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GUIDEBOOK FOR

PRE-ACCREDITATION ENTRY-LEVEL STANDARDS


FOR SMALL HEALTHCARE ORGANIZATIONS (SHCOs)
First Edition: May 2015

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PROGRASSIVE LEVEL
Accreditation

Pre-Accreditation
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ENTRY LEVEL
(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.
2 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.
3 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.
4 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.
5 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.

National Accreditation Board for Hospitals and Healthcare Providers


7 COP3 Documented procedures define rational use of blood and blood products. . . . . . 41
COP3c Procedure addresses documenting and reporting of transfusion reactions.
8 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.
9 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.
10 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.
11 COP7 Documented procedures guide the administration of anesthesia. . . . . . . . . . . . . 54
COP7a There is a documented policy and procedure for the administration of
anesthesia.
12 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 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.
14 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.

National Accreditation Board for Hospitals and Healthcare Providers


Chapter 6. RESPONSIBILITIES OF MANAGEMENT (ROM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
17 ROM1 The responsibilities of the management are defined. . . . . . . . . . . . . . . . . . . . . . 80
ROM1a The SHCO has a documented organogram.
18 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 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.
20 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.
21 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.
22 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 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.
24 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 IMS1 The SHCO has a complete and accurate medical record for every patient. . . . . . 123
IMS1e The contents of medical records are identified and documented.
26 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.

National Accreditation Board for Hospitals and Healthcare Providers


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

National Accreditation Board for Hospitals and Healthcare Providers


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 pre-
accreditation 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.

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National Accreditation Board for Hospitals and Healthcare Providers
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.

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National Accreditation Board for Hospitals and Healthcare Providers
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

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National Accreditation Board for Hospitals and Healthcare Providers
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.

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National Accreditation Board for Hospitals and Healthcare Providers
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 co-
authors 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.

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National Accreditation Board for Hospitals and Healthcare Providers
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

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National Accreditation Board for Hospitals and Healthcare Providers
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 National Accreditation Board for Hospitals and Healthcare Providers

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

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National Accreditation Board for Hospitals and Healthcare Providers
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

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National Accreditation Board for Hospitals and Healthcare Providers
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.

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National Accreditation Board for Hospitals and Healthcare Providers
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):

Clinical services
l

Support services
l

Additional services
l

Service exclusion, if any


l

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

Laboratory
l
Medical Records Department
Radiology-
l X-Ray, CT Scan, USG,
Mammogram

Pharmacy

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National Accreditation Board for Hospitals and Healthcare Providers
The scope of service for a department may be as follows:
Department of Imaging Services:
The department provides the following types of services:
General X-Ray
l

Barium Meal X-Ray


l

Special X-Ray such as HSG


l

Ultrasonography
l

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 Assigned staff
services' and place the same in an SOP manual
iv. Availability of the valid license related to the Administrative department
specific department
v. Display prominently the scope of services in two Administrative department/
languages 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 No Remarks


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

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National Accreditation Board for Hospitals and Healthcare Providers
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.
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 preparing a process for registering and admitting outpatients,
inpatients, and emergency patients.
It is recommended that:
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.

II. REQUIRED DOCUMENTS


i. Policy and SOP on registration
ii. Policy and SOP on admission

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National Accreditation Board for Hospitals and Healthcare Providers
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 Register
first-come first-served basis.
B The following details are taken Registration clerk Registration form
from the patient or relative:
Name, age, sex, occupation,
annual income, address, phone
(mobile/landline).
C The referral slip, if present, Registration clerk Referral slip
should be checked to identify
the specialty. If there is no
referral slip, the patient shall be
registered as specified by herself/
himself.
D The details are entered into the Registration clerk Register/OPD slip
OPD slip and the bill is raised.
E The patient is directed towards Registration clerk
the concerned OPD consultation
area.
F After the consultation, if there is Consultant OPD slip/referral book
any change in the specialty,
the patient is referred to the
concerned specialty OPD.
G Emergency registration is done Registration Register
24 hours a day. clerk/Emergency
registration counter
H For unidentified patients, Registration clerk Register
registration shall be done as a
medico-legal case (MLC).
I Patients revisiting the OPD for a Registration clerk Register
follow-up consultation shall be
re-registered; however, the same
Unique Hospital Identifier (UHID)
will continue.

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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


A Inpatient admission shall be done Admission Clerk Admission Register
through the OPD or the
Emergency department or the
NICU/Labour ward as applicable.
B The decision regarding admission Treating Doctor Admission slip/order
shall be made by the consultant
and an admission slip or order
issued by her/him.
C General consent for admission Treating Doctor General consent form
and treatment is obtained from the
patient and the patient's relative.
D The order for admission shall be Treating Doctor Admission note
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.
E At the admission counter, the Admission Clerk Admission note
consultant's note is checked for
admission.
F The IPD number and demographic Admission Clerk Admission file and
details of the patient are put into receipt
the admission register/computer
to generate an admission file
(case sheet). This is handed over
to the patient and the admission
fee is collected.
G The patient is directed to the Treating doctor/ staff Bed allotment record
concerned ward, where the bed nurse/ward attendant
will be allotted.
H The patient is received at the ward Staff nurse Medical record
by the ward nurse and allotted a bed.
Treatment is initiated as per the order.
The patient is oriented to the ward.

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National Accreditation Board for Hospitals and Healthcare Providers
III. TASKS AND RESPONSIBILITIES

No. Task Responsibility


i. Define the registration, admission and transfer Top management
process.
ii. Define the department policy on admission and Top management in consultation
transfer process with the specific department head
iii. Preparation of policy Quality team
iv. Staff orientation to the scope of service Quality team /training cell

IV. AUDIT CHECKLIST

No. Checkpoint Yes No Remarks


i. Availability of policy - apex manual
ii. Availability of registration form
iii. Availability of admission form including
consent
iv. Staff awareness

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.

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National Accreditation Board for Hospitals and Healthcare Providers
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.

II. REQUIRED DOCUMENTS

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


1 Transfer-out or referral-out shall be Admission Clerk Register
done through OPD or through
Emergency ward.
2 The Treating Doctor shall decide Treating Doctor Medical record
transfer-out/referral-out and explain
the reason and plan of transfer to
the patient and relative.
3 Consent for transfer-out/referral-out is Treating Doctor Consent
obtained from the patient and relative.
4 The order for transfer-out/referral-out Treating Doctor Transfer-out register
shall be written in the transfer-out
register with the patient's name, date,
time.

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III. AUDIT CHECKLIST

No. Checkpoint Yes No Remarks


i. Availability of policy - apex manual
ii. Availability of transfer-out form
iii. Consent form
iv. Staff awareness
v. Transfer-out register/record

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.
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 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.
It is recommended that:
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.

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National Accreditation Board for Hospitals and Healthcare Providers
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 Registered with INC/State Nursing
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


1 All patients who come to the emergency EMO/Treating Doctor Medical record
department shall be assessed. /Staff nurse
2 The following parameters shall be EMO/Treating Doctor Medical record
assessed in detail: /Staff Nurse
Chief
l complaints
History
l of illness
Allergies
l or any associated disease
Temperature,
l Pulse, Blood Pressure,
and Respiration
Physical examination
l

3 In case of mass casualties, triage shall be EMO/Treating Doctor Medical record


completed first, and then followed by /Staff Nurse.
assessment.

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National Accreditation Board for Hospitals and Healthcare Providers
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

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
l

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 Treating Doctor/ Medical record
documented in medical record with Doctor on Duty
name, time, date and signature.
2 The assessment shall include the Treating Doctor Medical record
following parameters:
Temperature,
l Pulse, Blood Pressure
and Respiration.
Physical examination.
l

3 The initial nursing assessment is done in Staff Nurse Medical record


the prescribed format.
Assessment of obstetric and high-risk
obstetric patients
1 (This includes pregnancies with diabetes, Consultant Medical record
HTN, asthma, eclampsia, convulsions,
multiple pregnancies, elderly primi
(>30 years), bad obstetric history
(abortions)
2 The assessment shall include: Medical record
Weight,
l height
BP
l

Routine
l lab investigations
Hb, blood
l group, urine (routine and
microbiological)

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National Accreditation Board for Hospitals and Healthcare Providers
No. Process Responsibility Supporting Document

BT, CT
l

NST (Non-stress
l test)
Foetal
l monitoring
Months
l of pregnancy (regularly noted
on each visit)
Tetanus
l injections
2-3 ultrasounds
l in whole period
(immediately after confirmation of
pregnancy, 20 week anomaly and
32 week growth scan)
PPTCT
l counseling
Multidisciplinary
l approach for
patients with medical disorders in
pregnancy
3 All patients shall be given appropriate Treating Doctor/Staff Medical record
explanations about their conditions. nurse
Descriptions of the following should be
shared:
The diagnosis
l or provisional diagnosis
as applicable
Plan of
l treatment as decided by the
treating consultant
4 Special needs of the vulnerable patients Treating Doctor/Staff Medical record
who are receiving treatment will be nurse
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 Department heads/Quality team

iii. Preparation of apex or department manual Quality team

iv. Staff orientation to the initial assessment Quality team /Training cell

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National Accreditation Board for Hospitals and Healthcare Providers
IV. AUDIT CHECKLIST

No. Checkpoint Yes No Remarks


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

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.
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 to prepare a department Lab Manual that incorporates all the
documented procedures for collection.
Lab Manual
It is recommended that:
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.

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National Accreditation Board for Hospitals and Healthcare Providers
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.

II. REQUIRED DOCUMENTS

The list of records or registers, and forms and formats shall be available in the laboratory.

No. Name (Register/Format) Responsible Person


1 Lab Manual Quality team in consultation with the
Department Head-Lab
2 Critical Result Intimation Book Lab Technicians
3 External Quality Register Lab Technicians
4 Internal Quality Register Lab Technicians
5 Refrigerator Temperature Register Lab Technicians
6 Quality Indicator Register Lab Technicians
7 List of hazardous material Quality team in consultation with the
Department Head-Lab or HIC Team

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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
All samples
l will be handled as per
the infection control guidelines.
Universal
l precautions are to be
observed while handling samples.
4. Safe Transportation of Samples Technician
All measures
l shall be taken in order
to prevent samples from undergoing
any deterioration.
Necessary
l precautions shall be taken
depending on the prevailing
environmental factors.
5. Processing of Samples Technician Procedure or Lab
l The processing of samples should be Manual
carried out as per the requirements
of individual tests.

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National Accreditation Board for Hospitals and Healthcare Providers
No. Process Responsibility Supporting Document

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

III. TASKS AND RESPONSIBILITIES

No. Task Responsibility

i. Define the content of the Lab Manual Department heads/Quality team

ii. Define the content of the Lab Safety Manual Top management in consultation
with the specific department head

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 No Remarks


i. Availability of policy
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

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National Accreditation Board for Hospitals and Healthcare Providers
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.

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 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.

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National Accreditation Board for Hospitals and Healthcare Providers
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)

Under
l 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.

The nursing staff and the doctor concerned should try to persuade the patient to stay and
l
at the same time try to find out why the patient wishes to leave. If possible, the problem
should be addressed.

The responsibility of the treating consultant is to explain the consequences of this action
l
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.

Despite this, if the patient still wishes to be discharged, all possible steps should be taken
l
to ensure the patient or authorized attendant signs a form to this effect before leaving
the hospital.

In the event that the patient refuses to sign the form, this should be documented clearly
l
in the Medical Records.

All discussions and risks explained should be recorded in the patient's Medical Records.
l

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.

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National Accreditation Board for Hospitals and Healthcare Providers
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 Is the patient Staff Nurse prepares


verified and seal put on a paying account settlement form
case sheet. Or that any other No case? Yes and hands over to patient's
scheme beneficiary seal is relatives along with case
put on case sheet. sheet.

Patient's relatives sent to


Discharge summary given cash counter for final
to Patient/relatives & bill settlement.
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

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National Accreditation Board for Hospitals and Healthcare Providers
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

1 Preparation of the contents of the Head of the Discharge summary


department-wise discharge summary. Department/ Quality
team
2 Treating Consultant decides to discharge Treating Doctor
the patient.
3 Development of a care plan for Treating Doctor
post-discharge care.
4 Arranging for the provision of services, Staff Nurse/CHD
including patient or family education.
5 Coordination related to discharge with Treating/Referral
specialty Consultants if cross-consultation Doctor/Staff Nurse
was obtained.
6 Preparation of final discharge summary. Treating Doctor
7 Preparation of account settlement form Staff Nurse/Billing
or final bill. section
8 Discharge summary handed over to the Treating Doctor/Staff Discharge summary
patient along with guidance on post Nurse
discharge medication, follow-up and
information regarding how to obtain
urgent care.
9 A copy of the discharge summary is Staff Nurse Discharge summary
attached to the patient case sheet.
10 Patient is accompanied till the hospital Ward attendant
exit.

III. TASKS AND RESPONSIBILITIES

No. Task Responsibility


i. Define the discharge process Top Management
ii. Define the time required for each process Top Management in consultation
with the specific department head
or Quality team
iii. Availability of the billing process requirements Administrative department
including display of the billing tariff
iv. Staff orientation to the discharge process Quality team/Training cell

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National Accreditation Board for Hospitals and Healthcare Providers
IV. AUDIT CHECKLIST

No. Checkpoint Yes No Remarks


i. Availability of policy
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

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.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customized documents.
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.

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National Accreditation Board for Hospitals and Healthcare Providers
II. REQUIRED DOCUMENTS

i. Standardized discharge summary

III. TASKS AND RESPONSIBILITIES

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 Treating doctor


summary

iv. Preparation of standard forms Quality team

IV. AUDIT CHECKLIST

No. Checkpoint Yes No Remarks


i. Availability of policy
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

V. REFERENCES
Accreditation Standards for Hospitals, NABH, 3rd Edition, November 2011.

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National Accreditation Board for Hospitals and Healthcare Providers
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.

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 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/1068-
downloads.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.

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National Accreditation Board for Hospitals and Healthcare Providers
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.

II. REQUIRED DOCUMENTS

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

III. TASKS AND RESPONSIBILITIES

Sr. No. Task / assignment Responsibility


1 Preparation of all policies and SOPs Quality team and/or Medical
superintendent
2 Induction and ongoing training for emergency HR and Quality team
department for policies and SOPs in handling
emergency patients
3 Induction and ongoing training for emergency Superintendent/ Head of
department for policies and SOPs in handling MLCs hospital; EMO on duty/
Consultant on duty
4 Ensuring required documentation process including MO and Quality person/
maintanance of different registers for emergency Consultant involved.
and MLCs
5 Audit and monitoring quality standards Quality Team
6 MLC Certificates EMO

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National Accreditation Board for Hospitals and Healthcare Providers
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 Doctor on duty Casualty register
medical services shall be screened {Casualty register format}
and first aid care and stabilizing
treatment be provided, if required.
The patient must receive stabilizing Doctor on duty and Patient case record and
treatment within the capabilities and Nurse on duty Casualty register
resources of the HCO.
Should the stabilizing treatment Consultant on duty Patient case record/Referral
require a specialist physician, the (full time or visiting) form
physician must be available to
respond in a timely manner.

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National Accreditation Board for Hospitals and Healthcare Providers
Process Flow Responsibility Supporting Document

The doctor on duty shall decide Doctor on duty MLC register


whether a case is an MLC.
All MLCs shall be notified to the Doctor on duty and MLC notification book and
police as per SOP following the Nurse on duty MLC register
guidelines provided by legal authority
or MCI guidelines; that is, treatment
first and other administrative/clerical
work later, but mandatory to
document.
If the doctor on duty concludes, Doctor on duty Casualty register - column
based on the results of the screening which states where patient
examination, that the patient does is sent after primary
not have an emergency medical treatment.
condition, the patient may be treated
as OPD or referred to a specific OPD.
If inpatient treatment is required as Doctor on duty Casualty register - column
per clinical conditions, the patient which states where the
shall be transferred to the designated patient is sent after primary
ward/OT/ICU/HDU after primary treatment
treatment.
Prior arrangement for availability of Nurse on duty in
bed in ward/ ICUs must be confirmed emergency
so that the HCO can be prepared for
the arrival of the new patient.
The copies of the emergency Doctor and nurse on Transfer record
department records are sent with the duty
patient including any test results.
In case there are more than two or Doctor on duty Triage record/Casualty
three patients, triaging and Register
prioritization for management shall Nurse on duty
be done based on the acuity and
complexity of the clinical condition.
Such triaging is known to all on
emergency duty.
If after stabilizing, the patient refuses Doctor on duty Transfer/DAMA register
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. Refer to AAC
If patient's clinical condition requires Doctor on duty Transfer register
treatment that is not within the scope
of hospital services, arrangements Nurse on duty

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National Accreditation Board for Hospitals and Healthcare Providers
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 Transfer register
about bed availability, brief staff
about the patient's condition on the Nurse on duty
phone, and confirm whether HCO can
receive the patient.
Paramedical staff shall accompany Doctor on duty Transfer register
stable patients and a trained nurse/ Nurse on duty
medical officer shall accompany
unstable patients.
A critical patient shall not be left Doctor on duty Transfer register
unattended either inside the hospital
or while transferring to another HCO. Nurse on duty
Transfer will be done in a suitable Doctor on duty Ambulance register
ambulance (stable patient in general
ambulance or critical patient in Nurse on duty
cardiac ambulance) depending on Ambulance driver/
availability. staff of the
ambulance if the
ambulance is from
the receiving hospital.
All documentation shall be complete Doctor on duty Patient case file
in the patient record Nurse on duty

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

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National Accreditation Board for Hospitals and Healthcare Providers
- 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


1 All complaints and events shall be EMO/Nursing Patient record/MLC
recorded. register
2 Each event shall be recorded in detail EMO Patient record/MLC
including the date, time and place of the register
event and involvement of person and
vehicle during the event.
3 Each case should be intimated to the EMO/Nursing Patient record/MLC
relevant police station by phone after register
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.
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 EMO/Nursing Patient record/MLC
for OPD /IPD cases and should be marked register
"MLC". MLC number shall be stamped on
all paper and patient records.
5 Clinical notes shall be entered in IPD/OPD EMO/Nursing MLC book
case paper and in an MLC form book
(in duplicate or triplicate).
Examine
l 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.

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National Accreditation Board for Hospitals and Healthcare Providers
No. Procedural steps Responsibility Supporting Document

For all
l MLCs, the injury sheet must be
filled up and all columns completed.
While
l 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.
Record
l 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.
All alleged
l 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.
In assault
l 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.
Obtain
l 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.
In all poisoning
l 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.

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National Accreditation Board for Hospitals and Healthcare Providers
No. Procedural steps Responsibility Supporting Document

No lavage sample
l should be attempted
in any acid or kerosene oil poisoning or
burn case.
In all MLCs,
l 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.
Clothes/weapon/gastric
l 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.
Picture
l 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.
No information
l 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.
6 A separate register shall be maintained for Nursing Patient record/MLC
each MLC with the required data at register
emergency.
7 A counter-signature from the police station Nursing Patient record/MLC
shall be taken from the representative in a register
patient's MLC form/book.
8 The time of informing the police and time Nursing Patient record/MLC
of arrival of the police shall be entered in register
the MLC form.
9 In case the police do not arrive within 2 EMO Patient record/MLC
4 hours of the MLC report, a reminder shall register
be sent asking for an acknowledgment.

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National Accreditation Board for Hospitals and Healthcare Providers
No. Procedural steps Responsibility Supporting Document

10 If any patient refuses to be registered as an EMO Patient record/MLC


MLC, the Medical Superintendent should be register
immediately informed for a further line of
procedural action.
11 All MLCs registered with the hospital shall EMO Patient record/MLC
be intimated to the consultant on duty and register
the medical superintendent.
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 EMO Patient record/MLC
during hospitalization, postmortem is a register
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.
14 A case summary shall be provided to the EMO Patient record/MLC
police at the time of handing over the dead register
body for submission to the district hospital.
15 When MLCs are discharged, the relevant EMO/Nursing Patient record/MLC
police station shall be notified. register
16 All medico-legal discharge cases should be EMO/Nursing Patient record/MLC
registered in the same way at all stages, as register
recorded at the time of admission.
17 A copy of all the reports of the investigation Nursing Patient record/MLC
shall be kept in the MRD file before register
discharging the patient.
18 After handing over the documents and Nursing Patient record/MLC
reports to the patient, the patient's or register
relative's signature shall be obtained for the
MRD file.
19 After discharge, MRD files of all MLCs shall MRD Patient record/MLC
be stored separately and be under the register
control of a designated person.
20 The responsible MO/Consultant shall MRD Pt record /MLC
arrange to prepare the injury certificate register
with the help of the CMO.
21 MRD shall preserve a copy of the signed MRD Patient record/MLC
certificate in the patient record. register

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National Accreditation Board for Hospitals and Healthcare Providers
No. Procedural steps Responsibility Supporting Document

22 At the time of handing over the certificate MRD Patient record/MLC


to police, the designation and buckle register
number of the police representative shall
be noted in the second copy and the
signature of the police taken.
23 All MLCs shall be reported to the medical MRD Patient record/MLC
superintendent on a monthly basis. register
24 The original injury certificate shall only be MO/MRD Patient record/MLC
issued to the police and not to the patient register
or relatives.

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

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National Accreditation Board for Hospitals and Healthcare Providers
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.


Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customized documents.

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.
It is recommended that:
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.

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National Accreditation Board for Hospitals and Healthcare Providers
iv. Standards for blood bank and blood transfusion may be found in :
National
l 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
http://www.naco.gov.in/NACO/Quick_Links/Publication/Blood_Safety__Lab_Services/
l
Operational__Technical_guidelines_and_policies/standards_for_blood_bank/
NACO,
l 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/

II. REQUIRED DOCUMENTS


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

Sr. No. Task / assignment Responsibility


i. Preparation of all policy and SOPs for blood and Blood bank officer/Pathologist/
blood component services Medical superintendent/In-
charge 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 Superintendent / responsible
transfusion services person or consultant

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National Accreditation Board for Hospitals and Healthcare Providers
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 Remarks
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

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National Accreditation Board for Hospitals and Healthcare Providers
Blood transfusion monitored by: Name: Signature

Transfusion Reaction Form

Patient Name UHID Blood Group Blood Bank No.

Blood Group Blood Bag 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, Pain:Site of pain

Icterus 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.

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National Accreditation Board for Hospitals and Healthcare Providers
COP4a. Care of patients is in consonance with the documented procedures.

Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customized documents.

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 day-
to-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:

Ministry
l 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

CDC Guidelines for Infection Control, 2003. Available at


l
www.cdc.gov/ncidod/hip/enviro/guide.htm

Critical Care Society Guidelines, 2010. Available at


l
www.isccm.org/pub-icuguidelines.aspx

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National Accreditation Board for Hospitals and Healthcare Providers
Royal College of Obstetricians and Gynaecologists Guidelines, 2014. Available at
l
https://www.rcog.org.uk/en/guidelines-research-services/guidelines/?p=5

FOGSI Guidelines. Available at


l
http://www.fogsi.org/index.php?option=com_content&view=article&id=84&Itemid=131

Ministry of Health, Government of India, NACO Guidelines. Available at


l
http://www.naco.gov.in/NACO/About_NACO/Policy__Guidelines/Policies__Guidelines1/

II. REQUIRED DOCUMENTS

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.

III. TASKS AND RESPONSIBILITIES

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.

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National Accreditation Board for Hospitals and Healthcare Providers
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 ICU in charge/ Doctor Patient record/ICU register
as per clinical need.

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 Doctor on duty Patient case record
their clinical need. Nurse on duty

All staff doctors, nurses and Doctor on duty HIC manual


attendants must maintain hand
hygiene as per WHO Hand Hygiene Nurse on duty
Guidelines.

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National Accreditation Board for Hospitals and Healthcare Providers
Process Flow Responsibility Supporting Document

All staff should follow universal Doctor on duty Patient record


precautions while managing the
patient. Nurse on duty ICU register

Staff must prevent the patient from Doctor on duty Patient record
falls. Nurse on duty ICU register

Staff must provide general nursing Doctor on duty Patient record


care and care for the general hygiene
of the patient. Nurse on duty ICU register

Nurse and staff must prevent bed Doctor on duty Patient record
sores by frequently changing the
position of the patient. Nurse on duty ICU register

Bundle care guidelines must be Doctor on duty Patient record


followed for all IV lines, catheters,
endotracheal tubes, and other tubes. Nurse on duty ICU register

Monitoring, patient assessment, and Doctor on duty Patient record


treatment should be documented in
the designated format and patient Nurse on duty ICU register
case file and ICU register.

Handing over, taking over between Doctor on duty Patient record


shifts, and transfers to other wards
should be appropriately documented. Nurse on duty ICU register

The patient may be discharged or Doctor on duty Patient record


stepped down to a ward as per
clinical need. 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.

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National Accreditation Board for Hospitals and Healthcare Providers
I. OVERVIEW

Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customized documents.

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.

II. REQUIRED DOCUMENTS

i. Scope of services that SHCO provides to the community.

ii. Scope of services displayed in a prominent area in the OPD.

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National Accreditation Board for Hospitals and Healthcare Providers
III. TASKS AND RESPONSIBILITIES

Sr. No. Task / assignment Responsibility


i Finalize the scope of maternal services that the Gynecology HOD/ Medical
SHCO can provide to community. superintendent or Consultant
in-charge/Nursing head
ii Finalize the services which will not be provided Gynecology HOD/ Medical
either due to lack of human resources, expertise, superintendent or Consultant
infrastructure, or other logistical problems. in-charge/Nursing head
iii. Disseminate the scope of services to all staff HR and Gynecology department
members.
iv. Prepare a board to display scope of services Management
publicly.
i. Annual review of scope of services and amendment Gynecology HOD/ Medical
when any addition or removal is required. superintendent or Consultant
in-charge/Nursing head

IV. AUDIT CHECKLIST

No. Checkpoint Yes NO Comments


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

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.

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National Accreditation Board for Hospitals and Healthcare Providers
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.

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 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

It is recommended that:

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.

II. REQUIRED DOCUMENTS

Defined scope of pediatric services available within the hospital.

III. TASKS AND RESPONSIBILITIES

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

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IV. AUDIT CHECKLIST

No. Checkpoint Yes NO Comments


i. Defined scope of pediatric services
available.
ii. Defined scope displayed bilingually in
prominent places.

COP6d. Procedure addresses Identification and Security Measures to Prevent Child or Neonate
Abduction and Abuse.
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 the prevention of neonate/child abductions and abuse and to ensure
proper safety for newborns and children.
It is recommended that:
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.

II. REQUIRED DOCUMENTS


i. Policy on Child Abduction and Abuse
ii. SOP on Child Abduction

III. TASKS AND RESPONSIBILITIES

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 Audit team
preventive action

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IV. AUDIT CHECKLIST

No. Checkpoint Yes NO Comments


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.

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 Nurses SOP/identification


born, identification bands are tied. band
2. One parent is allowed to be with the Security personnel/
patient at all times or allowed to visit the Nurse
patient frequently in the ICU.
3. Footprints of the newborn are imprinted Nurses Medical records
on the bedside record and on the mother's
case sheet.
4. The mother's identification tag includes Nurses
the baby's UHID and name and vice versa.
5. Infants are kept in direct, line-of-site Nurses
supervision at all times by an authorized
staff member and the mother.
6. Infants are transported only by authorized Nurses
staff along with the mother or father.
7. Strict vigilance is maintained for the Security staff
movement of children and infants in
NICU/PICU and that of bystanders.
8. Movement of unrelated/unidentified Security staff
attendants is restricted.

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No. Process Flow Responsibility Supporting Document

9. 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 Quality team Mock drill record
periodically, and corrective action and
preventive actions undertaken.

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.
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 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.

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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.

It is recommended that:

i. The SHCO develop policies for anesthesia services, including who can perform them (full-
time 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)

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III. TASKS AND RESPONSIBILITIES

No. Task Responsibility


i. Develop a policy for anesthesia services Management
ii. Appoint or make available anesthetists and teams as per HR / Superintendent/
the policy 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 HR/Quality team
stakeholders /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 NO Comments


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

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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.
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 to develop and implement policies and SOPs for conducting safe surgical
procedures and preventing potential adverse events.
It is recommended that:
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/

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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.

II. REQUIRED DOCUMENTS


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.

III. TASKS AND RESPONSIBILITIES

No. Task Responsibility


i. Adopt WHO surgical safety checklist and customize it for Surgical head/
local use; prepare other checklist formats for shifting Anesthetist/ Nurse in-
patient from ward to OT; SOPs for patient identification charge
and side- and site- marking.
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 /
designated Consultant/
person
iv. Reorientation or refresher training for the same. Quality team /
designated Consultant/
person

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IV. AUDIT CHECKLIST

No. Checkpoint Yes NO Comments


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).

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 Responsibility Supporting Document

1. Scheduling: The following information is a Primary Nurse and OT list, Consent form
must when scheduling an invasive/surgical Surgical team
procedure:
Correct
l spelling of the patient's full name
Inpatient
l number
Consent
l for procedure to be performed
2. Preprocedure/preoperative verification Physician and Surgical safety
The physician and anesthetist shall verify Anesthetist checklist
the patient's identity by asking
Patient's
l full name and compare with ID
band
Procedure
l 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.

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No. Process Flow Responsibility Supporting Document

3. Site mark: This should be completed before Physician and Surgical safety
the patient enters the procedure or Anesthetist, checklist
operating room. The site-mark is required Primary Nurse,
in invasive or surgical procedures that OR Nurse/Registrar
involve
Laterality
l (for example, right, left)
Multiple
l structures (for example, toes,
fingers, limbs)
Multiple
l 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 Infection Control
all procedures (for example, SS - Nurse, OR Nurse/
surgical site). The marker should be Doctor
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: OR Nurse Surgical safety
Time-out is required to confirm the checklist
following:
Correct
l patient
Correct
l side or site
Correct
l procedure
Correct
l patient position
Correct
l radiographs
Correct
l implants and equipment
8. A verbal time-out or pause is called by the OR Nurse/Doctor Surgical safety
OR Nurse or Registrar immediately before checklist
the procedure or surgery in the operating
room or procedure room.

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No. Process Flow Responsibility Supporting Document

9. 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 Surgical safety
will say 'yes' to all the details. The time-out Anaesthetist, checklist
will be documented in the medical records. OR Nurse/Doctor
It should include
Personnel
l present at the time-out
Verification
l of correct patient
Verification
l of correct side and site
Agreement
l on the procedure/verification
of radiographs
Verification
l of the correct position
Available
l 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 Attending
(if possible) must agree on the resolution Consultant
of the identified discrepancy. The attending (Physician and
Consultant in the patient's medical records Anesthetist)
must document the discrepancy and its
resolution.

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

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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: Medico-
legal 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/

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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.

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 procedures to be followed for purchase, storage, prescription and
dispensation of drugs in a safe manner and to avoid medication errors.

It is recommended that:

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

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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.

II. REQUIRED DOCUMENTS

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.

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SOP on Procurement of Medication

No. Procedure Responsibility

1. A list of medications used regularly in the SHCO is Pharmacy in-charge


maintained.

2. The stock of medicines is checked every morning. Pharmacy staff

3. If stock is less than minimum stock level, an order Pharmacy staff


note is raised.

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 Pharmacy/Purchase in-charge


from the person in-charge, and person ordering is
obtained.

6. The order is placed with different stockists or Pharmacy/Purchase in-charge


company representatives over the phone according
to the order note.

7. Items are received from the stockist as per the Pharmacy/Purchase in-charge
agreed turnaround time.

8. Items are checked according to the bill and the order Pharmacy/Purchase staff
note.

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


of items are checked before accepting from the
stockist or company representatives.

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No. Procedure Responsibility
10. A copy of the order note along with the bill is sent Pharmacy/Purchase staff
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 Pharmacy in-charge and
Ward or OT stocks (at the point of care). person in-charge of the
patient care area

2. Only authorized staff are allowed access to the Pharmacy staff,


stored medication. 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 Pharmacy in-charge and
and the ambient temperature is maintained as per person in charge of the
the manufacturer's specification. patient care area

5. Medications with "cold chain" requirements are Pharmacy in-charge and


kept in the refrigerator. person in charge of the
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 Pharmacy in-charge and


separation between the items in each of the person in charge of the
LASA pairs. patient care area

8. Medications are checked every month to identify Pharmacy in-charge and


those due to expire within the next one/two/three person in charge of the
months. patient care area

9. The near-expiry items are returned to the vendor Pharmacy in-charge


for exchange.

Note:For a list of High-Risk Medications, refer to Annexure.

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Procedure of Prescription of Medication

No. Procedure Responsibility


1. Registered doctors are authorized to prescribe Medical Professionals
medications in the SHCO. (Consultants/ Residents/Medical
Officers)

2. The prescription will contain the type of Medical Professionals


preparation, name of the drug, dose, route of (Consultants/ Residents/Medical
administration, frequency, and duration of usage. Officers)

3. Medication orders are written clearly and legibly Medical Professionals


in capitals, dated, timed, signed, and named. (Consultants/ Residents/Medical
Officers)

4. Medication orders are written only in the Medical Professionals


designated locations in the medical record. (Consultants/ Residents/Medical
Officers)

5. A list of high-risk medications used in the hospital Pharmacy in-charge with inputs
is maintained. 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 Pharmacist


the prescription prior to dispensing it with double
verification for high-risk medication.

3. As per prescription, the correct drug and its expiry Pharmacist


date are checked by the pharmacist.

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III. TASKS AND RESPONSIBILITIES

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 No Remarks

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

MOM1e. Documented procedures address procurement and usage of implantable prosthesis.

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 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.

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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.
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.

II 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 Purchase/Pharmacy in-charge


maintained.

2. Evidence-based medicine supports the usage of Clinician using the implant


the implant. Purchase/Pharmacy in-charge

3. Implants which are used frequently are stored in Purchase/Pharmacy in-charge


the hospital.

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No. Procedure Responsibility

4. The following information is recorded in the HOD/staff


order note: Name of the item
Quantity of the item
Order date
Name of the company
Last order date
Present stock

5. Once the order note is written, signatures are Purchase/Pharmacy in-charge


obtained from the in-charge and the person
ordering

6. Order for items is placed with different Purchase/Pharmacy in-charge


stockists or company representatives
over the phone as per the order note

7. Items are received from the stockist as per agreed Purchase/Pharmacy in-charge
TAT

8. Items are checked according to the bill and the order Pharmacy/Purchase staff
note

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


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 Pharmacy/Purchase staff
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 Pharmacy/ Store


on request

13. Implant details such as name, model, lot and batch OT staff
number, expiry date, size (label in the pack) are Pharmacy staff
recorded in the medical record and pharmacy

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III. TASKS AND RESPONSIBILITIES

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 No Remarks

i. List of implants

ii. Usage of implants

iii. Evidence of documentation of usage of implants

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
included in this Guidebook.

MOM2d. The SHCO defines a list of high-risk medication and process to prescribe them.

Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customized documents.

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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.

It is recommended that:

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 high-
risk medications.

II. REQUIRED DOCUMENTS

List of high-risk medicines are available in the Annexure.

III. TASKS AND RESPONSIBILITIES

No. Tasks Responsibility

i. Draw up a list of high-risk medications used in Pharmacist/Doctors


the hospital

ii. Define the storage and usage precautions or Management/Pharmacists/


identifiers for high-risk medications Doctors

iii. Availability of antidotes for high-risk medication, Management/Pharmacist


if available

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IV. AUDIT CHECKLIST

No. Checkpoint Yes No Remarks

i. List of high-risk medications

ii. Identifiers for high-risk medications

V. REFERENCES

Accreditation Standards for Hospitals, NABH, 3rd Edition, November 2011.

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

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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.

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 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).

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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.

II. REQUIRED DOCUMENTS

No. Name (Register/Format) Responsible Person

i. HIC Manual Person designated for HIC activities along


with a dedicated doctor

III. TASKS AND RESPONSIBILITIES

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 Designated HIC staff


practices and procedures

IV. AUDIT CHECKLIST

No. Checkpoint Yes No Remarks

i. Availability of the Manual

ii. Availability of designated staff for HIC


activities

iii. Availability of adequate PPE

iv. Staff training record

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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.

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 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

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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 root-
cause 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.

II. REQUIRED DOCUMENTS


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.
Clinical:
l 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.
Nonclinical:
l OPD waiting time, patient satisfaction rate, number of stock outs of
emergency medications, number of errors in billing.

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SOP for Collection and Analysis of KPI

Process Responsibility

Identification of quality team (members from various Administration


areas of an SHCO who are motivated to work towards
quality improvement)

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 Quality team


identified KPI

4. Periodicity of collection and review to be defined Quality team and administration

5. Collection of data using standardized format Quality team/personnel


identified by the Quality team

6. Verification and validation of data Quality team

7. Analysis of data Quality team with the


stakeholders

8. Identification of variation in trends Quality team

9. Root-cause analysis and corrective and preventive Quality team and stakeholders
action taken wherever necessary (in case of negative
trends or worsening of performance)

10. Review of the KPI Administration, Quality team


and stakeholders

11. Inclusion of new KPI Administration and Quality


team

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III. TASKS AND RESPONSIBILITIES

No. Tasks Responsibility


i. Form a Quality team with representation from Top management
various key areas
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 Quality team/Administration
committee meeting or KPI meeting)
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 No Remarks


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

V. REFERENCES

Accreditation Standards for Hospitals, NABH, 3rd Edition, November 2011.

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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.


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 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.

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II. REQUIRED DOCUMENTS

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 Top management Organogram
by the SHCO management
ii. All staff are aware of the organogram and the HR staff or Quality Induction training
organizational structure it represents. This is department staff or material
done through Heads of respective
l Induction program at the time of joining departments
lRegular training for existing staff Training material
on SHCO-wide
policies and
procedures

III. TASKS AND RESPONSIBILITIES

No. Task Responsibility


i. Prepare the draft organogram. HR in-charge
ii. Review the draft organogram Top management and
o Practice on the ground should reflect what the HR department
management planned.
o Opportunities for streamlining the hierarchy are
identified and suitable changes made.
iii. Authorizing the organogram Head of the SHCO
o Signature of the Head of the SHCO is affixed.
o The date from which it is effective is mentioned.

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IV. AUDIT CHECKLIST

Frequency of audit: At least once a year as part of a hospital-wide audit.

No. Checkpoint Yes No Remarks


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.

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 Second Level Leaders Second Level Leaders

Department Department Department

Sub-unit Sub-unit Department Department

Department Department Department

Department Sub-unit Sub-unit

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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 Section In-charge

Staff category Staff category Staff category Staff category

Section In-charge Section In-charge

Staff category 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.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customized documents.

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.

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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.

II. REQUIRED DOCUMENTS


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 Top management Mission statement
mission statement
2. This is made public in the following Operations Head Plaque (e.g. brass or
locations: and Maintenance marble).
Entrance lobby /Facility in-charge Boards and framed
Foundation stone statements. Slide
In all common waiting areas presentation.
Inhouse documents
as applicable. Online
content if present.
Others (the SHCO
shall specify other
modalities).

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No. Procedure Responsibility Supporting
Documents
3. All the staff are aware of the mission HR staff , or Quality Induction training
statement. This is done through department staff, or material.
l The induction program at the time Heads of respective Training material on
of joining departments SHCO-wide policies
l Regular training for existing staff and procedures.
4. The mission statement is included HR department, All manuals.
in all the manuals in the SHCO Quality department Hospital brochure.

III. TASKS AND RESPONSIBILITIES

No. Task Responsibility


i. List out the words that best describe the Top Management, senior leaders or
purpose, strategy, values and behavioral HODs
standards of the SHCO.
ii. Discuss the relationship of these elements Top Management, senior leaders or
for both organizational success and employee HODs
motivation.
iii. The list of descriptive words is clear and final, Top Management, senior leaders or
avoiding duplication and exaggeration. HODs
iv Frame a comprehensive statement which Top Management, senior leaders or
incorporates all the descriptive terms in a HODs
logical and meaningful manner. The statement
may be a single, all-inclusive sentence or
broken into simple short multiple sentences.
v Ensure that the mission statement is Top management
authorized by the Top management. The
signatory is identifiable or it may simply
mention "Management" or "Board of Trustees"
or the like.
vi Incorporate the mission statement in the Quality Department or HR
SHCO's documentation, such as manuals, department
brochures, training material.
vii Display the mission statement to the public Operations Head and
at the entrance lobby and in prominent Maintenance/Facility in-charge
common areas across the SHCO, and online IT Dept
media.

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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

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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
included in this Guidebook.

FMS1c. The SHCO has a system to identify the potential safety and security risks including
hazardous materials.
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 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
Staff
l be educated about the various risks in the hospital environment, identify potential
risks, manage and report them immediately.
Appropriate mechanisms be implemented for the staff and visitors to report any identified
l
potential risk.

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The reported
l risks be addressed immediately and appropriate corrective and preventive
measures be taken to mitigate the risk.

II. REQUIRED DOCUMENTS


i. Protocol for reporting potential risks
ii. Protocol for managing different risks when they occur
SAMPLE DOCUMENTS
Sample protocol for reporting potential risks

Supporting
Procedure Responsibility
Documents
All staff are trained to identify and report safety and HR/Training
Training records
security risks in the SHCO. department

Any staff member who identifies a potential risk


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

If the risk is of immediate concern, it should be Reporting forms/


All staff members
addressed through the SHCO phone number. Register
While calling the number, the reporter must
Reporting forms/
identify himself/herself, the identified risk, and the All staff members
Register
location.

The designated person along with the engineer/ Designated person/


Reporting forms/
concerned person should visit the spot and ensure Concerned
Register
that the complaint is addressed. departments

On receiving the call, the information should be


Reporting forms/
recorded in the Incident Register with the date, Front desk/ Reception
Register
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 Inspection
Designated person report
problems exist in other places in the SHCO, and if
so, address them.

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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.
Increase ventilation in the room by opening the windows.
l

Pick up
l the mercury with a dropper or scoop up beads with a piece of heavy paper like
playing cards.
Place the mercury-contaminated instruments (dropper/heavy paper) and any broken glass
l
in a plastic zipper bag.
Dispose of waste mercury as toxic waste. Double-bag the waste and incinerate it; however,
l
it is more environmentally acceptable to forward the waste to reclaim the mercury.
It is advisable
l to reduce the usage of mercury-containing equipment. All conventional
mercury thermometers may be replaced with infrared thermometers (non-touch). Hg-
containing BP apparatus may be replaced.
When cleaning up a mercury spill:
Do not
l use household cleaning products, particularly products that contain ammonia or
chlorine. These chemicals will react releasing a toxic gas.
Do not use a broom or paint brush. It will spread them around by breaking them into smaller
l
beads.
Do not use vacuum as it will disperse mercury vapour into the air and increase the likelihood
l
of human exposure.

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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
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
l
movements.
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
l
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:
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
l and control of contractors or employees using blowlamps, cutting or welding
equipment.
Risk
l assessment and control in the purchase of articles and substances to avoid the
introduction of fire hazards whenever and wherever possible.
Strict preventive maintenance programs for electrical wiring and appliances, like non use of
l
loose wires, extension cords, multiple tapping from a single load.
Supervision of cooking facilities.
l

Avoiding use of electrical and electronic equipment with damaged and twisted wires.
l

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.

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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
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
l good standard wiring and do not permit substandard wiring that does not follow
electrical safety requirements.
Staff operating the equipment must be trained and have adequate knowledge on the use of
l
equipment.
Conduct periodic safety inspections in order to detect potential problems.
l

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:
All wheelchairs and stretchers used for transferring patients should have restraint belts.
l

All roads
l and corridors must be level and any broken or chipped floor tiles should be
immediately replaced.
While cleaning, the area should be cordoned off with appropriate signage like "wet floor".
l
Any spillage must be cleaned immediately.
Handrails must be provided for staircases.
l

The end
l of a passage and the beginning of the stairs must be demarcated in a different
colour.
Grab bars must be provided in all toilets.
l

Adequate lighting must be present in all areas.


l

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III. TASKS AND RESPONSIBILITIES

No. Task Responsibility


i 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 No Remarks


i 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 Training records- Yes/ No
iii Documentation of reported
potential risks
iv Protocol followed to address the
reported incident or potential risk
v Analysis of the reported risks
vi Risk mitigation in terms of corrective
and preventive action taken Available/Not available
vii 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.

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FMS2b. There is a documented operational and maintenance (preventive and breakdown) plan.

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 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

Maintenance plan addresses preventive and breakdown maintenance.


l

The primary aim of preventive maintenance is to avoid or mitigate failure of equipment. It is


l
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.

Breakdown maintenance intends to address the mechanism to get the equipment repaired
l
properly, and without delay, if failures have occurred.

Both
l 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.

II. REQUIRED DOCUMENTS

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.

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SAMPLE DOCUMENTS
Sample inventory of equipment
As good
l 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.
Example for inventory number: Simple running numbers like 001, 002 or BBH/ BM/ DEFIB/
l
003.
nBBH- Bangalore Baptist Hospital
nBM- Biomedical Equipment
nDEFIB- Defibrillator
n003- Running number
Inventory
l number and serial number (assigned by manufacturer) are the two IDs of the
equipment.
A database
l in the form of an excel sheet, or in the form of hard copy as register, or a
software could be maintained.
Inventory should be managed and updated by the engineering team when new equipment
l
is bought or old equipment is condemned.

Sample of inventory software

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Sample protocol for the operational plan for all equipment

Supporting
Procedure Responsibility
Documents
The operational plan should be as per the
Operational plan
instructions of the manufacturer as each
Engineering for each
manufacturer and each model of equipment will
equipment
have different operating instructions.

Staff handling the equipment must be trained by


Engineering / Staff Training records/
the supplier of the machine and the instructions
handling the checklist and
strictly followed by personnel operating the
equipment records
machine for its safe operation.
Operational plan
The equipment must be operated based on the Staff handling the
for the
operating instructions or plan. equipment
equipment
The operating instructions should be available with Operational plan
Staff handling the
the operator or hung on the machine. for the
equipment
equipment

Sample Operational plan- User Checklist

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III. TASKS AND RESPONSIBILITIES

Supporting
Procedure Responsibility
Documents
A preventive maintenance schedule must be Preventive
prepared by the engineering team. Engineering
maintenance
schedule

The planned preventive maintenance schedule may


vary for different equipment - quarterly, semi- Operators
Engineering
annually or annually, depending on the Manual
manufacturer.

Records of
PPM can be carried out by the engineering staff or
Engineering preventive
outsourced.
maintenance

The operator or user must be informed in advance


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

Records of
Records of preventive maintenance must be
Engineering preventive
maintained for each equipment.
maintenance

Sample protocol for handling breakdown repairs of equipment

If the machine is not functioning, information


should be passed on to the engineer or the Staff who handles Complaint
outsourced company handling the equipment. the equipment register

The repair may include spare part replacement and Engineer/ Outsourced
Receipts
small component replacement. engineer
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, engineer done
before it is handed over to the user department.
The breakdown of life saving equipment, surgical
equipment and critical care equipment, may be Complaint
considered as Emergency breakdown and priority Engineer
Register
given for such breakdown.
Records of the time of raising the complaint, the
person who raised the complaint, the job Complaint
completion, and equipment handing over time Engineer
register
along with the types of repair done should be
maintained.
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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 Engineer/ Staff handling the
operator's manual equipment

iv. Preventive maintenance schedule for each machine Engineer


based on the operator's manual

v. Addressing breakdown and repairs Engineer

vi. Records of preventive and breakdown maintenance Engineer

IV. AUDIT CHECKLIST

No Checkpoint Yes No Remarks


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 Training records- Yes/ No
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 Available/ Not available
register - addressing and recording of
time for repairs

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.*

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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.
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 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.
It is recommended that:
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.

II. REQUIRED DOCUMENTS


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.

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Supporting
Procedure Responsibility
Documents
Medical gas installations and vacuum installations Personal Files
shall be managed by adequate staff. HR/Engineering

Appropriate backup (cylinders) shall be made


Engineering Records of
available to handle any emergencies that arise out
backup cylinders
of the failure of piped medical gases.
Appropriate personal protective devices such as Actual
earmuffs and rubber gloves should be used by the Engineering availability/
Inspections at
staff.
random
Medical gas and vacuum installations shall be Engineering Daily, weekly,
maintained as per protocol. 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 Line pressure, heater coil, cylinder stock
dioxide, oxygen manifold

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.

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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:

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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 Engineer
per requirement

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 No Remarks


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

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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.
It is recommended that:
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.

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II. REQUIRED DOCUMENTS
Protocol for the management of fire and nonfire emergencies.

SAMPLE DOCUMENTS

Sample protocol for the management fire and nonfire emergencies.

Supporting
Procedure Responsibility
Documents
All emergency detection and fighting systems in the
SHCO should be kept active at all times. For
example-
Fire alarm
l and detection system
Portable fire extinguishers
l Maintenance
Fire hydrants records and
l Engineering
checklists
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


l
medical gas
Maintenance
The systems should be tested frequently Engineering records and
checklists

All staff should be trained in handling fire and HR/Training


Training records
nonfire emergencies in the SHCO. department
Any person who witnesses a fire or leak or any
All staff
other emergency should immediately call for help.
The staff member should immediately try to fight
the fire or handle the situation based on the Staff
training provided.
The team set for the purpose should be present and
Designated team
take over the situation immediately.
Based on the situation, the team leader should
decide if additional help is required from outside Designated team
such as the fire department or police.

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III.TASKS AND RESPONSIBILITIES

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 HR/ Training


potential emergencies department

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

IV. AUDIT CHECKLIST

No Checkpoint Yes No Remarks


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

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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.

It is recommended that:

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.

II. REQUIRED DOCUMENTS

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".

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Example of Emergency Evacuation Plan
All staff
l in the SHCO should be trained in basic firefighting techniques, like handling fire
extinguishers.
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


l
supply is turned off.
The SHCO
l may have a central person designated to be the first point of contact in
emergencies.
In case of fire, it could be the security in-charge along with the engineering or
l maintenance
staff who could take over the fire fighting operation.
There should be an established method, like alarms, PA system or central phone to alert the
l
team.
The fire fighting team should immediately proceed to the scene with additional firefighting
l
equipment, try to extinguish the fire, or escalate to the city fire department.
The engineering
l 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 .

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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.
The evacuation
l 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.
One
l 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.

III. TASKS AND RESPONSIBILITIES

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 No Remarks


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.

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V. REFERENCES
Accreditation Standards for Hospitals, NABH, 3rd Edition, November 2011.
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.

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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.


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 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

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committee rules whether the grievance is genuine or not and gives its recommendations
accordingly. There is scope to appeal to a higher authority.

II. REQUIRED DOCUMENTS


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 No offence

Counseling or
No action
Warning

Hearing in disciplinary
committee

Complainant Staff allowed to


presents the details present his/her
of the offence explanation

Decision of disciplinary
committee

Gross misconduct Offence No Offence

Termination Disciplinary action

Decision up held
Appeal
Decision reversed

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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

Yes No Discussion with HR Resolution

No resolution No action

Hearing in grievance
handling committee

Complainant Respondent is allowed


presents the details to present his/her
of the grievance explanation

Decision of grievance
handling committee

Grievance upheld No cause for


concern

Grievance resolved Action taken

Decision upheld
Appeal by any
involved party Decision reversed

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III. TASKS AND RESPONSIBILITIES
No Task Responsibility
Disciplinary procedure

i. Step-by-step description of the disciplinary procedure HR department

ii. Composition of the team or the designated individual who Authorized by Top
reviews the offence(s) management

iii. List quantum of action to be taken, ensuring that it is Authorized by Top


commensurate to the offence management

iv. Hearing of both parties Disciplinary committee


or designated individual

v. Decision on action to be taken against the erring member Disciplinary committee


of staff or designated individual

vi. Opportunity given to staff member to appeal to a Authorized by Top


designated individual management

vii. Implementation of action against staff HR department

viii. Constitution of an Internal Complaints Committee (ICC) to Authorized by Top


address complaints of sexual harassment at the workplace management

ix. Making available the name of the person that the alleged Any member of ICC or
victim should contact in order to present a any senior staff in
written complaint. whom the victim
confides

x. Acknowledgment of receipt of the complaint by the Member Secretary


alleged offender of ICC

xi. Immediate separation of the concerned individuals at the HR department (on the
workplace with stern caution to all concerned not to written instruction of
interact with each other on the complaint 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

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Greivance Handling Procedure

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


handling procedure

ii. Appointment of grievance handling officers Head of the department


Senior HR staff or Top
management

iii. Proceedings of the grievance handling procedure HR department


documented and decision implemented

iv. The written document for disciplinary action and grievance HR department
handling is finalized Quality department

IV. AUDIT CHECKLIST


Frequency of audit: At least once a year as part of hospital-wide audit.

No Checkpoint Yes No Remarks


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
i 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.

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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
customized documents.

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 HR department
is included in Quality
department

lThe compilation of SOPs in the HR department

lThe material for training staff on hospital-wide policies and


procedures

ii. Make staff aware of the procedures concerning disciplinary action HR department
and grievance handling. This is done through training HOD of
programs such as: respective
departments

lTraining for new staff Quality


department

lRetraining 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.

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III. AUDIT CHECKLIST
Frequency of audit: At least once a year as part of hospital-wide audit.

No Checkpoint Yes No Remarks


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

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.
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 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

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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.

II. REQUIRED DOCUMENTS


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 HR staff List of staff
the ESI Act under ESI
2. Enrollment of eligible staff under ESI with all HR staff ESI
relevant supporting evidences in exchange for correspondence
an ESI card files
3. Financial contribution made by the hospital HR/Accounts Accounts
and the staff towards enlisting the eligible staff department statement
under the ESI: Employees contribute 1.75 ESI statement
percent and employers contribute 4.75 percent
4. The required amount is remitted into the ESI Accounts Accounts
account within 21 days from the end of the department statement
due month. ESI statement
5. Separate training classes are held and HR staff HR training
handouts listing the benefits under the ESI material
are given to the staff.
6. Staff may access investigations and treatment at Concerned staff Medical records
ESI-empanelled hospitals as needed. Billing details

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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 For staff not covered Percentage contribution from the staff and
insurance under ESI rest from the hospital
Optional for the staff

OPD All staff Percentage of discount


investigations

Staff dependents Percentage of discount

OPD All staff Percentage of discount


consultations

Staff dependents Percentage of discount

Inpatient stay 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

Procedure

No. Procedure Responsibility Supporting


Documents

1. The details of the health benefits for staff and HR staff List of health
their dependents is listed and maintained by benefits
the HR department.

2. The staff are made aware of the benefits at the HR staff HR training
time of joining the SHCO. material

3. The front office, billing and admission desk HOD of Front Internal
staff are responsible for extending the benefits office, Billing, communication
to the staff in times of need. Admission

4. Staff should contact the HR In-charge in case HR In-charge -


of difficulty in accessing the health benefits.

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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.
Wound or mucous membrane management
l

- 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.
Immediate reporting to designated individual (Casualty or Duty medical officer or Infection
l
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.
Post-exposure management: Assessment of infection risk.
l

- 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.

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- 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:
Unvaccinated
l person: Administer Hepatitis B vaccine regimen and Hepatitis B
immunoglobulin within 24 hours.
Vaccinated person: Test exposed person for antibody to HBsAg. If adequate, no treatment
l
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:
Unvaccinated person: Administer Hepatitis B vaccine regimen .
l

Vaccinated person: No treatment required.


l

Percutaneous (needle-stick) or mucosal exposure to HBsAg status-unknown blood or body fluids:


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
l
as if source were positive.
Vaccinated person: Test exposed person for antibody to HBsAg. If adequate, no treatment
l
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:
For the source, perform testing for anti-HCV.
l

For the person exposed to an HCV-positive source:


l

- 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 4-
6 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 HCV-
positive 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.

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Guidelines for post exposure prophylaxis for HIV
HIV positive source:
Less severe exposure: Solid needle-stick or superficial injury.
l

HIV positive low viral load asymptomatic source - 2 drug PEP.


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

HIV unknown
l source: Presence of high risk factors for exposure to HIV in the source.
Recommend 2 drug PEP.

III. TASKS AND RESPONSIBILITIES


No Task Responsibility

a. i. Employee State Insurance Act applicability HR Staff


in the SHCO

b. List of staff whose gross salary is less than HR staff


Rs. 15,000 per month

c. Enrollment under ESI with all relevant supporting HR staff


evidences with the local ESI office

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 HR staff


ESI beneficiaries regarding provisions under ESI

h. Pre-exposure prophylaxis Hospital management


extends free/concession/part-
paymentfor 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.

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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 A sufficient quantity of personal


protective equipment 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 Authorized by the management.


general illness at the SHCO. Health insurance
cover for staff.

IV. AUDIT CHECKLIST

No Checkpoint Yes No Remarks


i. Employee State Insurance Act Applicable/Not
applicability in the SHCO Applicable
ii. List of staff whose gross salary is less than Available - Yes/No
Rs. 15,000 per month Updated every month
- Yes/No
iii. Eligible new staff enrolled under ESI
iv. Remittance of amount to ESI Monthly remittance -
Yes/No
Timely remittance
(within 21 days)
- Yes/No
v. Staff interview shows awareness of the
provisions under ESI

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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
Accreditation Standards for Hospitals, NABH, 3rd Edition, November 2011.
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

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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
included in this Guidebook.

IMS1e. The contents of medical records are identified and documented.

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 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.

It is recommended that:

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.

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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.

II. REQUIRED DOCUMENTS

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)

lMandatory documented requirements: Admission record, discharge summary or death


summary, initial assessment, consultations, lab reports, reassessment, doctors' orders,
nursing assessment, nurses' record, TPR/BP chart.

lWhere 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 Registration counter/ Medical record
the UHID number. MRD

2. Required medical documentation Doctors/nurses/ Medical record


shall be completed by doctors/ dietitians/
nurses/dietitians/ physiotherapists, physiotherapists, as
as applicable. applicable

3. All the entries shall be dated, Doctors/nurses/ Medical record


timed, signed and named. dietitians/
physiotherapists, as
applicable

4. The contents of the hospital record Top management and Hospital formats
shall be defined as per the clinical Quality team
requirement.

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No. Process flow Responsibility Supporting Document
5. All the formats shall be assembled Medical records officer Medical record
according to the sequence decided.

6. Once the records are assembled, Medical records officer Medical record
they shall be checked for accuracy
(UHID), and completeness
according to the required
documentation and formats.

7. Deficiencies shall be identified in Medical records officer Deficiency checklist


the deficiency checklist and
corrective actions taken.

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)

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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 UHID

No. Points to check D/C* Responsibility Target Time Comments

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


*D= Deficient ; C = Compliant.

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III. TASKS AND RESPONSIBILITIES

No. Tasks Responsibility

i. To decide on the content of the medical records, Administrative in-charge, MRD


formats and contents of the discharge summary 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 Medical officers, nurses,
physiotherapists, dietitians
(where applicable)

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 records officer
medical officers within the target time

IV. AUDIT CHECKLIST

No. Checkpoint Yes No Remarks

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.

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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.

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 the safe management of confidentiality, integrity and security of
information stored in medical records such that loss, theft, and tampering are prevented.

It is recommended that:

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.

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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.

II. REQUIRED DOCUMENTS


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
lMaintain records in a proper and accessible manner.
lHand over the records as and when required by the chief administrator for
administrative purposes by getting a written requisition form duly signed.
lProvide records required for MLCs in a court of law by the Consultant or MOs.
lProvide inpatient records for the follow-up of inpatients by the Consultant as well as
by the patients.
lProvide 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 front-
office 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,

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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 MRO MRD receiving


records are stored in the medical records register
as per the UHID or the SHCO policy.

2. Only the relevant care providers have MRO/security staff


access to the medical records.

3. A tracer card process shall be followed MRO Tracer card


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.

4. The records are retrieved from the shelf MRO Tracer card/
and a tracer card is maintained after medical record
documenting the movement. The same
is also documented in a register.

5. Once the medical records are returned, MRO Medical records


the records are checked for integrity or
tampering of information and stored in
place. The tracer card is then closed.

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No. Process Flow Responsibility Document/Record
6. The medical records stored in the MRD MRO Pest control
shall be protected from loss due to records/fire safety
humidity, adverse environmental plan
conditions, and fire with adequate
measures being taken to safeguard
against these safety threats.

7. Whenever privileged health information Top management/ Privileged


is required by law, the SHCO will provide MRO communication
the information. record

III. TASKS AND RESPONSIBILITIES

No. Tasks Responsibility


i. Proper storage and retrieval, and maintenance of MRO
confidentiality and security of the record.

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 No Remarks


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 well-
protected 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.

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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.

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 the retention of medical records as per legal and regulatory
requirements and on the destruction of records when they are not required.

It is recommended that:

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.

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iv. If the process of destruction is outsourced, the hospital should take adequate measures
to safeguard against the leaking of information from these records.

II. REQUIRED DOCUMENTS

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 Quality team SOP


medical records, data and
information is defined as per the
regulatory requirements.

2. Medical records are retained MRO Medical records


safely and securely as per the policy.

3. Medical records are verified for their MRO Verification list


retention before destruction.

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.

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No. Process Flow Responsibility Supporting Documents

1. The retention policy for the medical Quality team SOP


records, data and information is
defined as per the regulatory
requirements.

2. Medical records which have been MRO List of medical records


stored beyond the retention period to be destroyed
are selected for destruction. (recorded in the
register)

3. The SHCO may display the UHID MRO Notification


numbers of the medical records
being selected for destruction for
the information of the public.

4. Medical records are verified for their MRO Verification list


retention before destruction.

5. Written permission is obtained from MRO Permission letter


the MS before destruction.

6. The selected medical records are MRO


destroyed by shredding.

7. If medical records are outsourced MRO MOU with vendor


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.

III.TASKS AND RESPONSIBILITIES

No. Process Flow Responsibility

i. Preparation policy and SOPs Quality team

ii. Implementation of the retention policy/SOP MRO

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IV. AUDIT CHECKLIST

No. Checkpoint Yes No Remarks


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 well-
preserved 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.

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

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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

lTo monitor, evaluate and improve care of patients so as to ensure high standards of
quality and safety for patients.

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lTo ensure the protection of patient rights and ethical practices across the organization.

lTo hold leaders, work groups, departmental heads and managers accountable for the
application of performance improvement principles and the aggressive pursuit of
improved performance.

lTo define the accreditation roadmap of the organization and ensure compliance to NABH
accreditation standards.

lTo review the quality measurement reports of the hospital and of departments and
services as well as to benchmark data from external sources.

lTo ensure that staff education plans are in accordance with quality improvement
priorities.

lTo oversee risk management activities for the hospital, such as training programs in fire
safety and biomedical waste management.

lTo oversee and review the effectiveness of other medical committees.

lTo 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:

vAppropriateness of care

vMedical assessment and treatment of patients

vCritical Incident Review

vEffectiveness of care

vUse of clinical guidelines

vClinical audits against established standards and clinical indicators

vMorbidity and mortality reviews

lTo 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.

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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

lTo 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.

lTo ensure that infection control policies and procedures are being consistently followed
throughout the SHCO.

lTo assess hospital-acquired infection rates through regular surveillance, and to ensure
that interventions are prioritized in order to reduce these rates.

lTo monitor surveillance data and identify opportunities for improvement.

lTo 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.

lTo 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.

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Sample Composition

No. Composition Designation

1. HOD Anesthesia/ Internal Medicine/ Chairperson


Microbiology

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

lTo ensure that policies and procedures related to CPR are consistently followed
throughout the organization.

lTo 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.

lTo use simulation in the form of mock drills in order to assess the responsiveness and
competence of the CPR Team.

lTo advise on the design and implementation of the audit process that monitors the
incidence and outcomes of cardiac arrest/medical emergency calls.

lTo ensure the availability and maintenance of the equipment and drugs required.

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lTo advise on the appropriate choice of equipment and medicines for use in resuscitation
procedures.

lTo offer guidance on the minimum level of resuscitation training for individual staff
groups based on their role and exposure to cardiac arrest/emergency situations.

lTo 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

lTo ensure that policies and procedures related to medication management are
consistently being followed throughout the SHCO.

lTo manage the drug formulary system by evaluating the usage of medications periodically
and requesting additions or deletions.

lTo move the SHCO towards a generic drug regime and away from the branded drug
system.

lTo monitor adverse drug events and ensure that corrective and preventive actions are
taken.

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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

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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 time-
frame for the Initial Assessment based on the organizational resources/patient load/patient
condition.

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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:
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


l

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

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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

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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

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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).

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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.

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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

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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.

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Appendix 3
GLOSSARY

lAssessment - All activities including history-taking, physical examination, and laboratory


investigations that contribute towards determining the prevailing clinical status of the
patient.

lBiomedical equipment - Any fixed or portable non-drug item or apparatus used for
diagnosis, treatment, monitoring and direct care of the patient.

lConfidentiality - 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.

lHazardous material - Substances dangerous to human and other living organisms which
include radioactive or chemical materials.

lHazardous 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.

lInformation: Processed data which lends meaning to the raw data .

lInventory 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.

lMaintenance: 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)

lPatient record/Medical record: A document which contains the chronological sequence


of events that a patient undergoes during his stay in the SHCO.

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

lProcedures: 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

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National Accreditation Board for Hospitals and Healthcare Providers
ensure the maximum use of resources and efforts to achieve the desired output.

lProcess: A set of interrelated or interacting activities which transform inputs into outputs
(Para 3.4.1 of ISO 9000: 2000).

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


intervention.

lReferral-out of patient: Safe transfer of a patient to another organization due to non-


availability of required resources including expert /equipment / facility.

lRisk 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.

lRisk management: Clinical and administrative activities to identify, evaluate, and reduce
the risk of injury.

lRisk 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.

lScope 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.

lSecurity: Protection from loss, destruction, tampering, and unauthorized access or use.

lUnstable 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.

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National Accreditation Board for Hospitals and Healthcare Providers
National Accreditation Board for Hospitals and Healthcare Providers
5th Floor, ITPI Building, 4A, Ring Road,
IP Estate, New Delhi 110 002, India
Phone: +91-11-2332 3416/ 17/18/19/20; Fax: 2332 3415
Email: info@nabh.co; helpdesk@nabh.co
Website: www.nabh.co