GUIDELINES FOR DEVELOPMENT OF POLICIES / SOPs
/ PROCESSESOFCRITICAL PATIENT SAFETY AREAS (CPSA)
Directorate of
Licensing and Accreditation
Punjab Healthcare Commission
February 2022
Table of Contents
Contents
CPSA 1: Qualified Human Resource as per declared scope of
services
CPSA 1.b: Staff List including qualified doctors/ consultant/specialist
CPSA 1.c: Qualified doctors providing 24/7 medical coverage
CPSA 2.A: Guidelines to Develop Emergency SOPs
2. A.6 Patient assessment
and care
2. A.8 Clinical laboratory
and radiology Services
2. A.9 Operating/ Procedure
room
2. A.10 Special care units
(ICU/ CCU)
2. A.12 Continuous
training of the ER staff
2. A.13 Management of
medico legal cases
2. A.15Patient transfer
from emergency department to inpatient areas or to another organization
CPSA 2.B: Emergency Management Clinical Protocols/ guidelines
CPSA 2.C: List of Emergency Equipment
CPSA .3: Safe Blood
Transfusion Services
Guidelines to develop these SOPs
CPSA 3.A: Policies and procedures for handling, use and administration of blood
and blood products
CPSA 3.B: PBTA registration/License
CPSA 4: Hospital Infection
Control
Guidelines to develop these SOPs
CPSA 4.A Hospital
Infection Control (IC) Plan
CPSA 4.B: Notification
of HIC Committee
CPSA 4. C Written Process for Sterilization Validation
CPSA 5: Operation Theater
Surveillance
Guidelines to develop these SOPs
CPSA 6: Fire & Non
Fire Emergencies
Guidelines to develop these SOPs
CPSA 6. A Fire & Non Fire Emergency Plan
CPSA 6. B Documented Safe Exit Plan
CPSA 7: Hospital Waste
Management
Guidelines to develop these SOPs
CPSA 7. A Hospital
Waste Management Plan
CPSA 7. B Notification of HWM Committee
CPSA 7. C MOU for Hospital Waste Disposal, if
disposal is not in house
Guidelines to develop these SOPs
CPSA 8.A Documented SOPs
for Surgical Procedures
Guidelines to develop these SOPs
CPSA 9.A Documented SOPs for Administration of Anesthesia
CPSA 10: Management of
Medication
Guidelines for developing these SOPs
CPSA 10.A Documented
SOPs for Prescription
CPSA 10.B Documented
policy on verbal orders
CPSA 10.B Documented
Process for Safety of High Risk Medications
CPSA 11: Continuous
Quality Improvement
Guidelines to develop these SOPs
CPSA 11.A Continuous Quality Improvement plan
Outline of the CQI Program
/ Plan:
Continues Quality Improvement
Plan
CPSA 11.A Defined set of Sentinel Events
Guidelines for developing these policies
CPSA 12.A Documented Process for Patient Unique Identification
CPSA 12.B Medical Record Policy
CPSA 13: Complaint
Management System
Guidelines to develop the complaint management system
CPSA 13.A Documented Complaint Management System
Guidelines to develop LAB manual
CPSA 14.B Imaging-PNRA license
Guidelines to develop back power supply policy / mechanism
CPSA 16. Proper medical
gas supply system
Guidelines to develop Proper Medical Gas Supply System / Policy
Introduction:
The Punjab Healthcare Commission (PHC), established
under the Punjab Healthcare Commission Act 2010, has been mandated to regulate
the quality of healthcare service delivery in the province. In this regard, the
Commission Registers Healthcare Service Provers of the Healthcare
Establishments (HCEs), sets Minimum Service Delivery Standards (MSDS) and
issues licenses to HCEs on the basis of implementation of these standards.
Under Section 16 of the PHC Act, 2010, it is mandatory
upon a Healthcare Establishment to obtain License from the Punjab Healthcare
Commission.Upon receipt of an application for license, complete in all respects
including Licensing fee and required documents, the HCE is issued a provisional
license. Regular license is issued on the basis of successful implementation of
relevant MSDS, assessed by the PHC Team, and approved by the BOC of the
Commission.
In order to ensure the patient safety, until the HCE
successfully implements the MSDS, the Commission issued a Directive vide No.
PHC/CEO/2021/103 dated 06-01-2022 making it mandatory for the hospitals to
submit documentary evidence of adequate arrangements in the below given Critical
Patient Safety Areas (CPSA), to obtain and retain provisional licensing (PL)
status.
1. Qualified Human Resource
as per declared scope of services
a.
List of Services
b.
Staff List including qualified doctors/
consultant/specialists
2. Emergency Services
a.
Emergency SOPs
b.
Emergency Management Protocols/
guidelines
c.
List of Emergency Equipment
3. Safe Blood Transfusion
Services
a.
Policies and procedures for handling
use and administration of blood and blood products
b. PBTA registration/License
4. Hospital Infection Control
a.
Hospital Infection Control Plan
b.
Notification of HIC Committee
c.
Written Process for Sterilization
Validation
5. Operation Theater
Surveillance
a.
External OT Swab Culture Report
6. Fire & Non Fire
Emergencies
a.
Fire & Non Fire Emergency Plan
b. Documented Safe
Exit Plan
7. Hospital Waste Management
a.
Hospital Waste Management Plan
b.
Notification of HWM Committee
c. MOU for Hospital Waste Disposal or
in-house arrangements
8. Surgical Services
a.
Documented SOPs for Surgical Procedures
b.
Documented policies to prevent adverse
events like wrong site, wrong patient and wrong surgery
9. Anesthesia Services
a. Documented SOPs
for Administration of Anesthesia
10. Management of Medication
a.
Documented SOPs for Prescription
b.
Documented policy on verbal orders
c.
Documented Process for Safety of High Risk Medications
11. Continuous Quality
Improvement
a.
Continuous Quality Improvement plan
b.
Designated CQI Focal Person
c.
Defined set of Sentinel Events
12. Medical Records
a.
Documented Process for Patient Unique
Identification
b.
Medical Record Policy
13. Complaint Management
System
a. Documented
Complaint Management System
14. Diagnostic Services
a.
Lab-Manual
b. Imaging-PNRA
license
15. Backup Power supply
a.
Backup Power Supply plan for all
patient areas, OTs and Life Support System
16. Proper medical gas supply system
a.
Documented arrangements for
uninterrupted supply of Medical Gases
These guidelines have been developed to facilitate the
hospitals to formulate the required policies / SOPs / processes. These
guidelines may be used by the hospitals to develop and implement policies /
SOPs regarding above mentioned CPSAs, depending upon the size of scope of
services, to ensure patient safety.
The hospitals are required to submit the documentary
evidence in support of fulfilment of CPSAs to obtain and retain the PL status. For
efficient two-way communication a web based system which is already in place
should be used. Alink namely CPSA has been provided in the HCE web portal to
upload the documents. The HCE will place the soft / scanned copies of required
documents against each relevant area. The HCE also has to submit the duly
signed, checklist (Annexure-A) for
submission of required documents in support of fulfilment of CPSAs. Please
note no hard copies of above required documents will be accepted. All those
hospitals which have not yet created their login on HCE web portal are urged to
create their login by following the below given steps:
1. Go
to https://webportal.phc.org.pk
2. Click
on Signup as new
3. Fill
in the required information in the displayed form
4. Press
Submit (Verification email shall be sent by PHC with login / password after
necessary verifications)
5. Login
to the web portal and go to CPSA Link and upload the required documents.
CPSA 1: Qualified Human Resource as per declared scope
of services
A hospital's medical staff, the physicians and dentists licensed to practice medicine and prescribe medications, plays a critical role in assuring quality care and improving patients' outcomes in the hospital. The availability of the medical staff should be in line with the type of services any hospital is providing. Following information is required to be submitted in prescribed manner.
CPSA 1.a: Services
List
CPSA 1.b: Staff
List including qualified doctors/ consultant/specialist
Provide the list of services being provided at the hospital with particulars of qualified consultants and specialists in the below given format:
Table-1:Services wise Consultants / specialists list
|
Healthcare
services |
Particulars of
consultant/ specialist providing these services |
|||||||
|
Name |
Qualification |
Specialty |
PMC Reg. number # |
Days at HCE (from…. To….) |
Timings at HCE (from…. To….) |
Cell # |
Email Add |
|
|
|
|
|
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CPSA 1.c: Qualified doctors providing 24/7 medical coverage
Provide the list of qualified doctors providing 24/7 medical
coverage at the hospital as per below format:
Table-1: List of Doctors providing 24/7 medical coverage
|
Name |
Qualification |
PMC Reg. # |
Cell # |
Days at HCE (from…. To….) |
Timings at HCE (from…. To….) |
Email Add |
|
|
|
|
|
|
|
|
CPSA 2: Emergency Services
Emergency Care is an essential part of the health system and serves as the first point of contact for many patients.
Documents to be submitted:
A.
SOPs for services in Emergency Room
B.
Emergency Management Clinical Protocols/ guidelines
C.
List of Emergency Equipment
D.
Written report of training of staff on these SOPs
CPSA 2.A: Guidelines
to Develop Emergency SOPs
The Emergency Room SOPs may include but not limited to the
followings:
2. A.1
Introduction:
An introductory paragraph containing total number of emergency beds, the
emergencies being taken like medical, surgical, cardiac, obstetric, pediatric, trauma etc. or only
first aid and average daily patient load in the emergency department.
2. A.2
Emergency Department Staff
The emergency staffing SOPs may contain but not
limited to the following areas:
§ 24/7 coverage of appropriately qualified and trained medical and nursing staff, with consultant’s support
§ ER medical and nursing staff trained on Advanced Trauma Life Support, Advance Cardiac Life Support, Trauma Nursing Care, Pediatrics Advanced Life Support
2. A.3
Admission/ Registration
The emergency admission / registration SOPs may
cover but not limited to the following areas:
§ Registration area
§ Registration staff
§ Acceptance criteria
§ Waiting time for registration
§ Information required
§ Record keeping
§ Registration process time
§ Unique identification of patients
2. A.4 Triage Policy
The triage SOPs may contain but not limited to the
following areas:
§ A process to identify patients with urgent or emergent care needs
§ Persons authorized to assign the priorities
2. A.5Initialscreening exam
Initial screening exam policy may contain but not
limited to the following areas:
§ Initial screening exam includes i) vital signs, ii) medical history iii) physical examination
§ Staff involved in initial screening examination of the patient presenting to the ER
§ Time from arrival of patient, within which initial screen exam will be done
§ Treatment plan or referral based on findings
§ Recording of the findings
2. A.6Patient assessment and care
Patient assessment policy includes but not limited
to the following areas:
§ Assessment must include patients’ medical, physical, psychological, and treatment plan accordingly
§ The A-E principle (airway, breathing, circulation, disability, and exposure)
§ Observing vital signs, and listening to the patient’s perceived symptoms of illness or injury
§ Ongoing patient assessment
§ Frequency and timing of ongoing patient’s assessment based on patient condition and needs
§ Clinical practice guidelines are available with clinical staff.
2. A.7Consent
The consent policy may contain but not limited to
the following areas:
§ Criteria for general and specific consent
§ Conditions for providing treatment without consent
§ Criteria for verbal and written consent
§ Contents of the general and specific consent
§ List of procedures requiring written consent
§ Patient consent form and medical record
2. A.8Clinical laboratory and radiology Services
The policy may contain but not limited to the
following areas:
§ Clinical Lab and Radiology services are available within emergency, hospital or outside hospital
§ Time frame for availability of Lab and Radiology results
§ A process to provide all investigations that are essential but not available
§ MOU for outsourced Lab and radiology services
§ Collection, storage and transportation of samples
2. A.9Operating/ Procedure room
The policy may contain but not limited to the
following areas:
§ OT/ procedure room available within ER or hospital OT is used
§ How to make requisition for OT
§ Responsibility of OT and equipment sterilization
§ Procedures record
§ Recovery area
§ Post operations stay
2. A.10Special care units (ICU/ CCU)
The policy may contain but not limited to the
following areas:
§ Special care units, including ICU/ CCU facilities available within ER or hospital
§ If not available within hospital, how to handle the patients requiring these facilities
§ Referral mechanism
§ Transport mechanism
§ Follow up
§ Medical record
2. A.11Patient discharge
The patient discharge policy may contain but not
limited to the following areas:
§ Written discharge criteria/ instructions
§ Information to be recorded in discharge slip
§ Staff responsible to take discharge decision
§ Discharge instructions to the patient
§ Discharge slip as part of patient medical record
§ Patient post discharge follow up plan
§ Transportation if required,
2. A.12Continuous training of the ER staff
Training policy of ER staff may contain but not
limited to the followings:
§ Training and education as relevant to the scope of services
§ Ongoing competency assessment and its documentation
§ Recording of the training
2. A.13Management of medico legal cases
Medico Legal policy should define but not limited
to the followings:
§ What type of cases should be reported
§ To whom be reported
§ How to report and
§ Who will report
2. A.14Patients Record
The patients’ record policy at ER may contain but
not limited to the followings:
§ Emergency department record form that is completed, for every patient presenting for care in the emergency room
§ Emergency record is kept in the patient’s medical record containing the history, findings, and treatment or disposition
§ Staff responsible for recording and monitoring of patient record
§ Periodic medical record review
§ Confidentiality of the patient record
§ Record retention time,
2. A.15Patient transfer from emergency department to inpatient areas or to another organization
The policy may contain but not limited to the
followings:
§ Criteria for transferring the patient
§ Responsibility for decision to transfer
§ Documentation at the time of transfer
§ Prior notification to receiving physician/ nurse
§ Medical record accompanying the patient
§ Patient consent
for transfer,
CPSA 2.B: Emergency
Management Clinical Protocols/ guidelines
§ To standardize and provide evidence based, appropriate and effective treatment, clinical protocols for treatment of emergencies managed in ER, based on national and international guidelines, must be developed and implemented
§ Readily available for ER staff and where ever possible displayed at prominent places to be used.
§ The staff training in these protocols.
§ These
clinical protocols may be developed for procedures/ emergencies managed in the
ER of the hospital.
CPSA 2.C: List
of Emergency Equipment
Provide the list of
medical equipment available in the ER on the following format:
|
Sr. No. |
Name of Equipment |
Type |
Model |
Quantity Available (#) |
Functional (#) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CPSA.3: Safe Blood Transfusion Services
Documents to be submitted:
1.
Policies and procedures for handling and administration of
blood and blood products in case of Blood Center and following areas must be
covered:
a.
Donor screening
b.
Processing of blood
c.
Storage of blood
d.
Administration of blood
e.
Use of blood products
f.
Identification and analysis of real or suspected transfusion
reactions
g.
Disposal of blood and related products
2.
PBTA Registration/License in case it has its own blood
center/bank
3.
MOU with PBTA licensed Blood Center/Bank if do not have the
Blood Bank of its own doesn’t exist with storage cabinet
4.
Written Report on training of staff on these SOPs
Guidelines to develop these SOPs
CPSA 3.A: Policies and procedures for handling, use and administration of blood and blood products
Safe
blood transfusion policies my cover but not limited to the following areas is
in place and implemented:
§ Safe and rational use of blood and blood products
§ Hospital working as a blood bank or blood center
§ Informed consent for blood donation and transfusion
§ A process for initial labeling of blood and blood components
§ Blood Screening
§ Processing of Blood
§ Storage and Collection of Blood from Blood storage cabinet - appropriate blood and blood components storage devices
§ A process for compatibility testing
§ A process for the issuance of blood/blood component for transfusion
§ Administration of blood and Blood products
§ Identification, analysis and documentation of real or suspected transfusion reactions
§ Documentation of the transfusion
CPSA 3.B: PBTA registration/License
§ Provide PBTA registration/ License
§ Provide MOU with licensed blood bank, vetted by PBTA
CPSA4: Hospital Infection Control
Documents to be submitted:
1. HIC Plan
2. Notification of HIC Committee
3. Written process sterilization validation
4. Written report on training of staff on these SOPs
Guidelines to develop these SOPs
CPSA 4.A Hospital Infection Control (IC) Plan
The hospital infection control plan, may cover but
not limited to the followings is in place and implemented:
CPSA 4.A.1Basic measures for IC, i.e. standard and additional precautions
§ Appropriate hand hygiene practices
§ Sufficient hand hygiene facilities
§ Supervision of usage of personal protective equipment
§ Safe injection practices
§ Top management support and adequate resources for IC plan
§ Information management system to support IC plan
§ Education and training of healthcare workers
§ Protection of healthcare workers, e.g. immunization, post exposure prophylaxis
§ Identification of hazards and minimizing risks
§ Policies and procedures for housekeeping
§ Policies and procedures on linen management that cover all steps starting from collecting linen from patients’ rooms until completion of the cleaning process
§ Routine practices essential to IC such as aseptic techniques, use of single use devices, reprocessing of instruments and equipment, antibiotic usage, management of blood/body fluid exposure, handling and use of blood and blood products, sound management of medical waste.
§ Effective work practices and procedures, such as environmental management practices including management of hospital/clinical waste, support services (e.g., food, linen), use of therapeutic devices.
§ Evidence-based interventions to prevent surgical site infection, catheter associated urinary tract infection, central intravascular catheter-associated blood stream infection etc.
§ A comprehensive system for investigation and management of outbreaks of infectious diseases
§ The hospital reports communicable diseases to the
relevant authorities
CPSA 4.A.2: Surveillance
To identify and monitor incidence and distribution
of nosocomial infections, prioritization and evaluate the effectiveness of IC
activities
§ Valid surveillance system for specific care areas, with specific objectives and timelines
§ Staff responsible for surveillance
§ Patients and units to be measures
§ Type of infection with clear definitions and relevant information to be collected for each case
§ Frequency and duration of monitoring
§ Methods for data collection
§ Methods for data analysis, feedback, and dissemination
§ Interventions for preventive actions
§ Evaluation of the impact of these interventions
§ Results of healthcare-associated infections surveillance are
integrated into the hospital’s quality improvement program
CPSA 4.A.3: Isolation Procedures
§ policies and procedures that address standard and transmission-based precautions
§ Facility design and available supplies support isolation practices
CPSA 4.B: Notification of HIC Committee
HIC committee may have but not limited to the following
roles and responsibilities:
§ Wide representation from the relevant departments
§ One member of the committee should be elected as the chairperson
§ Must meet regularly at least on quarterly basis.
§ In case of an emergency, such as on an outbreak of disease, this committee must be able to meet earlier than quarterly on emergent basis
§ Appoint an ICP (healthcare worker trained in the principles and practices of infection control, e.g. a doctor/physician, microbiologist or a nurse) as secretary
§ Secretary of the ICC will be responsible for taking notes and preparing minutes of each meeting and reminding the Chairperson to follow up on the recommendations
§ Review of the hospital infection prevention and control policies and procedures
§ Oversee, monitor and evaluate the performance of the IC plan
§ Enforce compliance with basic IC standards
§ Review and approve a yearly program of activity for surveillance and prevention
§ Assess and promote improved practice at all levels of the health facility
§ Ensure appropriate staff training in IC and safety management, provision of safety materials such as PPE and products
§ Oversee training of health workers
§ Oversee the development of facility specific IC manual, if needed
CPSA 4. C Written Process for Sterilization Validation
Written process for validation of sterilization may
cover but not limited to the followings:
§ A detailed process for sterilization
§ Uniformly done on each batch, that is sterilized
§ Specific methods for sterilization validation used
§ Documentation of sterilization validation methods
§ Date of sterilization and expiry on packaging
CPSA 5: Operation Theater Surveillance
Documents to be submitted:
1. OT SOPs
2. Last
External OT Swab Culture report from recommended six sites from PHC registered
laboratory
3.
List of OT Equipment
4. Written report on training of staff on these SOPs
Guidelines to develop these SOPs
CPSA 5. A OT SOPs
SOPs for Operations and
Surveillance of OT environment are in place and being implemented. The SOPs may
cover but not limited to the followings:
§ Infection prevention and control standards
§
Policy for traffic control in the operating room - Signage declaring the OT as a
restricted area and identification of persons allowed in the OT
§
Only operating room scrub clothing is allowed inside the restricted
areas of the operating room
§
Separation and transport of dirty linen
§
Scrubbing sinks are available at the entry of the operating room
§
Standard precautions, with special emphasis on hand hygiene and the
appropriate use of gloves, gowns, masks, and other barriers
§
Procedures for cleansing and disinfecting after surgical procedures
§
Procedures for cleaning and disinfecting anesthesia machines and other
equipment
§
OT waste management
§
Infected cases are scheduled towards the end of the operating list
§ OT Culture Swab frequency
§ Notification of the OT management committee with its TORs
§ OT in charge notification, qualification and JD
§ Handover process between unit nurse and operating room staff - Transportation of clients/patients from the ward to the OT and back
§ Transferring of patient onto a stretcher/chair from within the OT and not allowing a Stretcher/Chair from outside into the OT
§ Infection control measures in operating room and recovery room
§ Equipment daily checks and periodic maintenance(Provide list of OT equipment)
§ Annual review of functioning equipment in line with the services offered by the OT
§ Policy for patient acceptance into the operating room
§
Patient identification
§
The consent form
§
The site of surgery and its preparation and whether it is marked or not
§
The laboratory and radiology results
§
The pre-anesthesia sheet is checked for completion
§
The history and physical examination
§
Blood is reserved in the blood bank, if needed
§ A process to prevent inadvertent retention of instruments or sponges in surgical wounds
§ OT Registers / Record
§
Anesthesia Register
§
Surgeon's Register
§
Prosthesis Register
§
Electro medical equipment inventory
§
Biopsy Specimens Register
§
Record of weekly/monthly analyses of surgeries
§
Schedule for operations of the next day
§
Maintenance of stock levels of drugs and consumables (Stock Register).
§
Duty Roster
§
List of all OT Staff with their Qualifications
§
Job Descriptions (JDs) of all OT Staff
§
Operation Theatre Management Committee (OTMC) Quarterly Minutes of
Meetings
§ OT Waste Disposal Record
§ OT Quality Assurance Indicators
§ OT performance audit and its frequency at least quarterly
CPSA 6:
Documents to be submitted:
1. Fire
& Non Fire Emergency Plan
2.
Documented Safe Exit Plan
3. Written report on training of staff on these SOPs
Guidelines to develop these SOPs
CPSA 6. A Fire & Non Fire Emergency Plan
Fire and Non Fire Emergency
Plan, may contain but not limited to the followings is in place and implemented:
§ Early Detection
§ Containment
§ Abatement
§ Prevention
§ Adequate and qualified personnel for implementation of the plan.
§ Adequate firefighting equipment
§ Staff training program
§ Schedules for, and conduct, Mock Fire Drills
§ Mock Drill Records
§ Explicitly display Exit Plans
§ Liaison with fire and non-fire emergency rescue agencies like civil and police authorities, and Rescue 1122 and the Fire Brigade
CPSA 6. B Documented Safe Exit Plan
Documented safe exit plan,
covering but not limited to the followings is in place and implemented:
§ Fire Exit Signs
§ Number of exits
§ Keeping exits, obstruction free
§ Exits clearly marked
§ Size of signs
§ Separate ingress and egress routes
§ Staff training
§ Mock drills
§ Documentation of mock drills
CPSA 7:Hospital Waste Management
Documents to be submitted:
1.
Hospital Waste Management Plan
2.
Notification of the Hospital
Waste Management Committee
3.
MOU for hospital waste disposal
4. Written report on training of staff on these SOPs
Guidelines to develop these SOPs
CPSA 7. A Hospital Waste Management
Plan
Documented Hospital Waste
Management plan, covering but not limited to the followings is in place and
implemented:
§ Waste disposal points for both risk waste and non-risk waste for every department
§ Central storage facility for risk and non-risk waste
§ Details of the types and numbers of containers and waste bags required annually
§ Waste segregation
§ Time tables for collection of waste from all departments
§ Waste transportation
§ Waste storage
§ Waste disposal
§ Duties and responsibilities of the staff involved in generation and management of waste
§ Staff required for waste collection
§ Disposal of medical equipment and supplies including sharps
§ Management of radioactive and chemical waste
§ Labeling of waste collection bags
§ Procedures for the management of waste requiring special treatment like autoclaving before final disposal
§ Contingency plan for storage or risk of waste in case of failure in waste collection or disposal arrangements
§ Staff training
§ Monitoring, review and update of hospital waste management plan
§ Documentation of waste management activities
§ PPPs for staff involved in waste collection and disposal
§ Actions in case of accidents and spillage
§ Waste minimization and reuse
CPSA 7. B Notification
of HWM Committee
The notification of HWM
committee may contain but not limited to the following TORs:
§ Members should be from Administration, medical, surgical departments, OT, Labor room, Nursing, Infection control Committee, QA committee, pharmacy, housekeeping, depending upon the size of the hospital
§ Committee meetings frequency
§ Responsibilities of the committee and individual members
CPSA 7. C MOU for Hospital Waste Disposal, if disposal is not in house
§ MOU with external agency for disposal of hospitals waste
§ If waste disposal is in house, provide at least following details of waste disposal
§
Type of waste disposal method – Pit burial, Incinerator
§
If pit burial, size, SOPs, staff responsible
§
If incinerator, location, capacity, frequency, staff responsible, EPA
approval
CPSA 8: Surgical Services
Documents to be submitted:
1. Documented SOPs for Surgical Procedures
2. Documented policies to prevent adverse events like wrong site, wrong patient and wrong surgery
3. Written report of training of staff on these SOPs
Guidelines to develop these SOPs
CPSA 8.A Documented SOPs for Surgical Procedures
Documented SOPs for surgical
services, covering but not limited to the followings are in place and
implemented:
§ SOPs for day care surgeries
§
Types of surgical procedures that are performed as “day surgery”
§
A process for patients who have to be admitted to the hospital from the
day surgery unit
§
The staff responsible to write a discharge order
§
Patients are discharged in the company of a responsible adult who
assumes responsibility and is capable of taking care of the patient
§
Patient/family education and follow-up care instructions are provided
prior to discharge.
§ Pre-operative assessment on prescribed form containing at least:
§
History and physical examination
§
Pre-operative diagnosis
§
Required Surgical Procedure
§
Diagnostic tests (laboratory, radiology, etc.) as ordered
§
Fitness for undergoing the required surgical procedure
§ Informed Consent for
Surgery
§ Time out protocol
§
Confirming identification of the patient
§
Checking and confirmation of consent by the patient
§
Checking the Correctness of Procedure or Surgery to be performed
§
Marking of the Correct Site for surgery or other invasive procedures,
as applicable
§ Verification that
diagnostic images (and/or other relevant test results) are available and are
correct, as applicable
§
Intra-Operative - Operations
Notes containing:
§
Date and duration of operation
§
Anatomical site/place where surgery is undertaken
§
The name of the operating surgeon/s, operating assistants and the name
of the consultant
§
Procedure performed
§
Presence or absence of intra-operative complications
§
Surgical specimens removed and sent for histopathology
§
Amount of blood loss
§
Post-operative diagnosis
§
Status of the patient before shifting
§
Description of the findings.
§ Immediate post-operative
instructions
§ Post-Operative
§
Post-operative plan of care in recovery room
§
Wound care
§
Care of drains and catheters
§
Special patient positioning requirements
§
Nutritional instructions
§
When to start mobilization
§ Special referrals (e.g. physical therapy, respiratory therapy)
§
A new order for all required medications
§
Any other post-operative care needed including required follow up
§
The post-operative plan of care is available in the patient's medical
record before discharge from recovery
§
Each patient is assessed after surgery and reassessed at intervals appropriate
to the patient’s condition
§
Medical, nursing, and other care plans are documented in the patient’s
medical record
§
Procedures for post-operative handover of the patients
The
policy may contain but not limited to the followings is in place and
implemented:
§ Identification of the patient
§ Responsibility of the patient identification
§ Time Out
§
Confirming identification of the patient
§
Checking and confirmation of consent by the patient
§
Checking the Correctness of Procedure or Surgery to be performed
§
Marking of the Correct Site for surgery or other invasive procedures, as
applicable
§
Verification that diagnostic images (and/or other relevant Test
results) are available and are correct, as applicable
§
Patients shall be encouraged to actively participate in the identification
process
§ Marking of the surgical site, where needed
§
With an indelible skin marker where practical using initials
§
While marking the site/side, the patient should be awake, aware and
involved if possible and should occur before the patient enters the
operating/procedure room
§
The site must be marked, and initialed, by the Person performing the
procedure (or another senior team member who has been fully briefed about the
operation or procedure)
§
Skin preparation and draping, once appropriate marking has been
completed, must be documented in the clinical record
§
The marking method is consistent throughout the hospital
§
A patient’s refusal to have the site marked must also be documented in
the clinical record.
§ A pre-operative checklist that all needed documents are available
CPSA 9: Anesthesia Services
Documents to be submitted:
1. Documented
SOPs for Administration of Anesthesia
2. Written report of training of staff on these SOPs
Guidelines to develop these SOPs
CPSA 9.A Documented SOPs for Administration of Anesthesia
The
policy may contain but not limited to the followings:
§ Anesthesia is given by a qualified anesthetists
§ Required anesthesia equipment are available and regularly serviced and calibrated
§
Pre-anesthesia
evaluation.
§
Done before the patient is brought to the OT
§
Applicable for both routine and emergency cases
§
Done in a standardized format
§
By the Anesthetists (Anesthesia Professional) a day before their
scheduled day of operation
§
Patient’s medical condition from medical history, physical examination,
investigations and, when appropriate, past medical records
§
Determine and minimize risk factors for anesthesia
§
Inform and educate the patient about anesthesia, preoperative care and
pain management
§
All the findings are recorded in the specific form
§
Risk Assessment
§
Pre-operative Medication
§
An anesthesia plan for the patient is prepared on the basis of the Pre-anesthesia
assessment and the same is documented
§
The anesthesia plan depicts the type of anesthesia (local, general,
epidural etc), monitoring and plan for postoperative analgesia etc
§
Obtain consent for anesthesia
§
A written summary of the pre-anesthesia assessment, orders or
arrangements should be explicitly and legibly documented in the patient’s anesthetic
record
§ Assessment of an anesthesia risk and its scoring.
§
Identify any risks and determines the appropriate anesthetic approach
§
Mention the pre-medications, type of anesthesia i.e. GA, regional or
local, the drugs to be used for induction and the drug to be used for
maintenance
§
Other concomitant medications and IV fluids, special monitoring
requirements with appropriate and anticipated post-anesthesia care
§ Documentation required during anesthesia.
§
Anesthesia personnel shall be continuously present throughout the
conduct of anesthesia
§ Patient following parameters need to be continuously
monitored:
·
Oxygenation
·
Inspired gas
·
Blood oxygenation
·
Ventilation
·
Circulation
·
Body Temperature
§
The Monitoring Sheet used should have following fields for recording:
·
Patient Heart
rate
·
Cardiac Rhythm
·
Respiratory rate
·
Arterial Blood
Pressure
·
Oxygen Saturation
·
Airway Security
·
Patency
·
Level of Anesthesia
·
Evaluation of the
Circulatory Function
·
Temperature (in
case clinically significant changes in body temperature are intended,
anticipated or suspected)
§ The following information must be documented in each patient anesthesia record:
§
Age, sex, weight, height, and pre-operative vital signs
§
The anesthetic agent
§
The dosage, time, and route of administration of all medications and
anesthetic agents used
§
The techniques used to administer the anesthesia
§
If blood is used, the amount of blood, rationale for administration, and
the time given
§
Investigations carried out e.g. blood glucose, blood gases
§
Unusual events or complications.
§
The patient’s status at the end of the procedure.
§
Intravenous fluids given.
§
The anesthesiologist and anesthesia assistant(s)
§ Recording of any complications – a documented process to identify
and handle the event and to intensively analyze
§
Primary Anesthetist must concentrate on continuing care
§
Do NOT discard supplies or apparatus or tamper with equipment
§
Document events in the patient's record
§
Do NOT alter the record
§
Stay involved with follow-up care
§
Contact consultants as needed
§
Submit a follow-up report
§
Document continuing care in the patient's record
§
HoD or Clinical Director should directly supervise or delegate
responsibility for incident investigation.
§
Assure impounding of equipment, if necessary, and determine appropriate
disposition of equipment.
§
If pharmaceuticals or supplies were involved which may create hazard to
other patients, contact pharmacy, materials management, nursing or other
departments.
§
Supervise continuing investigation of equipment or supplied-related
issues or contact the manufacturer if appropriate.
§
The follow-up Supervisor should notify the individuals involved of
their responsibilities as defined in this document.
§
Be responsible for assuring that procedures are followed to the extent
necessary, reasonable and possible.
§
Ensure that information regarding the adverse event is communicated
through the proper channels to the department Quality Assurance program.
§ Post-anesthesia monitoring requirements.
§
Done in the recovery area/OT
§
Documented evidence of Post-Anesthesia Monitoring that includes at the
least:
·
Blood pressure
·
Pulse rate
·
Respiratory
status
·
Oximetry
·
Level of
consciousness
·
Pain
§
The essential activities of PACU (Post Anesthesia Care Unit/ Recovery
Room) Staff include:
·
Monitoring vital
signs (heart rate, blood pressure, temperature and respiratory rate).
·
Managing
postoperative pain.
·
Treating symptoms
of Postoperative Nausea and Vomiting (PONV).
·
Treating post
anesthesia shivering.
·
Monitoring
surgical site(s) for excessive bleeding, discharge, swelling, hematoma,
redness etc.
§
Upon arrival in the PACU, the patient shall be re-evaluated
§
The patient’s status on arrival in the PACU shall be documented
§
The patient’s condition shall be evaluated continually in the PACU.
§
Particular attention should be given to monitoring oxygenation,
ventilation, circulation, level of consciousness and temperature
§
An accurate written report of the PACU period shall be maintained
§
There shall be a policy to assure the availability in the facility of a
physician capable of managing complications and providing cardiopulmonary
resuscitation for patients in the PACU.
§ Discharge from post anesthesia/postoperative care (Recovery Room)
§
Documented criteria based on physiologic parameters and in consonance
with good clinical practices
§
The patient is fully conscious without excessive stimulation, able to
maintain a clear airway and exhibits protective airway reflexes.
§
Respiration and oxygenation are satisfactory.
§
The cardiovascular system is stable
§
Pain and Emesis should be controlled
§
Temperature should be within acceptable limits
§
Oxygen and intravenous therapy, if appropriate, should be prescribed.
§
Shifting from the recovery room is the responsibility of the anesthetist.
If the discharge criteria are not achieved, the patient should remain in the
recovery room and the anesthetist informed.
§
An anesthetist must be available at all times when a patient who has
not reached the criteria for discharge is present in the recovery room.
§
After medical assessment, patients who do not fulfill the discharge
criteria may be transferred to an ICU
§
Patients should be transferred to the ward accompanied by a suitably
trained member of staff and a caretaker
CPSA 10: Management of Medication
Documents to be submitted:
1. Documented
SOPs for Prescription
2.
Documented Policy on Verbal
Orders
3. Documented Process for Safety of High
Risk Medications
4.
Written report of training of staff on these SOPs
Guidelines for developing these SOPs
CPSA 10.A Documented
SOPs for Prescription
The
documented SOPs may contain but not limited to the followings is in place and
implemented:
§ Only Medical Doctors and Dental Surgeons are authorized for Prescription Writing in their own fields
§
A list of
all doctors must be available including:-
§
Name
§
Designation
§ Specimen
signatures
§ Drugs should only be administered against a Written Order of a Physician
§ No drug will be administered to a patient without a valid prescription of the treating doctor
§ In an emergency when a consultant is contacted on the phone and the drug is prescribed by him, the medicine may be given to the patient under the signature of the locally available treating doctor and this should be authenticated by the Prescribing Consultant within 24 hrs
§ Directions must be clearly stated
§ The hospital must have approved abbreviations
§ Orders are written in a uniform location in the medical records
§
Medication
orders are clear, legible, dated, timed, named and signed specifying the
following:
§
Drug name & dosage
§
Route of administration
§
Frequency of administration/application
§
Duration of therapy, where appropriate
§
Signature and status of physician/dentist with stamp
§ Additional
information, as indicated
§ If prescription is difficult to understand or any confusion the Prescriber should be contacted immediately, giving full details of drug and dose given/omitted and any other relevant details
CPSA 10.B Documented policy on verbal orders
The
documented SOPs may contain but not limited to the followings are in place and
implemented:
§ Verbal orders will be limited to emergencies and/or those situations where the physician is not immediately available
§ A qualified nurse may accept verbal/telephonic orders.
§ The authorized Health Care Professional receiving a verbal/telephonic order shall read his/her own transcription of the dictated order back to the prescriber
§ Unfamiliar drug names or sound-alike drug names shall be spelled back to the prescriber to avoid medication errors
§
The order will be
identified as a “Verbal Order” or "telephone order" on the Orders
for Treatment form and will include the following documentation:
§
Name of the Health Care Professional who dictated the order
§
Detailed order
§
Documentation that order was repeated back,
§
Date, and time of receiving the order
§ Signature
and position of the staff member writing the order.
§ Verbal orders will be written in red ink.
§
Verbal
orders will only acceptable only for STAT DOSES.
§ Only the physician who has already seen the patient can place verbal orders.
§ A Healthcare professional must not accept telephone orders for blood products, high risk medications and chemotherapy that require an informed consent prior to administration
§ Once the emergency is settled, Healthcare professional who wrote verbal order must get it verified in writing from the physician who dictated the order
CPSA 10.B Documented Process for Safety of High Risk Medications
A written multidisciplinary plan for managing high-alert medications and hazardous pharmaceutical chemicals may contain but not limited to the followings is in place and implemented:
§ Identification, location, labeling, storage, dispensing, and administration of high-alert medications
§ The hospital identifies an annually updated list of high-alert medications and hazardous pharmaceutical chemicals. The list contains, but is not limited to, the following:
§
Controlled and narcotics medications.
§
Neuromuscular blockers.
§
Chemotherapeutic agents.
§
Concentrated electrolytes (e.g., hypertonic sodium chloride,
concentrated potassium salts).
§
Antithrombotic medications (e.g., heparin, warfarin).
§
Insulins.
§ Anesthetic medications (e.g., propofol, ketamine)
§ Limit access to high-risk product
§ Double checks of orders
§ Standardize processesfor ordering, transcribing, preparation, dispensing, administration, and monitoring of high-alert medications
§ Secure medication in locked devices
§ Avoid unapproved abbreviations
§ Identify high-risk patients in advance
§ Patient Education
§
Orders for high list
medications must be verified atleast twice from prescriber
before administration
CPSA 11: Continuous Quality Improvement
Documents to be submitted:
1. Continuous
quality improvement plan
2.
Sentinel Events list and
policy
3.
Written
report of training of staff in these SOPs
Guidelines to develop these SOPs
CPSA 11.A Continuous Quality Improvement plan
Outline of the CQI Program / Plan:
§ Formulate a multidisciplinary CQI committee consisting of responsible persons from all clinical and non-clinical departments. In smaller hospitals, this committee may consists of two to three persons.
§ Notify a CQI coordinator, responsible for coordination and implementation of all CQI activities
§ Establish measurable performance indicators for all critical areas, including implementation of all SOPs/ Policies/ Procedures
§ Define benchmarks for all established indicators
§ Define what data is required to measure these indicators
§ Define how and who will collect this data
§ Define frequency of data collection
§ Establish responsibilities to aggregate and analyze the collected data against each indicator
§ CQI coordinate will be responsible to coordinate and ensure all these activities
§ The analysis will be presented in the CQI committee meetings.
§ CQI committee will do the root cause analysis of the indicators falling short of set benchmarks to find the reason of shortfall / poor performance
§ CQI committee will design activities / interventions to address the identified reasons to improve these areas.
§ Implement these activities / interventions and measure the progress to assess that desired results are achieved or not.
§ Prioritize the most critical areas for continuous improvement
§ Continue this cycle of identification of areas of improvement, planning and implementation of CQI projects for continuous improvement by raising the benchmarks.
Continues Quality Improvement Plan
The CQI Plan may contain but not limited to the followings is in place and implemented:
§ Covers processes of care involving high risk, high volume, problem-prone, and high cost areas
§ Notification of the QI Committee comprising of the following individuals:
§
CEO/ MS of the HCE,
§
Representative from the Hospital Board of Directors
§
HODs from clinical department
§
Managers/Directors, Ancillary Services
§
Nursing Managers/Director of Nursing,
§
QI Manager,
§
Head of Pharmacy Department,
§
Infection Control Nurse,
§ Any co-opted member
§ The responsibilities and authorities of the QICommittee
§
Development of CQI program
§
Regular orientation of the hospital staff regarding CQI program and its
methodology
§
Prioritizing issues referred to the CQI Committee for review
§
Assuring that the review functions outlined in the plan are completed
§
Set indicators for all departments / critical areas, services
§
Establish benchmarks for all set indicators
§
Collection of data from all the departments
§
Assuring that the data obtained through CQI activities are analyzed,
recommendations made, and problem resolution is appropriately followed
§
Monitoring and supportive supervision
§
Holding regular meetings, discussing the reports from various
departments and analyzed data and making appropriate decisions
§
Periodic review and modification of the CQI program
§
Appointment of sub committees or teams to work on specific issues, as
necessary
§
Assuring that the necessary resources are available
§
Reporting to the HCE Management/Medical Staff monthly, or as
appropriate.
§
Reporting the ongoing findings, recommendations and trends, quarterly
and annually, to the Board of Management/Directors.
§
Making recommendations to the Board of Management for necessary actions
for the implementation of CQIactivities
§
Calling meetings of the committee or Hospital Management as and when
required
§
Introducing new systems and formats in various departments for the QA
and QI
§
Taking necessary steps to assure patient safety and the security of the
hospital staff
§
Identifying other sources of Patient Safety Goals such as the PHC’s
MSDS, for incorporation into the hospitals overall quality improvement efforts
§
Identifying Continued Professional Development/educational needs and
assuring that staff education for quality improvement takes place.
§
Coordinating activities with the PHC as and when required.
§ The requirement for minutes of the committee meetings may be as below
Meeting
Date:____________ Participants:____________________________
|
Sr |
Agenda |
KPI |
Discussion |
Decision |
Responsibility |
Support required |
Time line |
Follow up |
|
|
|
|
|
|
|
|
|
|
§ Designated CQI Focal Person
§
A designated Quality Improvement Coordinator
§
Job description for this individual that defines the requisite
qualifications and the duties
§
Coordination of the committee for holding meetings
§
Recording the minutes of meetings and circulation of these minutes
§
Ensuring an active communication between the hospital staff and the CQI
Committee and the committee and the management
§
Liaison with external regulatory bodies like PHC
§
Identify quality indicators
§
Collect and analyze data
§
Develop and implement changes to improve service delivery
§
Monitoring to assure that improvement is made and sustained
§ The hospital monitors its performance through regular data collection and analysis
§ Hospital leaders define and implement a set of hospital performance indicators/ measures that focus on important managerial and clinical areas
§ For each indicator, there is a clear definition, sample size, data collection method, frequency, analysis, and expression
§ Indicators represent key care and service structures, processes and outcomes based on the mission and scope of services
§ Data are collected and aggregated on a regular basis from qualitative and quantitative sources
§ Data are coordinated with other performance monitoring activities such as patient safety and risk management.
§ Structure indicators including but not limited to the followings:
§
Availability of essential supplies and equipment.
§
Availability of medical records
§
Availability of blood and blood products.
§
Availability of emergency medications.
§
Surgical volumes.
§ Staffing ratios
§ Process indicators including but not limited to the followings:
§
Patient Assessment
·
Time for initial
assessment of indoor and emergency patients.
·
Percentage of
cases (in-patients) wherein management plan is documented and counter-signed by
the physician
·
Percentage of
cases (in-patients) wherein patients are discharged with satisfactory
condition.
·
Percentage of
cases (in-patients) wherein the initial clinical impression is same as the
final diagnosis
·
Waiting times for
treatment.
§
Diagnostic Services
·
Number of
reporting errors/1000 investigations.
·
Percentage of
re-dos.
·
Percentage of
reports co-relating with clinical diagnosis.
·
Percentage of
adherence to safety precautions by employees working in diagnostics.
§
Invasive Procedures
·
Percentage of
unplanned invasive procedures.
·
Percentage of
rescheduling of invasive procedures.
·
Percentage of
cases where the organization procedures, to prevent adverse events like wrong
patient and wrong procedure, have been adhered to.
·
Percentage of
cases who received appropriate prophylactic antibiotics within the specified
time frame
·
Venous thrombo-embolism prophylaxis for surgical patients
§
Adverse Drug Events
·
Percentage of
medication errors (Prescribing, dispensing, administration)
·
Incidence of
adverse drug reactions.
·
Percentage of
admissions with adverse drug reaction/s (ADR).
·
Percentage of
medication charts with error prone abbreviations.
·
Percentage of
patients receiving high risk medications developing adverse drug event.
§
Anesthesia
·
Percentage of
modification of anesthesia plan
·
Percentage of
unplanned ventilation following anesthesia
·
Percentage of
adverse anesthesia events
·
Anesthesia-related
mortality rate.
§
Blood and Blood Products
·
Percentage of
transfusion reactions.
·
Percentage of
wastage of blood and blood products.
·
Percentage of
blood component usage.
·
Turnaround time
for issue of blood and blood components.
§
Medical Records
·
Percentage of
medical records not having discharge summary.
·
Percentage of
medical records not having timed and named entries.
·
Percentage of
medical records having incomplete and/or improper consent.
·
Percentage of
missing records.
§ Outcome indicators may include, but are not limited to, the following
§
Mortality rates.
§
Healthcare associated infections.
§
Staff satisfaction.
§
Patient satisfaction.
§
Unplanned return to the operating room.
§
Return to the emergency room within 24 hours.
§
Unplanned transfer to the critical care unit.
§
Resuscitation of patients (cardiac/respiratory arrest).
§
Readmission to the hospital within 30 days of discharge.
§
Various adverse events (e.g., falls, injuries, and pressure ulcers).
§
Patient complaints.
§
Length of stay
§ Data collected is aggregated and analyzed.
§
Data collected is analyzed by staff qualified in data management.
§
Data collected is regularly aggregated and analyzed to yield useful
trends and variances.
§
Data is utilized for internal and external benchmarking to identify
deficiencies and opportunities for improvement.
§
Information is presented in the CQI committee and communicated to the
appropriate stakeholders in a way they can understand and use
§ The information resulting from data analysis to make improvements
§
Information resulting from data analysis is used for prioritizing
quality improvement projects as well as strategic and operational planning.
§
When appropriate, the hospital tests improvement interventions prior to
full implementation.
§
After implementing improvement interventions, the hospital measures
their effectiveness to ensure that interventions have achieved a sustained
improvement
§ Quality improvement teams are selected by the hospital leaders / CQI committee and these teams use quality tools to improve processes.
§
Quality improvement teams are assigned by the service leaders.
§
The quality improvement team includes staff members who are involved in
the process under study
§
The quality improvement team uses the quality tools to improve processes
(e.g., brainstorming, fishbone charts PDCA cycles etc.)
§ The CQI methodology to be used
§
One of the methodologies of CQI is PDCA (Plan, Do, Check and Act)
Cycle.
§
Plan – At this stage, following activities are beefing performed:
·
Design of the new
process or potential improvement process is identified
·
Initial data is
collected to determine, if there is a need for an improvement or change
·
An action Plan is
developed with goals and targets
·
Activities to
achieve goals have been determined
·
Determine, who
will implement the plan
§
DO
·
Action Plan is
implemented usually at small scale on trial basis
·
Education and
training of those involved in the process being improved
§ CHECK
·
Data is collected
again
·
Compare it with
previous data collected to determine, whether goal / targets have achieved or
not
·
Determine what
actions or modifications are necessary prior to the full implementation of the
action plan
§
ACT -
·
Implement changes
or actions needed on full scale
§ Reporting structure of CQI results
§
Designate staff member from each department responsible for data
collection required to measure set indicators and report to CQI coordinator on
defined timeline
§
Set timeline and frequency of data collection and reporting
§
The CQI coordinator may report it to the relevant department Head or
can call CQI meeting depending upon the nature of the issue.
§
The sub committees and the teams appointed by the CQI committee for
specific assignments will report to the committee according to the nature of
the assignment.
§
Report of each department will be presented to the committee in regular
meetings to be discussed and decided upon.
§
Final report with required action plans is submitted to the competent
authorities
§ The hospital develops and maintains a patient safety program
§
Promote a just culture that promotes both professional accountability
and reporting of adverse events/near misses.
§
Provide direction and resources to support the patient safety program.
§
Assigns a qualified individual to provide coordination and supervision
of the organization-wide patient safety program.
§
Establish a multidisciplinary patient safety committee (can be
integrated with quality improvement committee) to provide direction and
oversight of the patient safety program.
§
Safe practices that have been proven to improve patient safety and
reduce harm to patients
§
Equipment/devices with technological features proven to reduce errors
and improve safety.
§
Relevant information developed from patient safety activities is
integrated into quality improvement and risk management activities.
§
Patient safety activities and their results are communicated CQI
committee and used as the base for improving the hospital’s processes.
CPSA 11.A Defined set of Sentinel Events
§ There is a policy for management of sentinel events.
§ Sentinel events are identified in the hospital’s policy and include the following:
§
Unexpected death.
§
Unexpected loss of limb or function.
§
Wrong patient, wrong procedure, or wrong site.
§
Retained instrument or sponge.
§
Serious medication error leading to death or major morbidity.
§
Suicide of a patient in an inpatient unit.
§
Infant abduction or discharge to a wrong family
§
Maternal death.
§
Hemolytic blood transfusion reaction.
§
Air Embolism.
§ Reportable sentinel events are reported to CQI committee for further analysis and taking required action
§ The CQI committee its self or forms a team, to complete the root cause analysis along with an action plan for all sentinel events. The team should bring together those who have an intimate knowledge of the normal process.
§ Reportable sentinel events along with root cause analysis and action taken, are reported to the Commission in a notified manner.
CPSA 12: Medical Records
Documents to be submitted:
1. Documented
process for patient unique identification
2. Medical
Record Policy
3. Written report on training of staff on these policies
Guidelines for developing these policies
CPSA 12.A Documented Process for Patient Unique Identification
A
documented process for patient’s unique identification may contain but not
limited to the followings is in place and implemented:
§ At least two patient identifiers (e.g., patient full name and medical record number) are required whenever taking blood samples, administering medications or blood products, or performing procedures.
§ The hospital has a standardized approach to patient identification (e.g., use of ID bands with standardized information).
§ Patients are actively involved in the process of patient identification
§ There is patient identification on each page of the medical
record
CPSA 12.B Medical Record Policy
A
medical record policy may contain but not limited to the followings is in place
and implemented:
§ A medical record is initiated for every patient
§ The hospital maintains a master patient index (either manual or computerized) of all patients who have ever been admitted to or treated by the hospital
§ The master patient index is used to identify a patient's medical record number
§ The master patient index provides basic patient demographic information as well as patient activity (visit) information
§ The patient demographic information (identification information) includes:
§
medical record number, patient’s full name, date of birth, sex, marital
status, address, national identification number, next of kin (and his contacts)
and/or a person that the patient wishes to be contacted in an emergency, or
authorized representative/designee.
§ The patient activity (visit) information includes:
§
Admission and discharge/transfer dates for inpatient hospitalizations,
date of death when a death occurs, encounter date or date of service for
outpatient visits, most responsible physician, and mother’s name for newborns.
§ The master patient index is updated for each new episode of care for any change in information.
§ The master patient index is retained permanently to provide historical access to basic patient information and dates of stay in the hospital.
§ Medical records contain sufficient information to promote continuity and coordination of care and communication among care providers
§ The hospital has a complete and accurate medical record for every patient including reason for admission, diagnosis, plan of care, medicines given, operative and other procedures performed
§ The hospital identifies in a policy all staff members authorized to make entries in medical records.
§ All entries in the medical records must be legible, indelibly verified, dated, and authenticated.
§ Clinical staff authorized to make entries in the medical record receive formal training in clinical documentation improvement as per the national/international guidelines.
§ The author of each entry must be identified and authenticated by official stamp, signature, written initials, or computer entry.
§ The hospital has a policy to deal with delinquent medical records.
§ The hospital maintains the medical records in one central place
§ A discharge summary is completed for all discharged patients.
§ The discharge summary is complete and includes:
§
The reason for the patient’s admission.
§
The patient’s diagnosis.
§
Brief summary of hospitalization (therapies, consultations,
interventions and results of any important diagnostic testing).
§
A list of medications used.
§
Any surgery or procedures performed and their outcome.
§
The patient’s condition at discharge.
§
All medications to be taken by the patient after discharge.
§
Any special care the patient requires after discharge.
§ A process to ensure availability of the medical records in a timely manner
§ Medical records are consistently organized
§
The different sections of the medical record are organized
chronologically (e.g., the physician orders start with the initial set written
when the patient was admitted to the hospital and end with the discharge
order).
§ A policy on the retention of medical records.
§
The policy addresses the retention period of the different types of the
medical records as well as the permanent types (e.g., records of medico-legal
cases).
§
The method used for medical records destruction, when the retention period
is complete, renders the information unreadable.
§ A policy that outlines how the medical records are stored
§
The policy addresses how the medical records are protected from loss,
theft and deliberate alterations or destruction.
§
The policy addresses how confidentiality, integrity, and security of
the records will be maintained during storage
§ A policy for the release of medical records from the medical records department
§ Standardized forms in medical records
§ A system in place for review / monitoring of completion of medical records
§
The medical records are reviewed on an ongoing basis (e.g., monthly or
quarterly).
§
The review includes a representative sample.
§
The review is conducted by care providers authorized to make entries in
medical records.
§
The review process focuses on the appropriate and comprehensive
documentation, timeliness, and legibility.
§
The review process includes records of both active and discharged
patients
§
Data collected are analyzed and corrective actions are taken
CPSA 13: Complaint Management System
Documents to be submitted
1. Documented complaint management system
2. A report on training of staff on complaint management system
Guidelines to develop the complaint management
system
CPSA 13.A Documented Complaint Management System
A
documented complaint management system may include but not limited to the
followings is in place and implemented:
§ A Complaint Cell should be established at every hospital and resourced properly
§ The Complaint Cell shall essentially comprise of a core staff and be headed by a manager appointed by the HCE and be supported by a team of experts
§ The department/specialist against whom a complaint is received/under investigation will not be part of the committee for that particular case
§ Every complaint must be thoroughly investigated and documented
§ The Complaint Cell will maintain department wise records of complaints investigated and actions taken
§ A record of the Complaint Register must lie in the office of the MS or In-charge of the health facility, with the complete number and details of complaints received and action taken
§ The processes should define credible and transparent mechanisms for receiving and handling complaints against the functioning of the HCE and practice of its staff
§
The hospital should have
mechanisms to obtain feedback as an on-going process
§
A suggestion/complaint box at the facility that may be used by the
literate clients.
§
Periodic clients exit interviews.
§
Key informant interviews on periodic basis (within community).
§ Mystery client survey.
§ Registration/ Collection
§
The information as how to lodge a complaint must be clearly displayed
in the local language at prominent places
§
A number of Complaint Registers shall be maintained by each HCE, one of
which shall be available at help desk/reception, round the clock.
§
Every written or verbal complaint directly made to the HCE/Authorized
Person shall be entered in the register within 24 hours
§ A Complaint Processing Register shall be maintained by each HCE
§
Enter important points of the complaint in the register.
§
Take notice of allegations and requests made.
§
Assign priority according to the nature of the complaint.
§
Investigate in an impartial manner.
§
Keep the time factor in mind because any undue delay will reflect
poorly on the management
§ Communication
§
Inform the complainant about the progress of the investigation at
regular intervals and inform him/her about the outcome.
§
Stay in contact with the complainant and regularly update him/her about
the progress made in investigation.
§
Record the outcome of the investigation and inform the complainant
accordingly.
§
Don’t indulge in argumentation.
§
Be polite and empathetic
§ Quality Improvement
§
Use the results of the complaints investigation as part of the quality
improvement process.
§
The registers should be perused by the Chief Executive of the
establishment, at least once a month.
§
Make necessary changes in policy and procedures to improve the quality
of healthcare services.
CPSA 14: Diagnostic Services
Documents to be submitted:
1. Lab
Manual
2. License
from PNRA, if providing imaging services
3. Written report on training of staff on lab manual
Guide lines to develop LAB manual
CPSA 14.A Lab-Manual
A
Lab manual may include but not limited to the followings is in place and
implemented:
§ The laboratory services are provided by staff qualified by education, training, and experience.
§ The laboratory director, sections’ heads and supervisors are appropriately qualified according to the complexity of laboratory scope of services.
§ Specimen collection manual that may include but not limited to the following:
§
Available tests and services on and off-site (reference laboratory) and
their Turn Around Times (TAT).
§
Methods of patient preparation.
§
Procedures for positive patient identification.
§
Quality and quantity of sample.
§
Phlebotomy and sample collection procedures.
§
Recognizing and handling adverse reactions to phlebotomy.
§
Specimen labeling.
§
Requisition and required clinical data.
§
Specimen handling and transportation.
§
Specimen rejection criteria.
§
Laboratory services/specimen collection manual is available to all
relevant departments.
§ Policies and procedures to ensure correct specimen labeling, may include but not limited to the following:
§
Labeling of the specimen containers is conducted immediately after
sample collection at the patient side.
§
Two Patient’s identifiers (patient’s full name and medical record
number).
§
Date and time of sample collection.
§
Identification of the person collecting the specimen.
§ Policies and procedures on proper sample handling, transporting, and tracking. This may include but not limited to the following:
§
Packing instructions (use of biohazard leak-proof containers
§
Personnel training (including safety and proper packaging).
§
Specimen tracking system.
§
The laboratory has a system to maintain the identity of laboratory
specimen during receipt, processing, examination, and archiving.
§ Policies and procedures for the receipt and inspection of laboratory specimen to ensure the performance and documentation of, that may include but not limited to the following:
§
Date and time of specimen reception
§
Check for proper packaging.
§
Check for quality and quantity of specimen.
§
Check for adequacy of specimen labeling.
§
Check for request completion.
§
Check for label/request discrepancies.
§
The use of suboptimal specimen is clearly highlighted in the reported
results.
§
Final decision (accept/reject)
§ A written description for the format and contents of its reports which may include but not limited to the following:
§
Identification of the testing laboratory.
§
Patient identification (full name and medical record number, age and
sex).
§
Identification of the ordering physician.
§
Date and time of specimen collection and the source of specimen.
§
Reporting date and time.
§
Test results and reference intervals.
§ Identification of the authorized person releasing the report
§ A comprehensive system for Point-of Care Testing (POCT), which may include but not limited to the following.
§
Clear definition of POCT.
§
Assignment of the responsibility of managing the POCT to the
laboratory.
§
Guidelines describing the process of acquiring POCT devices/methods.
§
Training and competency testing requirements.
§
Maintenance, quality control, and quality management of the POCT
devices/methods.
§
The laboratory assigned a qualified individual as POCT coordinator.
§ A general laboratory records retention system that ensures but not limited to the following:
§
Laboratory test request forms, specimen collection logs, instrument
printouts, reported results, records of quality control, proficiency testing
records, and quality management reports (quality indicators, audits, process
improvement projects) are retained for three years.
§
Method/instrument validation records are retained for the entire period
of using the method/instrument and three years after discontinued.
§
Maintenance records are retained for the life time of the instrument
and three years after retirement.
§
Employee identification records (signature, initials, identification
code, and inclusive dates of hiring) are retained for the entire period of hiring
and three years after departure.
§
Abnormal patients testing records (records of patients with antibodies,
transfusion reactions or special requirements), patient’s transfusion history,
transfusion reaction, and transfusion transmitted diseases investigation
records are retained permanently.
§ A sample retention policy to ensure that general laboratory specimens are retained under appropriate conditions, may be for the periods specified below:
§
Whole blood specimens and urine specimens are retained for twenty four
hours.
§
Serum, plasma, cerebrospinal fluid and other body fluids specimens are
retained for forty eight hours.
§
Permanently fixed and stained blood films are retained for seven days.
§
Permanently fixed and stained microbiology slides are retained for
seven days.
§ A process for internal (self) and external assessment of operations and quality management system.
§ Policies and procedures on quality indicators and systems checks
§ The implemented system covers the selection, data collection, reporting, and monitoring of quality indicators.
§ Selects and monitors key quality indicators covering the pre-analytical, analytical, and post-analytical phases of the laboratory operations.
§ Selected general laboratory indicators may include, but are not limited to, the following:
§
Patient identification errors
§
Rejected specimens
§
Turnaround Time (TAT) of routine, STAT and urgent requests.
§
Critical value reporting failures.
§
Customer satisfaction
§
Corrected laboratory reports.
§
Blood culture contamination
§ The laboratory has a comprehensive system for Proficiency Testing (PT) sufficient for the extent and complexity of the laboratory scope of services.
§ Policies and procedures on inventory management and tracking the use of critical materials, supplies, and reagents to ensure the following:
§
Materials are used within their expiration dates.
§
New reagents lot numbers are tested against old lots or suitable
reference materials before use.
§
Kit components are used within the kit lot number.
§
Lot number use is traceable to patient/blood donors or inclusive dates
of use
§ Policies and procedures to ensure that prepared/reconstituted reagents and solutions are labeled, as applicable, with:
§
Content STANDARDS Laboratory (LB)
§
Concentration/titer.
§
Preparation/reconstitution date
§
Expiration Date.
§
Storage requirements.
§ Laboratory supplies and reagents are stored under appropriate conditions.
§
Critical laboratory supplies and reagents are stored according to the
manufacturer’s recommendations under controlled conditions or in an appropriate
storage device.
§
Critical supplies and reagents storage conditions are continuously
monitored using appropriate temperature monitoring/recording system.
§ In the event of monitoring systems failure, the storage temperature is monitored and recorded every eight hours using a standardized thermometric device.
§ Policies and procedures describing the validation of critical laboratory equipment for its intended use, including:
§
Installation Qualification.
§
Operational Qualification.
§
Detailed functional validation study with predefined acceptance
criteria.
§
Critical laboratory equipment are not used before completing the
validation studies
§ Policies and procedures on test method validation, which may include but not limited to the following:
§
Verification of accuracy/precision.
§
Verification of sensitivity (lower detection limit).
§
Verification of carryover acceptability.
§
Verification of the Analytic Measurement Range (AMR).
§
Approval of the method for clinical use.
§ Policies and procedures on quality control of test methods to satisfy the following:
§
Assignment of performance and review responsibility (control specimens
are handled and tested in the same manner and by the same laboratory personnel
testing patient samples).
§
Number and frequency of running controls.
§
Tolerance limits of controls results.
§
Corrective action to be taken in the event of unacceptable results.
§ A comprehensive work instructions and procedures manuals that may include but not limited to the following:
§
Conform to the hospital document control/management system
§
Readily available at the work areas.
§
Prepared in accordance with the instrument operating manual, reagent
inserts and/ or manufacturer’s instructions.
§ Safety and infection control policies and procedures that are in compliance with the national and international laboratory safety standards as well as the hospital safety and infection control plan. Policies may include but not limited to the following:
§
Chemical hygiene plan
§
Mercury reduction/elimination plan
§
Mechanism of fumes and vapors monitoring.
§
Mechanism of compressed and flammable gases control.
§
Radiation safety plan.
§
Biological safety procedures and use of standard precautions.
§
Tuberculosis and other biological hazards exposure plan
§
Electrical safety plan.
§
Fire prevention and control plan.
§
Provision and use of Personal Protective Equipment (PPE).
§
Provision and control of negative pressure in sections dealing with
highly infectious materials.
§
Provision, use, and control of fume hoods.
§
Provision, use, and control of biological safety cabinets.
§
Provision of safety equipment (eye wash, emergency shower, fire
extinguisher, fire blanket, biological and chemical spill kits).
§
Waste disposal/control plan (chemical, biological and sharps) using
prick proof containers and leak proof bags.
§
Provision and use of first aid kits.
§ Reporting of infection and safety incidents.
§ The laboratory has safety and infection control training program that includes:
§
Initial training and competency assessment.
§ Annual training, recertification and competency assessment
§ The laboratory has a system for monitoring the laboratory safety and infection control program.
§
Documented safety and infection control audits are conducted at regular
pre defined intervals (at least twice yearly).
§
Findings of the audits are reported to the laboratory director, the
facility safety officer, the infection control department, and other concerned
parties
CPSA 14.B Imaging-PNRA license
A License from Pakistan
Nuclear Regulatory Authority is available.
CPSA 15. Backup Power supply
Documents to be attached;
1. Backup Power Supply Mechanism / Policy
Guidelines to develop back power supply policy /
mechanism
Backup
power supply policy may include but not limited to the followings is in place
and implemented:
§ The hospital has a utility system management plan.
§ The hospital has adequate number of qualified staff to manage the utility system.
§ Emergency plans are tested in simulation at least once a year and the test results are evaluated.
§ Ensures that emergency power covers the critical areas in case of failure.
§ An emergency power that covers at least the following critical areas:
§
Operating room.
§
Labor and delivery.
§
Critical care units.
§
Alarm system.
§
Fire pumps FMS.
§
Blood storage.
§
Medical gas system.
§
Refrigerators in the pharmacy, laboratory, medical store, and kitchen.
§
Elevators.
§
Escape routes/corridors.
§
Medications stores.
§ Emergency room.
§ The hospital ensures the readiness of its emergency power generator(s).
§
The hospital maintains its generator(s) on a periodic basis. The
maintenance results are documented.
§
The hospital performs weekly test without load for ten minutes.
§
The hospital performs monthly on load test for thirty minutes.
§
The hospital performs full load test every three years on external
load.
§
The hospital generator starts normally without load for ten minutes.
CPSA 16. Proper medical gas supply system
Documents to be attached;
1. Proper Medical Gas Supply System / Policy
Guidelines to develop Proper Medical Gas Supply
System / Policy
Proper
medical gas supply system / policy may include but not limited to the
followings is in place and implemented:
§ Documented arrangements for uninterrupted supply of Medical Gases
§ The hospital ensures proper maintenance of the medical gas system.
§ The medical gas system is regularly tested for
§
Pressure.
§
Leaks.
§
Functionality of valves, alarms, pressure gauge, and switches.
§ There is a policy and procedure that ensures effective use of medical gas system.
§ Compressed medical air is regularly tested for humidity and purity.
§ The central medical gas station is in a safe and secure place.
§ The outlets of medical gases in patient care areas are clearly marked with the type of gas and have different connections according to the gas type.
§ All medical gas pipes are clearly marked and labeled for the contents and direction of gas flow.
§ In case of gas pipe repairs or new extensions, outlets are tested for the type of gas to ensure the correct type is delivered through the new pipe.
§ Results of testing are recorded and maintained with engineering and the unit manager
§ The hospital keeps standby oxygen and medical air cylinders enough for forty eight hours of average consumption.
§ The gas cylinders are regularly tested for gas type, amount, and any leaks.
§ Emergency shut off valves are available in all units and are clearly marked with areas/rooms affected.
§ The hospital dedicates the responsibility of the closure of shut off valves to well trained individual(s) available in the unit concerned.
Annexure A
HCE Name: PHC Registration No. ________
|
Checklist for Submission of Documents of
Critical Patient Safety Areas (CPSA) |
|||
|
Sr # |
CPSA |
Document |
Document Uploaded |
|
1 |
Qualified
Human Resource as per Declared Scope of Services |
Services List |
Yes |
|
Staff list
including qualified doctors/ consultants/ specialists List of
doctors providing 24/7 coverage |
Yes |
||
|
2 |
Emergency
Services |
Emergency
SOPs |
Yes |
|
Emergency
Management Protocols/ guidelines |
Yes |
||
|
List of
Emergency Equipment |
Yes |
||
|
Training
Report |
Yes |
||
|
3 |
Safe Blood
Transfusion Services |
SOPs for
Blood Transfusion |
Yes |
|
PBTA
Registration/ License |
Yes |
||
|
Training
Report |
Yes |
||
|
4 |
Hospital
Infection Control |
Hospital
Infection Control Plan |
Yes |
|
Notification
of HIC Committee |
Yes |
||
|
Written
Process for Sterilization Validation |
Yes |
||
|
Training
Report |
Yes |
||
|
5 |
Operation
Theatre Surveillance |
OT SOPs |
Yes |
|
External OT
Swab Culture Report |
Yes |
||
|
List of of
equipment |
Yes |
||
|
Training
Report |
Yes |
||
|
6 |
Fire &
Non Fire Emergencies |
Fire &
Non Fire Emergency Plan |
Yes |
|
Documented
Safe Exit Plan |
Yes |
||
|
Training
Report |
Yes |
||
|
7 |
Hospital
Waste Management |
Hospital
Waste Management Plan |
Yes |
|
Notification
of HWM Committee |
Yes |
||
|
MOU for
Hospital Waste Disposal or Documented in-house Arrangements |
Yes |
||
|
Training
Report |
Yes |
||
|
8 |
Surgical
Services |
Documented
SOPs for Surgical Procedures |
Yes |
|
Documented
policies to prevent adverse events like wrong site, wrong patient and wrong
surgery |
Yes |
||
|
Training
Report |
Yes |
||
|
9 |
Anaesthesia
Services |
Documented
SOPs for Administration of Anaesthesia |
Yes |
|
Training
Report |
Yes |
||
|
10 |
Management of
Medication |
Documented
SOPs for Prescription |
Yes |
|
Documented
policy on verbal orders |
Yes |
||
|
Documented
Process for Safety of High Risk Medications |
Yes |
||
|
Training
Report |
Yes |
||
|
11 |
Continuous
Quality Improvement |
CQI Program |
Yes |
|
Designated
CQI Focal Person |
Yes |
||
|
Sentinel
Events are Defined |
Yes |
||
|
Training
Report |
Yes |
||
|
12 |
Medical
Records |
Documented
Process for Patient Unique Identification |
Yes |
|
Medical
Record Policy |
Yes |
||
|
Training
Report |
Yes |
||
|
13 |
Complaint Management
System |
Documented
Complaint Management System |
Yes |
|
Training
Report |
Yes |
||
|
14 |
Diagnostic
Services |
Lab Policy
Manual (SOPs) |
Yes |
|
PNRA License |
Yes |
||
|
Training
Report |
Yes |
||
|
15 |
Backup Power
supply |
Backup Power
Supply plan for all patient areas, OTs and Life Support Systems |
Yes |
|
16 |
Proper
medicalgas supply system |
Documented
arrangements for uninterrupted supply of Medical Gases |
Yes |
DECLARATION
I/We, the undersigned, do hereby solemnly affirm and declare that the information provided above is true and correct and the SOPs / Policies / Process provided are being implemented in true letter and spirit. I/ we also state that if any false or incorrect information is provided to the Commission, it may result in rejection of my/ our application for registration / License and I/ we may also be liable to be punished as per PHC Act 2010 and Regulations framed there under.
|
Name of MS /
CEO / Administrator |
Signature |
|
Designation: CEO |
Date Signed: |
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