Apex Quality Manual-Ashwini Ver 2
Apex Quality Manual-Ashwini Ver 2
No AH/PPM/AQM/50
Issue No 02
APEX QUALITY MANUAL Revision No 01
Date of Issue 20/07/2018
Revision done 19/07/2021
Date Created
Date of Implementation
Prepared by Designation:
Name:
Signature :
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AMENDMENT SHEET
No./Date of Section and Page Details of amendment Reason for amendment Signature of the
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The holder of the copy of this manual is responsible for maintaining it in good and safe condition and in a readily identifiable and
retrievable.
The holder of the copy of this Manual shall maintain it in current status by inserting latest amendments as and when the
amended versions are received.
Accreditation Coordinator is responsible for issuing the amended copies to the copyholders; the copyholder should acknowledge
the same and should return the obsolete copies to the Quality Department.
The amendment sheet, to be updated (as and when amendments received) and referred for details of amendments issued.
The manual is reviewed once a year and is updated as relevant to the hospital policies and procedures. Review and amendment
can happen also as corrective actions to the non-conformities raised during the internal audit or assessment audits done by
internal or external audit team respectively.
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TABLE OF CONTENTS
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Ashwini Hospital, established in 2006, is a leading medical institute providing quality medical education and standard
health care services. Its evolving growth is based on value added medical education & research. Multi specialty facilities
like Dialysis, CT Scan, MRI, Cath Lab along with ICU, ICCU, HDU, Semi – ICU are present. The hospital also teaches
the sensitive issues in medical science and health care with simultaneous emphasis on the introduction of technology in
critical surgery, diagnosis and life support systems. Ashwini Hospital has a total number of 150 beds, Ashwini Hospital
offers therapeutic care with a focus on preventive care for a healthy society. Ashwini Hospital has a promise to serve the
society with care and human touch.
Apex Quality manual as per the guideline of NABH Standard has been developed to strictly abide by the norms of Quality
management standards. We have developed an extremely patient friendly system of physicians, nurses and other care givers
who each and every day blends the miracle of compassion with the marvel of technology to make a real difference in the lives of
our patients.
2.1.1. Vision: Strive to establish an ideal Healthcare Delivery Institution based on Modern Technology and Quality
Training.
2.1.2. Mission: To provide safe, ethical, well researched and cost effective health care with compassion and dedication to
ensure complete patient satisfaction.
2.1.3. Quality Policy: Continuously strive to improve the quality of services by adopting latest technology to strengthen
the processes & procedures to achieve set objectives to meet international standards
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3. ORGANIZATION STRUCTURE:
The organization Structure has been defined to document the hierarchy, line of control, coordination. Organization Structure is
disseminated to Process owners to follow a line of control and command. Since Quality system is a Top to bottom approach
hence Quality initiative and control is managed by various committees also part of the Organization Structure.
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4. SCOPE OF SERVICES
1. SCOPE OF SERVICE IN THE INSTITUTE:
1.1. Policy: The policy outlines the scope of clinical and non clinical Services at Hospital.
1.2.1. Anesthesiology:
The Department of Anesthesiology provides comprehensive 24 hr services (on call basis) through a group of Anesthesiologists
in all surgical specialties according to the scope of services.
The range of services offered in the department includes:
1. Anesthesia for routine surgeries
2. Anesthesia for emergency surgeries
3. Post operative analgesia and pain relief
The following categories of day care surgeries are performed at the hospital:
1.2.3. Cardiology
The department of cardiology through its qualified and trained cardiologist provide following facilities:
1. Outpatient patient consultation services.
2. Inpatient care.
3. Round the clock Non-invasive Cardiology facilities – Echo, TMT, Holter
The department of Surgery at hospital provides comprehensive round the clock surgical services. The department provides
services for all general surgical procedures including advanced gastrointestinal surgeries, rectal surgeries and laparoscopic
procedures including advanced laparoscopic surgeries.
The general surgeons work closely with other specialists involved in each patient's care to diagnose and provide timely surgical
intervention for complex conditions.
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Facilities include:
a. Gastrointestinal surgeries
b. Minimal access surgeries including laparoscopic appendicectomy, gall bladder removal, and hernia repair
c. Anorectal surgeries
d. Thoracic surgeries
e. 24 hrs surgical consultant availability on call basis.
The department of Internal Medicine has full OPD coverage for addressing complaints related to all systems and treatment of
inpatients with problems related to respiratory, endocrine, diabetic complication.
The department also offers specialty services in infectious diseases by qualified specialists and support to other services such
as surgery, OB &G, gastroenterology and neurology for medical problem.
1.2.6. Nephrology
The department of nephrology has facilities like hemodialysis, peritoneal dialysis, AV fistula etc.
1.2.7. Neurology :
1.2.8. Neurosurgery
State of art facilities for care of head injured patients and other acute neurosurgical diseases are available. Various complicated
neurosurgical operations are undertaken.
a. Neuroendoscopy
b. Neuro-navigation & micro-neurosurgery.
c. Backache & Neck Pain
d. Brain & Spine Injury
e. Epilepsy surgery
f. Other ailments
g. Surgery for stroke
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1.2.9. Urology
Urology dept has treatment for all medical and surgical conditions (including TURP, TURB, stone removal etc.).
All cases regarding accident and emergency are dealt in this department. It has all emergency facilities like emergency crash
cart, oxygen cylinder, defibrillator, cardiac monitor etc.
2. Diagnostic Services:
The hospital’s laboratory located in the first floor of the hospital provides comprehensive round the clock on call basis 24 hours
in the following areas:
1. Hematology
2. Clinical Pathology
3. Biochemistry
4. Serology
5. Microbiology
6. Histopathology
2.2. Radiology
The Radiology department is committed to provide safe, reliable and speedy radio diagnostic support round-the-clock on call
basis. The department has facilities for all 'conventional' radiography, including bedside radiographs for the critically ill patient
who cannot be moved.
a. X ray
b. Ultrasonography
c. CT Scan
d. MRI
3. Physiotherapy:
The department of Physiotherapy aims at delivering the most suitable treatment for all movement problems due to an injury
conditions, in order to enhance over all function and quality of life .Our physiotherapists assess and treat people with injuries,
disabilities etc. They also emphasize on patient education to avoid injuries and maintain a fit, healthy body. The treatment
modalities are chosen based on their physical head and tail mode.
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4. Pharmacy Services:
The pharmacy at Hospital caters to the need of outpatients only. All inpatient pharmaceutical requirements are met by the
Medical Store of the hospital.
5. Dietetics
Dietary department facilities like counseling and nutritional assessment are done by the dieticians for the IPD patients as well as
OPD patients.
6. Patient accommodation
Rooms
All rooms are adequately lit and ventilated. The private and semiprivate rooms have nurse call system which is connected to the
central nursing station.
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2. Organ Transplant
3. PET CT
Patients are accepted if required service for patient is available otherwise patient/relatives are communicated and in case of life
threatening situation patient is stabilized and sent to higher Institution where Service is available.
The service available in the organization is provided as per the need of the community and as per the disease prevalence status
of the Community of Odisha and nearby regions. The State Medical Regulatory norms is strictly adhered to for providing
services. All patient care services are approved and inspected as per the set guidelines of Council. All these services have been
displayed in and around the hospital to guide the patient and their relative to easily locate the department/service. Pictorial
presentation and Vernacular language is ensured for all display. Staffs of each category are well trained and motivated to know
about the department and its scope.
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2. The minutes of the meeting would be circulated among the members of the committee after the meeting under the
signature of the Medical Superintendent & Chairperson of the Committee.
3. Incase required the chairperson of the Committee may invite a person not among the scheduled member for the
meeting.
4. Notice for all scheduling committee meeting would be circulated at least 48 hrs prior to the scheduled time and should
information pertaining to the agenda of the meeting. In case of Emergency Short notice may be made by the chairman
of the Committee Stating the reason for the same.
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4.2.4. TENURE OF THE COMMITTEE: One year from the date of issue. Revision of TOR and Composition shall be done
after the completion of year.
4.2.5. MINUTES: The minutes of the meeting will be sent to MS for perusal or action whenever necessary and will also be
circulated among the committee members
4.2.6. ADMINISTRATIVE INFORMATION: -
1. Same as above.
5. CODE BLUE COMMITTEE
5.2.1. COMPOSITION OF THE COMMITTEE
SL NAME OF MEMBERS DESIGNATION IN DESIGNATION IN SIGNATURE
NO INSTITUTION COMMITTEE
1 Dr. Manas Nayak Critical Care Chairperson
2 Dr. Priyadarshi Tripathy Consultant – Cardiology Member
3 Dr. B. K. Reddy Medical Superintendent Member
4 Dr. Prasanna K Mishra Anaesthesiology Member – Secretary
5 Mrs. Swapna Rani Jena DNS Member
6 Dr. Soumyaraj Ghosh Anesthesist Member
7 Ms. Neeraj Anjana Shekhar Asst. Manager ,Quality Coordinator
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7. To assess post event analysis of all Code Blue Cases and ensure implementation of Corrective and preventive
action
5.2.3. FREQUENCY OF MEETING: Monthly
5.2.4. TENURE OF THE COMMITTEE: One year from the date of issue. Revision of TOR and Composition shall be done
after the completion of year.
5.2.5. MINUTES: The minutes of the meeting will be sent to MS for perusal or action whenever necessary and will also be
circulated among the committee members
5.2.6. ADMINISTRATIVE INFORMATION: - Same as above.
5.3. PHARMACY & THERAPEUTIC COMMITTEE
5.3.1. COMPOSITION OF THE COMMITTEE
PHARMACY & THERAPEUTIC COMMITTEE
SL NAME OF MEMBERS DESIGNATION IN INSTITUTION DESIGNATION IN SIGNATURE
NO COMMITTEE
1 Dr. Maya Gantayet Sr. Consultant Neurology Member
2 Ms. Suma Devi Director - Finance Member
3 Dr. Sandip Pradhan Consultant ,General Surgery Chairperson
4 Dr. Biswaranjan Jena Consultant -Cardiology Member
5 Dr. Sampat Dash Consultant Pulmonology Member
6 Dr. Manas Nayak HOD – Anaesthesia Member
7 Dr. Bimal K Sahu Consultant Neurosurgery Member
8 Dr. B.K. Reddy Consultant Orthopaedic Surgeon Member
9 Dr. Soumyaraj Ghosh Critical care Member
10 Dr. Kirti Ketan Pradhan Dept. of Plastic Surgery Member
11 Dr. Sourav K Rout Maxillo- facial Surgeon Member
12 Mr. Subrat Parida Quality Team Coordinator
13 Mr. Braja Kishore Behera Incharge - Pharmacy Member - Secretary
14 Mr. Swapnarani Jena DNS Member
a. The Committee would ensure formulation of policies regarding evaluation, selection, and therapeutic use of drugs and
related devices.
b. To assign responsibility to monitor the use of inpatient pharmacy daily.
c. Set system for periodic educational and advisory capacity to the medical staff, pharmacy and administration in all
matters pertaining to the purchase, stocking, distribution, prescription and use of drugs.
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d. Develop the hospital formulary and recommend on a periodical basis drug formulations to be added /deleted on the
basis of their relative therapeutic merits and safety.
e. Ensure a proper system for storing, prescribing and dispensing of narcotics and controlled drugs.
f. Develop guidelines for the hospitals antibiotic policy and review on a periodical basis the use and misuse of antibiotics.
The committee will monitor misuse and abuse of antibiotics and will have the authority to cancel the irrational
prescriptions of antibiotics and bring the names of defaulters to the medical superintendent.
g. Establish programs and procedures to promote rational prescribing practices and cost effective drug therapy.
h. Initiate and direct drug use evaluation programs and studies, and review the result of such activities.
i. Monitor reasons for adverse drug reactions or incidences and make appropriate recommendations.
j. Recommend policies and procedures for drug evaluation and clinical trials and consider requests for such drug trials
on hospital patients.
k. Plan suitable educational programs for hospital professionals on matters related to drug use.
l. To review data on medication errors on monthly basis.
m. To ensure medication advice of all discharge summaries checked prior to discharge of patient.
n. To ensure drug charts checked for its legibility and accuracy.
5.3.2. FREQUENCY OF MEETING: Once in three months
5.3.3. TENURE OF THE COMMITTEE: One year from the date of issue. Revision of TOR and Composition shall be done
after the completion of year.
5.3.4. MINUTES: The minutes of the meeting will be sent to MS for perusal or action whenever necessary and will also be
circulated among the committee members
5.3.5. ADMINISTRATIVE INFORMATION: - Same as above.
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7. To undertake the process of reviewing credentials and recommending the appropriate scope of clinical practice for all
new applicants applying for scope of clinical practice to provide health care facility.
8. To conduct competency mapping of the doctors and nurses on a predefined criteria and based on the outcome Clinical
privileges are awarded to each and every Care provider.
9. To verifying current registrations, education, training, and experience
4.9.3. FREQUENCY OF MEETING: Twice in a year
4.9.4. TENURE OF THE COMMITTEE: One year from the date of issue. Revision of TOR and Composition shall be done
after the completion of year.
4.9.5. MINUTES: The minutes of the meeting will be sent to MS for perusal or action whenever necessary and will also be
circulated among the committee members
4.9.6. ADMINISTRATIVE INFORMATION: - Same as above.
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4.11.4. TENURE OF THE COMMITTEE: One year from the date of issue. Revision of TOR and Composition shall be done
after the completion of year.
4.11.5. MINUTES: The minutes of the meeting will be sent to MS for perusal or action whenever necessary and will also
be circulated among the committee members
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Sl no Name of licenses Licensing Status Regd. Number Date of Issue Date of Expiry
Authority
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1. Building occupancy certificate CDA Available B.P. No. 1362/11 13.01.2012 Life Time
2. No objection certificate from Odisha Fire Available Certificate No. 56/CR CTC 27.11.2020 26.11.2022
the Chief Fire Officer for Fire Service
Safety.
3. Authorization under BMW SPCB- Available 7984/SPBC 02.09.2020 31.03.2022
rules,2016,2018 Odisha
4. Agreement with Saniclean Agreement Available 28AA878131 20.02.2017 19.02.2027
under BMW rules
5 Consent for discharge of SPCB- Available RO/CTC/CTO.84/14 31.03.2025
Sewerage and trade effluent Odisha (Consent Order) 19.08.2020
of Water (Prevention and
control of pollution Act)
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E HDU Available
F Cardiology Available
Department
G Radiology Available
Department
11 RSO Approval under AERB
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6. CHAPTERWISE DOCUMENTATION:
6.1. ACCESS, ASSESSMENT AND CONTINUITY OF CARE (AAC)
6.1.1. AAC.1. The organization defines and displays the healthcare services that it provides.
6.1.1.1. Objective element
Commitment:
a. The healthcare services being provided are clearly defined and are in consonance with the needs of the
community.
b. Each defined healthcare service should have appropriate diagnostics and treatment facilities with suitably
qualified personnel who provide out-patient, in-patient and emergency cover.
c. Scope of the healthcare services of each department is defined.
d. The Organization’s defined healthcare services are prominently displayed.
6.1.2. AAC 2: The organization has a well-defined registration and admission process.
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6.1.3. AAC.3: There is an appropriate mechanism for transfer (in and out) or referral of patients.
6.1.3.1. Objective Elements:
Commitment:
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c.During transfer or referral, accompanying staff are appropriate to the clinical condition of the patient.
d.The organization gives a summary of the patient’s condition and the treatment given.
6.1.4. AAC.4: Patients cared for by the organization undergo an established initial assessment.
b. Initial assessment is performed by person qualified, registered and trained as applicable laws and regulations.
Doctors, nurses, dietician conduct the assessment as per the discipline and scope of practice. (Refer
Personnel file of Staff)
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c. Timeframe for the initial assessment for OP, IP & Emergency patient has been defined and monitored.
Emergency patient are to be assessed within 10 minutes to the arrival by CMO/registrar & within 5 minutes by
nurse. Similarly Indoor patients are to be assessed within 120 minutes by doctors in wards and 10 minutes by
intensivist in ICUs whereas assessment in wards shall be completed within 30 minutes by nurses and within 5
minutes by nurse in ICUs. Patient who comes to OP for consultation shall be assessed within 120 minutes of
registration in general OPD as well as in super specialty OPD. (Refer-AH/PPM/HWP/01)
e. Initial assessment of In-patients is documented within 24 hrs or as early as possible. Initial assessment for in-
patients covers history, progress notes, investigation ordered and treatment ordered and duly signed by
treating doctor.(Refer Medical Record )
f. Nutritional assessment is also a part of initial assessment and it covers the patient’s screening for nutritional
needs. Nutritional screening is done for all patients including OP and IP. Parameters for screening are defined.
Nutritional screening result to a detailed nutritional assessment. (Refer Medical Record)
g. Unit head or doctor of the team documents plan of care of the patient as per initial assessment results and
diagnostic results as available. Care plan is modified at the subsequent re-assessment if needed. Care plan of
the patient is countersigned by the Unit head of the patient within 24 hours of admission. (Refer Medical
Record )
6.1.5. AAC.5. Patients cared for by the organization undergo a regular reassessment.
6.1.5.1. Objective Elements:
a.CORE: Patients are reassessed at appropriate intervals to determine their response to treatment and to plan further
treatment or discharge.
b.Commitment: Out-patients are informed of their next follow-up, where appropriate.
c.Commitment:
d. For in-patients during reassessment the care plan is monitored and modified, where found necessary.
e. Staff involved in direct clinical care document reassessments.*
f. Patients are reassessed to determine their response to treatment and to plan further treatment or discharge.
g. The organization lays down guidelines and implements processes to identify early warning signs of change or
deterioration in clinical conditions for initiating prompt intervention.
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b. Doctors while assessing patient in OPD shall inform patient of their next follow up which is documented in
OPD record. .(Refer Medical Record )
c. Plan of care patient is subjected to be re-modified if needed during re-assessment. Revised plan of care is
documented in the medical record such as progress notes, orders. Patient or his attendant is kept informed in
case of change in plan of care. .(Refer Medical Record )
d. Re-assessment is documented by the Treating doctor or his team member. Reassessment is done to
determine their response to treatment and further plan for treatment or discharge.(Refer Medical Record )
6.1.6. Processes have been laid down to identify early warning signs of change or deterioration in clinical conditions for
initiating prompt interventions. Staffs are trained to respond and manage such situation. (Refer-AH/PPM/HWP/01)
6.1.7. AAC 6: Laboratory services are provided as per the scope of services of the organization.
6.1.7.1. Objective Elements:
a. Commitment: Scope of the laboratory services is commensurate to the services provided by the
organization.
b. The infrastructure (physical and equipment) is adequate to provide the defined scope of services.
c. Human resource is adequate to provide the defined scope of services.
d. Qualified and trained personnel perform, supervise and interpret the investigations.
e. Requisition for tests, collection, identification, handling, safe transportation, processing and disposal of
specimens is performed according to written guidance.*
f. Laboratory results are available within a defined time frame. *
g. Critical results are intimated to the personnel concerned at the earliest.
h. Results are reported in a standardized manner.
i. There is a mechanism to address the recall / amendment of reports whenever applicable*.
j. Laboratory tests not available in the organization are outsourced to the organization(s) based on their
quality assurance system*.
6.1.7.2. Policies for AAC 6:
a. Laboratory services are provided as per the scope of Services of the Hospital. Round of the clock laboratory
service is available.
b. Laboratory is a permanent structure having state of the art equipment and competent manpower. Laboratory has
been planned as per its functional requirements. Laboratory information system exist and used for day to day
operations.
c. Availability of manpower is as per the work load. Permanent Staff including technical staff is available
d. Trained and competent staff having registration of qualification is available to process and conduct tests. Senior
Doctors are available for the Laboratory and its different units
e. Written policy and procedure is followed for the operations of laboratory. Procedure for ordering tests, collection,
identification, handling, safe transportation, processing and disposal of specimens is done as laid down in the
Manual of operations. ( Refer: AH/PPM/LS/14)
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f. Turnaround time for the tests is available for the different tests of the laboratory. Critical results have been defined
and followed. Immediate attention for patient management is done after the notification of critical values to the
concerned department.
g. All in house reports are generated through LIS (Laboratory Information System) and provided to patient after
authentication of person reporting the test. Parameters for the reporting has been defined and followed.
Outsourced laboratory results are also reported in a standardized manner by incorporating all relevant details.
h. Process to address recall/amendment of reports due to pre-analytical and post analytical error is followed.
Reports having error details are recalled /withdrawal from clinical areas, medical records, LIS and amended report
is issued with the caution to ignore the previous report. ( Refer: AH/PPM/LS/14)
i. Hospital has entered through an agreement with various external laboratory based on their Quality assurance
system. Documented procedure for outsourcing tests has been laid down and followed. Information of list of tests
outsourced, details of authorized personnel in the outsourced facilities, Turnaround time, Quality check of
outsource laboratory is documented ( Refer: AH/PPM/LS/14)
6.1.8. AAC 7: There is an established laboratory quality assurance programme.
a. Quality assurance programme for laboratory service is documented and followed. Internal quality control,
EQAS, Inter lab comparison, validation and verification of test methods and results is done. Feedback from
treating doctor is also obtained regularly to assess the level of their satisfaction on reporting and results
acceptance. Refer (AH/PPM/LQA/15)
b. Surveillance of laboratory results like controls, external and internal quality assurance results, and non
conformances resulting from process is periodically assessed by Laboratory Director.
c. Calibration and maintenance of equipment is done by the qualified engineer. Traceability certificate of all
calibration done is maintained in the equipment file. User level preventive maintenance is done daily whereas
Company level maintenance is done at periodical interval. Corrective and preventive action of any process
failure is taken and documented.
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d. Written policies and procedures are available and followed to ensure correct patient identification, safe and timely
transportation of patients to and from the imaging areas. Patient details are verified and approved prior to any procedure.
Refer (AH/PPM/RS/13)
e. Turnaround time for the imaging results has been developed and followed for reporting. Turnaround time is monitored by
the department. Refer (AH/PPM/RS/13)
f. Critical results those require immediate attention of clinicians is identified and defined. Staff working in the department is
made aware to report critical results to the concerned department for necessary treatment management of the patient. All
such notification of critical results is documented by the radiology. Refer (AH/PPM/RS/13)
g. All in house reports are generated under the supervision of radiologist and provided to patient after authentication of
person reporting the test. Parameters for the reporting has been defined and followed. Outsourced tests are also reported
in a standardized manner by incorporating all relevant details and hospital does not alter anything in the report.
h. Process to address recall/amendment of reports due to error at any level is followed. Reports having error details are
recalled /withdrawal from clinical areas, medical records and amended report is issued with the caution to ignore the
previous report. Refer (AH/PPM/RS/13)
i. Hospital has entered through an agreement with various external laboratory based on their Quality assurance system.
Documented procedure for outsourcing tests has been laid down and followed. Information of list of tests outsourced,
details of authorized personnel in the outsourced facilities, Turnaround time, Quality check I of outsource laboratory is
documented. Refer (AH/PPM/RS/13)
6.1.11. AAC 10: There is an established quality assurance programme for imaging services.
6.1.11.1. Objective Elements:
a. Commitment : The quality assurance programme for imaging services is implemented.
b. Quality assurance programme includes tests for imaging equipment
c. Quality assurance programme includes the reviews of imaging protocols.
d. Achievement:A system is in place to ensure the appropriateness of the investigations and procedures for the clinical
indication.
e. The programme addresses periodic internal / external peer review of imaging results using appropriate sampling.
f. Excellence:The programme addresses the clinico-radiological meetings.
g. Commitment: The programme includes periodic calibration and maintenance of all equipment.
h. The programme includes the documentation of corrective and preventive actions.
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d. Calibration and maintenance requirement of equipment is done as per AERB guideline as well as manufacturer
recommendations. Trained Bio medical engineer/agency is involved to carry out such activities. Traceability certificate of
all calibrations done by using calibrated equipment is maintained by the In-house Bio Medical Engineering department.
Corrective and preventive action of any process failure is taken and documented.
6.1.12. AAC 11: There is an established safety programme in the Imaging services.
6.1.12.1. Objective Elements:
a Commitment:The radiation-safety programme is implemented. *
d Imaging personnel and patients use appropriate radiation safety and monitoring devices where
applicable.
e Radiation-safety and monitoring devices and are periodically tested and results are documented.*
f Imaging and ancillary personnel are trained in imaging safety practice and radiation-safety measures.
a. Radiation Safety programme is documented and available to the department. Radiation Safety provision for high end
radiation prone equipments like CT machine is available. Refer (AH/PPM/RS/13)
b. Imaging safety programme is aligned with the safety programme of the hospital. Principles of safety is followed and uniform
as that of the hospital’s safety programme like Fire safety, Electrical Safety, Environmental safety, Safe transportation of
patient, Medication safety, Occupational hazard management, Bio waste management
c. Patients are educated and made aware of safety procedure prior to imaging in particular modality like MRI, CT and X-ray.
Attendants accompanying patient is also educated on safety norms. Informed consent is obtained prior to contrast injection,
moderate deep sedation etc
d. Bio medical waste management guidelines are adhered for handling, usage, and disposal of hazardous materials. MSDS
(Material Safety data sheet) is maintained by the department and well aware of action to be taken in case of exposure.
e. Required Safety devices as advised by AERB guidelines are available and used by the staff of department
f. Radiation monitoring devices (TLD badges), Lead aprons are available for every staff and periodically tested and checked.
Refer (AH/PPM/RS/13)
g. Each and every staff of the department are suitably trained on radiation safety practices at periodical interval by the
Radiation Safety officer. Record of the training is maintained in staff’s personal file.
h. Imaging Signage has been displayed in strategic locations of the department.
a. Commitment : During all phases of care, there is a qualified individual identified as responsible for the patient’s care.
b. Patient care is coordinated in all care settings within the organization.
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c. Information about the patient’s care and response to treatment is shared among medical, nursing and other care-providers.
d. CORE : The Organisation implements standardized hand-over communication during each staffing shift, between shift and
during transfers between units/departments.
e. Commitment:Patient transfer the Organisation is done safely in a safe manner.
f. Referral of patients to other departments / specialities follow written guidance.
g. Achievement: The organization ensures predictable service delivery by adhering tom defined timelines and informs the
patient/family and/or caregiver whenever there is a change in schedule.
h. The organization has a mechanism in place to monitor whether adequate clinical intervention has taken place in response to
a critical value alert.
6.1.13.2. Policies for AAC 12:
a. To maintain continuity of care throughout the patient’s stay in the hospital, the Doctor, nurses with overall
responsibility for coordination and continuity of the patient’s care or particular phase of the patient’s clearly
identified. The responsible individual category of staff is identified in the patient’s record. Care of the patient is
coordinated among various credential and competent staff. All these communications are clearly documented in
the medical record.
b. Medical and Nursing professionals periodically review patient response to the treatment and plan of care is
developed and followed in a coordinated approach.
c. Handover among doctors and nursing professionals are done to exchange information related to patient related
care during each shift, between shift and during transfers between units, departments. Record for the same is
maintained.
d. Safety during patient transfer is followed. Safety belts are used before transferring. Patient / attendant is made
aware of the purpose of transfer. Handover and taken over of transfer is maintained
e. Documented policy and procedure for the referral of patients to other department and specialties is available.
(Refer-AH/PPM/HWP/01)
f. Patients and relatives are informed about any change in waiting time, reason for waiting in defined activity to
ensure continuity of care.
g. Critical values of diagnostic results are reported to the doctors of concerned inpatient area for necessary care
management of concern patient. Response of doctor to intervene on the result of critical values are recorded and
reviewed by the Nursing Superintendent and report to the Quality Assurance Committee
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6.1.15.1.Objective Elements:
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6.2.1.1. COP.1: Uniform care to patients is provided in all settings of the organization and is guided by written
guidance, and applicable laws and regulations.
Objective Elements:
a. Commitment: Uniform care is provided following written guidance.
b. CORE: The organization has a uniform process for identification of patients and at a minimum, uses two
identifiers.
c. Commitment: Care shall be provided in consonance with applicable laws and regulations.
d. Achievement: The organization adapts evidence-based clinical practice guidelines and/or clinical protocols to
guide uniform patient care.
e. Excellence: Clinical care pathways are developed, consistently followed across all settings of care, and
reviewed periodically.
f. Commitment: Care delivery is uniform for a given clinical condition when similar care is provided in more than
one setting.
g. Excellence: Multi-disciplinary and multi-specialty care, where appropriate, is planned based on best clinical
practices/clinical practice guidelines and delivered in a uniform manner across the organization.
h. Commitment: Telemedicine facility is provided safely and based on written guidance.
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b. Evidence based clinical protocols are followed by care providers in their respective field to ensure uniform
patient care is maintained. All clinical staff are sensitized through training with the knowledge and skills to
recognize and intervene when patient assessments identify physiological signs that are outside of the normal
range, indicating a potential for patient deterioration. Early response to changes in a patient’s condition is critical
to potentially preventing further deterioration. Hospitals follow a systematic approach to early recognition and
intervention of patients whose condition is deteriorating may reduce cardiopulmonary arrests and patient
mortality.
6.2.2. COP.2: Emergency services are provided in accordance with written guidance, applicable laws and
regulations.
a. Commitment: There shall be an identified area in the organization which is easily accessible to receive and
manage emergency patients, with adequate and appropriate resources.
b. Achievement: Prevention of patient over-crowding is planned, and crowd management measures are
implemented.
c. CORE: Emergency care provided in consonance with statutory requirements and in accordance with the written
guidance.
d. Commitment: The organization manage medico-legal cases in accordance with statutory requirements.
e. Initiation of appropriate careis guided by a system of triage.
f. Patients waiting in the emergency are reassessed as appropriate for change in status..
g. Admission, discharge to home ,or transfer to another organization is documented..
h. In case of discharge to home or transfer to another organization, a discharge/ transfer note shall be given to
the patient.
i. Achievement: The organization shall implement a quality assurance programme..
j. Commitment: The organization has systems in place for the management of patients found dead on arrival and
patients who die within a few minutes of arrival.
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trained nurse. The triage process includes physiologic based criteria, where possible and appropriate. The
hospital trains staff to determine which patients need immediate care and how their care is given priority.
d. All Doctors and nurses working in the department is ACLS trained whereas attendant, Ambulance driver,
security guards and housekeeping staff are trained on BLS.
e. Evidenced based admission and discharge criteria to home or transfer to another organization is documented.
Patient with an emergency condition and the patient require transfer to a higher level of care, is stabilized
transferred after within our best capacity prior to transport. Refer (AH/PPM/ES/09)
f. Quality and Safety requirement of the department is documented and followed. Patient safety related to
transferring unstable patient, initiating treatment, Fire Safety measures, disaster management, monitoring of
outcome is part of its quality and safety requirement. Departmental HOD plays major role in inculcating
evidence based guideline in the department. Refer (AH/PPM/ES/09)
g. Brought dead policy is available and strictly followed. This includes following
1. Maintaining a log book of patients found dead on arrival
2. Police intimation and medico legal issues
3. Decision to suggest post mortem
4. Temporary storage of body in proper condition
5. Registration process
6. Documentation
COP.3: The ambulance services ensure safe patient transportation with appropriate care.
Objective Elements:
a.Commitment: The organisation has access to ambulance services commensurate with the scope of the services provided
by it.
b.There are adequate access and space for the ambulances.
c. The ambulance(s) is fit for purpose and is appropriately equipped..
d. The ambulance(s) is by trained personnel..
e.The ambulances is checked daily.
f. Equipment is checked daily using a checklist.
g. A mechanism is in place to ensure that emergency medications are available the ambulance
h. The ambulances has a proper communication system..
i. The emergency department identifies opportunities to initiate treatment at the earliest when the patient is in transit to the
organization.
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f. There is a provision of communication system for ambulances of hospital. Whole process of patient transportation is
communicated and coordinated by the communication system. Staff of ambulance is given mobile phone. Communication
made by mobile phones to the emergency department is documented in ambulance trip sheet.
g. There is a process for the ambulance where patient treatment is initiated at the earliest when patient is in transit to
hospital. Patient condition is communicated by the staff of ambulance to the emergency doctor. Necessary arrangement
is done based on the first assessment of patient by the staff of ambulance. Refer (AH/PPM/AS/03)
6.2.3. COP.4: The organization plans and implement mechanisms for the care of patients during community emergencies,
epidemics and other disasters.
COP.5: Cardio-pulmonary resuscitation services are provided uniformly across the organization.
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c. All the activities along with personnel details, events of CPR are recorded during actual CPR. Response time of
code blue team, availability of equipment, medicine and other details are recorded for the analysis and
necessary action. Outcome of all CPR given is analyzed by Code Blue Committee within 3 working days.
Corrective and preventive action as suggested by Code blue committee is taken.
6.2.4. COP.6: Nursing care is provided to patients in the organization in consonance with clinical protocols
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e. Informed consent is taken by the personnel performing the procedure, where applicable.
f. The procedure is done adhering to standard precautions.
g. Patients are appropriately monitored during and after the procedure.
h. Procedures are documented accurately in the patient record.*
6.2.6. COP.8: Transfusion services are provided as per the scope of services of the organization, safely.
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c. Periodic training is conducted for doctors and nurses by the I/C – Transfusion Services. Evidenced based
guideline for transfusion service is communicated through training programme.
6.2.7. COP.9: The organization provides care in intensive care and high dependency units in a systematic manner.
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b. The organization identifies and provides care to high-risk obstetric cases, and where needed, refers them to
another appropriate Centre.
c. Persons caring for high-risk obstetric cases are competent.
d. Ante-natal services are provided.
e. Obstetric Patients assessment also includes maternal nutrition.
f. Appropriate peri-natal and post-natal monitoring is performed.
g. The organization caring for high-risk obstetric cases has the facilities to take care of neonates of such cases.
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6.2.10.1.Objective Elements:
a. Commitment: Procedural sedation is administered in a consistent manner.
b. Informed consent for administration of procedure sedation is obtained.
c. Competent and trained persons administer sedation.
d. The person monitoring sedation is different from the person performing the procedure.
e. Intra-procedure monitoring includes at a minimum the heart rate, cardiac rhythm, respiratory rate, blood
pressure, oxygen saturation, and level of sedation.
f. Patient are monitored after sedation, and
g. Criteria are used to determine the appropriateness of discharge from the
observation/recovery area. *
h. Equipment and workforce are available to manage patients who have gone into a deeper level
of sedation than initially intended.
10.2.1. COP.13: Anaesthesia services are provided in a consistent and safe manner
10.2.1.1.Objective Elements:
a.Anaesthesia services are provided in consistent and safe manner
b. The pre-anaesthesia assessment results in the formulation of an anaesthesia plan which is documented
c. A pre-induction assessment is performed and documented.
d The anaesthesiologist obtains informed consent for administration of anaesthesia.
e.During anaesthesia, monitoring includes regular recording of temperature, heart rate, cardiac
rhythm, respiratory rate, blood pressure, oxygen saturation and end- tidal carbon dioxide.
f. Patient's post-anaesthesia status is monitored and documented.
g. The anaesthesiologist applies defined criteria to transfer the patient from the recovery area. *
h. The type of anaesthesia and anaesthetic medications used are documented in the patient
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record.
i. Procedures shall comply with infection control guidelines to prevent cross- infection
between patients.
j. Intraoperative adverse anaesthesia events are recorded and monitored.
11. Policy and Procedure for the administration of anaesthesia is available. Refer AH/PPM/AC/01
12. Administration of anesthesia is carefully planned. The patient’s pre-anesthesia assessment is done by the Qualified
anaesthesiologist by selecting type of anaesthesia and anaesthesia care plan, Safely administer an anesthetics and
interpret findings of patient including monitoring.
13. The pre-anaesthesia process is carried out in a shortened time frame when an emergency or obstetrics patient requires
anesthesia. As the pre-anaesthesia assessment is carried out some time prior to admission or prior to the surgical
procedure. Patients are re-evaluated immediately before the induction of anaesthesia. Any changes in the plan are
documented with reason.
14. An informed consent is obtained from the patient/patient’s attendant prior to administration of anaesthesia. Patient and
family members are clearly educated on the risks, benefits and alternatives of anaesthesia by the anaesthesiologist prior
to documentation of consent. Anaesthesia consent is not clubbed with surgical consent.
15. Regular monitoring record of the patient is documented during anesthesia which includes monitoring of temperature,
heart rate, cardiac output, respiratory rate, blood pressure, oxygen saturation and end tidal carbon dioxide.
Anaesthesiologist is made available throughout the procedure. Patient’s post anaesthesia status is monitored and
documented by the anaesthesiologist.
16. Defined criteria are available and followed to transfer the patient from the recovery area. Refer AH/PPM/AC/01
17. Infection control requirements are strictly followed to prevent cross infection between patients.
18. Adverse anaesthesia events are recorded and monitored.
.
18.2.1.1.Objective Elements:
a. Surgical services are provided in a consistent and safe manner. *
b. Surgical patients have a preoperative assessment, a documented pre-operative diagnosis, and pre-
operative instructions are provided before surgery.
c. Informed consent is obtained by a surgeon before the procedure.
d. Care is taken to prevent adverse events like the wrong site, wrong patient and wrong surgery. *
E. An operative note is documented before transfer out of patient from recovery.
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i. Operation theater complex is planned accordance to its functional flow. Provision of receiving area, pre-operative holding,
separate change room, clean utility, hand washing areas, operating rooms, waiting area, disposal zone, recovery room etc.
Adequate equipment and accessories for performing anaesthesia and surgical care is made available.
j. Quality assurance programme for Operating theatre complex is strictly followed. This includes safety, infection control,
monitoring outcome indicators, environmental safety, air conditioning norms, medication safety and antibiotic usage etc
k. Surveillance of Operation theatre complex is carried out as per the infection control procedure of the area. This includes
monitoring of Air quality, environmental culture, water quality, six monthly monitoring of integrity of HEPA filters etc.
l.
COP.16: The organisation identifies and manages patients who are at higher risk of morbidity/
mortality.
b. The organisation provides for a safe and secure environment for the vulnerable patient.
c. The organisation identifies and manages patients who are at a risk of fall.*
d. The organisation identifies and manages patients who are at risk of developing/worsening of
pressure ulcers.*
e. The organisation identifies and manages patients who are at risk of developing deep vein thrombosis.*
F. The organisation identifies and manages patients who need restraints. *
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d. Pain alleviation measures or medications are initiated and titrated according to the patient's need and
response
a.Scope of the rehabilitation services at a minimum is commensurate to the services provided by the
organisation.
b. Rehabilitation services are provided in a consistent manner.
c. Care providers collaboratively plan rehabilitation services.
d. There are adequate space and equipment to provide rehabilitation.
e. Care is guided by functional assessment and periodic re-assessments which are done and
documented.
f. Care is provided adhering to infection control and safety practices.
g. Care pathways are developed, implemented, and reviewed periodically.
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Objective Elements:
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c. Informed consent from concerned patient is obtained prior to the initiation of any research activities. Patient has the right to
withdraw from the research any stage.
6.2.22. COP.21: Documented policies and procedures guide nutritional therapy.
6.2.22.1. Objective Elements:
a. Policies and procedure is available to guide nutritional therapy including assessment and re-assessment of the patient.
Refer AH/PPM/NDS/32
b. Patient receives diet as per the diet order. Nutritional assessment is done by qualified dietician for all patient found at risk
during nutritional screening.
c. Nutritional therapy of patient is planned and provided in a collaborative manner. This includes involvement of treating
doctor & patient and patient’s relative after taking into regard patient’s food habit
d. Written diet order is generated for each patient in diet order sheet and patient receives food according to the diet order.
Patient receives food according to their clinical needs. Treating doctor’s advice is taken into consideration while planning
patient’s diet. Provision for diabetic diet, high protein diet, total parenteral nutrition etc
e. Food is safely prepared, stored and distributed in a safe manner. Covered Food trolleys are used for carrying prepared
food to the inpatient area. Kitchen area has been designed as per the functional requirement. Dedicated food storage area,
refrigerator for perishable item, separate cleaning and washing area.
6.2.23. COP.22: Documented policies and procedures guide the end of life care.
6.2.23.1. Objective Elements:
a. Documented policies and procedures guide the end of life care.
b. These policies and procedures are in consonance with the legal requirements.
c. These also address the identification of the unique needs of such patient and family
d. Symptomatic treatment is provided and where appropriate measures are taken for the alleviation of pain.
e. Staff are educated and trained in end of life care.
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b. A multidisciplinary committee guides the formulation and implementation of pharmacy services and
medication usage.
b. There is a mechanism in place to facilitate the multidisciplinary committee to monitor literature
reviews and best practice information on medication management and use the information to
update medication management processes.
c. There is a procedure to obtain medication when the pharmacy is closed. *
6.3.1.2. The organisation has a mechanism to inform relevant staff of key changes in pharmacy services and
medication usage to ensure uninterrupted and safe care
6.3.1.3. Policies for MOM 1:
a. Policy and Procedure for medication management is available and followed. Policy addresses all issues starting from
procurement, storage, formulary, prescription, dispensing, administration, monitoring and use of medication in hospital.
Refer AH/PPM/MOM/12
b. Policy and procedures meet the regulatory obligations of the Drugs and cosmetic Act, Pharmacy Act, Narcotic and
psychotropic substance Act & drugs and magical remedies Act etc
c. There is a Drugs and Therapeutic committee where major clinical and administrative heads are available to take decision
on the formulation and implementation of policies and procedure applicable. Committee meeting is conducted as per the
Terms of reference approved by the management.
d. Pharmacy of the hospital runs for 24 hours basis
.
6.3.2. MOM.2 The organisation develops, updates and implements a hospital formulary.
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d. Procurement of medicine as per the details of formulary is done from approved vendors after vendor evaluation. Re-order
level and safety stock of these medicines are developed and followed to avoid untoward situation. Procurement process of
the hospital is followed for the procurement of the medicine in a timely manner. Refer AH/PPMPSM/37
e. Procedure for Local purchase is available to guide the staff in case medication listed in the formulary is not available. Local
purchase is approved by Medical Superintendent. All details pertaining to local purchase of medicine is maintained and
produced to drugs and therapeutic committee to evaluate and authorize on its subsequent inclusion in formulary. Refer
AH/PPMPSM/37
MOM.3: Medications are stored appropriately and are available where required
6.3.2.3. Objective Elements:
a.Medications are stored in a clean, safe and secure environment; and incorporating the
manufacturer's recommendation(s).
b.Sound inventory control practices guide storage of the medications throughout the organisation.
c.The organisation defines a list of high-risk medication(s). *
d.High-risk medications are stored in areas of the organisation where it is clinically necessary.
e.High-risk medications including look-alike, sound-alike medications and different concentrations of
the same medication are stored physically apart from each other. *
f. The list of emergency medications is defined and is stored uniformly. *
g.Emergency medication are available all the time and are replenished promptly when used.
d.
6.3.2.4. Policies for MOM 3:
a. Policy and procedure for the storage of the medicine is available which address issues related to provision of ambient
temperature of room, refrigeration condition, light, ventilation, pest control. Storage of the medicine is done in neat and
clean & secure environment in the shelves. Medicines are stored alphabetically and labels, dangerous drugs and look alike
sound alike medicines are stored separately in controlled area. Vaccines are kept in vaccine refrigerator with appropriate
temperature and with the provision of monitoring. Refer AH/PPM/MOM/12
b. Sound inventory practices are followed for the storage and dispensing of medication in OP Pharmacy, Central Pharmacy
and in indoor units wherever medicine is stored. Inventory control technique like ABC, VED, FSN, and FIFO methods are
followed for proper management of inventory. Free samples are not allowed to be stored in patient care areas. Clinicians
are asked to take sample medications for their use. These medicines are declared out of the regular inventory. Refer
AH/PPMPSM/37
c. Emergency medicine is defined and made available with optimum level always for the hospital and it is uniform across the
hospital. Quantity of emergency medicine varies from place to place depending upon the consumption and requirement.
Dedicated storage area has been identified and created in every in patient unit to safely storing these medicines. Labeling
of these medicines has been done to clearly visualize staff. Emergency medicine are used and re-stocked in a timely
within 2 hours to avoid shortage. Inventory of emergency medicines are checked on daily basis.
6.3.3. MOM.4: Documented policies and procedures guide the safe and rational prescription of medications.
6.3.3.1. Objective Elements:
a. Documented policies and procedures exist for prescription of medications.*
b. These incorporate inclusion of good practices/guidelines for rational prescription of medications.
c. The organization determines the minimum requirements of a prescription.*
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a. Documented policies and procedures guide the safe dispensing of medications. This includes route of administration,
dosage, rate of administration, expiry date etc. Physician samples are not stored and sold. Refer AH/PPM/MOM/12
b. Medication recall procedure exists. Medicine recall from internal source is intimated to appropriate regulatory authority
Refer AH/PPM/MOM/12
c. Procedure for near expiry medicine is available. Medicines having three months left prior to the expiry date is considered
as near expiry medicine. These medicines are returned to distributor. Refer AH/PPM/MOM/12
d. Labeling requirements are documented and implemented. This includes labeling with drug name, strength, frequency of
administration, and expiry dates. This is done from the dispensing area where medications are dispensed either as cut
strips or from bulk containers.
e. All high risk medications are double checked by the two staff prior to dispensing. This is applicable both in Pharmacy as
well as in inpatient areas.
6.3.5. MOM.6: There are documented policies and procedures for medication administration.
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a. Documented policies and procedures guide the monitoring of patients after medication administration
b. The organisation defines those situations where close monitoring is required
c. Monitoring is done in a collaborative manner.
d. Medications are changed where appropriate based on the monitoring.
6.3.6.2. Policies for MON 7:
a. Policy and procedure to guide monitoring of patient after medication administration is available. This includes verification
of intended effect of medication, adverse drug events and medications errors if any. Refer AH/PPM/MOM/12
b. Situations have been defined where close monitoring of patient is required after medication administration. This includes
while administrating high risk medication, concentrated electrolyte, chemotherapeutic drugs etc. Monitoring of the patient
is done in a collaborative manner Refer AH/PPM/MOM/12
a. Medications are changed where appropriate based on the results of monitoring and patient’s clinical condition.
6.3.7. MOM.8: Near misses, medication errors and adverse drug events are reported and analyzed.
6.3.7.1. Objective Elements:
a. Documented procedure exists to capture near miss, medication error and adverse drug event.*
b. Near miss, medication error and adverse drug event are defined.*
c. These are reported within a specified time frame. *
d. They are collected and analyzed.
e. Corrective and/or preventive action(s) are taken based on the analysis where appropriate.
6.3.7.2. Policies for MOM 8:
a. Procedure available to capture near miss, medication error and adverse drug event. Staff are trained and sensitized to
capture these events for further analysis and remedial measures.
b. Near miss, medication error and adverse drug events have been defined. Refer AH/PPM/MOM/12
c. If medication error and adverse drug event causes harm to patient then it is reported to treating doctor and chairman of
drugs and therapeutic committee as soon as possible for analysis and action whereas near miss events are reported within
24 hours of incidence. Corrective and preventive actions are taken based on the analysis and findings.
6.3.8. MOM.9: Documented procedures guide the use of narcotic drugs and psychotropic substances.
6.3.8.1. Objective Elements:
a. Documented procedures guide the use of narcotic drugs and psychotropic substances which are in consonance with local
and national regulations.*
b. These drugs are stored in a secure manner.
c. A proper record is kept of the usage, administration and disposal of these drugs.
d. These drugs are handled by appropriate personnel in accordance with the documented procedure.
6.3.8.2. Policies for MOM 9:
j. Storage and record keeping of narcotic issues, administration, usage and disposal is done as per the statutory requirement
of Narcotic drugs and psychotropic substances Act. Refer AH/PPM/MOM/12
a. Narcotic drugs are securely stored under the provision of double lock and key and staff is identified in every shift for the
responsible of accounting and storage.
b. Only registered Doctors, pharmacists and nurses are allowed to prescribe, handle and use of narcotic drugs as per their
respective domain.
6.3.9. MOM.10: Documented policies and procedures guide the usage of chemotherapeutic agents.
6.3.9.1. Objective Elements:
a. Documented policies and procedures guide the usage of chemotherapeutic agents.*
b. Chemotherapy is prescribed by those who have the knowledge to monitor and treat the adverse effect of chemotherapy
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c. Chemotherapy is prepared in a proper and safe manner and administered by qualified personnel.
d. Chemotherapy drugs are disposed in accordance with legal requirements.
e. Patient and family are educated regarding benefits/risks of chemotherapy, precautions to be taken and possible adverse
reactions.
6.3.9.2. Policies for MOM 10:
a. Policy and procedure for the usage of chemotherapeutic agent is available. Refer AH/PPM/MOM/12
b. Chemotherapy is prescribed by medical oncologist having competency level to do so.
c. Safe environment is available to prepare chemotherapy drugs. Bio-Safety cabinet is available and used for the preparation
and mixing of chemotherapeutic agent.
d. Chemotherapeutic drugs are disposed as per the bio medical waste management and handling rules under cytotoxic
category.
e. Patient and family are educated regarding benefits/risks of chemotherapy precautions and its possible reaction. Doctors
and nursing staff of the unit are actively involved in explaining the benefits and risk and precaution
6.3.10. MOM.11: Documented policies and procedures govern usage of radioactive drugs.
6.3.10.1. Objective Elements:
a. Documented policies and procedures govern usage of radioactive drugs
b. These policies and procedures are in consonance with laws and regulations.
c. The policies and procedures include the safe storage, preparation, handling, distribution and disposal of radioactive drugs.
d. Staff, patients and visitors are educated on safety precautions.
6.3.10.2. Policies for MOM 11:
a. Radioactive drugs use is beyond the scope of service of the hospital.
6.3.11. MOM.12: Documented policies and procedures guide the use of implantable prosthesis and medical devices.
6.3.11.1. Objective Elements:
a. Usage of implantable prosthesis and medical devices is guided by scientific criteria for each individual item and
national/international recognized guidelines/ approvals for such specific item(s).
b. Documented policies and procedures govern procurement, storage/stocking, issuance and usage of implantable
prosthesis and medical devices incorporating manufacturer’s recommendation(s).*
c. Patient and his/her family are counselled for the usage of implantable prosthesis and medical device including precautions,
if any.
d. The batch and serial number of the implantable prosthesis and medical devices are recorded in the patient’s medical
record, the master logbook and the discharge summary.
6.3.11.2. Policies for MOM 12:
a. Selection of implantable prosthesis and medical devices are done based on following criteria (1)Selection of devices based
on available science and research (2)Special privileges for the surgeon and special training for the surgical team (3)
Unique infection control considerations (4) Special discharge instructions to the patient and the traceability of devices in
the event of a recall (5) approved from international or national body of the particular product Refer AH/PPM/MOM/12
b. Policies and procedure is available to guide procurement, storage/stocking, issuance and usage of implantable prosthesis
and medical devices Refer AH/PPM/MOM/12
c. Batch and serial number of implantable prosthesis and medical devices are recorded in the patients medical record and
the master log book and discharge summary.
6.3.12. MOM.13: Documented policies and procedures guide the use of medical supplies and consumables.
6.3.12.1. Objective Elements:
a. There is a defined process for acquisition of medical supplies and consumables.*
b. Medical supplies and consumables are used in a safe manner, where appropriate
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c. Medical supplies and consumables are stored in a clean, safe and secure environment; and incorporating manufacturer’s
recommendation(s).
d. Sound inventory control practices guide storage of medical supplies and consumables.
e. There is a mechanism in place to verify the condition of medical supplies and consumables.
6.3.12.2. Policies for MOM 13:
a. Process of procurement is available which addresses the essential issues of vendor selection, evaluation, indenting
process, generation of purchase order, receipts and quality check of materials etc.
b. Medication supplies and consumables are received, opened and stored in safe manner to maintain sterility and integrity
c. Storage conditions are appropriately followed to store materials in clean, safe and secure environment. Temperature
conditions are appropriate to store these materials.
d. Sound inventory control practices are used to guide storage of materials. This includes ABC analysis, VED, FSN and FIFO
analysis.
e. Materials received are checked for its efficacy and sterility. Opened packed are not accepted, culture results of certain
materials like cotton gauge, syringe, gloves are obtained to check efficacy and sterility.
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6.4.3. PRE.3: The patient and/or family members are educated to make informed decisions and are involved in the care planning
and delivery process.
6.4.3.1. Objective Elements:
a. The patient and/or family members are explained about the proposed care including the risks, alternatives and benefits.
b. The patient and/or family members are explained about the expected results.
c. The patient and/or family members are explained about the possible complications.
d. The care plan is prepared and modified in consultation with patient and/or family members.
e. The care plan respects and where possible incorporates patient and/or family concerns and requests.
f. The patient and/or family members are informed about the results of diagnostic tests and the diagnosis.
g. The patient and/or family members are explained about any change in the patient’s condition in a timely manner.
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a. Treating doctor and his team discuss the proposed care including the risks, alternatives and benefits, expected outcome
with the patient and patient’s family member. Details of the discussion held are documented in patient family meeting
record format.
b. Religious, cultural and spiritual views of the patient and/or family shall be considered during the process of care delivery.
c. Patient’s day to day condition, treatment, and outcome are communicated to patient and his family members.
6.4.4. PRE.4: A documented procedure for obtaining patient and/or family’s consent exists for informed decision making about their
care.
6.4.4.1. Objective Elements:
a. Documented procedure incorporates the list of situations where informed consent is required and the process for taking
informed consent.
b. General consent for treatment is obtained when the patient enters the organization.
c. Patient and/or his family members are informed of the scope of such general consent.
d. Informed consent includes information regarding the procedure, it’s risks, benefits, alternatives and as to who will perform
the procedure in a language that they can understand.
e. The procedure describes who can give consent when patient is incapable of independent decision making.*
f. Informed consent is taken by the person performing the procedure.
g. Informed consent process adheres to statutory norms.
h. Staff are aware of the informed consent procedure.
6.4.4.2. Policies for PRE 4:
a. Policy and procedure for the list of clinical procedure where informed consent is required and the process for taking
informed consent is available. This is developed keeping in mind the requirements of the standard and statutory
requirements. Refer : AH/PPM/HWP/21
b. General consent from patient is obtained when the patient enters the hospital for treatment /admission (Refer general
consent form of the hospital). Patient and family members are made aware about the scope of such general consent. The
consent is not for invasive procedure. Separate informed consent is available for invasive procedure.
c. Informed consent are designed and used as per the statutory requirement. Informed consent addresses details of
procedure, risks, benefits and alternate method clearly. Informed consent is signed by both patient or his surrogate as well
as doctors performing the procedure. Refer : AH/PPM/HWP/21
d. Statutory norms are taken into consideration for obtaining informed consent. If patient is not capable of giving consent then
next of kin/legal guardian is allowed to give consent for the patient. Refer : AH/PPM/HWP/21
e. Informed consent is obtained by the person actually performing the procedure. Informed consent is signed by the person
performing procedure not by his subordinate or nurse.
f. Informed consent process follows to statutory norms for documentation. This includes taking consent before the procedure
not after the procedure; at least one witness signing the consent form, transfusion dependent patient validity of consent is
6 months.
g. Staffs working in patient care areas are well aware about consent procedure.
6.4.5. PRE.5: Patient and families have a right to information and education about their healthcare needs.
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b. The organisation shall identify special situations where enhanced communication would be required.*
c. The organisation lays down an approach for effective communication in these identified situations.
d. The organisation also defines what constitutes an unacceptable communication and sensitizes the staff about the same.*
e. The organisation has a system to monitor and review the implementation of effective communication
f. The staff are trained in healthcare communication techniques periodically.
a. Written policy and procedure for the effective communication with the patient/or families is documented. Various situations
have been identified where enhanced communication is required. Unacceptable communication has been highlighted. All
staffs are made aware of the policy and procedure. Refer : AH/PPM/HWP/21
b. Situations to address challenging situations like breaking bad news, handling adverse events, handling an aggressive
patient/family , declaration of death of a patient has been documented. Refer : AH/PPM/HWP/21
c. Language barriers of the patient and family members are resolved as hospital has list of interpreter of staff working in the
hospital and aware of various regional and other languages.
d. Patient and family feedback are obtained to monitor and review the implementation of effective communication.
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d. There is an infection control team which is responsible for day to day functioning of infection prevention and control
programme. It carries out surveillance programme and detect outbreak. Various audits targeting to infection control
programme is conducted by the team. Team is different than committee however few team members are part of the
committee.
e. An infection control officer with defined roles and responsibilities plays major role in guiding and plans for the
implementation of infection control requirement. Infection control officer is a knowledgeable and competent microbiologist.
f. Certified, trained and competent Infection control nurses are made part of infection control team.
6.5.2. HIC.2: The Organization implements the policies and procedures laid down in the Infection Control Manual in all
areas of the hospital.
6.5.2.1. Objective Elements:
a. The Organization identifies the various high-risk areas and procedures and implements policies and/or
procedures to prevent infection in these areas.
b. The Organization adheres to standard precautions at all times.
c. The Organization adheres to hand-hygiene guidelines.
d. The Organization adheres to transmission-based precautions at all times.
e. The Organization adheres to safe injection and infusion practices.
f. The Organization adheres to cleaning, disinfection and sterilization practices.
g. An appropriate antibiotic policy is established and documented
h. The Organization implements the antibiotic policy and monitors rational use of antimicrobial agents.
i. The Organization adheres to laundry and linen management processes.
j. The Organization adheres to kitchen sanitation and food-handling issues.
k. The Organization has appropriate engineering controls to prevent infections.
l. The Organization adheres to housekeeping procedures.
6.5.2.2. Policies for HIC 2:
a. High risk areas of the hospital have been identified. High risk procedures have been identified from infection control point of
view and policies and procedures is implemented, directed & monitored at these areas Refer AH/PPM/IC/18
b. Standard precaution is adhered by the staff while in the patient care areas. Provision of gloves, masks, clean utility is
available. Refer AH/PPM/IC/18
c. Hand hygiene guidelines are strictly followed. Hand hygiene practices of the staff are monitored. Provision of display of
instructions for hand hygiene has been made near every hand washing area. Provision of single use tissue paper,
antimicrobial soap solutions, and hand sanitizer is done as per the WHO guideline of 2009. Refer AH/PPM/IC/18
d. Transmission based precautions are adopted at all times. Personal protective measures are used in various situations of
patient care. Refer AH/PPM/IC/18
e. Safe injection practices and infusion practices are followed strictly in all patient care areas as per the requirement. WHO
best practices for injection procedure is taken as reference to follow safe injection and infusion practices which includes
practice of single use syringe, hand hygiene, gloves, injection administration, sharp management etc Refer AH/PPM/IC/18
f. Cleaning, disinfection and sterilization practices are adhered to. Use of disinfectants is monitored. Infection control
committee approves and allows disinfectants use in the hospital. Hospital has a dedicated Central Sterile supply department
to deal with sterilization requirement of patient care areas. Refer AH/PPM/IC/18
g. Rational use of antibiotic is established by the infection control committee. Judicious use of antibiotics is monitored. Doctors
are trained to identify clinical conditions in which antimicrobial therapy are to be used. Department of Microbiology monitors
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the practices of the doctors and deviations if any is brought to the notice of doctors for necessary corrective abd preventive
action. Refer AH/PPM/IC/18
h. Laundry and linen management practices are outsourced. Patient’s linens are change on a daily basis or as when spillage is
noted. Linens are centrally collected and given in dedicated laundry area for cleaning and supply. Infected linens are
properly stored and transported to laundry room for cleaning, disinfection and washing in separate place. Covered trolleys
are used for transporting clean linen as well as dirty linen. Refer AH/PPM/IC/18
i. Kitchen safety and food handling issues are addressed. Kitchen service is outsourced. Practices of outsourced agency are
monitored and agency is directed to follow norms of hospital’s infection control policy. Kitchen sanitation, periodic screening
of food handlers, cleaning and washing protocol, water testing, housekeeping practices, food evaluation, health evaluation
of staff (Daily grooming check, test for HBSAg, parasites and salmonella once in six month and if the staff rejoins after leave
of 15 days or more) are included in kitchen safety and food handling issues Refer AH/PPM/IC/18
j. Engineering controls and facility management is done appropriately to prevent infections. This includes but not limited to
beds apace is one to two meter, planning of Operating rooms as per the norms of infection control, Air quality and water
supply, issues regarding Air conditioning (Temperature, humidity and ventilation), periodic cleaning of AC ducts, change of
HEPA filters, replacement and repair of plumbing issues, sewer lines are included. Any renovation work in hospital’s patient
care areas is planned with the guidance and necessary approval of infection control team with regard to architectural
realignment, traffic flow, use of materials etc. Refer AH/PPM/IC/18
k. Housekeeping practices are included in the infection and prevention rule of the hospital. Terminal cleaning procedure is
included. Spillage management is done by hazardous material management team comprising of trained personnel of
housekeeping. Use of disinfectants and its dilution factor and use process is known to housekeeping staff. Dry mopping is
not done in patient care areas. Wet mopping practices are propagated inside clinical areas. Refer AH/HK/31 Refer
AH/PPM/IC/18
b.
6.5.3. HIC.3: The Organization performs surveillance activities to capture and monitor infection prevention and control
data.
6.5.3.1. Objective Elements:
a. Surveillance activities are appropriately directed towards the identified high-risk areas and procedures.
b. A collection of surveillance data is an on-going process.
c. Verification of data is done on a regular basis by the infection control team.
d. The scope of surveillance activities incorporates tracking and analyzing of infection risks, rates and trends.
e. Surveillance activities include monitoring the compliance with hand-hygiene guidelines.
f. Surveillance activities include mechanisms to capture the occurrence of epidemiological significant diseases
and multi-drug-resistant organisms, and highly virulent infections.
g. Surveillance activities include monitoring the effectiveness of housekeeping services.
h. Appropriate feedback regarding healthcare associated infection ( HAIs) rates is provided on a regular basis to
appropriate personnel.
i. In cases of notifiable diseases, information (in relevant format) is sent to appropriate authorities.
6.5.3.2. Policies for HIC 3:
a. Surveillance activities are conducted on daily, weekly and monthly basis as per the plan of Infection control team.
Documents regarding surveillance in high risk areas are maintained by the Infection control officer. Surveillance activities
are also conducted in the area where demolition, construction or repair activities undertaken. Collection of data for the
surveillance programme is an ongoing process. Infection control nurses are trained to collect information as per the laid
down guideline. Refer AH/PPM/IC/18
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b. All data collected by infection control nurses are reviewed, verified and approved by the infection control team.
c. Analysis of infection risks, trend, and rates are done on a monthly basis and necessary corrective and preventive action is
initiated for the risk factors.
d. Hand hygiene practice is included as one of the essential monitoring requirement under surveillance programme of
theinfection and prevention programme. Active and passive methods for the surveillance of hand hygiene practices are
followed.
e. Hospital has a policy to monitor the occurrence of multi drug resistant organisms’ e.g MRSA and multi drug dram-
negative bacteria and monitors any suspected emergence and spread of infection with microorganisms. Refer
AH/PPM/IC/18
f. Effectiveness of housekeeping services are monitored and a essential part of surveillance activities. Routine
environmental sampling is done.
g. Doctors and nurses are given feedback about the rates, trends and remedial measures including data analyzed as part of
surveillance activities. Infection control bulletin is prepared and issued by the infection control team to make doctors and
nurses aware about the risk, trends and rates of their concern department
h. Notifiable diseases are reported to local Authority, National Health Mission as per the local laws. This is done directly in
the portal of National Health mission of notifiable disease surveillance programme
6.5.4. HIC.4: The Organization takes actions to prevent and control Healthcare Associated Infections (HAI) in patients.
6.5.4.1. Objective Elements:
a. The Organization takes action to prevent catheter associated urinary tract Infections.
b. The Organization takes action to prevent ventilator Associated Pneumonia.
c. The Organization takes action to prevent catheter linked blood stream infections.
d. The Organization takes action to prevent surgical site infections.
6.5.4.2. Policies for HIC 4:
a. Various evidenced based tools and practice guidelines are put into practice to track and take action to prevent Catheter
associated urinary tract infection, ventilator associated pneumonia, Catheter linked blood stream infections, surgical site
infections. Staffs are trained to use these tools for the prevention and control of Hospital associated infections in patients.
6.5.5. HIC.5: The Organization provides adequate and appropriate resources for prevention and control of Healthcare
Associated Infections (HAI).
6.5.5.1. Objective Elements
a. Adequate and appropriate personal protective equipment, soaps, and disinfectants are available and used
correctly.
b. Adequate and appropriate facilities for hand hygiene in all patient-care areas are accessible to healthcare
providers.
c. Isolation/barrier nursing facilities are available.
d. Appropriate pre- and post-exposure prophylaxis is provided to all staff members concerned.
6.5.5.2. Policies for HIC 5:
a. Necessary provision is made to timely and adequate supply of personal protective equipments which includes
gloves, protective eye wear, masks, apron, gown, hair cover etc to the staff of patient care areas uniformly.
Adequate soap solution having antimicrobial property, disinfectants is also made available.
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b. Facilities for hand hygiene are made at optimum level. This includes provision of large wash basins, hands free
control, soap and facility for drying hands without contamination. Hand hygiene instructions are displayed near
each wash basin and staffs are instructed to follow the technique.
c. Isolation and barrier nursing practices are followed wherever applicable. Conditions of isolation practices as
well as barrier nursing have been defined. Provision for Isolation room and air borne cases is available which
includes designated space with negative air pressure, double door system, signage to notify and resources like
hand hygiene, personal protective equipment is made.
d. Pre and post exposure prophylaxis is provided to all staff members concerned. Documentation of the all
occupational injuries sharp injuries, needle stick injuries, pre-post exposure prophylaxis records are maintained.
6.5.6. HIC.6: The Organization identifies and takes appropriate action to control outbreaks of infections.
6.5.6.1. Objective Elements:
a. Organization has a documented procedure for identifying an outbreak.*
b. Organization has a documented procedure for handling such outbreaks.*
c. This procedure is implemented during outbreaks.
d. After the outbreak is over appropriate corrective actions are taken to prevent recurrence.
6.5.6.2. Policies for HIC 6:
a. Policy and procedure for outbreak management is available. Investigation of outbreak is done according to the laid down
procedure of the hospital. Procedure is followed during sudden outbreak. Corrective and preventive action is taken to
prevent future reoccurrence. Refer AH/PPM/IC/18
6.5.7. HIC.7: There are documented policies and procedures for sterilization activities in the Organization.
6.5.7.1. Objective Elements:
a. The Organization provides adequate space and appropriate zoning for sterilization activities.
b. Documented procedure guides the cleaning, packing, disinfection and/or sterilization, storing and issue of items.*
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d. Validation of sterilization results are done suitably. This includes chemical indicator test o daily basis, biological
indicator test done on weekly basis, class 5 indicators etc. Engineering validation like Bowie-Dick tape test,
leak test.
e. There is an established documented recall procedure followed when breakdown of sterilization equipment.
Refer AH/CSSD/19
6.5.8. HIC.8: Biomedical waste (BMW) is handled in an appropriate and safe manner.
6.5.8.1. Objective Elements:
a. The Organization adheres to statutory provisions with regard to biomedical waste.
b. Proper segregation and collection of biomedical waste from all patient-care areas of the hospital is implemented
and monitored.
c. The Organization ensures that biomedical waste is stored and transported to the site of treatment and disposal
in properly covered vehicles within stipulated time limits in a secure manner.
d. The biomedical waste treatment facility is managed as per statutory provisions (if in- house) or outsourced to
authorized contractor(s).
e. Appropriate personal protective measures are used by all categories of staff handling biomedical waste.
6.5.8.2. Policies for HIC 8:
a. All Statutory requirements of Bio medical waste management and handling rules are adhered by the hospital.
This includes approval for consent to occupy and consent to operate, authorization under Bio Medical waste
handling and management rules etc.
b. Segregation and collection of bio medical waste from all patient care areas are done as per the laid down
norms of Pollution Control board. Different color coded bins as per the Bio medical waste management
guideline 2016 is followed. Collection & transportation of bio medical waste is done by adopting all safety
provisions. Covered transport container is used to transport bio waste in a pre-defined time by the dedicated
waste handlers of the hospital. Treatment of the bio medical waste has been outsourced to authorized agency
of pollution control board. Outsource facility is visited by infection control team at least once in 6 month to
ensure waste disposal is accordance to Bio medical waste management rules. Refer AH/BMWM/06
c. Staff handling bio medical waste is provided with adequate personal protective equipment.
6.5.9. HIC.9: The infection control program is supported by the management and includes training of staff.
6.5.9.1. Objective Elements:
a. The management makes available resources required for the infection control program.
b. The Organization earmarks adequate funds from its annual budget in this regard.
c. The Organization conducts induction training for all staff.
d. The Organization conducts appropriate “in-service” training sessions for all staff at least once in a year.8
6.5.10. Policies for HIC 9:
a. Resource required for improving and maintaining infection control activities are provided. Management of the
hospital has earmarked budgetary consideration for the infection control activities.
b. Induction training of all staff is provided to make them aware about infection and prevention policy of the
hospital. Training records of the same is maintained in staff personal file
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e. Quality improvement programme of the hospital uses innovation and evidence based approach to improve
clinical and managerial processes. Patient safety, care delivery, cost reduction strategies are core areas of
consideration.
f. All Staff of the hospital are made aware of the structure and process of the quality improvement programme.
Each staff is made aware of their roles for the contribution to the quality improvement programme as part of
their job description. Training materials (printed and soft copies) are provided by the quality team to hospital
staff. The minutes of the review meetings and action taken plans are recorded and maintained.
g. Quality Improvement programme of the hospital is reviewed at pre-defined interval. The quality improvement
programme is a continuous process and is updated at once in a year. Quality improvement programme is
updated after review is carried out by the quality improvement committee. Various audits are conducted at
regular interval to support and maintain quality improvement structure of the hospital. Internal audit is one of the
important audit programme. Internal audit is conducted by trained auditor who is well versed with NABH
Standards. Refer- AH/PPM/HQM/41, Refer AH/AQM/
h. Quality of nursing service is monitored and improved by nursing audit programme. Nursing audit tool is used to
conduct audit of nursing care.
6.6.2. CQI.2: There is a structured patient-safety program in the Organization.
6.6.2.1. Objective Elements
a. The patient-safety program is developed, implemented and maintained by a multi-disciplinary committee.
b. The patient safety program is documented.*
c. The patient safety program is comprehensive and covers all the major elements related to patient safety and
risk management.
d. The scope of the program is defined to include adverse events ranging from “no harm” to “sentinel events”.
e. There is a designated individual for coordinating and implementing the patient-safety program.
f. The designated program is communicated and coordinated amongst all the staff of the Organization through
appropriate training mechanism.
g. The patient-safety program identifies opportunities for improvement based on review at pre-defined intervals
h. The patient-safety program is a continuous process and updated at least once in a year.
i. The Organization adapts and implements national/international patient-safety goals/solutions.
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c. Patient safety programme identifies opportunities for improvement based on review at pre-defined intervals of
at least once in 4 months. Scope of review includes facility inspection rounds and analysis of key safety
indicators. Safety committee of the hospital review the progress made. Refer- AH/PPM/HS/26
d. Documented patient safety programme is updated based on findings of audit and change of process. However
review and update of the process is done at least once in a year.
e. Requirement of International patient safety goals are incorporated and implemented. Refer- AH/PPM/HS/26
6.6.3. CQI.3: The Organization identifies key indicators to monitor the clinical structures, processes and outcomes,
which are used as tools for continual improvement.
6.6.3.1. Objective Elements:
a. Monitoring includes appropriate patient assessment.
b. Monitoring includes safety and quality-control programs of all the diagnostic services.
c. Monitoring includes medication management.
d. Monitoring includes use of anaesthesia.
e. Monitoring includes surgical services.
f. Monitoring includes use of blood and blood components.
g. Monitoring includes infection control activities.*
h. Monitoring includes review of mortality and morbidity indicators.*
i. Monitoring includes clinical research.*
j. Monitoring includes patient safety goals.*
k. The Organization identifies and monitors priority aspects of patient care.
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CQI.4: The Organization identifies key indicators to monitor the managerial structures, processes and outcomes which are used as tools for
continual improvement.
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Objective Elements:
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26. Percentage of medical record not having codification as per International Classification of Disease(ICD)
27. Percentage of medical record having incomplete & or improper consent
28. Percentage of missing records
29. Appropriate handovers during shift change (To be done separately for doctors & nurses - (per patient per shift)
30. Incidence of patient identification error
31. Compliance to Hand hygiene practices
32. Compliance rate to Medication Prescriptions in Capitals
33. *
*** Data collection is done at predefined intervals (monthly/quarterly) and is different for different types of indicators to support
further improvements. This data is analyzed for improvement opportunities and the same are carried out. Data collection is
done to support evaluation of the improvements done earlier. All improvement activities carried out by the hospital have an evaluable
outcome. The same is captured and analyzed
6.6.4. CQI.5: There is a mechanism for validation and analysis of quality indicators to facilitate quality improvement
6.6.4.1. Objective Elements:
a. There is a mechanism for validation of data
b. There is a mechanism for analysis of data which results in identifying opportunities for improvement.
c. The opportunities for improvement are implemented and evaluated
d. The Organization uses appropriate quality improvement, statistical and management tools in its quality improvement
program
e. Feedback about care and service is communicated to staff
6.6.4.2. Policies for CQI 5:
a. Data collected for analysis of quality indicator is validated by the staff of quality department from time to time and in
response to queries or when unexplained trend occurs
b. Remedial measures require for improvement are implemented and evaluated.
c. Root -cause -analysis (RCA) and corrective and preventive action (CAPA) is used as an opportunity to improve the process
and outcome.
d. Patient’s feedback and level of satisfaction is communicated on a monthly basis.
Follow amendment
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b. The management makes available adequate resources required for quality improvement program.
c. Organization earmarks adequate funds from its annual budget in this regard.
d. The management identifies Organizational performance improvement targets.
6.6.5.2.Policies for CQI 6:
a. Process owner /In charge of the all department of the hospital is made aware of the importance of quality
improvement programme and the approach to its implementation. Management of the hospital encourages all its
departmental leaders to actively participate in quality improvement programme of the hospital. Printed materials
as applicable to the respective areas are provided and departmental leaders are held responsible for the
implementation and sustainability of Quality improvement requirement of their concerned areas.
b. Hospital Management has provided adequate resources required for quality improvement programme. This
includes the men, material, machine and method. There is steady supply of these to ensure that the programme
functions smoothly.
1. Hospital earmarks adequate funds from its annual budget in this regard
2. Appropriate fund allocation is done by the organization for the smooth functioning of the programme.
c. Management periodically defines performance improvement targets of each department that has a role in quality
improvement programme. Key result areas for each department and departmental leaders are defined and given
to the staff of the department. Regular feedback on the progress of the targets given is taken.
6.6.6. CQI 7: There is an established system for clinical audit.
6.6.6.1. Objective Elements:
a. Medical and nursing staff participates in this system.
b. The parameters to be audited are defined by the Organization.
c. Patient and staff anonymity is maintained.
d. All audits are documented.
e. Remedial measures are implemented.
6.6.6.2. Policies for CQI 7:
a. Hospital has a Clinical audit committee for conducting audits. Medical staff participates in audit of the patient
care services.
1. Members of the clinical audit committee are-
a) HOD Surgery, Hospital Administrator, Medicine, Prof. Obstetrics and Gynecology, Prof. Pediatrics,
Nursing Superintendent, Prof. Orthopedics, Prof. ENT, Dy. Director Laboratory
2. The parameters used in auditing are defined by the Clinical Audit committee. This includes disease based
parameters suggested by NICE (National Institute for Health and Care Excellence) Guideline. Tools for
auditing are available and followed.
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6.7.1. ROM.1: The responsibilities of those responsible for governance are defined.
6.7.1.1. Objective Elements:
a. Those responsible for governance lay down the Organization’s vision, mission and values.*
b. Those responsible for governance approve the strategic and operational plans and Organization’s annual
budget.
c. Those responsible for governance monitor and measure the performance of the Organization against the stated
mission.
d. Those responsible for governance establish the Organization’s organogram.*
e. Those responsible for governance appoint the senior leaders in the Organization.
f. Those responsible for governance support safety initiatives and quality improvement plans.
g. Those responsible for governance support research activities.
h. Those responsible for governance address the Organization’s social responsibility.
i. Those responsible for governance inform the public of the quality and performance of services.
6.7.1.2. Policies for ROM 1:
a. Mission, vision and values of the hospital has been laid down. Stakeholder and process owner of the hospital
has defined the statements in a collaborative approach. Refer- AH/PPMROM/30
b. Strategic and operational plans and annual budget is approved by the management.
c. Performance monitoring is done by the Top Management once in 6 months for the achievement and
sustainability of mission statement
d. The organization has a documented organogram. Organogram provide information about hierarchy, Line of
control, along with functions at various levels. Quality Improvement programme is given due consideration in
the organogram. Dissemination of organogram has been done to all stakeholders and process owners of the
hospital
e. Qualified and competent staffs are appointed as a senior leader in the hospital.
f. Safety initiatives and quality improvement plans are given due importance by the senior management. All risk
assessment and risk reduction activities are supported for corrective action.
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g. Research activities are supported by the management by providing resources; budget, following ethical and
legal norms.
h. Hospitals takes part in various social initiative like GO-Green initiative, free camps, outreach programme etc.
i. Outcome Performance and quality of service details are displayed strategically for the public and patient.
6.7.2. ROM.2: The Organization is responsible for and complies with the laid down and applicable legislations,
regulations and notifications.
6.7.2.1. Objective Elements:
a. The management is conversant with the applicable laws and regulations and undertakes the responsibility to
adhere to the same.
b. The management ensures that the policies and procedures pertaining to patient care are in compliance with
the prevailing laws, regulations and notifications.
c. The management has a mechanism which ensures implementation of these requirements.
d. Management has a mechanism which regularly updates any amendments in the prevailing laws of the land.
e. There is a mechanism to regularly update licenses/registrations/certifications.
6.7.2.2. Policies for ROM 2:
a. Hospital has identified its requirement for the statutory and regulatory norms. Hospital has obtained approval
from the competent licensing authorities. Hospital has developed a mechanism to ensure timely renewal and
update of all regulatory and statutory requirements. A system is available to track the status of licenses.
Application to update these statutory documents is made in accordance with the timeliness set out in the
relevant laws/ registration authority requirement so as to ensure continuity of statutory compliances. Refer-
AH/HWP/21
b. Policies and procedures pertaining to patient care area in consonance with the applicable laws and regulations
and notifications are implemented. These includes compliance to the requirement related to Bio medical waste
management rules, AERB norms, PCPNDT norms, MTP norms, Narcotic and psychotropic norms, blood bank
requirements, other notification issued by licensing authority time to time.
6.7.3. ROM.3: The services provided by each department are documented.
6.7.3.1. Objective Elements:
a. Scope of services of each department is defined.*
b. Administrative policies and procedures for each department are maintained.*
c. Each Organizational program, service, site or department has effective leadership.
d. Departmental leaders are involved in quality improvement.
6.7.3.2. Policies for ROM 3:
a. Each organizational program, service, site or department has effective leadership through the scope of
services which are defined for each department.
b. Administrative policies and procedure for each department like attendance, leave, code of conduct, service
standard has been documented.
c. Each organizational programme, service, site or department has effective leadership. Leaders of the
department are highly qualified and competent to deliver results.
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d. Departmental leaders are involved in quality improvement. Departmental leaders participate actively for a
quality improvement programme. Key performance indicator and objective and role of each department is
defined.
6.7.4. ROM.4: The Organization is managed by the leaders in an ethical manner.
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6.7.6. ROM.6: Management ensures that patient-safety aspects and risk-management issues are an integral part of
patient care and hospital management.
6.7.6.1. Objective Elements
a. Management ensures proactive risk management across the Organization.
b. Management provides resources for proactive risk assessment and risk-reduction activities.
c. Management ensures implementation of systems for internal and external reporting of system and process
failures.*
d. Management ensures that appropriate corrective and preventive actions are taken to address safety-related
incidents.
6.7.6.2. Policies for ROM 6:
a. Risk management strategy has been defined. This includes identification of clinical and non clinical risks. Risk
identification and risk reduction strategies are made and implemented. Emergency Contingency plan is
available and tested at periodic interval. Refer- AH/PPM/ROM/30
b. Resources are kept as contingency to address the risk reduction activities as when required
c. Hospital follows a system for internal and external reporting system and process failure. Contingency plan is in
place to deal with situation of system and process failure. Refer- AH/PPM/ROM/30
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6.8.1. FMS.1: The Organization has a system in place to provide a safe and secure environment.
6.8.1.1. Objective Elements:
a. Safety committee coordinates development, implementation, and monitoring of the safety plan and policies.
b. Patient-safety devices & infrastructure are installed across the Organization and inspected periodically.
c. The Organization is a non-smoking area.
d. There is a procedure which addresses the identification and disposal of material(s) not in use in the
Organization.*
e. Facility inspection rounds to ensure safety are conducted at least twice in a year in patient-care areas and at
least once in a year in non-patient-care areas.
f. Inspection reports are documented and corrective and preventive measures are undertaken.
g. There is a safety education program for staff.
6.8.1.2. Policies for FMS 1:
a. There is a safety committee in the hospital which functions on a monthly basis to coordinate development,
implementation and monitoring of the safety plans and policies so as to provide a safe and secure facility and
environment. Members of the committees are Hospital Administrator, Prof. Radiology (Radiation Safety
Officer), Executive Engineer-Electrical, Nursing Superintendent, Dy. Hospital Administrator, Chief Fire and
Safety officer, Officer I/c Law and Order, Housekeeping In charge. Hazard identification and risk analysis
(HIRA) in both clinical and non clinical area is conducted by the safety committee and accordingly suggest for
necessary action to eliminate or reduce such hazards and associated risks. Refer- AH/PPM/HS/26
b. Provision of patient safety devices and infrastructure have been installed which includes grab bars, bed rails,
sign posting, safety belts on stretcher and wheel chairs, alarms both visual and auditory, warning signs like
radiation or bio hazard, call bells, fire safety devices etc. Provision for physically challenged / vulnerable
person as per regulatory requirement like special toilet for physically challenged.
c. Hospital is declared as a non smoking area. Smoking is considered as punishable offence in the premises of
hospital.
d. There is a procedure for the condemnation and disposal of materials which are not in use. Condemnation
board is formed to identify and suggest for condemnation and disposal of materials. Materials are classified in
to category of Fair-wear and tear and unfair wear-tear and based on this decision for condemnation and
disposal is taken. Refer-AH/PPM/PSM/37
e. Facility inspection round is conducted once in six month by the members of the safety committee. Potential
safety risks are identified and remedial measures are suggested. Inspection report of the safety committee is
documented and corrective and preventive measures are taken. Evidence of pre- and post corrective actions
are maintained.
f. Safety education to each staff of the hospital is provided and made as part of employee induction training
programme. Training on fire safety, occupational safety, radiation safety, incident reporting, infection control
requirement as applicable is conducted. Training records are documented.
6.8.2. FMS.2: The Organization’s environment and facilities operate in a planned manner to ensure safety of patients,
their families, staff and visitors and promotes environment friendly measures.
6.8.2.1. Objective Elements:
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smooth manner. This includes availability of ladder, voltmeter, personal protective equipments like safety boots,
gloves by DG operator are properly followed.
g. Maintenance plan for facility and furniture is available. This includes regular inspections and timely repair of civil
structure like walls, servicing of furniture etc. Infection control requirements are adhered to while planning for
facility and furniture.
h. Response times are monitored from reporting to inspection and implementation of corrective action. All
complaints are recorded suitably by the maintenance department which includes time of receipt of complaint,
allotment of job, completion of the job is ratified by the user department
i. Provision for energy efficient lighting, water harvesting, more use of solar power is introduced as an initiative
towards an energy efficient and environmental friendly hospital.
6.8.3. FMS.3: The Organization has a program for engineering support services and utility system.
6.8.3.1. Objective Elements:
a. The Organization plans for equipment in accordance with its services and strategic plan.
b. Equipment are selected, rented, updated or upgraded by a collaborative process.
c. Equipments are inventoried and proper logs are maintained as required.
d. Qualified and trained personnel operate, inspect, test and maintain equipment and utility systems.
e. Utility equipment are periodically inspected and calibrated (wherever applicable) for their proper functioning.
f. There is a documented operational and maintenance (preventive and breakdown) plan.*
g. There is a maintenance plan for water management.*
h. There is a maintenance plan for electrical systems.*
i. There is a maintenance plan for heating, ventilation and air-conditioning.*
j. There is a maintenance plan for Information technology & communication network.
k. There is a documented procedure for equipment replacement and disposal.
6.8.3.2. Policies for FMS 3:
a. Procurement and planning for equipment is done in accordance with its services and strategic plan. Future
requirements of the equipment and machinery are well forecasted by the maintenance team as part of the
strategic plan.
b. Equipments are selected, rented and updated or upgraded by a collaborative process. Involvement of end user,
management, finance and engineering department is done while decision for procurement planning is initiated
c. Unique ID of each equipment and machinery is provided to each equipment and machinery. Documented
system is available to retain relevant details, quality conformance certificate/marks along with other details in the
respective equipment and machinery file of the hospital.
d. Qualified and trained personnel are involved in operating, inspection, test and maintenance of the equipment
and machinery.
e. Periodical inspection of utility equipment like medication refrigerator, pressure gauge of steam sterilizer, blood
bank refrigerators, DG sets are done by the bio medical engineering department of the hospital. Periodic
calibration of the utility equipment is also done by maintaining traceability to national or international guidelines.
Traceability certificate for the calibrator is maintained.
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f. A documented operational and maintenance plan for the equipment and machinery is available. There is a
planned preventive maintenance plan and breakdown plan for equipments. Refer-AH/PPM/MES/23
g. There is a maintenance plan for water management in the hospital. This includes periodic cleaning of water
tanks, water treatment, test for endotoxin levels of RO plant of dialysis unit every month, regular checking of pH,
TDS, hardness of water quality. . Refer-AH/PPM/MES/23
h. There is a maintenance plan for electrical systems, heating, ventilation and air conditioning, Information
technology and communication network. . . Refer-AH/PPM/MES/23
i. There is a documented procedure for equipment replacement and disposal. Unserviceable and obsolete
equipments, engineering waste materials and accessories are disposed off and records of the condemnation of
equipment, accessories are maintained. . Refer-AH/PPM/MES/23
6.8.4. FMS.4: The Organization has a program for bio-medical equipment management.
6.8.4.1. Objective Elements:
a. The Organization plans for equipment in accordance with its services and strategic plan.
b. Equipment are selected, rented, updated or upgraded by a collaborative process.
c. Equipments are inventoried and proper logs are maintained as required.
d. Qualified and trained personnel operate and maintain the medical equipment.
e. Equipment are periodically inspected and calibrated for their proper functioning.
f. There is a documented operational and maintenance (preventive and breakdown) plan for equipment.*
g. There is a documented procedure for equipment replacement and disposal.
h. The procedures addresses medical equipment recalls.
i. Response times are monitored from reporting to inspection and implementation of corrective actions.
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f. Documented operational and maintenance plan for the equipment is available. This includes operator level
inspection, inspection by bio medical engineer, preventive maintenance plan, comprehensive maintenance plan,
user training on equipment. Bio medical engineering department develops and executes planned preventive
maintenance of equipments in the hospital. . Refer-AH/PPM/MES/23
g. There is a documented procedure for equipment replacement and disposal. Unserviceable and obsolete
equipments, engineering waste materials and accessories are disposed off and records of the condemnation of
equipment, accessories are maintained . Refer-AH/PPM/MES/23
h. Recall procedure for the medical equipment is available. This includes recalls are on based on letters/hazards
notice issued from manufacturer and or from regulatory authority. Immediate action is taken when such
information of recall of equipment is obtained due to safety hazards. Bio medical engineering department
coordinates to ensure the said equipment is not put into further clinical use till the issue is resolved. . Refer-
AH/PPM/MES/23
i. Response times are monitored from reporting to inspection and implementation of corrective action. All
complaints are recorded suitably by the maintenance department which includes time of receipt of complaint,
allotment of job, completion of the job is ratified by the user department
6.8.5. FMS.5: The Organization has a program for medical gases, vacuum and compressed air.
a. Documented procedures govern procurement, handling, storage, distribution, usage and replenishment of
medical gases.
b. Medical gases are handled, stored, distributed and used in a safe manner.
c. The procedures for medical gases address the safety issues at all levels.
d. Alternate sources for medical gases, vacuum and compressed air are provided for, in case of failure.
e. The Organization regularly tests these alternate sources.
f. There is an operational, inspection, testing and maintenance plan for, piped medical gas, compressed air and
vacuum installation.*
6.8.5.2. Policies for FMS 5:
a. There is a documented procedure available for the procurement, handling, storage, distribution, usage and
replacement of medical gases in a timely manner. This includes the issue of statutory requirements and approval,
uniform color coding system, safety issues as per Indian explosive Act, gas cylinder rules and static and mobile
pressure vessels rules. . Refer-AH/PPM/MES/23
b. Safety issues are followed from the point of storage/source area, gas supply lines and the end user area. All
safety provision for medical gas supply system is implemented and monitored
c. Alternate source of medical gases, vacuum and compressed air provided in case of failure. Standby arrangement
for main source is available which includes stand by air compressor and vacuum pump, standby gas manifold /
bulk cylinders. Periodic testing of these alternate sources is done and documented.
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d. Operational plan for inspection , testing and maintenance plan for piped medical gas, compressed air and vacuum
installation . Refer-AH/PPM/MES/23
6.8.6. FMS.6: The Organization has plans for fire and non-fire emergencies within the facilities.
6.8.6.1. Objective Elements:
a. The Organization has plans and provisions for early detection, abatement and containment of fire, and non-fire
emergencies.
b. The Organization has a documented safe-exit plan in case of fire and non-fire emergencies.
c. Staff is trained for their role in case of such emergencies.
d. Mock drills are held at least twice in a year.
e. There is a maintenance plan for fire-related equipment &infrastructure
6.8.6.2. Policies for FMS 6:
a. Plans and provision for early detection, abatement and containment of fire and non fire emergencies has been
made in accordance with local fire safety norms of the State government. Fire hydrants, fire hoses
extinguishers and fire escapes are provided on each floor. Fire control panel is placed on every floor with a
centralized monitoring. Refer- AH/PPM/HS/26
b. Hospital has a safe exit plan put up at all floors and patient movement areas to be followed in case of the fire
and non-fire emergencies. (Ref-fire exit plans
c. Staff is trained for their role in case of such emergencies. This training is an on-going process and HR
department maintains a log of department wise training schedule. (Ref- Training schedules)
d. Mick drills are held at periodic interval to assess the preparedness of staff and fire safety team. Findings of the
mock drills are recorded and discussed during debriefing meeting
e. Fire safety devices and installations are periodically inspected and preventive maintenance carried out.
6.8.7. FMS.7: The Organization has a plan for management of hazardous materials.
6.8.7.1. Objective Elements:
a. Hazardous materials are identified within the Organization.*
b. The Organization implements processes for sorting, labelling, handling, storage, transporting and disposal of
hazardous material.*
c. Requisite regulatory requirements are met in respect of radioactive materials.(NA)
d. There is a plan for managing spills of hazardous materials.*
e. Staff are educated and trained for handling such materials.
6.8.7.2. Policies for FMS 7:
a. Hazardous materials are identified, sorted, stored, handled, and transported in a safe manner. There is a plan
for spillage management. Hazardous material management team is available to respond in case of hazardous
material spillage is notified
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b. Training of the staff is given to implement process for sorting, labeling, handling, storage and transportation and
disposal of hazardous material. HIRA (Hazard identification and Risk Analysis) is conducted by the safety
committee/Safety officer to notify and take remedial measures.
c. Hazmat spillage management kit is available in all patient care and areas where hazardous materials are
stored. Dedicated team and code is available and activated in case of hazardous material spillage.
6.9.2. HRM.2. The Organization has a documented procedure for recruiting staff and orienting them to the
Organization’s environment.
6.9.2.1. Objective Elements:
a. There is a documented procedure for recruitment.*
b. Recruitment is based on pre-defined criteria
c. Every staff member entering the Organization is provided induction training
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d. The induction training includes orientation to the Organization’s vision, mission and values.
e. The induction training includes awareness on employee rights and responsibilities.
f. The induction training includes awareness on patient’s rights and responsibilities.
g. The induction training includes orientation to the service standards of the Organization.
h. Every staff member is made aware of Organization's wide policies and procedures as well as relevant
department / unit / service / program’s policies and procedures.
6.9.2.2. Policies for HRM 2:
a. There is a documented procedure available for recruitment. Recruitment is undertaken in accordance with
statutory requirements which include necessary registration, qualification, skills and experience to perform
work. Refer- AH/PPM/HRM/24
b. Pre-defined criteria are used for the recruitment. Recruitment is done in a transparent manner.
c. Induction training of all new staff members within 1 month of joining. Content of induction training is defined and
followed which includes vision, mission, values, employee rights and responsibilities, patient’s rights and
responsibilities, service standard and code of conduct, hospital wide policies and procedures, Safety issues,
infection control, occupational hazards, etc . Organization specific and department specific training is provided
as part of induction training. Refer- AH/PPM/HRM/24
6.9.3. HRM.3. There is an on-going program for professional training and development of the staff.
6.9.3.1. Objective Elements:
a. A documented training and development policy exists for the staff.*
b. The Organization maintains the training record.
c. Training also occurs when job responsibilities change/ new equipment is introduced.
d. Evaluation of training effectiveness is done by the Organization
e. Feedback mechanisms are in place for improvement of training and development program.
6.9.3.2. Policies for HRM 3:
a. A documented competence assessment & training and development policy exists for the staff. . Refer-
AH/PPM/HRM/24
b. A training manual incorporating the procedure for identification of training needs, the training methodology,
documentation of training, training assessment, impact of training and the training calendar is prepared for the
hospital staff.
c. Hospital has a feedback mechanism for assessment of training and development programme. This is applicable
both for internal & external training.
6.9.4. HRM.4. Staff are adequately trained on various safety-related aspects.
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a. Training requirements are identified and accordingly provides for the same.
b. Performance appraisal is carried out at pre defined intervals and is documented
6.9.6. HRM.6. The Organization has documented disciplinary and grievance handling policies and procedures.
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c. Occupational health hazards are adequately addressed for the employees of the hospital.
6.9.8. HRM.8. There is documented personal information for each staff member.
6.9.8.1. Objective Elements:
a. Personal files are maintained with respect to all staff.
b. The personal files contain personal information regarding the staff’s qualification, disciplinary background and
health status.
c. All records of in-service training and education are contained in the personal files.
d. Personal files contain results of all evaluations.
6.9.8.2. Policies for HRM 8:
a. Personal files are maintained in respect of all employees. Each file is current and updated with information as
per the defined policy. Confidentiality of access to personal file is maintained. Refer- AH/PPM/HRM/24
b. The personal files contain personal information regarding the employees’ qualification, disciplinary
background and health status.
c. All records of in-service training and education are contained in the personal files. Training cards of each
employee is kept in personal file.
d. Personal files contain results of all evaluations. Evaluations include performance appraisals, training
assessment and outcome of health checks.
6.9.9. HRM.9. There is a process for credentialing and privileging of medical professionals, permitted to provide
patient care without supervision.
6.9.9.1. Objective Elements:
a. Medical professionals permitted by law, regulation and the Organization to provide patient cares without
supervision are identified.
b. The education, registration, training and experience of the identified medical professionals is documented
and updated periodically.
c. All such information pertaining to the medical professionals is appropriately verified when possible.
d. Medical professionals are granted privileges to admit and care for patients in consonance with their
qualification, training, experience and registration.
e. The requisite services to be provided by the medical professionals are known to them as well as the various
departments / units of the Organization.
f. Medical professionals admit and care for patients as per their privileging.
6.9.9.2. Policies for HRM 9:
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a. Medical professionals permitted by law, regulation and the hospital to provide patient care without
supervision is identified. The hospital identifies the individuals who have the required qualification (s),
training and experience to provide patient care in consonance with the law. Refer- AH/PPM/HRM/24
b. The education, registration, training and experience of the identified medical professionals is documented
and updated periodically. Updation is done after acquisition of new skills and/or qualification.
c. All such information pertaining to the medical professionals is appropriately verified when possible.
Hospital does the same by verifying the credentials from the organization which has awarded the
qualification/training.
d. The services provided by the Medical professionals are in consonance with their qualification, training and
registration.
e. The requisite services to be provided by the medical professionals are known to them as well as the
various departments / units of the hospital.
f. Medical professionals are awarded privileges based on the evaluation of credentialing and competency
mapping.
6.9.10. HRM.10. There is a process for credentialing and privileging of nursing professionals, permitted to provide
patient care without supervision.
6.9.10.1.Objective Elements:
a. Nursing staff permitted by law, regulation and the Organization to provide patient care without supervision
are identified.
b. The education, registration, training and experience of nursing staff is documented and updated periodically.
c. All such information pertaining to the nursing staff is appropriately verified when possible.
d. Nursing staff are granted privileges in consonance with their qualification, training, experience and
registration.
e. The requisite services to be provided by the nursing staff are known to them as well as the various
departments / units of the Organization.
f. Nursing professionals care for patients as per their privileging.
6.9.10.2.Policies for HRM 10:
a. Nursing professionals permitted by law, regulation and the hospital to provide patient care without
supervision is identified. The hospital identifies the individuals who have the required qualification (s),
training and experience to provide patient care in consonance with the law. Refer- AH/PPM/HRM/24
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b. The education, registration, training and experience of the identified nursing professionals is documented
and updated periodically. Updation is done after acquisition of new skills and/or qualification.
c. All such information pertaining to the nursing professionals is appropriately verified when possible.
Hospital does the same by verifying the credentials from the organization which has awarded the
qualification/training.
d. The services provided by the Nursing professionals are in consonance with their qualification, training and
registration.
e. The requisite services to be provided by the nursing professionals are known to them as well as the
various departments / units of the hospital.
f. Nursing professionals are awarded privileges based on the evaluation of credentialing and competency
mapping.
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f. The hospital has defined the system of releasing the relevant information to the authority as per statutory
norms
6.10.2. IMS.2. The Organization has processes in place for effective control and management of data
6.10.2.1.Objective Elements:
a. The Organization has an effective process for document control.*
b. Formats for data collection are standardized.
c. Necessary resources are available for analysing data.
d. Documented procedures are laid down for timely and accurate dissemination of data.
e. Documented procedures exist for storing and retrieving data.*
f. Appropriate clinical and managerial staff participates in selecting, integrating and using data.
6.10.2.2.Policies for IMS 2:
a. Policy and procedure for document control exists. This includes periodic updating of forms, formats, policies
and procedure. Documents are created, reviewed for adequacy, authorized and released by designated
individuals. Only updated and latest documents are used. All documents are reviewed for updation as per its
planned schedule. Obsolete documents are removed from the user area and updated documents are
provided after approval. Refer- AH/HQA/41
b. Formats for data collection are standardized. Patient statistics are collected in standardized manner .
c. Provision of resources in terms of trained staff, space and facilities are made for the analyzing data.
d. Timely and accurate dissemination of data to the administration is done after data generation and analysis.
e. Documented procedure for the storing and retrieval of data which includes safeguard for protection of data.
6.10.3. IMS.3. The Organization has a complete and accurate medical record for every patient.
6.10.3.1.Objective Elements:
a. Every medical record has a unique identifier.
b. Organization policy identifies those authorized to make entries in medical record.
c. Entry in the medical record is named, signed, dated and timed.
d. The author of the entry can be identified.
e. The contents of medical record are identified and documented.*
f. The Organization has a documented policy for usage of abbreviations and develops a list based on accepted
practice
g. The record provides a complete, up-to-date and chronological account of patient care.
h. Provision is made for 24-hour availability of the patient’s record to healthcare providers to ensure continuity of
care
a. Every medical record has a unique identifier. Hospital medical records are kept according to IPD numbers
for in-patient records Refer- SUM/forms and Formats/01
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b. Hospital has a policy which identifies those authorized to make entries in medical record. Progress record
entry is done by doctors and medication charts by nursing staff.
c. Every medical record entry is dated, named, signed and timed by the concerned staff. All entries are
documented immediately but no later than 1 hour of completion of the assessment/procedure.
d. The author of the entry can be identified in each medical record. For every entry in medical records author
puts his/her name against it. In case of electronic based records, authorized e-signature provision has
been made.
e. Hospital has identified the contents of the medical record and documented it. Hospital has a list of
records/documents to be added in every patient record file and the assembling order for the same.
f. Documented policy for usage of abbreviations is available. A standardized list has been made as per the
guideline of Institute of Safe medication Practice (ISMP). Staffs are motivated not to use error probe
abbreviation for avoiding confusion. Refer-AH/PPM/MRD/28
g. The record provides an up-to-date and chronological account of patient care. Hospital has a format for
maintaining the continuity in the medical records.
h. Provision is available to ensure 24 hours availability of the patient’s record to doctors to ensure continuity
of care. Policy for retrieval of medical record is available when medical record is closed. Authorized
personnel have been identified who can open the Medical record room and issue medical record. Records
of opening of medical record during off hour are maintained. Refer-AH/PPM/MRD/28
6.10.4. IMS.4. The medical record reflects continuity of care.
6.10.4.1.Objective Elements:
a. The medical record contains information regarding reasons for admission, diagnosis and care plan.
b. The medical record contains the results of tests carried out and the care provided.
c. Operative and other procedures performed are incorporated in the medical record.
d. When patient is transferred to another hospital, the medical record contains the date of transfer, the reason for
the transfer and the name of the receiving hospital.
e. The medical record contains a copy of the discharge summary duly signed by appropriate and qualified
personnel.
f. In case of death, the medical record contains a copy of the cause of death certificate.
g. Whenever a clinical autopsy is carried out, the medical record contains a copy of the report of the same.
h. Care providers have access to current and past medical record.
6.10.4.2.Policies for IMS 4:
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a. The hospital medical record contains information regarding reasons for admission, diagnosis and plan of care.
Refer-IPD files of the patient.
b. Operative and other procedures performed are incorporated in the medical record of each operative case.
c. When patient is transferred to another hospital, the medical record contains the date of transfer, the reason for
the transfer and the name of the receiving hospital.
a. The record also contains the information regarding the clinical condition of the patient.
d. The medical record contains a copy of the discharge summary duly signed by resident doctor and treating
consultant.
e. In case of death, the medical record contains a copy of the death certificate indicating the cause, date and time
of death. Hospital provides the death certificate as per the International Certification of cause of death.
f. Doctors and other care providers have access to current and past medical records of the concerned patient
whom they are treating or providing care.
6.10.5. IMS.5. Documented policies and procedures are in place for maintaining confidentiality, integrity and security
of records, data and information.
6.10.5.1.Objective Elements:
a. Documented policies and procedures exist for maintaining confidentiality, security and integrity of records, data
and information.*
b. Documented policies and procedures are in consonance with the applicable laws.
c. The policies and procedure (s) incorporate safeguarding of data/ record against loss, destruction and tampering.
d. The Organization has an effective process of monitoring compliance of the laid down policy and procedure.
e. The Organization uses developments in appropriate technology for improving confidentiality, integrity and
security.
f. Privileged health information is used for the purposes identified or as required by law and not disclosed without
the patient’s authorization.
g. A documented procedure exists on how to respond to patients / physicians and other public agencies requests
for access to information in the medical record in accordance with the local and national law.
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b. Policy defines control of movement of the file in and out of the MRD so as to maintain confidentiality, security,
safety and integrity of information. . Refer-AH/PPM/MRD/28
1. This is applicable for both manual and electronic records.
2. Policies and procedures are in consonance with the applicable laws.
3. These are Indian Evidence Act, Indian Penal Code and Code of medical Ethics
c. The policies and procedures incorporate safeguarding of data / record against loss, destruction and tampering.
1. For physical records the hospital ensures that there is adequate pest and rodent control measures.
2. For electronic data there is protection against virus/trojans and also a proper backup procedure.
3. To prevent tampering, for physical records, access is limited only to the concerned health care provider.
d. The hospital has an effective process of monitoring compliance of the laid down policy.
1. The hospital carries out regular audits/rounds to check compliance with policies.
e. The hospital uses developments in appropriate technology for improving confidentiality, integrity and security.
f. Hospital review and update its technological features so as to improve confidentiality, integrity and security of
information.
g. Privileged health information is used for the purposes identified or as required by law and not disclosed without
the patient’s authorization. Hospital has defined the procedure for privileged communication.
h. A documented procedure exists on how to respond to patients/ physicians and other public agencies requests
for access to information in the medical record in accordance with the local and national law.
6.10.6. IMS.6. Documented policies and procedures exist for retention time of records, data and information
6.10.6.1.Objective Elements:
a. Documented policies and procedures are in place on retaining the patient’s clinical records, data and
information.*
b. The policies and procedures are in consonance with the local and national laws and regulations.
c. The retention process provides expected confidentiality and security.
d. The destruction of medical records, data and information is in accordance with the laid-down policy.
6.10.6.2.Policies for IMS 6:
i. Documented policies and procedures are in place on retaining the patient’s clinical records, data and
information. Hospital has defined the retention period for each category of medical records.
j. Refer-AH/PPM/MRD/28
1. Out-patient 4 years,
2. In-patient 10 years
3. MLC – Till the case is settled by court of law
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a. The policies and procedures are in consonance with the local and national laws and regulations.
1. These are in consonance with Code of Medical Ethics 2002, Consumer protection act 1987 and other
relevant state legislation.
b. The retention process of hospital provides expected confidentiality and security of the records.
1. Applicable for manual records.
c. The destruction of medical records, data and information is in accordance with the laid down policy.
1. Destruction is done after the retention period is over and after taking approval of the competent
authority.
6.10.7. IMS.7. The Organization regularly carries out review of medical records.
6.10.7.1.Objective Elements:
e. The review process includes records of both active and discharged patients.
f. The review points out and documents any deficiencies in records.
g. Appropriate corrective and preventive measures are undertaken and are documented.