5th Edition Hospital STD April 2020

NATIONAL ACCREDITATION BOARD
FOR HOSPITALS AND HEALTHCARE

PROVIDERS (NABH)
th
APRIL 2020
NABH
ACCREDITATION
STANDARDS FOR
HOSPITALS
APRIL 2020
CELEBRATING
15years
QUALITY : SAFETY : WELLNESS
National Accreditation Board
for Hospitals and Healthcare
Providers (NABH)
Accreditation Standards for Hospitals

(5th Edition) April 2020
ISBN 978-81-944877-5-3
9 788194 487753
© All Rights Reserved

No part of this book may be reproduced or transmitted in any form without permission in writing
from the author.
April 2020
N ational Accreditation Board for Hospitals and Healthcare
Providers (NABH), is in its 15th year of creating an ecosystem of
quality in healthcare in India. NABH standards focus on patient
safety and quality of the delivery of services by the hospitals in the
changing healthcare environment. Without being prescriptive, the
objective elements remain informative and guide the organisation in
conducting its operations with a focus on patient safety.
Over the years, successive NABH standards have brought about not
only paradigm shifts in the hospitals' approach towards delivering
FOREWOR
the healthcare services to the patients but have equally sensitised
the healthcare workers and patients towards their rights and
responsibilities.
It is my privilege and pride to release and dedicate this 5th Edition
of Hospital Accreditation Standards of NABH to all healthcare workers.
This edition is unique in its approach and has been presented based
in entirety on the suggestions made by various stakeholders. For the
first time, the Objective Elements have been designed to be
assessed as Core, Commitment, Achievement and Excellence.
The NABH hallmark methodology of ten Standards Chapters
approach has been retained; but the Objective Elements have been
pruned to a total of 651 out of which 102 are in Core category which
will be mandatorily assessed during each assessment, 459 are in
Commitment category which will be assessed during the final
assessment, 60 are in Achievement category to be assessed during
surveillance and 30 are in Excellence category which will be assessed
during re-accreditation.
This objective methodology will aid any healthcare organisation in a
stepwise progression to mature quality system covering the full
accreditation cycle. The scoring methodology has been modified to a
graded scheme to help recognise every progressive effort by the
organisation in the implementation of the standards. The chapter on
Continuous Quality Improvement is now replaced with Patient Safety
and Quality Improvement to increase the focus on this critical aspect
of healthcare. Each chapter now has a bibliography for reference, and
this will provide organisations with a resource for taking quality beyond
the requirements of the objective elements. Another important incentive
to adopt these is the move towards a four-year cycle with a midterm
surveillance at two years.
These standards along with the Key Performance Indicator
Annexures have been made available free of charge as a
downloadable document on NABH website. I sincerely hope that all
healthcare organisations will certainly benefit from the collective
efforts of Technical committee of NABH and practical suggestions of
thousands of Quality Champions form India and abroad.
NABH remains committed to its mission of taking Quality Safety and
Wellness to the last man in the line.
Jai Hind
Dr. Atul Mohan Kochhar

CEO, NABH
I
acknowledge the contributions of the following in preparing this
standard.
Padma Bhushan Dr B. K. Rao, Chairman NABH, has been the

ACKNOWLEDGEMEN
guiding light throughout the development of this edition. I thank
him for his active participation, support and invaluable suggestions
despite his busy clinical schedule.
I sincerely thank Dr Ravi P. Singh, Secretary General of Quality

Council of India for his succinct guidance and continuous support
by making adequate resources available for this process.
I thank all board members of NABH in giving significant

suggestions for betterment of the standard.
The Technical Committee of NABH worked relentlessly and

meticulously to accommodate the best practices in patient safety and
healthcare quality, referred to innumerable academic references and
incorporated suggestions made by all of the stakeholders in
bringing this standard to reality. It was, indeed, a mammoth task. I
profoundly thank all the members for playing a pivotal role in the
development of this edition.
I thank all our passionate assessors, management of the hospitals,

quality managers, clinicians, nurses and paramedics who gave us
extensive feedback to improve upon the standards.
I thank the officers at NABH Secretariat for working round the clock,
to complete the work within time.
It is entirely due to the overwhelming participation, dedication,

and diligence of all concerned that we could present this
document on schedule.
To all of you a sincere, heartfelt and, profound - Thank you.
Dr. Atul Mohan Kochhar

CEO, NABH
T
CONTENTS
Chapter 1 Access Assessment and Continuity of Care (AAC) 1
Chapter 2 Care of Patients (COP) 13
Chapter 3 Management of Medication (MOM) 30
Chapter 4 Patient Rights and Education (PRE) 39
Chapter 5 Hospital Infection Control (HIC) 47
Chapter 6 Patient Safety and Quality Improvement (PSQ) 57
Chapter 7 Responsibilities of Management (ROM) 65
Chapter 8 Facility Management and Safety (FMS) 72
Chapter 9 Human Resource Management (HRM) 79
Chapter 10 Information Management System (IMS) 91
Glossary 98
Annexure I Key Performance Indicators 114
Annexure II Medication Errors 127

Chapter
1 Access Assessment and
Continuity of Care (AAC)
Intent of the chapter:
Patients are informed of the services provided by the organisation. Only those patients who can be cared for by
the organisation are admitted. Emergency patients receive life-stabilising treatment and are then either admitted
(if resources are available) or transferred appropriately to an organisation that has the resources to take care of
such patients. Out-patients who do not match the organisation's resources are similarly referred to organisations
that have the required resources.
Patients that match the organisation's resources are admitted using a defined process. Patients cared for by the
organisation undergo an established initial assessment and periodic reassessments.
These assessments result in the formulation of a care plan.
The organisation provides laboratory and imaging services commensurate to its scope of services. The laboratory
and imaging services are provided by competent staff in a safe environment for both patients and staff. Patient
care is continuous and multidisciplinary. Transfer and discharge protocols are well defined, with adequate
information provided to the patient.
Summary of Standards
AAC.1. The organisation defines and displays the healthcare services that it provides.
AAC.2. The organisation has a well-defined registration and admission process.
AAC.3. There is an appropriate mechanism for transfer (in and out) or referral of patients.
AAC.4. Patients cared for by the organisation undergo an established initial assessment.
AAC.5. Patients cared for by the organisation undergo a regular reassessment.
AAC.6. Laboratory services are provided as per the scope of services of the organisation.
AAC.7. There is an established laboratory quality assurance programme.
AAC.8. There is an established laboratory safety programme.
AAC.9. Imaging services are provided as per the scope of services of the organisation.
AAC.10. There is an established quality assurance programme for imaging services.
AAC.11. There is an established safety programme in imaging services.
AAC.12. Patient care is continuous and multidisciplinary.
AAC.13. The organisation has an established discharge process.
AAC.14. The organisation defines the content of the discharge summary.
* This implies that this objective element requires documentation.
1
STANDARDS AND OBJECTIVE ELEMENTS
Standard
The organisation defines and displays the healthcare services that it provides
AAC.1.
Objective Elements
Commitment
a. The healthcare services being provided are defined and are in consonance with
the needs of the community.
Commitment b. Each defined healthcare service should have diagnostic and treatment services
with suitably qualified personnel who provide out-patient, in-patient and
emergency cover.
Commitment c. Scope of the healthcare services of each department is defined. *
Commitment d. The organisation's defined healthcare services are prominently displayed.
Standard
The organisation has a well-defined registration and admission process.
AAC.2.
Objective Elements
Commitment a. The organisation uses written guidance for registering and admitting patients. *
C RE b. A unique identification number is generated at the end of the registration.
Commitment c. Patients are accepted only if the organisation can provide the required service.
Commitment d. The written guidance also addresses managing patients during non-availability
of beds. *
Achievement e. Access to the healthcare services in the organisation is prioritised according to

the clinical needs of the patient. *
C RE
Commitment Achievement Excellence
2
NABH Accr edi t at i on S t andards for Hospi t al s
Standard
There is an appropriate mechanism for transfer (in and out) or referral of pati
AAC.3.
Objective Elements
Commitment
a. Transfer-in of patients to the organisation is done appropriately. *
Commitment b. Transfer- out/referral of patients to another facility is done appropriately. *
Commitment c. During transfer or referral, accompanying staff are appropriate to the clinical
condition of the patient.
Commitment d. The organisation gives a summary of the patient's condition and the
treatment given.
Standard
Patients cared for by the organisation undergo an established initial assessme
AAC.4.
Objective Elements
C RE a. The initial assessment of the outpatients, day-care, in-patients and emergency
patients is done. *
Commitment b The initial assessment is performed by qualified personnel. *
Commitment c. The initial assessment is performed within a time frame based on the needs of
the patient. *
Commitment d. Initial assessment of day-care and in-patients includes nursing assessment,

which is done at the time of admission and documented.
Achievement e. The initial assessment for in-patients results in a documented care plan.
Achievement f. The care plan is countersigned by the clinician-in-charge of the patient within 24
hours.
Excellence g. The care plan includes the identification of special needs regarding care
following discharge.
C RE
3
Standard
AAC.5. Patients cared for by the organisation undergo a regular reassessment.
Objective Elements
C RE
a. Patients are reassessed at appropriate intervals to determine their response to
treatment and to plan further treatment or discharge.
Commitment b. Out-patients are informed of their next follow-up, where appropriate.
Achievement c. For in-patients during reassessment, the care plan is monitored and
modified, where found necessary.
Commitment d. Staff involved in direct clinical care document reassessments.
Commitment e. The organisation lays down guidelines and implements processes to identify
early warning signs of change or deterioration in clinical conditions for initiating
prompt intervention.
Standard
Laboratory services are provided as per the scope of services of the organis
AAC.6.
Objective Elements
Commitment a. Scope of the laboratory services is commensurate to the services provided by
the organisation.
Commitment b. The infrastructure (physical and equipment) is adequate to provide the defined
scope of services.
Commitment c. Human resource is adequate to provide the defined scope of services.
Commitment d. Qualified and trained personnel perform and supervise the investigations and
report the results.
Commitment e. Requisition for tests, collection, identification, handling, safe transportation,

processing and disposal of a specimen is performed according to written
guidance. *
Commitment f. Laboratory results are available within a defined time frame. *
C RE
4
NABH Acc re dit a ti on St a ndards for Hospi ta l s
Commitment g. Critical results are intimated to the person concerned at the earliest. *
Commitment h. Results are reported in a standardised manner.
Achievement i. There is a mechanism to address the recall / amendment of reports

whenever applicable. *
Commitment j. Laboratory tests not available in the organisation are outsourced to the
organisation(s) based on their quality assurance system. *
Standard
AAC.7. There is an established laboratory quality assurance programme.
Objective Elements
Commitment
a. The laboratory quality assurance programme is implemented. *
Commitment b. The programme addresses verification and/or validation of test methods. *
Commitment c. The programme ensures the quality of test results. *
Commitment d. The programme includes periodic calibration and maintenance of all equipment. *
Commitment e. The programme includes the documentation of corrective and preventive actions. *
Excellence f. The programme addresses clinicopathological meeting(s).
Standard
AAC.8. There is an established laboratory safety programme.
Objective Elements
Commitment a. The laboratory safety programme is implemented. *
Commitment b. This programme is aligned with the organisation's safety programme.
Commitment c. Laboratory personnel are appropriately trained in safe practices.
Commitment d. Laboratory personnel are provided with appropriate safety measures.
C RE
5
Standard
Imaging services are provided as per the scope of services of the organisation
AAC.9.
Objective Elements
C RE
a. Imaging services comply with legal and other requirements.
Commitment b. Scope of the imaging services is commensurate to the services provided by the
organisation.
Commitment c. The infrastructure (physical and equipment) and human resources are
adequate to provide for its defined scope of services.
Commitment d. Qualified and trained personnel perform, supervise and interpret the
investigations.
Commitment e. Patients are transported in a safe and timely manner to and from the imaging
services *
Commitment f. Imaging results are available within a defined time frame. *
Commitment g. Critical results are intimated immediately to the personnel concerned. *
Commitment h. Results are reported in a standardised manner.
Achievement i. There is a mechanism to address the recall / amendment of reports

whenever applicable. *
Commitment j. Imaging tests not available in the organisation are outsourced to the
organisation(s) based on their quality assurance system. *
Standard
There is an established quality assurance programme for imaging services.
AAC.10.
Objective Elements
Commitment a. The quality assurance programme for imaging services is implemented. *
Commitment b. Quality assurance programme includes tests for imaging equipment.
Commitment c. Quality assurance programme includes the review of imaging protocols.
C RE
6
NABH Accredi t at i on St andards for Hospi t al s
Achievement d. A system is in place to ensure the appropriateness of the investigations and

procedures for the clinical indication.
Achievement e. The programme addresses periodic internal/external peer review of imaging

results using appropriate sampling.
Excellence f. The programme addresses the clinico-radiological meeting(s).
Commitment g. The programme includes periodic calibration and maintenance of all equipment. *
Commitment h. The programme includes the documentation of corrective and preventive actions. *
Standard
AAC.11. There is an established safety programme in imaging services.
Objective Elements
Commitment a The radiation-safety programme is implemented. *
Commitment b. This programme is aligned with the organisation's safety programme.
Commitment c. Patients are appropriately screened for safety/risk before imaging.
Commitment d. Imaging personnel and patients use appropriate radiation safety and monitoring
devices where applicable.
Commitment e. Radiation-safety and monitoring devices are periodically tested, and results are
documented. *
Commitment f. Imaging and ancillary personnel are trained in imaging safety practices and
radiation-safety measures.
Commitment g. Imaging signage is prominently displayed in all appropriate locations.
C RE Commitment Achievement Excellence

7
Standard
AAC.12. Patient care is continuous and multidisciplinary.
Objective Elements
Commitment
a. During all phases of care, there is a qualified individual identified as responsible
for the patient's care.
Commitment b. Patient care is co-ordinated in all care settings within the organisation.
Commitment c. Information about the patient's care and response to treatment is shared
among medical, nursing and other care -providers.
C RE d. The Organisation implements standardiszed hand-over communication during

each staffing shift, between shifts and during transfers between units/
departments.
Commitment e. Patient transfer within the organisation is done safelyin a safe manner.
Commitment f. Referral of patients to other departments/ specialities follow written guidance.
Achievement g. The organisation ensures predictable service delivery by adhering to defined

timelines and informs the patient/family and/ or caregiver whenever there is a
change in schedule.
Excellence h. The organisation has a mechanism in place to monitor whether adequate

clinical intervention has taken place in response to a critical value alert.
Standard
AAC.13. The organisation has an established discharge process.
Objective Elements
Commitment
a. Thepatient'sdischargeprocessisplannedinconsultationwiththepatientand/orfamily.
Commitment
b. The discharge process is coordinated among various departments and agencies
involved (including medico-legal and absconded cases). *
Commitment
c. Written guidance governs the discharge of patients leaving against medical advice. *
Commitment
d. A discharge summary is given to all the patients leaving the organisation
(including patients leaving against medical advice).
Achievement
e. The organisation adheres to planned discharge.
Excellence
f. The organisation conforms to the defined timeframe for discharge and makes

8
continual
improvemen
t.

9
Standard
AAC.14. The organisation defines the content of the discharge summary.
Objective Elements
Commitment a. A discharge summary is provided to the patients at the time of discharge.
Commitment b. Discharge summary contains the patient's name, unique identification number,
name of the treating doctor, date of admission and date of discharge
Commitment c. Discharge summary contains the reasons for admission, significant findings and
diagnosis and the patient's condition at the time of discharge.
Commitment d. Discharge summary contains information regarding investigation results, any

procedure performed, medication administered, and other treatment given.
Commitment e. Discharge summary contains follow-up advice, medication and other

instructions in an understandable manner.
Achievement f. Discharge summary incorporates instructions about when and how to obtain
urgent care.
Commitment g. In case of death, the summary of the case also includes the cause of death.

1
0
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13
Chapter
2 Care of Patients (COP)
The organisation provides uniform care to all patients in various settings. The settings include care provided in
outpatient units, day care facilities, in-patient units including critical care units, procedure rooms and operation
theatre. When similar care is provided in these different settings, care delivery is uniform. Written
guidance, applicable laws and regulations guide emergency and ambulance services, cardio-pulmonary
resuscitation, use of blood and blood components, care of patients in the critical care and high dependency
units.
Written guidance, applicable laws and regulations also guide the care of patients who are at higher risk of
morbidity/mortality, high-risk obstetric patients, paediatric patients, patients undergoing procedural
sedation, administration of anaesthesia, patients undergoing surgical procedures and end of life care.
Pain management, nutritional therapy and rehabilitative services are also addressed to provide comprehensive
health care.
The management should have written guidelines for organ donation and procurement. The transplant
programme ensures that it has the right skill mix of staff and other related support systems to ensure safe and
high quality of care.
The standards aim to guide and encourage patient safety as the overarching principle for providing care
to patients.
COP.1. Uniform care to patients is provided in all settings of the organisation and is
guided by written guidance, and the applicable laws and regulations.
COP.2. Emergency services are provided in accordance with written guidance,
applicable laws and regulations.
COP.3. Ambulance services ensure safe patient transportation with appropriate care.
COP.4. The organisation plans and implements mechanisms for the care of
patients during community emergencies, epidemics and other disasters.
COP.5. Cardio-pulmonary resuscitation services are provided uniformly across the
organisation.
COP.6. Nursing care is provided to patients in the organisation in consonance
with clinical protocols.
COP.7. Clinical procedures are performed safely.
COP.8. Transfusion services are provided as per the scope of services of
the organisation, safely.
13
COP.9. The organisation provides care in intensive care and high dependency units in
a systematic manner.
COP.10. Organisation provides safe obstetric care.
COP.11. Organisation provides safe paediatric services.
COP.12. Procedural sedation is provided consistently and safely.
COP.13. Anaesthesia services are provided in a consistent and safe manner.
COP.14. Surgical services are provided in a consistent and safe manner.
COP.15. The organ transplant programme is carried out safely.
COP.16. The organisation identifies and manages patients who are at higher risk of
morbidity/mortality.
COP.17. Pain management for patients is done in a consistent manner.
COP.18. Rehabilitation services are provided to the patients in a safe, collaborative and
consistent manner.
COP.19. Nutritional therapy is provided to patients consistently and collaboratively.
COP.20. End of life care is provided in a compassionate and considerate manner.
Standard
Uniform care to patients is provided in all settings of the organisation and is g
COP.1.
Objective Elements
Commitment
a. Uniform care is provided following written guidance. *
C RE b. The organisation has a uniform process for identification of patients and at a

minimum, uses two identifiers.
Commitment c. Care shall be provided in consonance with applicable laws and regulations.

14
Achievement
d. The organisation adapts evidence-based clinical practice guidelines and/or
clinical protocols to guide uniform patient care.
Excellence e. Clinical care pathways are developed, consistently followed across all settings of
care, and reviewed periodically.
Commitment f. Care delivery is uniform for a given clinical condition when similar care is
provided in more than one setting. *
Excellence g. Multi-disciplinary and multi-speciality care, where appropriate, is planned based

on best clinical practices/clinical practice guidelines and delivered in a uniform
manner across the organisation.
Commitment h. Telemedicine facility is provided safely and securely based on written guidance. *
Standard
Emergency services are provided in accordance with written guidance, appli
COP.2.
Objective Elements
Commitment
a. There shall be an identified area in the organisation which is easily accessible to
receive and manage emergency patients, with adequate and appropriate
resources.
Achievement b. Prevention of patient over-crowding is planned, and crowd management

measures are implemented.
C RE c. Emergency care is provided in consonance with statutory requirements and in

accordance with the written guidance. *
Commitment d. The organisation manages medico-legal cases in accordance with statutory

requirements. *
Commitment e. Initiation of appropriate care is guided by a system of triage. *
Commitment f. Patients waiting in the emergency are reassessed as appropriate for change in
status.
Commitment g. Admission, discharge to home, or transfer to another organisation is

documented.

15
Commitment h. In case of discharge to home or transfer to another organisation, a discharge/

transfer note shall be given to the patient.
Achievement i. The organisation shall implement a quality assurance programme. *
Commitment j. The organisation has systems in place for the management of patients found
dead on arrival and patients who die within a few minutes of arrival *
Standard
Ambulance services ensure safe patient transportation with appropriate care
COP.3.
Objective Elements
Commitment
a. The organisation has access to ambulance services commensurate with the
scope of the services provided by it.
Commitment b. There are adequate access and space for the ambulance(s).
Commitment c. The ambulance(s) is fit for purpose and is appropriately equipped.
Commitment d. The ambulance(s) is operated by trained personnel.
Commitment e. The ambulance(s) is checked daily.
Commitment f. Equipment is checked daily using a checklist. *
Commitment g. A mechanism is in place to ensure that emergency medications are available in

the ambulance.
Commitment h. The ambulance(s) has a proper communication system.*
Achievement i. The emergency department identifies opportunities to initiate treatment at the

earliest when the patient is in transit to the organisation.

16
Standard
The organisation plans and implements mechanisms for the care of patients d
COP.4.
Objective Elements
Commitment
a. The organisation identifies potential community emergencies, epidemics and
other disasters.*
Commitment b. The organisation manages community emergencies, epidemics and other

disasters as per a documented plan.*
Commitment c. Provision is made for availability of medical supplies, equipment and materials
during such emergencies.
Commitment d. The plan is tested at least twice a year.
Standard
Cardio-pulmonary resuscitation services are provided uniformly across the
COP.5.
Objective Elements
Commitment a. Resuscitation services are available to patients at all times.
Commitment b. During cardio-pulmonary resuscitation, assigned roles and responsibilities are

complied with.
Commitment c. Equipment and medications for use during cardio-pulmonary resuscitation are
available in various areas of the organisation.
Commitment d. The events during cardio-pulmonary resuscitation are recorded.
Commitment e. A multidisciplinary committee does a post-event analysis of cardiopulmonary

resuscitations.
Commitment f. Corrective and preventive measures are taken based on the post-event analysis.

17
Standard
Nursing care is provided to patients in the organisation in consonance with c
COP.6.
Objective Elements
Commitment
a. Nursing care is provided to patients in accordance with written guidance. *
Achievement b. The organisation develops and implements nursing clinical practice guidelines
reflecting current standards of practice. *
Commitment c. Assignment of patient care is done as per current good clinical/ nursing practice
guidelines.
Excellence d. The organisation implements acuity-based staffing to improve patient outcomes.
C RE e. Nursing care is aligned and integrated with overall patient care.
Commitment f. Care provided by nurses is documented in the patient record.
Commitment g. Nurses are provided with appropriate and adequate equipment for providing
safe and efficient nursing care.
Commitment h. Nurses are empowered to make patient care decisions within their scope of practice.
Standard
COP.7. Clinical procedures are performed in a safe manner.
Objective Elements
Commitment
a. Procedures are performed based on the clinical needs of the patient.
Commitment
b. Performance of various clinical procedures is based on written guidance. *
Commitment
c. Qualified personnel order, plan, perform and assist in performing procedures.
C RE
d. Care is taken to prevent adverse events like a wrong patient, wrong procedure
and wrong site. *
Commitment
e. Informed consent is taken by the personnel performing the procedure, where
applicable.
Commitment
f. The procedure is done adhering to standard precautions.
Commitment
g. Patients are appropriately monitored during and after the procedure.
Commitment
h. Procedures are documented accurately in the patient record.

18
Standard
Transfusion services are provided as per the scope of services of the organis
COP.8.
Objective Elements
Commitment
a. Scope of transfusion services is commensurate with the services provided by
the organisation.
C RE b. Transfusion of blood and blood components is done safely. *
Commitment c. Blood and blood components are used rationally. *
Commitment d. Informed consent is obtained for transfusion of blood and blood components.
Commitment e. Informed consent also includes patient and family education about the donation.
Commitment
f. Blood/blood components are available for use in emergency situations within a
defined time-frame. *
Achievement
g. Post-transfusion form is collected, reactions if any identified and are analysed
for preventive and corrective actions.
Achievement h. The organisation shall implement a quality assurance programme. *
Standard
The organisation provides care in intensive care and high dependency units
COP.9.
Objective Elements
Commitment a. Care of patients in intensive care and high dependency units is provided based
on written guidance. *
Commitment
b. The defined admission and discharge criteria for intensive care and high
dependency units are implemented. *
Commitment
c. Adequate staff and equipment are available.
Excellence
d. The organisation endeavours to upgrade its physical infrastructure to meet
national and international guidelines.
Commitment
e. Defined procedures for the situation of bed shortages are followed. *
Commitment
f. Infection control practices are followed. *
Achievement
g. The organisation shall implement a quality assurance programme. *
Commitment
h. The organisation has a mechanism to counsel the patient and/or family
periodically.

19
Standard
COP.10. Organisation provides safe obstetric care.
Objective Elements
Commitment a. Obstetric services are organised and provided safely. *
Commitment b. The organisation identifies and, provides care to high-risk obstetric cases, and
where needed, refers them to another appropriate centre.
Commitment c. Persons caring for high-risk obstetric cases are competent.
Commitment d. Ante-natal services are provided. *
Commitment e. Obstetric patient's assessment also includes maternal nutrition.
Commitment f. Appropriate peri-natal and post-natal monitoring is performed.
Commitment g. The organisation caring for high-risk obstetric cases has the facilities to take
care of neonates of such cases.
Standard
COP.11. Organisation provides safe paediatric services.
Objective Elements
Commitment
a. Paediatric services are organised and provided safely. *
Commitment b. Neonatal care is in consonance with the national/ international guidelines. *
Commitment c. Those who care for children have age-specific competency.
Commitment d. Provisions are made for special care of children.
Commitment e. Paediatric assessment includes growth, developmental and immunisation

assessment.
Commitment f. The organisation has measures in place to prevent child/neonate abduction

and abuse. *
Commitment g. The child's family members are educated about nutrition, immunisation and
safe parenting.

20
Standard
COP.12. Procedural sedation is provided in a consistent and safe manner.
Objective Elements
Commitment
a. Procedural sedation is administered in a consistent manner *
Commitment b. Informed consent for administration of procedural sedation is obtained.
Commitment c. Competent and trained persons administer sedation.
Commitment d. The person monitoring sedation is different from the person performing the
procedure.
Commitment e. Intra-procedure monitoring includes at a minimum the heart rate, cardiac

rhythm, respiratory rate, blood pressure, oxygen saturation, and level of
sedation.
Commitment
f. Patients are monitored after sedation, and the same is documented.
Commitment
g. Criteria are used to determine the appropriateness of discharge from the
observation/recovery area. *
Commitment
h. Equipment and workforce are available to manage patients who have gone into
a deeper level of sedation than initially intended.
Standard
COP.13. Anaesthesia services are provided in a consistent and safe manner.
Objective Elements
Commitment a. Anaesthesia services are provided in a consistent manner*
C RE b. The pre-anaesthesia assessment results in the formulation of an anaesthesia

plan which is documented.
Commitment c. A pre-induction assessment is performed and documented.
Commitment d. The anaesthesiologist obtains informed consent for administration of

anaesthesia.
C RE e. During anaesthesia, monitoring includes regular recording of temperature,

heart rate, cardiac rhythm, respiratory rate, blood pressure, oxygen saturation
and end- tidal carbon dioxide.

21
Commitment f. Patient's post-anaesthesia status is monitored and documented.
Commitment g. The anaesthesiologist applies defined criteria to transfer the patient from the
recovery area. *
Commitment h. The type of anaesthesia and anaesthetic medications used are documented in
the patient record.
Commitment i. Procedures shall comply with infection control guidelines to prevent cross-
infection between patients.
Achievement j. Intraoperative adverse anaesthesia events are recorded and monitored.
Standard
COP.14. Surgical services are provided in a consistent and safe manner.
Objective Elements
Commitment
a. Surgical services are provided in a consistent and safe manner. *
Commitment b. Surgical patients have a preoperative assessment, a documented pre-operative

diagnosis, and pre-operative instructions are provided before surgery.
Commitment c. Informed consent is obtained by a surgeon before the procedure.
C RE d. Care is taken to prevent adverse events like the wrong site, wrong patient and
wrong surgery. *
Commitment e. An operative note is documented before transfer out of patient from recovery.
Commitment f. Postoperative care is guided by a documented plan.
Commitment g. Patient, personnel and material flow conform to infection control practices.
Commitment h. Appropriate facilities, equipment, instruments and supplies are available in the
operating theatre.
Achievement i. The organisation shall implement a quality assurance programme. *
Achievement j. The quality assurance programme includes surveillance of the operation theatre
environment. *

22
Standard
COP.15. The organ transplant programme is carried out safely.
Objective Elements
C RE
a. The organ transplant program shall be in consonance with the legal
requirements and shall be conducted ethically.
Commitment b. Care of transplant patients is guided by clinical practice guidelines. *
Commitment c. The organisation ensures education and counselling of recipient and donor
through trained/qualified counsellors before organ transplantation.
C RE d. The organisation shall take measures to create awareness regarding organ

donation.
Standard
The organisation identifies and manages patients who are at higher risk of m
Objective
COP.16. Elements
Commitment a. The organisation identifies and manages vulnerable patients. *
Commitment b. The organisation provides for a safe and secure environment for the vulnerable
patient.
C RE c. The organisation identifies and manages patients who are at a risk of fall.*
C RE d. The organisation identifies and manages patients who are at risk of

developing/worsening of pressure ulcers.*
C RE e. The organisation identifies and manages patients who are at risk of developing
deep vein thrombosis.*
Commitment f. The organisation identifies and manages patients who need restraints. *

23
Standard
COP.17. Pain management for patients is done in a consistent manner.
Objective Elements
Commitment a. Patients in pain are effectively managed. *
Commitment b. Patients are screened for pain.
Commitment c. Patients with pain undergo detailed assessment and periodic reassessment.
Commitment d. Pain alleviation measures or medications are initiated and titrated according to
the patient's need and response.
Standard
Rehabilitation services are provided to the patients in a safe, collaborative
COP.18.
Objective Elements
Commitment
a. Scope of the rehabilitation services at a minimum is commensurate to the
services provided by the organisation.
Commitment b. Rehabilitation services are provided in a consistent manner.
Commitment c. Care providers collaboratively plan rehabilitation services.
Commitment d. There are adequate space and equipment to provide rehabilitation.
Commitment e. Care is guided by functional assessment and periodic re-assessments which are
done and documented.
Commitment f. Care is provided adhering to infection control and safety practices.
Excellence g. Care pathways are developed, implemented, and reviewed periodically.

24
Standard
Nutritional therapy is provided to patients consistently and collaboratively.
COP.19.
Objective Elements
Commitment
a. Patients admitted to the organisation are screened for nutritional risk. *
Commitment b. Nutritional assessment is done for patients found at risk during nutritional
screening.
Commitment c. The therapeutic diet is planned and provided collaboratively.
Commitment d. Patients receive food according to the written order for the diet.
Commitment e. When family provides food, they are educated about the patient's diet limitations.
Standard
COP.20. End-of-life-care is provided in a compassionate and considerate manner.
Objective Elements
Commitment a. End-of-life care is provided in a consistent manner in the organisation. *
Achievement b. A multi-professional approach is used to provide end-of-life care.
Commitment c. End-of-life care is in consonance with the legal requirements.
Commitment d. End of life care also addresses the identification of the unique needs of such
patient and family.
Commitment e. Symptomatic treatment is provided and where appropriate measures are taken
for the alleviation of pain.

25
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51. Vanhaecht, K., De Witte, K., Panella, M., & Sermeus, W. (2009). Do pathways lead to better organized care
processes? Journal of Evaluation in Clinical Practice, 15(5), 782-788. doi:10.1111/j.1365-2753.2008.01068.x
52. Wax, D. B., McCormick, P. J., Joseph, T. T., & Levin, M. A. (2018). An Automated Critical Event Screening
and Notification System to Facilitate Preanesthesia Record Review. Anesthesia & Analgesia, 126(2),
606-610. doi:10.1213/ane.0000000000002141
53. Whitehead, L., & Myers, H. (2016). The effect of hospital nurse staffing models on patient and staff-related
outcomes. International Journal of Nursing Practice, 22(4), 330-332. doi:10.1111/ijn.12463
54. World Health Organization. World Alliance for Patient Safety. (2009). WHO Guidelines for Safe Surgery
2009: Safe Surgery Saves Lives.
55. World Health Organization. (2012). World Health Organization Guidelines on the Pharmacological Treatment
of Persisting Pain in Children with Medical Illnesses.
56. World Health Organization. (2019, March 28). The Clinical Use of Blood. Retrieved August 5, 2019,
from https://www.who.int/bloodsafety/clinical_use/en/Handbook_EN.pdf
57. World Health Organization. (n.d.). Global Atlas of Palliative Care at the End of Life. Retrieved August 5,
2019, from https://www.who.int/nmh/Global_Atlas_of_Palliative_Care.pdf
58. World Health Organization. (n.d.). WHO Guiding principles on human cell, tissue and organ transplantation.
Retrieved August 5, 2019, from https://www.who.int/transplantation/Guiding_PrinciplesTransplantation_
WHA63.22en.pdf?ua=1
29
Chapter
3 Management of
Medication (MOM)
The organisation has a safe and organised medication process. The availability, safe storage, prescription,
dispensing and administration of medications is governed by written guidance.
The pharmacy should have oversight of all medications stocked out of the pharmacy. The pharmacy should
ensure correct storage (as regards to temperature, light; high-risk medications including look-alike, sound-alike,
etc.), expiry dates and maintenance of documentation.
The availability of emergency medication is stressed upon. The organisation should have a mechanism to ensure
that the emergency medications are standardised throughout the organisation, readily available and replenished
promptly. There should be a monitoring mechanism to ensure that the required medications are always stocked
and well within expiry dates.
Every high-risk medication order should be verified by an appropriate person to ensure accuracy of the
dose, frequency and route of administration. Safety is paramount when using narcotics, chemotherapeutic
agents and radioactive agents.
The process also includes monitoring of patients after administration and procedures for reporting and analysing
near-misses, medication errors and adverse drug reactions.
Medications also include blood, implants and devices.
Medical supplies and consumables are available for use.
MOM.1. Pharmacy services and usage of medication is done safely.
MOM.2. The organisation develops, updates and implements a hospital formulary.
MOM.3. Medications are stored appropriately and are available where required.
MOM.4. Medications are prescribed safely and rationally.
MOM.5. Medication orders are written in a uniform manner.
MOM.6. Medications are dispensed in a safe manner.
MOM.7. Medications are administered safely.
MOM.8. Patients are monitored after medication administration.
MOM.9. Narcotic drugs and psychotropic substances, chemotherapeutic agents and
radioactive agents are used safely.
MOM.10. Implantable prosthesis and medical devices are used in accordance with
laid down criteria.
MOM.11. Medical supplies and consumables are stored appropriately and are available
where required.
30
Standard
MOM.1. Pharmacy services and usage of medication is done safely.
Objective Elements
Commitment
a. Pharmacy services and medication usage are implemented following written
guidance. *
Commitment b. A multidisciplinary committee guides the formulation and implementation of

pharmacy services and medication usage.
Excellence c. 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.
Commitment d. There is a procedure to obtain medication when the pharmacy is closed. *
Commitment e. The organisation has a mechanism to inform relevant staff of key changes in
pharmacy services and medication usage to ensure uninterrupted and safe
care.
Standard
MOM.2. The organisation develops, updates and implements a hospital formulary.
Objective Elements
C RE
a. A list of medications appropriate for the patients and as per the scope of the
organisation's clinical services is developed collaboratively by the
multidisciplinary committee.
Commitment b. The list is reviewed and updated collaboratively by the multidisciplinary

committee at least annually.
Commitment c. The current formulary is available for clinicians to refer to.
Excellence d. The clinicians adhere to the current formulary.
Commitment e. The organisation adheres to the procedure for the acquisition of formulary
medications. *
Commitment f. The organisation adheres to the procedure to obtain medications not listed in
the formulary. *

31
Standard
MOM.3. Medications are stored appropriately and are available where required.
Objective Elements
C RE
a. Medications are stored in a clean, safe and secure environment; and
incorporating the manufacturer's recommendation(s).
Commitment b. Sound inventory control practices guide storage of the medications throughout
the organisation.
C RE c. The organisation defines a list of high-risk medication(s). *
Achievement d. High-risk medications are stored in areas of the organisation where it is

clinically necessary.
C RE e. High-risk medications including look-alike, sound-alike medications and

different concentrations of the same medication are stored physically apart
from each other. *
Commitment f. The list of emergency medications is defined and is stored uniformly. *
C RE g. Emergency medications are available all the time and are replenished promptly
when used.
Standard
Objective
MOM.4. Elements
Medications are prescribed safely and rationally.
Commitment a. Medication prescription is in consonance with good practices/guidelines for the
rational prescription of medications. *
C RE b. The organisation adheres to the determined minimum requirements of a
prescription. *
Commitment c. Drug allergies and previous adverse drug reactions are ascertained before
prescribing.
Excellence d. The organisation has a mechanism to assist the clinician in prescribing

appropriate medication.
C RE e. Implementation of verbal orders ensures safe medication management practices. *

32
Achievement f. Audit of medication orders/prescription is carried out to check for safe and
rational prescription of medications.
Achievement g. Corrective and/or preventive action(s) is taken based on the audit, where
appropriate.
C RE h. Reconciliation of medications occurs at transition points of patient care.
Standard
MOM.5. Medications orders are written in a uniform manner.
Objective Elements
Commitment
a. The organisation ensures that only authorised personnel write orders. *
Commitment b. Medication orders are written in a uniform location in the medical records,
which also reflects the patient's name and unique identification number.
Commitment c. Medication orders are legible, dated, timed and signed.
Commitment d. Medication orders contain the name of the medicine, route of administration,
strength to be administered and frequency/time of administration.
Standard
MOM.6. Medications are dispensed in a safe manner.
Objective Elements
Commitment a. Dispensing of medications is done safely. *
Commitment b. Medication recalls are handled effectively. *
Commitment c. Near-expiry medications are handled effectively. *
C RE d. Dispensed medications are labelled. *
C RE e. High-risk medication orders are verified before dispensing.
Commitment f. Return of medications to the pharmacy is addressed. *

33
Standard
MOM.7. Medications are administered safely.
Objective Elements
Commitment
a. Medications are administered by those who are permitted by law to do so.
Commitment b. Prepared medication is labelled before preparation of a second drug.
Commitment c. The patient is identified before administration.

C RE d. Medication is verified from the medication order and physically inspected before
administration.
Commitment e. Strength is verified from the order before administration.
Commitment f. The route is verified from the order before administration.
Commitment g. Timing is verified from the order before administration.

C RE h. Measures to avoid catheter and tubing mis-connections during medication
administration are implemented. *
Commitment i. Medication administration is documented.
Commitment j. Measures to govern patient's self-administration of medications are implemented. *
Commitment k. Measures to govern patient's medications brought from outside the

organisation are implemented. *
Standard
MOM.8. Patients are monitored after medication administration.
Objective Elements
Commitment
a. Patients are monitored after medication administration. *
Commitment b. Medications are changed where appropriate based on the monitoring.
C RE c. The organisation captures near miss, medication error and adverse drug reaction. *
Commitment d. Near miss, medication error and adverse drug reaction are reported within a
specified time frame. *
Commitment e. Near miss, medication error and adverse drug reaction are collected and analysed.
Commitment f. Corrective and/or preventive action(s) are taken based on the analysis.

34
Standard
Narcotic drugs and psychotropic substances, chemotherapeutic agents and r
MOM.9.
Objective Elements
Commitment a. Narcotic drugs and psychotropic substances, chemotherapeutic agents and
radioactive agents are used safely. *
Commitment b. Narcotic drugs and psychotropic substances, chemotherapeutic agents and

radioactive agents are prescribed by appropriate caregivers.
Commitment c. Narcotic drugs and psychotropic substances, chemotherapeutic agents and

radioactive agents drugs are stored securely.
Commitment d. Chemotherapy and radioactive agents are prepared properly and safely and
administered by qualified personnel.
Commitment e. A proper record is kept of the usage, administration and disposal of narcotic
drugs and psychotropic substances, chemotherapeutic agents and radioactive
agents.
Standard
Implantable prosthesis and medical devices are used in accordance with la
MOM.10.
Objective Elements
Commitment
a. Usage of the implantable prosthesis and medical devices is guided by scientific
criteria for each item and national/international recognised guidelines/
approvals for such specific item(s).
Commitment b. The organisation implements a mechanism for the usage of the implantable
prosthesis and medical devices. *
Commitment c. Patient and his/her family are counselled for the usage of the implantable
prosthesis and medical device, including precautions if any.
Commitment d. The batch and the serial number of the implantable prosthesis and medical
devices are recorded in the patient's medical record, the master logbook and
the discharge summary.
Achievement e. Recall of implantable prosthesis and medical devices are handled effectively. *

35
Standard
Medical supplies and consumables are stored appropriately and are availabl
MOM.11.
Objective Elements
Commitment
a. The organisation adheres to the defined process for the acquisition of medical
supplies and consumables. *
Commitment b. Medical supplies and consumables are used in a safe manner, where appropriate.
Commitment c. Medical supplies and consumables are stored in a clean, safe and secure
environment; and incorporating the manufacturer's recommendation(s).
Commitment d. Sound inventory control practices guide storage of medical supplies and
consumables
Commitment e. There is a mechanism in place to verify the condition of medical supplies

and consumables

36
References:
1. Agency for Healthcare Research and Quality Patient Safety Network. (2019, January). Medication Errors and
Adverse Drug Events. Retrieved August 2, 2019, from http://psnet.ahrq.gov/primer.aspx?primerID=23
2. Agency for Healthcare Research and Quality Patient Safety Network. (2019, January). Medication
Reconciliation. Retrieved August 2, 2019, from https://psnet.ahrq.gov/primers/primer/1
3. Clinical Excellence Commission (CEC). (n.d.). High-Risk Medicines. Retrieved August 2, 2019, from
http://www.cec.health.nsw.gov.au/programs/high-risk-medicines
4. Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India. (2018,
December 27 ) . National List of Essential Medicines. Retrieved August 2 , 2019 , f rom
http://pharmaceuticals.gov.in/important-document/national-list-essential-medicines
5. Graham, L. R., Scudder, L., & Stokowski, L. (2015, October 22). Seven (Potentially) Deadly Prescribing
Errors. Retrieved from http://www.medscape.com/features/slideshow/prescribing-errors#page=1
6. Indian Pharmacopoeia Commission, National Coordination Centre. (2017, 1). Pharmacovigilance
Programme of India. Retrieved August 2, 2019, from https://ipc.gov.in//PvPI/pv_home.html
7. Institute for Safe Medication Practices. (2010, January 12). Guidelines for Standard Order Sets. Retrieved
August 2, 2019, from https://www.ismp.org/guidelines/standard-order-sets
8. Institute for Safe Medication Practices. (2011). ISMP Acute Care Guidelines for Timely Administration
of Scheduled Medications. Retrieved August 2, 2019, from https://www.ismp.org/sites/default/files/
attachments/2018-02/tasm.pdf
9. Institute for Safe Medication Practices. (2016). FDA and ISMP Lists of Look-Alike Drug Names with
Recommended Tall Man Letters. Retrieved August 2, 2019, from https://www.ismp.org/sites/default/files/
attachments/2017-11/tallmanletters.pdf
10. Institute for Safe Medication Practices. (2017, October 2). List of Error-Prone Abbreviations. Retrieved
August 2, 2019, from https://www.ismp.org/recommendations/error-prone-abbreviations-list
11. Institute for Safe Medication Practices. (2018, August 23). High-Alert Medications in Acute Care
Settings. Retrieved August 2, 2019, from https://www.ismp.org/recommendations/high-alert-medications-
acute-list
12. Institute for Safe Medication Practices. (2019, February 28). List of Confused Drug Names. Retrieved August
2, 2019, from https://www.ismp.org/recommendations/confused-drug-names-list
13. Kahn, S., & Abramson, E. L. (2018). What is new in paediatric medication safety? Archives of Disease
in Childhood, 104(6), 596-599. doi:10.1136/archdischild-2018-315175
14. National Coordinating Council for Medication Error Reporting and Prevention. (2015, January 29).
Recommendations to Enhance Accuracy of Prescription/Medication Order Writing. Retrieved August 2,
2019, from https://www.nccmerp.org/recommendations-enhance-accuracy-prescription-writing
15. National Coordinating Council for Medication Error Reporting and Prevention. (2015, September 2).
Recommendations to Reduce Medication Errors Associated with Verbal Medication Orders and
Prescriptions. Retrieved August 2, 2019, from https://www.nccmerp.org/recommendations-reduce-
medication-errors-associated-verbal-medication-orders-and-prescriptions
37
Recommendations to Enhance Accuracy of Dispensing Medications. Retrieved August 2, 2019, from
https://www.nccmerp.org/recommendations-enhance-accuracy-dispensing-medications
Recommendations to Enhance Accuracy of Prescription/Medication Order Writing. Retrieved August 2,
2019, from https://www.nccmerp.org/recommendations-enhance-accuracy-prescription-writing
Recommendations to Enhance Accuracy of Administration of Medications. Retrieved August 2, 2019, from
https://www.nccmerp.org/recommendations-enhance-accuracy-administration-medications
About Medication Errors. Retrieved August 2, 2019, from https://www.nccmerp.org/about-medication-errors
20. Tully, A. P., Hammond, D. A., Li, C., Jarrell, A. S., & Kruer, R. M. (2019). Evaluation of Medication Errors at
the Transition of Care From an ICU to Non-ICU Location. Critical Care Medicine, 47(4), 543-549.
doi:10.1097/ccm.0000000000003633
21. World Health Organization. (n.d.). Avoiding Catheter and Tubing Mis-Connections. Retrieved August 2,
2019, from https://www.who.int/patientsafety/solutions/patientsafety/PS-Solution7.pdf?ua=1
22. World Health Organization. (n.d.). How to Investigate Drug Use in Health Facilities: Selected Drug Use
Indicators - EDM Research Series No. 007. Retrieved August 2, 2019, f
r o m http://apps.who.int/medicinedocs/en/d/Js2289e/
23. World Health Organization. (n.d.). Improving Medication safety. Retrieved August 2, 2019, from
http://www.who.int/patientsafety/education/curriculum/who_mc_topic-11.pdf
24. World Health Organization. (n.d.). Look-Alike, Sound-Alike Medication Names. Retrieved August 2,
2019, from https://www.who.int/patientsafety/solutions/patientsafety/PS-Solution1.pdf?ua=1
25. World Health Organization. (n.d.). Rational use of medicines. Retrieved August 2, 2019, from
https://www.who.int/medicines/areas/rational_use/en/
26. World Health Organization. (n.d.). The High 5s Project -Standard Operating Protocol Assuring
Medication Accuracy at Transitions in Care: Medication Reconciliation. Retrieved August 2, 2019, from
https://www.who.int/patientsafety/implementation/solutions/high5s/h5s-sop.pdf
27. World Health Organization. (n.d.). WHO Model Lists of Essential Medicines. Retrieved August 2, 2019, from
https://www.who.int/medicines/publications/essentialmedicines/en/
38
Chapter 4
Patient Rights and
Education (PRE)
The organisation defines, protects and promotes the patient and family's rights and responsibilities. The staff is
aware of these rights and is trained to protect them. Patients are informed of their rights and educated about
their responsibilities at the time of entering the organisation.
The expected costs of treatment and care are explained clearly to the patient and/or
family. Patients are educated about the mechanisms available for addressing grievances.
Informed consent is obtained from the patient or family for specified procedures/care. The key components of
information shall include risks, benefits and alternatives.
Patients and families have a right to get information and education about their healthcare needs in a language and
manner that is understood by them.
The organisation develops effective patient-centred communication.
PRE.1. The organisation protects and promotes patient and family rights and informs
them about their responsibilities during care.
PRE.2. Patient and family rights support individual beliefs, values and involve the patient
and family in decision-making processes.
PRE.3. The patient and/or family members are educated to make informed decisions and
are involved in the care planning and delivery process.
PRE.4. Informed consent is obtained from the patient or family about their care.
PRE.5. Patient and families have a right to information and education about their
healthcare needs.
PRE.6. Patients and families have a right to information on expected costs.
PRE.7. The organisation has a mechanism to capture patient's feedback and to
redress complaints.
PRE.8. The organisation has a system for effective communication with patients
and/or families.
39
Standard
The organisation protects and promotes patient and family rights and inform
PRE.1.
Objective Elements
Commitment
a. Patient and family rights and responsibilities are documented, displayed and
they are made aware of the same. *
Achievement b. Patient and family rights and responsibilities are actively promoted. *
C RE c. The organisation protects patient and family rights.
C RE d. The organisation has a mechanism to report a violation of patient and family rights.
C RE e. Violation of patient and family rights are monitored, analysed, and

corrective/preventive action taken by the top leadership of the organisation.
Standard
Patient and family rights support individual beliefs, values and involve the p
PRE.2.
Objective Elements
Commitment
a. Patients and family rights include respecting values and beliefs, any special
preferences, cultural needs, and responding to requests for spiritual needs.
Commitment b. Patient and family rights include respect for personal dignity and privacy during
examination, procedures and treatment.
Commitment c. Patient and family rights include protection from neglect or abuse.
C RE d. Patient and family rights include treating patient information as confidential.
Commitment e. Patient and family rights include the refusal of treatment.
Commitment f. Patient and family rights include a right to seek an additional opinion regarding
clinical care.

40
C RE g. Patient and family rights include informed consent before the transfusion of
blood and blood components, anaesthesia, surgery, initiation of any research
protocol and any other invasive/high-risk procedures/treatment.
Commitment h. Patient and family rights include a right to complain and information on how to
voice a complaint.
Achievement i. Patient and family rights include information on the expected cost of the
treatment.
Commitment j. Patient and family rights include access to their clinical records.
Commitment k. Patient and family rights include information on the name of the treating
doctor, care plan, progress and information on their health care needs.
Commitment l. Patient rights include determining what information regarding their care would
be provided to self and family.
Standard
The patient and/or family members are educated to make informed decision
PRE.3.
Objective Elements
C RE a. The Patient and/or family members are explained about the proposed care,
including the risks, alternatives and benefits.
Commitment b. The patient and/or family members are explained about the expected results.
Commitment c. The patient and/or family members are explained about the possible
complications.
Achievement d. The care plan is prepared and modified in consultation with the patient and/or
family members.
Commitment e. The patient and/or family members are informed about the results of diagnostic
tests and the diagnosis.
Commitment f. The patient and/or family members are explained about any change in the
patient's condition in a timely manner.
Achievement g. The patient and/or family members are provided multi-disciplinary counselling
when appropriate.

41
Standard
PRE.4. Informed consent is obtained from the patient or family about their care.
Objective Elements
C RE
a. The organisation obtains informed consent from the patient or family for
situations where informed consent is required. *
Commitment b. Informed consent process adheres to statutory norms.
C RE c. 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.
Commitment d. The organisation describes who can give consent when a patient is incapable of
independent decision making and implements the same. *
C RE e. Informed consent is taken by the person performing the procedure.
Standard
Patient and families have a right to information and education about their he
PRE.5.
Objective Elements
C RE
a. Patient and/or family are educated in a language and format that they can
understand.
Commitment
b. Patient and/or family are educated about the safe and effective use of
medication and the potential side effects of the medication, when appropriate.
Commitment
c. Patient and/or family are educated about food-drug interaction
Commitment
d. Patient and/or family are educated about diet and nutrition.
Commitment
e. Patient and/or family are educated about immunisations.
Commitment
f. Patient and/or family are educated on various pain management techniques,
when appropriate.
Commitment
g. Patient and/or family are educated about their specific disease process,
complications and prevention strategies.
Commitment
h. Patient and/or family are educated about preventing healthcare associated
infections.
Achievement
i. The patients and/or family members' special educational needs are identified
and addressed.
42
Standard
PRE.6. Patients and families have a right to information on expected costs.
Objective Elements
C RE
a. The patient and/or family members are made aware of the pricing policy in
different settings (out-patient, emergency, ICU and inpatient).
Commitment b. The relevant tariff list is available to patients.
Commitment c. The patient and/or family members are explained about the expected costs.
Commitment d. Patient and/or family are informed about the financial implications when there
is a change in the care plan.
Standard
The organisation has a mechanism to capture patient's feedback and to re
PRE.7.
Objective Elements
Commitment
a. The organisation has a mechanism to capture feedback from patients, which
includes patient satisfaction.
Achievement b. The organisation has a mechanism to capture patient experience.
C RE c. The organisation redress patient complaints as per the defined mechanism. *
Commitment d. Patient and/or family members are made aware of the procedure for giving
feedback and/or lodging complaints.
Commitment e. Feedback and complaints are reviewed and/or analysed within a defined
time frame.
Commitment f. Corrective and/or preventive action(s) are taken based on the analysis where
appropriate.

43
Standard
The organisation has a system for effective communication with patients an
PRE.8.
Objective Elements
Commitment a. Communication with the patients and/or families is done effectively. *
Commitment b. The organisation shall identify special situations where enhanced

communication with patients and/or families would be required. *
Commitment c. Enhanced communication with the patients and/or families is done effectively. *
Commitment d. The organisation ensures that there is no unacceptable communication.
Achievement e. The organisation has a system to monitor and review the implementation of
effective communication.

44
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22. U S National Library of Medicine. (n.d.). Patient Rights: MedlinePlus. Retrieved August 2, 2019, from
https://medlineplus.gov/patientrights.html
23. Williams, A. M., Muir, K. W., & Rosdahl, J. A. (2016). Readability of patient education materials in
ophthalmology: a single-institution study and systematic review. BMC Ophthalmology, 16(1).
doi:10.1186/s12886-016-0315-0
46
Chapter 5
Hospital Infection
Control (HIC)
The organisation implements an effective healthcare associated infection prevention and control programme. The
programme is documented and aims at reducing/eliminating infection risks to patients, visitors and providers of
care. The programme is implemented across the organisation, including clinical areas and support services.
The organisation provides proper facilities and adequate resources to support the infection prevention and
control programme. The organisation measures and acts to prevent or reduce the risk of healthcare associated
infection in patients and staff.
The organisation has an effective antimicrobial management programme through regularly updated
antibiotic policy based on local data and monitors its implementation. Programme also includes monitoring
of antimicrobials usage in the organisation.
Surveillance activities are incorporated in the infection prevention and control programme.
The programme includes disinfection/sterilisation activities and biomedical waste (BMW) management.
HIC.1. The organisation has a comprehensive and coordinated Hospital Infection
Prevention and Control (HIC) programme aimed at reducing/eliminating risks to
patients, visitors, providers of care and community.
HIC.2. The organisation provides adequate and appropriate resources for infection
prevention and control.
HIC.3. The organisation implements the infection prevention and control programme in
clinical areas.
HIC.4. The organisation implements the infection prevention and control programme in
support services.
HIC.5. The organisation takes actions to prevent healthcare associated Infections (HAI)
in patients.
HIC.6. The organisation performs surveillance to capture and monitor infection
prevention and control data.
HIC.7. Infection prevention measures include sterilization and/or disinfection of
instruments, equipment and devices.
HIC.8. The organisation takes action to prevent or reduce healthcare associated
infections in its staff.
47
Standard
The organisation has a comprehensive and coordinated Hospital Infection Pre
HIC.1.
Objective Elements
C RE
a. The hospital infection prevention and control programme is documented, which
aims at preventing and reducing the risk of healthcare associated infections in
the hospital. *
Commitment b. The hospital infection prevention and control programme identifies high-risk
activities, and has written guidance to prevent and manage infections for these
activities.*
Commitment c. The infection prevention and control programme is reviewed and updated at
least once a year.
Achievement d. The infection prevention and control programme is reviewed based on infection
control assessment tool.
Commitment e. The organisation has a multi-disciplinary infection control committee, which co-
ordinates all infection prevention and control activities. *
Commitment f. The organisation has an infection control team, which coordinates the
implementation of all infection prevention and control activities. *
Commitment g. The organisation has designated infection control officer as part of the infection
control team. *
Commitment h. The organisation has designated infection control nurse(s) as part of the
infection control team. *
Commitment i. The organisation implements information, education and communication

programme for infection prevention and control activities for the community.
Commitment j. The organisation participates in managing community outbreaks.

48
Standard
The organisation provides adequate and appropriate resources for infectio
HIC.2.
Objective Elements
C RE
a. The management makes available resources required for the infection control
programme.
Commitment b. The organisation earmarks adequate funds from its annual budget in this regard.
Commitment c. Adequate and appropriate personal protective equipment, soaps, and

disinfectants are available and used correctly.
C RE d. Adequate and appropriate facilities for hand hygiene in all patient-care areas
are accessible to healthcare providers.
Achievement e. Isolation/barrier nursing facilities are available.
Standard
The organisation implements the infection prevention and control program
HIC.3.
Objective Elements
C RE a. The organisation adheres to standard precautions at all times. *
C RE b. The organisation adheres to hand-hygiene guidelines. *
Commitment c. The organisation adheres to transmission-based precautions. *
C RE d. The organisation adheres to safe injection and infusion practices. *

Commitment e. Appropriate antimicrobial usage policy is established and documented *
C RE f. The organisation implements the antimicrobial usage policy and monitors the
rational use of antimicrobial agents.
Excellence g. The organisation implements an antibiotic stewardship programme. *

49
Standard
The organisation implements the infection prevention and control program
HIC.4.
Objective Elements
Commitment a. The organisation has appropriate engineering controls to prevent infections. *
Commitment b. The organisation designs and implements a plan to reduce the risk of infection
during construction and renovation. *
C RE c. The organisation adheres to housekeeping procedures. *
C RE d. Biomedical waste (BMW) is handled appropriately and safely.
Commitment e. The organisation adheres to laundry and linen management processes. *
Commitment f. The organisation adheres to kitchen sanitation and food-handling issues. *
Standard
The organisation takes actions to prevent healthcare associated infections
HIC.5.
Objective Elements
Commitment
a. The organisation takes action to prevent catheter-associated urinary tract
Infections.
Commitment
b. The organisation takes action to prevent infection-related ventilator associated
complication/ventilator-associated pneumonia.
Commitment
c. The organisation takes action to prevent catheter linked blood stream infections.
Commitment
d. The organisation takes action to prevent surgical site infections.

50
Standard
The organisation performs surveillance to capture and monitor infection pre
HIC.6.
Objective Elements
C RE a. The scope of surveillance incorporates tracking and analysing of infection risks,
rates and trends.
Commitment b. Verification of data is done regularly by the infection control team.
Commitment c Surveillance is directed towards the identified high-risk activities.
C RE d. Surveillance includes monitoring compliance with hand-hygiene guidelines.
Commitment e. Surveillance includes mechanisms to capture the occurrence of multi-drug-

resistant organisms and highly virulent infections.
C RE f. Surveillance includes monitoring the effectiveness of housekeeping services.
Commitment g. Feedback regarding surveillance data is provided regularly to the appropriate

health care provider.
Commitment h. The organisation identifies and takes appropriate action to control outbreaks of
infections.
Commitment I. Surveillance data is analysed, and appropriate corrective and preventive actions
are taken.
Standard
Infection prevention measures include sterilisation and/or disinfection of ins
HIC.7.
Objective Elements
Commitment
a. The organisation provides adequate space and appropriate zoning for
sterilisation activities.
C RE
b. Cleaning, packing, disinfection and/or sterilisation, storing and the issue of
items is done as per the written guidance. *
Commitment
c. Reprocessing of single-use instruments, equipment and devices are done as per
written guidance. *
Commitment
d. Regular validation tests for sterilisation are carried out and documented. *
Commitment
e. The established recall procedure is implemented when a breakdown in the
sterilisation system is identified. *

51
Standard
The organisation takes action to prevent or reduce healthcare associated inf
HIC.8.
Objective Elements
Commitment
a. The organisation implements occupational health and safety practices to reduce
the risk of transmitting microorganisms among health care providers.
Commitment b. The organisation implements an immunisation policy for its staff. *
Achievement c. The organisation implements work restrictions for health care providers with
transmissible infections.
Commitment d. The organisation implements measures for blood and body fluid exposure
prevention.
Commitment e. Appropriate post-exposure prophylaxis is provided to all staff members

concerned. *

52
References:
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133(3), e235-e237. doi:10.1097/aog.0000000000003124
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ahrq.gov/topics/healthcare-infections/research-protocol
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39(2), 127-144. doi:10.1017/ice.2017.245
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(2017). Outbreak Response and Incident Management: SHEA Guidance and Resources for Healthcare
Epidemiologists in United States Acute-Care Hospitals. Infection Control & Hospital Epidemiology, 38(12),
1393-1419. doi:10.1017/ice.2017.212
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in Health-Care Facilities: Recommendations of CDC and the Healthcare Infection Control Practices
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S u r v e i l l a n c e . R e t r i e v e d A u g u s t 2 , 2 0 1 9 , f r o m h t t p s : / / w w w. c d c . g o v / n
h s n / P D F S / OutlineForHAISurveillance.pdf
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Prevention Controls, Infectious Agents - NIOSH Workplace Safety and Health Topic. Retrieved August
2, 2019, from https://www.cdc.gov/niosh/topics/healthcare/prevention.html
11. Centers for Disease Control and Prevention. (2019, May 24). Disinfection & Sterilization Guidelines |
Guidelines Library | Infection Control | CDC. Retrieved August 2, 2019, from https://www.cdc.gov/
infectioncontrol/guidelines/disinfection/index.html
12. Centers for Disease Control and Prevention. (2019, June 18). CAUTI Guidelines | Guidelines Library |
Infection Control | CDC. Retrieved August 2, 2019, from https://www.cdc.gov/infectioncontrol/
guidelines/CAUTI/index.html
13. Centers for Disease Control and Prevention. (2019, July 22). Isolation Precautions. Retrieved August 2,
2019, from https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html
53
14. Centers for Disease Control and Prevention. (2019, March 25). Surgical Site Infection | Guidelines | Infection
Control | CDC. Retrieved August 2 , 2019 , f rom https:// www.cdc.gov/infectioncontrol/
guidelines/ssi/index.html
15. Centers for Disease Control and Prevention. (2019, April 9). MDRO Management | Guidelines Library |
Infection Control | CDC. Retrieved August 2, 2019, from https://www.cdc.gov/infectioncontrol/
guidelines/mdro/index.html
16. Centers for Disease Control and Prevention. (2019, April 1). BSI | Guidelines Library | Infection Control
| CDC. Retrieved August 2, 2019, from https://www.cdc.gov/infectioncontrol/guidelines/bsi/index.html
17. Centers for Disease Control and Prevention. (2019, July 25). Transmission-Based Precautions.
Retrieved August 2, 2019, from https://www.cdc.gov/infectioncontrol/basics/transmission-based-
precautions.html
18. Centers for Disease Control and Prevention. (2019, June 3). Healthcare-associated infections | HAI | CDC.
Retrieved August 2, 2019, from https://www.cdc.gov/hai/index.html
19. Centers for Disease Control and Prevention. (2019, June 26). Recommended Vaccines for Healthcare
Workers. Retrieved August 2, 2019, from https://www.cdc.gov/vaccines/adults/rec-vac/hcw.html
20. Centers for Disease Control and Prevention. (2019, July 22). PEP | HIV Basics | HIV/AIDS | CDC. Retrieved
August 2, 2019, from https://www.cdc.gov/hiv/basics/pep.html
21. Centers for Disease Control and Prevention. (2019, February 5). Postexposure Prophylaxis. Retrieved August
2, 2019, from https://www.cdc.gov/hepatitis/hbv/pep.htm
22. Centers for Disease Control and Prevention. (n.d.). Checklist for Prevention of Central Line Associated Blood
Stream Infections. Retrieved August 2, 2019, from https://www.cdc.gov/hai/pdfs/bsi/checklist-for-
CLABSI.pdf
23. De Sousa Martins, B., Queiroz e Melo, J., Logarinho Monteiro, J., Rente, G., & Teixeira Bastos, P. (2019).
Reprocessing of Single-Use Medical Devices: Clinical and Financial Results. Portuguese Journal of
Public Health, 1-7. doi:10.1159/000496299
24. Dolan, S. A., Arias, K. M., Felizardo, G., Barnes, S., Kraska, S., Patrick, M., & Bumsted, A. (2016). APIC
position paper: Safe injection, infusion, and medication vial practices in health care. American Journal
of Infection Control, 44(7), 750-757. doi:10.1016/j.ajic.2016.02.033
25. Fishman, N. (2012). Policy Statement on Antimicrobial Stewardship by the Society for Healthcare
Epidemiology of America (SHEA), the Infectious Diseases Society of America (IDSA), and the Pediatric
Infectious Diseases Society (PIDS). Infection Control & Hospital Epidemiology, 33(4), 322-327.
doi:10.1086/665010
26. Han, J. H., Sullivan, N., Leas, B. F., Pegues, D. A., Kaczmarek, J. L., & Umscheid, C. A. (2015).
Cleaning Hospital Room Surfaces to Prevent Health Care-Associated Infections. Annals of Internal Medicine,
163(8), 598. doi:10.7326/m15-1192
27. Indian Council of Medical Research. (2017). Treatment Guidelines for Antimicrobial Use in Common
Syndromes. Retrieved August 2 , 2019 , f rom https:// www.icmr.nic.in/sites/default/files/
guidelines/treatment_guidelines_for_antimicrobial.pdf
28. Indian Council of Medical Research. (n.d.). Hospital Infection Control Guidelines. Retrieved from
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29. Lee, T. B., Montgomery, O. G., Marx, J., Olmsted, R. N., & Scheckler, W. E. (2007). Recommended practices
for surveillance: Association for Professionals in Infection Control and Epidemiology (APIC), Inc. American
Journal of Infection Control, 35(7), 427-440. doi:10.1016/j.ajic.2007.07.002
30. McDonald, L. C., Gerding, D. N., Johnson, S., Bakken, J. S., Carroll, K. C., Coffin, S. E., … Wilcox, M.
H. (2018). Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update
by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of
America (SHEA). Clinical Infectious Diseases, 66(7), 987-994. doi:10.1093/cid/ciy149
31. Ministry of Health & Family Welfare, Government of India. 51. National Centre for Disease Control,
Directorate General of Health Services. (2016). Guidelines for Antimicrobial Use in Infectious Diseases.
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32. Ministry of Health & Family Welfare, Government Of India. (n.d.). Swachhta Guidelines for Public
Health F ac il i t ie s. R e tr i e v e d August 2 , 2019 , f rom h ttp:/ / t r i pu r a n rh m . gov. i n/ QA/
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33. Ministry of Health and Family Welfare, Government of India. National AIDS Control Organization.
(n.d.). National Technical Guidelines on Anti Retroviral Treatment. Retrieved August 2, 2019, from
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20on%20ART_October%202018%20%281%29.pdf
34. Munoz-Price, L., Banach, D., Bearman, G., Gould, J., Leekha, S., Morgan, D., . . . Wiemken, T. (2015).
Isolation Precautions for Visitors. Infection Control & Hospital Epidemiology, 36(7), 747-758.
doi:10.1017/ice.2015.67
35. Munoz-Price, L., Bowdle, A., Johnston, B., Bearman, G., Camins, B., Dellinger, E., . . . Birnbach, D. (2019).
Infection prevention in the operating room anesthesia work area. Infection Control & Hospital Epidemiology,
40(1), 1-17. doi:10.1017/ice.2018.303
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Pathogens and Needlestick Prevention. Retrieved August 2, 2019, from https://www.osha.gov/SLTC/
bloodbornepathogens/index.html
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Healthcare - I n f ect i ou s Di s ea se s . Ret r i ev ed Au gu st 2 , 2 0 1 9 , f r om h t t ps: / / w w w.
osh a. gov / SLTC/ healthcarefacilities/infectious_diseases.html
38. Petersen, B. T., Cohen, J., Hambrick, R. D., Buttar, N., Greenwald, D. A., Buscaglia, J. M., … Eisen, G.
(2017). Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update. Gastrointestinal
Endoscopy, 85(2), 282-294.e1. doi:10.1016/j.gie.2016.10.002
39. Sfeir, M., Simon, M. S., & Banach, D. (2017). Isolation Precautions for Visitors to Healthcare Settings.
Infection Prevention, 19-27. doi:10.1007/978-3-319-60980-5_4
40. Society for Healthcare Epidemiology of America. (n.d.). Compendium of Strategies to Prevent HAIs.
Retrieved August 2, 2019, from https://www.shea-online.org/index.php/practice-resources/priority-
topics/compendium-of-strategies-to-prevent-hais
41. The Society for Healthcare Epidemiology of America. (n.d.). SHEA Expert Guidance: Infection Prevention in
the Operating Room Anesthesia Work Area. Retrieved August 2, 2019, from https://www.shea-
online.org/index.php/practice-resources/41-current-guidelines/635-shea-expert-guidance-infection-
prevention-in-the-operating-room-anesthesia-work-area
55
42. Swaminathan, S., Prasad, J., Dhariwal, A. C., Guleria, R., Misra, M. C., Malhotra, R., … Srikantiah, P. (2017).
Strengthening infection prevention and control and systematic surveillance of healthcare associated
infections in India. BMJ, j3768. doi:10.1136/bmj.j3768
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2, 2019, from https://www.who.int/gpsc/5may/tools/9789241597906/en/
45. World Health Organization. (2010, March). WHO best practices for injections and related procedures toolkit.
Retrieved August 2, 2019, from https://apps.who.int/iris/bitstream/handle/10665/44298/9789241599252_
eng.pdf?sequence=1
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Control Programmes at the National and Acute Health Care Facility Level. Retrieved August 2, 2019,
from https://www.who.int/gpsc/core-components.pdf
47. World Health Organization. (2016). Global Guidelines for the Prevention of Surgical Site Infection. Retrieved
August 2, 2019, from https://apps.who.int/iris/bitstream/handle/10665/250680/9789241549882- eng.pdf?
sequence=8
48. World Health Organization. (2019, April). Summary of WHO Position Papers - Immunization of Health Care
Workers. Retrieved August 2, 2019, from https://www.who.int/immunization/policy/Immunization_
routine_table4.pdf?ua=1
49. World Health Organization. (n.d.). Post-exposure prophylaxis (PEP). Retrieved August 2, 2019, from
https://www.who.int/hiv/topics/prophylaxis/en/
56
Chapter 6
Patient Safety and Quality
Improvement (PSQ)
The standards encourage an environment of patient safety and continual quality improvement. The patient safety
and quality programme should be documented and involve all areas of the organisation and all staff members.
National/international patient-safety goals/solutions are implemented.
The organisation should collect data on structures, processes and outcomes, especially in areas of high-risk
situations. The collected data should be collated, analysed and used for further improvements. Appropriate
quality tools shall be used for carrying out quality improvement activities. Clinical audits shall be used as a tool to
improve the quality of patient care. The improvements should be sustained. Department leaders play an active
role in patient safety and quality improvement.
The organisation should have a robust incident reporting system. Sentinel events shall be defined. All incidents are
investigated, and appropriate action is taken.
The management should support the patient safety and quality programme.
PSQ.1. The organisation implements a structured patient-safety programme.
PSQ.2. The organisation implements a structured quality improvement and continuous
monitoring programme.
PSQ.3. The organisation identifies key indicators to monitor the structures, processes
and outcomes, which are used as tools for continual improvement.
PSQ.4. The organisation uses appropriate quality improvement tools for its quality
improvement activities.
PSQ.5. There is an established system for clinical audit.
PSQ.6. The patient safety and quality improvement programme are supported by the
management.
PSQ.7. Incidents are collected and analysed to ensure continual quality improvement.
57
Standard
PSQ.1. The organisation implements a structured patient-safety programme.
Objective Elements
C RE
a. The patient-safety programme is developed, implemented and maintained by a
multi-disciplinary safety committee. *
Commitment b. The patient-safety programme is comprehensive and covers all the major
elements related to patient safety.
Commitment c. The programme covers incidents ranging from "no harm" to "sentinel events".
Commitment d. Designated patient safety officer(s) coordinates implementation of the patient-

safety programme.
Excellence e. Designated clinical safety officer(s) coordinates implementation of the clinical

aspects of the patient-safety programme.
Commitment f. The patient-safety programme identifies opportunities for improvement based

on the review at pre-defined intervals.
Excellence g. The organisation performs proactive analysis of patient safety risks and makes
improvements accordingly.
Commitment h. The patient-safety programme is reviewed and updated at least once a year.
C RE I. The organisation adapts and implements national/international patient-safety

goals/solutions.
Standard
The organisation implements a structured quality improvement and continu
PSQ.2.
Objective Elements
C RE
a. The quality improvement programme is developed, implemented and
maintained by a multi-disciplinary committee.*
Commitment
b. The quality improvement programme is comprehensive and covers all the
major elements related to quality assurance.*
Excellence
c. The quality improvement programme improves process efficiency and
effectiveness.
58
Commitment d. There is a designated individual for coordinating and implementing the

quality improvement programme.*
Commitment e. The quality improvement programme identifies opportunities for

improvement based on the review at pre-defined intervals.*
Commitment
f. The quality improvement programme is reviewed and updated at
least once a year.
Commitment g. Audits are conducted at regular intervals as a means of continuous monitoring.*
C RE h. There is an established process in the organisation to monitor and improve the

quality of nursing care.*
Standard
The organisation identifies key indicators to monitor the structures, processes and o
PSQ.3.
Objective Elements
Commitment
a. The organisation identifies and monitors key indicators to oversee the clinical
structures, processes and outcomes.
C RE
b. The organisation identifies and monitors the key indicators to oversee infection
control activities.
Commitment c. The organisation identifies and monitors key indicators to oversee the
managerial structures, processes and outcomes.
C RE d. The organisation identifies and monitors key indicators to oversee patient

safety activities.
Excellence e. The organisation has a mechanism to capture patient reported outcome

measures.
Commitment f. Verification of data is done regularly by the quality team.
Commitment g. There is a mechanism for analysis of data which results in identifying

opportunities for improvement.
Commitment h. The improvements are implemented and evaluated.
Achievement i. Feedback about care and service is communicated to staff.

59
Standard
The organisation uses appropriate quality improvement tools for its quality
PSQ.4.
Objective Elements
C RE a. The organisation undertakes quality improvement projects.
Commitment b. The organisation uses appropriate analytical tools for its quality
Commitment c. The organisation uses appropriate statistical tools for its quality
Commitment d. The organisation uses appropriate managerial tools for its quality
Standard
PSQ.5. There is an established system for clinical audit.
Objective Elements
Commitment a. Clinical audits are performed to improve the quality of patient care.
Commitment b. The parameters to be audited are defined by the organisation.
Achievement c. Medical and nursing staff participate in clinical audit.
Commitment d. Patient and staff anonymity are maintained.
Commitment e. Clinical audits are documented.
Commitment f. Remedial measures are implemented.

60
Standard
The patient safety and quality improvement programme are supported by t
PSQ.6.
Objective Elements
Achievement
a. The management creates a culture of safety.
Commitment
b. The leaders at all levels in the organisation are aware of the intent of the
patient safety and quality improvement programme and the approach to its
implementation.
Commitment
c. Departmental leaders are involved in patient safety and quality improvement.
Commitment
d. The management makes available adequate resources required for patient
safety and quality improvement programme.
Commitment
e. Organisation earmarks adequate funds from its annual budget in this regard.
Achievement
f. The management identifies organisational performance improvement targets.
Excellence
g. The management uses the feedback obtained from the workforce to improve
patient safety and quality improvement programme.
Standard
Incidents are collected and analysed to ensure continual quality improvem
PSQ.7.
Objective Elements
C RE a. The organisation implements an incident management system.*
Commitment b. The organisation has a mechanism to identify sentinel events.*
Commitment c. The organisation has established processes for analysis of incidents.
Commitment d. Corrective and preventive actions are taken based on the findings of such analysis.
Achievement e. The organisation incorporates risks identified in the analysis of incidents into
the risk management system.
Excellence f. The organisation shall have a process for informing various stakeholders in case
of a near miss/adverse event/sentinel event.

61
References:
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patientsafety/patientsafetyculture/pscintusers.html
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Process (Page 1 of 2). Retrieved August 2, 2019, from https://www.ahrq.gov/cahps/quality-
improvement/improvement-guide/4-approach-qi-process/index.html
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Performance and Patient Safety. Retrieved August 2, 2019, from http://www.ahrq.gov/professionals/
education/curriculum-tools/teamstepps/index.html
9. American Society for Quality. (n.d.). 7 Basic Quality Tools: Quality Management Tools. Retrieved August 2,
2019, from https://asq.org/quality-resources/seven-basic-quality-tools
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https://asq.org/quality-resources/root-cause-analysis
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from https://www.patientsafetyinstitute.ca/en/toolsResources/IncidentAnalysis/Documents/Canadian%
20Incident%20Analysis%20Framework.PDF
13. Charles, R., Hood, B., Derosier, J. M., Gosbee, J. W., Li, Y., Caird, M. S., … Hake, M. E. (2016). How to
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62
16. Doyle, C., Lennox, L., & Bell, D. (2013). A systematic review of evidence on the links between patient
experience and clinical safety and effectiveness. BMJ Open, 3(1), e001570. doi:10.1136/bmjopen-2012-
001570
17. Ewen, B. M., & Bucher, G. (2013). Root Cause Analysis. Home Healthcare Nurse, 31(8), 435-443.
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18. Fung, C. H., Lim, Y., Mattke, S., Damberg, C., & Shekelle, P. G. (2008). Systematic Review: The Evidence
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Management Practices Are Strongly Related To Hospital Performance On Clinical Quality Metrics.
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43. Wagner, C., Smits, M., Sorra, J., & Huang, C. C. (2013). Assessing patient safety culture in hospitals across
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44. Weaver, S. J., Lubomksi, L. H., Wilson, R. F., Pfoh, E. R., Martinez, K. A., & Dy, S. M. (2013). Promoting a
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https://www.who.int/patientsafety/topics/reporting-learning/en/
64
Chapter 7
Responsibilities of
Management (ROM)
The management of the healthcare organisation is aware of and manages all the key components of governance.
Those responsible for governance are identified and their roles defined. The standards encourage the
governance of the organisation professionally and ethically. The responsibilities of management are defined. The
responsibilities of the leaders at all levels are defined. The management executes its responsibility for compliance
with all applicable regulations.
Leaders ensure that patient-safety and risk-management issues are an integral part of patient care and hospital
management.
Note: "Responsible for Governance' refers to the governing entity of the healthcare organisation and can exist in
many configurations. For example, the owner(s), the board of directors, or in the case of public hospitals,
the respective Ministry (Health/Railways/Labour).
ROM.1. The organisation identifies those responsible for governance and their roles
are defined.
ROM.2. The organisation is ethically managed by the leaders.
ROM.3. The organisation is headed by a leader who shall be responsible for operating
the organisation on a day-to-day basis.
ROM.4. The organisation displays professionalism in its functioning.
ROM.5. Management ensures that patient-safety aspects and risk-management
issues are an integral part of patient care and hospital management.
65
Standard
The organisation identifies those responsible for governance and their roles
ROM.1.
Objective Elements
C RE
a. Those responsible for governance are identified, and their roles and
responsibilities are defined and documented. *
Commitment b. Those responsible for governance lay down the organisation's vision, mission
and values.*
Commitment c. Those responsible for governance approve the strategic and operational plans
and the organisation's annual budget.
Achievement d. Those responsible for governance monitor and measure the performance of the
organisation against the stated mission.
Commitment e. Those responsible for governance appoint the senior leaders in the organisation.
Commitment f. Those responsible for governance support safety initiatives and quality
improvement plans.
Achievement g. Those responsible for governance support the ethical management framework
of the organisation.
Excellence h. Those responsible for governance inform the public of the quality and
performance of services.
Standard
ROM.2. The leaders manage the organisation in an ethical manner.
Objective Elements
Commitment
a. The leaders make public the vision, mission and values of the organisation.
C RE b. The leaders establish the organisation's ethical management framework. *

Excellence c. The ethical management framework includes processes for managing issues
with ethical implications, dilemmas and concerns.
Commitment d. The organisation discloses its ownership.
Commitment e. The organisation honestly portrays its affiliations and accreditations.

66
Standard
The organisation is headed by a leader who shall be responsible for operating
ROM.3.
Objective Elements
Commitment
a. The person heading the organisation has requisite and appropriate
administrative qualifications.
Commitment b. The person heading the organisation has requisite and appropriate
administrative experience.
C RE c. The leader is responsible for and complies with the laid-down and applicable
legislations, regulations and notifications.
Commitment d. The leader appoints/participates in the recruitment of senior leadership of the

organisation who will assist in the day-to-day functioning of the organisation.
Excellence e. The leader ensures that each organisational programme, service, site or
department has effective leadership.
Achievement f. The performance of the organisation's leader is reviewed for effectiveness.
Standard
ROM.4. The organisation displays professionalism in its functioning.
Objective Elements
Commitment
a. The organisation has strategic and operational plans, including long-term and
short-term goals commensurate to the organisation's vision, mission and values
in consultation with the various stakeholders.
Achievement
Excellence
Commitment
Achievement
Commitment
Commitment

67
b. The
organisation
coordinates
the
functioning
with
departments
and external
agencies
and
monitors
the progress
in achieving
the defined
goals and
objectives.
c. The organisation
plans and budgets
for its activities
annually.
d. The functioning of
committees is
reviewed for their
effectiveness.
e. The organisation
documents staff
rights and
responsibilities. *
f. The
organisation
documents
the service
standards
that are
measurable
and
monitors
them.*
g. Systems and
processes are in
place for change
management.

68
Standard
Management ensures that patient-safety aspects and risk-management issue
ROM.5.
Objective Elements
C RE a. Management ensures proactive risk management across the organisation.*
Commitment b. Management provides resources for proactive risk assessment and risk-
reduction activities.
Commitment c. Management ensures integration between quality improvement, risk

management and strategic planning within the organisation.
Achievement d. Management ensures implementation of systems for internal and external

reporting of system and process failures.*
Commitment e. Management ensures that it has a documented agreement for all outsourced
services that include service parameters.
Achievement f. Management monitors the quality of the outsourced services and improvements
are made as required.

69
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72
Chapter 8
Facility Management
and Safety (FMS)
The standards guide the provision of a safe and secure environment for patients, their families, staff and visitors.
The organisation attends to the facility, equipment, and internal physical environment for improving patient
safety and quality of services by consistently addressing issues that may arise out of the same. The organisation
does this through proactive risk analysis, safety rounds, training of staff on the enhancement of safety and
management of disasters. To ensure this, the organisation conducts regular facility inspection rounds and takes
the appropriate action to ensure safety.
The organisation provides for safe water, electricity, medical gases and vacuum systems.
The organisation has a programme for medical and utility equipment management.
The organisation plans for fire and non-fire emergencies within the facilities.
The organisation is a no-smoking area.
The organisation safely manages hazardous materials.
The organisation works towards measures on being energy efficient.
FMS.1. The organisation has a system in place to provide a safe and
secure environment.
FMS.2. The organisation's environment and facilities operate in a planned manner and
promotes environment-friendly measures.
FMS.3. The organisation's environment and facilities operate to ensure the safety of
patients, their families, staff and visitors.
FMS.4. The organisation has a programme for the facility, engineering support services
and utility system.
FMS.5. The organisation has a programme for medical equipment management.
FMS.6. The organisation has a programme for medical gases, vacuum and compressed air.
FMS.7. The organisation has plans for fire and non-fire emergencies within the facilities.
73
Standard
The organisation has a system in place to provide a safe and secure environm
FMS.1.
Objective Elements
C RE
a. Patient-safety devices and infrastructure are installed across the organisation
and inspected periodically.
Commitment b. The organisation has facilities for the differently-abled.
C RE c. Facility inspection rounds to ensure safety are conducted at least once a month.
Commitment d. Inspection reports of facility rounds are documented, and corrective and
preventive measures are undertaken.
Excellence e. Before construction, renovation and expansion of existing hospital, risk

assessment are carried out.
Standard
The organisation's environment and facilities operate in a planned manner
FMS.2.
Objective Elements
Commitment
a. Facilities and space provisions are appropriate to the scope of services.
Commitment
b. As-built and updated drawings are maintained as per statutory requirements.
C RE c. There are internal and external sign postings in the organisation in a manner
understood by the patient, families and community.
C RE d. Potable water and electricity are available round the clock.
Commitment e. Alternate sources for electricity and water are provided as a backup for any
failure/shortage.
Commitment f. The organisation tests the functioning of these alternate sources at a

predefined frequency.
Excellence g. The organisation takes initiatives towards an energy-efficient and

environmentally friendly hospital.*

74
Standard
The organisation's environment and facilities operate to ensure the safety o
FMS.3.
Objective Elements
Excellence
a. Patient safety aspects in terms of structural safety of hospitals especially of
critical areas are considered while planning, design and construction of new
hospitals and re-planning, assessment, and retrofitting of existing hospitals.
Commitment
b. Operational planning identifies areas which need to have extra security and
describes access to different areas in the hospital by staff, patients, and
visitors.
Achievement
c. The organisation conducts electrical safety audits for the facility.

Commitment
d. There is a procedure which addresses the identification and disposal of

material(s) not in use in the organisation. *
C RE e. Hazardous materials are identified and used safely within the organisation.*
Commitment f. The plan for managing spills of hazardous materials is implemented. *
Standard
The organisation has a programme for the facility, engineering support serv
FMS.4.
Objective Elements
Commitment
a. The organisation plans for utility and engineering equipment in accordance with
its services and strategic plan.
Commitment b. Equipment is inventoried, and proper logs are maintained as required.
C RE c. The documented operational and maintenance (preventive and breakdown)

plan is implemented. *
Commitment d. Utility equipment, are periodically inspected and calibrated (wherever

applicable) for their proper functioning.
Commitment e. Competent personnel operate, inspect, test and maintain equipment and utility
systems.
75
Commitment f. Maintenance staff is contactable round the clock for emergency repairs.
Achievement g. Downtime for critical equipment breakdowns is monitored from reporting to

inspection and implementation of corrective actions.
Commitment h. Written guidance supports equipment replacement, identification of unwanted

material and disposal. *
Standard
FMS.5. The organisation has a programme for medical equipment management.
Objective Elements
Commitment
a. The organisation plans for medical equipment in accordance with its services
and strategic plan.
Commitment b. Medical equipment is inventoried, and proper logs are maintained as required.
C RE c. The documented operational and maintenance (preventive and breakdown)

plan for medical equipment is implemented. *
Commitment d. Medical equipment is periodically inspected and calibrated for their proper
functioning.
Commitment e. Qualified and trained personnel operate and maintain medical equipment.
Commitment f. Written guidance supports medical equipment replacement and disposal. *
Commitment g. There is a monitoring of medical equipment and medical devices related to

adverse events, and compliance hazard notices on recalls. *
Achievement h. Downtime for critical equipment breakdown is monitored from reporting to

inspection and implementation of corrective actions.

76
Standard
The organisation has a programme for medical gases, vacuum and compresse
FMS.6.
Objective Elements
Commitment
a. Written guidance governs the implementation of procurement, handling,
storage, distribution, usage and replenishment of medical gases. *
C RE b. Medical gases are handled, stored, distributed and used in a safe manner.
Commitment c. The procedures for medical gases address the safety issues at all levels.
C RE d. Alternate sources for medical gases, vacuum and compressed air are provided
for, in case of failure.
Commitment e. The organisation regularly tests the functioning of these alternate sources.
Commitment f. There is an operational, inspection, testing and maintenance plan for piped
medical gas, compressed air and vacuum installation. *
Standard
The organisation has plans for fire and non-fire emergencies within the fac
FMS.7.
Objective Elements
C RE
a. The organisation has plans and provisions for early detection, abatement and
containment of the fire, and non-fire emergencies. *
Commitment b. The organisation has a documented and displayed exit plan in case of fire
and non-fire emergencies.
Commitment c. Mock drills are held at least twice a year.
Commitment d. There is a maintenance plan for fire-related equipment and infrastructure *
Achievement e. The organisation has a service continuity plan in case of fire and non-fire
emergencies

77
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overview. Quality and Safety in Health Care, 19(Suppl 2), i3-i8. doi:10.1136/qshc.2010.040501
2. Association for the Advancement of Medical Instrumentation. (n.d.). EQ89: Guidance for the use of medical
equipment maintenance strategies and procedures. Retrieved August 3 , 2019 , f rom
https://www.aami.org/productspublications/ProductDetail.aspx?ItemNumber=2421
3. BOC. (n.d.). Handle medical gases safely. Retrieved from http://www.boc-healthcare.com.au/en/
images/HCD186_Gases%20safety%20pocket%20guide_V3_FA_web_tcm350-131320.pdf
4. British Compressed Gases Association. (n.d.). Medical Gases. Retrieved August 3, 2019, from
http://www.bcga.co.uk/pages/index.cfm?page_id=29&title=medical_gases
5. British Standards Institution. (n.d.). BS EN 12021:2014. Retrieved August 3, 2019, from
https://shop.bsigroup.com/ProductDetail?pid=000000000030315779
6. Bureau of Indian Standards. (2016). National Building Code of India, 2016. New Delhi.
7. Coulliette, A. D., & Arduino, M. J. (2015). Hemodialysis and Water Quality. Semin Dial, 26(4), 427-438.
8. Department of Health: Estates and Facilities Division. (2006). Medical Gas Pipeline Systems. London,
England: The Stationery Office.
9. Dhillon, V. S. (2015). Green Hospital and Climate Change: Their Interrelationship and the Way Forward.
JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH. doi:10.7860/jcdr/2015/13693.6942
10. Government of India. Ministry of Health and Family Welfare. (n.d.). Medical Devices Rules 2017. Retrieved
A u gu st 3 , 2 0 1 9 , f r o m h t t ps: / / m o h f w. go v. i n / s i t e s/ de f a u l t / f i l e s/ Me d i ca l
% 2 0 D e v i ce % 20Rules%2C%202017.pdf
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Guidelines. Hospital Safety. Retrieved August 3, 2019, from https://ndma.gov.in/images/guidelines/
Guidelines-Hospital-Safety.pdf
12. Government of India. National Health MIssion. (n.d.). Biomedical Equipment Management and Maintenance
Program. Retrieved August 3, 2019, from https://nhm.gov.in/New_Updates_2018/NHM_Components/
Health_System_Stregthening/BEMMP/Biomedical_Equipment_Revised_Guidelines.pdf
13. Gudlavalleti, V. (2018). Challenges in Accessing Health Care for People with Disability in the South Asian
Context: A Review. International Journal of Environmental Research and Public Health, 15(11), 2366.
doi:10.3390/ijerph15112366
14. Hart, J. R. (2018). Medical Gas and Vacuum Systems Handbook. National Fire Protection Association.
15. Health Facilities Management. (2015, December 2). Infrastructures to improve patient safety. Retrieved
August 3, 2019, from https://www.hfmmagazine.com/articles/1827-infrastructures-to-improve-patient-
safety
16. International Organization for Standardization. (n.d.). ISO 10524-1:2018. Retrieved August 3, 2019, from
https://www.iso.org/standard/67190.html
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from https://www.iso.org/standard/60316.html
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23. International Organization for Standardization. (n.d.). ISO 7396-1:2016. Retrieved August 3, 2019,
28. National Fire Protection Association. (2018, January). Medical Gas Cylinder Storage. Retrieved August
3, 2019, from https://www.nfpa.org/~/media/4B6B534171E04E369864672EBB319C4F.pdf
29. National Health Mission. Ministry of Health & Family Welfare, Government of India. (n.d.). Indian Public
Health Standards. Retrieved August 3, 2019, from https://nhm.gov.in/index1.php?
lang=1&level= 2&sublinkid=971&lid=154
30. Sarangi, S., Babbar, S., & Taneja, D. (n.d.). Safety of the medical gas pipeline system. Journal of
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34/1/99/227571
31. World Health Organization. (2011). Guidelines for Drinking-water Quality (Fourth Edition). Retrieved August
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79
Chapter 9
Human Resource
Management (HRM)
The most important resource of the organisation is its human resource. Human resources are an asset for
the effective and efficient functioning of the organisation. The management plans on identifying the right
number and skill mix of staff required to render safe care to the patients.
Recruitment of staff is accomplished by having a uniform and standardised system. The organisation must orient
the staff to its environment and also orient them to specific duties and responsibilities related to their position.
The organisation should plan to have an ongoing professional training/in-service education to enhance the
competencies and skills of the staff continually.
A systematic and structured appraisal system must be used for staff development. The organisation uses this as
an opportunity to discuss, motivate, identify gaps in the performance of the staff.
The organisation promotes the physical and mental well-being of staff. A grievance handling mechanism
and disciplinary procedure should be in place.
Credentialing and privileging of health-care professionals (medical, nursing and other para-clinical professional)
are done to ensure patient safety.
A document containing all such personal information has to be maintained for all staff.
Note: The term "employee" refers to all salaried personnel working in the organisation. The term "staff" refers
to all personnel working in the organisation including employees, "fee for service" medical professionals,
part-time workers, contractual personnel and volunteers.
HRM.1. The organisation has a documented system of human resource planning.
HRM.2. The organisation implements a defined process for staff recruitment.
HRM.3. Staff are provided induction training at the time of joining the organisation.
HRM.4. There is an on-going programme for professional training and development of
the staff.
HRM.5. Staff are appropriately trained based on their specific job description.
HRM.6. Staff are trained in safety and quality-related aspects.
HRM.7. An appraisal system for evaluating the performance of staff exists as an integral
part of the human resource management process.
80
HRM.8. Process for disciplinary and grievance handling is defined and implemented
in the organisation.
HRM.9. The organisation promotes staff well-being and addresses their health and
safety needs.
HRM.10. There is documented personal information for each staff member.
HRM.11. There is a process for credentialing and privileging of medical
professionals, permitted to provide patient care without supervision.
HRM.12. There is a process for credentialing and privileging of nursing
HRM.13. There is a process for credentialing and privileging of para-clinical
81
Standard
HRM.1. The organisation has a documented system of human resource planning.
Objective Elements
Excellence
a. Human resource planning supports the organisation's current and future ability
to meet the care, treatment and service needs of the patient.
C RE b. The organisation maintains an adequate number and mix of staff to meet the
care, treatment and service needs of the patient.
Achievement c. The organisation has contingency plans to manage long- and short-term
workforce shortages, including unplanned shortages.
Commitment d. The job specification and job description are defined for each category of staff. *
Commitment e. The organisation performs a background check of new staff.
Commitment f. Reporting relationships are defined for each category of staff. *
Achievement g. Exit interviews are conducted and used as a tool to improve human
resource practices.
Standard
HRM.2. The organisation implements a defined process for staff recruitment.
Objective Elements
C RE a. Written guidance governs the process of recruitment. *
Commitment b. A pre-employment medical examination is conducted on the staff.
C RE c. The organisation defines and implements a code of conduct for its staff.
Commitment d. Administrative procedures for human resource management are documented .*

82
Standard
HRM.3. Staff are provided induction training at the time of joining the organisation.
Objective Elements
C RE a. Staff are provided with induction training.
Commitment b. The induction training includes orientation to the organisation's vision, mission
and values.
Commitment c. The induction training includes awareness on staff rights and responsibilities
and patient rights and responsibilities.
Commitment d. The induction training includes training on safety.
Commitment e. The induction training includes training on cardio-pulmonary resuscitation for

staff providing direct patient care.
Commitment f. The induction training includes training in hospital infection prevention

and control.
Commitment g. The induction training includes orientation to the service standards of the
organisation.
Commitment h. The induction training includes an orientation on administrative procedures.
Commitment i. The induction training includes an orientation on relevant department/unit/

service/programme's policies and procedures.
Standard
There is an on-going programme for professional training and developmen
HRM.4.
Objective Elements
C RE a. Written guidance governs training and development policy for the staff.*
Commitment b. The organisation maintains the training record.
Commitment c. Training also occurs when job responsibilities change/new equipment is introduced.
Commitment d. Feedback mechanisms are in place for improvement of training and

development programme.
Excellence e. Evaluation of training effectiveness is done by the organisation.
Achievement f. The organisation supports continuing professional development and learning.

83
Standard
HRM.5. Staff are appropriately trained based on their specific job description.
Objective Elements
Commitment a. Staff involved in blood transfusion services are trained on the handling of blood
and blood products.
Commitment b. Staff are trained in handling vulnerable patients.
Commitment c Staff are trained in control and restraint techniques.
Commitment d. Staff are trained in healthcare communication techniques.
C RE e. Staff involved in direct patient care are provided training on cardiopulmonary

resuscitation periodically.
Commitment f. Staff are provided training on infection prevention and control.
Standard
HRM.6. Staff are trained in safety and quality-related aspects.
Objective Elements
Commitment a. Staff are trained on the organisation's safety programme.
Commitment b. Staff are provided training on the detection, handling, minimisation and
elimination of identified risks within the organisation's environment.
Commitment c. Staff members are made aware of procedures to follow in the event of an incident.
Commitment d. Staff are trained in occupational safety aspects.

C RE e. Staff are trained in the organisation's disaster management plan.
C RE f. Staff are trained in handling fire and non-fire emergencies.
Commitment g. Staff are trained on the organisation's quality improvement programme

84
Standard
An appraisal system for evaluating the performance of staff exists as an in
HRM.7.
Objective Elements
Commitment a. Performance appraisal is done for staff within the organisation.*
Commitment b. The staff are made aware of the system of appraisal at the time of induction.
Commitment c. Performance is evaluated based on the pre-determined criteria.
Achievement d. The appraisal system is used as a tool for further development.
Commitment e. Performance appraisal is carried out at defined intervals and is documented.
Standard
Process for disciplinary and grievance handling is defined and implemented
HRM.8.
Objective Elements
Commitment a. Written guidance governs disciplinary and grievance handling mechanisms.*
Commitment b. The disciplinary and grievance handling mechanism is known to all categories
of staff of the organisation.
Commitment
c. The disciplinary policy and procedure are based on the principles of
natural justice.
C RE d. The disciplinary and grievance procedure is in consonance with the

prevailing laws.
Commitment e. There is a provision for appeals in all disciplinary cases.
Commitment f. Actions are taken to redress the grievance.

85
Standard
The organisation promotes staff well-being and addresses their health and
HRM.9.
Objective Elements
Achievement a. Staff well-being is promoted.
Commitment b. Health problems of the staff, including occupational health hazards, are taken
care of in accordance with the organisation's policy.
Commitment c. Health checks of staff dealing with direct patient care are done at least once a
year and the findings/results are documented.
Commitment d. Organisation provides treatment to staff who sustain workplace-related injuries.
C RE e. The organisation has measures in place for prevention and handling workplace
violence.
Standard
HRM.10. There is documented personal information for each staff member.
Objective Elements
Commitment
a. Personal files are maintained with respect to all staff, and their confidentiality is
ensured
Commitment b. The personal files contain personal information regarding the staff's
qualification, job description, verification of credentials and health status.
Commitment c. Records of in-service training and education are contained in the personal files.
Commitment d. Personal files contain results of all evaluations and remarks.

86
Standard
There is a process for credentialing and privileging of medical professionals, p
HRM.11.
Objective Elements
C RE a. Medical professionals permitted by law, regulation and the organisation to
provide patient care without supervision are identified.
Commitment b. The education, registration, training and experience of the identified medical
professionals are documented and updated periodically.
Commitment
c. The information about medical professionals is appropriately verified when
possible.
C RE d. Medical professionals are granted privileges to admit and care for patients in
consonance with their qualification, training, experience and registration.
Commitment e. The requisite services to be provided by the medical professionals are known to
them as well as the various departments/units of the organisation.
Commitment f. Medical professionals admit and care for patients as per their privileging.
Standard
There is a process for credentialing and privileging of nursing professionals,
HRM.12.
Objective Elements
C RE a. Nursing staff permitted by law, regulation and the organisation to provide
patient care without supervision are identified.
Commitment b. The education, registration, training and experience of nursing staff are
appropriately verified, documented and updated periodically.
Commitment c. The information about the nursing staff is appropriately verified when possible.
C RE d. Nursing staff are granted privileges in consonance with their qualification,

training, experience and registration.
Commitment e. The requisite services to be provided by the nursing staff are known to them as
well as the various departments/units of the organisation.
Commitment f. Nursing professionals care for patients as per their privileging.

87
Standard
There is a process for credentialing and privileging of para-clinical profession
HRM.13.
Objective Elements
C RE a. Para-clinical professionals permitted by law, regulation and the organisation to
provide patient care without supervision are identified.
Commitment b. The education, registration, training and experience of para clinical

professionals are appropriately verified, documented and updated periodically.
C RE c. Para-clinical professionals are granted privileges in consonance with their

qualification, training, experience and registration.
Commitment d. The requisite services to be provided by the para-clinical professionals are

known to them as well as the various departments/units of the organisation.
Commitment e. Para-clinical professionals care for patients as per their privileging.

88
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91
Chapter 10
Information Management
System (IMS)
The goal of information management in the organisation is to ensure that the right information is available to the
right person at the right time.
Information management includes management of hospital information system as well as all modalities of
information communicated to staff, patients, visitors and community in general.
Data and information management must be directed to meet the organisation's needs and support the delivery
of quality patient care. The information needs are provided in an authenticated, secure and accurate manner at
the right time and place.
Confidentiality, integrity and security of records, data and information is maintained. Confidentiality of protected
health information is paramount and is safeguarded across all information processing, storing and disseminating
platforms.
Information management also includes periodic review, revision and withdrawal of obsolete information to avoid
confusion among staff, patients and visitors.
The organisation maintains a complete and accurate medical record for every patient. Various aspects of
the medical record like contents, staff authorised to make entries and retention of records are addressed
effectively by the organisation. The medical record is available for appropriate care providers. The medical
records are reviewed at regular intervals.
IMS.1. Information needs of the patients, visitors, staff, management and external
agencies are met.
IMS.2. The organisation has processes in place for management and control of data
and information.
IMS.3. The patients cared for by the organisation have a complete and accurate
medical record.
IMS.4. The medical record reflects the continuity of care.
IMS.5. The organisation maintains confidentiality, integrity and security of records, data
and information.
IMS.6. The organisation ensures availability of current and relevant documents, records,
data and information and provides for retention of the same.
IMS.7. The organisation carries out a review of medical records.
92
Standard
Information needs of the patients, visitors, staff, management and external
IMS.1.
Objective Elements
C RE
a. The organisation identifies the information needs of the patients, visitors, staff,
management external agencies and community. *
Commitment b. Identified information needs are captured and/or disseminated.
Commitment c. Information management and technology acquisitions are commensurate with

the identified information needs.
Commitment d. A maintenance plan for information technology and communication network is

implemented.
Achievement e. Contingency plan ensures continuity of information capture, integration and

dissemination.
Excellence f. The organisation ensures that information resources are accurate and meet
stakeholder requirements.
Commitment g. The organisation contributes to external databases in accordance with the law
and regulations.
Standard
The organisation has processes in place for management and control of data
IMS.2.
Objective Elements
Commitment a. Processes for data collection are standardised.
Commitment b. Data is analysed to meet the information needs.
Commitment c. The organisation disseminates the information in a timely and accurate manner.
Commitment d. The organisation stores and retrieves data according to its information needs. *
Commitment e. Clinical and managerial staff participate in selecting, integrating and using data
for meeting the information needs.

93
Standard
The patients cared for by the organisation have a complete and accurate m
IMS.3.
Objective Elements
Commitment a. The unique identifier is assigned to the medical record.
Commitment b. The contents of the medical record are identified and documented. *
C RE c. The medical record provides a complete, up-to-date and chronological account

of patient care.
Commitment d. Authorised staff make the entry in the medical record. *
Commitment e. Entry in the medical record is signed, dated and timed.
Commitment f. The author of the entry can be identified.
Commitment g. The medical record has only authorised abbreviations.
Standard
IMS.4. The medical record reflects the continuity of care.
Objective Elements
Commitment
a. The medical record contains information regarding reasons for admission,
diagnosis and care plan.
Commitment
b. The medical record contains the details of assessments, re-assessments and
consultations.
Commitment
c. The medical record contains the results of investigations and the details of the
care provided.
Commitment
d. Operative and other procedures performed are incorporated in the medical record.
Commitment
e. When a patient is transferred to another organisation, the medical record
contains the details of the transfer.
Commitment
f. The medical record contains a copy of the discharge summary.
Commitment
g. In case of death, the medical record contains a copy of the cause of death report.
Commitment
h. Care providers have access to current and past medical record.

94
Standard
The organisation maintains confidentiality, integrity and security of records
IMS.5.
Objective Elements
C RE
a. The organisation maintains the confidentiality of records, data and information.*
C RE
b. The organisation maintains the integrity of records, data and information. *
C RE
c. The organisation maintains the security of records, data and information.*
Achievement d. The organisation uses developments in appropriate technology for improving

confidentiality, integrity and security.
Commitment e. The organisation discloses privileged health information as authorised by the

patient and/or as required by law.
Commitment f. Request for access to information in the medical records by patients/physicians

and other public agencies are addressed consistently.*
Standard
The organisation ensures availability of current and relevant documents, rec
IMS.6.
Objective Elements
C RE a. The organisation has an effective process for document control. *
C RE b. The organisation retains patient's clinical records, data and information

according to its requirements. *
Commitment c. The retention process provides expected confidentiality and security.
Commitment d. The destruction of medical records, data and information are in accordance
with the written guidance.*

95
Standard
IMS.7. The organisation carries out a review of medical records.
Objective Elements
C RE a. The medical records are reviewed periodically.
Commitment b. The review uses a representative sample based on statistical principles.
Commitment c. The review is conducted by identified individuals.
Commitment d. The review of records is based on identified parameters.
Commitment e. The review process includes records of both active and discharged patients.
Commitment f. The review points out and documents any deficiencies in records.
Commitment g. Appropriate corrective and preventive measures are undertaken.

96
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1. Alotaibi, Y., & Federico, F. (2017). The impact of health information technology on patient safety.
Saudi Medical Journal, 38(12), 1173-1180. doi:10.15537/smj.2017.12.20631
2. American College of Obstetricians and Gynecologists. (2015, January). Patient Safety and Health
Information Technology. Retrieved September 1, 2019, from https://www.acog.org/-/media/Committee-
Opinions/ Committee- on- Patient- Safety- and- Quality- Improvement/ co621. pdf?dmc=1&
ts= 20190901T1157446882
3. Anderson, J. G. (2010). Improving Patient Safety with Information Technology. Handbook of Research on
Advances in Health Informatics and Electronic Healthcare Applications, 144-152. doi:10.4018/978-1-60566-
030-1.ch009
4. Blum, B. I. (1986). Clinical Information Systems-A Review. West J Med., 145(6), 791-797. Retrieved from
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1307152/pdf/westjmed00160-0055.pdf
5. Borycki, E., & Kushniruk, A. (2017). Patient Safety and Health Information Technology. E-Health Two-Sided
Markets, 19-31. doi:10.1016/b978-0-12-805250-1.00004-6
6. Feldman, S. S., Buchalter, S., & Hayes, L. W. (2018). Health Information Technology in Healthcare Quality
and Patient Safety: Literature Review. JMIR Medical Informatics, 6(2), e10264. doi:10.2196/10264
7. Hamidovic, H., & Kabil, J. (2011). An Introduction to Information Security Management in Health Care
Organizations. ISACA Journal, 5. Retrieved from https://www.isaca.org/Journal/archives/2011/Volume-
5/Documents/jolv5-11-An-Introduction.pdf
8. Hamiel, U., Hecht, I., Nemet, A., Pe'er, L., Man, V., Hilely, A., & Achiron, A. (2018). Frequency,
comprehension and attitudes of physicians towards abbreviations in the medical record. Postgraduate
Medical Journal, 94(1111), 254-258. doi:10.1136/postgradmedj-2017-135515
9. Haux, R. (2006). Health information systems - past, present, future. International Journal of Medical
Informatics, 75(3-4), 268-281. doi:10.1016/j.ijmedinf.2005.08.002
10. International Organization for Standardization. (n.d.). ISO 27799:2016. Health Informatics -- Information
Security Management in Health Using ISO/IEC 27002. Retrieved September 2, 2019, from
11. Mann, R., & Williams, J. (2003). Standards in medical record keeping. Clinical Medicine, 3(4), 329-332.
doi:10.7861/clinmedicine.3-4-329
12. Mathiharan, K. ( 2001 ) . Medical Records. Indian Journal of Medical Ethics, 1 ( 2 ) , 59 .
doi:10.20529/IJME.2004.029
13. Ministry of Health and Family Welfare, Government of India. (2016, December 30). Electronic Health Record
(EHR) Standards for India -2016. Retrieved September 1, 2019, from
https://mohfw.gov.in/sites/default/files/ EMR-
EHR_Standards_for_India_as_notified_by_MOHFW_2016.pdf
14. Myuran, T., Turner, O., Ben Doostdar, B., & Lovett, B. (2017). The e-CRABEL score: an updated method for
auditing medical records. BMJ Quality Improvement Reports, 6(1), u211253.w4529. doi:10.1136/
bmjquality.u211253.w4529
15. National Institute of Biologicals, Ministry of Health & Family Welfare, Government of India. (n.d.).
Haemovigilance Programme of India. Retrieved from http://nib.gov.in/haemovigilance.html
97
16. Patient Safety Network, Agency for Healthcare Research and Quality. (2012, July). Patient Safety and Health
Information Technology: Learning from Our Mistakes. Retrieved September 1, 2019, from
https://psnet.ahrq.gov/perspectives/perspective/124/patient-safety-and-health-information-technology-
learning-from-our-mistakes
17. Royal College of Physicians. (2015, October 26). Generic medical record keeping standards. Retrieved
September 2, 2019, from https://www.rcplondon.ac.uk/projects/outputs/generic-medical-record-keeping-
standards
18. Schweitzer, M., & Hoerbst, A. (2015). A Systematic Investigation on Barriers and Critical Success Factors for
Clinical Information Systems in Integrated Care Settings. Yearbook of Medical Informatics, 24(01), 79-89.
doi:10.15265/iy-2015-018
19. Thomas, J. (2009). Medical records and issues in negligence. Indian Journal of Urology, 25(3), 384.
doi:10.4103/0970-1591.56208
20. Tuffaha, H., Amer, T., Jayia, P., Bicknell, C., Rajaretnam, N., & Ziprin, P. (2012). The STAR score: a method
for auditing clinical records. The Annals of The Royal College of Surgeons of England, 94(4), 235-239.
doi:10.1308/003588412x13171221499865
21. Winter, A., Ammenwerth, E., Bott, O., Brigl, B., Buchauer, A., Gräber, S., … Winter, A. (2001).
Strategic information management plans: the basis for systematic information management in hospitals.
International Journal of Medical Informatics, 64(2-3), 99-109. doi:10.1016/s1386-5056(01)00219-2
98
Glossary
The commonly-used terminologies in the NABH standards are briefly described and explained herein to remove
any ambiguity regarding their comprehension. The definitions narrated have been taken from various authentic
sources as stated, wherever possible. Notwithstanding the accuracy of the explanations given, in the event of
any discrepancy with a legal requirement enshrined in the law of the land, the provisions of the latter shall apply.
Accreditation is self-assessment and external peer review process used by

health care organisations to accurately assess their level of performance in
Accreditation
relation to established standards and to implement ways to improve the
health care system continuously.
Accreditation The evaluation process for assessing the compliance of an organisation

assessment with the applicable standards for determining its accreditation status.
Emergency medical care for sustaining life, including defibrillation,

Advance life support
airway management, and drugs and medications.
A response to a drug which is noxious and unintended and which occurs at

Adverse drug reaction doses normally used in man for prophylaxis, diagnosis, or therapy of
disease or for the modification of physiologic function.
An injury related to medical management, in contrast to complications of

the disease. Medical management includes all aspects of care, including
diagnosis and treatment, failure to diagnose or treat, and the systems and
Adverse event
equipment used to deliver care. Adverse events may be preventable or
non- preventable. (WHO Draft Guidelines for Adverse Event Reporting
and Learning Systems)
It is defined as death occurring within 24 hours of administration of

Anaesthesia Death anaesthesia due to cases related to anaesthesia. However, death may
occur even afterwards due to the complications.
All activities including history taking, physical examination, laboratory

Assessment investigations that contribute towards determining the prevailing clinical
status of the patient.
The nursing of patients with infectious diseases in isolation to prevent

the spread of infection.
As the name implies, the aim is to erect a barrier to the passage of
Barrier nursing infectious pathogenic organisms between the contagious patient and
other patients and staff in the hospital, and thence to the outside world.
The nurses wear gowns, masks, and gloves, and they observe strict rules
that minimise the risk of passing on infectious agents.
Basic life support (BLS) is the level of medical care which is used for
Basic life support patients with life-threatening illnesses or injuries until the patient can be
given full medical care
99
Activities which are associated with the repair and servicing of site
Breakdown infrastructure, buildings, plant or equipment within the site's agreed
maintenance building capacity allocation which have become inoperable or unusable
because of the failure of component parts.
A rule governing the internal management of an organisation. It can

supplement or complement the government law but cannot countermand it,
Byelaws
e.g. municipal by-laws for construction of hospitals/nursing homes, for
disposal of hazardous and/or infectious waste
Set of operations that establish, under specified conditions, the relationship

between values of quantities indicated by a measuring instrument or
Calibration
measuring system, or values represented by a material measure or a
reference material, and the corresponding values realised by standards.
A plan that identifies patient care needs, lists the strategy to meet
those needs, documents treatment goals and objectives, outlines the
criteria for ending interventions, and documents the individual's
Care Plan progress in meeting specified goals and objectives. The format of the
plan may be guided by specific policies and procedures, protocols,
practice guidelines or a combination of these. It includes preventive,
promotive, curative and rehabilitative aspects of care.
Citizen's Charter is a document which represents a systematic effort to

focus on the commitment of the organisation towards its citizens in
Citizen's charter respects of standard of services, information, choice and consultation, non-
discrimination and accessibility, grievance redress, courtesy and value for
money.
(Reference: https://goicharters.nic.in/faq.htm)
A quality improvement process that seeks to improve patient care and
outcomes through systematic review of care against explicit criteria and the
Clinical audit
implementation of change. (Reference: Principles for Best Practice in
Clinical Audit 2002, NICE/CHI)
It is a surgical procedure that consists of an examination of a corpse by

dissection to identify the cause, mode and manner of death or to evaluate
Clinical autopsy
any disease or injury that may be present for research or educational
purposes.
Clinical care pathways are standardised evidence-based,

multidisciplinary management plans. They identify an appropriate
Clinical care pathway
sequence of clinical interventions, timeframes, milestones and expected
outcomes for a homogenous patient group.
Clinical practice guidelines are systematically developed statements to

Clinical practice
assist practitioner and patient decisions about appropriate health care
guidelines
for specific clinical circumstances.
100
Demonstrated ability to apply knowledge and skills (para 3.9.2 of ISO 9000:
Competence 2015). Knowledge is the understanding of facts and procedures. Skill is the
ability to perform a specific action.
Restricted access to information to individuals who have a need, a

reason and permission for such access. It also includes an individual's
Confidentiality
right to personal privacy as well as the privacy of information related to
his/her healthcare records.
1. The willingness of a party to undergo examination/procedure/

treatment by a healthcare provider. It may be implied (e.g.
patient registering in OPD), expressed which may be written or
verbal. Informed consent is a type of consent in which the
healthcare provider has a duty to inform his/her patient about the
procedure, its potential risk and benefits, alternative procedure with
their risk and benefits so as to enable the patient to make an
Consent
informed decision of his/her health care.
2. In law, it means active acquiescence or silent compliance by a person

legally capable of consenting. In India, the legal age of consent is 18
years. It may be evidenced by words or acts or by silence when
silence implies concurrence. Actual or implied consent is
necessarily an element in every contract and every agreement.
The statistical tool used in quality control to (1) analyse and understand
process variables, (2) determine process capabilities, and to (3)
monitor effects of the variables on the difference between target and
actual performance. Control charts indicate upper and lower control
Control Charts limits, and often include a central (average) line, to help detect the
trend of plotted values. If all data points are within the control limits,
variations in the values may be due to a common cause and process is said
to be 'in control'. If data points fall outside the control limits, variations
may be due to a special cause, and the process is said to be out of
control.
Correction Action to eliminate the detected non-conformity (Reference: ISO 9000:2015)
Action to eliminate the cause of a non-conformity and to prevent

Corrective action
recurrence. (Reference: ISO 9000:2015)
The process of obtaining, verifying and assessing the qualification of a

Credentialing
healthcare provider.
Data Data is a record of the event.
A part of a patient record that summarises the reasons for admission,

Discharge summary significant clinical findings, procedures performed, treatment rendered,
patient's condition on discharge and any specific instructions given to
the patient or family (for example follow-up medications).
101
A sequence of activities to be carried out when staff does not conform to

Disciplinary procedure
the laid-down norms, rules and regulations of the healthcare organisation.
The preparation, packaging, labelling, record keeping, and transfer of a

prescription drug to a patient or an intermediary, who is responsible for the
Drug dispensing
administration of the drug. (Reference: Mosby's Medical Dictionary, 9th
edition, 2009, Elsevier.)
The giving of a therapeutic agent to a patient, e.g. by infusion, inhalation,

Drug Administration
injection, paste, pessary, suppository or tablet.
Effective Communication is a communication between two or more persons

wherein the intended message is successfully delivered, received and
Effective understood.
communication
The effective communication also includes several other skills such as non-
verbal communication, engaged listening, ability to speak assertively, etc.
Employees All members of the healthcare organisation who are employed full time and
are paid suitable remuneration for their services as per the laid-down
policy.
Helps all those with an advanced, progressive, incurable illness to live

as well as possible until they die. It enables the supportive and palliative
care needs of both patient and family to be identified and met throughout
End-of-life Care
the last phase of life and into bereavement. It includes management of
pain and other symptoms and provision of psychological, social,
spiritual and practical support.
Enhanced communication is using the methods of communication to

ensure meaning and understanding through the recognition of the
Enhanced limitations of others. The intent is to ensure purposeful, timely and
communication
reliable communication. The communication must be sensitive,
empathetic and inclusive.
Ethics Moral principles that govern a person's or group's behaviour.
Evidence-based medicine is the conscientious, explicit, and judicious

Evidence-based
use of current best evidence in making decisions about the care of
medicine
individual patients.
The person(s) with a significant role in the patient's life. It mainly includes
spouse, children and parents. It may also include a person not legally
Family
related to the patient but can make healthcare decisions for a patient if the
patient loses decision-making ability.
Failure Mode and A method used to prospectively identify error risks within a particular process.
Effect Analysis (FMEA)
An approved list of drugs. Drugs contained in the formulary are

Formulary
generally those that are determined to be cost-effective and medically
102
effective.
103
A broad statement describing a desired future condition or achievement

without being specific about how much and when. (Reference:
American Society for Quality)
Goal
The term "goals" refers to a future condition or performance level that one
intends to attain. Goals can be both short- and longer-term. Goals are ends
that guide actions. (Reference: Malcolm Baldridge National Quality Award)
Grievance- handling The sequence of activities carried out to address the grievances of patients,
procedures visitors, relatives and staff.
Substances dangerous to human and other living organisms. They include

Hazardous materials
radioactive or chemical materials.
Waste materials dangerous to living organisms. Such materials require

special precautions for disposal. They include the biologic waste that
Hazardous waste can transmit disease (for example, blood, tissues) radioactive materials,
and toxic chemicals. Other examples are infectious waste such as used
needles, used bandages and fluid soaked items.
Healthcare-associated infection (HAI), also referred to as "nosocomial"

Healthcare- or "hospital" infection, is an infection occurring in a patient during the
associated infection process of care in a hospital or other health care facility which was not
present or incubating at the time of admission. (Reference: World Health
Organization)
The generic term is used to describe the various types of organisation that
Healthcare
provide healthcare services. This includes ambulatory care centres,
organisation
hospitals, laboratories, etc.
A high-dependency unit (HDU) is an area for patients who require more

High-dependency unit intensive observation, treatment and nursing care than are usually provided
for in a ward. It is a standard of care between the ward and full intensive
care.
High-risk/high-alert medications are medications involved in a high
percentage of medication errors or sentinel events and medications
that carry a high risk for abuse, error, or other adverse outcomes.
High Risk/High
Alert Medications Examples include medications with a low therapeutic index, controlled
substances, psychotherapeutic medications, and look-alike and sound-
alike medications.
It is defined as written or verbal reporting of any event in the process

Incident reporting of patient care, that is inconsistent with the deserved patient outcome
or routine operations of the healthcare facility.
Organised education/training usually provided in the workplace for

In-service education/
enhancing the skills of staff members or for teaching them new skills
training
relevant to their jobs/tasks.
104
A statistical measure of the performance of functions, systems or processes

Indicator over time. For example, hospital acquired infection rate, mortality rate,
caesarean section rate, absence rate, etc.
Information Processed data which lends meaning to the raw data.
A brief explanation of the rationale, meaning and significance of the

Intent
standards laid down in a particular chapter.
The method of supervising the intake, use and disposal of various goods in
hands. It relates to supervision of the supply, storage and accessibility
Inventory control of items in order to ensure an adequate supply without
stock-outs/excessive storage. It is also the process of balancing ordering
costs against carrying costs of the inventory so as to minimise total costs.
Separation of an ill person who has a communicable disease (e.g.,measles,

chickenpox, mumps, SARS) from those who are healthy. Isolation prevents
transmission of infection to others and also allows the focused delivery
Isolation
of specialised health care to ill patients. The period of isolation varies
from disease-to-disease. Isolation facilities can also be extended to patients
for fulfilling their individual, unique needs.
1. It entails an explanation pertaining to duties, responsibilities and

conditions required to perform a job.
2. A summary of the most important features of a job, including the
general nature of the work performed (duties and responsibilities)
Job description and level (i.e., skill, effort, responsibility and working conditions)
of the work performed. It typically includes job specifications that
include employee characteristics required for competent performance
of the job. A job description should describe and focus on the job
itself and not on any specific individual who might fill the job.
1. The qualifications/physical requirements, experience and skills

required to perform a particular job/task.
Job specification
2. A statement of the minimum acceptable qualifications that an
incumbent must possess to perform a given job successfully.
The combination of all technical and administrative actions, including

supervision actions, intended to retain an item in, or restore it to, a state in
Maintenance
which it can perform a required function. (Reference: British Standard
3811:1993)
Any fixed or portable non-drug item or apparatus used for diagnosis,

Medical equipment
treatment, monitoring and direct care of a patient.
105
A medication error is any preventable event that may cause or lead to

inappropriate medication use or patient harm while the medication is in the
control of the health care professional, patient, or consumer.
Such events may be related to professional practice, health care products,
Medication error procedures, and systems, including prescribing; order communication;
product labelling, packaging, and nomenclature; compounding;
dispensing; distribution; administration; education; monitoring; and
use. (Reference: The National Coordinating Council for Medication Error
Reporting and Prevention)
A written order by a physician, dentist, or other designated health

professionals for a medication to be dispensed by a pharmacy for
Medication Order
administration to a patient. (Reference: Mosby's Medical Dictionary,
10th edition, Elsevier)
An organisation's purpose. This refers to the overall function of an

organisation. The mission answers the question, "What is this organisation
Mission attempting to accomplish?" The mission might define patients,
stakeholders, or markets served, distinctive or core competencies or
technologies used.
The performance and analysis of routine measurements aimed at

identifying and detecting changes in the health status or the
Monitoring environment, e.g. monitoring of growth and nutritional status, air quality
in operation theatre. It requires careful planning and use of standardised
procedures and methods of data collection.
A generic term which includes representatives from various disciplines,

Multidisciplinary
professions or service areas.
A near-miss is an unplanned event that did not result in injury, illness,

or damage--but had the potential to do so.
Near-miss
Errors that did not result in patient harm, but could have, can be
categorised as near-misses.
This is used synonymously with a near miss. However, some authors draw
a distinction between these two phrases.
A near-miss is defined when an error is realised just in the nick of time, and
abortive action is instituted to cut short its translation. In no harm scenario,
the error is not recognised, and the deed is done, but fortunately for
the healthcare professional, the expected adverse event does not
No harm occur. The distinction between the two is important and is best exemplified
by reactions to administered drugs in allergic patients. A prophylactic
injection of cephalosporin may be stopped in time because it suddenly
transpires that the patient is known to be allergic to penicillin (near-miss).
If this vital piece of information is overlooked, and the cephalosporin
administered, the patient may fortunately not develop an anaphylactic
reaction (no harm event).
106
Certain specified diseases, which are required by law to be notified to the

public health authorities. Under the international health regulation (WHO's
International Health Regulations 2005), the following diseases are always
notifiable to WHO:
(a) Smallpox
(b) Poliomyelitis due to wild-type poliovirus
(c) Human influenza caused by a new subtype
(d) Severe acute respiratory syndrome (SARS).
In India, the following is an indicative list of diseases which are also

notifiable, but may vary from state to state:
Notifiable
(a) Polio
disease
(b) Influenza
(c) Malaria
(d) Rabies
(e) HIV/AIDS
(f) Louse-borne typhus
(g) Tuberculosis
(h) Leprosy
(i) Leptospirosis
(j) Viral hepatitis
(k) Dengue fever
Empowerment for nurses may consist of three components: a

workplace that has the requisite structures to promote empowerment; a
psychological belief in one's ability to be empowered; and
acknowledgement that there is power in the relationships and caring that
nurses provide.
It could include structural empowerment and psychological empowerment.
Structural empowerment refers to the presence or absence of empowering
conditions in the workplace. Kanter's (1993) theory of structural
empowerment includes a discussion of organisational behaviour and
empowerment. According to this theory, empowerment is promoted in work
Nursing environments that provide employees with access to information,
empowerment
resources, support, and the opportunity to learn and develop. Psychological
empowerment is related to a sense of motivation towards the
organisational environment, based on the dimensions of meaning,
competence, self- determination, and impact
Evidence of nursing empowerment include initiating and carrying out CPR
even in the absences of physicians, implementing standard protocols in the
ICU such as weaning a patient off ventilator, tapering or titrating inotropic
as per standard policies, nurse-led discussions during patient rounds,
preparing nursing budgets, decisions to procure equipment that aid and
ease nursing care, empowered to correct, stop non-compliance to
protocols defined by the hospital.
107
A specific statement of a desired short-term condition or achievement

Objective includes measurable end-results to be accomplished by specific teams
or individuals within time limits. (Reference: American Society for Quality)
It is that component of standard which can be measured objectively on

Objective element a rating scale. Acceptable compliance with the measurable elements
will determine the overall compliance with the standard.
The hazards to which an individual is exposed during the course of the

Occupational performance of his job. These include physical, chemical, biological,
health hazard
mechanical and psychosocial hazards.
The operational plan is the part of your strategic plan. It defines how you
will operate in practice to implement your action and monitoring plans -
Operational plan what your capacity needs are, how you will engage resources, how you will
deal with risks, and how you will ensure the sustainability of the
organisation's achievements.
Organogram A graphic representation of the reporting relationship in an organisation.
Hiring of services and facilities from other organisation based upon

one's own requirement in areas where such facilities are either not
available or else are not cost-effective. For example, outsourcing of house-
keeping, security, laboratory/certain special diagnostic facilities. When
Outsourcing
an activity is outsourced to other institutions, there should be a
memorandum of understanding that clearly lays down the obligations of
both organisations: the one which is outsourcing and the one who is
providing the outsourced facility. It also addresses the quality-related
aspects.
The location where a patient is provided health care as per his needs,
Patient-care setting
e.g. ICU, speciality ward, private ward and general ward.
A document which contains the chronological sequence of events that a

Patient record/ patient undergoes during his stay in the healthcare organisation. It includes
medical record/ demographic data of the patient, assessment findings, diagnosis,
clinical record consultations, procedures undergone, progress notes and discharge
summary.
Patient-reported Patient-reported experience measures are questionnaires measuring

experience measures
(PREMs) the patients' perceptions of their experience whilst receiving care.
Patient-reported Patient-reported outcome measures are questionnaires measuring the
outcome measures
(PROMs) patients' views of their health status.
Patient satisfaction is a measure of the extent to which a patient is content

with the health care which they received from their health care
Patient Satisfaction and
provider. Patient satisfaction is thus a proxy but a very effective indicator
to measure the success of Health care providers.
108
Patient Experience is the sum of all interactions, shaped by an

organisation's culture, that influence patient perceptions across the
Patient Experience
continuum of care.
It is a holistic perception that the patient forms about the healthcare
provider based on the overall interactions/ care touchpoints.
It is the process of evaluating the performance of staff during a defined

Performance appraisal period of time with the aim of ascertaining their suitability for the job,
the potential for growth as well as determining training needs.
Medical Equipment that is used to deliver care/intervene at or near the site

of patient care. These are primarily Point-of-care testing (POCT), or
Point of care
bedside testing equipment that helps in reducing turn-around times.
equipment
POCT Machine examples; Glucometer, ABG Analyser, Stat Lab at
ICU/ER, portable USG etc.
They are the guidelines for decision-making,e.g. admission, discharge

Policies
policies, antibiotic policy,etc.
Action to eliminate the cause of a potential non-conformity. (Reference ISO

Preventive action
9000:2015)
It is a set of activities that are performed on plant equipment, machinery,

Preventive
maintenance and systems before the occurrence of a failure in order to protect them
and to prevent or eliminate any degradation in their operating conditions.
The maintenance carried out at predetermined intervals or according to
prescribed criteria and intended to reduce the probability of failure or
the degradation of the functioning of an item.
A prescription is a document given by a physician or other healthcare

practitioner in the form of instructions that govern the care plan for an
individual patient.
Prescription Legally, it is a written directive, for compounding or dispensing and
administration of drugs, or for other service to a particular patient.
(Reference: Miller-Keane Encyclopedia and Dictionary of Medicine,
Nursing, and Allied Health, Seventh Edition, Saunders)
It is the process for authorising all medical professionals to admit and treat
Privileging patients and provide other clinical services commensurate with their
qualifications and skills.
Confidential information furnished (to facilitate diagnosis and

Privileged
treatment) by the patient to a professional authorised by law to provide
communication
care and treatment.
109
Procedural sedation is a technique of administering sedatives or

dissociative agents with or without analgesics to induce a state that allows
the patient to tolerate unpleasant procedures while maintaining
Procedural sedation cardiorespiratory function. Procedural sedation and analgesia (PSA) is
intended to result in a depressed level of consciousness that allows the
patient to maintain oxygenation and airway control independently.
(Reference: The American College of Emergency Physicians)
1. A specified way to carry out an activity or a process (Para 3.4.5

of ISO 9000: 2015).
Procedure 2. A series of activities for carrying out work which when observed
by all help to ensure the maximum use of resources and efforts to
achieve the desired output.
A set of interrelated or interacting activities which transforms inputs

Process
into outputs (Para 3.4.1 of ISO 9000: 2015).
Programme A sequence of activities designed to implement policies and

accomplish objectives.
A plan or a set of steps to be followed in a study, an investigation or an

Protocol
intervention.
1. Degree to which a set of inherent characteristics fulfil

requirements (Para 3.1.1 of ISO 9000: 2015).
Characteristicsimplyadistinguishingfeature(Para 3.5.1 of ISO 9000:
Quality 2015). Requirements are a need or expectation that is stated,
generally implied or obligatory (Para 3.1.2 of ISO 9000:2015).
2. Degree of adherence to pre-established criteria or standards.
Part of quality management focussed on providing confidence that quality

Quality assurance
requirements will be fulfilled (Para 3.2.11 of ISO 9000:2015).
Ongoing response to quality assessment data about a service in ways that

Quality improvement
improve the process by which services are provided to consumers/patients.
Radiation safety refers to safety issues and protection from radiation

hazards arising from the handling of radioactive materials or chemicals and
exposure to Ionizing and Non-Ionizing Radiation.
This is implemented by taking steps to ensure that people will not
receive excessive doses of radiation and by monitoring all sources of
radiation to which they may be exposed.(Reference: McGraw-Hill
Radiation Safety Dictionary of Scientific & Technical Terms)
In a Healthcare setting, this commonly refers to X-ray machines, CT/PET
CT Scans, Electron microscopes, Particle accelerators, Cyclotron etc.
Radioactive substances and radioactive waste are also potential Hazards.
Imaging Safety includes safety measures to be taken while performing an
MRI, Radiological interventions, Sedation, Anaesthesia, Transfer of patients,
Monitoring patients during imaging procedure etc.
110
It implies a continuous and ongoing assessment of the patient, which is

Re-assessment
recorded in the medical records as progress notes.
Medication reconciliation is the process of creating the most accurate

list possible of all medications a patient is taking - including drug name,
Reconciliation of dosage, frequency, and route - and comparing that list against the
medications physician's admission, transfer, and/or discharge orders, with the goal
of providing correct medications to the patient at all transition points within
the hospital. (Reference: Institute for Healthcare Improvement)
It implies all inputs in terms of men, material, money, machines,

Resources minutes (time), methods, metres (space), skills, knowledge and
information that are needed for the efficient and effective functioning of an
organisation.
Devices used to ensure safety by restricting and controlling a person's

Restraints movement. Many facilities are "restraint-free" or use alternative methods to
help modify behaviour. Restraint may be physical or chemical (by use of
sedatives).
Risk abatement Risk abatement means minimising the risk or minimising the impact of that
risk.
Risk assessment is the determination of the quantitative or qualitative value
Risk assessment of risk related to a concrete situation and a recognised threat (also
called hazard). Risk assessment is a step in a risk management procedure.
Clinical and administrative activities to identify, evaluate and reduce the risk
Risk management
of injury.
Risk mitigation is a strategy to prepare for and lessen the effects of threats
Risk mitigation and disasters. Risk mitigation takes steps to reduce the negative effects of
threats and disasters.
The conceptual framework of elements considered with the possibilities to

minimise vulnerabilities and disaster risks throughout society to avoid
(prevention) or to limit (mitigation and preparedness) the adverse impacts
Risk reduction of hazards, within the broad context of sustainable development.
It is the decrease in the risk of a healthcare facility, given activity, and
treatment process with respect to patient, staff, visitors and community.
Root Cause Analysis (RCA) is a structured process that uncovers the

physical, human, and latent causes of any undesirable event in the
workplace. Root cause analysis (RCA) is a method of problem-solving
that tries to identify the root causes of faults or problems that cause
Root Cause operating events.
Analysis (RCA) RCA practice tries to solve problems by attempting to identify and
correct the root causes of events, as opposed to simply addressing
their symptoms. By focusing correction on root causes, problem recurrence
can be prevented. The process involves data collection; cause charting,
root cause identification and recommendation generation and
111
implementation.
112
The degree to which the risk of an intervention/procedure, in the care

Safety
environment is reduced for a patient, visitors and healthcare providers.
Safety programme A programme focused on patient, staff and visitor safety.
Scope of services Range of clinical and supportive activities that are provided by a healthcare
organisation.
Security Protection from loss, destruction, tampering, and unauthorised access or use.
The administration to an individual, in any setting for any purpose, by any

route, moderate or deep sedation. There are three levels of sedation:
Minimal sedation (anxiolysis) - A drug-induced state during which
patients respond normally to verbal commands. Although cognitive
function and coordination may be impaired, ventilatory and cardiovascular
functions are not affected.
Sedation Moderate sedation/analgesia (conscious sedation) - A drug-induced

depression of consciousness during which patients respond purposefully to
verbal commands either alone or accompanied by light tactile stimulation.
No interventions are needed to maintain a patent airway.
Deep sedation/analgesia - A drug-induced depression of
consciousness during which patients cannot be easily aroused but
respond purposefully after repeated or painful stimulation. Patients may
need help in maintaining a patent airway.
A relatively infrequent, unexpected incident, related to system or

process deficiencies, which leads to death or major and enduring loss
of function for a recipient of healthcare services.
Sentinel events Major and enduring loss of function refers to sensory, motor,
physiological, or psychological impairment not present at the time services
were sought or begun. The impairment lasts for a minimum period of
two weeks and is not related to an underlying condition.
A balanced approach for an organisation to address economic, social

and environmental issues in a way that aims to benefit people,
Social responsibility
communities and society,e.g. adoption of villages for providing health care,
holding of medical camps and proper disposal of hospital wastes.
Practitioner decisions based on available knowledge, principles and

Sound clinical practice
practices for specific clinical situations.
In addition to routine carried by the healthcare professionals, patients and

family have special educational needs depending on the situation. For
example, a post-surgical patient who has to take care of his wound,
nasogastric tube feeding, patient on tracheostomy getting discharged who
Special Educational
has to be taken care of by the family etc. The special educational needs are
needs of the
also greatly influenced by the literacy, educational level, language,
patient
emotional barriers and physical and cognitive limitations. Hence it is
important for the staff to determine the special educational needs and the
challenges influencing the effective education.
113
All personnel working in the organisation including employees, "fee-for-

Staff service" medical professionals, part-time workers, contractual personnel
and volunteers.
1. A method of infection control in which all human blood and other

bodily fluids are considered infectious for HIV, HBV and other blood-
borne pathogens, regardless of patient history. It encompasses a
variety of practices to prevent occupational exposure, such as the
use of personal protective equipment (PPE), disposal of sharps and
safe housekeeping
Standard precautions
2. A set of guidelines protecting first aiders or healthcare professionals
from pathogens. The main message is: "Don't touch or use anything
that has the victim's body fluid on it without a barrier." It also
assumes that all body fluid of a patient is infectious, and must be
treated accordingly.
Standard Precautions apply to blood, all body fluids, secretions, and
excretions (except sweat) regardless of whether or not they contain visible
blood, non-intact skin and mucous membranes
A statement of expectation that defines the structures and process that
Standards
must be substantially in place in an organisation to enhance the quality of
care.
It is the process of killing or removing microorganisms including their
Sterilisation
spores by thermal, chemical or irradiation means.
Strategic planning is an organisation's process of defining its strategy

or direction and making decisions on allocating its resources to pursue
this strategy, including its capital and people. Various business analysis
techniques can be used in strategic planning, including SWOT analysis
(Strengths, Weaknesses, Opportunities and Threats), e.g. Organisation can
Strategic plan have a strategic plan to become a market leader in the provision of
cardiothoracic and vascular services. The resource allocation will have
to follow the pattern to achieve the target.
The process by which an organisation envisions its future and develops
strategies, goals, objectives and action plans to achieve that future.
The continuous scrutiny of factors that determines the occurrence and

distribution of diseases and other conditions of ill health. It implies
Surveillance watching over with great attention, authority and often with suspicion.
It requires professional analysis and sophisticated interpretation of data
leading to recommendations for control activities.
114
A table-top exercise is an activity in which key personnel assigned

emergency management roles and responsibilities are gathered to discuss,
Table-top exercise in a non-threatening environment, various simulated emergency situations.
(Reference: https://uwpd.wisc.edu/content/uploads/2014/01/What_is_a_
tabletop_exercise.pdf)
115
Traceability is the ability to trace the history, application, use and location
Traceability of an item or its characteristics through recorded identification data.
(Reference: ISO 9000:2015)
A transfusion reaction is a problem that occurs after a patient receives

Transfusion reaction
a transfusion of blood.
Triage is a process of prioritising patients based on the severity of their

Triage condition so as to treat as many as possible when resources are insufficient
for all to be treated immediately.
Turnaround Ttime (TAT) means the amount of time taken to complete

Turn-around-time
a process or fulfil a request.
A patient whose vital parameters need external assistance for their

Unstable patient
maintenance.
A validated tool refers to a questionnaire/scale that has been developed to

be administered among the intended respondents. The validation
processes should have been completed using a representative sample,
Validated tool
demonstrating adequate reliability (the ability of the instrument to
produce consistent results) and validity (the ability of the instrument to
produce true results).
Validation is verification, where the specified requirements are adequate for

Validation
the intended use.
The fundamental beliefs that drive organisational behaviour and

Values
decision-making.
This refers to the guiding principles and behaviours that embody how
an organisation and its people are expected to operate. Values reflect
and reinforce the desired culture of an organisation.
Verbal orders are those orders given by a physician with prescriptive

Verbal order
authority to a licensed person who is authorised by the organisation.
Verification is the provision of objective evidence that a given item

Verification
fulfils specified requirements.
An overarching statement of the way an organisation wants to be, an ideal

state of being at a future point.
Vision This refers to the desired future state of an organisation. The vision
describes where the organisation is headed, what it intends to be, or how it
wishes to be perceived in the future.
116
Those patients who are prone to injury and disease by virtue of their
age, sex, physical, mental and immunological status,e.g. infants,
Vulnerable patient
elderly, physically- and mentally-challenged,
semiconscious/unconscious, those on immunosuppressive and/or
chemotherapeutic agents.
Incidents where staff are abused, threatened or assaulted in circumstances
related to their work, including commuting to and from work, involving an
Workplace violence
explicit or implicit challenge to their safety, well-being or health. (Adapted
from European Commission)
117
PROVIDERS (NABH)
Annexure-I
th
APRIL 2020
KEY NATIONAL ACCREDITATION BOARD
PERFORMANCE
FOR HOSPITALS & HEALTHCARE PROVIDERS (NABH)
ITPI Building, 5th Floor, 4A, IP Estate, Ring Road, New Delhi-
110002 Email: [email protected] | Website: www.nabh.co
INDICATORS ISBN 978-81-944877-5-3
9 788194 487753
NABH Key
Performance Indicators
The concept of performance in health services represents an instrument for bringing quality, efficiency
and efficacy together. Performance represents the extent to which set objectives are accomplished.
Performance is a multidimensional one, covering various aspects, such as evidence-based practice (EBP),
continuity and integration in healthcare services, health promotion, orientation towards the needs and
expectation of patients and family members.
Key Performance Indicators (KPIs) help to systematically monitor, evaluate, and continually improve
service performance. By themselves, KPIs cannot improve performance. However, they do provide
“signposts” that signal progress toward goals and objectives as well as opportunities for sustainable
improvements.
Well-designed KPIs should help the organisation to do a number of things, including:

• Establish baseline information i.e., the current state of performance
• Set performance standards and targets to motivate continual improvement
• Measure and report improvements over time
• Compare performance across geographic locations
• Benchmark performance against regional and international peers or norms
• Allow stakeholders to independently judge health sector performance.
Healthcare organisations (HCO) are encouraged to capture all data which involves clinical and support
services. The data needs to be analysed and risks, rates and trends for all the indicators have to be
demonstrated for appropriate action.
The intent of the NABH KPIs is to have comprehensive involvement of scope of services for which a HCO
has applied for the accreditation program. Standardised definitions for each indicator along with
numerator and denominator have been explained. Each HCO can have the data set measure, analyse the
aggregated data and appropriate correction, corrective and preventive action can be formulated. Each
HCO can also design their own methodology of data collection but a broad guidance note has been
given to facilitate organisation's compliance.
Suggested minimum sample size to be taken for various audits and KPIs as applicable has been specified.
(Table at the end).
115
NABH Key Performance Indicators: Annexure: 5
th Edition Hospital Standards 2020
NABH
Key Performance Indicators Expected to be Monitored
by Healthcare Organisation
The Key performance indicators expected to be monitored by healthcare organisation:

Frequency
of Data
S. No. Standards Indicator Definition Formula Unit Collation/ Remarks
Monitoring
Sum of time This shall be captured

The time shall begin taken for either through the HIS,
from the time that the initial the or through audit. In case
Time taken for
patient has arrived at assessment of audit, the sample size
initial
1. PSQ3a the bed of the ward till Minutes Monthly shall be as specified in
assessment of
indoor patients the time that the initial the sample size
assessment has been Total
calculation table.
completed by a doctor. number of
Day care patients are
admissions
not included.
This includes reporting

errors picked up after
dispatch.
This shall be captured in
the laboratory and
radiology. Reporting
errors include
Number of transcription errors.
reporting For better analysis, the
errors organisation could
capture the data
separately for different
laboratory departments
(For example,
Biochemistry /
Microbiology/Pathology
Number of ) and Imaging
reporting modalities (for example,
2. PSQ 3a errors per x1000 /1000 Monthly X-Ray/USG/CT/MRI).
1000 tests Further, the organisation
investigations could consider
capturing data
pertaining to reporting
errors that were
identified and rectified
before dispatch of the
reports. This would
Number of
enable the organisation
tests
to improve on its
performed
process.
Although the indicator is

collated on a monthly
basis, immediate
correction is to be
initiated when such
instances happen.
116
Frequency
of Data
Monitoring
This shall be captured in

the laboratory and
Number of radiology.
staff This shall be captured
adhering to by doing an audit on a
safety monthly basis. The
Percentage of precautions audit should be done by
adherence to the competent individual
safety outside of the
3. PSQ3a precautions by X 100 Percentage Monthly
department being
staff working audited.
in diagnostics. Even if the staff is not
adhering to anyone of
Number of the
staff audited organisation's/statutory
safety requirements, it
shall be considered as
non- adherence.
A medication error is
any preventable event
that may cause or lead
to inappropriate
medication use or
patient harm while the Total
medication is in the number of
control of the
medication
healthcare professional,
errors
patient or consumer.
(Ref: NCC-MERP) ). The methodology for
Examples include, but capture shall be as
Medication are not limited to: stated in NABH's
4. PSQ3a Errors Rate X 100 Percentage Monthly
Prescribing error document on
Transcribing error medication errors
Dispensing error
Administration error Total
Monitoring error number of
opportunitie
Wrong drug, Wrong s of
strength, Wrong dose medication
errors; errors
Wrong patient errors;
Wrong route of
administration error
Number of
medication
Error-prone charts with
Percentage of abbreviations shall be This includes only for
error prone
medication defined in consonance in-patients and could be
abbreviation
5. PSQ3a charts with with the guidelines laid Percentage Monthly clubbed with the activity
(s)
error-prone down by Institution for for capturing medication
X 100
abbreviations Safe Medication Number of errors.
Practices. medication
charts
reviewed
117
th
NABH Key Performance Indicators: Annexure: 5 Edition Hospital Standards 2020
Frequency
of Data
Monitoring
Adverse Drug reaction Number of

is a response to a drug patients
which is noxious and developing The organisation needs
Percentage of unintended and which adverse to have a mechanism in
in-patients occurs at doses drug place to ensure that all
6. PSQ3a developing normally used in man reactions X 100 Percentage Monthly
adverse drug reactions
adverse drug for prophylaxis,
are captured and
reaction(s). diagnosis, or therapy of
disease or for the reported.
Number of
modification of in - patients
physiologic function.
The data shall be
captured with a delay of
30 days. This ensures
that the organisation has
adequate time to capture
Unplanned return to the
Number of complications that
OT is defined as any
unplanned require unplanned return
secondary procedure
required for a return to OT to the OT. For example,
complication resulting the data which is collated
directly from the index in January would include
Percentage of
operation during same surgeries done in the
7. PSQ3a unplanned X 100 Percentage Monthly
admission. For month of November.
return to OT
example, post-operative This also includes
bleeding, debridement, unplanned re-exploration.
secondary suturing, This shall not include
Number of
embolectomy, surgeries under LA.
patients who
evaluation under However if any such
anaesthesia etc. underwent
surgeries in patient required
the OT unplanned return to the
OT, the same shall be
captured in the Incident
Report Form.
This should be done by
prospective audit. The
Number of audit shall be done when
surgeries the surgery is being
Percentage of where the performed. A person(s)
surgeries procedure working in the OT
where the was complex could be
organisation's followed entrusted with this
procedure to responsibility. It is
prevent preferable that the
adverse
8. PSQ3a X 100 Percentage Monthly identity of the person
events like
auditing is anonymised
wrong site,
wrong patient from the operating team.
and wrong The sample size shall be
surgery have as specified in the
Number of
been sample size calculation
surgeries
adhered to. sheet. Further sampling
performed
shall be random and
stratified (distributed
across various days and
operating surgeons).
118
Frequency
of Data
S. No. Standards Indicator Definition Formula Unit Remarks
Collation/
Monitoring
Any adverse reaction to

the transfusion of blood
Number of
or blood components
transfusion
shall be considered as
transfusion reaction. It reactions
Percentage of Number of units
may range from a mild includes whole blood
9. PSQ3a transfusion X 100 Percentage Monthly
allergic reaction
reactions and components.
(including chills/rigors) Number of
to life-threatening units
complications like
transfused
TRALI and Graft-
Versus-Host Disease.
Standardised Mortality Predicted death shall be

Ratio is the ratio of the Actual calculated from models
observed or actual deaths in such as APACHE, SOFA,
mortality and the ICU SAPS, MPM, and PRISM
Standardised predicted mortality for a etc.
10. PSQ3a Mortality Ratio specified time period. It X 100 Percentage Monthly
for ICU requires an estimate of 1 = Normal/expected
predicted mortality rate Predicted > = Higher than
using a scoring system deaths in expected
(APACHE, SOFA, SAPS, <= Lower than
ICU
MPM, and PRISM etc.) expected
Number of
returns to
emergency
Return to the within 72 To capture this indicator
emergency hours with it may be a good
department similar practice to capture
within 72 presenting during the initial
11. PSQ3a hours with X 100 Percentage Monthly assessment itself if the
complaints
similar patient had come
presenting Number of within72 hours for
complaints patients who similar complaints.
have come
to the
emergency.
Incidence of A pressure ulcer is Number of The organisation shall

hospital localized injury to the patients who use The European and
associated skin and/or underlying develop new US National Pressure
pressure tissue usually over a / worsening /1000 Ulcer Advisory panels
12. PSQ3a ulcers after bony prominence, as a of pressure X 1000 patient Monthly (EPUAP and NPUAP)
admission result of pressure, or days
ulcer staging system to look
(Bed sore per pressure in
1000 patient combination with shear for worsening pressure
Total no. of ulcers.
days) and/or friction. patient days
119
Frequency
of Data
S. No. Standards Indicator Definition Formula Unit Remarks
Collation/
Monitoring
Number of
urinary
catheter
associated
Catheter UTIs in a /1000
associated As per the latest month X 1000 urinary
13. PSQ3b Monthly
Urinary tract CDC/NHSN definition catheter-
infection rate Number of days
urinary
catheter
days in that
month
Number of
“Ventilator
Associated
Ventilator Pneumonia”
/1000
associated As per the latest in a month
14. PSQ3b X 1000 ventilator- Monthly
Pneumonia CDC/NHSN definition
days
rate Number of
ventilator
days in that
month
Number of
central line -
associated
blood
Central line - stream
/1000
associated As per the latest infections in
15. PSQ3b X 1000 central line Monthly
Blood stream CDC/NHSN definition a month.
days
infection rate
No. of
central line
days in that
month
Surgical site As per the latest Number of

infection rate CDC/NHSN definition surgical site
infections in
a given /100
16. PSQ3b month X 100 surgical Monthly Remarks*
Number of procedures
surgeries
performed in
that month
*Remarks Keeping
in mind the definition of SSI, the numbers would have to be updated on a continual basis until such time that the monitoring period is over. For example, in January
the data of December would be reported. The denominator would be the number of surgeries performed in December and that would not change. With respect to
numerator, there would be some data but it would not be complete data. Hence, whatever value the organisation gets at this stage would at best be a preliminary value.
The organisation will continue to monitor the patients and by end January, would have got complete data with respect to procedures which have a 30-day
surveillance period. At this point of time based on the data that the organisation has collated the numerator may change and hence the SSI rate.
However, this again would not be the final data. The organisation will continue to monitor procedures which have a 90-day surveillance period and if there are new SSIs it
would get added to the numerator and thus the rate would change. The surveillance period for surgeries which are done in December and have a 90-day surveillance
period would end on March 31st (give or take a few days).
at this point of time that the organisation can have the final SSI rate for December.
120
Frequency
of Data
Monitoring
Observation involves
Total directly watching and
number of recording the hand
Hand hygiene behaviour of
hygiene health care workers and
actions the physical
performed environment. Good
Hand Hygiene
reference is WHO hand
17. PSQ3b Compliance X 100 Percentage Monthly
Rate hygiene compliance
monitoring tool.
Please refer:
Total http://www.who.int/gpsc/
number of 5may/tools/en/
hand hygiene http://www.who.int/entity
opportunities /gpsc/5may/Observation
_Form.doc?ua=1
Appropriate prophylactic
antibiotic should be
according to hospital
Number of
policy. The numerator
patients who
shall include patients
did receive
who received the
appropriate
appropriate drug (and
prophylactic
Percentage of dose) within the
antibiotic(s)
cases who appropriate time. A
received patient who was not
appropriate given prophylactic
18. PSQ3b prophylactic X 100 Percentage Monthly antibiotic because it was
antibiotics not indicated (e.g. clean
within the surgery) shall be
specified included in the
timeframe numerator.
Number of
A patient, who is given
patients who
prophylactic antibiotic
underwent
even though it was not
surgeries in
indicated, shall be
the OT
considered as having
received it
inappropriately.
Number of Any case included in the

Re-scheduling of cases re- OT list (including
Percentage of surgeries includes scheduled tentative/provisional) but
19. PSQ3c re- scheduling cancellation and X 100 Percentage Monthly
of surgeries rescheduled shall be
postponement (beyond Number of
4 hours)of the surgery. included in the
surgeries
numerator.
planned
121
Frequency
of Data
Monitoring
Sum of time
Time taken to be taken
calculated from the
Turnaround time the request is This will include blood
Total number
time for issue received in the blood outsourced from other
of blood and
20. PSQ3c of blood and bank till the blood is Minutes Monthly Blood Banks, for those
blood
blood cross organisations not having
Components
components matched/reserved and in-house Blood Banks.
available for cross-
transfusion. . matched/
reserved
The HCOs should

calculate the staffing
patterns separately for
Number of ICUs and for the wards.
nursing staff The in-charge/supervisor
of the area shall not be
Nurse-patient included for calculating
ratio for ICUs Monthly the number of staff.
21. PSQ3c Ratio
and wards It is preferable that in
case of ICU the
organisation capture the
Number of ratio for ventilated and
occupied non-ventilated patients
beds separately.
To be calculated for each
shift separately.
Waiting time is a length

of time which one must
wait in order for a In case of appointment
Sum total
specific action to occur, patients, the time shall
Patient-in
after that action is
time for begin with scheduled
requested or mandated.
consultation appointment time and
Waiting time for out-
patient consultation is end when the concerned
Waiting time the time from which the consultant (not the junior
22. PSQ3c for out- patient patient has come to the Minutes Monthly doctor/resident) begins
consultation concerned out- patient the assessment. In
department(it may or cases where the patient
may not be the same has been seen ahead of
time as registration )till Total
the appointment time,
the time that the Number of
the waiting time shall be
concerned consultant out-patients
taken as zero minutes.
(not the junior
doctor/resident) begins
the assessment.
122
Frequency
of Data
Monitoring
Waiting time for

diagnostics is applicable
Sum total only for outpatients and
patient for laboratory and
reporting imaging
Waiting time for
time
diagnostics is the time In case of appointment
from which the patient patients, the time shall
has come to the begin with the scheduled
Waiting time
23. PSQ4c diagnostic service Minutes Monthly
for diagnostics appointment time and
(requisition form has
end when the diagnostic
been presented to the
counter) till the time procedure begins. In
Number of cases where the patient's
that the test is initiated.
patients diagnostic test
reported in commences ahead of the
Diagnostics appointment time the
waiting time shall be
taken as zero minutes.
In case patients request

Sum of time additional time to leave
The discharge process
taken for the clinical unit that shall
is deemed to have
Time taken for discharge not be added. The
started when the
24. PSQ4c discharge consultant formally Minutes Monthly discharge is deemed to
approves discharge and have been complete
ends with the patient Number of when the formalities for
leaving the clinical unit patients the same have been
discharged completed.
Informed consent is a Number of If any of the essential

type of consent in medical element/requirement of
which the healthcare records consent is missing it
provider has a duty to having shall be considered as
Percentage of
inform his/her patient incomplete.
medical incomplete
about the procedure, its
records having and/or
potential risks and If any consent obtained
25. PSQ4c incomplete improper X 100 Percentage Monthly
benefits, alternative is invalid/void (consent
and/or consent
procedure or treatment obtained from wrong
improper
with their risks and
consent person/consent obtained
benefits so as to enable Number of by wrong person etc.) it
the patient to take an discharges
informed decision of is considered as
and deaths improper.
his/her healthcare.
123
Frequency
of Data
Monitoring
To capture this,
organisation should
maintain a register in the
pharmacy and stores
Number of
(and also if necessary in
stock outs
the wards) wherein all
of
such events are
emergency
captured. The
drugs
A stock out is an event organisation shall
which occurs when an capture the number of
item listed as an instances. In one
Stock out Rate instance, it is possible
emergency medication
26. PSQ4c of Emergency X 100 Percentage Monthly
by the organisation is that there was stock out
medications
not available upon the of more than one
requested need date in emergency drug. For
the organisation. example, if on the 7th
Number of
drugs listed there was an instance of
as stock out of two
emergency emergency drugs and on
drugs in 24th there was an
hospital instance of stock out of
formulary one emergency drug, the
value of the indicator
would be two.
Mock drill is a
simulation exercise of
preparedness for any To capture the variation it
type of event. It could is suggested that every
be event or disaster. Total
Number of organisation develop a
This is basically a dry number of
variations checklist to capture the
27. PSQ4d run or preparedness variations Number Monthly
observed in events during a mock
drill. observed in
mock drills drill. This shall also
For example, fire mock a mock drill
drill, disaster drill, Code include table top
Blue Drill, Global exercises.
Pandemic preparedness
drill.
124
Frequency
of Data
Monitoring
Falls may be:

• at different levels–
i.e., from one level to
ground level e.g.
from beds,
wheelchairs or down
A fall is defined as
stairs
“Loss of upright • on the same level as
Number of
position that results in
patient falls a result of slipping,
landing on the floor,
ground or an object or tripping, or
furniture or a sudden, stumbling, or from a
uncontrolled, collision, pushing, or
unintentional, non- shoving, by or with
purposeful, downward another person
Patient fall rate displacement of the /1000 • belowground level,
28. PSQ4d (Falls per 1000 body to the X 1000 patient Monthly i.e. into a hole or
patient days) floor/ground or hitting days other opening in
another object like a surface
chair or stair.”
All types of falls are to be
It is an event that included whether they
results in a person result from physiological
coming to rest reasons (fainting) or
inadvertently on the Total
environmental reasons.
ground or floor or other number of
Assisted falls (when
lower level. patient days
another person attempts
to minimize the impact of
the fall by assisting the
patient's descent to the
floor) should be
included. (NDNQI, 2005).
A near miss is an
unplanned event that A key to any near miss
Number of report is the "lesson
did not result in injury,
near misses learned". Near miss
illness, or damage – but
reported reporters can describe
had the potential to do
Percentage of so. what they observed of
29. PSQ4d X 100 Percentage Monthly
the beginning of the
near misses
Errors that did not event, and
result in patient harm, Number of The factors that
but could have, can be incidents prevented loss from
categorized as near reported occurring.
misses.
Needle stick injury is a

penetrating stab wound Number of
from a needle (or other parenteral Parenteral exposure
sharp object) that may exposures means injury due to any
Incidence of result in exposure to /1000
sharp.
30. PSQ3d needle stick blood or other body X 1000 patient Monthly
injuries fluids. days
This includes only in-
Needle stick injuries are Number of
patients.
wounds caused by in-patient
needles that accidentally days
puncture the skin.
125
th
NABH Key Performance Indicators: Annexure: 5 Edition Hospital Standards 2020
Frequency
of Data
Monitoring
Appropriate Total no. of Handover is an important

handovers handovers
during shift communication tool used
done by the healthcare
change (To be
appropriately workers.
done
31. PSQ3d X 100 Percentage Monthly Handover documentation
separately for
doctors and Total no. of by each shift can be
nurses) - (per handover used as a guide to
patient per opportunities capture the information.
shift).
Total no. of
Compliance prescriptions
rate to in capital This includes only Out-
32. PSQ3d Medication letters X 100 Percentage Monthly
patients prescriptions.
Prescription in
capitals Total no. of
prescriptions
Sample size calculation

Solvent formula
n= N/(1+Ne²)
(where n = Number of samples, N = Total population and e = Error tolerance)
By using 95% confidence level (margin of error of 0.05)
By using this formula the values calculated are the following:
Screening Population Sample Size*
50 44
100 80
150 109
200 133
500 222
1000 286
2000 333
5000 370
10000 385
20000 392
For values beyond the purview of the table, minimum 10% of the population
size can be taken as representative sample.
It is preferred to take the samples on Stratified random basis than on Continuous basis to eliminate the bias that can occur in convenient
sampling.
Stratified random sampling accurately reflects the population being studied because researchers are stratifying the entire population before
applying random sampling methods. In short, it ensures each subgroup within the population receives proper representation within the sample.
126
PROVIDERS (NABH)
Annexure-II
th
APRIL 2020
MEDICATION
ERRORS
Medication Errors
Definition
NCCMERP (National Coordinating Council for Medication Error Reporting and Prevention) defines
medication error as
"A medication error is any preventable event that may cause or lead to inappropriate medication use
or patient harm while the medication is in the control of the health care professional, patient or
consumer. Such events may be related to professional practice, health care products, procedures and
systems, including prescribing, order communication, product labelling, packaging and nomenclature,
compounding, dispensing, distribution, administration, education, monitoring and use."
Level of Harm Category of Error Explanation of events/ error
NO ERROR Category A Circumstances or events that have the capacity to cause error
ERROR, An error occurred but the error did not reach the patient
Category B
NO (An "error of omission" does reach the patient.)
HARM
An error occurred that reached the patient, but did not cause
Category C
patient harm.
An error occurred that reached the patient and required

Category D monitoring to confirm that it resulted in no harm to the
patient and/or required intervention to preclude harm
ERROR, An error occurred that may have contributed to or resulted

Category E
HARM in temporary harm to the patient and required intervention
An error occurred that may have contributed to or resulted in

Category F temporary harm to the patient and required initial or
prolonged hospitalization
Category G An error occurred that may have contributed to or resulted

in permanent patient harm
Category H An error occurred that required intervention necessary to

sustain life
ERROR, Category I An error occurred that may have contributed to or resulted

DEATH in the patient's death.
128
Gui debook to NABH Accredi t at i on S t andards for Hospi t al s
National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) index for
categorizing medication errors. © 2001 National Coordinating Council for Medication Error Reporting and
Prevention.
129
130
Gui debook to NABH Accredi t at i on St andards for Hospit al s
Algorithm developed by the National Coordinating Council for Medication Error Reporting and Prevention (NCC
MERP) for applying the NCC MERP index for categorizing medication errors. © 2001, National Coordinating
Council for Medication Error Reporting and Prevention.
Methodology
Chart Review, Audit and Self Reporting of Medication Errors are preferred methods in case medication charts are
documented manually in the HCO. Software programmes can be used where prescriptions are generated online.
The format for capturing medication errors by routine chart review is provided in Annexure-1.
The idea of trying to identify personnel involved in errors is to ensure that the organisation does a proper root
cause analysis and takes appropriate corrective and/or preventive action. It is not meant for punitive
action. Process improvements are a must to reduce errors.
Formula
Total number of errors identified
Total number of opportunities x100

• Total No of errors identified / No of drugs per chart reviewed * No of
charts reviewed
Note:
• Self-reported medication errors, medication errors identified during audits

or medication errors identified by any other methodology shall be added
to the numerator i.e. total number of errors identified.
Sample size
Adhere to the formula stated by NABH Advisory for sample size calculation. The 'population' would be calculated
from the running average of the previous three months admissions.
Care needs to be taken to ensure that files from all clinical specialities.are included. Stratified sampling will help
the organisation achieve this.
131
Gui debook to NABH Acc re dit a ti on St a ndards for Hospi ta l s
Correction
Pending analysis, it is imperative that the organisation do correction to mitigate the effect(s) of the error.
An example of how correction could be done is provided below.
For category A and B Administer the drug within reasonable time frame
For Category C and D Consult the clinician and follow orders accordingly
Analysis
The first step in analysis is collation of data. This would help identify
• Categories of error
• Personnel involved in error
The data could be collated as per the table below.
A B C D E F G H I Total
DOCTORS
NURSES
PHARMACISTS
TOTAL
The organisation should identify the proper root cause to ensure that effective corrective and/ or preventive
action are taken. It is suggested that appropriate tools are used for the same.
Some of the possible causes of medications errors are provided in the table below.
PEOPLE ENVIRONMENT EQUIPMENT PROCESS
Pharmacy- poor drug

storage- poor
Casual Attitude Defective syringe pumps 'Ten' rights not observed
ventilation, lighting,
humidity
Pharmacy space
Inexperienced/ New staff Wrong stocking
constraint for storage,
Pharmacy manpower
Untrained staff Wrong labelling
constraint for dispensing
Shift change time/ Inappropriate syringe/

in hurry diluent
Emotionally unfit No cross checking
132
Gui debook to NABH Accredi t at i on St andards for Hospit al s
PEOPLE ENVIRONMENT EQUIPMENT PROCESS
Physically unfit Stock outs
Unauthorized
Wrong indent/ receiving
replacement of drug
Patient identification LASA medicine error

error
Wrong dispensing
pharmacy
Wrong distribution GDA
Illegible handwriting
doctors
Some of the common corrective actions include:

• Training
• Manpower recruitment
• Pharmacy stock rectification
• Equipment replacement/ rectification
Suggested Reading
1. www.nccmerp.org. National Coordinating Council for Medication Error Reporting and Prevention
2. American Society of Health-System Pharmacists. ASHP guidelines on preventing medication errors in
hospitals. Am J Health-Syst Pharm. 2018; 75:1493–1517.
3. Nrupal Patel, Mira Desai, Samdih Shah et al. A study of medication errors in a tertiary care hospital. Perspect
Clin Res. 2016 Oct-Dec; 7(4): 168–173.
4. Khandelwal AK. Getting it Right. Healthcare Radius 2014; March: 32-34
Annexure-1: Medication Chart Review Checklist
Auditor: Date of Audit: Location:

UHID: Date of Admission: Primary Consultant:
Error Perpetuation (Write Category of error from A to I)#

In case of no error, kindly write 0; if a particular parameter is not applicable, kindly write NA
(Multiple errors can be there and documented for each row and column)
Drug 1 Drug 2 Drug 3 Drug 4 Drug 5 Drug 6 Drug 7 Drug 8 Drug 9 Drug 10
DOCTORS
1. Incorrect prescription
Incorrect drug selection
133

No/wrong dose
No/wrong unit
No/wrong frequency
No/wrong route
No/wrong concentration
No/wrong rate
of administration
2. Drug allergies not

documented
3. Illegible handwriting
4. Non-approved
abbreviations used
5. Non-usage of capital
letters for drug
names
6. Non usage of generic
names
7. Non-modification of
drug dose keeping in
mind drug-drug
interaction
8. Non modification of
time of drug
administration/
dose/drug keeping in
mind food-drug
interaction
PHARMACIST
9. Wrong drug dispensed
10. Wrong dose dispensed
11. Wrong formulation

dispensed
12. Expired/Near-expiry drugs

dispensed
13. No/wrong labelling
14. Delay in dispense >

defined time
134

15. Generic or class

substitute done without
consultation with the
prescribing doctor
NURSES
16. Wrong Patient
17. Dose Omission
18. Improper Dose
19. Wrong Drug
20. Wrong Dosage Form
21. Wrong Route

of
Administration
22. Wrong Rate
23. Wrong Duration
24. Wrong Time*
25. No documentation
of drug
administration
26. Incomplete/Improper
documentation by
nursing staff **
27. Documentation without

administrationOthers
Number of errors (Number of cells having a value between A to I) =

Number of opportunities {Number of cells having a value of either 0 or a value between A to I (excluding
NA)} =
# Select only one of the medication error categories or subcategories, whichever best fits the error that is being
reported. In selecting the patient outcome category, select the highest level severity that applies during the
course of the event. For example, if a patient suffers a severe anaphylactic reaction (Category H) and requires
treatment (Category F) but eventually recovers completely, the event should be coded as Category H.
* Deviation from the organisation's defined timeframe for administration of drugs for which the time has not
been written. The basis for stating 'wrong time' should be evidence-based. The organisation could
adopt/adapt the ISMP Acute Care Guidelines for Timely Administration of Scheduled Medications.
** Incomplete documentation includes missing date, time, signature. Improper documentation includes writing
the wrong dose like instead of stating ½ tablet of 500 mg being administered, stating that 1 tablet of 250 mg
was administered (based on how the medication order was written) or not stating the actual brand that was
administered in cases of brand substitution.
135
FOR HOSPITALS & HEALTHCARE PROVIDERS (NABH)
ITPI Building, 5th Floor, 4A, IP Estate, Ring Road, New Delhi-
110002 Email: [email protected] | Website: www.nabh.co
ISBN 978-81-944-8776-0
9 788194 487760

5th Edition Hospital STD April 2020

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NATIONAL ACCREDITATION BOARD

FOR HOSPITALS AND HEALTHCARE

Accreditation Standards for Hospitals

© All Rights Reserved

Dr. Atul Mohan Kochhar

Padma Bhushan Dr B. K. Rao, Chairman NABH, has been the

I sincerely thank Dr Ravi P. Singh, Secretary General of Quality

I thank all board members of NABH in giving significant

The Technical Committee of NABH worked relentlessly and

I thank all our passionate assessors, management of the hospitals,

It is entirely due to the overwhelming participation, dedication,

To all of you a sincere, heartfelt and, profound - Thank you.

Dr. Atul Mohan Kochhar

Chapter 2 Care of Patients (COP) 13

Chapter 3 Management of Medication (MOM) 30

Chapter 4 Patient Rights and Education (PRE) 39

Chapter 5 Hospital Infection Control (HIC) 47

Chapter 6 Patient Safety and Quality Improvement (PSQ) 57

Chapter 7 Responsibilities of Management (ROM) 65

Chapter 8 Facility Management and Safety (FMS) 72

Chapter 9 Human Resource Management (HRM) 79

Chapter 10 Information Management System (IMS) 91

Annexure I Key Performance Indicators 114

Annexure II Medication Errors 127

Intent of the chapter:

* This implies that this objective element requires documentation.

Commitment c. Scope of the healthcare services of each department is defined. *

Commitment d. The organisation's defined healthcare services are prominently displayed.

C RE b. A unique identification number is generated at the end of the registration.

Achievement e. Access to the healthcare services in the organisation is prioritised according to

Commitment b. Transfer- out/referral of patients to another facility is done appropriately. *

Commitment b The initial assessment is performed by qualified personnel. *

Commitment d. Initial assessment of day-care and in-patients includes nursing assessment,

Commitment b. Out-patients are informed of their next follow-up, where appropriate.

Commitment d. Staff involved in direct clinical care document reassessments.

Commitment c. Human resource is adequate to provide the defined scope of services.

Commitment e. Requisition for tests, collection, identification, handling, safe transportation,

Commitment f. Laboratory results are available within a defined time frame. *

Commitment h. Results are reported in a standardised manner.

Achievement i. There is a mechanism to address the recall / amendment of reports

Commitment b. The programme addresses verification and/or validation of test methods. *

Commitment c. The programme ensures the quality of test results. *

Excellence f. The programme addresses clinicopathological meeting(s).

Commitment b. This programme is aligned with the organisation's safety programme.

Commitment c. Laboratory personnel are appropriately trained in safe practices.

Commitment d. Laboratory personnel are provided with appropriate safety measures.

Commitment f. Imaging results are available within a defined time frame. *

Commitment g. Critical results are intimated immediately to the personnel concerned. *

Commitment h. Results are reported in a standardised manner.

Achievement i. There is a mechanism to address the recall / amendment of reports

Commitment b. Quality assurance programme includes tests for imaging equipment.

Commitment c. Quality assurance programme includes the review of imaging protocols.

Achievement d. A system is in place to ensure the appropriateness of the investigations and

Achievement e. The programme addresses periodic internal/external peer review of imaging

Excellence f. The programme addresses the clinico-radiological meeting(s).

Commitment b. This programme is aligned with the organisation's safety programme.

Commitment c. Patients are appropriately screened for safety/risk before imaging.

Commitment g. Imaging signage is prominently displayed in all appropriate locations.