Medicines/Services are costly
7. Waiting time is too long
8. Staff is discourteous/unsatisfactory behavior
9. Staff is not competent
10. Relevant staff NOT available
11. Female staff NOT available (gender issue)
12. I suffered from side effects of the treatment
13. Relevant staff NOT available
14. Other (specify) _________________________
Signature of patient/relative:
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1. Name of HCE:
2. Name of in-charge:
4. General cleanliness
5. Washroom cleaned/functional
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Date________________________________
Treatment/Procedure/Investigation
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Patient's Declaration (Patient required to read carefully, discuss with the doctor if there are
any concerns and tick the understood and agreed points)
CNIC # : CNIC # :
1.0 OBJECTIVE
To ensure that complaints are handled in a standardized manner at all healthcare establishments (dental
clinics/surgeries) in Punjab.
2.0 SCOPE
This document provides general guidelines to Healthcare Service Providers (HCSPs) to develop or
improve their Complaint Management Systems.
3.0 RESPONSIBILITY
The responsibility of complaints handling rests with the HCSP. However, all staff members of the
establishment are responsible for providing the necessary support.
4.0 DISPLAY OF INFORMATION
4.1 Inform the patient of his/her right to express his/her concern or complain either verbally or in
writing.
4.2 This shall be done by clearly displaying the following information, in Urdu, at the entrance, help
desk, every department (and at the back of admission and discharge slips)
5.2 Registration
5.2.1 A Complaint Management Register shall be maintained by each clinic, which shall be
available at the help desk/reception during working hours.
5.2.2. Register shall have:
5.2.2.1 A 3” X 4” white paper pasted on the cover page with the following:
5.2.2.2 The following certi cate on the inner side of the cover page:
“It is certi ed that this register contains _____ pages; each page has been numbered
(at the top center), stamped with the dental clinic/surgery seal (at top right corner) and
initialed by me.”
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S r . Complainant's Contact Address Description Signature/ Details Date(s) Outcome Date Quality Signature
No. Name No. of the Thumb Print of the Complainant Complainant improvement
Complaint of Investigation Contacted Informed Policy or
Complainant Procedure
Change
6.0 COMMUNICATION
6.1 Inform the complainant about the progress of the investigation at regular intervals and
inform him/her about the outcome.
6.2 Stay in contact with the complainant and regularly update him/her about the progress made in
the investigation.
6.3 Record the outcome of the investigation and inform the complainant accordingly.
6.4 Don't indulge in argumentation and be polite and empathetic.
Make necessary changes in policy and procedures to improve the quality of clinical services.
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Reviewers/Contributors
Sr. # Name Designation
1. Dr. Majed Latif Additional Director (Internal & External Training) PHC
2. Dr. Basharat Javed Khan Deputy Director (Training) PHC
3. Dr. Sha que ur Rehman Deputy Director (Training) PHC
4. Dr. Imtiaz Ali Deputy Director (Training) PHC
5. Ha z Dr. Fayzan Akhtar Deputy Director (Training) PHC
Reviewers
Sr. # Name Designation
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The Punjab Healthcare Commission (PHC) has been established under the Punjab Healthcare Commission Act, 2010. It is an
independent health regulatory body with the mandate to introduce a regime of clinical governance through enforcing
Minimum Service Delivery Standards (MSDS) at the primary, secondary and tertiary healthcare establishments (HCEs), in
both public and private sectors, to improve the quality of healthcare service delivery in Punjab. All HCEs are required to
imp[lement MSDS to acquire a license for thin lawful operation and to deliver healthcare services in Punjab.
www.phc.org.pk
Office No. 1 & 2, 4th Floor, Shaheen Complex, PUNJAB HEALTHCARE COMMISSION
All rights reserved. No part of this publication can be reproduced in any form or by any means without written permission from the PHC.