MSDS for Hospitals: Standards & Indicators
MSDS for Hospitals: Standards & Indicators
Table of Contents
Section Page
1. Introduction .................................................................................................................. 5
1.1 Service Delivery Standards ........................................................................................... 5
1.2 Focus Group Discussion................................................................................................ 5
2. Standards...................................................................................................................... 7
2.1 Access, Assessment, and Continuity of Care (AAC) ...................................................... 7
2.2 Care of Patients (COP) ................................................................................................ 13
2.3 Management of Medication (MOM) .......................................................................... 25
2.4 Patient Rights and Education (PRE) ............................................................................ 31
2.5 Hospital Infection Control (HIC) ................................................................................. 36
2.6 Continuous Quality Improvement (CQI) ..................................................................... 39
2.7 Responsibilities of Management (ROM) .................................................................... 44
2.8 Facility Management and Safety (FMS)...................................................................... 48
2.9 Human Resource Management (HRM) ...................................................................... 54
2.10 Information Management System (IMS).................................................................... 60
Acknowledgements
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Foreword
The Punjab Healthcare Commission (PHC) is an autonomous health regulatory body established
under the PHC Act 2010 for the standardization of healthcare service delivery in Punjab. Under
this mandate, the PHC has developed the Minimum Service Delivery Standards (MSDS) and
associated Indicators for Hospitals to introduce a culture of Clinical Governance grounded in the
principles of responsibility and accountability so that the quality, safety and efficiency of
healthcare service delivery in Punjab could subsequently be improved.
A product of collaborative deliberations between international and local health experts, and
extensive consultations with the relevant stakeholders, these standards have been reviewed
and endorsed by the Technical Advisory Committee (TAC), and approved by the Board of
Commissioners (BOC) of the PHC and the Government of Punjab.
A total of 30 Standards and 162 indicators are prescribed in the MSDS covering all vital aspects
of healthcare service delivery, ranging from Care of Patients and Management of Medication to
Continuous Quality Improvement, Infection Control and Information Management Systems,
among others. Each indicator is accompanied by a scoring matrix to assess compliance with the
Standards and to facilitate their implementation.
I would like to thank the international consultants from the DFID and the Pakistani experts for
their valuable inputs in the compilation of this document. My thanks are also due to all the
stakeholders who made extremely beneficial suggestions for making the MSDS practically
applicable in the Pakistani context. I am also indebted to the TAC for a highly professional critical
appraisal of the final document. My special appreciation also goes to the team of the PHC under
the leadership of the Chief Operating Officer for their diligence and hard work in achieving this
crucial milestone. Lastly, I am grateful to my fellow Commissioners of the Board for their
guidance and support in the development of this document.
I sincerely hope that these MSDS, developed by the PHC, would mark its first step towards
achieving its purpose of providing quality healthcare services to the people of Punjab.
Chairman
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1. Introduction
The Government of the Punjab, charged with the role of protecting its citizens, promulgated the
Punjab Healthcare Commission (PHC) Act 2010. The vision of the PHC is ‘to promote high quality
and safe healthcare delivery for all’ and the mission is ‘to continually raise standards of
healthcare delivery’ throughout Punjab. A reputable team of Pakistani practitioners with
international collaboration derived these standards. The origin of the standards can be found in
the 1500+ Joint Commission International (JCI) Indicators and in the review of Australian, New
Zealand, Indian, UK, and Canadian standards. They have been considerably reduced in number,
and the scope has been adapted for the local context to ensure a realistic approach in the
foundation years for their introduction.
Minimum Service Delivery Standards (MSDS) and indicators include the fundamental elements
that should be present in all healthcare establishments in order to deliver safe health services.
They are consistent with the Pakistani national indicators currently being developed. This is to
promote consistency and down-stream comparison. They recognize that some establishments
are starting from a low base, and cover (i) Patient and (ii) Organization centered standards. They
have been developed by Pakistani Experts working in the field of healthcare provision and
management and include advice on the surveillance process and scoring.
Health Standards and Indicators are dynamic, reflecting the constant development of healthcare
treatments, practices and protocols. They are driven by evidence-based research and are
designed to promote a safe environment with managed risks. This benefits both patients and
healthcare establishments and contributes to the social objectives of Punjab and the Nation.
Over time, it is anticipated that the range and scope of standards and their indicators will
increase and develop with the collaboration of Health Sector Leaders, Councils, Colleges, Boards
and Associations.
The PHC is pleased to adopt these 30 professionally developed "Foundation Standards" and 162
associated Indicators for Secondary and Tertiary Hospitals on behalf of the citizens of Punjab.
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Participants included renowned medical practitioners from key public and private hospitals who
have also been actively involved in the PHC Stakeholder Workshop held in January 2011 and in
the Licensing, Accreditation and Regulation Workshop in March 2011. The FGDs were part of a
series of consultative meetings that TAMA’s consultants for the PHC project undertook with
relevant stakeholders and health professionals in order to ensure their involvement and
engagement with the PHC.
The PHC’s Technical Advisory Committee (TAC) reviewed, amended and endorsed the MSDS in
August 2012 prior to adoption by the Board of Commissioners.
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2. Standards
2.1 Access, Assessment, and Continuity of Care (AAC)
Standard 1. AAC-1: Laboratory services are provided as per the
requirements of patients.
Indicators (1-6):
Ind 1. Scope of the laboratory services is commensurate to the clinical services
provided by the organization.
Survey Process:
This will require an understanding of the full scope of services provided at the healthcare
establishment and observation of the diagnostic facilities provided both on and off site. Check
on the external reference testing arrangements and validate.1
Scoring:
If the healthcare establishment’s laboratory and any qualified outsourced services2 support
the scope of services and are validated with external reference testing, then score as fully
met.
If there is an insufficient scope of laboratory diagnostic procedures to support the services
provided by the hospital3 or by an accredited laboratory with adequate service support4, and
no external validation exists, then score as not met.
Ind 2. Adequately qualified and trained personnel perform and/or supervise the
investigations.
Survey Process:
Each laboratory personnel should have a job description equivalent to the specifications for
laboratory staff in the Job Descriptions and Performance Evaluation Criteria for Medical, Nursing
and Paramedical Staff, Punjab Devolved Social Services Programme, Govt. of the Punjab, 2008-
09 that defines the required level of training and experience. Review a sample (3 files or 25% of
the staff – whichever is the greater) of human resource files for laboratory technical and
supervisory staff to determine if their qualifications, experience and training match the
requirements in the job description and to operate the equipment that is being used. A system
of Continuous Professional Development5 should be active.
Scoring:
If the sampled individuals’ qualifications match the requirements in the job description, or if
there are only minor variances (such as only 4 years of experience instead of 5), then score
as fully met.
If only one technician does not have the qualifications required by the job description, then
score as partially met, provided that there is evidence of enhanced supervision or training of
this individual.
If two or more technicians do not have the required qualifications (in the job description),
then score as not met.
1
Patients should be informed about laboratory tests that are outsourced.
2
Independently accredited by a Government of Punjab recognized laboratory standards agency
3
A future date to be determined for all laboratories which will be required to be externally accredited
4
Adequate communication, specimen pick up and timely provision of results
5A recognized program administered by a professional college/council or equivalent
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accurate and timely, this experience can be sufficient. The arrangements including quality
Indicators and turnaround times should be specified in a formal contractual arrangement.
Scoring:
If there is documented evidence that the referral laboratory or laboratories deliver quality
indicators (even if only by the hospital’s experience in the first year), then score as fully met.
If there is no or limited evidence that the referral laboratory demonstrates quality, then score
as not met.
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Ind 8. Scope of the imaging services is commensurate to the clinical services provided
by the organization.
Survey Process:
This requires an understanding of the full scope of services provided at the establishment and
observation of the diagnostic facilities provided both on and off site. A full complement of
imaging services should also be provided to cater for emergency situations that may arise from
the services delivered by the hospital. Where invasive imaging services are provided there must
be adequate support service in the event of an emergency. This involves resuscitation, and in
some cases, emergency surgery when cardiac procedures are involved.
Scoring:
If there is access to a full array of imaging services commensurate with the scope of hospital
services, then score as fully met.
If there is insufficient scope and number of imaging services to support the services within
the hospital, then score as not met.
Ind 9. Adequately qualified and trained personnel perform, supervise and interpret
the investigations.
Survey Process:
Each member of the Radiology Department should have a job description that defines the
required level of training and experience equivalent to the specifications for imaging and
diagnostic staff described in the Job Descriptions and Performance Evaluation Criteria for
Medical, Nursing and Paramedical Staff, Punjab Devolved Social Services Programme, Govt. of
the Punjab, 2008-09. Review a sample (3-5 or 25% of staff whichever is greater) of human
resource files for radiology technical and supervisory staff to determine if their qualifications,
training and experience match the requirements in the job description and to operate the
equipment that is being used. Continuous professional development7 should be active.
Scoring:
If the sampled individuals’ qualifications match the requirements in the job description, or if
there are only minor variances (such as only 4 years of experience instead of 5), then score
as fully met.
6
Building Code of Pakistan and management of ionising radiation
7A recognized program administered by a professional college/council or equivalent
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If only one technician does not have the qualifications required by the job description, then
score as partially met, provided that there is evidence of enhanced supervision or training of
this individual.
If two or more technicians do not have the required qualifications (in the job description),
then score as not met.
Ind 10. Policies and procedures guide identification and safe transportation of patients
to imaging services.
Survey Process:
Review the policies and procedures. Specifically look for how the patient is positively identified
and it is ensured that the correct imaging procedure is done. Look for evidence that specific
medical attendance or equipment is available and provided if needed to accompany the patient
to the department and that there is a clear process to ensure this happens. Specifically look for
evidence (by observation and interview of staff) that the patient is positively identified.
Scoring:
If there are implemented policies and procedures for patient identification and safe
transport, then score as fully met.
If either there are no policies or that there is no evidence that they have been implemented
and is being followed, then score as not met.
Ind 11. Imaging results are available within a defined time frame.
Survey Process:
While visiting the Radiology Department, review their written definition of time frames both for
the availability of the procedure and the availability of the report. Then, see if the department
has data to show that the times are being met. If the surveyor needs further validation, while
on an in-patient unit, review 3-5 medical records. Look for the time of the physician order for
the procedure, and compare with when the result was available.
Scoring:
If there are defined times for the procedure to be available and the results to be available
and these times are met with only occasional delays (less than 5 percent), then score as fully
met.
If there are defined time frames, but they are met between 85-95 percent of the time, then
score as partially met.
If there are no defined time frames or when they are met is less than 85 percent of the time,
then score as not met.
Ind 12. Critical results are intimated immediately to the concerned personnel.
Survey Process:
Unlike the laboratory, critical findings on images depend to a great extent on the clinical
judgment of the radiologist. However, the department should at least have some general
guidelines and a way to document that the findings were reported as soon as possible. This is a
significant patient safety issue.
Scoring:
If there are guidelines to manage critical findings and there is documentation that they are
reported as soon as available, then score as fully met.
If there is no understanding of what constitutes a critical imaging finding, or if there is no
consistent and defined process to report them as soon as available, then score as not met.
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Ind 13. Quality Assurance activities are evident in the Imaging Department.
Survey Process:
There should be documented evidence that a Quality Assurance (QA) plan is active in the
department. This should include observation of activities such as a register of repeat images due
to image quality related reasons and recording of adverse occurrences.
Scoring:
If a copy of the QA plan is available along with evidence that 80% of staff is aware of its
contents and the associated activities, then score as fully met.
If there is no copy of evidence of a QA plan or less than 80% of staff are aware of its contents,
then score as not met.
Ind 14. Imaging tests not available in the organization are outsourced to
organization(s) based on their quality assurance system and compliance with
applicable laws and regulations.
Survey Process:
There should be documented evidence that the radiology services to which patients are referred
have been approved by the Pakistan Nuclear Regulatory Authority (PNRA) and that the hospital
has a history of receiving timely and accurate reports from the referral radiology service
commensurate with the clinical needs of the patient.
Scoring:
If the PNRA approves the referral imaging services and the hospital demonstrates sufficient
experience to know that reports are timely and accurate, then score as fully met.
This should only be scored as not met if a majority of the survey team agrees that there are
significant problems with the referral radiology services.
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Ind 15. Policies and procedures for emergency care are documented.
Survey Process:
Review the policies and procedures, which should cover the administration of the emergency
area (triage, waiting times, admission/registration, legal reporting requirements, discharge and
patient transfer). There should be observation of the policy and procedure manual and evidence
that staff members are aware of its existence. There should be evidence by observation and
interview with staff that the policies and procedures have been implemented.
Scoring:
If there are policies and procedures, that staff members are aware of, and there is evidence
that they are followed by ALL staff, then score as fully met.
If there are policies and procedures and only 1-2 staff members are not aware of them, or if
only 1-2 policies and procedures have not yet been implemented, then score as partially met.
If there are no policies and procedures, or if none have been implemented, then score as not
met.
Ind 17. The patients receive care in consonance with the policies.
Survey Process:
This will need to be surveyed by observation and interview with staff members. The policies
should be readily available and understood by staff and embrace ALL the aspects of care being
received by patients. There should be evidence of a process where the staff is made aware of
and receive training regarding the policies and associated procedures.
Scoring:
If agreed by the team that there is sufficient evidence that policies are being followed by
staff, then score as fully met.
If a majority of the survey team agrees that there is evidence that one or more policies are
not being followed, then score as not met.
Ind 18. Policies and procedures guide the triage of patients for initiation of
appropriate care.
Survey Process:
Look for a formal triage process, ideally based on a written algorithm. The most important issue
is to validate that triage is based on an evaluation of the patient’s presenting complaint and/or
condition (clinical need) and NOT on time of arrival (first come, first served) or mode of arrival
(ambulance versus walk-in). A walk-in patient may well have more emergent needs than the
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patient who arrived by ambulance. Existing standards on emergency management and disaster
response should be observed.8
Scoring:
If there is: 1. A triage process and 2. It is based on actual clinical evaluation9 3. By
appropriately trained staff 4. Using appropriate facilities and 5. Staff members are aware and
6. Applying the process, then score as fully met.
If there is a triage process, but it is not consistently based on at least a brief clinical evaluation
of the patient using appropriate facilities, then score as partially met. Surveyor judgment is
required since some presenting complaints (chest pain and acute respiratory distress) should
trigger immediate attention even without a brief clinical evaluation.
If there is no triage process or if it is only on a first come, first served basis, then score as not
met.
Ind 19. Staff members are familiar with the policies and trained on the procedures for
care of emergency patients.
Survey Process:
This is surveyed by observation and interview with staff members. Training and orientation
should be documented in terms of content and participation.
Scoring:
This should be scored the same as for Ind 15.
Ind 20. Admission or discharge to home or transfer to another organization is
documented.
Survey Process:
Review a sample of at least 10 medical records, files or other documentation (emergency
services log book) of patients who were treated in the Emergency Department. Observe the
records and determine the discharge process. Review the advice and information provided to
the patient or other clinician or treatment facility and determine if it is adequate to ensure
support, recovery, on going treatment and follow-up that is clinically required.
Scoring:
If this is 100 percent documented, then score as fully met.
If only 1-2 cases fail to meet this requirement, then score as partially met.
If 3 or more of the cases reviewed do not document this, then score as not met.
8In keeping with the National Disaster Management Agency and Government of Punjab hospital
requirements for the management of disasters. – The Society of Emergency Physicians Pakistan (SEPP)
9
Commensurate with the triage process of initial assessment
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Ind 21. Documented policies and procedures are used to guide rational use of blood
and blood products.
Survey Process:
Review the policies and procedures. Policies should at least cover: 1. donor screening, 2.
processing of blood, 3. storage of blood, 4. administration of blood, 5. use of blood products, 6.
identification and analysis of real or suspected transfusion reactions and 7. disposal of blood
and related products. This is a significant patient safety issue.
Scoring:
If there are policies and procedures and they include at least these 7 requirements (relevant
to the scope of services available for the hospital’s blood service), then score as fully met.
Since blood services are such a critical patient safety issue, if any of the 7 requirements
(relevant to the scope of service for the hospital’s blood service) are not present, then score
as not met.
Ind 22. The transfusion services are governed by the applicable laws and regulations.
Survey Process:
The surveyors will need to be aware of the applicable laws and regulations. This is surveyed by
reviewing documentation (such as an external official inspection, copies of the legislation and
compliance requirements), interviews, and observation. This includes an observable mechanism
to ensure that only blood and blood products derived employing recognized Indicators10 is
provided to patients. This is a significant patient safety issue.
Scoring:
If the laws and regulations are present and being employed by all staff, then score as fully
met.
Considering the critical nature and risk with blood services, if there are any examples of non-
compliance that compromise the safety of patients, then score as not met.
Ind 23. Informed consent is obtained for donation and transfusion of blood and blood
products.
Survey Process:
While visiting the blood bank identify the names of at least 10 patients who have received blood.
Then review the medical records of these patients to determine if there is documented
‘informed consent’ and if the consent adequately informs the patient. If the hospital processes
donors, also review a sample of at least 5 people to determine if the donor gave informed
consent and this was appropriate for the individuals concerned. It is important to note that
evidence of informed consent can be either a signed form or a note by the physician that the
patient’s verbal consent was obtained. Informed consent must be designed to ensure that
people of ALL backgrounds truly understand the risks and options involved and the evidence
provided must clearly support this. This includes information and education of the patient and
their family, when present.
Scoring:
If informed consent is obtained for 100 percent of cases, then score as fully met.11
10See Standards and Guidelines for Blood transfusion Services, Pakistan Ministry of Health, 1999
11
There are exceptions when the recipient is an emergency unconscious patient without family or
guardians present at the time.
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Since this is a significant medico-legal issue, if ANY case does not have a documented
informed consent, then score as not met.
Ind 25. Transfusion reactions are analyzed for preventive and corrective actions.
Survey Process:
Ask for documentation that reports transfusion reactions. Evaluate whether the documentation
demonstrates adequate analysis and remedial actions. In the case where no reactions are
reported as occurring12, the surveyors should evaluate whether there are adequate clearly
written procedures for analysis and remedial action if a reaction does occur. Check that staff
members are aware of the reporting process.
Scoring:
If there had been a transfusion reaction and it was fully analyzed and remedial action
proposed or if the survey team is comfortable that there are written procedures to follow if
one occurs, then score as fully met.
If there had been a transfusion reaction and there is no documented evidence of how it was
analyzed, or if there had been no transfusion reaction and the blood bank also does not have
any written procedure for analysis, then score as not met.
12
This would be highly unlikely.
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Standard 5. COP-3: Policies and procedures guide the care of high risk
obstetrical patients
Indicators (26-30):
Ind 26. The organization defines and displays whether high-risk obstetric cases can be
cared for or not.
Survey Process:
Since many patients will not know if they are high risk or not, it is important that the hospital
has informed its obstetrical patients of the definition of high risk and its capability to provide
services for these women. The second important issue is that the hospital has informed those
practitioners and facilities that might refer such patients of the hospital’s capability to provide
care to high-risk obstetric cases.
There must be documentation of this information (such as letters to referring doctors and
facilities plus information available to give to its own obstetric patients).
Scoring:
If the hospital has informed its own obstetric patients and its referring practitioners and
other facilities of its capability to care for high-risk obstetric cases, then score as fully met.
If the hospital has informed its own patients, but not referring providers or facilities, then
score as partially met.
If the hospital has neither informed its own patients or referring providers or facilities, then
score as not met.
Ind 27. Persons caring for high-risk obstetric cases are competent.
Survey Process:
Surveyors should look for the availability of at least four13 specialists (so that there is 24
hours/day, 7 days/week coverage) who are fully qualified in obstetrics and who have advanced
training in high-risk obstetrics and documented experience. In addition, there should be
evidence that members of the nursing staff who care for such patients have advanced
qualifications and documented experience14.
Scoring:
This standard should default to a score of fully met unless a majority of the survey team
agrees that there is lack of evidence that ALL personnel who participate in the care of high-
risk obstetric patients have appropriate qualifications.
Ind 28. High-risk obstetric patient's assessment also includes maternal nutrition.
Survey Process:
This will be surveyed by review of a sample of at least 5 medical records of high-risk obstetric
patients.
Scoring:
If ALL records document assessment of the patient’s nutritional status (including corrective
measures if needed), then score as fully met.
13
This is the absolute minimum to provide 24hrs, 7 days per week service based on 3 shifts per day and
270 productive workdays per employee per year.
14
As per the specifications for ALL clinical staff in the Job Descriptions and Performance Evaluation Criteria
for Medical, Nursing and Paramedical Staff, Punjab Devolved Social Services Programme, Govt. of the
Punjab, 2008-09
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If only one medical record does not document this but it is clinically obvious that the patient
had good nutritional status, then score as partially met.
If more than one record fails to document the patient’s nutritional status, then score as not
met.
Ind 29. The organization caring for high risk obstetric cases has the facilities and
technically competent staff to take care of neonates of such cases.
Survey Process:
Although this may require some surveyor judgment, the following minimum should be present
(and in working order): 1. Emergency resuscitation drugs, 2. Ambu bag with 3. Appropriate
neonatal size facemasks, 4. Laryngoscope with neonatal size blades, 5. A selection of neonatal
size endo-tracheal tubes, 6. An oxygen and suction source, 7. A warmer work station,
8.Incubators, 9. Trays to allow cannulation of an umbilical artery, 10. Exchange transfusion trays,
11. Infusion pumps to assure no volume overload of the neonate and 12. Neonatal resuscitation
drugs.
Scoring:
If ALL the equipment listed above is present and in good working order, then score as fully
met.
If ALL the required equipment and supplies defined above are not present, but the survey
team agrees that the hospital has safely defined alternatives, then score as partially met.
If the survey team agrees that any critical equipment or supplies are not available, then score
as not met.
Ind 30. No treatment should be administered unless the identity of the patient can be
guaranteed.
Survey Process:
The surveyor should identify a form of safe patient identification system15 and confirm that the
administration of ALL treatments and therapies are preceded by confirming the identity of the
patient.
Scoring:
If the identification of the patient is clearly observable and fail safe for ALL patients and staff
confirm identity, then score as fully met.
If a fail-safe method of identification is present and staff does not consistently check the
identity before treatment, then score as partially met.
If there is no fail-safe system of identification, then score as not met.
15For ALL patients the system employed must be permanently with the patient and fail-safe.
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Ind 32. ALL patients for anaesthesia have a pre-anaesthetic assessment by a qualified
individual.
Survey Process:
Review a sample of at least 10 records of patients who underwent anaesthesia. Determine if
there is a documented pre-anaesthetic assessment. An anaesthetist should do the assessment
unless the hospital has identified another specialty that is qualified to do the pre-anaesthesia
assessment.
Scoring:
If there is a pre-anaesthesia assessment by an anaesthetist or qualified doctor with
documented appropriate training for ALL patients, then score as fully met.
Since this is an important patient safety issue, if ANY medical record does not include a
documented pre-anaesthesia assessment, then score as not met.
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Ind 36. During anaesthesia, monitoring includes regular and periodic recording of
heart rate, cardiac rhythm, respiratory rate, blood pressure, oxygen saturation,
airway security and patency, and level of anaesthesia.
Survey Process:
This standard is surveyed by observation. While visiting the operating theatre look for the
presence (and full functionality) of equipment that supports ALL the requirements in this
standard.
Scoring:
This should default to a score of fully met unless a majority of the survey team agrees that
there are significant deficiencies in the hospital’s ability to monitor patients during
anaesthesia (for example, only one monitor for two or more rooms such that some patients
are not monitored).
Ind 37. No anaesthetic should be administered unless the identity of the patient can
be guaranteed.
Survey Process:
The surveyor should identify a form of safe patient ID system18 and confirm that the
administration of anaesthesia is preceded by confirming the identity of the patient.
Scoring:
If the identification of the patient is clearly observable and fail safe for ALL patients and staff
confirm identity prior to induction, then score as fully met.
17
Informed consent must truly be appropriate for each patient and include reference to the associated
risks involved
18
For ALL patients the system employed must be permanently with the patient and fail-safe.
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If there is no fail safe system of identification or any patient’s identity is not confirmed, then
score as not met.
Ind 39. A qualified individual applies defined criteria to transfer the patient from the
recovery area.
Survey Process:
Look first for the written criteria for discharge from the recovery area. Then while reviewing the
records as in Ind 38, determine if an anaesthetist or other qualified person with appropriate
training19 has done so.
Scoring:
If there is an observable documented process that ensures the safe transfer of post
anaesthetic patients, then score as fully met.
If the staff is unaware of criteria for the safe transfer of post anaesthetic patients, then score
as not met.
Ind 40. ALL adverse anaesthesia events are recorded and monitored.
Survey Process:
Ask for the report(s) of any anaesthesia related adverse events. Review the analysis and any
corrective action that is specified. If there have been no adverse events, which is unlikely unless
a new service, validate that there is a process to identify the event and to intensively analyze it,
including recommended corrective actions.
Scoring:
If there has been an adverse anaesthesia event and there is evidence of meaningful
evaluation and appropriate action if warranted, then score as fully met.
If there has been no adverse anaesthesia event but the survey team is comfortable that the
hospital has a process to identify such events and also has a process to analyze them, then
score as fully met.
If there was an anaesthetic related adverse occurrence and it was not either reported or
analyzed, or if there is no process to analyze an adverse event if it were to occur, then score
as not met.
19
This may include nurses who have received documented training
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Ind 42. Surgical patients have a pre-operative assessment and a provisional diagnosis
documented prior to surgery.
Survey Process:
Review a sample (10) of medical records of patients who underwent surgery to determine if a
pre-operative assessment (surgeon’s history and physical examination or pre-operative note) is
present and that a pre-operative provisional diagnosis was documented.
Scoring:
If there is a pre-operative history and physical examination or a pre-operative note by the
surgeon that includes a provisional pre-operative diagnosis, then score as fully met.
If there is a pre- operative history and physical examination or surgeon’s note, but no pre-
operative provisional diagnosis, then score as partially met.
If there is no pre- operative history and physical examination or surgeon’s note, then score
as not met.
Ind 43. An informed consent is obtained by a qualified medical member of the surgical
team prior to the procedure.
Survey Process:
Review the same 10 records to determine if an informed consent was obtained and documented
in the medical record. The informed consent must include evidence that the patient was
educated/informed. This is surveyed in the same way as policies and procedures guide for the
administration of anaesthesia.
Scoring:
If ALL the medical record documents an informed consent (a signed form or a note by the
physician, then score as fully met.
Since this is a significant medico-legal issue, if ANY record does not have documentation of
informed consent, then score as not met.
Ind 44. Documented policies and procedures exist to prevent adverse events like
wrong site, wrong patient and wrong surgery.
Survey Process:
This is a critically important patient safety issue. In at least 10 medical records of patients who
had surgery look for the following implemented and documented processes: marking of the
surgical site when there is the possibility of bilateral confusion, a pre-operative checklist to
ensure that ALL documents (X-rays, medical records, etc.) and needed equipment is available,
and a “time out” prior to induction of anaesthesia to ensure that ALL members of the surgical
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team are in agreement that this is the correct patient; this is the correct procedure for this
patient, and that this is (if relevant) the correct side.
Scoring:
If ALL 3 requirements (marking when relevant, use of a checklist, and a “time-out” recorded)
are used and documented in the medical record, then score as fully met.
If ANY of the three requirements are not documented in the medical record, then score as
not met.
Ind 45. Persons qualified by law are permitted to perform the procedures that they
are entitled to perform.
Survey Process:
The surveyors should look for documents that demonstrate a process to validate the
qualifications, experience and registration status of physicians to ensure that they are legally
permitted, and competent to perform specific procedures. The scope of clinical practice shall be
defined and documented for all surgeons and performance monitored through the recording of
adverse outcomes and peer review.
Scoring:
If there is a recognized process to validate that the physician is authorized (currently
registered) and competent (based on academic credentials, experience, training and internal
recognition) to perform the procedure he/she is conducting, then score as fully met.
If there is no process to validate the authorization or competence to perform the
procedure(s), then score as not met.
Ind 46. A brief operative note is documented by the surgeon or a doctor in the surgical
team prior to transferring the patient out of the recovery area.
Survey Process:
Review the same 10 medical records as noted for Ind 44. Determine if there is a documented
operative note that was recorded prior to the patient being transferred from the recovery area.
Also, while in the recovery area, review the medical records of patients who are about to be
transferred out of the recovery area to determine if an operative note is in the medical record.
Scoring:
If there is an operative note and it was documented in the medical record prior to transfer
from the recovery area, then score as fully met.
If there is either no operative note, or it was completed after the patient was transferred out
of the recovery area, then score as not met.
Ind 47. The operating surgeon or their surgical assistant20 documents the post-
operative plan of care.
Survey Process:
Review the 10 medical records as noted for Ind 44 and validate that the surgeon (or their
representative such as a surgical assistant) has written post-operative orders.
Scoring:
If there are post-operative orders, then score as fully met.
If there are no post-operative orders, then score as not met.
20
Medical practitioner directly involved with the surgical procedure
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Ind 48. A quality assurance program is followed for the surgical services.
Survey Process:
Review any documentation (such as minutes of a quality improvement committee or Surgical
Department meeting minutes or research projects) that demonstrates there are quality
indicators of surgical care that are being monitored.
Scoring:
If there is documented evidence that some aspects of the quality of surgical care are being
monitored, then score as fully met.
If there are aspects of surgical care that are being monitored, but they do not relate to the
quality of care, then score as partially met.
If there is no monitoring of surgical care, then score as not met.
Ind 49. The surgical quality assurance program includes surveillance of the operation
theatre environment.
Survey Process:
The following evidence should be reviewed: 1. Infection control surveillance, 2. Medical
equipment maintenance, and 3. Cleaning of the theatres between cases. The results of these
surveillance activities should be documented (perhaps tabled at the relevant committee
meetings and minuted).
Scoring:
If there is evidence that the safety and cleanliness of the operation theatre environment is
evaluated, then score as fully met.
If there is no surveillance of the operating theatre, then score as not met.
Ind 50. The plan also includes monitoring of surgical site infection rates.
Survey Process:
This should be found in the minutes of an Infection Control Committee. Specifically look for
evidence that the infection rates are physician, procedure, and room specific. (Global rates
without organizing the data into categories are of little use.) Determine the action that arises
from the reports and determine if this is able to influence the rate of infection.
Scoring:
If there is data about surgical site infections and it is segregated into individual physicians,
procedures, and rooms, with evidence that remedial management has been initiated, then
score as fully met.
If there is data about surgical site infections, but only in the aggregate without specific
analysis, then score as partially met.
If there is no data about surgical site infections, then score as not met.
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Scoring:
If there are policies for prescription/ordering of medications and the policy explicitly defines
what is done when the prescription or order is not clear, then score as fully met.
If there are policies for prescription/ordering of medication, but the policy does not define
what is to be done when the prescription/order is not clear, then score as partially met.
If there are no observable policies, then score as not met.
Ind 52. The organization formally determines who can write orders.
Survey Process:
There should be a policy that identifies practitioners who may write medication orders in the
medical record or on a prescription. However, determine if any other professionals (such as
midwives, anaesthetic nurses, emergency nurses, dentists, optometrists, podiatrists and
psychologists) are permitted to write prescriptions or order medication. The policy should
delineate which practitioners can prescribe restricted classes of drugs22.
Scoring:
If the clinical staff members are fully aware of who may write orders and this is supported by
evidence in the medication chart, then score as fully met.
If the survey team finds evidence that there is any confusion about who (which professionals)
is permitted to order or prescribe medication, then score as not met.
Ind 53. Orders are written in a uniform location in the medical records.
Survey Process:
While reviewing medical records determine if medication orders are uniformly written in the
same location in the record across the various wards in the establishment.
Scoring:
If ALL of the medication orders are in the specified area of the medical record, then score as
fully met.
Since this is a common source of “oversight” errors, if any orders are not in the designated
location, then score as not met.
21Example – contraindicated due to other drugs prescribed or allergy, adult dose for child or restricted;
wrong patient name or illegible
22
Example – chemotherapy or very expensive drugs or unlicensed drugs administered as part of a research
program
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Ind 54. Medication orders are clear, legible, dated, timed, named and signed.
Survey Process:
Determine what is done if a medication order is not legible. While reviewing medical records,
determine if ALL medication orders are legible, dated, timed, named, and signed. The score is
based on the cumulative findings of ALL the records reviewed.
Scoring:
If ALL orders are legible, dated, timed, named, and signed, then score as fully met.
If only 1-2 orders are not timed, then score as partially met.
If 3 or more orders are not legible, dated, timed, named, and signed, then score as not met.
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Ind 58. Documented policies and procedures guide the safe storage and dispensing of
medications.
Survey Process:
The policies should include at least: matching the order with the correct patient and medication,
confirming look alike drugs, and labelling.
Scoring:
If there are policies and procedures and evidence that they are implemented, then score as
fully met.
If there are policies and procedures, but implementation is inconsistent, then score as
partially met.
If there are no policies and procedures or if none have been implemented, then score as not
met.
Ind 60. Expiry dates are checked and documented prior to dispensing.
Survey Process:
This is best surveyed by observation. While on a patient unit, check a sample of medications for
their expiration date. Check the procedure where stock bottles are used to ensure that stock is
rotated.
Scoring:
If no expired medications are found, then score as fully met.
If there is any expired medication found, then score as not met.
23It is recognized that the establishment of appropriate systems may require a negotiated implementation
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Ind 63. Prepared medications are labelled prior to preparation of a second drug.
Survey Process:
Observe a nurse or an anaesthetist preparing medication. Verify that each medication is labelled
prior to preparing the next one.
Scoring:
If the survey team finds that all drugs were labelled prior to preparing subsequent
medications, then score as fully met.
If the survey team finds one or more violations of this requirement, then score as not met.
24For ALL patients the system employed must be permanently with the patient and fail-safe.
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Scoring:
If there is clear evidence that the order was checked for dose, then score as fully met.
If ANY example is seen of medication not being checked against the order, then score as not
met.
Ind 71. Policies and procedures govern patient's medications brought from outside the
organization.
Survey Process:
Review the policy and procedure. Usually this requires the pharmacy to verify specifically what
the medication is. Also, it is common that the hospital retains the medication but does not use
it during the patient’s stay in the hospital.
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Scoring:
If there is an implemented policy on medication brought from the outside, then score as fully
met.
If there is no policy or it is not implemented, then score as not met.
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Ind 72. General consent for treatment is obtained when the patient enters the
organization. Patient and/or their family members are informed of the scope
of such general consent.
Survey Process:
Review 10 medical records (this can be done simultaneously with review for other reasons).
Determine if ALL records document a general consent. Also determine if the content of the
general consent is made clear to the patient and/or family.
Scoring:
If ALL records have a documented general consent, then score as fully met.
Since this is a medico-legal issue, if ANY record does not have a general consent, then score
as not met.
Ind 73. The organization has listed those situations where specific informed consent is
required.
Survey Process:
Review any written policy or list. Then review 10 medical records of patients who should have
(by hospital policy) a specific informed consent to validate that it is documented in the record.
This would include consent related to procedures and therapies with particular concern for
anaesthesia, surgery, sterilization, termination of pregnancy and high-risk medications.
Scoring:
If ALL records document an informed consent, then score as fully met.
Since this is also a medico-legal issue, if ANY records do not document consent, then score
as not met.
Ind 74. Informed consent includes information on risks, benefits, and alternatives and
as to who will perform the requisite procedure in a language that they can
understand.
Survey Process:
This standard relates to the “informed” part of informed consent. Review the same 10 records
as for Ind 73 above to verify if the required information is included and documented.
Scoring:
If ALL records document informed consent, then score as fully met.
Since this is also a medico-legal issue, if ANY records do not document informed consent,
then score as not met.
Ind 75. The policy describes who can give consent when patient is incapable of
independent decision-making.
Survey Process:
Review the policy to determine who is identified as being able to give consent in addition to the
patient.
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Scoring:
If there is a policy describing who, other than the patient, may give informed consent, then
score as fully met.
If there is no policy, then score as not met.
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Ind 76. There is uniform pricing policy in a given setting (out-patient and ward
category).
Survey Process:
Visit the finance or billing office. Review the policy and verify that it is uniformly applied.
Scoring:
If the policy is uniformly applied, then score as fully met.
If the survey team finds evidence that it is not uniformly applied, then score as not met.
Ind 78. Patients and family are educated about the estimated costs of treatment.
Survey Process:
Review the process used to inform/educate the patient and/or family about the estimated costs.
Also determine if this is done by someone who is knowledgeable (surveyor judgment).
Scoring:
If there is a process to inform patients and/or families about the estimated costs and it is
done by a knowledgeable person, then score as fully met.
If there is a process to inform patients and/or families about the estimated costs but it is not
done by a knowledgeable person, then score as partially met.
If there is no process, then score as not met.
Ind 79. Patients and family are informed about the financial implications when there
is a change in the patient condition or treatment setting.
Survey Process:
Review the process. Determine what prompts the patient and/or family to be informed,
including who makes the decision and who provides the information.
Scoring:
If there is a consistent process, including when it is done, who makes the decision, and who
provides the information, then score as fully met.
If there is a process, but there are no clear guidelines of when it is done, then score as
partially met.
If there is no process, then score as not met.
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Ind 80. The organization informs the patient of his/her right to express his/her concern
or complain either verbally or in writing.
Survey Process:
Review the process and determine how policies are implemented.
Scoring:
If there are policies to handle appeals and the files substantiate dealing of the appeals
according to the policies, then score as fully met.
If there are policies to handle appeals but no record available how the policies are
implemented, then score as partially met.
If there is no appeal process, then score as not met.
Ind 81. There is a documented process for collecting, prioritizing, reporting and
investigating complaints, which is fair and timely.
Survey Process:
Review the process and determine through records how the policies are implemented.
Scoring:
If there are policies for collecting, prioritizing, reporting and investigating complaints and
records that the policies are implemented, then score as fully met.
If there are policies for collecting, prioritizing, reporting and investigating complaints but no
record available on how the policies are implemented, then score as partially met.
If no policies for collecting, prioritizing, reporting and investigating complaints, then score as
not met.
Ind 82. The organization informs the patient of the progress of the investigation at
regular intervals and informs about the outcome.
Survey Process:
Review the process and determine how the policies are implemented. Review files that include
all the elements associated with managing a complaint and demonstrate the progressive follow-
up with complainants.
Scoring:
If there are policies to inform the patients about the progress of the investigation and the
outcome, and records reflect that the policies are implemented, then score as fully met.
If there are policies to inform the patients about the progress of the investigation and about
the outcomes but no record available on how the policies are implemented, then score as
partially met.
If there are no policies to inform the patients about the progress of the investigation and
about the outcome, then score as not met.
Ind 83. The organization uses the results of complaints investigations as part of the
quality improvement process.
Survey Process:
Review the process and documentation. Identify and observe actual examples of policy and
procedure changes that have been made as a result of complaints analysis.
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Scoring:
If there is a quality improvement process to use complaint-handling data and reports are
available, then score as fully met.
If there is a quality improvement process to use complaint handling data and no evidence
available how that data was used for improvement, then score as partially met.
If no quality improvement process about using complaint-handling data, then score as not
met.
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Ind 87. The hospital has designated a qualified infection control nurse(s) for this
activity.
Survey Process:
Review the job description of the infection control nurse or nurses to determine the required
qualifications. Then review the human resource file for this individual(s) to validate if their
qualifications match the requirements of the job description.
Scoring:
If the qualifications of the individual(s) match the requirements in the job description, or if
there are only minor variances (such as a little less experience than noted in the job
description, then score as fully met.
This standard should be scored as not met with the agreement of the entire survey team, if
the job description and qualifications of the infection control personnel do not match.
Ind 88. The establishment has appropriate consumables, collection and handling
systems, equipment and facilities to manage the control of infection.
Survey Process:
Observe the clinical areas and check for the presence and use of hand washing facilities in ALL
care and treatment areas. Determine if there is 1. Hand washing soap/liquid, 2. Gloves, 3.Masks,
4. Sharps collection containers, 5. Single use syringes and 6. A full system of waste management
from the point of generation to the point of destruction. Adequate cleaning equipment and
appropriate consumables should be readily available and the staff trained to use it effectively.
Scoring:
If there are fully resourced hand-washing and sharps disposal facilities to service all care and
treatment areas, and trained cleaning staff with appropriate facilities, then score as fully met.
If there are fully resourced facilities, cleaning staff and facilities in some areas, then score as
partially met.
If there are areas without facilities or appropriate supplies of consumables, cleaning staff and
facilities, then score as not met.
Ind 89. ALL staff involved in the creation, handling and disposal of medical waste shall
receive regular training and ongoing education in the safe handling of medical
waste.
Survey Process:
Identify the staff that conduct training in infection control and review the training manual.
Speak with a range of staff involved with the generation, handling and management of medical
waste to determine their level of training and applied knowledge. This should include the
situation for temporary or short-term staff. The system employed by the healthcare
establishment should encompass the full process on site and include what happens once the
waste leaves the site. Adequate systems, facilities, safety equipment/consumables and training
should be observable.
Scoring:
If there is evidence that training takes place at induction, when new waste management
systems are introduced, or when new consumables or equipment are employed related to
medical waste, then score as fully met.
If training takes place when some of the above factors prevail, then score as partially met.
If no training takes places, then score as not met.
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Indicators (90-92):
Ind 91. Regular validation tests for sterilization are carried out and documented.
Survey Process:
This is an important patient safety issue. Review the process/procedure to validate that
complete sterilization has occurred. This should be uniformly done on each “batch” that is
sterilized. There are several methods that can be used (such as colour change strips). Whatever
method is used, it must be effective and documented. Observe that the date of sterilization and
expiry are clearly indicated on the packaging.
Scoring:
If there is a process/procedure to verify that complete sterilization has occurred, it is used
for ALL “batches” that are sterilized, and it is documented, and production and expiry dates
are indicated, then score as fully met.
If it is only done on a random sample, and dates are not fully indicated, then score as partially
met.
If there is no process/procedure, or if it is rarely (once a day) used, or if it is not documented,
or dates are not indicated, then score as not met.
Ind 92. There is an established recall procedure when breakdown in the sterilization
system is identified.
Survey Process:
Review any written recall procedure. If an actual breakdown had occurred, review how the recall
was implemented. Check to see if staff members receive training in the procedure.
Scoring:
If there is a written recall procedure that staff members are aware of, then score as fully met.
If there is no written procedure, then score as not met.
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Ind 96. The quality improvement programme is comprehensive and covers ALL the
major elements related to quality improvement and risk management.
Survey Process:
The definition of “comprehensive” and “ALL major elements” includes at least the following:
1.All departments participate, and 2. All high-risk areas (blood bank, laboratory, operating
theatres, emergency room, and equivalent) 3. Have documented quality improvement activities.
This requires some surveyor judgment.
Scoring:
Unless the survey team agrees that there are significant gaps in the programme’s coverage,
then this should default to a score of fully met.
Ind 97. The designated programme is communicated and coordinated amongst ALL
the employees of the organization through a proper training mechanism.
Survey Process:
There should be documented evidence that ALL the appropriate staff including a minimum of 1.
All the senior leaders, 2. All department heads, and 3. All members of the CQI committee have
participated in a formal process to ensure they fully understand the program. Interview staff
and ask to be shown examples of the impact of the CQI program.
Scoring:
If there is documented evidence of training of ALL the personnel listed above, then score as
fully met.
If only 1-2 department heads have not been trained, then score as partially met.
If there has been no training, or it has not included at least the senior leadership, the
committee members and “most” of the department heads, then score as not met.
Ind 98. The quality improvement programme is a continuous process and updated at
least once in a year.
Survey Process:
Review the documented evidence that the program has been reviewed at least once in the past
year or at the frequency defined in the hospital’s policy.
Scoring:
If there is documented evidence that the programme was reviewed at least once in the past
year, or more frequently if required by hospital policy, then score as fully met.
If there has been no review or if the review is more than one year ago, then score as not met.
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Ind 100. Monitoring includes safety and quality control programmes of the diagnostic
services.
Survey Process:
Review the documentation in the committee minutes. Check these and the diagnostic service
locations to observe the following: 1. Documented Standard Operating Procedures (SOPs),
2.Documented training of staff in SOPs and Occupational Health and Safety (OH&S), 3.Reference
testing to ensure validity, 4. External audit of facilities, procedures and protocols, 5.
Documented occupational health and safety protocols and 6. Documented staff training.
Scoring:
If there is documented evidence that these factors are present and related activities are
being monitored and reflected in the minutes of the CQI program, then score as fully met.
If not, then score as not met.
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26Integrated
notes involve all careers writing sequentially in the progress notes so that doctors’ nurses
and paramedics all write in the same section of the notes.
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Ind 107. Sentinel events are intensively analyzed when they occur.
Survey Process:
Ask for any documentation of intense analysis of any sentinel event that has occurred in the
past 12 months. (It is highly unlikely that none have occurred. If none were reported, the
surveyors should explore the reporting process). Determine the corrective actions taken as a
result of the analysis such as a change in policy and operating procedures and training for staff.
Scoring:
If there was a reported sentinel event and it was intensively analyzed, including corrective
action to prevent or reduce the likelihood of reoccurrence, then score as fully met.
If no sentinel event was reported, but the survey team is comfortable that if one occurred it
would be reported and analyzed, then also score as fully met.
If there was a sentinel event, but there was either no analysis or the analysis was “superficial”
such as limited to assigning blame to an individual, then score as not met.
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Ind 109. Those responsible for governance lay down the strategic and operational
plans.
Survey Process:
Review the strategic and operational plans. Verify if the plans are commensurate with the
hospital’s mission and that resources support them. Check to see if staff members are aware of
the plans and know where they can access a copy.
Scoring:
If there are both strategic and operational plans and they are in accord with the hospital’s
mission and adequately supported by the senior management, then score as fully met.
If there is a strategic plan but no operational plans yet to define how the strategy will be
implemented, then score as partially met.
If there is no strategic plan, then score as not met.
Ind 110. Those responsible for governance approve the organization's budget and
allocate the resources required to meet the organization's mission.
Survey Process:
Review the budget formulation process. Determine by review of the budget how it is approved
and if it adequately supports the mission with resources.
Scoring:
If there is a budget process and a clear process for its approval and it supports the
organization’s mission, then score as fully met.
If there is no budget process (i.e., it is just handed down from “on high”), then score as not
met.
Ind 111. Those responsible for governance monitor and measure the performance of
the organization against the stated mission.
Survey Process:
Review any documentation (such as meetings of the governing body or the senior leadership of
the hospital). There should be objective measures/indicators that allow monitoring of progress
toward meeting the hospital’s strategic objectives that support its mission.
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Scoring:
If there is documentation of monitoring of the progress toward the hospitals strategic and
operational goals, then score as fully met.
If there is no documentation, then score as not met.
Ind 112. Those responsible for governance establish the organization's organogram.
Survey Process:
Review the organizational chart that defines the hospital's organizational structure.
Scoring:
If there is an organizational chart (“organogram”), then score as fully met.
If there is none, then score as not met.
Ind 113. Those responsible for governance appoint the senior leaders in the
organization.
Survey Process:
Review the process for appointment of the hospital’s senior leaders. It must support the
appointment of the most appropriate people for all positions in terms of credentials and
experience.
Scoring:
If there is a clearly defined process for appointment of the hospital’s senior leaders, then
score as fully met.
If the process is limited to only the hospital director, then score as partially met.
If there is no formal process, then score as not met.
Ind 114. Those responsible for governance support research activities and quality
improvement plans.
Survey Process:
All research must be formally approved by the hospital. Review any reports to the governing
body that document the results of the CQI program or research activities (including the process
for approving the research protocols). Ideally, there should be evidence that the governing body
asks for more information or directs actions.
Scoring:
If there is documented evidence that the governing body receives reports about research
activities (if applicable) and CQI activities, then score as fully met.
If there is research of any kind underway and no documented evidence to support this has
been received by the governing body, then score as not met.
Ind 115. The organization complies with the laid down and applicable legislations and
regulations.
Survey Process:
The surveyors should be aware of the applicable laws and regulations that relate to hospitals in
Punjab27. Ask to view the laws and regulations that apply and determine if appropriate staff
members are aware of the legal and regulatory obligations for the hospital.
Scoring:
Unless the survey team agrees that there are significant deficiencies in compliance with laws
and regulations, then score as fully met.
27
Related to finance, building and safety codes, business practice and so forth.
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Ind 116. Those responsible for governance address the organization's social and
community responsibilities.
Survey Process:
Look for documents that demonstrate the hospital has evaluated its community’s healthcare
needs. Also look for any “out-reach” activities, such as cancer or hypertension screening or
home based care.
Scoring:
Unless the survey team agrees that there is insufficient evidence that the hospital is sensitive
to the needs of the community it serves, then score as fully met.
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28
This would be tertiary qualifications in the field of management plus considerable experience and
continuous professional development in the field of hospital management. A doctor with extensive
medical CV and no management credentials would not be considered qualified to run a major hospital.
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Ind 119. The management regularly updates any amendments in the prevailing laws
of the land.
Survey Process:
Directly observe evidence of routinely updated laws and regulations.
Scoring:
If there is evidence of a process to identify and acknowledge changes in laws and regulations,
then score as fully met.
If there is no evidence of an update process, then score as not met.
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Scoring:
If there is a full range of current compliance documents, then score as fully met.
If there is a full range of compliance documents however some are not current, then score
as partially met.
If there is incomplete range of compliance documents, then score as not met.
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Standard 22. FMS-2: The organization has a program for clinical and
support service equipment management
Indicators (122-125):
Ind 122. The organization plans for equipment in accordance with its services and
strategic plan.
Survey Process:
Review any written plan that includes at least: 1. Acquisition, 2. Testing, 3. Planned preventive
maintenance of medical equipment, and 4. An inventory of ALL medical equipment in the
hospital that includes evidence of a formal disposal (write-off) process. While visiting patient
care areas, identify 5 pieces of medical equipment. Then ask for documentation that the
equipment is listed on the hospital’s inventory and that scheduled preventive maintenance has
been done on time. Check with the maintenance staff that they have the required training,
service manuals and required tools, parts and consumables to deliver the required preventive
maintenance and servicing regime. Check for valid sub-contracts to service equipment that is
beyond the scope of in-house engineers. Confirm that there is an adequate budget to support
implementation of the full maintenance plan.
Scoring:
If there is a plan (and evidence that it is resourced and being implemented), then score as
fully met.
If there is a plan but it does not include the requirement for testing prior to use, or there are
inadequate skills and resources for implementation, then score as partially met.
If there is no medical equipment plan or if it does not include the requirement for preventive
maintenance or if there is no inventory of medical equipment, then score as not met.
Ind 123. Equipment is selected by a collaborative process.
Survey Process:
Review the process for assessing needs and prioritizing the requests for new or replacement
medical equipment. There should be evidence that the appropriate department heads and ‘end-
users’ participate in determining the best options and procurement priorities. There should
preferably be a dedicated team appointed with senior membership from the clinical, financial,
engineering and management departments.
Scoring:
If there is a prioritized process for requesting new or replacement medical equipment and
there is input from the appropriate department heads, then score as fully met.
If there is a process, but no “meaningful” (surveyor judgment) input from the appropriate
department heads, then score as partially met.
If there is no process, or if the decision is left to a single individual, then score as not met.
Ind 124. Qualified and trained personnel operate and maintain29 the equipment.
Survey Process:
To determine if appropriate personnel operate the equipment correctly, look for documented
training and any data (in the medical equipment department) that identifies “user error”30. Also
review the job description of medical equipment maintenance personnel and their human
resources file to verify that they have the required qualifications, knowledge and experience.
29Servicing and planned preventive maintenance can be outsourced to appropriately qualified technicians
if required – or a combination of in-house and outsourced maintenance and servicing would be fine
30
Equipment failures due to incorrect use is common in hospitals
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Scoring:
If staff are adequately qualified and experienced and trained for all equipment within the
scope of their ability and other equipment is serviced by reputable contractors, then score
as fully met.
If there is evidence of a system of planned preventive maintenance but concerns with the
ability of the staff and service contractors, then score as partially met.
If there are inadequately qualified staff or sub-contractors, then score as not met.
Ind 125. Equipment is periodically inspected, serviced and calibrated to ensure their
proper function. There is a documented operational and maintenance
(preventive breakdown and replacement) plan.
Survey Process:
There should be a written schedule that is based at least on manufacturer’s recommendations.
The inspection, calibration (if needed), and maintenance must be documented. The surveyors
should review this documentation.
Scoring:
If ALL the requirements for this standard are documented, then score as fully met.
Since this is a significant patient safety issue, if any of the requirements are not documented,
then score as not met.
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Standard 23. FMS-3: The organization has plans for fire and non-fire
emergencies within the facilities.
Indicators (126-129):
Ind 126. The organization has plans and provisions for 1. Early detection,
2.Containment and 3. Abatement of fire and non-fire emergencies.
Survey Process:
Review the plan to ensure that it addresses ALL 3 requirements. Then, by observation, review
of documentation and interview, determine if ALL the requirements have been implemented31.
Scoring:
If the plan includes ALL 3 requirements and there is evidence that ALL are implemented, then
score as fully met.
Since this is such an important patient safety issue, if any of the requirements are not
included in the plan, or if any are not clearly implemented, then score as not met.
Ind 127. The organization has a documented safe exit (evacuation) plan in case of fire
and non-fire emergencies.
Survey Process:
Review the “evacuation” plan. There should also be documented evidence that the plan has
been tested. It is not necessary that the hospital has actually evacuated patients, but at least
has conducted a “mock” evacuation to verify that the plan would work in an actual emergency.
Since it is unlikely that the entire hospital must be evacuated, “mock” drills can be conducted
for a single area or department. However, the plan should clearly define a “whole hospital”
evacuation (as in an earthquake) plan, including defined alternate sites for the patients and how
to transport them. This should be included in the induction program for new staff. The plan
should be readily available and visible.
Scoring:
If there is a written facility evacuation plan, staff is aware of and trained in its use and it has
been tested, then score as fully met.
If there is a written evacuation plan but it has not yet been tested, then score as partially
met.
If there is no plan, then score as not met.
Ind 129. Staff members are trained for their role in case of such emergencies.
Survey Process:
Look for documentation of the training. The training should include at least key personnel from
every area. They should be able to demonstrate awareness of their own role and the role of
others.
31A threat matrix employed by SKMT is available at the PHC website as an example of industry standard
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Scoring:
If there is documented evidence of training of key personnel in every area, then score as fully
met.
If only a few (approximately 5) key personnel (surveyor judgment) have not yet been trained,
then score as partially met.
If there has been no training or if more than 5-10 key personnel (surveyor judgment) have
not been trained, then score as not met.
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Ind 131. Each staff member is made aware of hospital wide policies and procedures as
well as relevant department/unit/service/program policies and procedures.
Survey Process:
This would be part of the hospital wide and departmental orientation as in Ind 130 and will be
surveyed and then scored as for that standard. Observe the orientation program and evidence
of its implementation.
Scoring:
If there is documented evidence that all staff have participated in an orientation process that
includes induction to the policies and procedures for their work area, then score as fully met.
If there is an adequate orientation program and at least 80% of staff has been inducted, then
score as partially met.
If there is an absence of an orientation program or less than 80% of the staff has been
involved in an orientation and induction program, then score as not met.
Ind 132. Each staff member is made aware of his/her rights and responsibilities.
Survey Process:
This standard would require that each staff member have a written job description that defines
his or her responsibilities. The staff member’s rights should be detailed in the human resources
employee manual or other documentation that is shared with the staff member.
Scoring:
If each staff member has a written job description and there is a document shared with the
individual that defines their rights, then score as fully met.
If every staff member does not have a written job description or if there is no formal way to
let the member know of their rights, then score as not met.
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Ind 133. ALL employees are educated with regard to patients' rights and
responsibilities.
Survey Process:
If this is not part of the general hospital orientation, there should be other documentation of
how ALL employees are educated about patient rights and responsibilities.
Scoring:
If there is documented evidence that all employees have been so educated, then score as
fully met.
If only direct caregivers have been educated, then score as partially met.
If there is no evidence that this education has been given, then score as not met.
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Ind 135. The employees are made aware of the system of performance appraisal at
the time of induction.
Survey Process:
This should be part of the initial orientation and there should be documented evidence (such as
the employee’s signature on the job description) that confirms the employee understood how
they were to be evaluated.
Scoring:
If there is a clear system/process for the employee to understand how their performance will
be evaluated, then score as fully met.
If there is no system/process, then score as not met.
Ind 136. The appraisal system is used as a tool for further development.
Survey Process:
There should be documented evidence (when appropriate to the employee’s appraisal) that the
appraisal system is used as a tool for further development (such as more experience, more
training, a different job assignment). This may not be required for every appraisal – only if the
appraisal indicated the need.
Scoring:
When appropriate the appraisal indicates the need for further development and this is
documented, then score as fully met.
If the appraisal indicates the need for further development (surveyor judgment), but there is
no documentation of this, then score as not met.
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It is common that a hospital has a schedule for periodic appraisals, but inconsistently follows it.
Select a sample (10-15) human resources files and determine if there was a documented
periodic appraisal and if it was done “on time”.
Scoring:
If the hospital has defined the frequency of employee appraisal and there is documentation
that greater than 90 percent of employees have received timely appraisals, then score as
fully met.
If the hospital has defined the frequency of employee appraisal, but the documentation
shows that only between 75 and 90 percent of employees had their appraisal on time, then
scores partially met.
If either the hospital does not have a schedule for periodic employee appraisal or if less than
75 percent of the employees received their appraisal “on time”, then score as not met.
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Ind 139. The personnel files contain personal information regarding the employee’s
qualification, disciplinary background and health status.
Survey Process:
Review the same files as for Ind 138.
Scoring:
If ALL reviewed files have documented information regarding the employee’s qualification,
disciplinary background and health status, then score as fully met.
If any do not contain ALL the required information, then score as not met.
Ind 140. ALL records of in-service training and education are contained in the personnel
files.
Survey Process:
Review the same files as for indicator Ind 138.
Scoring:
If ALL the reviewed files contain documentation of in-service education (when relevant to
the individual – surveyor judgment) and the employee’s education, then score as fully met.
If any file does not document relevant in-service training (surveyor judgment), or does not
document the employee’s education, then score as not met.
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Ind 145. Organization policy identifies those authorized to make entries in the medical
record.
Survey Process:
Review any policy and then during review of medical records for any of the previous reasons for
review, confirm that only authorized individuals have made entries into the medical record.
Scoring:
If ALL entries are by authorized persons, then score as fully met.
If there are any entries by unauthorized persons, then score not met.
32
An alpha/numeric system that gives each patient their own code number
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Ind 148. The record provides an up-to-date and chronological account of patient care.
Survey Process:
Review the record to determine if the record adequately records the care and treatment
pathway for all patients. Check the systems of records storage to ensure they are in good order
and stored for a period in compliance with the statute of limitations33.
Scoring:
This should default to a score of fully met unless the survey team identifies significant
deficiencies in the medical records.
33
The Limitation Act 1908 requires records be stored for 12 years. Some hospitals in Pakistan have
electronically stored records with capacity for analytical reporting and research.
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Indicators (149-155):
Ind 149. The medical record contains information regarding reasons for admission,
diagnosis and plan of care.
Survey Process:
Review 10 medical records (they can be the same record as for previous Indicators) to determine
if the reason for 1. Admission, 2. The presumptive diagnosis, and 3. The plan of care is
documented. This is then scored on the cumulative findings for ALL the records reviewed.
Scoring:
If ALL the required 3 elements above are documented in ALL the records, then score as fully
met.
If any of the 3 is missing in any record, then score as not met.
Ind 150. Operative and other procedures performed are incorporated in the medical
record.
Survey Process:
Review 10 records of patients who underwent surgery or an invasive procedure to verify that
the record documents the procedure. The documentation should include at least: 1. The name
of the service provider, 2. The procedure undertaken, 3. The findings, 4. Any specimens
removed, and 5. The patient’s condition at the conclusion of the surgery/procedure.
Scoring:
If ALL medical records have documentation of the above 5 requirements of the
surgery/procedure, then score as fully met.
If ANY medical records do not have ALL the 5 requirements documented, then score as not
met.
Ind 151. When a patient is transferred to another hospital, the medical record contains
the date of transfer, the reason for the transfer and the name of the
receiving hospital.
Survey Process:
Ask for the medical record of 3 or more patients who were transferred to another hospital.
Check the forwarded information to determine if it includes the results of any diagnostic
investigations and any treatments rendered prior to transfer and the clinical status of the
patient.
Scoring:
If the medical record documents the date of transfer, the reason for transfer, and the name
of the receiving hospital, then score as fully met.
If the medical record fails to document any of these 3 requirements, then score as not met.
Ind 152. The medical record contains a copy of the discharge note duly signed by
appropriate and qualified personnel.
Survey Process:
Review 10 medical records of discharged patients. The discharge summary should include at
least the following: 1. The reason for admission, 2. Significant diagnostic investigation results, 3.
Any procedures or other treatments, 4. The patient’s response to treatment, 5. Any discharge
medications, and 6. Follow-up instructions.
Scoring:
If ALL discharge summaries include ALL the 6 requirements above, then score as fully met.
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Since this is a significant continuity of care issue, if ANY discharge summary does not include
ALL the 6 requirements, then score as not met.
Ind 153. In the case of death, the medical record contains a copy of the death
certificate indicating the cause, date and time of death.
Survey Process:
Ask for 2-3 records of patients who have died. Review these records to verify that they contain
a copy of the death certificate that includes the cause, date and time of death.
Scoring:
If ALL death records include the cause, date and time of death, then score as fully met.
If any do not include ALL the requirements (cause, date and time of death), then score as not
met.
Ind 154. Whenever a clinical autopsy is carried out, the medical record contains a copy
of the report of the same.
Survey Process:
Ask for 2-4 medical records of patients who had an autopsy, verify that the final report is in the
medical record.
Scoring:
If ALL the reviewed medical records contain the final autopsy report, then score as fully met.
If any do not have the final report, then score as not met.
Ind 155. Care providers have access to current and past medical records.
Survey Process:
Request the names of 5 patients who were previously discharged. Then request that these
records be brought to the surveyor.
Scoring:
If ALL the requested records are available (brought to the surveyor), then score as fully met.
If only 4 of the 5 are available, then score as partially met.
If only 3 are available, then score as not met.
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Ind 157. The review uses a representative sample based on statistical principles.
Survey Process:
Check the documentation of the review to determine if the sample was reflective of the
hospital’s services and staff. There should be evidence that the hospital defined the sample size.
Scoring:
If there is evidence that a representative sample (covering the scope of the hospital’s services
and its staff) is reviewed, then score as fully met.
If in the collective opinion of the survey team the sample is not statistically representative,
then score as partially met.
If there is no review, then score as not met.
Ind 158. The review is conducted by identified care providers and health professionals.
Survey Process:
Look for documented evidence that the review was conducted by professionals from disciplines
that are authorized to make entries into the medical record. The review should not be done only
by medical records personnel.
Scoring:
If there is documented evidence that the review was done by members of disciplines that
are authorized to make entries into the medical record, then score as fully met.
If the review does not include representatives of ALL disciplines who are authorized to make
entries into the medical record, then score as partially met.
If the review is done only by medical records personnel, then score as not met.
Ind 159. The review focuses on the timeliness, legibility and completeness of the
medical records.
Survey Process:
Analyze documentation of the review to verify that it includes timeliness, legibility and
completeness of the medical records.
Scoring:
If the documentation of the review demonstrates evidence of review of timeliness, legibility
and completeness of the medical records, then score as fully met.
If the review process does not include ALL of timeliness, legibility and completeness, then
score as not met.
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Ind 160. The review process includes records of both active (current) and discharged
patients.
Survey Process:
Consider the documentation of the review process to verify that both “open” and “closed”
records were included. An “open” record is that of a patient currently hospitalized. A “closed”
record is of a patient who has been discharged.
Scoring:
If the review includes both “open” and “closed” records, then score as fully met.
If the review does not include both “open” and “closed” records, then score as not met.
Ind 161. The review identifies, and documents any deficiencies in the record.
Survey Process:
Review the minutes or other documents that demonstrate the findings of the review, including
deficiencies found. It is highly unlikely that the hospital’s review has not identified any problems
with medical record documentation.
Scoring:
If the documentation includes identification of any deficiencies, then score as fully met.
If not, then score as not met.
Ind 162. Appropriate corrective and preventive measures undertaken are documented.
Survey Process:
Review the minutes to confirm the response to deficiencies.
Scoring:
If the minutes document corrective action when indicated (surveyor judgment), then score
as fully met.
If not, then score as not met.
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Acknowledgments
Our special thanks go to the members of the Core Group who were consulted for Pakistan’s
National Accreditation Indicators for Hospitals Phase 1, April 2009. These included:
1. Dr. Haroon R. Khan, Pakistan Institute of Medical Sciences, Islamabad - Chairman
2. Dr. Sayed Mairajuddin Shah, Aga Khan University, Karachi.
3. Dr. Faisal Sultan, Shaukat Khanum Memorial Cancer Hospital & Research Centre, Lahore.
4. Dr. S.M. Sabeeh, National University of Sciences and Technology, Islamabad.
5. Mr. Ateeq-ur-Rehman Memon, Pakistan National Accreditation Council
6. Dr. M. Javaid Khan GTZ, Peshawar
7. Expert Advisor: Dr Thomas E. Schwark (formerly of JCAH, JCI and Abt. Associates)
We would also like to thank the Secretary Health, Government of the Punjab and the Project
Director, Punjab Health Sector Reforms Unit and their teams for their continued support. Special
thanks go to the medical professionals from public and private sectors who took the time to
participate in the workshops, FGDs and seminars and remained engaged with us since January
2011 in the process of the setting up of PHC and preparation of MSDS.
Consideration and endorsement of the MSDS by the Technical advisory Committee of the PHC
added to the value of the document and contributed to its release.
PHC acknowledges the valuable contribution to the MSDS from review and adaption of
standards from JCI, Australia, New Zealand, India, UK and Canada. Lastly the PHC thanks the
team of TAMA consultants, led by Mr. Lindsay Sales (Clinical Governance Expert) and the Core
Group for their work in developing these standards for Punjab.
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