Guidebook For Preacc Entrylevelstandards SHCO

GUIDEBOOK FOR
PRE-ACCREDITATION ENTRY-LEVEL STANDARDS

FOR SMALL HEALTHCARE ORGANIZATIONS (SHCOs)
First Edition: May 2015
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ENTRY LEVEL
Accreditation
Pre-Accreditation
(Progressive- Level)
Pre-Accreditation
(Entry-Level)
NATIONAL ACCREDITATION BOARD FOR HOSPITALS AND

HEALTHCARE PROVIDERS (NABH)
GUIDEBOOK FOR
PRE-ACCREDITATION ENTRY-LEVEL STANDARDS

FOR SMALL HEALTHCARE ORGANIZATIONS (SHCOs)
First Edition: May 2015
NATIONAL ACCREDITATION BOARD FOR HOSPITALS AND

HEALTHCARE PROVIDERS (NABH)
All Rights Reserved

No part of this book may be reproduced or transmitted in any form without permission in writing from the author.
First Edition May 2015
National Accreditation Board for Hospitals and Healthcare Providers
CONTENTS
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 01
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 03
Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 04
List of Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 06
Chapter 1. ACCESS, ASSESSMENT AND CONTINUITY OF CARE (AAC). . . . . . . . . . . . . . . . . . . . . . . . 09

1
AAC1
The SHCO defines and displays the services that it can provide.. . . . . . . . . . . . . . 09
AAC1a
The services being provided are clearly defined.
AAC2
The SHCO has a documented registration, admission and transfer process. . . . . . 12
AAC2a
Process addresses registering and admitting outpatients, inpatients,

and emergency patients.
AAC2b
Process addresses mechanism for transfer or referral of patients who

do not match the SHCO's resources.
AAC3
Patients cared for by the SHCO undergo an established initial assessment. . . . . . 17
AAC3a
The SHCO defines the content of the assessments for inpatients and
emergency patients.
AAC5
Laboratory services are provided as per the scope of the SHCO's services . . . . . . 21
and laboratory safety requirements.
AAC5b
Procedures guide collection, identification, handling, safe transportation,

processing, and disposal of specimens.
AAC7
The SHCO has a defined discharge process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
AAC7a
Process addresses discharge of all patients including medico-legal cases

and patients leaving against medical advice.
AAC7c
Discharge summary contains the reasons for admission, significant findings,

investigation results, diagnosis, procedure performed (if any),
treatment given, and the patient's condition at the time of discharge.
Chapter 2. CARE OF PATIENTS (COP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

6
COP2
Emergency services including ambulance are guided by documented . . . . . . . . . 31

procedures and applicable laws and regulations.
COP2a
Documented procedures address care of patients arriving in the

emergency including handling of medico-legal cases.
10
11
12
COP3
Documented procedures define rational use of blood and blood products. . . . . . 41
COP3c
Procedure addresses documenting and reporting of transfusion reactions.
COP4
Documented procedures guide the care of patients as per the scope of . . . . . . . 44

services provided by the SHCO in Intensive Care and High Dependency Units.
COP4a
Care of patient is in consonance with the documented procedures.
COP5
Documented procedures guide the care of obstetrical patients as per . . . . . . . . . 48

the scope of services provided by the SHCO.
COP5a
The SHCO defines the scope of obstetric services.
COP6
Documented procedures guide the care of pediatric patients as per . . . . . . . . . . 50

the scope of services provided by the SHCO.
COP6a
The SHCO defines the scope of its pediatric services.
COP6d
Procedure addresses identification and security measures to prevent child

or neonate abduction and abuse.
COP7
Documented procedures guide the administration of anesthesia. . . . . . . . . . . . . 54
COP7a
There is a documented policy and procedure for the administration of

anesthesia.
COP8
Documented procedures guide the care of patients undergoing . . . . . . . . . . . . . 57

surgical procedures.
COP8c
Documented procedures address the prevention of adverse events like

wrong site, wrong patient, and wrong surgery.
Chapter 3. MANAGEMENT OF MEDICATION (MOM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

13
14
MOM1
Documented procedures guide the organization of pharmacy services and . . . . . 63

usage of medication.
MOM1a
Documented procedures incorporate purchase, storage, prescription,

and dispensation of medications.
MOM1e
Documented procedures address procurement and usage of implantable prosthesis.
MOM2
Documented procedures guide the prescription of medications. . . . . . . . . . . . . . 71
MOM2d
The SHCO defines a list of high-risk medication and the process to prescribe them.
Chapter 4. HOSPITAL INFECTION CONTROL (HIC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

15
HIC1
The SHCO has an Infection Control Manual which it periodically updates; . . . . . 74

the SHCO conducts surveillance activities.
Hospital Infection Control Manual (as Annexure)
Chapter 5. CONTINUOUS QUALITY IMPROVEMENT (CQI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

16
CQI2
The SHCO identifies key indicators to monitor the structures, processes, . . . . . . 76

and outcomes which are used as tools for continuous improvement.
CQI2a
The SHCO identifies the appropriate key performance indicators in both

clinical and managerial areas.
Chapter 6. RESPONSIBILITIES OF MANAGEMENT (ROM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

17
18
ROM1
The responsibilities of the management are defined. . . . . . . . . . . . . . . . . . . . . . 80
ROM1a
The SHCO has a documented organogram.
ROM2
The SHCO is managed by the leaders in an ethical manner. . . . . . . . . . . . . . . . . . 83
ROM2a
The management makes public the mission statement of the SHCO.
Chapter 7. FACILITY MANAGEMENT AND SAFETY (FMS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

19
20
21
22
FMS1
The SHCO's environment and facilities operate to ensure safety of patients, . . . . 87

their families, staff, and visitors.
FMS1c
The SHCO has a system to identify the potential safety and security
risks including hazardous materials.
FMS2
The SHCO has a program for clinical and support service equipment . . . . . . . . . 92
management.
FMS2b
There is a documented operational and maintenance

(preventive and breakdown) plan.
FMS3
The SHCO has provisions for safe water, electricity, medical gas, . . . . . . . . . . . . . 97
and vacuum systems.
FMS3c
There is a maintenance plan for medical gas and vacuum systems.
FMS4
The SHCO has plans for fire and nonfire emergencies within the facilities. . . . . . 102
FMS4a
The SHCO has plans and provisions for detection, abatement,

and containment of fire and nonfire emergencies.
FMS4b
The SHCO has a documented safe exit plan in case of fire and nonfire emergencies.
Chapter 8. HUMAN RESOURCE MANAGEMENT (HRM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

23
24
HRM2
The SHCO has a well-documented disciplinary and grievance . . . . . . . . . . . . . . 109

handling procedure.
HRM2a
A documented procedure regarding disciplinary and grievance handling is in place.
HRM2b
The documented procedure is known to all categories of employees in the SHCO.
HRM3
The SHCO addresses the health needs of its employees. . . . . . . . . . . . . . . . . . . 115
HRM3a
Health problems of the employees are taken care of in accordance with

the SHCO's policy.
Chapter 9. INFORMATION MANAGEMENT SYSTEM (IMS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

25
26
IMS1
The SHCO has a complete and accurate medical record for every patient. . . . . . 123
IMS1e
The contents of medical records are identified and documented.
IMS3
Documented policies and procedures are in place for maintaining. . . . . . . . . . . 128

confidentiality, security, and integrity of records, data, and information.
IMS3a
Documented procedures exist for maintaining confidentiality, security,

and integrity of information.
27
IMS4
Documented procedures exist for retention time of records, data, . . . . . . . . . . 132

and information.
IMS4a
Documented procedures are in place regarding retention of the patient's

clinical records, data, and information.
IMS4c
The destruction of medical records, data, and information is in accordance

with the laid down procedure.
APPENDIXES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
1. Formation of Committees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
2. Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
3. Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
FOREWORD
Since January 2011, the Forum of Government Sponsored Health Insurance Schemes in India,
organized by World Bank in close partnership with central and state governments, has been a
platform for facilitating knowledge-sharing between key policymakers heading central and state
government health insurance schemes. This practitioner-to-practitioner knowledge exchange
created a subgroup, a Quality and Accreditation Collaborative, which includes Government of India
(GOI) and state government-financed health insurance and health financing programs, commercial
insurers, hospitals, National Accreditation Board for Hospitals and Healthcare Providers (NABH),
industry chambers such as the Federation of Indian Chambers of Commerce and Industry (FICCI),
and other health sector stakeholders. By contributing to overall improvement in the quality of
service delivery, the potential impact of this initiative extends far beyond the 15 or so participating
health programs, to the healthcare system as a whole.
The Collaborative has embarked on several initiatives aimed at contributing to healthcare quality,
particularly where payers could play a catalytic role. It has been supporting the development of
standard treatment guidelines, promoting the use of systematic priority setting and health
technology assessments, and also the promotion of linkages to provider accreditation. As a
landmark initiative that could go a long way to strengthen the quality of healthcare delivery in the
country, particularly among the network hospitals participating in Government Sponsored Health
Insurance Schemes, it developed Pre-Accreditation Entry-level Standards for Small Healthcare
Organizations (SCHOs). These pre-accreditation entry-level standards are in accordance with the
standards of the National Accreditation Board for Hospitals and Healthcare Organizations (NABH).
The Collaborative considered several potential subsets of NABH standards and objective elements,
and identified a subset suited for the creation of pre-accreditation entry-level certification by
NABH, which could be feasibly undertaken by resource restrained hospitals, could be
independently assessed, and which could be used as standardized empanelment criteria for health
insurance programs, meeting their common needs for quality and patient safety. Two sets of preaccreditation entry-level standards, one based on NABH SHCO standards for hospitals under 50
beds, and the other using NABH standards for hospitals with 50 beds or more, were suggested by
the Collaborative which were finalized and published by the NABH in 2014. This has created a
quality benchmark which is not only within the reach of the vast majority of hospitals, but also sets
the stage for steady progress to higher levels of NABH standards.
The NABH Pre-Accreditation Entry-Level Standards for SHCOs consist of 41 standards1 and 149
objective elements2 .
However, the task of the Collaborative did not end when the pre-accreditation entry-level standards
were published. To facilitate the attainment of pre-accreditation entry-level standards by small
1
A standard is a statement of expectation that defines the structures and process that must be substantially in place in an
organization to enhance the quality of care.
2
An objective element is that component of a standard which can be measured objectively on a rating scale. The acceptable
compliance with the measureable elements will determine the overall compliance with the standard.
1
hospitals which may not be able to access or afford consultants to help them on this journey, the
Collaborative embarked on developing a Guidebook that could be useful for small hospitals to
understand the standards better, and also demystified the process of achieving them. Thus,
regardless of their size, hospitals that aspire to improve the quality of their care but lack the internal
capacity to achieve this on their own, will benefit from this document. A team of renowned experts
in healthcare quality, with considerable experience and exposure to accreditation and quality
assessments, joined hands to undertake the development of this Guidebook, which consists of
supporting tools and templates for selected pre-accreditation entry-level standards and objective
elements published by NABH, as prioritized by the Collaborative based on their complexity and
need for further detailing.
This Guidebook for Pre-Accreditation Entry-Level Standards for SHCOs contains comprehensive
information on the prioritized 27 standards and 34 objective elements (including the Hospital
Infection Control [HIC] Manual included as an Annexure in the soft copy version of this guide). The
Guidebook includes an overview of each objective element, suggestions on how to fulfil the
objective element, tasks and responsibilities of various team members in the hospital to fulfil the
objective element, and various other tools such as audit checklists, training material, sample
Standard Operating Procedures (SOPs), and other sample templates to assist in the implementation
of the standards by SHCOs. The Guidebook also provides guidance on the organizational structure
required in SCHOs to achieve compliance with the pre-accreditation entry-level standards. The soft
copy version of this Guidebook also includes several additional reference documents, including
specimens graciously contributed by several hospitals to improve an understanding of what final
documents have been used by real-life hospitals.
NABH's pre-accreditation entry-level standards will soon be followed by pre-accreditation
progressive-level standards as an intermediate stage to full accreditation, and all these sets of
standards will aim to serve as important milestones in a hospital's journey towards greater quality
and patient safety, contributing to the overall shared objective of safer, accessible, and affordable
healthcare.
Somil Nagpal, Senior Health Specialist, World Bank.

Abha Mehndiratta, Consultant, World Bank.
Alexander Thomas, President, Consortium of Accredited Healthcare Organizations (CAHO);
Chairman, Advisory Committee, NABH Accreditation of Government Hospitals, Govt. of Karnataka.
2
PREFACE
Despite the rapid growth of the health industry in India, patient safety and quality care remains a
great concern.
NABH has been operating an accreditation and allied program since 2006. Only 295 hospitals and 49
small healthcare organizations (SHCOs) have achieved accreditation till date. Furthermore, the
myth that achieving accreditation is a mammoth task and is very costly has been a deterrent for the
majority of hospitals. In order to be more inclusive, Pre-Accreditation Entry-level Standards have
been developed through the collaborative efforts of various stakeholders, so that more hospitals
can join the quality journey. A step-wise approach to enhance quality was considered more suitable
given the existing challenges.
This Guidebook has been prepared with the objective of enabling SHCOs to prepare for the
accreditation process on their own, without an external agency, thus making the entire
accreditation process more cost-effective and sustainable. The Guidebook is expected to help
SHCOs achieve a proper understanding of the standards and the objective elements and how they
can be implemented. It will also promote uniformity in the interpretation and implementation of
the standards across hospitals.
This excellent work is the outcome of the Forum of Government Sponsored Health Insurance
Schemes, supported by World Bank, which created a Quality and Accreditation Collaborative for
this purpose. The Guidebook has been approved by the Technical Committee of NABH and shall be
made available online.
Dr. K. K. Kalra,
CEO, NABH
3
ACKNOWLEDGEMENTS
The conceptualization, compilation and production of this document has been possible due to the
elaborate and collective effort of various stakeholders, including the members of the Quality and
Accreditation Collaborative, World Bank, officials from NABH, technical experts on healthcare
quality, and a team of reviewers and resource persons. We would like to express our great
appreciation to all the stakeholders involved in developing this Guidebook and the funding support
provided by the World Bank-DFID Trust Fund.
List of Contributors and Co-Authors
Convener
Dr. Alexander Thomas, President, Consortium of Accredited Healthcare Organizations (CAHO);
Chairman, Advisory Committee, NABH Accreditation of Government Hospitals, Govt. of Karnataka.
Co-Authors
Dr. Antony Lazar Basile, Medical Director, STAR Hospitals, Hyderabad.
Dr. Manju Chacko, Team Leader, Quality, Bangalore Baptist Hospital, Bangalore.
Dr. Badari Datta H.C., Head of Quality and Consultant ENT Surgeon, Bangalore Baptist Hospital,
Bangalore.
Ms. Lallu Joseph, Quality Manager, Christian Medical College, Vellore.
Dr. K. Kalra, CEO, National Accreditation Board for Hospitals and Healthcare Providers (NABH).
Ms. Beenamma Kurien, Quality Assurance Coordinator, Karnataka Health System Development and
Reform Project (KHSDRP), Government of Karnataka.
Dr. A. Malathi, Head of Medical Services, Compliance and Education, Manipal Health Enterprises
Pvt. Ltd.
Dr. Suneel C. Mundkur, Additional Professor, Department of Pediatrics, Kasturba Medical College,
Manipal.
Dr. Nitin Shantilal Raithatha, Professor of Obstetrics and Gynecology, Pramukh Swami Medical
College, Shree Krishna Hospital, Karamsad.
Dr. Arati Verma, Senior Vice President, Medical Quality, Max Healthcare; Chair, NABH Appeals
Committee; Chair, NABH Assessor Management Committee.
World Bank facilitation team
Dr. Somil Nagpal, Senior Health Specialist, World Bank.
Dr. Abha Mehndiratta, Consultant, World Bank.
4
Conceptualization, Review and Guidance: Members of the Quality and Accreditation

Collaborative
Shri Rajeev Sadanandan, Joint Secretary, Government of India.
Dr. K. Ellangovan, Secretary, Department of Health and Family Welfare, Government of Kerala.
Ms. Asha Nair, Director and General Manager, UIIC, Chennai.
Dr. K. Phani Koteswara Rao, Chief Medical Auditor, Rajiv Aarogysri, Government of Telangana.
Ms. Shobha Mishra Ghosh, Sr. Director, FICCI, New Delhi.
Dr. T.S. Selvavinayagam, Joint Director of Health Services, Government of Tamil Nadu.
Dr. Ravi Babu Shivaraj, Joint Director, CMCHIS, Government of Tamil Nadu.
Dr. Narayana Swamy, Dy. Director, Suvarna Arogya Suraksha Trust, Government of Karnataka.
Mr. Vijendra Katre, Addl. CEO, RSBY, Government of Chhattisgarh.
Dr. K. Sandeep, Sr. Consultant, M&E, Government of Kerala.
Major Ashutosh Shrivastava, Chief Operating Officer, Glocal Healthcare.
Dr. K. Madan Gopal, Sr. Tech. Advisor, GIZ, and RSBY.
We express our sincere thanks to NABH Technical Committee members, Dr. S. Murali, Dr. Antony
Lazar Basile, Dr. Parag R. Rindani, Dr. Naveen Chitkara, Mr. Satish Kumar, Dr. Vikas Manchanda,
Dr.Badari Datta, Mr. Deepak Agarkhad, Dr. Farhan A. Rashid Shaikh, Ms. Abanti Gopan, Dr. Ashish
Rakheja and Dr. Kashipa Harit, who contributed their valuable time and suggestions to review and
finalize the Guidebook for Pre-Accreditation Entry-Level Standards.
We express our special thanks to Dr. Manju Chacko, Team Leader, Quality, Bangalore Baptist
Hospital, Bangalore; Dr. Nancy Ramya I., Executive Program Manager, Bangalore Baptist Hospital,
Bangalore; and Divya Alexander, Independent Consultant, Bangalore for closely supporting the coauthors in coordination and finalization of this Guidebook. Last but not the least, our special thanks
to Ms. Usha Tankha for her excellent editorial support at all stages of this Guidebook and for
bringing it out in its final shape.
We are grateful to the following NABH accredited institutions for allowing their de-identified
documents to be used as samples in this exercise:
1. Bangalore Baptist Hospital
2. Max Healthcare
3. Cimar Fertility Clinic
4. Giridhar Eye Institute
5. Shree Krishna Hospital, HM Patel Centre for Medical Care and Education
Note: All diagrams and forms in this document are original unless otherwise stated. Policies and Standard
Operating Procedures (SOPs) shared are samples to guide SHCOs in developing their own customized
documents.
5
LIST OF ABBREVIATIONS
ACLS
Advanced Cardiac Life Support
AHPI
Association of Healthcare Providers, India.
BP
Blood Pressure
BPL
Below Poverty Line
BT
Bleeding Time
CCTV
Closed-Circuit Television
CDC
Centers for Disease Control
CEO
Chief Executive Officer
CMO
Chief Medical Officer
CSSD
Central Sterile Supply Department
CT
Computed Tomography
CTVS
Cardiothoracic and Vascular Surgeon
DAMA
Discharge Against Medical Advice
EMO
Emergency Medical Officer
ENT
Ear-Nose-Throat
ER
Emergency Room
ESI
Employees State Insurance
FICCI
Federation of Indian Chambers of Commerce and Industry
FOGSI
Federation of Obstetric and Gynaecological Societies of India
HDU
High Dependency Unit
HOD
Head of Department
HCO
Healthcare Organization
HR
Human Resources
HSG
Hysterosalpingogram
6
ICC
Internal Complaints Committee
ICN
Infection Control Nurse
ICU
Intensive Care Unit
ID
Identification
IG
Immunoglobulin
IMC
Indian Medical Council
INC
Indian Nursing Council
IPD
Inpatient Department
ISMP
Institute for Safe Medication Practices
KMC
Karnataka Medical Council
KPI
Key Performance Indicator
Lab
Laboratory
LAMA
Leaving Against Medical Advice
LASA
Look Alike Sound Alike
LMO
Liquid Medical Oxygen
LPG
Liquefied Petroleum Gas
MCI
Medical Council of India
MO
Medical Officer
MRD
Medical Records Department
MRSA
Methicillin-Resistant Staphylococcus Aureus
MS
Medical Superintendent
MTP
Medical Termination of Pregnancy
NABH
NABL
National Accreditation Board for Testing and Calibration Laboratories
NACO
National AIDS Control Organisation
NALS
Neonatal Advanced Life Support
NBM
Nil by Mouth
NBC
National Building Code
7
NICU
Neonatal Intensive Care Unit
OBD
Obstetrics and Gynecology
OPD
Outpatient Department
OT
Operating Theatre
PA
Public Announcement
PAC
Preanesthesia Consent
PALS
Pediatric Advanced Life Support
PEP
Pre-exposure Prophylaxis
PICU
Pediatric Intensive Care Unit
PNDT
Prenatal Diagnostic Techniques
PPE
Personal Protective Equipment
PPTCT
Prevention of Parent To Child Transmission
RCOG
Royal College of Obstetricians and Gynecologists
RMO
Resident Medical Officer
SHCO
Small Healthcare Organization
SOP
Standard Operating Procedure
TAT
Turn Around Time
TPA
Third Party Administrator
UHID
Unique Hospital Identifier
USG
Ultrasonography
WHO
World Health Organization
8
Chapter 1
ACCESS, ASSESSMENT AND CONTINUITY OF CARE (AAC)
STANDARD AAC1. THE SHCO DEFINES AND DISPLAYS THE SERVICES THAT IT CAN PROVIDE.
Objective Elements
AAC1a. The services being provided are clearly defined.
AAC1b. The defined services are prominently displayed.*
AAC1c. The relevant staff are oriented to these services.*
AAC1a. The services being provided are clearly defined.

Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customized documents.
I. OVERVIEW
Scope: To guide the SHCO on how to define the scope of services and ensure that these services are
displayed for the convenience and information of patients.
SHCOs may differ in the kind of services they provide, in terms of the number of beds, or specialties.
For example, one SHCO may have maternity services as its main offering, with 30 beds, while
another may have all secondary care services such as general surgery and ICU. This objective
element guides the SHCO on how to prepare a list of services that it is providing to its patients. These
may be further divided into overall services provided by the SHCO, and services provided by each
department. It is recommended that the services listed match the actual facilities that the SHCO is
capable of providing, and permitted to provide, and also comply with statutory and regulatory
requirements. For example, the Medical Termination of Pregnancy (MTP) service can be provided
only if the SHCO has a licence for the same.
*Objective Elements AAC1b and AAC1c are self-explanatory and therefore not included in this Guidebook.
AAC1b. The defined services are prominently displayed.
Of the list of services that have been defined in the scope, the SHCO can identify those that are relevant to the patients,
and display these bilingually, so that patients are fully informed and can avail of these services. As the method of display
has not been specified by NABH, SHCOs may customize the same. They may use boards placed at the entrance and in
reception areas, and additionally, put these on their website, or have pamphlets for distribution if needed.
AAC1c. The relevant staff are oriented to these services.
The SHCO should ensure that clinical and nonclinical staff are familiar with the services on offer, so that they can guide the
patients accordingly. This may be done through training of staff.
9
It is recommended that:
i.
The Head of the SHCO take input from other team members and departmental staff to
compile the list of services.
ii. The responsibility for ensuring that the services are listed correctly lies with the Head of the
SHCO who approves the same by signing off the policy document that lists the scope.
iv. Whenever a new service is introduced, the scope of services policy document is amended
accordingly.
v. The scope of service may be divided as follows (NABH has not specified a template or
minimum structure for listing the scope of services):
l
Clinical services
l
Support services
l
Additional services
l
Service exclusion, if any
Note: The scope of services may be customized for each SHCO.

For example, the scope of service for a general hospital may be as follows:
Clinical Services
Support Services
General Medicine
Dietary
General Surgery
Central Sterile Supply Department
Pediatrics
Hospital Laundry
Gynecology & Obstetrics

Dental
Medico-social department
Anesthesiology
Biomedical Engineering Services
Emergency Department
Ambulance
Diagnostic Services
l
Laboratory
Medical Records Department
l
Radiology-
X-Ray, CT Scan, USG,

Mammogram
Pharmacy
10
The scope of service for a department may be as follows:

Department of Imaging Services:
The department provides the following types of services:
l
General X-Ray
l
Barium Meal X-Ray
l
Special X-Ray such as HSG
l
Ultrasonography
II. REQUIRED DOCUMENTS

i.
Policy on scope of services
ii. A valid licence related to the scope of services such as MTP licence, Prenatal Diagnostic
Techniques (PNDT), if applicable.
III. TASKS AND RESPONSIBILITIES
No.
Task
Responsibility
i.
Define the general scope of service
Head of SHCO
ii.
Define the departmental scope of service
Top management in consultation

with the specific department head
iii.
Document the above into a policy on 'scope of

services' and place the same in an SOP manual
Assigned staff
iv.
Availability of the valid license related to the

specific department
Administrative department
v.
Display prominently the scope of services in two

languages
Administrative department/
Engineering department
vi.
Update the scope of service
Top management/ Head of the

concerned department
vii.
Staff orientation to the scope of service
Quality team/ Training cell
IV. AUDIT CHECKLIST

No.
Checkpoint
Yes
i.
Availability of scope of service policy

document including licenses
ii.
Bilingual display of scope of service in a

prominent area
iii.
Staff training records
No
11
Remarks
STANDARD AAC2. THE SHCO HAS A DOCUMENTED REGISTRATION, ADMISSION AND

TRANSFER PROCESS.
Objective Elements
AAC2a. Process addresses registering and admitting outpatients, inpatients, and emergency
patients.
AAC2b. Process addresses mechanism for transfer or referral of patients who do not match the
SHCO's resources.
AAC2a. Process addresses registering and admitting outpatients, inpatients, and emergency
patients.
I. OVERVIEW
Scope: To guide the SHCO on preparing a process for registering and admitting outpatients,
inpatients, and emergency patients.
Once the patient is brought to the SHCO, the patient is registered and admitted, if required.
Only patients that can be cared for by the SHCO are admitted.
Patients that match the SHCO's resources are registered and admitted using a defined process.
The defined process covers all patients OPD, new and follow-up patients, and emergency patients.
The defined process:
i.
Provides guideline instructions regarding the outpatient registration process.
ii. Has a uniform registration system for patients and maintains the records of patients coming
to the hospital.
iii. Provides registration for IPD if it matches the scope of services provided.
iv. Provides a mechanism for admission such that the patient can avail of healthcare services.

i.
Policy and SOP on registration
ii. Policy and SOP on admission
12
i. Policy on registration
Each patient being assessed at the hospital should be registered and provided with a unique
identification number.
SOP on OPD registration
No.
Process
Responsibility
Supporting Document
For OPD Registration

A
OPD registration shall be done on Registration clerk

first-come first-served basis.
Register
The following details are taken

from the patient or relative:
Name, age, sex, occupation,
annual income, address, phone
(mobile/landline).
Registration form
The referral slip, if present,

Registration clerk
should be checked to identify
the specialty. If there is no
referral slip, the patient shall be
registered as specified by herself/
himself.
Referral slip
The details are entered into the

OPD slip and the bill is raised.
Registration clerk
Register/OPD slip
The patient is directed towards

the concerned OPD consultation
area.
Registration clerk
After the consultation, if there is

any change in the specialty,
the patient is referred to the
concerned specialty OPD.
Consultant
OPD slip/referral book
Emergency registration is done

24 hours a day.
Registration
clerk/Emergency
registration counter
Register
For unidentified patients,

registration shall be done as a
medico-legal case (MLC).
Registration clerk
Register
Patients revisiting the OPD for a Registration clerk

follow-up consultation shall be
re-registered; however, the same
Unique Hospital Identifier (UHID)
will continue.
Register
Registration clerk
13
ii. Policy on admission

The hospital shall admit patients in consonance with the scope of services only if the hospital can
provide the required services.
SOP on inpatient admission
No.
Process
Responsibility
Supporting Document
Inpatient admission shall be done

through the OPD or the
Emergency department or the
NICU/Labour ward as applicable.
Admission Clerk
Admission Register
The decision regarding admission

shall be made by the consultant
and an admission slip or order
issued by her/him.
Treating Doctor
Admission slip/order
General consent for admission

and treatment is obtained from the
patient and the patient's relative.
Treating Doctor
General consent form
The order for admission shall be

written in the OPD book with the
ward name, date, time, name and
signature of the consultant. The
patient or patient's relative shall be
directed to the admission counter
to complete all the admission
formalities.
Treating Doctor
Admission note
At the admission counter, the

consultant's note is checked for
admission.
Admission Clerk
Admission note
The IPD number and demographic

details of the patient are put into
the admission register/computer
to generate an admission file
(case sheet). This is handed over
to the patient and the admission
fee is collected.
Admission Clerk
Admission file and

receipt
The patient is directed to the

concerned ward, where the bed
will be allotted.
Treating doctor/ staff

nurse/ward attendant
Bed allotment record
The patient is received at the ward

by the ward nurse and allotted a bed.
Treatment is initiated as per the order.
The patient is oriented to the ward.
Staff nurse
Medical record
14

No.
Task
Responsibility
i.
Define the registration, admission and transfer

process.
Top management
ii.
Define the department policy on admission and

transfer process

iii.
Preparation of policy
Quality team
iv.
Staff orientation to the scope of service
Quality team /training cell
IV. AUDIT CHECKLIST

No.
Checkpoint
Yes
i.
Availability of policy - apex manual
ii.
Availability of registration form
iii.
Availability of admission form including

consent
iv.
Staff awareness
No
Remarks
AAC2b. Process addresses mechanism for transfer or referral of patients who do not match the
SHCO's resources.
Note: Sections II and III are provided as samples to guide the SHCO in developing its own customized
documents.
I. OVERVIEW
Scope: To guide the SHCO on transfer or referral of patients who do not match the SHCO's resources.
It is recommended that the following standardized approach be used for referring a patient in case
the service required does not match with the service available in the HCO:
i.
Patients who do not match the SHCO's resources are referred to organizations that have
matching resources.
ii. All patients reaching the emergency department in critical conditions are provided with
first-aid and all available life-saving measures.
iii. In case of non-availability of beds in the inpatient care wards, patients are placed in the
emergency ward until beds are available.
15
iv. In case of absolute non-availability of beds, or if the patient's medical needs are not within
the scope of the hospital, the doctor on duty makes enquiries about the availability of beds
in the nearest Government facility or at a hospital of the patient's preference, and transfers
the patient in the hospital's ambulance or 108 ambulance. The patient is accompanied by
the appropriate doctor or nurse if required.
v. Emergency patients receive life-stabilizing treatment and if resources are not available,
transferred to an organization that has the required resources.

i.
Policy and SOP for transfer-out and referral-out
ii. Policy on patient transfer and patient referral-out to another organization

The SHCO can refer out the patient if
The medical problem is not within the scope of the services defined by the hospital
The resources do not match
A higher level of care or specialized care is required
Special investigations are required that are not available in the hospital
However, the patient shall be shifted only after first-aid is provided and the patient is stabilized.
SOP for referral-out or transfer-out
No.
Process Flow
Responsibility
Supporting Document
Transfer-out or referral-out shall be

done through OPD or through
Emergency ward.
Admission Clerk
Register
The Treating Doctor shall decide

transfer-out/referral-out and explain
the reason and plan of transfer to
the patient and relative.
Treating Doctor
Medical record
Consent for transfer-out/referral-out is

obtained from the patient and relative.
Treating Doctor
Consent
The order for transfer-out/referral-out

shall be written in the transfer-out
register with the patient's name, date,
time.
Treating Doctor
Transfer-out register
16
III. AUDIT CHECKLIST

No.
Checkpoint
Yes
i.
Availability of policy - apex manual
ii.
Availability of transfer-out form
iii.
Consent form
iv.
Staff awareness
v.
Transfer-out register/record
No
Remarks
STANDARD AAC3. PATIENTS CARED FOR BY THE SHCO UNDERGO AN ESTABLISHED INITIAL
ASSESSMENT.
Objective Elements
AAC3a. The SHCO defines the content of the assessments for inpatients and emergency patients.
AAC3b. The SHCO determines who can perform the assessments.*
AAC3c. The initial assessment for inpatients is documented within 24 hours or earlier.*
*Objective Elements AAC3b and AAC3c are self-explanatory and therefore not included in this
Guidebook.
AAC3a. The SHCO defines the content of the assessments for inpatients and emergency patients.
I. OVERVIEW
Scope: To guide the SHCO to (i) follow a uniform protocol for the initial clinical assessments of
inpatients/emergency patients requiring healthcare services; and (ii) ensure that the care provided
to each patient is based on an assessment of the patient's relevant medical needs.
i.
The SHCO have a standardized format for initial assessment for emergency and inpatient
departments.
ii. The initial assessment is standardized across the hospital or it may be modified depending
on the needs of the department.
iii. The format is designed so as to ensure that the laid-down parameters are captured.
iv. Every initial assessment contains the presenting complaint, vital signs, and salient
examination findings.
v. Time frame for initial assessment: Every patient of the hospital (IPD and Emergency
services) be appropriately assessed for her/his clinical condition based on standard norms
of medical practice. The initial assessment should be done within a specified time frame to
facilitate the early plan of care. Initial assessments and timelines should be followed for
every patient admitted.
17
Assessment by
Unstable Patient
Stable Patient
Documentation
Doctor
Immediately
Immediately
Within 24 hours of admission
Nurse
Immediately
Immediately
Within 4 hours of admission
Qualified and registered professionals perform the assessment as applicable by law:

Professional
Basic Qualification
Registration
Medical
M.B.B.S. PG in various specialties
Registered with MCI
Nursing
Diploma/Degree/Postgraduate in
Nursing
Registered with INC/State Nursing

Council
III. REQUIRED DOCUMENTS

i.
Policy and SOP on initial assessment
ii. Apex manual

Policy on initial assessment
All patients registered in the hospital will undergo an established initial assessment.
SOP on initial assessment
Initial Assessment at Emergency
Patients who come directly to the emergency department and need emergency care are received
by the staff nurse; the EMO will attend to the patient immediately.
No. Process
Responsibility
Supporting Document
All patients who come to the emergency EMO/Treating Doctor Medical record
department shall be assessed.
/Staff nurse
The following parameters shall be

assessed in detail:
l
Chief
EMO/Treating Doctor Medical record

/Staff Nurse
complaints
l
History
of illness
l
Allergies
or any associated disease
l
Temperature,
Pulse, Blood Pressure,

and Respiration
l
Physical examination
In case of mass casualties, triage shall be EMO/Treating Doctor Medical record

completed first, and then followed by
/Staff Nurse.
assessment.
18
Initial Assessment after Admission

Each patient upon admission shall be assessed by qualified individuals for appropriate care or
treatment needs or need for further assessment. The scope and intensity of the assessment shall be
determined by
l
The patient's condition/diagnosis
l
The care setting
l
The patient's response to any previous care and the patient's consent to treatment
The patient shall be assessed and the records shall be documented. Then a documented plan of care
is drawn up, based on the initial assessment.
No. Process
Responsibility
Supporting Document
Initial assessment of admitted patient

1
Initial assessment is made and

documented in medical record with
name, time, date and signature.
Treating Doctor/
Doctor on Duty
Medical record
The assessment shall include the

following parameters:
Treating Doctor
Medical record
Staff Nurse
Medical record
(This includes pregnancies with diabetes, Consultant

HTN, asthma, eclampsia, convulsions,
multiple pregnancies, elderly primi
(>30 years), bad obstetric history
(abortions)
Medical record
The assessment shall include:
Medical record
l
Temperature,
Pulse, Blood Pressure

and Respiration.
l
Physical examination.
The initial nursing assessment is done in

the prescribed format.
Assessment of obstetric and high-risk
obstetric patients
l
Weight,
height
l
BP
l
Routine
lab investigations
l
Hb, blood
group, urine (routine and

microbiological)
19
No. Process
Responsibility
Supporting Document
Treating Doctor/Staff
nurse
Medical record
nurse
Medical record
l
BT, CT
l
NST (Non-stress
l
Foetal
test)
monitoring
l
Months
of pregnancy (regularly noted

on each visit)
l
Tetanus
injections
l
2-3 ultrasounds
in whole period
(immediately after confirmation of
pregnancy, 20 week anomaly and
32 week growth scan)
l
PPTCT
counseling
l
Multidisciplinary
approach for
patients with medical disorders in
pregnancy
All patients shall be given appropriate

explanations about their conditions.
Descriptions of the following should be
shared:
l
The diagnosis
or provisional diagnosis
as applicable
l
Plan of
treatment as decided by the

treating consultant
Special needs of the vulnerable patients

who are receiving treatment will be
assessed.
IV. TASKS AND RESPONSIBILITIES

No.
Task
Responsibility
i.
Define the content of the initial assessment form
Department heads/Quality team
ii.
SOP for the initial assessment
iii.
Preparation of apex or department manual
Quality team
iv.
Staff orientation to the initial assessment
Quality team /Training cell
20
IV. AUDIT CHECKLIST

No.
Checkpoint
Yes
i.
Availability of policy
ii.
Availability of the initial assessment form
iii.
Availability of equipment like BP

apparatus, thermometer
iv.
Staff awareness
v.
Patient case record
No
Remarks
STANDARD AAC5. LABORATORY SERVICES ARE PROVIDED AS PER THE SCOPE OF THE
SHCO'S SERVICES AND LABORATORY SAFETY REQUIREMENTS.
Objective Elements
AAC5a. Scope of the laboratory services are commensurate with the services provided by the
SHCO.*
AAC5b. Procedures guide collection, identification, handling, safe transportation, processing and
disposal of specimens.
AAC5c. Laboratory results are available within a defined time frame and critical results are
intimated immediately to the concerned personnel.*
AAC5d. Laboratory personnel are trained in safe practices and are provided with appropriate safety
equipment or devices.*
* Objective Elements AAC5a, AAC5c and AAC5d are self explanatory and therefore not included in
this Guidebook
AAC5b. Procedures guide collection, identification, handling, safe transportation, processing and
disposal of specimens.
I. OVERVIEW
Scope: To guide the SHCO to prepare a department Lab Manual that incorporates all the
documented procedures for collection.
Lab Manual
i.
The SHCO has a department Lab Manual that incorporates all the documented procedures
for collection, identification, handling, safe transportation, processing and disposal of
specimens.
21
ii. The SHCO has a Lab Safety Manual that incorporates all safety aspects including the use of
PPE, disposal and discarding of specimens, biomedical waste management rules, and staff
training.
iii. The SHCO ensures the safety of the specimen till the test (and retest, if required).
iv. The SHCO ensures that a unique hospital identification number (UHID) is used for the
identification of the patient.
v. In addition, it may use another number to identify the sample.
vi. The disposal of waste is as per the statutory requirements (Bio-medical Waste
Management and Handling Rules).
vii. Reporting of critical results: critical results are those result values which require immediate
attention by the doctor/nurse failing which there is a danger of harm to the patient. The
policy for reporting such result values are as follows:
viii. All laboratory test results, which are so far from the reference range that they indicate a
potentially dangerous condition requiring immediate attention, are intimated to the
concerned Consultant immediately.
ix If the consultant is not reachable, the result is brought to the notice of the Medical Officer
on duty.
x. The concerned Ward nurse is also informed of the result if the patient has been admitted.
xi. The list of values considered as critical may be displayed at prominent locations in the lab.

The list of records or registers, and forms and formats shall be available in the laboratory.
No.
Name (Register/Format)
Responsible Person
Lab Manual
Quality team in consultation with the

Department Head-Lab
Critical Result Intimation Book
Lab Technicians
External Quality Register
Lab Technicians
Internal Quality Register
Lab Technicians
Refrigerator Temperature Register
Lab Technicians
Quality Indicator Register
Lab Technicians
List of hazardous material
Quality team in consultation with the

Department Head-Lab or HIC Team
22
Procedure
Sample Collection, Identification, Handling, and Transportation of Samples, Processing of
Samples, Disposal of Specimens
No.
Process Flow
Responsibility
Supporting Document
1.
Sample Collection
Technician
LAB Sample Book
Sample collection shall be carried out

on a 24-hour basis either in the sample
collection room or in the laboratory
2.
Sample Identification
Technician
o All samples will be labeled with the

name, age, sex, lab serial number,
and the unique ID number of the
patient.
o All samples will be accompanied by a
written requisition from the treating
doctor for lab investigation and
necessary payment (if applicable).
o The lab reception receiving the
samples will enter the details into
the register.
3.
Sample Handling
Technician
l
All samples
will be handled as per

the infection control guidelines.
l
Universal
precautions are to be
observed while handling samples.
4.
Safe Transportation of Samples
Technician
l
All measures
shall be taken in order

to prevent samples from undergoing
any deterioration.
l
Necessary
precautions shall be taken

depending on the prevailing
environmental factors.
5.
Processing of Samples
Technician
l
The processing of samples should be
carried out as per the requirements
of individual tests.
23
Procedure or Lab
Manual
No. Process
Responsibility
Supporting Document
l
The procedure
for testing should be

standardized and necessary
instructions issued to all concerned
personnel.
l
Samples
should be processed
without delay, and on a priority
basis for emergency cases.
6.
Disposal of Specimens
Technician
l
Disposal
is to be carried out in
accordance with Biomedical
Waste-Handling Rules.
l
Precautions
should be observed in
accordance with the Hospital
Infection Control Manual.

No.
Task
Responsibility
i.
Define the content of the Lab Manual
ii.
Define the content of the Lab Safety Manual

iii.
Preparation of lab related policy
Quality team
iv.
Staff orientation to the safety aspects and SOPs
Quality team/Training cell
IV. AUDIT CHECKLIST

No.
Checkpoint
Yes
i.
ii.
Availability of the required documents
iii.
Availability of equipment as per the scope
iv.
Availability of PPE
v.
Staff training record
vi.
Waste disposal management
No
24
Remarks
STANDARD AAC7. THE SHCO HAS A DEFINED DISCHARGE PROCESS.

Objective Elements
AAC7a. Process addresses discharge of all patients including medico-legal cases (MLCs) and
patients leaving against medical advice.
AAC7b. A discharge summary is given to all the patients leaving the SHCO (including patients leaving
against medical advice).*
AAC7c. Discharge summary contains the reasons for admission, significant findings,
investigations results, diagnosis, procedure performed (if any), treatment given, and the
patient's condition at the time of discharge.
AAC7d. Discharge summary contains follow-up advice, medication and other instructions in an
understandable manner.*
*Objective Elements AAC7b, and AAC7d are self-explanatory and therefore not included in this
Guidebook.
AAC7a. Process addresses discharge of all patients including medico-legal cases and patients
leaving against medical advice.
I. OVERVIEW
Scope: To guide the SHCO to develop a documented discharge process, to observe that patient care
is multidisciplinary in nature, and to encourage continuity of care through a well-defined discharge
process.
It is recommended that the discharge procedures are documented as below to ensure coordination
among various departments, including Accounts, so that the discharge papers are ready on time:
i.
For MLCs, the SHCO ensures that police are informed.
ii. Discharge planning be initiated by the Consultant on the basis of the patient's condition.
iii. The patient be assessed as 'medically stable' and fit for discharge. This may include
assessment of functional, medical, medication, and nutritional needs.
iv. The discharge summary be provided to every patient at the time of discharge.
v. A copy of the discharge summary be kept in the medical record.
vi. At the time of discharge, there should be coordination with the Billing Department.
25
vii. For MLCs, the treating Consultant should document the discharge in the case sheet, which
is then intimated to the RMO. The RMO endorses it and intimates the nearest police station
through the EMO by filling up the police intimation form.
viii. In case of death of non MLCs, the death summary should also contain the cause of death.
The body should be handed over to the relatives or shifted to the mortuary.
ix. In case of death of MLCs, the body should be shifted to the mortuary immediately. The EMO
informs the nearest police station of the death. The body is later handed over to the police
for further necessary action.
x. LEFT AGAINST MEDICAL ADVICE (LAMA)
l
Under
the scope of patient rights, no patients may be kept in hospital against their will
except in some conditions such as major psychiatric illness, intoxication, or when the
patient is in police custody.
l
The nursing staff and the doctor concerned should try to persuade the patient to stay and
at the same time try to find out why the patient wishes to leave. If possible, the problem
should be addressed.
l
The responsibility of the treating consultant is to explain the consequences of this action
to the patient or attendant, and also that if the patient leaves the hospital against
medical advice, the hospital ceases to be responsible for her/his care.
l
Despite this, if the patient still wishes to be discharged, all possible steps should be taken
to ensure the patient or authorized attendant signs a form to this effect before leaving
the hospital.
l
In the event that the patient refuses to sign the form, this should be documented clearly
in the Medical Records.

l
All discussions and risks explained should be recorded in the patient's Medical Records.
xi. The discharge summary should be prepared and handed over to the patient and a copy of
the discharge summary should be attached to the patient case sheet.
xii. At the time of discharge, the investigation results should also be handed over to the patient
and a copy should be kept by the hospital.
The discharge process should be coordinated with other departments in case the patient had
consultations with other departments.
26
Discharge Process
Treating Consultant informs Ward nurse about discharging the patient
(evening before the scheduled day of discharge)
Patient's relative informed about discharge by the Ward nurse
Final decision on discharge taken by the treating consultant
(on the scheduled day of discharge)
Check whether BPL card is

verified and seal put on
case sheet. Or that any other No
scheme beneficiary seal is
put on case sheet.
Is the patient
a paying
case?
Yes
Staff Nurse prepares

account settlement form
and hands over to patient's
relatives along with case
sheet.
Patient's relatives sent to
cash counter for final
bill settlement.
Discharge summary given

to Patient/relatives &
counseled by ward nurse.
Patient's relatives hand

over the account settled case
sheet to the ward staff nurse.
Patient send-off
Staff Nurse checks for bill settlement

by crosschecking with receipt
and case sheet. Discharge
summary given to Patient/relatives
and counseled by ward nurse.
Patient send-off
I. REQUIRED DOCUMENTS
i.
Policy on Discharge
ii. Standardized discharge summary form

iii. DAMA/LAMA form
iv. Consent form
27
Policy
The SHCO shall have a Discharge Plan which is a multidisciplinary, collaborative process involving
the patient, patient's family, and concerned team members during a specific episode of illness.
Process of discharge
No. Process
Responsibility
Supporting Document
Preparation of the contents of the

department-wise discharge summary.
Head of the
Department/ Quality
team
Discharge summary
Treating Consultant decides to discharge

the patient.
Treating Doctor
Development of a care plan for

post-discharge care.
Treating Doctor
Arranging for the provision of services,

including patient or family education.
Staff Nurse/CHD
Coordination related to discharge with

Treating/Referral
specialty Consultants if cross-consultation Doctor/Staff Nurse
was obtained.
Preparation of final discharge summary.
Treating Doctor
Preparation of account settlement form

or final bill.
Staff Nurse/Billing
section
Discharge summary handed over to the

patient along with guidance on post
discharge medication, follow-up and
information regarding how to obtain
urgent care.
Nurse
Discharge summary
A copy of the discharge summary is

attached to the patient case sheet.
Staff Nurse
Discharge summary
10
Patient is accompanied till the hospital

exit.
Ward attendant

No.
Task
Responsibility
i.
Define the discharge process
Top Management
ii.
Define the time required for each process
Top Management in consultation

or Quality team
iii.
Availability of the billing process requirements

including display of the billing tariff
Administrative department
iv.
Staff orientation to the discharge process
Quality team/Training cell
28
IV. AUDIT CHECKLIST

No.
Checkpoint
Yes
i.
ii.
Availability of required documents
iii.
Standardized discharge form

DAMA form
LAMA form
iv.
Patient records for compliance of the policy
v.
Medical Record Audit
No
Remarks
AAC7c. Discharge summary contains the reasons for admission, significant findings, investigation
results, diagnosis, procedure performed (if any), treatment given, and the patient's condition at
the time of discharge.
I. GUIDANCE NOTE
To guide the SHCO to prepare a discharge summary which includes adequate information that is
required when the patient leaves the SHCO.
After the final decision to discharge the patient is taken, the treating Consultant prepares the
discharge summary of the patient which contains the following information:
i.
Reasons for admission
ii.
Investigations performed and summarized information about the results of the

investigations
iii. Final diagnosis

iv. Record of any procedures (operations) performed
v.
Condition of the patient at the time of discharge
vi. Medication instructions

vii. Follow-up advice
viii. How to obtain emergency contact
ix. A standardized discharge summary for uniformity
x.
Departments shall prepare discharge summary forms based on the content specific to
their department
xi. In case of a death, the death summary shall also contain the cause of death
xii. Periodic medical record audits shall be conducted to ensure that the discharge summary
complies with the content requirement.
29

i.
Standardized discharge summary

No.
Task
Responsibility
i.
Define the content of discharge summary
Top Management or HOD
ii.
Preparation of policy
Quality team
iii.
Accuracy of the content of the discharge

summary
Treating doctor
iv.
Preparation of standard forms
Quality team
IV. AUDIT CHECKLIST

No.
Checkpoint
Yes
i.
ii.
Availability of required documents
iii.
Standardized discharge form

DAMA form
LAMA form
iv.
Patient records for compliance of the policy
v.
Medical Record Audit
No
V. REFERENCES
Accreditation Standards for Hospitals, NABH, 3rd Edition, November 2011.
30
Remarks
Chapter 2
CARE OF PATIENTS (COP)
STANDARD COP2. EMERGENCY SERVICES INCLUDING AMBULANCE ARE GUIDED BY
DOCUMENTED PROCEDURES AND APPLICABLE LAWS AND REGULATIONS.
Objective Elements
COP2a. Documented procedures address care of patients arriving in the emergency including
handling of medico-legal cases.
COP2b. Staff should be well versed in the care of Emergency patients in consonance with the scope
of the services of hospital.*
COP2c. Admission or discharge to home or transfer to another organization is also documented.*
*Objective Elements COP2b and COP2c are self-explanatory and therefore not included in this
Guidebook.
COP2a. Documented procedures address care of patients arriving in the emergency including
handling of medico-legal cases.
I. OVERVIEW
Scope: To guide the SHCO on the provision of uniform and appropriate care to all patients based on
acuity and patient need; and at the same time to follow all legal and patient safety requirements.
It is recommended that each SHCO be able to provide a defined standard of care to patients
presenting there, within the scope of available staff and resources. These could include SOPs or
protocols to provide either general emergency care or management of specific conditions such as
poisoning, acute abdominal pain (see http://clinicalestablishments.nic.in/En/1068downloads.aspx).
i.
The procedure for medico-legal cases (MLCs) should be in line with statutory requirements
with respect to documentation and intimation to police. The SHCO should also define what
constitutes an MLC (in accordance with statutory rules).
ii. A list of common emergencies that the SHCO has received in the last five years be prepared.
31
iii. Based on this list, the sequence of steps or procedures to be followed in each case should be
defined and documented. Staff should be trained for the same.
iv. Process to ensure safe transfer of the patient within the hospital and outside the hospital
including good referral practices should be in place
v. Staff should be aware of their roles and responsibilities in different emergency scenarios
(roles of the attendant, nurse, doctor).
vi. Some resources that may be helpful to develop such mechanisms in the hospital are
available in the References.

i.
Policy for providing services for emergency patient and in medico-legal cases.
ii. SOP for handling different emergency situations common to SHCO including initial
screening, admission, first aid, referral, DAMA/LAMA, transfer within or outside hospital,
ambulance, code blue/CPR.
iii. SOP for handling MLCs.
iv. Required registers for MLC.s

Sr. No. Task / assignment
Responsibility
Preparation of all policies and SOPs
Quality team and/or Medical

superintendent
Induction and ongoing training for emergency

department for policies and SOPs in handling
emergency patients
HR and Quality team
Induction and ongoing training for emergency

Superintendent/ Head of
department for policies and SOPs in handling MLCs hospital; EMO on duty/
Consultant on duty
Ensuring required documentation process including MO and Quality person/

maintanance of different registers for emergency
Consultant involved.
and MLCs
Audit and monitoring quality standards
Quality Team
MLC Certificates
EMO
32
IV. AUDIT CHECKLIST

Checkpoint
Yes
NO
Comments
Availability of required Policies and SOPs for

receiving, managing, transfer in ward/
discharge / referral / DAMA; for potential
emergency cases
Availability of required Policies and SOPs for
receiving, managing, transfer in ward/
discharge / referral / DAMA; for potential MLC
Processes are in place to ensure Documentation
related to MLC including MLC registers, Police
intimation and MLC certification
All resources manpower, equipment,
medications and consumables are available
24 x 7 and processes are in place to arrange for
the same in case of mass emergencies.
Doctors and staff training records
Policy
The following sample may guide the SHCO in developing its own customized document.
All patients arriving at the hospital shall be immediately assessed and managed including MLCs
irrespective of time, race, religion, gender or financial status. If the patient's condition requires
treatment that is not within the scope of the services of the hospital, the patient shall be referred or
transferred to the nearest relevant healthcare setup after primary measures are undertaken.
SOP for receiving and managing patients in emergency
Process Flow
Responsibility
Supporting Document
Any patient seeking emergency

medical services shall be screened
and first aid care and stabilizing
treatment be provided, if required.
Doctor on duty
Casualty register
{Casualty register format}
The patient must receive stabilizing

treatment within the capabilities and
resources of the HCO.
Doctor on duty and

Nurse on duty
Patient case record and

Casualty register
Should the stabilizing treatment

require a specialist physician, the
physician must be available to
respond in a timely manner.
Consultant on duty
(full time or visiting)
Patient case record/Referral

form
33
Process Flow
Responsibility
Supporting Document
The doctor on duty shall decide

whether a case is an MLC.
Doctor on duty
MLC register
All MLCs shall be notified to the

Doctor on duty and
police as per SOP following the
Nurse on duty
guidelines provided by legal authority
or MCI guidelines; that is, treatment
first and other administrative/clerical
work later, but mandatory to
document.
MLC notification book and

MLC register
If the doctor on duty concludes,

Doctor on duty
based on the results of the screening
examination, that the patient does
not have an emergency medical
condition, the patient may be treated
as OPD or referred to a specific OPD.
Casualty register - column

which states where patient
is sent after primary
treatment.
If inpatient treatment is required as

Doctor on duty
per clinical conditions, the patient
shall be transferred to the designated
ward/OT/ICU/HDU after primary
treatment.
Casualty register - column

which states where the
patient is sent after primary
treatment
Prior arrangement for availability of

bed in ward/ ICUs must be confirmed
so that the HCO can be prepared for
the arrival of the new patient.
Nurse on duty in
emergency
The copies of the emergency

Doctor and nurse on
department records are sent with the duty
patient including any test results.
Transfer record
In case there are more than two or

three patients, triaging and
prioritization for management shall
be done based on the acuity and
complexity of the clinical condition.
Such triaging is known to all on
emergency duty.
Triage record/Casualty
Register
If after stabilizing, the patient refuses

to be admitted in the hospital, and
wants a transfer to another hospital
or wants to go home, she/he should
understand the risks and benefits.
Doctor on duty
Nurse on duty
Doctor on duty
Transfer/DAMA register
Refer to AAC
If patient's clinical condition requires Doctor on duty

treatment that is not within the scope
of hospital services, arrangements
Nurse on duty
Transfer register
34
Process Flow
Responsibility
Supporting Document
shall be made to transfer out the

patient to a nearby healthcare setup
that has a scope of service which
matches the patient's needs.
Call the respective hospital to ask
Doctor on duty
about bed availability, brief staff
about the patient's condition on the
Nurse on duty
phone, and confirm whether HCO can
receive the patient.
Transfer register
Paramedical staff shall accompany

stable patients and a trained nurse/
medical officer shall accompany
unstable patients.
Doctor on duty
Nurse on duty
Transfer register
A critical patient shall not be left

unattended either inside the hospital
or while transferring to another HCO.
Doctor on duty
Transfer register
Transfer will be done in a suitable

ambulance (stable patient in general
ambulance or critical patient in
cardiac ambulance) depending on
availability.
All documentation shall be complete

in the patient record
Nurse on duty
Doctor on duty
Ambulance register
Nurse on duty
Ambulance driver/
staff of the
ambulance if the
ambulance is from
the receiving hospital.
Doctor on duty
Nurse on duty
Patient case file
List of cases that should be considered as MLC (cases may include and not be limited to):
i.
ALL suspected accidental, suicidal and homicidal cases that may include
- poisoning
- road traffic accidents
- falls from a height
- sharp-edged injuries
- near drowning
- blunt injuries
35
- fire-arm injuries
- burn injuries
ii. Sexual assault /rape
iii. Brought-dead patients
iv. When clinical findings do not correspond with history (suspected foul play)
v. Any accidental or domestic injury to any female within seven years of marriage.
SOP for handling MLC
No. Procedural steps
Responsibility
Supporting Document
All complaints and events shall be

recorded.
EMO/Nursing
Patient record/MLC
register
Each event shall be recorded in detail

including the date, time and place of the
event and involvement of person and
vehicle during the event.
EMO
Patient record/MLC
register
Each case should be intimated to the

EMO/Nursing
relevant police station by phone after
counseling the patient and relatives about
the hospital policy and procedures.
The name and buckle number with
designation of the police personnel who
has taken down the information along with
date and time shall be noted.
Patient record/MLC
register
A written intimation shall be prepared and

given to the police when they come to the
HCO or shall be sent across noting the date
and time of telephonic intimation
(the format is enclosedin Exhibit 1).
4
All MLCs after registration are to be issued

for OPD /IPD cases and should be marked
"MLC". MLC number shall be stamped on
all paper and patient records.
EMO/Nursing
Patient record/MLC
register
Clinical notes shall be entered in IPD/OPD

case paper and in an MLC form book
(in duplicate or triplicate).
EMO/Nursing
MLC book
l
Examine
the patient for all injuries. Take

a detailed history of the event. Start the
medical management as required.
Inform the concerned Consultant
accordingly; proceed further with the
necessary investigations.
36
Responsibility
l
For all
MLCs, the injury sheet must be

filled up and all columns completed.
l
While
filling the injury sheet, place

special emphases on identification
marks, who the patient was brought by,
the site of accident, name, age, sex, date,
time of arrival and detailed examination
of the injury.
l
Record
all injuries in an order starting

from top to bottom. Injuries on the scalp
are to be mentioned first and those on
toes to be mentioned last. Wound
description, type of injury, dimension,
extension, site/location according to the
nearest landmark, opinion on wound whether fresh or old -- should be
recorded in detail. Opinions on any
investigation required for the wound
should be mentioned with each wound
description.
l
All alleged
poisoning cases shall be

marked 'No External Trauma/Wound
Observed'. These cases shall be observed
carefully to rule out any external injury
or abnormal mark on the body.
l
In assault
or trauma cases, the left

thumb impression of the patient along
with two marks of identification is
mandatory to identify the patient whether conscious or unconscious.
l
Obtain
the consent of the patient and a

declaration that 'I have shown all my
injuries to the Doctor on Duty'. This is
mandatory in assault cases.
l
In all poisoning
cases, a gastric lavage

sample (20-50ml) shall be taken and
clothes of the patient preserved, sealed
and handed over to the police as soon as
possible. Till the police receive it, lavage
samples should be stored at 4 to
8 degree celsius.
37
Supporting Document
Responsibility
Supporting Document
l
No lavage sample
should be attempted
in any acid or kerosene oil poisoning or
burn case.
l
In all MLCs,
medico-legal
evidence like patient's clothes with
blood stains, stab injury, cut mark and
bullet hole marks shall be encircled,
signed by the examining doctor, and
preserved. Any foreign body recovered
from the patient after an operation, such
as a bullet, shall be sealed and handed
over to the police under receipt.
l
Clothes/weapon/gastric
lavage samples
of all MLCs should be properly
preserved, labeled and handed over to
the medical records department (MRD)
to be handed over to the police when
demanded.
l
Picture
sketches in all MLCs such as

burns, assault, trauma, shall be marked
properly and completely on the body
sketches on the reverse of the injury
sheet.
l
No information
about any document or

investigation shall be released in any
MLC unless an Authority Letter from the
patient himself on court orders, and/or a
Police Requisition Note is received.
Police requisition should pertain to
queries related to the injury sheet.
A separate register shall be maintained for Nursing

each MLC with the required data at
emergency.
Patient record/MLC
register
A counter-signature from the police station Nursing

shall be taken from the representative in a
patient's MLC form/book.
Patient record/MLC
register
The time of informing the police and time

of arrival of the police shall be entered in
the MLC form.
Patient record/MLC
register
In case the police do not arrive within 2

EMO
4 hours of the MLC report, a reminder shall
be sent asking for an acknowledgment.
Nursing
38
Patient record/MLC
register
Responsibility
Supporting Document
10
If any patient refuses to be registered as an EMO

MLC, the Medical Superintendent should be
immediately informed for a further line of
procedural action.
Patient record/MLC
register
11
All MLCs registered with the hospital shall EMO

be intimated to the consultant on duty and
the medical superintendent.
Patient record/MLC
register
12
In case of any doubt regarding registering a EMO

case as an MLC, the medical superintendent
shall be consulted.
13
If any patient registered under MLC dies

during hospitalization, postmortem is a
mandatory procedure and the patient's
body shall not be handed over to the
patient's relative but to the respective
police station in order for the postmortem
to be conducted at the district hospital.
EMO
Patient record/MLC
register
14
A case summary shall be provided to the

EMO
police at the time of handing over the dead
body for submission to the district hospital.
Patient record/MLC
register
15
When MLCs are discharged, the relevant

police station shall be notified.
EMO/Nursing
Patient record/MLC
register
16
All medico-legal discharge cases should be EMO/Nursing

registered in the same way at all stages, as
recorded at the time of admission.
Patient record/MLC
register
17
A copy of all the reports of the investigation Nursing

shall be kept in the MRD file before
discharging the patient.
Patient record/MLC
register
18
After handing over the documents and

Nursing
reports to the patient, the patient's or
relative's signature shall be obtained for the
MRD file.
Patient record/MLC
register
19
After discharge, MRD files of all MLCs shall MRD

be stored separately and be under the
control of a designated person.
Patient record/MLC
register
20
The responsible MO/Consultant shall

arrange to prepare the injury certificate
with the help of the CMO.
MRD
Pt record /MLC
register
21
MRD shall preserve a copy of the signed

certificate in the patient record.
MRD
Patient record/MLC
register
39
Responsibility
Supporting Document
22
At the time of handing over the certificate

to police, the designation and buckle
number of the police representative shall
be noted in the second copy and the
signature of the police taken.
MRD
Patient record/MLC
register
23
All MLCs shall be reported to the medical

superintendent on a monthly basis.
MRD
Patient record/MLC
register
24
The original injury certificate shall only be

issued to the police and not to the patient
or relatives.
MO/MRD
Patient record/MLC
register
Exhibit 1
Format of Intimation
To
The Police Sub-Inspector,
M.L.C. NOTIFICATION
(This form should be filled by the Doctor while admitting/discharging the patient)
Patient Name :---------------------------------------------------------------------------------------------Address:----------------------------------------------------------------------------------------------------Age:-------------------- Sex:-------------------- M/F:---------------------- UHID : --------------------Admitted on : ------------ ---at : --------------------------- IP No: ---------- MLC No.: -------------Date
Time
Patient Brought: -------------------------------------------------------------------------------------------Treating Doctors: ------------------------------------------------------------------------------------------Admitted by M. O.: ----------------------------------------------------------------------------------------Observation of injuries/History while admitted:
X- RAY/CT Scan/MRI
Date/ Time of Admission/ Discharge/Death : ------------------------------------------------
Doctor
40
STANDARD COP3. DOCUMENTED PROCEDURES DEFINE RATIONAL USE OF BLOOD AND

BLOOD PRODUCTS.
COP3 deals entirely with the rational use of blood and blood products. The emphasis is on the
rational use of blood components as far as possible instead of using whole blood. Each transfusion
should be adequately justified in order to avoid unnecessary transfusion and to reduce the risk of
transfusion-related infection such as HIV and HBsAg (World Health Organization, Safe and Rational
Clinical Use of Blood. Available at: http://www.who.int/bloodsafety/clinical_use/en/).
Objective Elements
COP3a. The transfusion services are governed by the applicable laws and regulations.*
COP3b. Informed consent is obtained for donation and transfusion of blood and blood products.*
COP3c. Procedure addresses documenting and reporting of transfusion reactions.
COP3c. Procedure addresses documenting and reporting transfusion reactions.

I. OVERVIEW
Scope: To sensitize SHCOs on the legal requirements and regulations as well as preparing all staff on
patient safety, especially the importance of informed consent, recognizing transfusion reactions,
and the importance of reporting it for further improvement.
i.
The SHCO have an SOP for blood or blood component transfusion, monitoring and
reporting any untoward reaction in the patient ranging from mild (itching, skin rash, chills,
rigor or fever) to severe (hemolysis, hemoglobinuria, acute renal failure, or death).
ii. All blood transfusion monitoring be documented in the standardized format.

iii. The SHCO ensures that any transfusion reaction is reported to the blood bank.
*Objective Elements COP3a and COP3b are self-explanatory and therefore not included in this Guidebook.
COP3a: The transfusion services shall be governed by applicable laws and regulations. The SHCO should have an MoU with
an accredited blood bank or blood storage center which follows quality practice guidelines. There should be documented
policies for obtaining blood and blood components, including at night, and on holidays, and the staff should be trained on
these. The doctor on duty shall be in charge of arranging for blood components and their safe transportatation.
Transportation should be done with cold chain maintenance and accompanied by all the relevant forms and papers to
ensure a cross-match and patient identity and safety.
COP3b: Informed consent shall be obtained for the donation and transfusion of blood and blood products. Consent should
be taken for every transfusion. However, the same consent may be used for multiple transfusions in one sitting. For
example, two pints of blood may be transfused serially using the same consent form. However, if two pints are transfused
over two days, then separate consent forms are required.
41
iv. Standards for blood bank and blood transfusion may be found in :
l
National
AIDS Control Organisation (NACO), Ministry of Health and Family Welfare,

Government of India. Standards for Blood Banks and Blood Transfusion Services.
Available at
http://www.naco.gov.in/upload/Final%20Publications/Blood%20Safety/Standards%
20for%20Blood%20Banks%20and%20Blood%20Transfusion%20Services.pdf
l
http://www.naco.gov.in/NACO/Quick_Links/Publication/Blood_Safety__Lab_Services/
Operational__Technical_guidelines_and_policies/standards_for_blood_bank/
l
NACO,
Ministry of Health and Family Welfare, Government of India, Operational and

Technical Guidelines and Policies for Blood Safety and Lab Services. Available at
http://www.naco.gov.in/NACO/Quick_Links/Publication/Blood_Safety__Lab_Service/

i.
Policy for blood transfusion services.
ii. SOPs for handling blood and blood components including acquisition, storage, transport,
blood component transfusion, and monitoring during transfusion.
iii. SOP for detecting and reporting blood transfusion reactions for improving patient safety.
iv. Legal papers and licenses and applicable MOUs, whichever is applicable as per regulation.
III. TASKS AND RESPONSIBILTIES
Responsibility
i.
Preparation of all policy and SOPs for blood and

blood component services
Blood bank officer/Pathologist/

Medical superintendent/Incharge consultant/person
ii.
Procuring or maintaining MOUs
Medical superintendent/ person

in charge
iii.
Induction and ongoing training for blood and blood Superintendent/Head of

component related policies and SOPs
hospital
iv.
Ensuring required documentation process including MO and /or Quality person/

informed consent, blood and component
Consultant involved
transfusion monitoring, blood reaction monitoring
and reporting
v.
Audit and monitoring quality standards for blood

transfusion services
Superintendent / responsible
person or consultant
42
IV. AUDIT CHECKLIST

Checkpoint
Yes
NO
Comments
Availability of required policies and SOPs for

blood and blood component transfusion
services
Availability of required documentation, MOUs
Availability of informed consent form for blood
and blood component transfusion
Blood appropriately checked as per SOP and
documented before starting the transfusion and
documented in format for monitoring
transfusion
Availability of transfusion reaction reporting
form
All human resources, equipment, and
consumables are available
Doctors and staff training records
Blood Transfusion Monitoring Chart
Note: Formats or templates can be used as per local requirement and complexity of SHCO
Patient Name
UHID
Blood Bank No.
Blood Group
Blood Unit No.
All tests - positive/negative
Blood unit checked by
Name:
Designation:
Signature:
Name:
Designation:
Signature:
Blood transfusion starting time:

Time
Pulse
BP
Respiration Rate
Blood Drop Rate/ min
O Hr
15 min
30 min
1 hr
1hr 30 min
2 hr
2 hr 30 min
Blood transfusion completion time
Post transfusion vitals
At 30 min
At 1 hr
43
Remarks
Blood transfusion monitored by: Name:
Signature
Transfusion Reaction Form

Patient Name
UHID
Blood Group
Blood Bag No.
Blood Group
Blood Bank No.

Date
Type of blood/component:
Time of issue:
Time of starting transfusion :
Time of completion:
Nature of transfusion reaction:
Sign and symptoms to BTR:
Fever: Rigors with chills,

Icterus
Pain:Site of pain
Hemoglobinuria
Allergic symptoms: Urticaria/rash/swelling

Nausea and vomiting:
Any other symptoms:
Vitals :T/pulse/BP/respiration
Samples: Blood in both EDTA and plain bulb; Urine sample (within 6 hours of suspected reaction)
Name:
Date:
Time:
Signature
STANDARD COP4. DOCUMENTED PROCEDURES GUIDE THE CARE OF PATIENTS AS PER THE
SCOPE OF SERVICES PROVIDED BY THE SHCO IN INTENSIVE CARE AND HIGH DEPENDENCY
UNITS.
Objective Elements
COP4a. Care of patients is in consonance with the documented procedures.
COP4b. Adequate staff and equipment are available.*
* Objective Element COP4b is self-explanatory and therefore not included in this Guidebook.
44
COP4a. Care of patients is in consonance with the documented procedures.

I. OVERVIEW
Scope: To instil confidence in the SHCO regarding NABH standards which can be helpful for better
patient management and satisfaction.
It is recommended that SHCOs prepare written SOPs for all possible common procedures in order to
care for High Dependency Unit (HDU) and ICU patients safely and consistently.
It is recommended that SHCOs prepare a manual for ICU and HDU which contains a list of all the dayto-day general procedures as well as special procedures within the scope of the hospital services
(cardiac/neuro/obstetric/surgical ICU):
i.
General procedures include Ryles tube insertion, IV line care, catheter care, ventilator care,
bundle care, bed sore and fall prevention, blood component therapy, total parenteral
nutrition.
ii. The structure of the SOP should be simple, easy to understand, and contain step-by-step
algorithms to illustrate care pathways. Big procedures may be split into small multiple
procedures to simplify them. For example, ventilator care may be split into preparation
before patient arrives, putting patient on ventilator (initiation), continuous monitoring,
weaning, extubation and post-extubation care.
iii. SOPs should be based on standard national or international guidelines (CDC Guidelines for
Infection Control, Critical Care Society Guidelines, 2010; AHPI, FOGSI, NACO, WHO
Guidelines) that adopt customized changes to suit local requirements of infrastructure and
feasibility.
For details, see:
l
Ministry
of Health and Family Welfare, Government of India, Standard Treatment

Guidelines, the Clinical Establishments Act, 2010. Available at
http://clinicalestablishments.nic.in/En/1068-downloads.aspx
l
CDC Guidelines for Infection Control, 2003. Available at
www.cdc.gov/ncidod/hip/enviro/guide.htm
l
Critical Care Society Guidelines, 2010. Available at
www.isccm.org/pub-icuguidelines.aspx
45
l
Royal College of Obstetricians and Gynaecologists Guidelines, 2014. Available at
https://www.rcog.org.uk/en/guidelines-research-services/guidelines/?p=5
l
FOGSI Guidelines. Available at
http://www.fogsi.org/index.php?option=com_content&view=article&id=84&Itemid=131
l
Ministry of Health, Government of India, NACO Guidelines. Available at
http://www.naco.gov.in/NACO/About_NACO/Policy__Guidelines/Policies__Guidelines1/

i.
Policy for providing critical care services for medical, surgical, pediatric, obstetrics or
neonatal patients.
ii. SOPs for holistic care of critically ill patients and their management in ICUs or HDUs.
iii. Forms and formats for informed consent, Procedure checklists, Lab or Imaging
investigations, Monitoring sheets for doctors and and nurses, Blood and blood component
transfusion.

i.
Key personnel meet and finalize the scope of critical care for different category of patients,
such as surgical, medical, neonate and pediatrics within ICU / HDU.
ii. Policy and SOPs for admission, discharge, transfer and management of patients in ICU and
HDU.
iii. SOPs for different procedures to be done within ICU / HDU.
iv. Process to ensure regular update of these SOPs as per current evidence-based practices
should be established
v. Training of all doctors, nurses and support staff regarding SOPs, clinical and administrative
processes including infection control practices.
vi. Ensuring good inventory practices for essential medications, biomedical equipment and
consumables, throughout the day, every day and throughout the year.
vii. Provision for acquiring them in case they are out of stock in an emergency.
46
IV. AUDIT CHECKLIST

Checkpoint
Yes
NO
Comments
Updated ICU / HDU Manual available to all

end-users
Manual contains all relevant SOPs
Staff is aware of all SOPs
Informed consent forms, Monitoring sheets,
and Documentation process are in place
Equipment, medications, consumables are
available as per the scope of the ICU/ HDU
services
Training record of doctors, nurses and other
relevant staff
Note: Some samples may be used as templates to develop customized SOPs.
Process Flow
Responsibility
Supporting Document
All patients in ICUs shall be admitted

as per clinical need.
ICU in charge/ Doctor Patient record/ICU register
All patients shall undergo an initial

ICU doctor and Nurse Patient case record
assessment by the ICU doctor on duty on duty
and nurse on duty.
In case of non-availability of beds, the ICU doctor and doctor ICU register/transfer
ICU doctor will find out whether any in casualty
register/patient record
settled patient can step down or any
space be created to accommodate
the new patient based on available
human and other resources.
If it is not possible, the patient shall
be transferred to another hospital as
per the transfer-out procedure.
All patients shall receive care as per
their clinical need.
Doctor on duty
Nurse on duty
Patient case record
All staff doctors, nurses and

attendants must maintain hand
hygiene as per WHO Hand Hygiene
Guidelines.
Doctor on duty
HIC manual
Nurse on duty
47
Process Flow
Responsibility
Supporting Document
All staff should follow universal

precautions while managing the
patient.
Doctor on duty
Patient record
Nurse on duty
ICU register
Staff must prevent the patient from

falls.
Doctor on duty
Nurse on duty
Patient record
ICU register
Staff must provide general nursing

care and care for the general hygiene
of the patient.
Doctor on duty
Patient record
Nurse on duty
ICU register
Doctor on duty
Patient record
Nurse on duty
ICU register
Doctor on duty
Patient record
Nurse on duty
ICU register
Doctor on duty
Patient record
Nurse on duty
ICU register
Nurse and staff must prevent bed

sores by frequently changing the
position of the patient.
Bundle care guidelines must be
followed for all IV lines, catheters,
endotracheal tubes, and other tubes.
Monitoring, patient assessment, and
treatment should be documented in
the designated format and patient
case file and ICU register.
Handing over, taking over between

Doctor on duty
shifts, and transfers to other wards
should be appropriately documented. Nurse on duty
The patient may be discharged or
stepped down to a ward as per
clinical need.
Patient record
ICU register
Doctor on duty
Patient record
Nurse on duty
ICU register
STANDARD COP5. DOCUMENTED PROCEDURES GUIDE THE CARE OF OBSTETRICAL

PATIENTS AS PER THE SCOPE OF SERVICES PROVIDED BY THE SHCO.
Objective Elements
COP5 a. The SHCO defines the scope of obstetric services.
COP5b. Obstetric patient's care includes regular antenatal check-ups, maternal nutrition, and
postnatal care.*
COP5c. The SHCO has the facilities to take care of neonates.*
*Objective Elements COP5b, and COP5c are self-explanatory and therefore not included in this
Guidebook.
48
I. OVERVIEW
Scope: To guide the SHCO on how to clearly communicate the different obstetrical services that the
SHCO can or cannot provide for pregnant women during the antenatal, intranatal and postnatal
period.
It is recommended that the SHCO:
i.
Clearly define and display the services that it can provide such as antenatal services,
intranatal and postnatal services.
ii. List the different diagnostic facilities available for this category of patients.
iii. Define and display whether it can cater to high-risk pregnancies such as eclampsia , or
medical disorder with pregnancy.
iv. Provide details on provision for termination of pregnancy and family planning services, if
applicable.

i.
Scope of services that SHCO provides to the community.
ii. Scope of services displayed in a prominent area in the OPD.
49

Responsibility
Finalize the scope of maternal services that the

SHCO can provide to community.
Gynecology HOD/ Medical

superintendent or Consultant
in-charge/Nursing head
ii
Finalize the services which will not be provided

either due to lack of human resources, expertise,
infrastructure, or other logistical problems.
Gynecology HOD/ Medical

iii.
Disseminate the scope of services to all staff

members.
HR and Gynecology department
iv.
Prepare a board to display scope of services

publicly.
Management
i.
Annual review of scope of services and amendment Gynecology HOD/ Medical

when any addition or removal is required.
IV. AUDIT CHECKLIST

No.
Checkpoint
Yes
i.
Availability of scope service policy

document, including licenses if
applicable, such as PNDT, MTP.
ii.
Bilingual display of scope of service in a

prominent area.
iii.
Staff training records
NO
Comments
STANDARD COP6. DOCUMENTED PROCEDURES GUIDE THE CARE OF PEDIATRIC PATIENTS AS PER
THE SCOPE OF SERVICES PROVIDED BY THE SHCO.
Objective Elements
COP6a. The SHCO defines the scope of its pediatric services.
COP6b. Provisions are made for special care of children by competent staff.*
COP6c. Patient assessment includes detailed nutritional growth and immunization assessment.*
COP6d. Procedure addresses identification and security measures to prevent child or neonate
abduction and abuse.
50
COP6e. The children's family members are educated about nutrition, immunization and safe
parenting.*
*Objective Elements COP6b, COP6c, COP6e, are self-explanatory and therefore not included in this
Guidebook.
COP6a. The SHCO defines the scope of its pediatric services.

I. OVERVIEW
Scope: To guide the SHCO on how to decide and communicate clearly to the community the
different pediatric services that can or cannot be provided for neonates, infants and children.
The scope of pediatric services is defined by the hospital and may include:
Pediatric/neonatal services
Immunization services
Emergency services
Child guidance clinics
Well baby clinic
Developmental clinic
Any superspecialty/subspecialty services

i. The scope of services be displayed bilingually (in English and the State language) in
prominent places.
ii. In case a change is required in the scope, the HOD Pediatrics requests the same and the MS
approves it.

Defined scope of pediatric services available within the hospital.

Sr. No. Task
Responsibility
i.
Formulate the scope of services.
HOD Pediatrics
ii.
Approval of the scope of services or its correction.
MS
iii.
Display of scope of pediatric services.
MS
51
IV. AUDIT CHECKLIST

No.
Checkpoint
Yes
i.
Defined scope of pediatric services

available.
ii.
Defined scope displayed bilingually in

prominent places.
NO
Comments
COP6d. Procedure addresses Identification and Security Measures to Prevent Child or Neonate
Abduction and Abuse.
I. OVERVIEW
Scope: To guide the SHCO on the prevention of neonate/child abductions and abuse and to ensure
proper safety for newborns and children.
i.
Hospital staff are trained and parents educated about the policy and procedures for
preventing infant and child abduction, and safety measures and precautions are taken to
prevent infant abduction and abuse. Parents are advised to supervise their children at all
times in waiting rooms and outpatient clinics.
ii. Proper security measures are taken to avoid any abduction or abuse of children in the
hospital premises by posting security guards outside each department in the hospital.
iii. Electronic surveillance in the form of CCTVs may be installed in closed areas for monitoring.
The HCO may also have a code pink protocol or SOP for the prevention of child /neonatal
abduction or abuse.
i.
Policy on Child Abduction and Abuse
ii. SOP on Child Abduction

No.
Task
Responsibility
i.
Formulate SOP/policies
Quality officer
ii.
Allocate resources for name tags, CCTV
Medical superintendent
iii.
Patient education
Nurses/Medical officers
iv.
Safety and security of NICU/PICU wards
Security personnel
v.
Code pink mock drill, corrective action, and

preventive action
Audit team
52
IV. AUDIT CHECKLIST

No.
Checkpoint
Yes
i.
Documented procedures are in place for

the prevention of child abduction and
abuse.
ii.
Procedures documented are

implemented.
iii.
Infrastructure and manpower are

provided as per the procedure.
iv.
Staff in ICU/Pediatric care are aware of

the policy and procedure.
v.
Mock drills are conducted (if code pink

is followed), deviations pointed out,
corrective and preventive actions are
undertaken.
NO
Comments
Note : Samples may be used as templates to guide the SHCO to develop customized SOPs.
No. Process Flow
Responsibility
Supporting Document
1.
Once the child is admitted, or neonate is

born, identification bands are tied.
Nurses
SOP/identification
band
2.
One parent is allowed to be with the

patient at all times or allowed to visit the
patient frequently in the ICU.
Security personnel/
Nurse
3.
Footprints of the newborn are imprinted

Nurses
on the bedside record and on the mother's
case sheet.
4.
The mother's identification tag includes

the baby's UHID and name and vice versa.
Nurses
5.
Infants are kept in direct, line-of-site

supervision at all times by an authorized
staff member and the mother.
Nurses
6.
Infants are transported only by authorized

staff along with the mother or father.
Nurses
7.
Strict vigilance is maintained for the

movement of children and infants in
NICU/PICU and that of bystanders.
Security staff
8.
Movement of unrelated/unidentified
attendants is restricted.
Security staff
53
Medical records
No. Process Flow

9.
Responsibility
Supporting Document
The hospital staff and the parents are

Audit/HRD
trained and educated about the policy and
procedures for preventing infant and child
abduction, and on safety measures and
precautions to be taken to prevent infant
abduction and abuse.
10. Code pink protocol (if defined) is checked

periodically, and corrective action and
preventive actions undertaken.
Quality team
Mock drill record
STANDARD COP7. DOCUMENTED PROCEDURES GUIDE THE ADMINISTRATION OF

ANESTHESIA.
Objective Elements
COP7a. There is a documented policy and procedure for the administration of anesthesia.
COP7b. All patients for anesthesia have a preanesthesia assessment by a qualified or trained
individual.*
COP7c. The preanesthesia assessment results in formulation of an anesthesia plan which is
documented.*
CPO7d. An immediate preoperative reevaluation is documented.*
COP7e. Informed consent for administration of anesthesia is obtained by the anesthetist.*
COP7f. Anesthesia monitoring includes regular and periodic recording of heart rate, cardiac rhythm,
respiratory rate, blood pressure, oxygen saturation, airway security, and potency and level of
anesthesia.*
COP7g. Each patient's postanesthesia status is monitored and documented.*
*Objective Elements COP7b, COP7c, COP7d, COP7e, COP7f, and COP7g are self-explanatory and
therefore not included in this Guidebook.
COP7a. There is a documented policy and procedure for the administration of anesthesia.
I. OVERVIEW
Scope: To guide the SHCO on how to develop and implement policies and SOPs related to the
administration of anesthesia with emphasis for patient safety and smooth day- to-day functioning
of OT.
54
Compliance with COP7 a is starting point and acts as guiding document in the SHCO. This element
helps to increase the capacity of the SHCO for patient safety while administering anesthesia. It also
helps the SHCO minimize adverse events and medico-legal issues.
i.
The SHCO develop policies for anesthesia services, including who can perform them (fulltime staff or visiting consultants who are qualified or trained) and when (elective or
emergency services) along with a back-up mechanism in case of non-availability of
designated individual.
ii. The SHCO develops processes for all anesthesia procedures relevant to the scope of
services of the hospital, including the preanesthetic check-up and review, immediate
preoperative assessment, different anesthesia procedures such as spinal, epidural,
regional blocks, short GA, full general anesthesia, IV deep sedation with local anesthesia,
intra-operative monitoring and documentation in a standardized format, immediate
postoperative monitoring, transferring patient to ward or ICU based on defined criteria
(that is, Aldrette criteria).
iii. There is a defined process for taking informed consent from the patient and relatives.
iv. The SHCO trains all doctors and surgical staff according to the WHO surgical safety checklist.
(WHO Surgical Safety Checklist and Implementation Manual. Available at
http://www.who.int/patientsafety/safesurgery/ss_checklist/en/)
I. REQUIRED DOCUMENTS
i.
Policy for providing safe anesthesia services within the SHCO.
ii. SOPs for handling day-to-day functioning and providing anesthesia services.
iii. SOPs for elective and emergency surgeries.
iv. SOPs to handle a potential situation where the patient needs to be referred for further
management.
v. SOPs for postanesthesia status monitoring.
vi. Informed consent formats.
vii. Formats for preanesthesia assessment, immediate preoperative re-evaluation, monitoring
during and after anesthesia.
viii. WHO surgical safety checklist (anesthesia related component)
55

No.
Task
Responsibility
i.
Develop a policy for anesthesia services
Management
ii.
Appoint or make available anesthetists and teams as per

the policy
HR / Superintendent/
Head of SHCO
iii.
Develop SOPs for different anesthesia-related activities
Anesthetist, OT nurse,
Quality team/ designated
person
iv.
Training related to these SOPs is provided for all

stakeholders
HR/Quality team
/Consultant in-charge
v.
Day-to-day activity and documentation
Anesthetist/OT nurse
vi.
Regular documentation audit for adherence to SOPs
Quality team/
designated person /
Consultant in-charge
IV. AUDIT CHECKLIST

Policy and SOPs for anesthesia services are available
Further, to check the implementation of the service the following can be helpful:
No.
Checkpoint
Yes
i.
Policy and SOPs for anesthesia services

are available
ii.
PAC documented
iii.
Transfer checklist from ward to OT filled

appropriately
iv.
Informed Consent documentation obtained
v.
Immediate preoperative assessment of

patient done
vi.
Anesthesia plan confirmed
vii.
All medication and procedure

documented for induction of anesthesia
viii.
Intraoperative monitoring chart

documented
ix.
Postoperative monitoring done
x.
Patient has obtained the discharge

criteria before being shifted
xi.
Appropriate handover of patient to

receiving department/ward/ICU is
documented
56
NO
Comments
STANDARD COP8. DOCUMENTED PROCEDURES GUIDE THE CARE OF PATIENTS

UNDERGOING SURGICAL PROCEDURES.
Objective Elements
COP8a. Surgical patients have a preoperative assessment and a provisional diagnosis documented
prior to surgery.*
COP8b. Informed consent is obtained by a surgeon prior to the procedure.*
COP8c. Documented procedures address the prevention of adverse events like wrong site, wrong
patient, and wrong surgery.
COP8d. Qualified persons are permitted to perform the procedures that they are entitled to
perform.*
COP8e. The operating surgeon documents the operative notes and postoperative plan of care.*
COP8f. The operation theatre is adequately equipped and monitored for infection control
practices.*
*Objective Elements COP8a, COP8b, COP8d, COP8e, and COP8f are self-explanatory and therefore
not included in this Guidebook.
COP8c. Documented procedure addresses the prevention of adverse events like wrong site,
wrong patient and wrong surgery.
I. OVERVIEW
Scope: To guide the SHCO to develop and implement policies and SOPs for conducting safe surgical
procedures and preventing potential adverse events.
i.
Personnel involved in care of surgical patients take all necessary measures to reduce the risk
of occurrence of adverse events in surgical patients. Refer to:
WHO, Surgical Safety Checklist and Implementation Manual. Available at
http://www.who.int/patientsafety/safesurgery/ss_checklist/en/
WHO, Safe Surgery. Available at
http://www.who.int/patientsafety/safesurgery/en/
WHO, Tools and Resources on Patient Safety. Available at
http://www.who.int/patientsafety/safesurgery/tools_resources/en/
57
ii. The SHCO has SOPs to implement and demonstrate methods to prevent adverse surgical
events such as identification tags, badges, and cross-checks.
iii. All personnel follow site- and side-marking procedures uniformly, and regularly check the
same.
iv. All stakeholders follow the checklist at preoperative ward level, checklist for receiving the
patient in the immediate preoperative area, and the checklist before the patient is taken
onto the table, along with the surgical safety checklists before induction of anesthesia,
before incision, and at the end of the surgery.
v. Proper coordination takes place between ward/ICU staff, OT staff, medical officers,
anesthesiologist and consultant surgeon.
vi. Patient participation during the checklist process could help reduce adverse events and
near-misses.
vii. Any adverse event with a surgical patient be reported to hospital management and to the
concerned people. These committees do a root-cause analysis and take appropriate
preventive measures to prevent the occurrence of a similar event in the future.

i.
SHCO policy to provide safe surgical services.
ii. SOPs for surgical services including informed consent process, wheel-in, execution of
surgery, infection control practices, and safe hand over of the patient.
iii. WHO surgical safety checklist format.
iv. Incident report form in case of any event.

No.
Task
Responsibility
i.
Adopt WHO surgical safety checklist and customize it for

local use; prepare other checklist formats for shifting
patient from ward to OT; SOPs for patient identification
and side- and site- marking.
Surgical head/
Anesthetist/ Nurse incharge
ii.
Disseminate the checklist to all stakeholders.
HR/Quality team /
designated Consultant/
person
iii.
Audit of adherence to real-time usage of these checklists. Quality team /

person
iv.
Reorientation or refresher training for the same.
Quality team /
person
58
IV. AUDIT CHECKLIST

No.
Checkpoint
Yes
i.
SOP in place to implement surgical safety

checklist
ii.
Training record of doctors and staff
iii.
All steps taken in order to identify the

patient before wheel-in (transfer from
Ward to OT)
iv.
All steps taken by Anesthetist and

Circulating nurse before the induction of
anesthesia (sign-in)
v.
All steps of the surgical checklist are

followed before skin incision (time-out)
vi.
All steps of the surgical checklist are

followed before sign out (sign-out).
NO
Comments
Checklist for real-time documentation of surgical safety

Note: Some samples could be useful as templates to create customized SOPs.
SOP to prevent wrong site, wrong patient, and wrong surgery
No. Process Flow
1.
Scheduling: The following information is a Primary Nurse and

must when scheduling an invasive/surgical Surgical team
procedure:
l
Correct
Supporting Document
OT list, Consent form
spelling of the patient's full name
l
Inpatient
l
Consent
2.
Responsibility
number
for procedure to be performed
Preprocedure/preoperative verification
Physician and
Surgical safety
The physician and anesthetist shall verify

the patient's identity by asking
Anesthetist
checklist
l
Patient's
full name and compare with ID
band
l
Procedure
or surgery to be performed
If the patient is a minor, incompetent, sedated,

or not able to speak, the information should
be obtained from a blood-relative or legal
guardian.
59
No. Process Flow
Responsibility
3.
Physician and
Surgical safety
Anesthetist,
checklist
Primary Nurse,
OR Nurse/Registrar
Site mark: This should be completed before

the patient enters the procedure or
operating room. The site-mark is required
in invasive or surgical procedures that
involve
l
Laterality
Supporting Document
(for example, right, left)
l
Multiple
structures (for example, toes,

fingers, limbs)
l
Multiple
levels (for example, spine)
This includes bedside invasive procedures.

4.
Before making the site-mark, the

Physician and
Consultant performing the procedure or
Anesthetist
surgery verifies the patient's identity and
medical records. In the case of a minor, the
verification process must involve parents or
the legal guardian.
5.
There should be standardized marking for

all procedures (for example, SS surgical site). The marker should be
hypo-allergenic, latex-free, and sterile.
The marking should be clear and
unambiguous.
6.
The site-mark should not be removed until Physician and

the procedure is over.
Anesthetist,
OR Nurse/Doctor
7.
Time-out procedure:
Infection Control
Nurse, OR Nurse/
Doctor
OR Nurse
Time-out is required to confirm the

following:
8.
l
Correct
patient
l
Correct
side or site
l
Correct
procedure
l
Correct
patient position
l
Correct
radiographs
l
Correct
implants and equipment
Surgical safety
checklist
A verbal time-out or pause is called by the

OR Nurse or Registrar immediately before
the procedure or surgery in the operating
room or procedure room.
OR Nurse/Doctor
60
Surgical safety
checklist
No. Process Flow

9.
Responsibility
Supporting Document
The patient doses not have to be awake for OR Nurse/Doctor

the time-out. Site-marking must be visible
at time-out or pause.
10. As soon as the patient enters the operating OR Nurse/Doctor

or procedure room, the OR Nurse/Registrar
assigned to call time-out will call for a
pause and loudly call the full name of the
patient, inpatient number, procedure
name, and site.
11. The Scrub Nurse, Anesthetist, and Surgeon Physician and
will say 'yes' to all the details. The time-out Anaesthetist,
will be documented in the medical records. OR Nurse/Doctor
It should include
l
Personnel
Surgical safety
checklist
present at the time-out
l
Verification
of correct patient
l
Verification
of correct side and site
l
Agreement
on the procedure/verification
of radiographs
l
Verification
l
Available
of the correct position
implants and equipment
12. Discrepancies
Physician and
If any discrepancy is found at any point,

Anesthetist,
the case must not proceed until completely OR Nurse/Registrar
resolved.
13. All team members and the patient
(if possible) must agree on the resolution
of the identified discrepancy. The attending
Consultant in the patient's medical records
must document the discrepancy and its
resolution.
Attending
Consultant
(Physician and
Anesthetist)
V. REFERENCES
Resources for SOPs and formats taken from H. M. Patel Center for Medical Care and Education;
and NABH Standards for Hospitals (3rd Edition), November 2011.
CDC Guidelines for Infection Control. Available at
http://www.cdc.gov/HAI/prevent/prevent_pubs.html.
FOGSI Guidelines. Available at
http://www.fogsi.org/index.php?option=com_content&view=article&id=84&Itemid=131
61
Gautam Biswas, Recent Advances in Forensic Medicine and Toxicology, Jaypee Brothers, 2015.
Jagdish Singh, Medical Negligence and Compensation, Bharat Law Publishers, 2014.
Medico-legal Forms and Formats, Kerala Medico-Legal Society. Available at
https://sites.google.com/site/keralamedicolegalsociety/medico-legal-certificates
Ministry of Health and Family Welfare Acts, Government of India. Available at
http://www.mohfw.nic.in/index1.php?page=1&ipp=50&lang=1&level=2&sublinkid=2526&lid=18
10
Ministry of Health and Family Welfare, Government of India, Guidelines and Protocols: Medicolegal Care for Survivors/Victims of Sexual Violence. Available at
http://www.mohfw.nic.in/WriteReadData/l892s/9535223249GuidelinesandProtocolsorsexualvio
lence_MOHFWf.pdf
Ministry of Health and Family Welfare, Government of India, Standard Treatment Guidelines, the
Clinical Establishments Act 2010. Available at
http://clinicalestablishments.nic.in/En/1068-downloads.aspx
Ministry of Health, Government of India, NACO Guidelines. Available at
http://www.naco.gov.in/NACO/About_NACO/Policy__Guidelines/Policies__Guidelines1/
NACO, Ministry of Health and Family Welfare, Government of India, Operational and Technical
Guidelines and Policies for Blood Safety and Lab Services. Available at
http://www.naco.gov.in/NACO/Quick_Links/Publication/Blood_Safety__Lab_Services/
NACO, Ministry of Health and Family Welfare, Government of India. Standards for Blood Banks
and Blood Transfusion Services. Available at
http://www.naco.gov.in/upload/Final%20Publications/Blood%20Safety/Standards%20for%20Blo
od%20Banks%20and%20Blood%20Transfusion%20Services.pdf
Royal College of Obstetricians and Gynaecologists Guidelines. Available at
https://www.rcog.org.uk/guidelines
Satish Tiwari, Textbook on Medico-legal Issues, Jaypee Brothers, 2012.
Society of Critical Care Medicine Guidelines. Available at
http://www.learnicu.org/pages/guidelines.aspx
WHO, Surgical Safety Checklist and Implementation Manual. Available at
http://www.who.int/patientsafety/safesurgery/ss_checklist/en/
WHO, Safe Surgery. Available at
http://www.who.int/patientsafety/safesurgery/en/
WHO, Tools and Resources on Patient Safety. Available at
http://www.who.int/patientsafety/safesurgery/tools_resources/en/
WHO, Safe and Rational Clinical Use of Blood. Available at
http://www.who.int/bloodsafety/clinical_use/en/
62
Chapter 3
MANAGEMENT OF MEDICATION (MOM)
STANDARD MOM1. DOCUMENTED PROCEDURES GUIDE THE ORGANIZATION OF
PHARMACY SERVICES AND USAGE OF MEDICATION.
Objective Elements
MOM1a. Documented procedures incorporate purchase, storage, prescription, and dispensation
of medications.
MOM1b. These comply with the applicable laws and regulations.*
MOM1c. Sound alike and look alike medications are stored separately.*
MOM1d. Medications beyond the expiry date are not stored or used.*
MOM1e. Documented procedures address procurement and usage of implantable prosthesis.
*Objective Elements MOM1b, MOM1c, and MOM1d are self-exlanatory and therefore not
included in this Guidebook.
MOM1a. Documented procedure shall incorporate purchase, storage, prescription and
dispensation of medications.
I. OVERVIEW
Scope: To guide the SHCO on procedures to be followed for purchase, storage, prescription and
dispensation of drugs in a safe manner and to avoid medication errors.
i. There is a defined process for the acquisition of medications as per the defined list of the
SHCO. A list of vendors is selected by the SHCO depending on their reputation.
ii. Medications are ordered according to the defined reorder level proposed by the SHCO.
iii. Medications are stored in a clean and safe environment as recommended by the
manufacturer.
iv. There are some medicines which"look alike", for example, Adrenaline and Atropine. There
are some medicines which"sound alike", for example, Levoflox and Levocet, Depomedrol
63
and Solumedrol. These types of medications are called "Look-alike Sound-alike"medicines

or LASA medicines (see Annexure). The hospital should consider making special
arrangements for storage of these medications (for example, making a list, educating staff,
and labelling LASA medicines with the help of stickers and avoiding keeping them
together).
v. All prescriptions be written by registered medical practitioners.
vi. All prescriptions have the patient's name, admission number, drug name (generic names
written in full), strength and quantity, dosage, treatment duration, that is, days, weeks, or
months, doctor's signature, and date.
vii. Dispensation of medication should be done in a safe manner that ensures quick and
efficient patient care and minimizes errors.
viii.In case of government hospitals, the purchase is usually done by the department or
medical services corporation.

i. Procedure for Purchase
ii. Procedure for Storage
iii. Procedure for Prescription
iv. Procedure for Dispensing
Each hospital can decide on its process depending on the scope of services, work flow and patient
load. Given below are some examples of procedures. Keeping this framework in mind, SHCOs may
modify it according to their requirement.
64
SOP on Procurement of Medication

No.
Procedure
Responsibility
1.
A list of medications used regularly in the SHCO is

maintained.
Pharmacy in-charge
2.
The stock of medicines is checked every morning.
Pharmacy staff
3.
If stock is less than minimum stock level, an order

note is raised.
Pharmacy staff
4.
The order note contains the following:
HOD/staff
i.
Name of the item
ii. Quantity of the item

iii. Order date
iv. Name of the company
v.
Last order date
vi. Present stock

5.
Once the order note is written, the signature

from the person in-charge, and person ordering is
obtained.
Pharmacy/Purchase in-charge
6.
The order is placed with different stockists or

company representatives over the phone according
to the order note.
7.
Items are received from the stockist as per the

agreed turnaround time.
8.
Items are checked according to the bill and the order

note.
Pharmacy/Purchase staff
9.
Quantities, batch number, expiry date, any breakage

of items are checked before accepting from the
stockist or company representatives.
65
No.
Procedure
Responsibility
10.
A copy of the order note along with the bill is sent

to the Accounts department after getting the
signature of the person in charge.
11.
Payment is made by the Accounts department.
Accounts department
Procedure of Storage of Medication

No.
Procedure
Responsibility
1.
Medications are stored in the pharmacy or in the

Ward or OT stocks (at the point of care).
Pharmacy in-charge and

person in-charge of the
patient care area
2.
Only authorized staff are allowed access to the

stored medication.
Pharmacy staff,
Nursing staff in patient care
areas
3.
The area is clean and well-ventilated.
Pharmacy staff, Housekeeping
4.
The medications are protected from direct sunlight

and the ambient temperature is maintained as per
the manufacturer's specification.

person in charge of the
patient care area
5.
Medications with "cold chain" requirements are

kept in the refrigerator.
Temperature is monitored at least once every shift.

patient care area
6.
LASA medications are identified
Pharmacy in-charge
7.
Individual LASA medications are stored with a

separation between the items in each of the
LASA pairs.

patient care area
8.
Medications are checked every month to identify

those due to expire within the next one/two/three
months.

patient care area
9.
The near-expiry items are returned to the vendor

for exchange.
Pharmacy in-charge
Note:For a list of High-Risk Medications, refer to Annexure.
66
Procedure of Prescription of Medication
No.
Procedure
Responsibility
1.
Registered doctors are authorized to prescribe

medications in the SHCO.
Medical Professionals
(Consultants/ Residents/Medical
Officers)
2.
The prescription will contain the type of

preparation, name of the drug, dose, route of
administration, frequency, and duration of usage.
Officers)
3.
Medication orders are written clearly and legibly

in capitals, dated, timed, signed, and named.
Officers)
4.
Medication orders are written only in the

designated locations in the medical record.
Officers)
5.
A list of high-risk medications used in the hospital

is maintained.
Pharmacy in-charge with inputs

from the consultants
SOPs on Dispensing Medication

No.
Procedure
Responsibility
1.
Dispensing of medication is done by a qualified

pharmacist
Pharmacist
2.
The pharmacist cross-verifies the medication with

the prescription prior to dispensing it with double
verification for high-risk medication.
Pharmacist
3.
As per prescription, the correct drug and its expiry

date are checked by the pharmacist.
Pharmacist
67

No.
Tasks
Responsibility
i.
Define list of medications used in the SHCO
Pharmacist/Doctors
ii.
List approved vendors
Purchase/Pharmacist
iii.
Storage conditions of medications
Management/Quality
team/Pharmacist
iv.
Prescription Format
Quality
team/Pharmacist/Doctors
v.
Applicable Policies and SOPs
Quality team/
Pharmacists/Doctors/ Nurse
IV. AUDIT CHECKLIST

No.
Checkpoint
Yes
i.
List of medications used in the SHCO
ii.
Monitoring of storage conditions
iii.
Prescription with patient's name, admission

number, dosage, written in capitals, doctor's
signature, and State Medical Council registration
No
Remarks
MOM1e. Documented procedures address procurement and usage of implantable prosthesis.

I. OVERVIEW
Scope: To guide the SHCO on how to define the policy and procedure on procurement and usage of
implan table prosthesis.
i.
Medical implants are devices or tissues that are placed inside or on the surface of the
body. Many implants are prosthetics, intended to replace missing body parts. Other
implants deliver medication, monitor body functions, or provide support to organs and
tissues.
68
ii.
Some implants are made from skin, bone or other body tissues. Others are made from
metal, plastic, ceramic or other materials.
iii.
Implants can be placed permanently or they can be removed once they are no longer
needed. For example, stents or hip implants are intended to be permanent. But
chemotherapy ports or screws to repair broken bones can be removed when they are no
longer needed. The risks of medical implants include surgical risks during placement or
removal, infection, and implant failure. Some people also have reactions to the materials
used in implants.
iv.
The selection of implants is based on scientific criteria that are recognized nationally and
internationally. The primary selection of implants is done by the consultants.
v.
Implantable prostheses are procured either on a consignment basis or with a regular

order.
vi.
Once the implants are procured, they are stored in the General Stores/OT Stores/Trauma
OT Store/Pharmacy; whenever the stock level reaches the reorder level, a purchase
order is placed and stock procured. Stocks are stored as per the manufacturer's
recommendations.
vii. Ophthalmological implants such as IOLs are stored in the pharmacy and should be
procured against a written prescription order.
viii. The patient and/or family members are counseled before the usage of a particular
implant and urged to report any adverse situation that may arise following implantation.
II
ix.
The batch and serial numbers of the implants used are recorded in the master file and
patient record.
x.
All standard precautionary measures in terms of sterilization should be adhered to.
REQUIRED DOCUMENTS
Note: The following is a sample list of documents which may be modified by the hospital according
to its function.
No.
Procedure
Responsibility
1.
A list of implants that are used in the SHCO is

maintained.
Purchase/Pharmacy in-charge
2.
Evidence-based medicine supports the usage of

the implant.
Clinician using the implant

3.
Implants which are used frequently are stored in

the hospital.
69
No.
Procedure
Responsibility
4.
The following information is recorded in the

order note: Name of the item
Quantity of the item
Order date
Name of the company
Last order date
Present stock
HOD/staff
5.
Once the order note is written, signatures are

obtained from the in-charge and the person
ordering
6.
Order for items is placed with different

stockists or company representatives
over the phone as per the order note
7.
Items are received from the stockist as per agreed

TAT
8.
Items are checked according to the bill and the order

note
9.
Quantities, batch number, expiry date, any breakage,

relating to all the items are checked before accepting
from the stockist or company representatives
10.
A copy of the order note along with the bill is sent

to the Accounts department after getting the
signature of the person in charge
11.
Payment is made by the Accounts department
Accounts Department
12.
Implants are supplied to the point of care

on request
Pharmacy/ Store
13.
Implant details such as name, model, lot and batch

number, expiry date, size (label in the pack) are
recorded in the medical record and pharmacy
OT staff
Pharmacy staff
70

No.
Task
Responsibility
i.
Select Implant
Treating Doctor
ii.
List approved vendors
Pharmacy/ Stores
iii.
Check availability of the implant
Stores
iv.
Check supply to the OT
Stores
v.
Verify implant as per selected implant
OT Staff
IV. AUDIT CHECKLIST

No.
Checkpoint
Yes
i.
List of implants
ii.
Usage of implants
iii.
Evidence of documentation of usage of implants
No
Remarks
Standard MOM2. Documented procedures guide the prescription of medications.

Objective Elements
MOM2a. The SHCO determines who can write orders.*
MOM2b. Orders are written in a uniform location in the medical records.*
MOM2c. Medication orders are clear, legible, dated and signed.*
MOM2d. The SHCO defines a list of high-risk medication and process to prescribe them.
*Objective Elements MOM2a, MOM2b, and MOM2c are self-explanatory and therefore not
MOM2d. The SHCO defines a list of high-risk medication and process to prescribe them.
71
I. OVERVIEW
Scope: To guide the SHCO on how to define the list of high-risk medications and the process to
prescribe them in order to ensure patient safety.
There are many medicines which have low therapeutic index. An error in prescribing these
medicines may result in catastrophy. These medicines are called 'high-risk medicines'. Examples of
high-risk medicines are muscle relaxants, sedatives, electrolyte solutions. The SHCO should make a
list of high-risk medicines and educate its staff regarding their usage. As added caution, the SHCO
may consider labelling the high-risk medicines, keeping them seperately, and avoiding verbal orders
for the medicines.
i.
The SCHO prepare a list of high-risk medications used in the SHCO. This list should be made
known to all staff (nursing/pharmacists/doctors). The medications should be doubly
checked before dispensing as well as during administration. (The list of high-risk
medicines may be prepared as per the Annexure in the Institute for Safe Medication
Practices (ISMP) list.)
ii. All high-risk medications be adequately labelled.

iii. Antidotes for these drugs be made available. No verbal orders should be followed for highrisk medications.

List of high-risk medicines are available in the Annexure.
No.
Tasks
Responsibility
i.
Draw up a list of high-risk medications used in

the hospital
Pharmacist/Doctors
ii.
Define the storage and usage precautions or

identifiers for high-risk medications
Management/Pharmacists/
Doctors
iii.
Availability of antidotes for high-risk medication,

if available
Management/Pharmacist
72
IV. AUDIT CHECKLIST

No.
Checkpoint
Yes
i.
List of high-risk medications
ii.
Identifiers for high-risk medications
No
Remarks
V. REFERENCES
de Vries, T.P.G.M., R. H. Henning, H. V. Hogerzeil and D. A. Fresle, A Guide to Good Prescription,
World Health Organization Action Programme on Essential Drugs, Geneva, 1994.
General Medical Council (GMC), 2013. Good Practice in Prescribing and Managing Medicines and
Devices. Available at
http://www.gmc-uk.org/Good_practice_in_prescribing.pdf_58834768.pdf
Institute for Safe Medication Practices, 4th April 2013. ISMP's List of High-Alert Medications. ISMP
Medication Safety Alert.
WHO, 2003.Guidelines for the Storage of Essential Medicines and Other Health Commodities.
Available at
http://apps.who.int/medicinedocs/en/d/Js4885e/
ANNEXURES
1.
List of high-alert medications. Available at

https://www.ismp.org/tools/highalertmedications.pdf
2.
List of look-alike sound-alike (LASA) medications. Available at

https://www.ismp.org/tools/confuseddrugnames.pdf
73
Chapter 4
HOSPITAL INFECTION CONTROL (HIC)
STANDARD HIC1. THE SHCO HAS AN INFECTION CONTROL MANUAL WHICH IT
PERIODICALLY UPDATES; THE SHCO CONDUCTS SURVEILLANCE ACTIVITIES*.
Objective Elements
HIC1a. It focuses on adherence to standard precautions at all times.
HIC1b. Cleanliness and general hygiene of facilities will be maintained and monitored.
HIC1c. Cleaning and disinfection practices are defined and monitored as appropriate.
HIC1d. Equipment cleaning, disinfection and sterilization practices are included.
HIC1e. Laundry and linen management processes are also included.
*A sample Hospital Infection Control (HIC) manual has been included as an annexure in the soft
copy of this document. It addresses all the objective elements listed above. Hence, limited details
on the HIC manual are provided in this chapter.
I. OVERVIEW
Scope: To guide both staff and patients in the SHCO on the standard precautions to be followed in
order to:
i.
Reduce and prevent the incidence of hospital acquired infections in the SHCO.
ii. Identify high-risk areas where active surveillance should be practiced in an SHCO so as to
reduce the rate of infections.
iii. Develop policies and procedures for standards of cleanliness, sanitation, and asepsis in the
SHCO.
Hospital Infection Control (HIC) Manual
It is recommended that the SHCO have an HIC Manual on standard precautions that staff should
follow to prevent patients from acquiring infections within the SHCO.
It is recommended that the HIC Manual:
i.
Explains to staff the standard precautions and the universal precautions that should be
ideally practiced in the SHCO.
ii. Focuses on the importance of hand hygiene as this is one of the root causes for all hospital
acquired infections.
iii. Provides guidelines for the care to be taken in high-risk areas like OT (Operation
Theatre), CSSD (Central Sterile Supply Department), and ICU (Intensive Care Unit).
74
iv. Defines the protocol to be followed in case of a needle-stick injury to any staff.
v. Defines the colour coding for biomedical waste segregation which should be as per the
State regulations or as per statutory regulations.
vi. Enlists the conditions to be followed by the SHCO for isolation practices.
vii. Lists the standard cleaning, disinfection and sterilization practices to be followed in the
HCO to prevent infections.
viii. Outlines the precautions and the methodology to be followed in case of spills.
ix. Lists the standard housekeeping practices to be practiced by the SHCO.
x
Lists the standard laundry and linen management processes.
xi. Lists the hygiene practices to be followed in the kitchen of the SHCO.
xii. Defines conditions that will help SHCOs to identify an outbreak and the measures that need
to be followed in case of an outbreak.
No.
Name (Register/Format)
Responsible Person
i.
HIC Manual
Person designated for HIC activities along

with a dedicated doctor

No.
Task
Responsibility
i.
Define the content of the HIC Manual Clinical Department Heads along with
designated HIC staff
ii.
Staff orientation to infection control

practices and procedures
Designated HIC staff
IV. AUDIT CHECKLIST

No.
Checkpoint
Yes
i.
Availability of the Manual
ii.
Availability of designated staff for HIC

activities
iii.
Availability of adequate PPE
iv.
Staff training record
No
75
Remarks
Chapter 5
CONTINUOUS QUALITY IMPROVEMENT (CQI)
STANDARD CQI2. THE SHCO IDENTIFIES KEY INDICATORS TO MONITOR THE STRUCTURES,
PROCESSES, AND OUTCOMES WHICH ARE USED AS TOOLS FOR CONTINUOUS
IMPROVEMENT.
Objective Elements
CQI2a. The SHCO identifies the appropriate key performance indicators in both clinical and
managerial areas.
CQI2b. These indicators shall be monitored.*
*Objective Element CQI2b is self-explanatory and therefore not included in this Guidebook.
CQI2a. The SHCO identifies the appropriate key performance indicators in both clinical and
managerial areas.
I. OVERVIEW
Scope: To guide the SHCO on how to measure the performance of an SHCO by indicators that
represent the functioning of various services, personnel, and departments.
There are three dimensions of quality, namely, Structures, Processes and Outcomes. Examples of
Structures are infrastructure, number of nurses available, number of doctors available, availability
of biomedical equipment. Examples of Processes include hand washing, administration of
medications, reporting of X-Ray. Examples of Outcomes include Surgical Site Infection Rate,
Patient Satisfaction Index, number of falls in the hospital.
If Structures and Processes are good, the Outcomes will consequently also be good. For example, to
ensure quality care in the ER, the Structures necessary are availability of doctors and nurses,
availability of equipment and medicines. For Processes, the doctors and nurses should provide the
correct treatment using standard treatment guidelines and protocols. The presence of Structures
alone does not ensure quality. If both Structures and Processes are appropriate, they will lead to
good Outcomes.
When we want to measure quality, we may measure either the structure, process or outcome. If we
measure outcome, indirectly we are measuring both structure and process. But if we are measuring
either structure or process, it is uncertain whether good outcomes will be achieved. For example, if
76
we measure percentage of beds with hand sanitizer available by the bedside, it does not give us any
idea of how often it is used. If we are measuring a process, for example, compliance with hand
washing, we know that is an important component to control hospital-acquired infection, but we
are still uncertain whether the hospital-acquired infection rate is low. If we measure surgical site
infection rate, which is an outcome of several structures and processes, we are indirectly measuring
structures and processes. Therefore, if the surgical site infection rate has gone up, we need to look
into individual structures and processes that contribute to the outcome. For example, we may look
into factors such as whether antibiotic prophylaxis was given half an hour before surgery (process),
presence of hand wash facilities in the surgical ward (structure), proper OT air conditioning
(structure), and availability of sterile equipment (structure).
To summarize, we may measure quality by measuring structure, process or outcome by using Key
Performance Indicators (KPI). KPIs are indicators that help to objectively discern the functioning of a
particular process or a system. As the health system is very complex with multiple stakeholders
playing a key role in any process, it is very difficult to determine the performance of a process unless
an indicator which is measurable is developed. For example, if a doctor is asked about the
medication errors in his workplace, he may accept that medication errors do happen, but he will not
be able to identify the nature of medication errors and the measures to be taken to decrease them.
If the number of medication errors are captured as an indicator, they may be classified and a rootcause analysis conducted to decrease the number of medication errors. Some indicators such as the
time taken for the initial assessment, surgical site infection rate, catheter-associated urinary tract
infection rate, are clinical indicators which are directly related to clinicians, which include doctors
and nurses. There are other indicators that are directly related to hospital administration, such as
the number of emergency medicines which are out of stock.

The SHCO may choose some indicators from the list of indicators found in NABH Accreditation
Standards, third edition, November 2011.
i.
SOP for Collection and Analysis of KPI

Each SHCO can create its own indicators but listed below are some examples of Key
Performance Indicators. There is no rule on the number of indicators an SHCO should have,
but it is usual to start with three to four clinical and non-clinical indicators. As the SHCO
moves forward in its quality journey, it needs to identify many more indicators. For
example, a fully accredited NABH hospital is expected to capture at least 64 indicators (as
per NABH Accreditation Standards, third edition). Some examples of Key Performance
Indicators are.
l
Clinical:
mortality rate, percentage of cases where preoperative antibiotic was given,

incidence of catheter-associated UTI, number of surgical site infections, number of
errors in reporting of Lab investigations.
l
Nonclinical:
OPD waiting time, patient satisfaction rate, number of stock outs of

emergency medications, number of errors in billing.
77
SOP for Collection and Analysis of KPI

Process
Responsibility
Identification of quality team (members from various

areas of an SHCO who are motivated to work towards
quality improvement)
Administration
1.
Identification of KPI
Quality team/Administration
2.
Identification of personnel to collect the data
Quality team
3.
Data collection format to be defined for each of the

identified KPI
Quality team
4.
Periodicity of collection and review to be defined
Quality team and administration
5.
Collection of data using standardized format

identified by the Quality team
Quality team/personnel
6.
Verification and validation of data
Quality team
7.
Analysis of data
stakeholders
Quality team with the
8.
Identification of variation in trends
Quality team
9.
Root-cause analysis and corrective and preventive

action taken wherever necessary (in case of negative
trends or worsening of performance)
Quality team and stakeholders
10. Review of the KPI
Administration, Quality team

and stakeholders
11. Inclusion of new KPI

team
Administration and Quality
78
No.
Tasks
Responsibility
i.
Form a Quality team with representation from

various key areas
Top management
ii.
Identify KPI
Departmental heads,
Quality team, Top management
iii.
Agree on sample size and data collection format
Quality team
iv.
Collect data
Selected personnel from Quality

team
v.
Validate data
Quality team
vi.
Present data in a common forum (quality

committee meeting or KPI meeting)
Quality team/Administration
vii.
Compile the data in a presentation
Quality team
viii.
Presentation and analysis of KPI
All stakeholders, Top

management, Quality team
ix.
Conduct root-cause analysis
User departments and Quality

team
x.
Take corrective and preventive action
User departments, Quality team,

Administration
xi.
Periodic review of quality function
Quality team, Top management
IV.AUDIT CHECKLIST
No.
Checkpoint
Yes
i.
Quality team is formed
ii.
Some KPIs are identified
iii.
Formula or sample size, and method of

data collection is determined
iv.
Indicators are discussed and measures taken

to improve the quality
No
V. REFERENCES
79
Remarks
Chapter 6
RESPONSIBILITIES OF MANAGEMENT (ROM)
STANDARD ROM1. THE RESPONSIBILITIES OF THE MANAGEMENT ARE DEFINED.
Objective Elements
ROM1a. The SHCO has a documented organogram.
ROM1b. The SHCO is registered with appropriate authorities as applicable.*
ROM1c. The SHCO has a designated individual(s) to oversee the hospital-wide safety program.*
*Objective Elements ROM1b and ROM1c are self-explanatory and therefore not included in this
Guidebook.
ROM1a. The SHCO has a documented organogram.

I. OVERVIEW
Scope: To guide the SHCO on prepaing a picture of the structure of the SHCO, namely, its leadership,
its functional levels - departments, units, subunits - and the jobs at different levels, as well as the
relationship between personnel and between levels of jobs.
An effective organogram may be prepared with the help of the following steps and principles:
i.
The different functionaries (designations) and functional units (departments) are listed.
ii. A clear chain of command or hierarchy exists in the functioning of the SCHO which provides:
a. A pathway for the flow of information from top to bottom and vice versa.
b. An indication of whom to report to regarding day-to-day functioning.
c. An indication of whom to approach for escalation in problem resolution.
d. An indication of cross-related functional departments and individuals.
iii. This is represented in the form of a flow chart.
iv. Under each functional unit or department, it is possible to similarly list out the different
categories of staff in the unit, number of staff in each category, and the hierarchy within the
unit starting from the department head, and section in-charges. This is optional.
v. The organogram forms the framework based on which an adequate mix of staff is made
available to cater to the services rendered in the SHCO.
80

Policy
The SHCO has an up-to-date organogram (see Annexure) that outlines the leadership, the different
functional departments, and hierarchical relationship between these entities.
Procedure
No. Procedure
Responsibility
Supporting
Documents
i.
The organogram is prepared and authorized

by the SHCO management
Top management
Organogram
ii.
All staff are aware of the organogram and the

organizational structure it represents. This is
done through
l
Induction program at the time of joining
HR staff or Quality
department staff or
Heads of respective
departments
Induction training
material
l
Regular
training for existing staff
Training material
on SHCO-wide
policies and
procedures

No.
Task
Responsibility
i.
Prepare the draft organogram.
HR in-charge
ii.
Review the draft organogram

o Practice on the ground should reflect what the
management planned.
Top management and

HR department
o
iii.
Opportunities for streamlining the hierarchy are

identified and suitable changes made.
Authorizing the organogram

o Signature of the Head of the SHCO is affixed.
o
Head of the SHCO
The date from which it is effective is mentioned.
81
IV. AUDIT CHECKLIST

Frequency of audit: At least once a year as part of a hospital-wide audit.
No.
Checkpoint
Yes
i.
The organogram is present.
ii.
The organogram is approved by the Top

management.
iii.
All departments are represented in the

organogram.
iv.
All management levels are represented.
v.
The hierarchy is accurate.
vi.
Cross-reporting, if any, is represented.
No
Remarks
ANNEXURE
Organogram (This is a representative organogram. The hospital may replace the prompts with
actual designations and suitably modify it.)
Head of the SHCO

(Designation)
Second Level Leaders
Department
Sub-unit
Sub-unit
Department
Department
Department
Department
Department
Department
Department
Department
Sub-unit
Sub-unit
82
Departmental structure (This is optional. The hospital may replace the prompts with actual
designations and names of unit or subunits)
Department Head
Sub-unit
Sub-unit
Section In-charge
Staff category
Section In-charge
Staff category
Staff category
Section In-charge
Staff category
Staff category
Section In-charge
Staff category
Staff category
Staff category
STANDARD ROM2. THE SHCO IS MANAGED BY THE LEADERS IN AN ETHICAL MANNER.

Objective Elements
ROM2a. The management makes public the mission statement of the SHCO.
ROM2b. The leaders or management guide the SHCO to function in an ethical manner.*
ROM2c. The SHCO discloses its ownership.*
ROM2d. The SHCO's billing process is accurate and ethical.*
*Objective Elements ROM2b, ROM2c, and ROM2dare self-explanatory and therefore not included
in this Guidebook.
ROM2a. The management makes public the mission statement of the SHCO.
I. OVERVIEW
Scope: To orient the management of the SHCO, and in turn the staff, to the rationale of the SHCO
that is encapsulated in the mission statement.
83
The mission statement refers to the overall purpose of an organization. The mission answers the
question, "What does the organization aim to accomplish?"
Mission statements are designed to fulfil three basic purposes:
a. To inspire and motivate organizational members to higher levels of performance.
b. To guide resource allocation in a consistent manner.
c.
To create a balance among the competing, and often conflicting interests of various
organizational stakeholders.
The content of the mission statement usually includes the following components:
a. Purpose - defines the patients, stakeholders, markets, and geographical areas served, and
services provided.
b. Strategy - refers to the tools used such as distinctive or core competencies, technologies,
elements of growth and profitability, and the self-image of the organization.
c.
Values - the compass which guides the philosophy in the SHCO, such as social or civic
responsibility, commitment, dedication, accountability, stewardship, employee well-being,
learning, training and development.
d. Behavioral Standards - How employees are expected to behave - ethically, morally, honestly,
with integrity, professionally - as well as to be improvement-oriented, achievement-oriented,
empowering, innovative, adaptive, and creative.

Policy
The hospital has a defined mission statement, displays the same, and abides by it.
No. Procedure
Responsibility
Supporting
Documents
1.
The Top management enunciates the

mission statement
Top management
Mission statement
2.
This is made public in the following

locations:
Entrance lobby
Foundation stone
In all common waiting areas
Operations Head
and Maintenance
/Facility in-charge
Plaque (e.g. brass or

marble).
Boards and framed
statements. Slide
presentation.
Inhouse documents
as applicable. Online
content if present.
Others (the SHCO
shall specify other
modalities).
84
No. Procedure
Responsibility
Supporting
Documents
3.
All the staff are aware of the mission

statement. This is done through
l
The induction program at the time
of joining
l
Regular training for existing staff
HR staff , or Quality
department staff, or
Heads of respective
departments
Induction training
material.
Training material on
SHCO-wide policies
and procedures.
4.
The mission statement is included

in all the manuals in the SHCO
HR department,
All manuals.
Quality department Hospital brochure.
No.
Task
Responsibility
i.
List out the words that best describe the

purpose, strategy, values and behavioral
standards of the SHCO.
Top Management, senior leaders or

HODs
ii.
Discuss the relationship of these elements

for both organizational success and employee
motivation.

HODs
iii.
The list of descriptive words is clear and final,

avoiding duplication and exaggeration.

HODs
iv
Frame a comprehensive statement which

incorporates all the descriptive terms in a
logical and meaningful manner. The statement
may be a single, all-inclusive sentence or
broken into simple short multiple sentences.

HODs
Ensure that the mission statement is

authorized by the Top management. The
signatory is identifiable or it may simply
mention "Management" or "Board of Trustees"
or the like.
Top management
vi
Incorporate the mission statement in the

SHCO's documentation, such as manuals,
brochures, training material.
Quality Department or HR
department
vii
Display the mission statement to the public

at the entrance lobby and in prominent
common areas across the SHCO, and online
media.
Operations Head and

Maintenance/Facility in-charge
IT Dept
85
IV. AUDIT CHECKLIST

Frequency: One time audit
One time audit: Presence or absence of a mission statement.
V. REFERENCES
Forehand, A., "Mission and Organizational Performance in the Healthcare Industry". Journal of
Health Management, July-August 2000, Vol. 45, No. 4, pp. 267-77.
Pearce, John A. and Fred David, Corporate Mission Statements: The Bottom Line, The Academy of
Management Executives, May 1987, Vol. 1, No. 2, pp.109-115.
Smith, Mark, Ronald B. Heady et al. Do Missions Accomplish their Missions? An Exploratory Analysis
of Mission Statement Content and Organizational Longevity. Available at
http://www.huizenga.nova.edu/Jame/articles/mission-statement-content.cfm
86
Chapter 7
FACILITY MANAGEMENT AND SAFETY (FMS)
STANDARD FMS1. THE SHCO's ENVIRONMENT AND FACILITIES OPERATE TO ENSURE SAFETY OF
PATIENTS, THEIR FAMILIES, STAFF AND VISITORS.
Objective Elements
FMS1a. Internal and external signages shall be displayed in a language understood by the patients
or families and communities.*
FMS1b. Maintenance staff is contactable round the clock for emergency repairs.*
FMS1c. The SHCO has a system to identify the potential safety and security risks including
hazardous materials.
FMS1d. Facility inspection rounds to ensure safety are conducted periodically.*
FMS1e. There is a safety education programme for relevant staff.*
*Objective Elements FMS1a, FMS1b, FMS1d, and FMS1e are self-explanatory and therefore not
FMS1c. The SHCO has a system to identify the potential safety and security risks including
hazardous materials.
I. OVERVIEW
Scope: To ensure the safety of patients, families, staff and visitors to the SHCO by identifying all the
potential risks, and having adequate safety measures in place to prevent accidents and harm.
Risk is a potential threat that affects the ability to achieve the desired outcome. A SHCO setting is an
environment of risk and potential danger. There are potential hazards in every area of the SHCO
such as radiation leaks, chemical exposure, infections, and security issues. Risk management is
achieved through detecting, managing, reporting, and correcting potential deficiencies. It is
recommended that
l
Staff
be educated about the various risks in the hospital environment, identify potential
risks, manage and report them immediately.
l
Appropriate mechanisms be implemented for the staff and visitors to report any identified
potential risk.
87
l
The reported
risks be addressed immediately and appropriate corrective and preventive

measures be taken to mitigate the risk.

i.
Protocol for reporting potential risks
ii. Protocol for managing different risks when they occur

SAMPLE DOCUMENTS
Sample protocol for reporting potential risks
Responsibility
Supporting
Documents
All staff are trained to identify and report safety and

security risks in the SHCO.
HR/Training
department
Training records
Any staff member who identifies a potential risk

should immediately call (Front Desk/Reception/any
24 hour area), or fill the online reporting form and
submit it.
All staff members
Reporting forms/
Register
If the risk is of immediate concern, it should be

addressed through the SHCO phone number.
All staff members
Reporting forms/
Register
While calling the number, the reporter must

identify himself/herself, the identified risk, and the
location.
All staff members
Reporting forms/
Register
The designated person along with the engineer/

concerned person should visit the spot and ensure
that the complaint is addressed.
Designated person/
Concerned
departments
Reporting forms/
Register
Front desk/ Reception
Reporting forms/
Register
Procedure
On receiving the call, the information should be

recorded in the Incident Register with the date,
time, caller details and the reported incident.
The information should be passed on to the

Front desk/Reception/
designated person concerned, who in turn will have Designated person/ Reporting forms/
to contact groups responsible for addressing the
Concerned
Register
complaint.
departments
Once rectified, the designated person should
conduct a random inspection and see if similar
problems exist in other places in the SHCO, and if
so, address them.
Designated person
88
Inspection
report
Sample protocol for managing different risks when they occur

Some of the common risks in a hospital environment include:
a) Chemical hazards - hazardous chemicals (including blood, and their spillage)
b) Security risks - theft, abduction, sabotage
c) Fire risks due to smoking, short circuits
d) Risk to building and infrastructure - lightning, termites
e) Risk to patient like infections, falls, medication errors, cautery burns
a) Risks due to Hazardous Chemicals
There are many hazardous chemicals in the SHCO environment such as mercury, glutaraldehyde,
cleaning chemicals, lab reagents. The primary objective is to identify all the chemicals stored in the
SHCO and guide their storage, usage and spill kits made available as per the MSDS (Material Safety
and Data Sheet) for each chemical. All staff handling these chemicals must be aware of how to
handle them and what to do in case of a spill or splash of the chemical.
Example1: Handling mercury spills in hospitals
A mercury spill kit with plastic zipper bag, dropper, heavy paper card, absorbent material may be
kept in a box and provided in wards and other places handling thermometers and BP apparatus. If
the spill occurs, the following protocol may be adopted.
l
Increase ventilation in the room by opening the windows.
l
Pick up
the mercury with a dropper or scoop up beads with a piece of heavy paper like
playing cards.
l
Place the mercury-contaminated instruments (dropper/heavy paper) and any broken glass
in a plastic zipper bag.

l
Dispose of waste mercury as toxic waste. Double-bag the waste and incinerate it; however,
it is more environmentally acceptable to forward the waste to reclaim the mercury.

l
It is advisable
to reduce the usage of mercury-containing equipment. All conventional

mercury thermometers may be replaced with infrared thermometers (non-touch). Hgcontaining BP apparatus may be replaced.
When cleaning up a mercury spill:

l
Do not
use household cleaning products, particularly products that contain ammonia or

chlorine. These chemicals will react releasing a toxic gas.
l
Do not use a broom or paint brush. It will spread them around by breaking them into smaller
beads.
l
Do not use vacuum as it will disperse mercury vapour into the air and increase the likelihood
of human exposure.
89
b) Security Risks
SHCOs face a wide range of security issues from handling thefts, workplace violence, abduction,
aggrieved patients or mobs to bomb threats. Adequate mechanisms must be in place to prevent
their occurrence and to address them, in case they happen.
Theft in hospital
l
All staff should wear hospital ID at all times.
l
Staff must report any unidentified individuals or suspicious activity.
l
Visitors without guest passes will not be permitted inside the SHCO.
l
CCTV monitoring of the corridors and common areas is necessary.
l
Patients to be instructed to keep their belongings safe and locked.
l
Theft must be immediately reported to the security department.
l
Security department must take control of the scene and scrutinize all CCTV recordings and
movements.
l
All staff in the area should be interrogated about any suspicious movement.
l
Every effort must be made to solve the case. Security department must include the senior
doctor or senior nurse while handling the investigation.

c) Risk of Fire
To avoid fire accidents from happening, it is important to have a system or a team to analyze the
potential risk factors that may induce fire, and take necessary steps to avert an incident. Fire
prevention measures include the following:
l
Strict prohibition on smoking.
l
Positioning of heat sources away from combustible materials.
l
Good housekeeping and prevention of accumulation of easily ignitable rubbish or paper.
l
Supervision
and control of contractors or employees using blowlamps, cutting or welding
equipment.
l
Risk
assessment and control in the purchase of articles and substances to avoid the
introduction of fire hazards whenever and wherever possible.
l
Strict preventive maintenance programs for electrical wiring and appliances, like non use of
loose wires, extension cords, multiple tapping from a single load.

l
Supervision of cooking facilities.
l
Avoiding use of electrical and electronic equipment with damaged and twisted wires.
Training of the employees on fire prevention and fire management is most essential for ensuring
safety in the structure. The SHCO should train all employees on how to avoid fire incidents specific
to their workplace as well as basic techniques on the use of fire extinguishers.
90
d) Risk of Electrical Shocks

Although the chance of electrical shock is less common, once it occurs, there is a high chance that it
will result in casualties and property damage.
General Prevention Measures
l
Do not expose the live part of a wire or any electrical appliance.
l
All electrical appliances must be grounded properly.
l
Circuit breakers must be installed for reducing the severity of electric shock accidents.
l
Do not touch electrical appliances with wet hands.
l
Be sure to use standard regulation fuses for switches and not copper or steel wire.
l
Do no permit use of faulty or malfunctioning electrical products.
l
Do not use wiring with a link in the middle to connect two separate wires.
l
Do not have loose wires in the facility.
l
Have
good standard wiring and do not permit substandard wiring that does not follow
electrical safety requirements.
l
Staff operating the equipment must be trained and have adequate knowledge on the use of
equipment.
l
Conduct periodic safety inspections in order to detect potential problems.
e) Risk of Fall
The risk of a fall applies not just for patients but for all staff of an SHCO, visitors and patient
attendants. Fall prevention strategies and also the incidence of fall should be audited to check if
they are serving the purpose for which they were constituted and also to review if any new
interventions are required to prevent falls.
To prevent falls, the following may be observed:
l
All wheelchairs and stretchers used for transferring patients should have restraint belts.
l
All roads
and corridors must be level and any broken or chipped floor tiles should be
immediately replaced.
l
While cleaning, the area should be cordoned off with appropriate signage like "wet floor".
Any spillage must be cleaned immediately.

l
Handrails must be provided for staircases.
l
The end
of a passage and the beginning of the stairs must be demarcated in a different
colour.
l
Grab bars must be provided in all toilets.
l
Adequate lighting must be present in all areas.
91

No.
Task
Responsibility
Train staff on potential risks
HR Department / Training department
ii
Report any potential risk
All staff
iii
Analyze the risk
Designated person or group
iv
Implement risk mitigation strategies
Administration, designated person or group
IV. AUDIT CHECKLIST

No
Checkpoint
Yes
Training of staff on risks - identification,

management and reporting of risks
ii
Staff interviews that show awareness

of staff on risks, identification,
management and reporting of risks
iii
Documentation of reported
potential risks
iv
Protocol followed to address the

reported incident or potential risk
Analysis of the reported risks
vi
Risk mitigation in terms of corrective

and preventive action taken
vii
No
Remarks
Training records- Yes/ No
Available/Not available
If there was any change in protocol,

awareness of staff on the recent
protocol.
STANDARD FMS2. THE SHCO HAS A PROGRAM FOR CLINICAL AND SUPPORT SERVICE EQUIPMENT
MANAGEMENT
Objective Elements
FMS2a. The SHCO plans for equipment in accordance with its services.*
FMS2b. There is a documented operational and maintenance (preventive and breakdown) plan.
*Objective Element FMS2a is self-explanatory and therefore not included in this Mnaual.
92
FMS2b. There is a documented operational and maintenance (preventive and breakdown) plan.
I. OVERVIEW
Scope: To ensure that equipment is used or operated in the right manner, equipment is checked
periodically to avert repairs, and also to address repairs immediately, if they occur.
SHCO equipment includes biomedical equipment like monitors or infusions, used for direct patient
care and engineering equipment such as generators and motors for the functioning of the hospital.
It is recommended that they be operated and maintained appropriately, otherwise it could
compromise patient care.
Operational plan
Operational plan is to ensure that the equipment is used or operated by the technician as per the
instructions of the manufacturer. In order to do so, it is recommended that the operator or
technician be trained in safe operation by the equipment company.
Maintenance plan
l
Maintenance plan addresses preventive and breakdown maintenance.
l
The primary aim of preventive maintenance is to avoid or mitigate failure of equipment. It is
designed to preserve and restore equipment reliability by replacing worn components

before they actually fail, and includes partial or complete overhaul at specified periods. For
example, oil changes, lubrication.
l
Breakdown maintenance intends to address the mechanism to get the equipment repaired
properly, and without delay, if failures have occurred.

l
Both
preventive and breakdown maintenance may be outsourced in the form of Annual

Maintenance Contract (AMC) or Comprehensive Maintenance Contract (CMC) or it could
be done by qualified inhouse engineers.

i.
Inventory of equipment.
ii. Checklists and operational instructions for all equipment based on operator's manual.
iii. Planned preventive maintenance schedule for all equipment.
iv. Handling breakdown repairs of equipment.
93
SAMPLE DOCUMENTS
Sample inventory of equipment
l
As good
practice, all equipment should be inventoried with a unique numbering system

developed by the SHCO. This could be available on the machine in the form of a sticker or
written with marking ink.
l
Example for inventory number: Simple running numbers like 001, 002 or BBH/ BM/ DEFIB/
003.
n
BBH- Bangalore Baptist Hospital
n
BM- Biomedical Equipment
n
DEFIB- Defibrillator
n
003- Running number
l
Inventory
number and serial number (assigned by manufacturer) are the two IDs of the
equipment.
l
A database
in the form of an excel sheet, or in the form of hard copy as register, or a

software could be maintained.
l
Inventory should be managed and updated by the engineering team when new equipment
is bought or old equipment is condemned.
Sample of inventory software
94
Sample protocol for the operational plan for all equipment

Responsibility
Supporting
Documents
The operational plan should be as per the

instructions of the manufacturer as each
manufacturer and each model of equipment will
have different operating instructions.
Engineering
Operational plan
for each
equipment
Staff handling the equipment must be trained by

the supplier of the machine and the instructions
strictly followed by personnel operating the
machine for its safe operation.
Engineering / Staff
handling the
equipment
Training records/
checklist and
records
The equipment must be operated based on the

operating instructions or plan.
Staff handling the

equipment
Operational plan
for the
equipment
Staff handling the

equipment
Operational plan
for the
equipment
Procedure
The operating instructions should be available with

the operator or hung on the machine.
Sample Operational plan- User Checklist
95

Procedure
Responsibility
Supporting
Documents
A preventive maintenance schedule must be

prepared by the engineering team.
Engineering
The planned preventive maintenance schedule may

vary for different equipment - quarterly, semiannually or annually, depending on the
manufacturer.
Engineering
Operators
Manual
PPM can be carried out by the engineering staff or

outsourced.
Engineering
Records of
preventive
maintenance
The operator or user must be informed in advance

about the scheduled preventive maintenance, so
that appropriate arrangements are made by the
users to keep the equipment free of use.
Engineering
Intimation to the
users
Records of preventive maintenance must be

maintained for each equipment.
Engineering
Records of
preventive
maintenance
Preventive
maintenance
schedule
Sample protocol for handling breakdown repairs of equipment

If the machine is not functioning, information
should be passed on to the engineer or the
outsourced company handling the equipment.
Staff who handles

the equipment
The repair may include spare part replacement and Engineer/ Outsourced
small component replacement.
engineer
Complaint
register
Receipts
After the machine is brought back to normal

working condition, complete calibration and testing Engineer/ Outsourced Records of repair
has to be performed, including electrical safety,
done
engineer
before it is handed over to the user department.
The breakdown of life saving equipment, surgical
equipment and critical care equipment, may be
considered as Emergency breakdown and priority
given for such breakdown.
Engineer
Complaint
Register
Records of the time of raising the complaint, the

person who raised the complaint, the job
completion, and equipment handing over time
along with the types of repair done should be
maintained.
Engineer
Complaint
register
96
TASKS AND RESPONSIBILITIES

No.
Tasks
Responsibility
i.
Inventory of all equipment
Engineer
ii.
Training of the technician operating the equipment
Engineer
iii.
Operational plan for every machine based on the

operator's manual
Engineer/ Staff handling the

equipment
iv.
Preventive maintenance schedule for each machine

based on the operator's manual
Engineer
v.
Addressing breakdown and repairs
Engineer
vi.
Records of preventive and breakdown maintenance
Engineer
IV. AUDIT CHECKLIST

No
Checkpoint
Yes
i.
Engineer or outsourcing of the

equipment management based on
competency
ii.
Updated inventory of all the equipment
iii.
Availability of inventory number on

the machines
iv.
Training or competency of technician

on the operation of the equipment
v.
Operational plan for the equipment as

per the operator's manual
vi.
Preventive maintenance schedule as

per the operator's manual
vii.
Breakdown maintenance or complaint

register - addressing and recording of
time for repairs
No
Remarks
Training records- Yes/ No
Available/ Not available
STANDARD FMS3. THE SHCO HAS PROVISIONS FOR SAFE WATER, ELECTRICITY, MEDICAL
GAS, AND VACUUM SYSTEMS.
Objective Elements
FMS3a.Potable water and electricity are available round the clock.*
FMS3b. Alternate sources are provided for in case of failure and tested regularly.*
97
FMS3c. There is a maintenance plan for medical gas and vacuum systems.
*Objective Elements FMS3a and FMS3b are self-explanatory and therefore not included in this
Guidebook.
FMS3c. There is a maintenance plan for medical gas and vacuum systems.
I. OVERVIEW
Scope: To ensure that there is safe and continuous supply of medical gases and vacuum for the
patients in the wards, ICUs, OTs.
Medical gases form the very backbone of an SHCO. Without them it would be impossible to run a
healthcare organization, as they play an essential role in the functioning of critical care units and key
operational areas.
Medical gas installations are constructed as per norms and licenses obtained for Liquid Medical
Oxygen (LMO) as per requirements.
Strict safety requirements as per the norms are followed.
Trained medical gas operators or technicians be available in the case of central supply and
continuous supply.
Maintenance should be done regularly as per requirements.

i.
Protocol for operating medical gas and vacuum installations shall be managed as per policy.
ii. Daily, weekly, monthly and annual maintenance schedule.

iii. Uniform colour coding of medical gas pipelines.
SAMPLE DOCUMENTS
Sample Protocols for operating medical gas and vacuum installations shall be managed as per
policy.
98
Procedure
Responsibility
Supporting
Documents
Medical gas installations and vacuum installations

shall be managed by adequate staff.
HR/Engineering
Appropriate backup (cylinders) shall be made

available to handle any emergencies that arise out
of the failure of piped medical gases.
Engineering
Records of
backup cylinders
Appropriate personal protective devices such as

earmuffs and rubber gloves should be used by the
staff.
Engineering
Actual
availability/
Inspections at
random
Medical gas and vacuum installations shall be

maintained as per protocol.
Engineering
Personal Files
Daily, weekly,
monthly and
annual
maintenance
schedule,
records of
maintenance.
Daily, weekly, monthly and annual maintenance schedule

No.
Daily Check
Parameters to be checked
1.
LMO tank (if available)
Tank level, pressure
2.
Vacuum pump
Pressure, machine running status (lead, standby, last),

oil level, belt tension, loading and unloading pressure
range, auto drain
3.
Air compressor
Pressure, machine running status (lead, standby), oil level,

belt tension, temperature, water pressure, cooling tower
working, loading and unloading pressure range
4.
Nitrous oxide, carbon

dioxide, oxygen manifold
Line pressure, heater coil, cylinder stock
Weekly Maintenance
All medical gas outlets of the clinical area to be checked for pressure range and leaks. If the
pressure drops, the outlet needs to be scanned.
99
Monthly Maintenance
No
Daily Check
Parameters to be checked
1.
Vacuum Pump
Cleaning, oil level and quality, belt tension check for fasteners, auto
drain and check for silencer cleaning, loading and unloading
pressure range.
2.
Manifolds
Line pressure, heater coil, cylinders stock, leak test.
3.
Air compressors
Cleaning, oil level and quality, belt tension check for fasteners, auto
drain and check for silencer cleaning, water pressure, temperature
sensor, cooling tower, loading and unloading pressure range,
servicing suction and discharge valves, and servicing of NonReturn
Valve.
Annual Maintenance
As per the equipment requirements and manual, thorough overhaul should be performed.
Colour coding of medical gas pipelines:
100
III.TASKS AND RESPONSIBILITIES

No
Task
Responsibility
i.
Procure license for the LMO
Engineer
ii.
Ensure daily, weekly, monthly and annual checks are done as

per requirement
Engineer
iii.
Uniformly colour code in a standardized manner (as per international Engineer

colour coding of medical gas and vacuum systems)
iv.
Update medical gas pipeline drawing
Engineer
v.
Ensure safety signage
Engineer
IV. AUDIT CHECKLIST

No
Checkpoint
Yes
i.
Safety signage present
ii.
Actual storage of empty and filled cylinders
iii.
By-pass in case of emergencies and back up
iv.
Valves shut off in different loops
v.
Chained cylinders
vi.
Mechanism of loading and unloading cylinders
vii.
Leak detection systems
viii.
Daily, weekly and monthly checks by operator
ix.
Annual overhaul
x.
Standardized colour coding of pipelines
xi.
Condition of the cylinders, colour coding.
xii.
Personnel protective equipment for the staff
101
No
Remarks
STANDARD FMS4. THE SHCO HAS PLANS FOR FIRE AND NONFIRE EMERGENCIES WITHIN
THE FACILITIES.
Objective Elements
FMS4a. The SHCO has plans and provisions for early detection, abatement, and
containment of fire and nonfire emergencies.
FMS4b. The SHCO has a documented safe exit plan in case of fire and nonfire
emergencies.
FMS4c. Staff is trained for their role in case of such emergencies.*
FMS4d. Mock drills are held at least twice in a year.*
*Objective Elements FMS4c and FMS4d are self-explanatory and therefore not included in
this Guidebook.
FMS4a. The SHCO has plans and provisions for detection, abatement and containment of
fire and nonfire emergencies.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing
their own customized documents.
I. OVERVIEW
Scope: To ensure that adequate systems are available for the early detection, abatement
and containment of fire and nonfire emergencies to ensure the safety of the occupants
(patients, relatives, staff) and infrastructure of the SHCO.
In an SHCO set-up, potential emergency situations include fire emergencies and nonfire
emergencies such as terrorist attacks, stray animals, earthquakes, antisocial behaviour of
relatives, chemical spillage, structural collapse, patient fall, flooding, and bursting of
pipelines.
i. Smoke detectors, leak detectors, and systems like alarms, hooters, and Public
Address (PA) systems be available for use in case of emergencies.
ii. These systems be maintained and tested to ensure their functionality at all times.
iii. A trained multidisciplinary team handle such emergencies wherein a common
telephone number (help line) or other mechanisms be used to alert and activate
this team.
102

Protocol for the management of fire and nonfire emergencies.
SAMPLE DOCUMENTS
Sample protocol for the management fire and nonfire emergencies.
Procedure
Responsibility
Supporting
Documents
All emergency detection and fighting systems in the

SHCO should be kept active at all times. For
examplel
Fire alarm
and detection system

l
Portable fire extinguishers
l
Fire hydrants
l
Fire hose boxes and reels
l
Fire water pumps
l
Water storage and sumps for fire fighting
l
Leak detection system. For example, LPG or
medical gas
Engineering
Maintenance
records and
checklists
The systems should be tested frequently
Engineering
Maintenance
records and
checklists
All staff should be trained in handling fire and

nonfire emergencies in the SHCO.
HR/Training
department
Training records
Any person who witnesses a fire or leak or any

other emergency should immediately call for help.
All staff
The staff member should immediately try to fight

the fire or handle the situation based on the
training provided.
Staff
The team set for the purpose should be present and

take over the situation immediately.
Designated team
Based on the situation, the team leader should

decide if additional help is required from outside
such as the fire department or police.
Designated team
103

No
Task
Responsibility
i.
Fire detection systems as per National Building Code (NBC)
Head of SHCO
ii.
Fire fighting systems as per NBC
Head of SHCO
iii.
Leak detection system of LPG bank, medical gas bank as per norms
Engineer
iv.
Protocol for emergency contact
Designated
team
v.
Staff awareness of their role in reporting or escalation of any

potential emergencies
HR/ Training
department
vi.
Staff awareness of their role in early containment of a potential

emergency
HR/ Training
department
IV. AUDIT CHECKLIST

No
Checkpoint
Yes
i.
Fire detection systems as per norms
ii.
Fire fighting systems as per norms
iii.
Checking or testing records of the detection and

fighting systems
iv.
Leak detection systems as per norms
v.
Emergency communication systems
vi.
Plan for managing fire and nonfire emergencies
vii.
Staff training
viii.
Awareness of staff on the plan
104
No
Remarks
FMS4b. The SHCO has a documented safe exit plan in case of fire and nonfire
emergencies.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing
their own customized documents.
I. OVERVIEW
Scope: To ensure that the occupants of the SHCO building are evacuated to safety in case of
an emergency situation. In order to do so, it is recommended that the SHCO should have
safe exit plans for its occupants.
i.
In case of an emergency situation, the occupants of the SHCO are evacuated to a safe
area as quickly as possible. The National Building Code (NBC) has prescribed structural
specifications for buildings which conduct evacutions in an emergency.
ii. Irrespective of the infrastructure, the staff in the SHCO should be trained to evacuate
patients to safety in any emergency according to the plan that is prepared for the
purpose.
iii. Appropriate evacuation plans should be documented and tested out frequently by
conducting mock drills.

i.
Emergency Floor Plans
ii. Emergency Evacuation Plan
SAMPLE DOCUMENTS
Sample of Emergency Floor Plan
Emergency Floor Plans: An emergency floor plan shows the possible evacuation routes in
the floor of the building. It is usually color-coded and uses broad arrows to indicate the
designated exit. This should be available in all conspicuous places, especially in all clinical
areas. Marking of the location of the display should also be available in the floor plan to
orient the person looking at the floor plan, which is usually marked as "You are here".
105
Example of Emergency Evacuation Plan

l
All staff
in the SHCO should be trained in basic firefighting techniques, like handling fire
extinguishers.
l
All staff in the SHCO should be aware of their role in any emergency.
l
Signages such as emergency floor plans and fire exits, should be available in all areas.
l
Emergency lights should be available for facilitating evacuation in an emergency, as power
supply is turned off.

l
The SHCO
may have a central person designated to be the first point of contact in

emergencies.
l
In case of fire, it could be the security in-charge along with the engineering or
maintenance
staff who could take over the fire fighting operation.

l
There should be an established method, like alarms, PA system or central phone to alert the
team.
l
The fire fighting team should immediately proceed to the scene with additional firefighting
equipment, try to extinguish the fire, or escalate to the city fire department.
l
The engineering
team should ensure that the fire pumps are kept running and that the
correct pressure is maintained, ensure that the firewater tank is kept topped up, ensure
that the sub-station is staffed and that electric supply to the fire-affected area is cut off .
106
The housekeeping staff and other staff may form a ring around the scene of fire and ensure
l
that the functioning and movement of the fire fighting team or Fire Brigade personnel are
not hampered. They can also assist the team if required.
l
The evacuation
team may consist of the doctors and nursing staff who can move the
patients in the immediate fire area to the designated assembly areas or to other beds
totally away from the scene of fire. Walking patients can be conducted in a group to a safe
area through fire exits or other exit staircases. Patients on life-support systems should be
evacuated along with the equipment.
l
One
staff member should be designated by the Senior Nurse to check toilets and other
rooms to make sure that there are no patients hiding or trapped in those areas.

No
Task
Responsibility
i.
Building or Infrastructure facilities
Head of SHCO
ii.
Signage as per the requirement
Designated person
iii.
Emergency floor plans
Designated person
iv.
Emergency lights and availability
Engineer
v.
Emergency evacuation plan
Designated team
vi.
Mock drills for safe evacuation
Designated team
IV. AUDIT CHECKLIST

No
Checkpoint
Yes
i.
Green-coloured exit signage is clearly visible.
ii.
Emergency lighting.
iii.
Emergency floor plans are visible on all the floors

and at conspicuous places.
iv.
An emergency evacuation plan exists.
v.
Staff are trained in the emergency evacuation plan.
vi.
Staff are aware of their roles during an emergency

evacuation.
vii.
Mock drills are conducted to test the plan.
107
No
Remarks
V. REFERENCES
Bureau of Indian Standards, National Building Code of India 2005, Group 1, New Delhi.
G. B. Menon, Fire Advisor, Government of India, Handbook on Building Fire Codes, Fire Fighting
and Fire Safety Requirements. Available at
www.urbanindia.nic.in/publicinfo/byelaws/chap-7.pdf
Fire Fighting and Fire Safety Requirements, Chapter 7. Available at
www.urbanindia.nic.in/publicinfo/byelaws/chap-7.pdf
IITK-GSDMA, Fire 05-V3.0. Available at
http://www.iitk.ac.in/nicee/IITK-GSDMA/F05.pdf
Indian Standards, Basic Requirements for Hospital Planning, Part 1 upto 30 bedded hospital, IS
12433 (Part 1): 1988.
Indian Standards, Basic Requirements for Hospital Planning, Part 2 upto 100 bedded hospital, IS
12433 (Part 2): 2001.
Indian Standards, Recommendations for Basic Requirements of General Hospital Buildings,
Part 3, Engineering services department, IS: I0905 (Part 3)-1984.
Medical Equipment Maintenance Program Overview. Available at
http://whqlibdoc.who.int/publications/2011/9789241501538_eng.pdf
NABH & Fire Safety. Available at
http://nabh.co/Images/PDF/Fire_Safety_NABH.pdf
OSHA (Occupational Safety & Health Administration) Technical Manual. Available at
www.osha.gov
R. Craig Schroll, Fire Detection and Alarm Systems: A Brief Guide, Dec. 01, 2007. Available at
http://ohsonline.com/Articles/2007/12/Fire-Detection-and-Alarm-Systems-A-Brief-Guide.aspx
www.bis.org.in
R. R. Nair, Fire Safety Expert and Consultant, Maintenance Schedule, adapted from lecture notes
of 2014.
108
Chapter 8
HUMAN RESOURCE MANAGEMENT (HRM)
STANDARD HRM2. THE SHCO HAS A WELL-DOCUMENTED DISCIPLINARY AND GRIEVANCE
HANDLING PROCEDURE
Objective Elements
HRM2a. A documented procedure regarding disciplinary and grievance handling is in place.
HRM2b. The documented procedure is known to all categories of employees in the SHCO.
HRM2c. Actions are taken to redress the grievance.*
*Objective HRM2c is self-explanatory and therefore not included in this Guidebook.
HRM2a. A documented procedure with regard to these is in place.

I. OVERVIEW
Scope: To guide the SHCO on taking prompt action for disciplinary action and grievance redressal by
designated individuals which helps to avoid bias or prejudice. It is recommended that the
management of the SHCO predefines the mechanism for addressing disciplinary action and
grievance redressal.
i.
Disciplinary action: This is the recommended sequence of activities carried out when staff
do not comply with laid-down norms, service standards, rules and regulations of the SHCO.
Staff should be made aware of the consequences of not abiding with the applicable policies
of the SHCO. A member of staff who is aware of disciplinary action is less likely to commit an
offence. The mechanism identifies situations that warrant a review of the event by a
committee. The quantum of the disciplinary action may be predefined for certain situations
or the committee may give its suggestions to the SHCO management. There is scope for an
appeal if the member of staff wishes to do so. There is a separate mechanism to address
breach of conduct with regard to sexual harassment at the workplace in accordance with
the law.
ii. Grievance redressal: This is the recommended sequence of activities carried out to address
the grievances of patients, visitors, relatives and staff. The staff in the SHCO should be aware
that there is a grievance redressal procedure if they do not get what is due to them, thereby
safeguarding their rights. The mechanism describes which person the staff can contact and
the process of review of the case by a grievance redressal officer or committee. The
109
committee rules whether the grievance is genuine or not and gives its recommendations
accordingly. There is scope to appeal to a higher authority.

i. Policy and SOP on Disciplinary Action
Disciplinary Policy and Procedure
Policy: Staff who do not comply with their job description and other general requirements in the
SHCO will be subject to an established disciplinary hearing and disciplinary action if necessary.
Procedure
This is a sample of a disciplinary procedure.
Complaint against staff
Preliminary assessment
of complaint by the HOD
Major offence
Repeat offender
Minor offence
Counseling or
Warning
Hearing in disciplinary
committee
Staff allowed to
present his/her
explanation
Complainant
presents the details
of the offence
Decision of disciplinary
committee
No Offence
Gross misconduct
Offence
Termination
Disciplinary action
Decision up held
Appeal
Decision reversed
110
No offence
No action
Grievance Handling Policy and Procedure

Policy: Staff are empowered to use an established mechanism to address grievances, if any.
Procedure
This is a sample of a grievance handling procedure.
Staff discusses
grievance with HOD
Resolution of grievance
No
Yes
Discussion with HR
Resolution
No resolution
No action
Hearing in grievance
handling committee
Respondent is allowed
to present his/her
explanation
Complainant
presents the details
of the grievance
Decision of grievance
handling committee
No cause for
concern
Grievance upheld
Action taken
Grievance resolved
Decision upheld
Appeal by any
involved party
Decision reversed
111
No
Task
Disciplinary procedure
Responsibility
i.
Step-by-step description of the disciplinary procedure
HR department
ii.
Composition of the team or the designated individual who

reviews the offence(s)
Authorized by Top
management
iii.
List quantum of action to be taken, ensuring that it is

commensurate to the offence
Authorized by Top
management
iv.
Hearing of both parties
Disciplinary committee
or designated individual
v.
Decision on action to be taken against the erring member

of staff
Disciplinary committee
or designated individual
vi.
Opportunity given to staff member to appeal to a

designated individual
Authorized by Top
management
vii.
Implementation of action against staff
HR department
viii.
Constitution of an Internal Complaints Committee (ICC) to

address complaints of sexual harassment at the workplace
Authorized by Top
management
ix.
Making available the name of the person that the alleged

victim should contact in order to present a
written complaint.
Any member of ICC or

any senior staff in
whom the victim
confides
x.
Acknowledgment of receipt of the complaint by the

alleged offender
Member Secretary
of ICC
xi.
Immediate separation of the concerned individuals at the

workplace with stern caution to all concerned not to
interact with each other on the complaint
HR department (on the

written instruction of
the Member Secretary
of ICC)
xii.
Proceedings of ICC
Member Secretary
of ICC
xiii.
Action taken against the erring staff member
Member Secretary
of ICC
HR department
Top management
112
Greivance Handling Procedure

i.
A step-by-step description of the grievance

handling procedure
HR department
ii.
Appointment of grievance handling officers
Head of the department

Senior HR staff or Top
management
iii.
Proceedings of the grievance handling procedure

documented and decision implemented
HR department
iv.
The written document for disciplinary action and grievance

handling is finalized
HR department
Quality department
IV. AUDIT CHECKLIST

Frequency of audit: At least once a year as part of hospital-wide audit.
No
Checkpoint
Yes
i.
Procedure for disciplinary action is available
ii.
Procedure is available for addressing complaints

of sexual harassment in the workplace
iii.
Procedure is available for addressing

grievance-handling
Grievance handling procedure is reviewed and

approved by Top management on a yearly basis
v.
All concerned documents and materials have the

updated procedure
vi.
Records of disciplinary proceedings are maintained
vii.
Records of grievance handling proceedings

are maintained
viii.
Records of proceedings that handle complaints

of sexual harassment in the workplace are
maintained confidentially.
113
No
Remarks
HRM2b. The documented procedure is known to all categories of employees in the SHCO.
Note: Sections II and III below are provided as samples to guide SHCOs in developing their own
I. OVERVIEW
Scope: To make staff aware of the disciplinary procedure so that they are less likely to err since they
know the consequences. Staff also become aware that the disciplinary proceedings are free of bias
or prejudice as well as how to access the grievance handling mechanism in a timely manner.
It is important for the staff to know the procedures that will be followed both for disciplinary action
and grievance redressal. It is recommended that the management should take the time and make
the effort to conduct training for the staff right from the time they join the SHCO, and also to
periodically retrain them on the same.
II. TASKS AND RESPONSIBILITIES

No
Task
Responsibility
i.
The written document for disciplinary action and grievance handling

is included in
HR department
Quality
department
l
The
compilation of SOPs in the HR department
l
The
material for training staff on hospital-wide policies and

procedures
ii.
Make staff aware of the procedures concerning disciplinary action

and grievance handling. This is done through training
programs such as:
l
Training
for new staff
HR department
HOD of
respective
departments
Quality
department
l
Retraining
for staff - Retraining of staff on the

hospital-wide policies and procedures is done at least
once a year. This may be done by the HR department or
the respective department heads.
114
III. AUDIT CHECKLIST

Frequency of audit: At least once a year as part of hospital-wide audit.
No
Checkpoint
Yes
i.
All relevant documents and materials have the

updated procedure
ii.
Staff interviews to check staff awareness and

understanding of the disciplinary procedure
iii.
Staff interviews to check if staff show adequate

awareness on the grievance handling procedure
iv.
Staff interviews to check staff awareness on

dealing with sexual harassment at the workplace
No
Remarks
STANDARD HRM3. THE SHCO ADDRESSES THE HEALTH NEEDS OF EMPLOYEES.

Objective Elements
HRM3a. Health problems of the employees are taken care of in accordance with the SHCO's
policy.
HRM3b. Occupational health hazards are adequately addressed.*
*Objective Element HRM3b is self-explanatory and therefore not included in this Guidebook.
HRM3a. Health problems of the employees are taken care of in accordance with the SHCO's
policy.
I. OVERVIEW
Scope: To ensure a healthy workforce. It also aims to avoid occupational health-related issues
among the staff and to address them when they do occur. Proper attention to the health and
occupational safety of the staff boosts morale, reduces absenteeism, and increases the quality of
services rendered.
The extent to which the hospital management supports the healthcare needs of the staff is partly
mandatory and partly discretionary as per the following principles:
i.
Employee health benefit is a statutory requirement if the SHCO falls within the gamut of the
Employee State Insurance Norms (more than 10 or more staff employed on the rolls). Staff
who earn less than Rs.15,000 gross salary are eligible as per the act and are provided free
treatment at the Employee's State Insurance (ESI) or ESI-empanelled hospitals. There is a
financial contribution from the hospital and the staff towards enlisting the eligible staff
115
under the ESI: employees contribute 1.75 percent and employers contribute 4.75 percent.
Remittance into the ESI account is made within 21 days from the end of the due month. The
SHCO should refer to the latest norms issued under the ESI Act.
ii. Occupational hazards resulting in health problems also should be covered by the SHCO.
These include:
a. Preventive measures such as pre-exposure prophylaxis when possible - for example,
Hepatitis B vaccine or Influenza vaccine for staff who are at risk.
b. Post-exposure prophylaxis such as immunoglobulin treatment post-Hepatitis B
exposure and Antiviral medication for staff involved in the treatment of patients with
H1N1.
c. Provision of safety measures such as the provision of masks and gloves to protect the
staff from acquiring diseases in the SHCO.
d. Staff benefits may also include discounts for investigations or treatment for general
illness at the hospital. This may be in the form of a health insurance cover. The amount of
discount or insurance premium that is contributed by the hospital is left to the discretion
of the SHCO management.

Policy: The health problems of the staff are addressed through pre- and post-exposure prophylaxis
and other health benefits.
SOP on Employee State Insurance
No.
Procedure
Responsibility
Supporting
Documents
1.
Identification of all staff who are eligible under

the ESI Act
HR staff
List of staff
under ESI
2.
Enrollment of eligible staff under ESI with all

relevant supporting evidences in exchange for
an ESI card
HR staff
ESI
correspondence
files
3.
Financial contribution made by the hospital

and the staff towards enlisting the eligible staff
under the ESI: Employees contribute 1.75
percent and employers contribute 4.75 percent
HR/Accounts
department
Accounts
statement
ESI statement
4.
The required amount is remitted into the ESI

account within 21 days from the end of the
due month.
Accounts
department
Accounts
statement
ESI statement
5.
Separate training classes are held and

handouts listing the benefits under the ESI
are given to the staff.
HR staff
HR training
material
6.
Staff may access investigations and treatment at Concerned staff

ESI-empanelled hospitals as needed.
116
Medical records
Billing details
Health and Treatment Benefits for Staff

The following are some of the health benefits which the SCHO may provide to the staff. This is
optional and entirely at the discretion of the management of the SCHO. Relevant areas may be
modified or deleted.
Type of benefit
Eligibility
Benefit
General health
insurance
For staff not covered

under ESI
Optional for the staff
Percentage contribution from the staff and

rest from the hospital
OPD
investigations
All staff
Percentage of discount
Staff dependents
All staff
Staff dependents
All staff
Percentage of discount for eligible room category

Percentage of discount on investigations
Percentage of discount on consultation and
professional fees for procedures
Staff dependents
Percentage of discount for eligible room category

Percentage of discount on investigations
Percentage of discount on consultation and
professional fees for procedures
OPD
consultations
Inpatient stay
Procedure
No.
Procedure
Responsibility
Supporting
Documents
1.
The details of the health benefits for staff and

their dependents is listed and maintained by
the HR department.
HR staff
List of health
benefits
2.
The staff are made aware of the benefits at the

time of joining the SHCO.
HR staff
HR training
material
3.
The front office, billing and admission desk

staff are responsible for extending the benefits
to the staff in times of need.
HOD of Front
office, Billing,
Admission
Internal
communication
4.
Staff should contact the HR In-charge in case

of difficulty in accessing the health benefits.
HR In-charge
117
SOP on Pre-exposure prophylaxis

Pre-exposure prophylaxis for Hepatitis B
1. Members of staff, at the time of joining, are evaluated for need of vaccination and then offered
vaccination.
2. If there is no evidence of Hepatitis B vaccination in the past, the vaccine series is started.
3. If there are low levels of antibody despite previous vaccination, then a booster dose is
indicated.
4. The vaccination schedule used for adults is three intramuscular injections, the second and third
doses administered at 1 and 6 months, after the first dose.
5. Costs for testing and vaccination may be borne by the hospital at its discretion.
SOP on post-exposure prophylaxis
The following steps are initiated after a needle-stick injury or exposure of skin and mucous
membranes to blood and body fluids.
A post-exposure prophylaxis is indicated when the staff member is exposed to blood or body fluid or
needle-stick injury.
l
Wound or mucous membrane management
- Clean wounds with soap and water.

- Flush mucous membranes with water.
- No evidence of benefit for application of antiseptics or disinfectants or squeezing
(milking) puncture site.
- Avoid the use of hypo or other agents.
l
Immediate reporting to designated individual (Casualty or Duty medical officer or Infection
Control officer).
- Date and time of exposure.
- Procedure details: what, where, how, with what device.
- Exposure details: route, body substance involved, volume or duration of contact.
- Information about source person and exposed person.
l
Post-exposure management: Assessment of infection risk.
- If source person testing is possible: test for presence of HBsAg/HCV antibody/HIV

antibody
- If source person testing is not possible: consider risk factors in the source that predict
higher incidence of HBV, HCV, HIV infection.
- Testing of needles and other sharp instruments is not recommended.
118
- Follow guidelines for post-exposure prophylaxis for individual situations.

- Medical Officer and Pharmacy In-charge are authorized to provide free evaluation,
testing and medication to staff that have been exposed.
Guidelines for post-exposure prophylaxis for Hepatitis B
Percutaneous (needle-stick) or mucosal exposure to HBsAg-positive blood or body fluids:
l
Unvaccinated
person: Administer Hepatitis B vaccine regimen and Hepatitis B

immunoglobulin within 24 hours.
l
Vaccinated person: Test exposed person for antibody to HBsAg. If adequate, no treatment
required. If not adequate, administer HBIG and one Hepatitis B vaccine booster dose.
Percutaneous (needle-stick) or mucosal exposure to HBsAg-negative blood or body fluids:
l
Unvaccinated person: Administer Hepatitis B vaccine regimen .
l
Vaccinated person: No treatment required.
Percutaneous (needle-stick) or mucosal exposure to HBsAg status-unknown blood or body fluids:

l
If known high-risk source, treat as if source were positive.
l
Unvaccinated person: Start the Hepatitis B vaccine regimen. If known high-risk source, treat
as if source were positive.

l
Vaccinated person: Test exposed person for antibody to HBsAg. If adequate, no treatment
required. If not adequate, administer one Hepatitis B vaccine booster dose.

Guidelines for post-exposure prophylaxis for Hepatitis C
The following are recommended for follow-up of occupational HCV exposures:
l
For the source, perform testing for anti-HCV.
l
For the person exposed to an HCV-positive source:
- Perform baseline testing for anti-HCV and ALT activity.

- Perform follow-up testing (for example, at 4-6 months) for anti-HCV and ALT activity (if
earlier, diagnosis of HCV infection is desired, testing for HCV RNA may be performed at 46 weeks).
- Confirm all anti-HCV results reported positive by enzyme immunoassay using
supplemental anti-HCV testing.
Healthcare professionals who provide care to persons exposed to HCV in the occupational setting
should be knowledgeable about the risk of HCV infection and appropriate counseling, testing, and
medical follow-up. IG and antiviral agents are not recommended for PEP after exposure to HCVpositive blood. In addition, no guidelines exist for the administration of therapy during the acute
phase of HCV infection. However, limited data indicate that antiviral therapy might be beneficial
when started early in the course of HCV infection. When HCV infection is identified early, the person
should be referred for medical management to a specialist knowledgeable in this area.
119
Guidelines for post exposure prophylaxis for HIV

HIV positive source:
l
Less severe exposure: Solid needle-stick or superficial injury.
HIV positive low viral load asymptomatic source - 2 drug PEP.

HIV positive high viral load, symptomatic source AIDS - recommend expanded 3 drug PEP.
l
More severe exposure: Large bore hollow needle, deep puncture, visible blood on device,
needle used in patient's artery or vein. HIV positive source. Recommend expanded 3 drug
PEP.
l
HIV negative source: No specific treatment
l
HIV unknown
source: Presence of high risk factors for exposure to HIV in the source.
Recommend 2 drug PEP.

No
Task
Responsibility
a. i.
Employee State Insurance Act applicability

in the SHCO
HR Staff
b.
List of staff whose gross salary is less than

Rs. 15,000 per month
HR staff
c.
Enrollment under ESI with all relevant supporting

evidences with the local ESI office
HR staff
d.
ESI card for the eligible staff
HR staff
e.
Calculation of contribution to ESI
HR department or Pay and

Accounts department
f.
Remittance of amount to ESI
Accounts department
g.
Separate training classes and handouts for

ESI beneficiaries regarding provisions under ESI
HR staff
h.
Pre-exposure prophylaxis
Hospital management
extends free/concession/partpaymentfor vaccines..
Pre- employment check-up
identifies staff for pre-exposure
prophylaxis (HR staff and
Physician/Infection control nurse).
HR creates the process flow for
staff member to be administered
the vaccine.
HR maintains records.
120
i.
Postexposure prophylaxis
General physician/ER physician to

identify potential situations for
postexposure prophylaxis and
describe the work flow.
SHCO management authorizes free
and timely treatment in these
situations as well as the procedure
to be followed General
physician/ER physician identify staff
who need post-exposure
prophylaxis after an incident.
Pharmacy staff are authorized to
dispense the required medication
to the caregivers.
HR staff or the Infection control
nurse or officer maintains records.
j.
Provision of safety measures - personal

protective equipment
A sufficient quantity of personal

protective equipment is made
available by the management.
In-charge of clinical areas keeps the
items ready at hand and supervises
its usage.
k.
Discounts for investigations or treatment for

general illness at the SHCO. Health insurance
cover for staff.
Authorized by the management.
IV. AUDIT CHECKLIST

No
Checkpoint
Yes
No
Remarks
i.
Employee State Insurance Act

applicability in the SHCO
Applicable/Not
Applicable
ii.
List of staff whose gross salary is less than

Rs. 15,000 per month
Available - Yes/No
Updated every month
- Yes/No
iii.
Eligible new staff enrolled under ESI
iv.
Remittance of amount to ESI
v.
Staff interview shows awareness of the

provisions under ESI
Monthly remittance Yes/No

Timely remittance
(within 21 days)
- Yes/No
121
vi.
Pre-exposure prophylaxis given for

concerned staff
vii.
Postexposure prophylaxis given following

an incident
viii.
Provision of safety measures - personal

protective equipment. Audited during
facility tour.
V. REFERENCES
CDC, Updated U.S. Public Health ServiceGuidelines for the Management of Occupational
Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis. MMWR,
2001, 50(No. RR-11). Available at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5011a1.htm
The Gazette of India, Registered no - DL (N) 04/0007/2003---13. Part II, Section I, No 18, New
Delhi, Tuesday, April 23, 2003 / Visakha 3, 1935 (SAKA).
WHO, Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and
Recommendations for Postexposure Prophylaxis. Available at
http://www.who.int/occupational_health/activities/5pepguid.pdf
122
Chapter 9
INFORMATION MANAGEMENT SYSTEM (IMS)
STANDARD IMS1. THE SHCO HAS A COMPLETE AND ACCURATE MEDICAL RECORD FOR
EVERY PATIENT.
Objective Elements
IMS1a. Every medical record has a unique identifier.*
IMS1b. The SHCO identifies those authorized to make entries in medical record.*
IMS1c. Every medical record entry is dated and timed.*
IMS1d. The author of the entry can be identified.*
IMS1e. The contents of medical records are identified and documented.
*Objective Elements IMS1a, IMS1b, IMS1c, and IMS1d are self-explanatory and therefore not
IMS1e. The contents of medical records are identified and documented.

I. OVERVIEW
Scope: To guide the management on how to ensure medical records are complete, accurate, and
readily retrievable for review by various stakeholders such as doctors, regulators, auditors, patients,
and administrators.
i.
The medical report contain demographic information including the patient's name, age
or date of birth, gender, address, telephone number, details of any legally-authorized
representative.
ii.
The SHCO decide the sequence in which these records can be stored (details in the next
section).
iii.
A copy of the discharge summary containing the discharge diagnosis, medications

advised on discharge, death summary, discharge against medical advice note, emergency
care management, among others, also be documented and filed.
123
iv.
The same are audited at the time of placement of these records within the Medical
Records Department. Any deficiency and incompleteness may be documented and
corrected.
v.
All the formats contain the UHID number and assembled chronologically.
vi.
All the documentation is made by the identified careproviders with date and time.

Policy and SOP on having a complete and accurate medical record for every patient.
Policy: It is the policy of the SHCO to provide complete and accurate medical records of the patient.
The SHCO shall decide the sequence in which these records can be stored. It may be as follows: (The
list may be expanded or trimmed as per the hospital policy)
l
Mandatory
documented requirements: Admission record, discharge summary or death

summary, initial assessment, consultations, lab reports, reassessment, doctors' orders,
nursing assessment, nurses' record, TPR/BP chart.
l
Where applicable, the record may include: consent forms, hemodialysis, chemotherapy,
diabetic charts, diet, pain assessment sheets, PAC/Anesthesia consent monitoring forms,
recovery charts, pre-op checklist, OT records, post-op records, surgical safety checklist,
intake-output chart, fluid chart, ICU monitoring chart, trauma/emergency sheet.
SOP on providing a complete and accurate medical record for every patient
No.
Process flow
Responsibility
Supporting Document
1.
All the medical records shall have

the UHID number.
Registration counter/
MRD
Medical record
2.
Required medical documentation

shall be completed by doctors/
nurses/dietitians/ physiotherapists,
as applicable.
Doctors/nurses/
dietitians/
physiotherapists, as
applicable
Medical record
3.
All the entries shall be dated,

timed, signed and named.
Doctors/nurses/
dietitians/
physiotherapists, as
applicable
Medical record
4.
The contents of the hospital record Top management and

shall be defined as per the clinical Quality team
requirement.
124
Hospital formats
No.
Process flow
Responsibility
Supporting Document
5.
All the formats shall be assembled Medical records officer

according to the sequence decided.
Medical record
6.
Once the records are assembled,

they shall be checked for accuracy
(UHID), and completeness
according to the required
documentation and formats.
Medical records officer
Medical record
7.
Deficiencies shall be identified in

the deficiency checklist and
corrective actions taken.
Deficiency checklist
Sequence in which medical records should be stored:

(The list may be expanded or trimmed as per the hospital policy)
i.
Mandatory documented requirements: admission record, discharge summary or death

summary, clinical information such as the reason(s) for admission, initial diagnosis,
findings of assessments and reassessments (by doctors/nurses/dietician/
physiotherapist), allergies, results of diagnostic and therapeutic tests and procedures,
final diagnosis, treatment goals, plan of care, revisions to the plan of care, progress notes,
any medications ordered or prescribed, other orders, any medications administered
including the strength, dose, frequency and route, any adverse drug reactions,
consultation reports, consent forms, counselling forms, lab reports, reassessment,
doctors' orders, nursing assessment, nurses' record, TPR/BP chart.
ii.
Where applicable, the document may also include consent forms, hemodialysis,
chemotherapy, diabetic charts, diet, pain assessment sheets, PAC, anaesthesia consent
monitoring, recovery charts, pre-op checklist, OT record, post-op record, surgical safety
checklist, intake-output chart, fluid chart, ICU monitoring chart, trauma/emergency
sheet.
The SHCO may decide the sequence in which these records are to be stored:
1.
Admission record / admission consent
2.
Consent forms
3.
Discharge summary /death summary / death certificate
4.
Trauma/Emergency sheet
5.
Initial assessment sheet (delivery report/partograph)
125
6.
Consultation sheets
7.
Lab report master
8.
Progress sheet
9.
Doctors' orders
10. Hemodialysis/chemotherapy/diabetic charts/diet/pain assessment sheets

11. PAC/Anesthesia consent monitoring/recovery charts
12. Preop checklist
13. OT record/post-op record
14. Surgical safety checklist/pain assessment
15. Intake-output chart
16. Fluid chart
17. Nursing assessment
18. Nurses' record
19. TPR/BP chart/ICU monitoring chart.
Sample audit checklist for deficiencies while submitting medical records to the MRD
Hospital Name
Hospital No. of the Patient
No.
Points to check
D/C*
1.
Final diagnosis in the

admission record
2.
Final outcome
3.
Signatures with date, name

and time
4.
Discharge summary
5.
Initial assessment form
6.
Consent forms
7.
OT/post-operative notes
8.
Death case sheet
Responsibility
Target Time
*D= Deficient ; C = Compliant.
126
UHID
Comments
No.
Tasks
Responsibility
i.
To decide on the content of the medical records,

formats and contents of the discharge summary
Administrative in-charge, MRD

and Medical records officer
ii.
To complete the sequencing of the medical records Medical records officer

formats
iii.
To check for completeness of the medical records
iv.
Deficiency check at the submission of the record to Medical records officer

MRD
v.
Corrections of the deficiencies
Medical officer
vi.
Getting the deficiencies corrected by the nursing/

medical officers within the target time
Medical officers, nurses,

physiotherapists, dietitians
(where applicable)
IV. AUDIT CHECKLIST

No.
Checkpoint
Yes
i.
The contents of medical records are identified and

documented in the SOP.
ii.
Samples of audited medical records have all the

documents, records and formats filed in the
medical records in a chronological manner as per
the SOP.
iii.
Date, time, name and signature of the medical

documentations have been accurately recorded.
iv.
Medical records are checked for deficiencies in

terms of accuracy and completeness.
127
No
Remarks
STANDARD IMS3. DOCUMENTED POLICIES AND PROCEDURES ARE IN PLACE FOR

MAINTAINING CONFIDENTIALITY, SECURITY, AND INTEGRITY OF RECORDS, DATA AND
INFORMATION.
Objective Elements
IMS3a. Documented procedures exist for maintaining confidentiality, security and integrity of
information.
IMS3b. Privileged health information is used for the purposes identified or as required by law and
not disclosed without the patient's authorization.*
*Objective Element IMS3b is self-explanatory and therefore not included in this Guidebook.
IMS3a. Documented procedures exist for maintaining confidentiality, security and integrity of
information.
I. OVERVIEW
Scope: To guide the SHCO on the safe management of confidentiality, integrity and security of
information stored in medical records such that loss, theft, and tampering are prevented.
i.
The patient is the owner of his or her medical record and no form of it should be made
available to any third party without written authorization from the patient. Access to the
Medical Records Department (MRD) is limited to authorized department staff.
ii.
The patient's relatives require written authorization from the patient to obtain
information from the medical records. The administrator or members of the Quality team
(for audit reasons), or court-of-law or police (for legal reasons) may have access to
information within medical records with an approved written request form. For patients
and the TPAs (for financial reasons), such information should not be given in its original
form; a photocopy of the same may be handed over to the patient after obtaining the
approved authorization.
iii.
Once the patient is discharged from the SHCO, the medical records can reach the MRD in a
stipulated time frame (defined by the SHCO).
iv.
The MRD is responsible for proper storage, retrieval, and maintenance of confidentiality
and security of the record.
128
v.
The Medical Records Officer (MRO) is the overall supervisor of the medical records from
when they are generated, through storing, until destruction. However, it is the
responsibility of every doctor/nurse/administrator to take care of the medical records at
their level -- in the wards or in the billing section -- to maintain the confidentiality and
privacy of information.
vi.
This is also applicable to all electronic information such as discharge summaries, cath lab
reports, lab reports, digitized X-Rays, electronic medical records, and any other electronic
information.

The policy on maintaining confidentiality, security and integrity of information.
Policy: The SHCO is committed to maintaining the confidentiality, integrity and security of vital
information of the patient contained in the medical record and to prevent its loss, theft or
tampering.
i.
The MRD is responsible for the proper storage and retrieval of the record as well as the
maintenance of confidentiality and security. During normal working hours, the SHCO
shall have at least one member of staff available in the department.
ii.
A tracer card process may be followed when a medical record is retrieved.
iii.
Regarding control on retrieval or accessibility of the medical record, the SHCO shall
l
Maintain records in a proper and accessible manner.
l
Hand
over the records as and when required by the chief administrator for
administrative purposes by getting a written requisition form duly signed.
l
Provide records required for MLCs in a court of law by the Consultant or MOs.
l
Provide inpatient records for the follow-up of inpatients by the Consultant as well as
by the patients.
l
Provide a discharge summary, investigation reports,
as and when required.
iv.
In case the patient's medical record data is lost or tampered with, the MRO shall
immediately inform the chief administrator, who is responsible for taking appropriate
action.
v.
At the end of the workday, the MRO is responsible for locking up the department. The key
should be handed over to the security post. Thereafter, the security department is
responsible for the protection of the medical record room.
vi.
If a medical record is requested by a doctor outside working hours, an MRO or a frontoffice executive or a medical officer with a security guard may retrieve it from the MRD
after proper documentation in a register including the patient's hospital number, name,
129
requesting doctor's name, retrieving doctor's/officer's name, employee code, purpose of

retrieval, and date and time of retrieval. The same should be verified by the security
guard's counter-signature in the same register. The MRO should subsequently follow up
on these records for completeness and integrity until they are returned to the MRD.
vii. The medical records stored in the MRD are prone to destruction by rodents, necessitating
the proper planning and implementation of pest control. A record must be maintained in
this regard.
viii. The medical records stored in the MRD must be protected from loss due to humidity,
adverse environmental conditions, and fire. Adequate measures should be taken to
safeguard against these safety threats. Periodic mock drills should preferably be
conducted.
ix.
The records which the hospital must preserve for the long term (such as medico-legal and
death files) may preferably be segregated, identified and stored in a separate area. The
same shall be retrieved and transported to a safer place in case of an emergency.
No.
Process Flow
Responsibility
Document/Record
1.
Once the deficiencies are corrected, the

records are stored in the medical records
as per the UHID or the SHCO policy.
MRO
MRD receiving
register
2.
Only the relevant care providers have

access to the medical records.
MRO/security staff
3.
A tracer card process shall be followed

when a medical record is retrieved.
The tracer card is prepared with the
patient's name and hospital number, the
requesting person's name, ward and
the date.
MRO
Tracer card
4.
The records are retrieved from the shelf

and a tracer card is maintained after
documenting the movement. The same
is also documented in a register.
MRO
Tracer card/
medical record
5.
Once the medical records are returned,

the records are checked for integrity or
tampering of information and stored in
place. The tracer card is then closed.
MRO
Medical records
130
No.
Process Flow
Responsibility
Document/Record
6.
The medical records stored in the MRD

shall be protected from loss due to
humidity, adverse environmental
conditions, and fire with adequate
measures being taken to safeguard
against these safety threats.
MRO
Pest control
records/fire safety
plan
7.
Whenever privileged health information

is required by law, the SHCO will provide
the information.
Top management/
MRO
Privileged
communication
record

No.
Tasks
Responsibility
i.
Proper storage and retrieval, and maintenance of

confidentiality and security of the record.
MRO
ii.
Tracer cards/tracer methodology implementation
MRO
iii.
Retrieval of medical records
MRO
iv.
Pest/rodent control
Administration in-charge/MRO
v.
Security and access control
Security staff
IV. AUDIT CHECKLIST

No.
Checkpoint
Yes
i.
Documented procedures are in place to maintain

the confidentiality, security and integrity of
information.
ii.
The documented procedures are implemented.
iii.
The audited sample of case sheets are wellprotected from loss, theft and tampering.
iv.
The process of retrieval of files is implemented.
v.
Missing files are traced.
vi.
Adequate fire detection and firefighting

equipment is available and mock drills are
conducted.
131
No
Remarks
STANDARD IMS4. DOCUMENTED PROCEDURES EXIST FOR RETENTION TIME OF THE

PATIENT'S RECORDS, DATA AND INFORMATION.
Objective Elements
IMS4a. Documented procedures exist for retention time of the patient's clinical records, data and
information.
IMS4b.The retention process provides expected confidentiality and security.*
IMS4c. The destruction of medical records, data, and information is in accordance with the laid
down procedure.
*Objective Element IMS4b is self-explanatory and therefore not included in this Guidebook.
IMS4a. Documented procedures exist for retention time of the patient's clinical records, data and
information.
IMS4c. The destruction of medical records, data and information is in accordance with the laid
down procedure.
I. OVERVIEW
Scope: To guide the SHCO on the retention of medical records as per legal and regulatory
requirements and on the destruction of records when they are not required.
i.
The records are stored in the MRD for the following retention period as per the
requirements.
Inpatient Record: Minimum of three years (as per MCI requirements)
Outpatient Record: As per the state law and hospital policy
Medico-Legal Record: Lifetime
Birth and Death Record: Lifetime
ii.
After the retention period, the medical record may be destroyed unless a competent
authority approves its further retention.
iii.
The destruction of medical records is achieved by shredding them.
132
iv.
If the process of destruction is outsourced, the hospital should take adequate measures
to safeguard against the leaking of information from these records.

i.
Policy and SOP on retention period of medical records.
ii.
Policy and SOP on destruction of medical records.
Policy: The SHCO retains its medical records (both outpatient and inpatient) as per the applicable
legal and regulatory requirements
Inpatient Record: Minimum of three years (as per MCI requirements)
Outpatient Record: As per the state law and hospital policy
Medico-Legal Record: Life time
Birth and Death Record: Life time
No.
Process Flow
Responsibility
Supporting Documents
1.
The retention policy for the

medical records, data and
information is defined as per the
regulatory requirements.
Quality team
SOP
2.
Medical records are retained

safely and securely as per the policy.
MRO
Medical records
3.
Medical records are verified for their

retention before destruction.
MRO
Verification list
Policy: The SHCO defines the process of the destruction of medical records in a safe and secure
manner after the completion of the retention period without compromising on the confidentiality
and privacy of the information.
133
No.
Process Flow
Responsibility
Supporting Documents
1.
The retention policy for the medical

records, data and information is
defined as per the regulatory
requirements.
Quality team
SOP
2.
Medical records which have been

stored beyond the retention period
are selected for destruction.
MRO
List of medical records

to be destroyed
(recorded in the
register)
3.
The SHCO may display the UHID

numbers of the medical records
being selected for destruction for
the information of the public.
MRO
Notification
4.
Medical records are verified for their

retention before destruction.
MRO
Verification list
5.
Written permission is obtained from

the MS before destruction.
MRO
Permission letter
6.
The selected medical records are

destroyed by shredding.
MRO
7.
If medical records are outsourced

for destruction, they are transported
in a safe manner and shredded in the
presence of the MRO or any other
personnel identified by the MS and
then handed over to the vendor for
disposal.
MRO
MOU with vendor

No.
Process Flow
Responsibility
i.
Preparation policy and SOPs
Quality team
ii.
Implementation of the retention policy/SOP
MRO
134
IV. AUDIT CHECKLIST

No.
Checkpoint
Yes
i.
Documented procedures are in place for retaining

the patients' clinical records, data and information.
ii.
The documented procedures are implemented.
iii.
The audited sample of case sheets are wellpreserved for the duration of the retention period.
iv.
The process of destruction of medical records is

defined and implemented.
v.
If the process of destruction is outsourced,

adequate measures are taken to safeguard against
leakage of information from these records.
No
Remarks
V. REFERENCES
Accreditation Standards for Hospitals, NABH, 3rd edition, November 2011.
Code Pink, 2006. Available at
http://www.the-hospitalist.org/article/code-pink/
Edna K. Huffman, Medical Record Management, Physicians' Record Company, 1st edition,1990.
Francis, C.M., C. Mario de Souza, Hospital Administration, Jaypee Brothers, 2004.
Indian Public Health Standards, Guidelines for MRD in Hospitals: Guidelines for District Hospitals,
Revision 2012, DGHS, Ministry of Health and Family Welfare, Government of India.
Preservation of Records, Code of Ethics Regulations, 2002, amended in 2009.
WHO, Medical Records Manual, A Guide for Developing Countries, Revised edition, 2006.
http://www.wpro.who.int/publications/docs/MedicalRecordsManual.pdf
135
APPENDIXES
Appendix 1
FORMATION OF HOSPITAL COMMITTEES
Hospital committees (or hospital teams, in case of limited human resources) can provide a platform
for multidisciplinary stakeholders to work together in implementing high-quality care across
SHCOs, and to conduct periodic evaluations for continuous improvement. The appointment and/or
re-appointment of members to these committees or teams will be made by the Medical Director.
Unless otherwise stated, the committees or teams will include a broad representation of
stakeholders and shall consist of an appropriate number of individuals to be of an effective, yet
manageable, size.
The membership to a committee or team is determined by a nomination process for a term of one
year. The committee/team chairperson may co-opt additional members on a temporary basis
according to need, and will inform the Medical Director of any additional members. The
committees/teams are required to meet as per calendars planned, monthly or quarterly (or earlier
if there are issues that require attention). If a member does not attend three consecutive meetings,
he or she will automatically lose membership and be replaced. Each committee/team will record
the minutes of each meeting, including the list of attendees. Actions will be closed in a timely
manner. The list of the various medical committees/teams is given below, along with a detailed note
on their purpose, responsibilities and composition.
1.
Performance Improvement and Safety Committee
2.
Infection Control Committee
3.
CPR Committee
4.
Pharmacy and Therapeutics Committee
1. PERFORMANCE IMPROVEMENT AND SAFETY COMMITTEE/ TEAM

Purpose
To develop a Quality Management Program that is systematic, organization-wide and consistent
with the mission, vision and values of the SHCO.
Responsibilities
l
To monitor,
evaluate and improve care of patients so as to ensure high standards of

quality and safety for patients.
136
l
To ensure the protection of patient rights and ethical practices across the organization.
l
To hold
leaders, work groups, departmental heads and managers accountable for the
application of performance improvement principles and the aggressive pursuit of
improved performance.
l
To define the accreditation roadmap of the organization and ensure compliance to NABH
accreditation standards.
l
To review
the quality measurement reports of the hospital and of departments and

services as well as to benchmark data from external sources.
l
To ensure
that staff education plans are in accordance with quality improvement
priorities.
l
To oversee
risk management activities for the hospital, such as training programs in fire
safety and biomedical waste management.
l
To oversee and review the effectiveness of other medical committees.
l
To review or delegate to other appropriate committees or departments, the examination
of patient complaints, incident reports, or other matters involving quality of care and
clinical performance, and ensuring that appropriate action is taken for the problems that
have been identified. This includes but is not limited to:
v
Appropriateness of care
v
Medical assessment and treatment of patients
v
Critical Incident Review
v
Effectiveness of care
v
Use of clinical guidelines
v
Clinical audits against established standards and clinical indicators
v
Morbidity and mortality reviews
l
To evaluate patient satisfaction and the quality of patient care through an objective and
systematic monitoring of services, complaints and MLCs, and to recommend and oversee
corrective and preventive actions.
137
Sample Composition
No.
Composition
Designation
1.
Medical Superintendent/ Head of Hospital
Chairperson
2.
Medical Quality
Coordinator
3.
Clinical HODs of 3-4 Departments
Member
4.
Emergency Head
Member
5.
Nursing Head
Member
6.
MRD Head
Member
2. INFECTION CONTROL COMMITTEE/TEAM

Purpose
To ensure that there is an active, effective, institution-wide infection control program that develops
effective measures to prevent, identify, and control infections acquired in the hospital or brought
into facilities from the community. It provides a multidisciplinary forum for laying down the
infection control policies and procedures and ensures their implementation.
Responsibilities
l
To oversee
the infection control program of the SHCO, so as to ensure that the best
standards are in place and that risks of infection are minimized.
l
To ensure that infection control policies and procedures are being consistently followed
throughout the SHCO.

l
To assess
hospital-acquired infection rates through regular surveillance, and to ensure

that interventions are prioritized in order to reduce these rates.
l
To monitor surveillance data and identify opportunities for improvement.
l
To advise
on matters related to the proper use of antibiotics, to develop antibiotic

policies, and to recommend remedial measures when antibiotic-resistant strains are
detected.
l
To ensure
that training programs on infection control-related parameters (such as hand

hygiene or biomedical waste segregation) are held for staff on a regular basis.
138
Sample Composition
No.
Composition
Designation
1.
HOD Anesthesia/ Internal Medicine/

Microbiology
Chairperson
2.
Quality Manager
Coordinator
3.
Medical Administration (MS)
Member
4.
3-4 HODs (Clinical)
Member
5.
Nursing Head
Member
6.
Infection Control Nurse
Member
7.
Staff Representation from CSSD
Member
8.
Head of Support Services
Member
9.
Head of Engineering
Member
10.
Head of Food and Beverages
Member
11.
Head of Housekeeping
Member
3. CPR COMMITTEE /TEAM

Purpose
To ensure an effective hospital-wide Cardio Pulmonary Resuscitation (CPR) program.
Responsibilities
l
To
ensure that policies and procedures related to CPR are consistently followed
throughout the organization.
l
To ensure
CPR training for all staff in CPR, training for selected staff, and to ensure that
they understand their roles and responsibilities for code blue.
l
To use
simulation in the form of mock drills in order to assess the responsiveness and
competence of the CPR Team.
l
To advise
on the design and implementation of the audit process that monitors the
incidence and outcomes of cardiac arrest/medical emergency calls.
l
To ensure the availability and maintenance of the equipment and drugs required.
139
l
To advise on the appropriate choice of equipment and medicines for use in resuscitation
procedures.
l
To offer
guidance on the minimum level of resuscitation training for individual staff

groups based on their role and exposure to cardiac arrest/emergency situations.
l
To review all cardiac arrest case files to assess the adequacy of response and to evaluate
the scope of improvement for the same.

Sample Composition
No.
Composition
Designation
1.
HOD Emergency
Chairperson
2.
Medical Administrator (MS)
Coordinator
3.
Medical Quality
Member
4.
Nursing Head
Member
5.
Emergency Doctor
Member
6.
Anesthesia Representative
Member
7.
ICU Representative
Member
8.
HOD Security
Member
4. PHARMACY AND THERAPEUTIC COMMITTEE /TEAM

Purpose
To ensure that the selection, compliance, distribution, storage, safe use, and administration of
drugs within the SHCO are as per standards laid down.
Responsibilities
l
To
ensure that policies and procedures related to medication management are

consistently being followed throughout the SHCO.
l
To manage the drug formulary system by evaluating the usage of medications periodically
and requesting additions or deletions.

l
To move
the SHCO towards a generic drug regime and away from the branded drug
system.
l
To monitor
adverse drug events and ensure that corrective and preventive actions are
taken.
140
Sample Composition
No.
Composition
Designation
1.
Clinical HOD
Chairperson
2.
Pharmacy Head
Coordinator
3.
Medical Administrator (MS)
Member
4.
3-4 Clinical HODS
Member
5.
Quality Manager
Member
6.
Nursing Head
Member
141
Appendix 2
FREQUENTLY ASKED QUESTIONS (FAQs)
ACCESS, ASSESSMENT AND CONTINUITY OF CARE (AAC)

What is scope of service?
The scope of service refers to the range of clinical and supportive activities that are provided by a
healthcare organization. For example, clinical activities: general medicine, general surgery,
paediatrics, OBG; and support services: ambulance, pharmacy.
How can the scope of services provided by an SHCO be displayed?
The scope of services provided by the SHCO should be displayed at least bilingually (English and the
State language or the language spoken by the majority of the people in that area). The display
boards should be permanent in nature and in an area visible to all patients and visitors entering the
SCHO.
Who is responsible for defining the general scope of services of the SHCO?
The Administrative Head of the organization in consultation with the department heads will define
the scope of services.
While applying for accreditation, is it necessary to mention the scope of all services available,
including outsourced services such as laboratory services?
Yes. While applying for accreditation, the scope of all services available including outsourced
services shall be mentioned. Whenever a new service is added, the same shall be communicated to
the accreditation authority according to the agreement.
Do all patients coming to the SHCO have to be registered?
Yes, all patients who are assessed in the SHCO, including those in the Emergency department and
OPD, shall be registered and given a unique identification number to ensure continuity of care.
What is an Initial Assessment?
This is the first assessment done on the patient within the defined time-frame. The initial
assessment includes activities such as history-taking, a physical examination, and laboratory
investigations that contribute towards determining the prevailing clinical status of the patient.
What is the defined time-frame for the Initial Assessment?
The time-frame shall be from the time that the patient has registered until the time that Initial
Assessment is documented by the treating consultant or nurse. The SHCO shall define its timeframe for the Initial Assessment based on the organizational resources/patient load/patient
condition.
142
What is 'critical result'?

This is a test result beyond the normal variation with a high probability of a significant increase in
morbidity and/or mortality in the foreseeable future and requires rapid communication of results
to determine intervention. Critical results are those result values which require immediate
attention by the consultant/nurse, failing which there is a danger of harm to the patient.
Should a discharge summary be given to all patients discharged from the SHCO?
Yes. A discharge summary should be given to all patients discharged from the SHCO, including
patients leaving against medical advice (LAMA)/on request/MLC patients.
What is the defined content of a discharge summary?
A discharge summary shall contain the following:
l
Patient name
l
Unique Identification Number
l
Date and time of admission and discharge
l
Reason for admission
l
Significant findings
l
Information regarding investigation results
l
Diagnosis and any procedure performed
l
Medication administered
l
Other treatment given
l
Patient condition at the time of discharge
l
Follow-up advice
l
Medication and other instructions in an understandable manner
l
How and when to obtain urgent care
l
Name and signature of the doctor
CARE OF PATIENTS (COP)

Is it mandatory to have Code Pink?
It is not mandatory, but it is preferable to have a Code Pink protocol.
What constitutes an MLC (Medico-Legal Case)?
An MLC can be defined as a case of injury or ailment in which investigations by law-enforcement
agencies are essential to fix the responsibility regarding the causation of the said injury or ailment.
In other words, it is a medical case with legal implications for the attending doctor where the
143
attending doctor, after eliciting history and examining the patient, believes that some investigation
by law enforcement agencies is essential.
How should an MLC certificate be given?
The following link provides examples and formats for different types of MLC:
http://dhs.kerala.gov.in/docs/orders/code.pdf
How does one seal samples in MLC situations?
This link provides details on sealing samples: https://www.youtube.com/watch?v=J4N4h9IBYqc
What is triage?
During a medical triage, patients' injuries or ailments are evaluated and sorted according to the
urgency of the treatment required. This is an effective strategy in situations where there are many
patients and only limited resources available in a short time-period, such as after a natural disaster
or terrorist attack. Triage should take place as soon as possible after victims are located or rescued.
During medical triage, the victims' conditions are evaluated and prioritized into four categories:
-
Immediate (I): The victim has life-threatening injuries (airway, bleeding, or shock) that
demands immediate attention to save his or her life; rapid, lifesaving treatment is urgent.
Delayed (D): Injuries do not jeopardize the victim's life. The victim may require professional
care, but treatment can be delayed.
Minor (M): Walking, wounded and generally ambulatory.
Dead (DEAD): No respiration after two attempts to open the airway. Because CPR is
one-on-one care and is labour-intensive, CPR is not performed when there are many more
victims than rescuers.
What is a high-risk pregnancy?

Any pregnancy that requires support from a medical team and has a risk of mortality or morbidity,
i.e. prolonged hospitalization, complex surgical or medical intervention or that has co-morbid
medical or surgical conditions, is called high-risk pregnancy.
MANAGEMENT OF MEDICATIONS (MOM)
What are the minimum requirements of a prescription order?
The prescription shall be written by a doctor and the minimum requirements to be included are:
o Patient's name, age and sex
o IP/OP number
o Date of prescription
o Ward or department name
o Form of the drug: tablet, injection or syrup
144
o Name of the drug (generic name) written in block letters

o Dosage of the drug (500mg, 1g, etc.)
o Route of administration (oral, etc.)
o Time and frequency of administration (before food, once a day, etc.)
o Duration of treatment (for one week, two weeks, etc.)
o Doctor's full name and signature
What is a medication recall?
A medication recall is the removal of a drug from a sub-store/ward because it is either defective or
potentially harmful. The pharmacist is responsible for the recall of medication.
What are the statutory requirements for a hospital pharmacy?
All laws, regulations, directives, guidelines and licensure requirements of the drugs control
department and excise department should be met. The department should have, at all times, a valid
and current pharmacy license issued by the drug control department. This should be posted in
public view within the premises. All pharmacists must maintain valid and current registrations with
the state pharmacy council according to law. A photocopy of the current registration certificate of
the pharmacist shall be kept in the pharmacy file. All required records will be maintained by the
Pharmacy Department, including Narcotic requisitions (for 1 year) within their record books.
a. Licenses:
i. Retail license - Form 20 & Form 21

ii. Wholesale drug license - Form 20B & Form 21B
iii. Narcotic license - Form V (NDV)
b. Registration certificates: State Pharmacy council registration certificate

c. Acts:
i. Pharmacy Act, 1948

ii. Drugs and Cosmetics Act, 1940
iii. Narcotics and Psychotropic Substances Act, 1985
iv. Drugs and Magic Remedies Act, 1954
How are psychotropic and narcotic drugs managed?

Narcotic drugs are always kept in a separate almirah under lock and key. The stock/narcotic register
should have the following information:
a. For ward/departments: serial number of the entry register, date, quantity of drugs issued from
pharmacy, serial number of the indent, indent duly signed by the MD/DMS.
b. For OP/IP patients: Serial number of the entry register, date, name of the patient, name of the
consultant.
There should be proper handing-over of the stock with signature of the staff who hands over and
145
takes over. Empty ampules should be returned to the pharmacy against which narcotics will be
issued. There will be a separate entry register for broken ampules.
What are verbal medication orders and who can carry out verbal orders?
Verbal orders are carried out only during medical emergencies where the ordering doctor is not
available to write the order and any delay will result in compromised patient care. Verbal orders
shall only be accepted by a registered nurse. The verbal order shall be documented by the nurse
who accepts the order, including the name of the doctor issuing the order. The nurse accepting the
order shall record and then read back the order to the doctor and document the same. The verbal
order must be signed by the doctor as soon as possible.
HOSPITAL INFECTION CONTROL (HIC)
What are nosocomial infections? How are they transmitted?
Nosocomial infections or healthcare associated infections are defined as infections acquired
during, or as a result of, hospitalization. Generally, a patient who develops an infection after 48
hours of hospitalization is considered to have healthcare associated infections (HAIs). Such
infections can be transmitted through contact, droplets, and air.
What is MRSA? What is the single most important factor in containing MRSA?
MRSA is Methicillin-Resistant Staphylococcus Aureus. The single most important factor in
containing (prevention of) MRSA is maintaining good hand hygiene.
What forms of protection are necessary to prevent the spread of respiratory infections?
Heavy-duty N95 or N97 masks should be used for open pulmonary tuberculosis or suspected
pulmonary tuberculosis, and surgical masks for other common droplet infections, for example,
respiratory viral illness. Surgical masks can also be used to contain transmission of invasive
meningococcal disease (Meningococcal Meningitis and meningococcemia). Nonimmune or
pregnant staff should not enter the room of patients known or suspected to have rubella, varicella,
and measles.
What are the common modes of sterilization used in hospitals?
Common modes of sterilization are steam sterilization (autoclave), gas sterilization (ethylene
oxide), and hot air oven.
What is CSSD and what is its purpose? List the zones of CSSD.
CSSD stands for Central Sterile Supply Department. The purpose of CSSD is to provide all the
required sterile items required in a hospital in order to meet the needs of all patient care areas.
CSSD is divided into 3 zones: soiled (decontamination), clean zone (packaging), and sterile zone
(sterilization and storage).
146
CONTINUOUS QUALITY IMPROVEMENT (CQI)

What is CQI?
Continuous Quality Improvement is the term used for improvement in the structures and processes
that will lead to improvement in outcomes. Since quality does not have an end point, it is a constant
journey where the improvement process has to be continuous.
What is a Key Performance Indicator (KPI)?
KPIs are measurable indicators that measure the performance of a structure, process or outcome.
These indicators are important as they affect the quality of care, performance, and safety in an
SHCO.
Is measuring the KPIs the responsibility of the Quality Officer?
The Quality Officer should ensure that the KPIs are collected and analyzed, and that appropriate
actions are taken. But all the stakeholders have to participate and contribute for effective quality
improvement.
How many KPIs should be developed?
The SHCO can develop any number of KPIs, but it is imperative to capture at least some common
indicators. If the organization feels that a particular area needs improvement, the indicators for that
particular area can be captured as a tool for improvement. For example, if an SHCO wants its
surgeons to start the Operation Theatre before 8.30 a.m., an indicator can be developed to monitor
the percentage of surgeries that start before 8.30 a.m.
What should the sample size be?
The NABH standards can be referred to for formula and sample size. However, at least 10% of the
total population is a reasonable sample size.
Who should analyze the KPIs?
All the stakeholders, the Quality officer and a representative from administration should analyze
the data collected in order to reach the appropriate corrective and preventive actions.
What is root-cause analysis?
Every problem might have many superficial and apparent causes but on thorough investigation, a
root cause can be found. It is very important to identify the root cause, otherwise the solution will
not be effective. Many statistical tools like the 5-why analysis or fish-bone analysis can be used to
find out the root cause.
What is CAPA (Corrective and Preventive Action)?
Whenever an incident takes place or the data shows a problem, there has to be corrective action
aimed at solving the problem immediately. But a much more focused effort should be made to
contemplate and implement preventive actions.
147
What is a "trend"?
When data over a period of months is depicted in the form of a graph, it is easier to see whether
quality is improving or deteriorating. This is known as a trend. However, in the initial phases of the
quality journey, the trend appears to be downward because of improved data collection.
Are there any special precautions to be taken while measuring KPIs?
Indicators should be carefully chosen so that they really measure the important performance.
There should be no bias in data collection. The formula used should be correct and the data has to
be validated by an authorized person. The proper root cause has to be identified, and corrective and
preventive action implemented. There should be a constant collection of data to see the
effectiveness of implementation of actions. If these points are not taken care of, KPIs may give
incorrect information regarding performance, which may turn out to be detrimental.
RESPONSIBILITIES OF MANAGEMENT (ROM)
What is an organogram? How frequently does it have to be updated?
An organogram is the graphic representation of a reporting relationship in an organization. It has to
be updated at least once a year, or as and when there are changes made in the organizational
structure.
What should the mission statement be comprised of?
The mission should define the following:
1. Purpose of the organization
2. Strategy of the organization
3. Values of the organization
FACILITIES MANAGEMENT AND SAFETY (FMS)
What is MSDS and why is it required?
A Material Safety Data Sheet (MSDS) is a document that contains information on the potential
hazards of a chemical and how to work safely with it. It is an essential starting point for the
development of a complete health and safety program. An MSDS is prepared by the manufacturer
of the material. It should explain the hazards of the product, how to use the product safely, what to
expect if the recommendations are not followed, what to do if accidents occur, how to recognize
symptoms of overexposure, and what to do if such incidents occur.
Why should medical gas pipelines have standardized colour coding? What standard should SHCOs
follow for colour coding?
Since health risks can result from using the wrong medical gas, medical gas pipelines should be
colour coded. This will also help in identifying problems in different lines and isolating them if
148
required. The color coding may follow standards such as IS/ISO 9170-1 : 2008, NFPA 99. HTM, ANSI
and CGA C-9 standards.
What building norms should be followed while constructing an SHCO? Where are the fire
protection and detection requirements for buildings to be found?
The National Building Code of India (NBC), a comprehensive building code, provides guidelines for
regulating the building construction activities across the country. The Code contains administrative
regulations, development control rules and general building requirements; fire safety
requirements; stipulations regarding materials, structural design and construction (including
safety); and building and plumbing services.
Considering a series of developments in the field of building construction including the lessons
learnt in the aftermath of a number of natural calamities like devastating earthquakes and super
cyclones, the NBC was revised and has now been published as the National Building Code of India
2005 (NBC 2005). The comprehensive NBC 2005 contains 11 Parts some of which are further divided
into Sections, totalling 26 chapters.
Part 4 of the National Building Code covers the requirements for fire prevention, life safety in
relation to fire and fire protection of buildings. The Code specifies construction, occupancy and
protection features that are necessary to minimize danger to life and property from fire.
HUMAN RESOURCES MANAGEMENT (HRM)
What is a grievance-handling mechanism?
The sequence of activities carried out to address the grievances of patients, visitors, relatives and
staff is known as the grievance-handling mechanism. The mechanism describes whom the staff,
patient and patient attenders may contact to review the facts of the case by a grievance redressal
officer or committee.
INFORMATION MANAGEMENT SYSTEM (IMS)
Is it mandatory to have a medical records officer?
No, it is not mandatory. However, in view of the many processes involved and the large amount of
information to be preserved and managed, it is preferable for an SHCO to appoint a medical records
officer (MRO) to take care of the same.
149
Appendix 3
GLOSSARY
l
Assessment - All activities including history-taking, physical examination, and laboratory
investigations that contribute towards determining the prevailing clinical status of the
patient.
l
Biomedical
equipment - Any fixed or portable non-drug item or apparatus used for

diagnosis, treatment, monitoring and direct care of the patient.
l
Confidentiality
- Restricted accesses to information to individuals who have a need, a

reason and permission for such access. It also includes an individual's right to personal
privacy and privacy of information related to his/her healthcare records.
l
Hazardous material - Substances dangerous to human and other living organisms which
include radioactive or chemical materials.

l
Hazardous waste - Waste materials dangerous to living organisms. Such materials require
special precautions for disposal. They include biologic waste that can transmit disease
(for example, blood and tissues), radioactive materials, and toxic chemicals. Other
examples are infectious waste such as used needles, used bandages and fluid-soaked
items.
l
Information: Processed data which lends meaning to the raw data .
l
Inventory
control: The method of supervising the intake, use and disposal of various
goods in hands. It relates to supervision of the supply, storage and accessibility of items in
order to ensure 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
minimize total costs.
l
Maintenance:
The combination of all technical and administrative actions, including

supervision action, intended to retain an item in, or restore it to, a state in which it can
perform a required function. (British Standard 3811: 1993)
l
Patient record/Medical record: A document which contains the chronological sequence
of events that a patient undergoes during his stay in the SHCO.

l
Policies: They are the guidelines for decision-making, e.g. admission, discharge policies,
antibiotic policy, etc.

l
Procedures: A specified way to carry out an activity or a process (Para 3.4.5 of ISO 9000:
2000) or a series of activities for carrying out work, which when observed by all, helps to
150
ensure the maximum use of resources and efforts to achieve the desired output.
l
Process: A set of interrelated or interacting activities which transform inputs into outputs
(Para 3.4.1 of ISO 9000: 2000).

l
Protocol:
A plan or a set of steps to be followed in a study, an investigation or an

intervention.
l
Referral-out
of patient: Safe transfer of a patient to another organization due to nonavailability of required resources including expert /equipment / facility.
l
Risk
assessment: Risk assessment is the determination of quantitative or qualitative

value of risk related to a concrete situation and a recognized threat (also called hazard).
Risk assessment is a step in a risk management procedure.
l
Risk management: Clinical and administrative activities to identify, evaluate, and reduce
the risk of injury.

l
Risk reduction: The conceptual framework of elements considered with the possibilities
to minimize vulnerabilities and disaster risks throughout a society to avoid (prevention)

or to limit (mitigation and preparedness) the adverse impacts of hazards, within the
broad context of sustainable development.
(Source: http://www.preventionweb.net/english/professional/terminology/)
It is the decrease in the risk of a healthcare facility, given activity, and treatment process
with respect to patient, staff, visitors and the community.
l
Scope of service: Range of clinical and supportive activities that are provided by an SHCO,
e.g. clinical activities: General medicine, General surgery, Paediatrics, OBG, etc.; support
services: Ambulance, Pharmacy, etc.
l
Security: Protection from loss, destruction, tampering, and unauthorized access or use.
l
Unstable
patient: A patient whose vital parameters need external assistance for their
maintenance.
Note: The complete glossary is available in the NABH Manual on Accreditation Standards for
Hospitals, 3rd Edition, November 2011.
151

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GUIDEBOOK FOR

PRE-ACCREDITATION ENTRY-LEVEL STANDARDS

NATIONAL ACCREDITATION BOARD FOR HOSPITALS AND

PRE-ACCREDITATION ENTRY-LEVEL STANDARDS

NATIONAL ACCREDITATION BOARD FOR HOSPITALS AND

All Rights Reserved

National Accreditation Board for Hospitals and Healthcare Providers

Chapter 1. ACCESS, ASSESSMENT AND CONTINUITY OF CARE (AAC). . . . . . . . . . . . . . . . . . . . . . . . 09

The services being provided are clearly defined.

The SHCO has a documented registration, admission and transfer process. . . . . . 12

Process addresses registering and admitting outpatients, inpatients,

Process addresses mechanism for transfer or referral of patients who

Patients cared for by the SHCO undergo an established initial assessment. . . . . . 17

Procedures guide collection, identification, handling, safe transportation,

The SHCO has a defined discharge process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Process addresses discharge of all patients including medico-legal cases

Discharge summary contains the reasons for admission, significant findings,

Chapter 2. CARE OF PATIENTS (COP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Emergency services including ambulance are guided by documented . . . . . . . . . 31

Documented procedures address care of patients arriving in the

National Accreditation Board for Hospitals and Healthcare Providers

Documented procedures define rational use of blood and blood products. . . . . . 41

Procedure addresses documenting and reporting of transfusion reactions.

Documented procedures guide the care of patients as per the scope of . . . . . . . 44

Care of patient is in consonance with the documented procedures.

Documented procedures guide the care of obstetrical patients as per . . . . . . . . . 48

The SHCO defines the scope of obstetric services.

Documented procedures guide the care of pediatric patients as per . . . . . . . . . . 50

The SHCO defines the scope of its pediatric services.

Procedure addresses identification and security measures to prevent child

Documented procedures guide the administration of anesthesia. . . . . . . . . . . . . 54

There is a documented policy and procedure for the administration of

Documented procedures guide the care of patients undergoing . . . . . . . . . . . . . 57

Documented procedures address the prevention of adverse events like

Chapter 3. MANAGEMENT OF MEDICATION (MOM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

Documented procedures guide the organization of pharmacy services and . . . . . 63

Documented procedures incorporate purchase, storage, prescription,

Documented procedures address procurement and usage of implantable prosthesis.

Documented procedures guide the prescription of medications. . . . . . . . . . . . . . 71

Chapter 4. HOSPITAL INFECTION CONTROL (HIC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74

The SHCO has an Infection Control Manual which it periodically updates; . . . . . 74

Chapter 5. CONTINUOUS QUALITY IMPROVEMENT (CQI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

The SHCO identifies key indicators to monitor the structures, processes, . . . . . . 76

The SHCO identifies the appropriate key performance indicators in both

National Accreditation Board for Hospitals and Healthcare Providers

Chapter 6. RESPONSIBILITIES OF MANAGEMENT (ROM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80

The responsibilities of the management are defined. . . . . . . . . . . . . . . . . . . . . . 80

The SHCO has a documented organogram.

The SHCO is managed by the leaders in an ethical manner. . . . . . . . . . . . . . . . . . 83

The management makes public the mission statement of the SHCO.

Chapter 7. FACILITY MANAGEMENT AND SAFETY (FMS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

The SHCO's environment and facilities operate to ensure safety of patients, . . . . 87

There is a documented operational and maintenance

There is a maintenance plan for medical gas and vacuum systems.

The SHCO has plans and provisions for detection, abatement,

Chapter 8. HUMAN RESOURCE MANAGEMENT (HRM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

The SHCO has a well-documented disciplinary and grievance . . . . . . . . . . . . . . 109

A documented procedure regarding disciplinary and grievance handling is in place.

The documented procedure is known to all categories of employees in the SHCO.

The SHCO addresses the health needs of its employees. . . . . . . . . . . . . . . . . . . 115

Health problems of the employees are taken care of in accordance with

Chapter 9. INFORMATION MANAGEMENT SYSTEM (IMS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

The contents of medical records are identified and documented.