NABHPreAccreditationEntryLevel SHCO PDF

GUIDEBOOK FOR
PRE-ACCREWTATON ENTRY-LEVEL STANDARDS

FOR SMALL HEALTHCARE ORGANIZATIONS (SHCOs)
First Edition: May 2015
NATIONAL ACCREDITATION BOARD FOR HOSPITALS AND
HEALTHCARE PROVIDERS (NABH)
CONTENTS
Chapter 1 ACCESS ASSESSMENT AND CONTINUITY OF CARE (AAC)
1 AAC1 The SKCO defines and displays the services that it can provide
AAC1.a The services being provided are clearly defined.
2 AAC2 The SHCO has a documented registration, admission and transfer process
Process addresses registering and admitting outpatients, inpatients, and

AAC2a
emergency patients.
Process addresses mechanism for transfer or referral of patients who do

AAC2b
not match the SHCO’s resources.
3 AAC3 Patients cared for by the SHCO undergo an established initial assessment
The SHCO defines the content of the assessments for inpatients and
AAC3a
emergency patients.
Laboratory services are provided as per the scope of the $HCO’s services
AAC5
4 and laboratory safety requirements.
Procedures guide collection, identification, handling, safe transportation,

AAC5b
processing, and disposal of specimens.
5 AAC7 The SHCO has a defined discharge process
Process addresses discharge of all patients including medico-legal cases

AAC7a
and patients leaving against medical advice.
Discharge summary contains the reasons for admission, significant findings,

AAC7c investigation results, diagnosis, procedure performed (if any>, treatment
given, and the patients condition at the time of discharge.
Chapter2.CARE OF PATIENTS(COP)
Emergency services including ambulance are guided by documented

6 COP2 procedures and applicable laws and regulations.
Documented procedures address care of patients arriving in the emergency

COP2a
including handling of medico-legal cases.
7 COP3 Documented procedures define rational use of blood products
COP3c Procedures addresses documenting and reporting of transfusion reactions.
8 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.
COP4a Care of patients is in consonance with the documented procedures.
Documented procedures guide the care of obstetrical patients as per the

9 COP5
scope of services provided by the SHCO.
COP5a The SHCO defines the scope of obstetric services.
Documented procedures guide the care of pediatric patients as per the

10 COP6
scope of services provided by the SHCO
COP6a The SHCO defines the scope of its pediatric services.
Procedure addresses identification and security measures to prevent child

COP6d
or neonate abduction and abuse.
11 COP7 Documented procedures guide the administration of anesthesia
There is a documented policy and procedure for the administration of

COP7a
anesthesia
Documented procedures guide the care of patients undergoing surgical

12 COP8
procedures
Documented procedures address the prevention of adverse events like

COP8c
wrong site, wrong patient and wrong surgery.
Chapter 3.MANAGEMENT OF MEDICATION (MOM).
Documented procedures guide the organization of pharmacy services and

13 MOM1
usage of medication.
Documented procedures incorporate purchase, storage, prescription and

MOM1a
dispensation of medications
Documented procedures address procurement and usage of implantable

MOM1e
prosthesis.
14 MOM2 Documented procedures guide the prescription of medications
The SHCO defines a list of high-risk medication and the process to

MOM2d
prescribe them
Chapter4.HOSPITAL INFECTION CONTROL.(HIC)
15 HIC1 The SHCO has an infection control Manual which it periodically updates
the SHCO conducts surveillance activities.
Hospital Infection Control Manual (as Annexure)
Chapter 5 . CONTINUOUS QUALITY IMPROVEMENT(CQI).
The SHCO identifies key indicators to monitor the structures, processes and
16 CQI2
outcomes which are used as tools for continuous improvement.
The SHCO identifies the appropriate key performance indicators in both

CQI2a
clinical and managerial areas.
Chapter 6. RESPONSIBILITIES OF MANAGEMENT(ROM)
17 ROM1 The responsibilities of the management are defined.
ROM1a The SHCO has a documented organogram.
18 ROM2 The SHCO is managed by the leaders in an ethical manner
ROM2a The management makes public the mission statement of the SI-ICO.
Chapter 7.FACILITY MANAGEMENT AND SAFETY(FMS)
The SHCO’s environment and facilities operate to ensure safety of patients,

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

FMS2b
breakdown) plan.
The SHCO has provisions for safe water, electricity, medical gas and
21 FMS3 vacuum systems.
FMS3c There is a maintenance plan for medical gas and vacuum systems.
22 FMS4 The SHC0 has plans for fire and non fire emergencies within the facilities
The SHCO has plans and provisions for detection, abatement, and
FMS4a
containment of fire and non fire emergencies.
The SHCO has a documented safe exit plan in case of fire and non fire
FMS4b
emergencies.
The SHCO has a well-documented disciplinary and grievance 109
23 HRM2
handling procedure.
A documented procedure regarding disciplinary and grievance handling is in

HRM2a
place.
The documented procedure is known to all categories of employees in the

HRM2b
SHCO.
24 HRM3 The SHCO addresses the health needs of its employees
HRM3a Health problems of the employees are taken care of in accordance with the
SHCOs policy.
25 IMS1 The SHCO has a complete and accurate medical record for every patient
IMS1e The contents of medical records are identified and documented.
Documented policies and procedures are in place for maintaining

26 IMS3
confidentiality, security, and integrity of records, data, and information.
Documented procedures exist for maintaining confidentiality, security, and

IMS3a
integrity of information.
Documented procedures exist for retention time of records data, and

27 IMS4 information.
Documented procedures are in place regarding retention of the patient’s

IMS4a
clinical records, data, and information.
The destruction of medical records, data, and information is in accordance

IMS4c
with the laid down procedure
APPENDIXES
1. Formation of Committees
2. Frequently Asked Questions
3. Glossary
FOREWORDS
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 (GOl) 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.
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
NASH, 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 [HICI 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 Nagpat, 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.
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 SHCO5 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. Kaira,
CEO, NABH
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-DFlD 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, Ba nga lore.
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, QualityAssurance 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, NPH Assessor Management Committee.
World Bank facilitation team
Dr. Somil Nagpal, Senior Health Specialist, World Bank.
Dr. Abha Mehndiratta, Consultant, World Bank.
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, RajivAarogysri, Government of

Telangana.
Ms. Shobha Mishra Ghosh, Sr. Director, FICCI, New Delhi.
Dr. T.S. Selvavinayagam, Joint Director of Health Services, Government ofTamil Nadu.
Dr. Ravi Babu Shiva raj, Joint Director, CMCHIS, Government ofTamil Nadu.
Dr. Narayana Swamy, Dy. Director, Suvarna Arogya Suraksha Trust, Government of
Karnataka.
Mr. Vijendra Katre, AddI. CEO, RSBY, Government of Chhattisgarh.

Dr. K. Sandeep, Sr. Consultant, M&E, Government of Kerala.
MajorAshutosh Shrivastava, Chief Operating Officer, Glocal Healthcare.
Dr. K. Madan Gopal, Sr. Tech. Advisor, GIZ, and RSBY.
We express our sincere thanks to NABH Technical Committee members, Dr. S. Murali, Dr.
Antony Lazar Basile, Dr. Parag R. Rindani, Dr. Naveen Chitkara, Mr. Satish Kumar, Dr.
Vikas Manchanda, Dr.Badari Datta, Mr. Deepak Agarkhad, Dr. Farhan A. Rashid Shaikh,
Ms. Abanti Gopan, Dr. Ashish Rakheja and Dr. Kashipa Harit, who contributed their
valuable time and suggestions to review and finalize the Guidebook for Pre-Accreditation
Entry-Level Standards.
We express our special thanks to Dr. Manju Chacko, Team Leader, Quality, Bangalore
Baptist Hospital, Bangalore; Dr. Nancy Ramya I., Executive Program Manager, Bangalore
Baptist Hospital, Bangalore; and Divya Alexander, Independent Consultant, Bangalore for
closely supporting the coauthors in coordination and finalization of this Guidebook. Last
but not the least, our special thanks to Ms. Usha Tankha for her excellent editorial support
at all stages of this Guidebook and for bringing it out in its final shape.
We are grateful to the following NABH accredited institutions for allowing their de-identified
documents to be used as samples in this exercise:
1. Bangalore Baptist Hospital
2. Max Healthcare
3. Cimar Fertility Clinic
4. Giridhar Eye Institute
5. Shree Krishna Hospital, HM Patel Centre for Medical Care and Education
Note: All diagrams and forms in this document are original unless otherwise stated.
Policies and Standard Operating Procedures (SOPs) shared are samples to guide SHCOs
in developing their own customized documents.
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 CT 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 Gynecological Societies of India
HDU High Dependency Unit
HOD Head of Department
HCO Healthcare Organization

HR Human Resources
HSG Hysterosalpingogram
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 Organization
NALS Neonatal Advanced Life Support
NBM Nil by Mouth
NBC National Building Code
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
CHAPTER 1
ACCESS, ASSESSMENT AND CONTINUITY OF CARE (AAC)
¾ STANDARD AAC1. THE SHCO DEFINES AND DISPLAYS THE

SERVICESTHAT 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, Ill, 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 license for the same.
*Objectjve Elements AAC1b and AAC1c are self-explanatory and therefore not included in
this Guidebook.
AAClb. 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, SHCO5 may customize the same. They may use boards placed at the entrance
and reception areas, and additionally, put on their website, or have pamphlets for
distribution if needed.
AAClc. 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.
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.
iii. Whenever a new service is introduced, the scope of services policy document is
amended accordingly.
iv. 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
• Support services
• Additional service’s
• Service exclusion, if any
Note: The scope of services may be customized for each SHCO.

For example, the scope of service for a general hospital may be as follows:
Clinical Services Support Services

General Medicine Dietary
General Surgery Central Sterile Supply Department
Pediatrics Hospital Laundry
Gynecology & Obstetrics
Dental Medico-social department
Anesthesiology Biomedical Engineering Services
Emergency Department Ambulance
• Laboratory
• Radiology, X-Ray, CT Scan, USG, Medical Records Department
Mammogram
Pharmacy
The scope of service for a department maybe as follows:
Department of Imaging Services:
The department provides the following types of services:
• General X-Ray
• Barium Meal X-Ray
• Special X-Ray such as HSG
• Ultrasonography
II. REQUIRED DOCUMENTS
i. Policy on scope of services

ii. A valid license related to the scope of services such as MTP license, Prenatal
Diagnostic Techniques (PNDT), if applicable.
III. TASKSAND RESPONSIBILITIES
i Define the general scope of service Head of SHCO
Top management in consultation

ii Define the departmental scope of service
with the specific department head
Document the above into a policy on ‘scope

iii Assigned staff
of services’ and place the same in an SOP
manual
Availability of the valid license related to the

iv Administrative department
specific department
Display prominently the scope of services in Administrative department!

v
two languages Engineering department
Top management! Head of the

Update the scope of service
vi concerned department
Staff orientation to the scope of service Quality team/training cell

vii
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
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
I. OVERVIEW
Scope: To guide the SHCO on preparing a process for registering and admitting
outpatients, inpatients, and emergency patients.
• Once the patient is brought to the SHCO, the patient is registered and admitted,
if required.
• Only patients that can be cared for by the SHCO are admitted.
• Patients that match the SHCO’s resources are registered and admitted using a
defined process.
• The defined process covers all patients—OPD, new and follow-up patients, and
emergency patients.
The defined process:
I) Provides guideline instructions regarding the outpatient registration process.
II) Has a uniform registration system for patients and maintains the records of
patients coming to the hospital.
III) Provides registration for IPD fit matches the scope of services provided.
IV) Provides a mechanism for admission such that the patient can avail of
healthcare services.

i. Policy and SOP on registration
ii. Policy and SOP on admission
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
Supporting
No. Process Responsibility
Document
For OPD Registration
OPD registration shall be done on first-

A Registration clerk Register
come first-served basis.
The following details are taken from the

patient or relative:
B Name, age, sex, occupation, annual Registration clerk Registration
income, address, phone (mobile/land form
line).
The referral slip, if present, should be

checked to identify the specialty, If there
C Registration clerk Referral slip
is no referral slip, the patient shall be
registered as specified by herself/ himself
D
The details are entered into the OPD slip Register/OPD
Registration clerk
and the bill is raised. slip
The patient is directed towards the

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

F change in the specialty, the patient is slip/referral
Consultant
referred to the concerned specialty OPD. book
Emergency registration is done 24 hours

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

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

I up consultation shill be re-registered; Register
however, the same Unique Hospital
Identifier (UHID) will continue.
iii. 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
Supporting
Process Responsibility
document
No.
Inpatient admission shall be done

through the OPD or the Admission Clerk Admission Register
Emergency department or the
A
NICU/Labour ward as applicable.
The decision regarding admission
shall be made by the consultant and
B Treating Doctor Admission slip/order
an admission slip or order issued by
her/him.
General consent for admission and

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

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

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

details of the patient are put into the
admission register/computer to
Admission file and
F generate an admission file (case Admission clerk
receipt
sheet). This is handed over to the
patient and the admission fee is
collected.
The patient is directed to the Treating doctor/staff

G Bed allotment record
concerned ward, where the bed will nurse/ward attendant
be allotted.
The patient is received at the ward

by the ward nurse and allotted a bed.
H Treatment is initiated as per the Staff nurse Medical record
order. The patient is oriented to the
ward.
iii.TASKS AND RESPONIBILITIES
NO. Task Responsibility
i Define the registration, admission and transfer Top Management

process.
ii Define the department policy on admission and Top Management in

transfer process consultation 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

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 arc 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.
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 accompanie1 by the appropriate doctor or nurse if
required.
v. Emergency patients receive life-stabilizing treatment and if resources are not

available, transferred to an organization that has the required resources.
i. Policy and SOP for transfer-out and referral-out
ii. Policy on patient transfer and patient referral-out to another organization
The SHCO can refer out the patient if
• The medical problem is not within the scope of the services defined by the hospital
• The resources do not match
• A higher level of care or specialized care is required
• Special investigations are required that are not available in the hospital
However, the patient shall be shifted only after first-aid is provided and the patient is
stabilized.
SOP for referral-out or transfer-out
No. Process flow Responsibility Supporting

Document
1 Transfer-out or referral-out shall done Admission clerk Register

through ORD 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
III. AUDIT CHECKLIST
No Checklist Yes No Remarks
i Availability of policy-apex manual
ii Availability of transfer-out form
iii Consent form
iv Transfer-out register/record
STANDARD AAC3. PATIENTS CARED FOR BYTHE SHCO UNDERGO AN

ESTABLISHED INITIAL ASSESSMENT
Objective Elements
AAC3a. The SHCO defines the content of the assessments for in patients 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, Ill, 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.
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 appropriate4ssessed for her/his clinical
condition based on standard norm 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.
Assessment by Unstable patient stable patient Documentation

within 24 hours of
Doctor Immediately Immediately
admission
within 4 hours of
Nurse Immediately Immediately
admission
Qualified and registered professionals performs 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.
Supporting
NO Process Responsibility
Document
1 All patients who come to the EMO/Treating Medical record

emergency Doctor/Staff nurse
department shall be assessed
2 The following parameters shall be EMO/Treating Medical record

assessed in detail: Doctor/Staff nurse
• Chief complaints
• History of illness
• Allergies or any associated disease
• Temperature, Pulse, Blood
Pressure, and Respiration
• Physical examination
3 In case of mass casualties, triage EMO/Treating Medical record

shall be completed first, and then Doctor/Staff nurse
followed by assessment.
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
• The care setting
• The patient’s response to any previous care and the patient’s consent to treatment
The patient shall be assessed and the records shall be documented. Then a
documented plan of care s drawn up, based on the initial assessment.
No. Process Responsibility Supporting

Document
Initial assessment of admitted patient
1 Initial assessment is made and documented in Treating Medical

medical record with name, time, date and Doctor record
signature. /Doctor on
Duty
2 The assessment shall include the following Treating Medical
parameters: Doctor record
• Temperature, pulse, blood pressure and

Respiration
• Physical examination.
3 The initial nursing assessment is done in the Staff nurse Medical

prescribed format. record
Assessment of obstetric and high-risk

obstetric patients
1 (This includes pregnancies with diabetes, HTN, Consultant Medical

Asthma, Eclampisa, record
convulsions, multiple pregnancies, elderly
primi(>30 years),bad obstetric history(abortion)
2 The assessment shall include: Medical
record
• Weight, height
• BP
• Routine lab investigations
• Hb, blood group, urine(routine and

microbiological)
• BT,CT
• NST(Non stress test)
• Fetal monitoring
• Months of pregnancy (regularly noted on

each visit)
• Tetanus injections
• 2-3 ultrasounds in whole

period(immediately after confirmation of
pregnancy,20 week anomaly and 32
week growth scan)
• PPTCT counseling
• Multidisciplinary approach for patients

with medical disorders in pregnancy
3 All patients shall be given appropriate Treating Medical

explanations about their conditions Doctor / staff record
,Descriptions of the following should be shared: nurse
• The diagnosis or provisional diagnosis as

applicable
• Plan of treatment as decided by the

treating consultant
4 Special needs of the vulnerable patients who Treating Medical

are receiving treatment will be assessed. Doctor / staff record
nurse
III. 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
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 AACS. LABORATORY SERVICES ARE PROVIDED AS PER THE SHCO’S

SERVICES AND LABORATORY SAFETY REQUIREMENTS.
Objective Elements
AAC5a. Scopes of the laboratory services are commensurate with the services provided
by the SHCO.*
AAC5b. Procedures guide collection, identification, handling, safe transportation,

processing and disposal of specimens.
AAC5c. Laboratory results are available within a defined time frame and critical results are
intimated immediately to the concerned personnel.*
AAC5d. Laboratory personnel are trained in safe practices and are provided with
appropriate safety equipment or devices.*
* Objective Elements AAC5a, AAC5c and AAC5d are self explanatory and therefore not
included in this Guidebook
AAC5b. Procedures guide collection, identification, handling, safe transportation,
processing and disposal of specimens.
I. OVERVIEW
Scope: To guide the SHCO to prepare a department Lab Manual that incorporates all the
documented procedures for collection.
Lab Manual
i. The SI-ICO has a department Lab Manual that incorporates all the
documented procedures for collection, identification, handling, safe
transportation, processing and disposal of specimens.
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 records or registers, and forms and formats shall be
available in the laboratory.
The list of records or registers, 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
Procedure
Sample collections identifications, Handlling, and Transportation of samples,

Processing of samples, Disposal of specimens.
No Process Flow Responsibility Supporting

Document
1 Sample collection Lab Sample book
Technician
Sample collection shall be carried out on
a 24 hours basis either in the samples
collection room or in the laboratory
2 Sample identification Technician
• All samples will be labeled with the

name, age, sex, lab serial number,
and the unique ID number of the
patient.
• All samples will be accompanied
by a written requisition from the
treating doctor for lab investigation
and necessary payment (if
applicable).
• The lab reception receiving the

samples will enter the details into
the register.
3 Sample Handling Technician
• All samples will be handled as per

the infection control guidelines
• Universal precautions are to be

observed while handling samples
4 Safe Transportation of Samples Technician
• All measures shall be taken in order to

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

depending on the prevailing
environmental factors.
5 Processing of Samples Technician Procedure or Lab
Manual
• The processing of samples should
be Manual carried out as per the
requirements of individual tests.
• The procedure for testing should
be standardized and necessary
instructions issued to all concerned
personnel.
• Samples should be processed
without delay, and on a priority
basis for emergency cases.
6 Disposal of specimens Technician
• Disposal is to be carried out in

accordance with Biomedical Waste
Handling Rules.
• Precautions should be observed in
accordance with the Hospital
Infection Control Manual.
III.TASKS AND RESPONSIBILITIES
NO Task Responsibility
Define the content of the Lab Department heads/Quality team

i Manual
Define the content of the tab Top management in consultation with the
ii
Safety Manual specific department head
iii Preparation of lab related policy Quality team
Staff orientation to the safety

iv Quality team/Training cell
aspects and SOPs
IV.AUDIT CHECKLIST
No checkpoint yes NO Remarks
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
STANDARD AAC7. THE SHCO HASA DEFINED DISCHARGE PROCESS.
Objective Elements
AAC7a. Process addresses discharge of all patients including medico-legal cases (MLC5)
and Patients leaving against medical advice.
AAC7b. A discharge summary is given to all the patients leaving the SHCO (including
patients leaving nst 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 Guide book
AAC7a. Process addresses discharge of all patients including medico-legal cases

and patients n.ng against medical advice.
Note: sections II, Ill, and IV below are provided as samples to guide SHCOs in developing
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
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.
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 an 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 the scope of patient rights, no patients may be kept in hospital
against the 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. 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 to the patient or attendant, and also that if the
patient leaves the hospital 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 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 c in the Medical Records.
• All discussions and risks explained should be recorded in the patient’s

Medical Record.
xi. The discharge summary should be prepared and handed over to the patient and a co
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 pa
and a copy should be kept by the hospital.
The discharge process should be coordinated with other departments in case the
patient consultations with other departments.
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

department-wise discharge summary. Department / summary
Quality team
2 Treating Consultant decides to discharge Treating Doctor

the patient
3 Development of a care plan for post- Treating Doctor

discharge care.
4 Arranging for the provision of services, Staff

including patient or family education Nurse/CHD
Coordination related to discharge with Treating/Referra

5 specialty Consultants if cross-consultation l Doctor/Staff
was obtained Nurse
6 Preparation of final discharge summary. Treating Doctor
Staff
Preparation of account settlement form or
7 Nurse/Billing
final bill.
section
Discharge summary handed over to the

patient along with guidance on post Treating
8 discharge medication, follow-up and Doctor/Staff Discharge
information regarding how to obtain Nurse summary
urgent care.
Staff Nurse
9 A copy of the discharge summary is Discharge
attached to the patient case sheet. summary
Patient is accompanied till the hospital

10
exit. Ward attendant
i Define the discharges 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
IV. AUDIT CHECKLIST
No Checkpoint Yes No Remarks
ii Availability of required documents
iii Standardize 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.
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.
i. Standardized discharge summary
No Task Responsbility
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
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.
CHAPTER 2
CARE OF PATIENTS (COP)
STANDARD COP2. EMERGENCY SERVICES INCLUDING AMBULANCE ARE GUIDED

BY DOCUMENTED PROCEDURES AND APPLICABLE LAWS AND REGULATIONS.
COP2a. Documented procedures address care of patients arriving in the emergency

CDP2b. 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 ortransferto another organization is also

documented.*
*Objective Elements COP2b and COP2c are self-explanatory and therefore not included in
this guide book
COP2a. Documented procedures address care of patients arriving in the emergency

Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing
their 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 (MLC5) 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.
iii. Based on this list, the sequence of steps or procedures to be followed in each case
should be defined and documented. Staff should be trained for the same.
iv. Process to ensure safe transfer of the patient within the hospital and outside the
hospital including good referral practices should be in place
v. Staff should be aware of their roles and responsibilities in different emergency

scenarios (roles of the attendant, nurse, doctor).
vi. Some resources that may be helpful to develop such mechanisms in the hospital
are available in the References.
i. Policy for providing services for emergency patient and in medico-legal cases.
ii. SOP for handling different emergency situations common to SHCO including initial
screening, admission, first aid, referral, DAMA/LAMA, transfer within or outside
hospital ambulance, code blue/CPR.
iii. SOP for handling MLCs.
iv. Required registers for MLC.s
Sr.No Task / assignment Responsibility
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 hospital; EMO on
MLCs duty/Consultant on duty
4 Ensuring required documentation process MO and Quality person

including maintenance of different registers for /consultant involved.
emergency and MLCs
5 Audit and monitoring quality standards Quality team
6 MLC certificates EMO
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 inward/discharge/
referral/ DAMA; for potential MLC
Processes are in place to ensure Documentation

related to MIC 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 Doctor on duty Casualty register

emergency medical services {Casualty register format}
shall be screened and first
aid care and stabilizing
treatment be provided, if
required.
The patient must receive Doctor on duty and Nurse Patient case record and
stabilizing treatment within
the capabilities and on duty Casualty register
resources of the HCO.
Should the stabilizing Consultant on duty (full Patient case

treatment require a specialist time or visiting) record/Referral form
physician, the physician must
be available to respond in a
timely manner.
The doctor on duty shall Doctor on duty MLC register

decide whether a case is an
MLC
All MLCs shall be notified to Doctor on duty and Nurse MLC notification book and
the police as per SOP on duty MLC register.
following the 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 Doctor on duty Casualty register- column

concludes, based on the which states where patient
results of the screening is sent after primary
examination, that the patient treatment.
does not have an emergency
medical
condition, the patient may be
treated as OPD or referred to
a specific OPD
If inpatient treatment is Doctor on duty Casualty register- column

required as per clinical which states where patient
conditions, the patient is sent after primary
shall be transferred to the treatment.
designated
ward/OT/ICU/HDU after
primary
treatment.
Prior arrangement for Nurse on duty in

availability of Nurse on duty emergency
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 duty Transfer record
department records are sent
with the
patient including any test
results.
In case there are more than Doctor on duty Triage record / casualty
two or three patients, triaging register
and prioritization for Nurse on duty
management shall
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 Doctor on duty Transfer / DAMA / register

refuses to be admitted in the
hospital, and wants a
transfer to another hospital
or wants to go home, she/he
should
understand the ri4s and
benefits.
If patient’s clinical condition Doctor on duty Transfer register
requires treatment that is not
within the scope of hospital Nurse on duty
services, arrangements 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 Doctor on duty Transfer register

to ask about bed availability,
brief staff about the patient’s Nurse on duty
condition on the phone, and
confirm whether HCO can
receive the patient.
Paramedical staff shall Doctor on duty Transfer register
accompany stable patients
and a trained nurse/medical Nurse on duty
officer shall accompany
unstable patients.
A critical patient shall not be Doctor on duty Transfer register

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

suitable ambulance(stable
patient in general ambulance Nurse on duty
or critical patient in cardiac
ambulance)depending on Ambulance driver/staff of
availability. the ambulance if the
ambulance is from the
receiving hospital.
All documentation shall be Doctor on duty Patient case file

complete 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
¾ Poisoning
¾ Road traffic accidents
¾ Falls from a height
¾ Sharp edged injuries
¾ Near drowning
¾ Blunt injuries
¾ fire-arm injuries
¾ 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 recorded. EMO/Nursing Patient
record/MLC
register
2 Each event shall be recorded in detail including EMO Patient

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

police station by phone after counseling the record/MLC
patient and relatives about the hospital policy register
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 Patient
record/MLC register and time of telephonic
intimation (the format is enclosed in Exhibit 1).
4 All MLCs after registration are to be issued for EMO/Nursing Patient

OPD /IPD cases and should be marked “MLC’. record/MLC
MLC number shall be stamped on all paper and register
patient records
5 Clinical notes shall be entered in IPD / EMO/Nursing MLC book

OPD case paper and in an MLC form
book (in duplicate or triplicate)
Examine the patient for all injuries. Take a

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

and all columns completed.
While filling the injury sheet, place special

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

to bottom. Injuries on the scalp
are to be mentioned first and those on toes to
be mentioned last. Wound description; type of
injury; dimension, extension, site/location
according to the nearest landmark, opinion on
wound - whether fresh or old --should be
recorded in detail. Opinions on any investigation
required for the wound should be mentioned
with each wound description.
All alleged poisoning cases shall be marked ‘No

External Trauma/Wound
Observed’. These cases shall be observed
carefully to rule out any external injury
or abnormal mark on the body.
In assault or trauma cases, the left thumb

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

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

(20-SOmI) 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.
No lavage sample should be attempted

in any acid or kerosene oil poisoning or
burn case.
In all MLCs, medico-legal evidence like
patient’s clothes with blood stains, stab injury,
cut mark and bullet hole marks shall be
encircled, signed by the examining doctor, and
reserved. 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 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 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 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 each Nursing Patient

MLC with the required data at emergency record/MLC
register
7 A counter signature from the police station shall Nursing Patient

be taken from the representative in a patients record/MLC
MLC form / book register
8 The time of informing the police and time of Nursing Patient

arrival of the police shall be entered in the MLC record/MLC
form register
9 In case the police do not arrive within 24 hours EMO Patient

of the MLC report a reminder shall be sent record/MLC
asking for an acknowledgment. register
10 If any patient refuses to be registered as an EMO Patient
MLC, the Medical Superintendent should be record/MLC
immediately informed for a further line of register
procedural action.
11 All MLCs registered with the hospital shall be EMO Patient

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

case as an MLC, the medical superintendent record/MLC
shall be consulted. register
13 If any patient registered under MIC dies during EMO Patient

hospitalization, postmortem is a mandatory record/MLC
procedure and the patient’s body shall not be register
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 police EMO Patient

at the time of handing over the dead body for record/MLC
submission to the district hospital. register
15 When MLC5 are discharged, the relevant police EMO/Nursing Patient

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

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

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

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

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

prepare the injury certificate with the help of the record/MLC
CMOs register
21 MRD shall preserve a copy of the signed MRD Patient

certificate in the patient record record/MLC
register
22 At the time of handling over the certificate to MRD Patient

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

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

issued to the police and not to the patient or record/MLC
relatives. register
Exhibit 1
Format of information
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
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.
their 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.
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 (hemolytic, 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 coP3 bare 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 transportation. 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.
iv. Standards for blood bank and blood transfusion maybe found in:
• National AIDS Control Organisation (NCO), Ministry of Health and Family

Welfare, Government of India. Standards for Blood 8anks and Blood
Transfusion Services. Available at
http://www.naco.gov.in/upload/Final%2oPublications/Blood%2Osafety/St
andards%
Zofor%ZOBlood%2OBanks%Zoand%2OBIood%2oTransfusion%zoservic
es.pdt
• http://www.naco.gov.in/NACO/Quick_Links/Publication/Blood Safety Lab

Services/ Operational_Technical_guidelines_and_policies/standa rds for
blood bank/
• 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/QuiclçLinks/Publication/Blood Safety Lab
Service/
i. Policy for blood transfusion services.
ii. SOPs for handling blood and blood components including acquisition,
storage, transport, blood component transfusion, and monitoring
during transfusion.
iii. SOP for detecting and reporting blood transfusion reactions for
improving patient safety.
iv. Legal papers and licenses and applicable MOUs, whichever is

applicable as per regulation.
Ill. TASKS AND RESPONSIBILTIES
S.No Task/Assigned Responsibility
i Preparation of all policy and SOPs for blood and Blood bank
blood component services officer/Pathologist/Medical
superintendent/ Incharge
consultant/person
ii Procuring or maintaining MOUs Medical

superintendent/person in
charge
iii Induction and ongoing training for blood and blood Superintendent/ Head of
component related policies and SOPs hospital
iv Ensuring required documentation process MO and/or Quality person/

including informed consent, blood and component consultant involved
transfusion monitoring, blood reaction monitoring
and reporting
v Audit and monitoring quality standards for blood Superintendent /

transfusion services responsible person or
consultant
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
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 BloodBank 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
0Hr
15min
30min
1hr
1hr 30min
2hr
2hr 30min
Blood transfusion completion time
Post transfusion vitals
At 30 min
At 1 hr
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 Hemoglabinuria
Allergic symptoms: Urticaria/rash/swelling
Nausea and vomiting:
Any other symptoms:
Vitals/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 ElementCOP4b is self-explanatory and therefore not included in this

Guidebook.
COP4a. Care of patients is in consonance with the documented procedures.
I. OVERVIEW
Scope: To instill 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 CU 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 of Health and Family Welfare, Government of India, Standard Treatment

Guidelines, the Clinical FstablishmentsAct, 2010. Available at
http://clinicalestablishments.nic.in/En/1068-downloads.aspx
• CDCGuidelinesfor Infection Control, 2003. Available at

www. cdc.gov/ncidod/hip/enviro/guide.htm
• Critical Care Society Guidelines, 2010. Available at

www.isccm.org/pub-icu—guidelines.aspx
• Royal College of Obstetricians ond Gynaecologists Guidelines, 2014. Available at

https://www. rcog. org. uk/en/guideline.-research-services/guidelines/?p=5
• FOGSI Guidelines. Available at

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

http://www.naco.gov.in/NACO/About_NACO/Policy_Guidelines/Policies_Guidelinesl/
i. Policy for providing critical care services for medical, surgical, pediatric,
obstetrics or neonatal patients.
ii. SOPs for holistic care of critically ill patients and their management in ICUs or
HDUs.
iii. Forms and formats for informed consent, Procedure checklists, Lab or Imaging
investigations, Monitoring sheets for doctors and and nurses, Blood and blood
component transfusion.
i. Key personnel meet and finalize the scope of critical care for different category
of patients, such as surgical, medical, neonateand pediatrics within ICU I HDU.
ii. Policy and SOPs for admission, discharge, transfer and management of
patients in CU 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.
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, Mointoring sheets, and

Documentation process are in a 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 ICU in charge/Doctor Patient record/ICU

admitted as per clinical need. register
All patients shall undergo an initial ICU doctor and Nurse Patient case record
assessment by the ICU doctor on on duty
duty and nurse on duty.
In case of non availability of ICU doctor and doctor ICU register/transfer

beds,the ICU doctor will find out in casualty register/patient record
whether any settled patient can step
down or space be created to
accommodate the new patient
based on available human and
other resources.
If it is not possible the patient shall Doctor on duty

be transferred to another hospital
as per the transfer-out procedure. Nurse on duty
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.
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
Bundle care guidelines must be Doctor on duty Patient record

followed for all IV lines, catheters,
endotracheal tubes, and other Nurse on duty ICU register
tubes.
Monitoring, patient assessment, Doctor on duty Patient record

and treatment should be
documented in the designated Nurse on duty ICU register
format and patient case file and ICU
register.
Handing over, taking over between Doctor on duty Patient record

shifts, and transfers to other wards
should be appropriately Nurse on duty ICU register
documented.
The patient may be discharged o Doctor on duty Patient record

stepped down to a ward as per
clinical need. Nurse on duty ICU register
STANDARD COPS. DOCUMENTED PROCEDURES GUIDE THE CARE OF
OBSTETRICAL PATIENTS AS PER THE SCOPE OF SERVICES PROVIDED BY THE
SHCO.
Objectives 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 as the facilities to take care of rieonates.*
*Objective Elements COP5b, and COP5c are self-explanatory and therefore not included
in this Guidebook.
I. OVERVIEW
Scope: To guide the SF-ICC 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 aritenatal
services, intranatal and postnatal services.
ii. List the different diagnostic facilities available for this category of patients.
iii. Define and display whether it can cater to high-risk pregnancies such as
eclampsia , or medical disorder with pregnancy.
iv. Provide details on provision for termination of pregnancy and family planning
services, if applicable.
i. Scope of services that SHCO provides to the community.
ii. Scope of services displayed in a prominent area in the OPD.

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 provised Gynecology HOD/Medical

either due to lack of human resources, expertise, superintendent or
infrastructure or other logistical problems consultant in-
charge/Nursing head
iii Disseminate the scope of services to all staff HR and Gynecology

members department
iv Prepare a board to display scope of services Management

publicly
v Annual review of scope of services an 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 Billing display of scope of service in a

prominent area.
iii Staff training records
STANDARD COP6.DOCUMENTED PROCEDUES GUIDE THE CARE OF PEDIATRIC

PATIENTS AS PER THE SCOPE OF SERVICES PROVIDED BY THE SHCO.
Objectives 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.
COP6e. The childrens family members are educated about nutrition, immunization and
sage parenting.*
*Objective Elements COP6b, COP6c, COP6e,are self explanatory and therefore not
included in this Guidebook.
COP6a.The SHCO defines the scope of its pediatric services.
I. OVERVIEW
Scope: To guide the SHCO on how to decide and communicate clearly to the community
the different pediatric 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/sub specialty services
i. The scope of services be displayed bilingually(in English and the state

language)in prominent places.
ii. In case a change is required in the scope the HOD pediatrics requests the same
and the MS approves it.
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 service or its correction MS
iii Display of scope of pediatric services MS
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.
I.Overview
Scope: To guide the SHCO on the prevention of neonate/child abductions and abuse and
to ensure proper safety for newborns and children.
i. Hospital staff are trained and parents educated about the policy and procedures for
preventing infant and child abduction, and safety measures and precautions are
taken to prevent infant abduction and abuse. Parents are advised to supervise their
children at all times in waiting rooms and outpatient clinics.
ii. Proper security measures are taken to avoid any abduction or abuse of children in
the hospital premises by posting security guards outside each department in the
hospital.
iii. Electronic surveillance in the form of CCTVs may be installed in closed areas for
monitoring. The HCO may also have a code pink protocol or SOP for the prevention
of child /neonatal abduction or abuse.
i. Policy on Child Abduction and Abuse
ii. SOP on Child Abduction
No. Task Responsibility
i Formulate SOP/Policies Quality officer
ii Allocate resources for name tags, CCTV Medical superintendent
iii Patient education Nurses/Medical officers
iv Safety and security of NICU /PICU wards Security personnel
v Code pink mock drill, corrective action and Audit team

preventive action
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 Nurses SOP/identification
neonate is born, identification bands band
are tied.
2 One parent is allowed to be with the Security
patient at all times or allowed to visit personnel/Nurse
the patient frequently in the ICU.
3 Footprints of the newborn are Nurses Medical records
imprinted on the bedside record and
on the mother’s case sheet.
4 The mother’s identification tag Nurses
includes 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 Nurses
authorized 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
9 The hospital staff and the parents Audit/HRD
are 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 Quality team Mock drill record
checked 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, COP7L and COP7g are self-
explanatory and therefore not included in this Guidebook.
COP7a. There is a documented policy and procedure for the administration of

anesthesia.
I. OVERVIEW
Scope: To guide the SHCO on how to develop and implement policies and SOPs related
to the administration of anesthesia with emphasis for patient safety and smooth day- to-
day functioning of OT.
Compliance with COP7 a is starting point and acts as guiding document in the SHCO. This
element helps to increase the capacity of the SHCO for patient safety while administering
anesthesia. It also helps the SHCO minimize adverse events and medico-legal issues.
i. The SHCO develop policies for anesthesia services, including who can
perform them (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 post anesthesia status monitoring.
vi. Informed consent formats.
vii. Formats for pre anesthesia assessment, immediate preoperative re-evaluation,

monitoring during and after anesthesia.
viii. WHO surgical safety checklist (anesthesia related component)
II. TASKS AND RESPONSIBILITIES
i Develop a policy for anesthesia services Management
ii Appoint or make available anesthetists and HR/Superintendent/Head

team as per the policy of SHCO
iii Develop SOPs for different anesthesia related Anesthetist, OT nurse,
activities Quality team/designated
person
iv Training related to theses SOPs is provided HR/Quality

for all stakeholders team/consultant in-
charge
v Day-to-Day activity and documentation Anesthetist/OT Nurse
vi Regular documentation audit for adherence to Quality team/designated

SOPs 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 Intra operative 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
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.*
C0P8b. 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.
C0P8d. 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
ofcare.*
COP8f. The operation theatre is adequately equipped and monitored for infection control
practices.*
*Objective Elements COP8a, COP8b, COP8d, COP8e, and COP8f are self-explanatory
and therefore not included in this guidebook.
COP8c. Documented procedure addresses the prevention of adverse events like

wrong site, wrong patient and wrong surgery.
I. OVERVIEW
Scope: To guide the SHCO to develop and implement policies and SOPs for conducting
safe surgical procedures and preventing potential adverse events.
i. Personnel involved in care of surgical patients take all necessary measures

to reduce the risk of occurrence of adverse events in surgical patients. Refer
to:
WHO, Surgical safety Checklist and Implementation Manual Available at
http://www.who.int/patientsafety/safesurgery/ss_checklist/en/
WHO, Safe Surgery. Available at
http://www.who.int/patiqtsafety/safesu rgery/en/
WHO, Tools and Resources on Patient Safety. Available at
http://www.who.int/patientsafety/safesurgery/tools_resources/en/
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 stiff. 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 hospital management
and to the concerned people. These committees at a root-cause analysis
and take appropriate preventive measures to prevent the occurrence of a
event in the future.
III. 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 patient.
iii. WHO surgical safety check list format.
iv. Incident report form in case of any event.
i Adopt WHO surgical checklist and customize it for Surgical

local use; prepare other checklist formats for head/Anesthetist/Nurse
shifting patient from ward to OT,SOPs for patient incharge
identification and side and site marking
ii Disseminate the checklist to all stakeholders HR/Quality team/designed

consultant/person
iii Audit of adherence to real time usage of these Quality team/designated

checklists consultant/person
iv Reorientation or refresher training for the same Quality team/designated

consultant/person
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(time-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

Document
1 Scheduling: The following information Primary nurse and OT list, consent

is a must when scheduling an surgical team form
invasive/surgical procedure:
• Correct spelling of the patient’s full
name
• Inpatient number
• Consent for procedure to be
performed
2 Preprocedure/preoperative Physician and Surgical safety

verification Anesthetist checklist
The physician and anesthetist shall
verify
the patients identity by asking
• Patient’s full name and compare
with ID band
• Procedure or surgery to be
performed If the patient is a minor,
incompetent, sedated or not able to
speak, the information should be
obtained from a blood-relative or
legal guardian.
3 Site mark: This should be completed Physician and Surgical safety

before the patient enters the Anesthetist, Primary checklist
procedure or operating room.The site nurse, OR
mark is required in invasive or Nurse/Register
surgical procedures that involve
• Laterality (for example, right,

left)
• Multiple structures(for
example, toes, fingers, limbs)
• Multiple levels (for example,

spine)
This includes bedside invasive

procedures.
4 Before making the site-mark, the Physician and

Consultant performing the procedure Anesthetist
or surgery verifies the patient’s
identity and medical records. In the
case of a minor verification process
must involve parents or the legal
guardian.
5 Infection control
There should be standardized Nurse, OR
marking for all procedures (for nurse/Doctor
example, SS - surgical site). The
marker should be hype-allergenic,
latex-free, and sterile. The marking
should be clear and unambiguous.
6 The site-mark should not be removed Physician and

tint the procedure is over. Anesthetist OR
Nurse/Doctor
7 Time-out procedure: OR Nurse Surgical safety

Time-out is required to confirm the checklist
• Correct patient
• Correct side or site
• Correct procedure
• Correct patient position
• Correct radiographs
• Correct implants and equipment
8 A verbal time-out or pause is called OR Nurse/Doctor Surgical safety
by the OR Nurse or Registrar checklist
immediately before the procedure or
surgery in the operating room or
procedure room.
9 The patient doses not have to be OR Nurse/Doctor

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

operating 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 Physician and Surgical safety

Surgeon will say ‘yes’ to all the Anesthetist OR checklist
details. The time-out will be Nurse/Doctor
documented in the medical records. It
should include
• Personnel present at the time-

out
• Surgical safety checklist
• Verification of correct patient
• Verification of correct side and

site
• Agreement on the
procedure/verification of
radiographs
• Verification of the correct

position
• Available implants and

equipment
12 Discrepancies Physician and

Anesthetist OR
If any discrepancy is found at any Nurse/Doctor
point, the case must not proceed until
completely resolved.
13 All team members and the patient (if Attending consultant

possible) must agree on the (Physician and
resolution of the identified Anesthetist)
discrepancy. The attending
Consultant in the patient’s medical
records 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 NASH Standards for Hospitals (3rd Edition), November 2011.
CDC Guidelines for Infection Conl. 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=ar-
ticle&id=84&ltemid=131
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/kerala med icolega Isoci ety/med ico-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=2s
26&Id 10
Ministry of Health and Family Welfare, Government of India, Guidelines and

Protocols: Mea:
legal Care for Survivors/Victims of Sexual Violence. Available at
http://www.mohfw.nic.in/WriteReadData/l892s/9s3s223249GuidelinesandProtocols
orsexua lenceMOHFWf.pdf
Ministry of Hearth and Family Welfare, Government of India, Standard Treatment

Guidelines, 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_Guidehline
ss
NACO, Ministry of Health and Family Welfare, Government of India, Operational

and Techn.:r3 Guidelines and Policies for Blood Safety and Lab Services. Available
at
http://www.naco.gov.in/NACO/QuiclçLinks/Publication/Blood_Safety_Labjervices/
NACO, Ministry of Health and Family Welfare, Government of India. Standards for
Blood Bar< and Blood Transfusion Services. Available at
http://www.naco.gov.in/upload/Final%2oPublications/Blood%2oSafety/Standards%
2Ofoñt2C od%ZoBanks%2oand%2OBlood%2oTransfusion%2oServices.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 pnd 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.*io.int/patientsafety/safesurgery/tools_resources/en/
WHO, Safe and Rational Clinical Use of Blood. Available at
http://www.who.int/bloodsafety/clinical_use/en/
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
MOM1b. These comply with the applicable laws and regulations.*
MOM1c. Sound alike and lookalike 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
MOM1a. Documented procedure shall incorporate purchase, storage, prescription

and dispensation of medications.
I OVERVIEW
Scope: To guide the SHCO on procedures to be followed for purchase, storage,

prescription and dispensation of drugs in a safe manner and to avoid medication errors.
It 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 and solumedrol.These of medications are called
“Look-alike sound-alike” medicines or LASA medicines (see Annexure).The
hospital should consider making special arrangements for storage for these
medications (for examples, making a list, educating staff, and labeling LASA
medicines with the help of stickers and avoiding keeping them together).
v. All prescriptions be written by registered medical practitioners.
vi. All prescription 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.
SOP procurement of Medication
No Procedure Responsibility
1 A list of medications used regularly in the SHCO is Pharmacy In-charge

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

company representatives over the phone charge
according to the order note.
7 Items are received from the stock list as per the Pharmacy/Purchase in-
agreed turnaround time. charge
8 Items are checked according to the bill and the Pharmacy/Purchase in-
order note. charge
9 Quantities, batch number, expiry date, any Pharmacy/Purchase in-

breakage of items are checked before accepting charge
from the stock list 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

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,Nursing staff
stored medication 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 manufactures specification patient care area
5 Medications with “Cold chain” requirements are Pharmacy in-charge and

kept in the refrigerator. person in charge of the
patient care area
Temperature is monitored at least once every shift.
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 LASA person in charge of the
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.
Procedure of prescription of Medication
1 Registered doctors are authorized to prescribe Medical Profesionals

medications in the SHCO. (Consultants/
Residents/Medical
Officers)
2 The prescription will contain the type of Medical Profesionals
preparation, name of the drug, dose, route of (Consultants/
administration, frequency, and duration of usage. Residents/Medical
Officers)
3 Medical Profesionals
Medication orders are written clearly and legibly in (Consultants/
capitals dated, timed, signed, and named Residents/Medical
Officers)
4 Medication orders are written only in the Medical Profesionals

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

is maintained inputs from the consultants
SOPs on Dispensing Medication]
1 Dispensing of medication is done by a qualified Pharmacist

Pharmacist
2 The pharmacist cross-verifies the medication with

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

date are checked by the pharmacist
IV. TASKS AND RESPONSIBILITIES
No Tasks Responsibility
i Define list of medications used in the SHCO List Pharmacist / Doctors

approved vendors
ii List approved vendors Purchase/Pharmacist
iii Storage conditions of medications Management / Quality

team/Pharmacist
iv Prescription Format Quality team

/Pharmacist/Doctors
v Quality team /Pharmacist/
Applicable Policies and SOPs Doctors/Nurse
V. AUDIT CHECKLIST
i List of medications used in the SHCO
ii Mointoring of storage conditions
iii Prescription with patients name,admission

number,dosage,written in capitals, doctors
signature and state Medical council
registration
MOM1e. Documented procedures address procurement and usage of implantable

prosthesis.
I. OVERVIEW
Scope: To guide the SHCO on how to define the policy and procedure on procurement
and usage of implan table prosthesis.
i. Medical implants are devices or tissues that are placed inside or on the surface of
the body. Many implants are prosthetics, intended to replace missing body parts.
Other implants deliver medication, monitor body functions, or provide support to
organs and tissues.
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.
REQUIRED DOCUMENTS
Note: The following is a sample list of documents which may be modified by the hospital
according to its function.
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.
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

obtained from the in-charge and the person Purchase/Pharmacy in-charge
ordering
6 Order for items is placed with different stock lists Purchase/Pharmacy in-charge
or company representatives over the phone as
per the order note
7 Items are received from the stock list as per

Purchase/Pharmacy in-charge
agreed TAT
8 Items are checked according to the bill and the Pharmacy/Purchase staff
order note
9 Quantities, batch number, expiry date, any Pharmacy/Purchase staff

breakage, relating to all the items are checked
before accepting from the stock list or company
representatives
10 A copy of the order note along with the bill is Pharmacy/Purchase staff
sent to the Accounts department after getting the
signature of the person in charge
11 Payment is made by the Accounts department Accounts Department
12 implants are supplied to the point of care on Pharmacy/store

request
13 Implant details such as name, model, lot and OT staff

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

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.
Objectives 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.
Objectives Elements MOM2a, MOM2b, and MOM2c are self-explanatory and therefore not
MOM2d.The SHCO defines a list of high-risk medication and process to prescribe

them.
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 labeling the high-
risk medicines, keeping them separately, and avoiding verbal orders for the medicines.
i. The SCHO prepare a list of high-risk medications used in the SHCO. This list
should be made known to all staff (nursing/pharmacists/doctors). The
medications should be doubly checked before dispensing as well as during
administration. (The list of high-risk medicines may be prepared as per the
Annexure in the Institute for Safe Medication Practices (ISMP) list.)
ii. All high-risk medications be adequately labelled.
iii. Antidotes for these drugs be made available. No verbal orders should be
followed for high- risk medication
List of high-risk medicines are available in the Annexure.
Draw up a list of high-risk medications used in the

i Pharmacist/Doctors
hospital
Define the storage and usage precautions or Management/Pharmacists/

ii.
identifiers for high-risk medications Doctors
Availability of antidotes for high-risk medication, if

iii Management/Pharmacist
available
N. AUDIT CHECKLIST

i List of high-risk medications
ii Identifiers for high-risk medications
V.References
de Vries, T.RC.M., R. H. Henning, H. V. Hogerzeil and 0. 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 Medicines. Available at
ctp://www.gmc-uk.org/Good_practiceJnprescribing.pdf_S8834768.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
hltp://apps.who.int/medicinedocs/en/d/Js4885e/
Annexures
1. list of high-alert medications. Available at

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

https://www.ismp.org/tools/confuseddrugnames.pdf
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 at 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, Ill, and IV below are provided as samples to guide SI-ICOs in developing
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 (CU (Intensive Care
Unit).
iv. Defines the protocol to be followed in case of a needle-stick injury to any staff.
v. Defines the colour coding for biomedical waste segregation which should be as per
the State regulations or as per statutory regulations.
vi. Enlists the conditions to be followed by the SHCO for isolation practices.
vii. Lists the standard cleaning, disinfection and sterilization practices to be followed in
the HCO to prevent infections.
viii. Outlines the precautions and the methodology to be followed in case of spills.
ix. Lists the standard housekeeping practices to be practiced by the SHCO.
x. Lists the standard laundry and linen management processes.
xi. Lists the hygiene practices to be followed in the kitchen of the SHCO.
xii. Defines conditions that will help SHCOs to identify an outbreak and the measures
that need to be followed in case of an outbreak.
No Name(Register/Format) Responsible person
1 HIC Manual Person designated for HIC activities along with a

dedicated doctor
III.Tasks and Responsibilities
No Task Responsibilities
i Define the content of the HIC Manual Clinical Department Heads

along with designated HIC
staff
ii Staff orientation to infection control practices Designated HIC staff

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
CHAPTER 5
CONTINUOUS QUALITY IMPROVEMENT (CQI)
STANDARD CQI2. THE SHCO IDENTIFIES KEY INDICATORS TO

PROCESSES, AND OUTCOMES WHICH ARE USED AS
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 managerial areas.
I. OVERVIEW
Scope: To guide the SHCO on how to measure the performance of an SHCO by indicators
that represent the functioning of various services, personnel, and departments.
There are three dimensions of quality, namely, Structures, Processes and Outcomes.
Examples & Structures are infrastructure, number of nurses available, number of doctors
available, and availability of biomedical equipment. Examples of Processes include hand
washing, administration 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 nurse 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 Structure alone does not ensure quality. If both Structures and
Processes are appropriate, they will lead good Outcomes.
When we want to measure quality, we may measure either the structure, process or
outcome. lf measure outcome, indirectly we are measuring both structure and process. But
if we are either structure or process, it is uncertain whether good outcomes will be
achieved. For example, if
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 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 individual
structures and processes that contribute to the outcome. For example, we may look
factors such as whether antibiotic prophylaxis was given half an hour before surgery
(process), since 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 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 ie to identify the nature of medication
errors and the measures to be taken to decrease them. number of medication errors are
captured as an indicator, they may be classified and a routine analysis conducted to
decrease the number of medication errors. Some indicators such as the taken for the initial
assessment, surgical site infection rate, catheter-associated urinary tract ion rate, are
clinical indicators which are directly related to clinicians, which include doctors nurses.
There are other indicators that are directly related to hospital administration, such as
number of emergency medicines which are out of stock.
II.REQUIRED DOCUMENTS
The may choose some indicators from the list of indicators found in NABH Accreditation
third edition, November2011.
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: 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: OPD waiting time, patient satisfaction rate, number of stock outs of
emergency medications, number of errors in billing.
SOP for Collection and Analysis of KPI
Process Responsibility
Identification of quality team (members from various

areas of an SHCO who are motivated to work towards Administration
quality improvement)
1. Identification of KIN 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
Quality team and

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

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

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

10. Review of the KPI
and stakeholders
11. Inclusion of new KPI team Administration and Quality
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
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,November2011.
CHAPTER 6
RESPONSIBILITIES OF MANAGEMENT (ROM)
STANDARD ROM1. THE RESPONSIBILITIES OF THE MANAGEMENTARE DEFINED.
Objective Elements
ROM1a. The SHCO has a documented organogram.

ROM1b. The SHCO is registered with appropriate authorities as applicable.*
ROM1c. The SHCO has a designated individual(s) to oversee the hospital-wide safety
program.*
*Objective Elements ROM1b and ROM1c are self-explanatory and therefore not included
in this Guidebook.
ROM1a. The SHCO has a documented organogram.
I. OVERVIEW
Scope: To guide the SHCO on preparing 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 path way 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 site, 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.
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
Supporting
Documents
i The organogram is prepared and Top management Organogram

authorized by the SHCO
management
ii All staff are aware of the HR staff or Quality Induction training

organogram and the organizational department staff or material
structure it represents. This is Heads of respective
done through • Induction program departments
at the time of joining
• Regular training for existing staff

Training material on
SHCO-wide policies
and procedures
Tasks and Responsibilities
No. Task
Responsibility
i Prepare the draft organogram HR in-charge
Review the draft organogram
• Practice on the ground should reflect what the

Top management and
ii management planned.
HR department
• Opportunities for streamlining the hierarchy are
identified and suitable changes made.
Authorizing the organogram
iii • Signature of the Head of the SHCO is affixed. Head of the SHCO
• The date from which it is effective is mentioned.

IV. AUDIT CHECKLIST
Frequency of audit: At least once a year as part of a hospital-wide audit.
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 acute
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 Second Level Second Level
Departmen Departmen Departmen
Departmen Departmen
Sub- Sub-
Departmen
Departmen
Departmen
Sub- Sub-
Departmen
Departmental structure(This is optional.The hospital may replace the prompts with actual
designations and names of unit or subunits)
Departmental Head
Sub-unit Sub-unit
Section In- Section In-
Staff Category Staff Category Staff Category Staff Category
Section In- Section In-
Staff Category Staff Category

Staff Category Staff Category
STANDARD ROM2. THE SHCO IS MANAGED BYTHE 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 , this Guidebook.
ROM2a. The management makes public the mission statement of the SHCO.
OVERVIEW
Scope: To orient the management of the SHCO, and in turn the staff, to the rationale of
the SHCO rat is encapsulated in the mission statement.
The mission statement refers to the overall purpose of an organization. The mission
answers the question, “What does the organization aim to accomplish?”
Mission statements are designed to fulfil three basic purposes:
a. To inspire and motivate organizational members to higher levels of performance.
b. To guide resource allocation in a consistent manner
c. To create a balance among the competing, and often conflicting interests of various
organizational stakeholders.
The content of the mission statement usually includes the following components:
a. Purpose - defines the patients, stakeholders, markets, and geographical

areas served, and services provided.
b. Strategy - refers to the tools used such as distinctive or core competencies,

technologies, elements of growth and profitability, and the self-image of the
organization.
c. Values - the compass which guides the philosophy in the SHCO, such as
social or civic responsibility, commitment, dedication, accountability,
stewardship, employee well-being, learning, training and development.
d. Behavioral Standards - How employees are expected to behave - ethically,

morally, honestly, with integrity, professionally - as well as to be
improvement-oriented, achievement-oriented, empowering, innovative,
adaptive, and creative.
Policy
The hospital has a defined mission statement, displays the same, and abides by it.
No Procedure Responsibility Supporting
Documents
1 The Top management enunciates Top Management Mission statement

the mission statement
2 This is made public in the Operations Head and Plaque(e.g. brass

following Maintenance/Facility or marble).
locations: in-charge
Entrance lobby 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).
3 All the staff are aware of the HR staff, or quality Induction training
mission statement. This is done department staff or material,Training
through heads of respective material on SHCO
department wide policies and
• The induction program at procedures.
the time of joining
• Regular training for existing

staff
4 The mission statement is included HR All

in all the manuals in the SHCO department,Quality manuals,Hospital
department brochure.
III.TASKSAND RESPONSIBILITIES
i List out the words that best describe the purpose, Top Management, senior
strategy, values and behavioral standards of the leaders or HODs
SHCO.
ii Discuss the relationship of these elements for both Top Management, senior
organizational success and employee motivation. leaders or HODs
iii The list of descriptive words is clear and final, Top Management, senior
avoiding duplication and exaggeration. leaders or HODs
iv Frame a comprehensive statement which Top Management, senior
incorporates all the descriptive terms in a logical and leaders or HODs
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 authorized by Top Management

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 SHCO’s Quality Department or HR

documentation, such as manuals, brochures, department
training material.
vii Display the mission statement to the public at the Operations Head and
entrance lobby and in prominent common areas Maintenance /Facility in-
across the SHCO and online media. charge IT dept
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 Healthcaré Industry”.

Journal 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 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 Ana of Mission Statement Content and Organizational Longevity. Available at
http://www.huizenga.nova.edu/iame/articles/m ission-statement-content.cfm
CHAPTER 7
FACILITY MANAGEMENT AND SAFETY (FMS)
STANDARD FM51. 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 familiesandcommunities.*
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
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 EMS1e are self-explanatory and
therefore not included in this Guidebook.
FMS1c. The SHCO has a system to identify the potential safety and security risks
Note: Sections II,III and IV below are provided as samples to guide SHCOs in developing
I. OVERVIEW
Scope: To ensure the safety of patients, families, staff and visitors to the SHCO by
identifying all the Dotential 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 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 potential risk.
The reported risks be addressed immediately and appropriate
corrective and preventive measures be taken to mitigate the risk.
i. Protocol for reporting potential risks
ii. Protocol for managing different risks when they occur.
SAMPLE DOCUMENTS
Sample protocol for reporting potential risks
Procedure Responsibility Supporting

Documents
All staff are trained to identify and report HR/Training Training records
safety and security risks in the SHCO. department
Any staff member who identifies a potential All staff members Reporting
risk should immediately call (Front forms/Register
Desk/Reception/any 24 hour area), or fill the
online reporting form and
submit it.
If the risk is of immediate concern, it should All staff members Reporting

be addressed through the SHCO phone forms/Register
number.
While calling the number, the reporter must All staff members Reporting
identify himself/herself, the identified risk,and forms/Register
the location.
The designated person along with the Designate Reporting

engineer/concerned person should visit the person/concerned forms/Register
spot and ensure that the complaint is departments
addressed.1
On receiving the call,the information should Front Reporting

be recorded in the incident register with the desk/Reception forms/Register
date,time,caller details and the reported
incident.
The information should be passed on to the Front Reporting

designated person concerned, who in turn desk/Reception/ forms/Register
will have to contact groups responsible for Designate
addressing the complaint. person/concerned
departments
Once rectified, the designated person should Designated person Inspection report
conduct a random inspection and see if
similar problems exist in other places in the
SHCO, and if so, address them.
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, glutaral
dehyde, 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
spiash of the chemical.
Example: 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.
• Pick up 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 in a plastic zipper bag.
• Dispose of waste mercury as toxic waste. Double-bag the waste and
incinerate it; however, it is more environmentally acceptable to forward
the waste to reclaim the mercury.
• It is advisable 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 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. twill spread them around by breaking
them into smaller beads.
• Do not use vacuum as it will disperse mercury vapour into the air and
increase the likelihood of human exposure.
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 lD at all times.
• Staff must report any unidentified individuals or suspicious activity.
• Visitors without guest passes will not be permitted inside the SHCO.
• CCTV monitoring of the corridors and common areas is necessary.
• Patients to be instructed to keep their belongings safe and locked.
• Theft must be immediately reported to the security department.
• Security department must take control of the scene and scrutinize all
CCTV recordings and movements.
• All staff in the area should be interrogated about any suspicious

movement.
• Every effort must be made to solve the case. Security department must
include the senior doctor or senior nurse while handling the investigation.
c) Risk of Fire
To avoid fire accidents from happening, it is important to have a system or a team

to analyze the potential risk factors that may induce fire, and take necessary steps
to avert an incident. Fire prevention measures include the following:
• Strict prohibition on smoking.
• Positioning of heat sources away from combustible materials.
• Good housekeeping and prevention of accumulation of easily ignitable

rubbish or paper
• Supervision and control of contractors or employees using blowlamps,

cutting or welding equipment.
• Risk 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 loose wires, extension cords, multiple tapping
from a single load.
• Supervision of cooking facilities.
• Avoiding use of electrical and electronic equipment with damaged and

twisted wires.
Training of the employees on fire prevention and fire management is most essential
for ensuring safety in the structure. The SHCO should train all employees on how to
avoid fire incidents specific to their workplace as well as basic techniques on the
use of fire extinguishers.
c) 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.
• All electrical appliances must be grounded properly.

• Circuit breakers must be installed for reducing the severity of electric
shock accidents.
• Do not touch electrical appliances with wet hands.
• Be sure to use standard regulation fuses for switches and not copper or
steel wire.
• Do not permit use of faulty or malfunctioning electrical products.
• Do not use wiring with a link in the middle to connect two separate wires.
• Do not have loose wires in the facility.
• Have 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 equipment.
• Conduct periodic safety inspections in order to detect potential problems.
d) 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 maybe observed:
• All wheelchairs and stretchers used for transferring patients should have
restraint belts.
• All roads 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”. Any spillage must be cleaned immediately.
• Handrails must be provided for staircases.
• The end of a passage and the beginning of the stairs must be

demarcated in a different colour.
• Grab bars must be provide in all toilets.
• Adequate lighting must be present in all areas.

III. TASKSAND RESPONSIBILITIES
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
i Training of staff on risks-identification,

management and reporting of risks
ii Staff interviews that show awareness of staff on Training

risks, identification, management and reporting records- yes/No
of risks
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 Available / Not

preventive action taken available
vii If there was any change in protocol, awareness

of staff on the recent protocol.
STANDARD FMS2. THE SHCO HAS A PROGRAM FOR CLINICALAND SUPPORT

SERVICE EQUIP 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)
*Objective Element FS2a is self-explanatory and therefore not included in this Manual.
FMS2b. There is a documented operational and maintenance (preventive and
breakdown) plan.
Note: Sections II, Ill, and IV below are provided as samples to guide SHCOs in
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 re 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.
• The primary aim of preventive maintenance is to avoid or mitigate failure

of equipment. It is designed to preserve and restore equipment reliability
by replacing worn components before they actually fail, and includes
partial or complete overhaul at specified periods. For example, oil
changes, lubrication.
• Breakdown maintenance intends to address the mechanism to get the

equipment repaired properly, and without delay, if failures have occurred.
• Both preventive and breakdown maintenance may be outsourced in the

form of Annual Maintenance Contract (AMC) or Comprehensive
Maintenance Contract (CMC) and it could be done by qualified in house
engineers.
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.
SAMPLE DOCUMENTS
Sample inventory of equipment
• As good practice, all equipment should be inventoried with a unique

numbering system developed by the SHCO. This could be available on
the machine in the form of a sticker cft written with marking ink.
• Example for inventory number: Simple running numbers like 001, 002 or
BBH/ BM/ DEFIB/ 003.
BBH- Bangalore Baptist Hospital
BM- Biomedical Equipment
DEFIB- Defibrillator
003-Runningnumber
• Inventory number and serial number (assigned by manufacturer) are the

two IDs of the equipment.
• A database 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 is bought or old equipment is condemned
Sample of inventory software
Sample protocol for the operational plan for all equipment
Procedure Responsibility Supporting Documents

The operational plan should be as per Engineering Operational plan for
the instructions of the manufacturer each equipment
as each manufacturer and each
model of equipment will have different
operating instructions.
Staff handling the equipment must be Engineering / Staff Training

trained by the supplier of the machine handling the records/checklist and
and the instructions strictly followed equipment records
by personnel operating the machine
for its safe operation.
The equipment must be operated Staff handling the Operational plan for the
based on the operating instructions or equipment equipment
plan.
The operating instructions should be Staff handling the Operational plan for the
available with the operator or hung on equipment equipment
the machine.
Sample operational plan user checklist
Procedure Responsibility Supporting documents
A preventive maintenance schedule Engineering Preventive

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

schedule may vary for different Operators
equipment quarterly, semi- annually
Manual
or annually, depending on the
manufacturer.
PPM can be carried out by the Engineering Records of preventive

engineering staff or maintenance
outsourced.
The operator or user must be Engineering Intimation to the users

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

must be maintained for each maintenance
equipment
Sample protocol for handling breakdown repairs of equipment
If the machine is not functioning, Staff who handles the Complaint register
information should be passed on to equipment
the engineer or the outsourced
company handling the equipment
The repair may include spare part Engineer/outsources Receipts
replacement and small component engineer
replacement
After the machine is brought back to Engineer/outsources Records of repair done
normal working condition, complete engineer
calibration and testing has to be
performed, including electrical safety,
before it is handed over to the user
department
The breakdown of life saving Engineer Complaint register
equipment,surgical equipment and
critical care equipment, may be
considered as Emergency breakdown
and priority given for such
breakdown.
Records of the time of raising the Engineer Complaint register
complaint, the person who raised the
complaint, the job completion, and
equipment handling over time along
with the types of repair done should
be maintained
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
operator’s manual the equipment
iv Preventive maintenance schedule for each Engineer

machine based on the operator’s manual
v Addressing breakdown and repairs Engineer
vi Records of preventive and breakdown Engineer

maintenance
IV AUDIT CHECKLIST
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 machine
iv Training or competency of technician on the Training

operation of the equipment records-Yes/No
v Operational plan for the equipment as per the

operators manual
vi Preventive maintenance schedule as per the

operators manual
vii Breakdown maintenance or complaint register- Available/Not

addressing and recording of time for repairs available
STANDARD FMS3. THE SHCO HAS PROVISIONS FOR SAFE

WATER,ELECTRICITY,MEDICAL GAS,AND VACUUM SYSTEMS
Objectives Elements
FMS3a. Potable water and electricity are available round the clock.
FMS3b. Alternate sources are provided for in case of failure and tested regularly.
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:Section II,III,and IV below are provided as samples to guide SHCOs in developing

I. OVERVIEW
Scope: To ensure that there is safe and continuous supply of medical gases and vacuum
for patients in the wards, ICUs, OTs.
Medical gases form the very backbone of an SHCO. Without them it would be impossible
to r healthcare organization, as they play an essential role in the functioning of critical care
units an operational areas.
Medical gas installations are constructed as per norms and licenses obtained for
Liquid Me’ 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 continuous supply.
Maintenance should be done regularly as per requirements.
i. Protocol for operating medical gas and vacuum installations shall be managed as
per policy.
ii. Daily, weekly, monthly and annual maintenance schedule.
iii. Uniform colour coding of medical gas pipelines.
SAMPLE DOCUMENTS
Sample Protocols for operating medical gas and vacuum installations shall be managed
policy.
Procedure Responsibility Supporting Documents

Medical gas installations and vacuum HR/Engineering Personal Files
installations shall be managed by
adequate staff.
Appropriate backup (cylinders) shall Engineering Records of backup

be made available to handle any cylinders
emergencies that arise out of the
failure of piped medical gases.
Appropriate personal protective Engineering Actual

devices such as earmuffs and rubber availability/Inspections at
gloves should be used by the staff random
Medical gas and vacuum installations Engineering Daily,weekly,monthly and

annual maintenance
shall be maintained as per protocol. 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,last),oil level,belt
tension,temperature,water pressure,cooling
tower working,loading and unloading pressure
range
4 Nitrous oxide,carbon Line pressure,heater coil,cyclinder 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.
Monthly Maintenance
No Daily check Parameters to be checked
Cleaning, oil level and quality, belt tension check for

1 Vacuum pump faserners,auto drain and check for silencer cleaning, loading
and unloading pressure range.
2 Manifolds Line pressure, heater coil, cylinders stock, leak test.
Cleaning, oil level and quality, belt tension check for

fasteners, auto drain and check for silencer cleaning, water
3 Air compressors pressure, temperature sensor, cooling tower, loading and
unloading pressure range, servicing suction and discharge
valves, and servicing of Non Return Valve.
Annual Maintenance
i Procure license for the LMO Engineer
ii Ensure daily, weekly, monthly and annual checks Engineer

are done as Engineer per requirement
iii Uniformly colour code in a standardized manner Engineer

(as per international colour coding of medical gas
and vacuum systems)
iv Update medical gas pipeline drawing Engineer
v Ensure safety signage Engineer
IV Audit checklist
i Safety signage present
ii Actual storage of empty and filled cylinders
iii By pass in case of emergencies and back up
iv Valves shutoff 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

STANDARD FMS4. THE SHCO HAS PLANS FOR FIRE AND NONFIRL EMERGENCIES
WITHIN THE FACILITIES.
Objective Elements
FMS4a. The SHCO has plans and provisions for early detection, abatement, and
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
I. OVERVIEW
Scope: To ensure that adequate systems are available for the early detection, abatement
and containment of fire and non fire 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 non fire
emergencies such as terrorist attacks, stray animals, earthquakes, antisocial behaviour of
relatives, chemical spillage, structural collapse, patient fall, flooding, and bursting of
pipelines.
I. Smoke detectors, leak detectors, and systems like alarms, hooters, and Public
Address (PA) systems be available for use in case of emergencies.
II. These systems be maintained and tested to ensure their functionality at all
times.
III. A trained multidisciplinary team handle such emergencies wherein a common

telephone number (help line) or other mechanisms be used to alert and activate
this team.

Protocol for the management of fire and non fire emergencies.
SAMPLE DOCUMENTS
Sample protocol for the management fire and non fire emergencies.
Procedure Responsibility Supporting

Documents
All emergency detection and fighting Engineering Maintenance records

systems in the SHCO should be kept and checklists
active at all times. For example-
• Fire alarm and detection system
• Portable fire extinguishers
• Fire hydrants
• Fire hose boxes and reels
• Fire water pumps
• Water storage and sumps for fire

fighting
• Leak detection system. For example,

LPG or medical gas
The systems should be tested frequently Engineering Maintenance records

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

and nonfire emergencies in the SHCO department
Any person who witnesses a fire or leak or All staff

any other emergency should immediately
call for help
The staff member should immediately try staff

to fight the fire or handle the situation
based on the training provided
The team set for the purpose should be Designated team

present and take over the situation
immediately
Based on the situation, the team leader Designated team
should decide if additional help is required
from outside such as the fire department
or police
i Fire detection systems as per National Building Head of SHCO

Code (NBC)
ii Fire fighting systems as per NBC Head of SHCO
iii Leak detection system of LPC bank, medical gas Engineer

bank as per norms
iv Protocol for emergency contact Designated team
v Staff awareness of their role in reporting or HR/Training department

escalation of any potential emergencies
vi Staff awareness of their role in early containment HR/Training department

of a potential emergency
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 non fire emergencies

vii Staff training
viii Awareness of staff on the plan
FMS4b. The SHCO has a documented safe exit plan in case of fire and nonfire
emergencies.
OVERVIEW
Scope: To ensure that the occupants of the SHCO building are evacuated to safety in
case of an emergency situation. In order to do so, it is recommended that the SHCO
should have safe exit plans for its occupants.
i. In case of an emergency situation, the occupants of the SHCO are evacuated to a

safe area as quickly as possible. The National Building Code (NBC) has prescribed
structural specifications for buildings which conduct evacutions in an emergency.
ii. Irrespective of the infrastructure, the staff in the SHCO should be trained to
evacuate patients to safety in any emergency according to the plan that is prepared
for the purpose.
iii. Appropriate evacuation plans should be documented and tested out frequently by
conducting mock drills.
II REQUIRED DOCUMENTS
1. Emergency Floor Plans
2. 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”.
Example of Emergency Evacuation Plan
• All staff 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.
• Signages such as emergency floor plans and fire exits, should be available in all
areas.
• Emergency lights should be available for facilitating evacuation in an

emergency, as power supply is turned off.
• The SHCO 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
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 team.
• The fire fighting team should immediately proceed to the scene with additional
firefighting equipment, try to extinguish the fire, or escalate to the city fire
department.
• The engineering team should ensure that the fire pumps are kept running and
that the correct pressure is maintained, ensure that the firewater tank is kept
topped up, ensure that the sub-station is staffed and that electric supply to the
fire-affected area is cutoff.
• The housekeeping staff and other staff may form a ring around the scene of fire
and ensure 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 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 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.
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

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
V. REFERENCES
Accreditation Standards for Hospitals, NABH, 3’rd 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.pdt
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: 10905 (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 :1/na bh .co/l mages/P DF/Fi re_Safety_NAB H. pdf
OSHA (Occupational Safety & Health Administration) Technical Manual. Available at

www.osha.gov
R. Craig Schroll, Fire Detection and Alarm Systems: A Brief Guide, Dcc. 01, 2007.
Available at
http://ohsonline.com/Articles/2007/12/Fi re-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.
CHAPTER 8
HUMAN RESOURCE MANAGEMENT (HRM)
STANDARD HRM2. THE SHCO HAS AWELL DOCUMENTED DISCIPLINARY AND

GRIEVANCE HANDLING PROCEDURE
HRMZa. 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 is self-explanatory and therefore not included in this Guidebook.
HRMZa. A documented procedure with regard to these is in place.
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.
• 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.
• 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 committee rules
whether the grievance is genuine or not and gives its recommendations
accordingly. There is scope to appeal to a higher authority.
Task
No Responsibility
Disciplinary procedures
Step-by-step description of the disciplinary

i HR department
procedure
Composition of the team or the designated Authorized by Top

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

iii.
commensurate to the offence management
Disciplinary committee
iv. Hearing of both parties
or designated individual
Decision on action to be taken against the erring Disciplinary committee

v.
member of staff or designated individual
Opportunity given to staff member to appeal to a Authorized by Top

vi.
designated individual management
vii. Implementation of action against staff HR department
Constitution of an Internal Complaints Committee

Authorized by Top
viii. (ICC) to address complaints of sexual harassment
management
at the workplace
Making available the name of the person that the Any member of ICC or any
ix. alleged victim should contact in order to present a senior staff in whom the victim
written complaint. confides
Acknowledgment of receipt of the complaint by the

x. Member Secretary of ICC
alleged offender
Immediate separation of the concerned individuals HR department (on the written

xi. at the workplace with stern caution to all concerned instruction of the Member
not to interact with each other on the complaint Secretary of ICC)
xii Proceedings of ICC Member Secretary of ICC

Member Secretary
of ICC
xiii. Action taken against the erring staff member
HR department
Top management
Grievance Handling procedure
A step-by-step description of the grievance

i. HR department
handling procedure
Head of the department Senior HR

ii. Appointment of grievance handling officers staff or Top management
Proceedings of the grievance handling

iii procedure documented and decision HR department
implemented
HR department
The written document for disciplinary action and
iv
grievance handling is finalized
Quality department
IV. Audit checklist

Frequency of audit: At least once a year as part of hospital-wide audit.
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
iv 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.
HRM2b. The documented procedure is known to all categories of employees in the

SHCO.
Note: Sections II and Ill below are provided as samples to guide SHCOs in developing
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 ft periodically retrain them on the same.
II. TASKS AND RESPONSIBILITIES
i The written document for disciplinary action and HR department

grievance handling
is included in Quality department
• The compilation of SOPs in the HR

department
• The material for training staff on

hospital-wide policies and
procedures
ii Make staff aware of the procedures concerning HR department HOD of

disciplinary action and grievance handling. This is respective departments
done through training programs such as.
• Training for new staff

Quality
• Retraining for staff - Retraining of staff department
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.
1. AUDIT CHECKLIST
Frequency of audit: At least once a year as part of hospital-wide audit.
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.
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 SHCD 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 under the ESI: employees
contribute 1.75 percent and employers contribute 4.75 percent. Remittance into the
ESI account is made within 21 days from the end of the due month. The SHCO
should refer to the latest norms issued under the ESI Act.
ii. Occupational hazards resulting in health problems also should be covered by the,
SHCO. These include:
a) Preventive measures such as pre-exposure prophylaxis when

possible - for example, Hepatitis B vaccine or Influenza vaccine for
staff who are at risk.
b) Post-exposure prophylaxis such as immunoglobulin treatment post-
Hepatitis B exposure and Antiviral medication for staff involved in the
treatment of patients with H1N1.
c) Provision of safety measures such as the provision of masks and

gloves to protect the staff from acquiring diseases in the SHCO.
d) Staff benefits may also include discounts for investigations or

treatment for general illness at the hospital. This may be in the form of
a health insurance cover The amount of discount or insurance
premium that is contributed by the hospital is left to the discretion of
the SHCO management.
Policy: The health problems of the staff are addressed through pre- and post-exposure
prophylaxis and other health benefits.
SOP on Employee State Insurance
Procedure Supporting
No Responsibility
Documents
Identification of all staff who are eligible List of staff under

1. HR staff
under the ES! Act ESI
Enrollment of eligible staff under ESI with all ESI

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

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

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

HR training
5. handouts listing the benefits under the ESI HR staff
material
are given to the staff.
Medical records
Staff may access investigations and
Billing details
6 treatment at ESI-empanelled hospitals as Concerned staff
needed.
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 Benefit

Eligibility
General health percentage contribution from the
For staff not covered under
insurance staff and rest from the hospital
ESI optional for the staff
OPD
Percentage of discount
investigations All staff
Staff dependents
OPD
Consultations All staff
Staff dependents
Percentage of discount for eligible
room category
Percentage of discount on
inpatient stay investigations
All staff
consultation and
professional fees for procedures
Percentage of discount for eligible

room category
Staff dependents investigations
consultation and
professional fees for procedures
Procedure
No Procedure Responsibility Supporting
Documents
1 The details of the health benefits HR staff List of health
for staff and their dependents is benefits
listed and maintained by the HR
department
2 The staff are made aware of the HR staff HR training
benefits at the time of joining the material
SHCO
3 The front office, billing and HOD of front office, Internal
admission desk staff are billing, admission communication
responsible for extending the
benefits to the staff in times of
need.
4 Staff should contact the HR in- HR in-charge
charge in case of difficulty in
accessing the health benefits
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 thin doses administered at land 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
• 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 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.
• If source person testing is possible: test for presence of

HB5Ag/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.
• Follow guide lines 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.
Guide lines for post-exposure prophylaxis for Hepatitis B
Percutaneous (needle-stick) or mucosal exposure to HBs Ag-positive blood or body

fluids:
• Unvaccinated 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 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.
• Vaccinated person: No treatment required.
• Percutaneous (needle-stick) or mucosal exposure to HBs Ag status-unknown

blood or body fluids:
• If known high-risk source, treat as if source were positive.
• Unvaccinated person: Start the Hepatitis B vaccine regimen. If known high-risk

source, treat as if source were positive.
• Vaccinated person: Test exposed person for antibody to HBs Ag. If adequate,
no treatment required. If not adequate, administer one Hepatitis B vaccine
booster dose.
Guidelines for post-exposure prophylaxis for Hepatitis C
The following are recommended for follow-up of occupational HCV exposures:
• For the source, perform testing for anti-HCV.
• For the person exposed to an HCV-positive source:
• Perform base line 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.
Guide lines for post exposure prophylaxis for HIV
HIV positive source :
• Less severe exposure: Solid needle-stick or superficial injury.
• HIV positive low viral load asymptomatic source -2 drug PER
• HIV positive high viral load, symptomatic source AlDS- recommend expanded 3
drug PER
• More severe exposure: Large bore hollow needle, deep puncture, visible blood on
device, needle used in patients artery or vein. HIV positive source. Recommend
expanded 3 drug PEP.
• HIV negative source: No specific treatment
• HIV unknown source: Presence of high risk factors for exposure to HIV in the
source. Recommend 2 drug PEP.
a.i. Employee state insurance Act HR staff

applicability in the SHCO
b List of staff whose gross salary is less HR staff

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

supporting evidences with 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 HR staff

for ESI beneficiaries regarding
provisions under ESI
h Pre-exposure prophylaxis Hospital management extends
free/concession/part payment for
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.
i Post-exposure prophylaxis General physician/ER physician to

identify potential situations for post
exposure 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 identifies
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.
Incharge of clinical areas keeps the
items ready at hand and supervise
its usage.
k Discounts for investigations or treatment Authorized by the management.

for general illness at the SHCO.Health
insurance cover for staff.
IV. AUDIT CHECKLIST
i Employee state insurance act applicability

in the SHCO
ii List of staff whose gross salary is less than
Rs.15,000 per month.
iii Eligible new staff enrolled under ESI
iv Remittance of amount to ESI
v Staff interview shows awareness of the

provisions under ESI
vi Pre-exposure prophylaxis given for concerned

staff
vii Post-exposure prophylaxis given following an

incident
viii Provision of safety measures-personal

protective equipment. Audited during facility
tour.
V. REFERENCES
CDC, Updated U.S. Public Health Service Guidelines for the Management of Occupational
Exposures to HBV HCV, and HIV and Recommendations for Postexposure Prophylaxis. M
MWR, 2001, 50(No. RR-11). Available at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rrSOllal.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 Post exposure Prophylaxis. Available at
http://www.who. int/occupationa l_health/activities/5pepguid.pdf
CHAPTER9
INFORMATION MANAGEMENT SYSTEM (IMS)
STANDARD IMS1. THE SHCO HAS A COMPLETE AND ACCURATE MEDICAL

RECORD FOR EVERY PATIENT.
Objective Elements
IMSla. Every medical record has a unique identifier.
IMSlb. The SF-ICQ identifies those authorized to make entries in medical record.*
IMSlc. Every medical record entry is dated and timed
IMSld. 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.
IMSle.The contents of medical records are identified and documented.
I. OVERVIEW
scope: To guide the management on how to ensure medical records are complete,
accurate, and readily retrievable for review by various stakeholders such as doctors,
regulators, auditors, patients, administrators.
Its 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.
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. AD the documentation is made by the identified care providers with date and
time.
Policy and SOP on having a complete and accurate medical record for every patient.
Policy: It is the policy of the SHCO to provide complete and accurate medical records of
the patient.
The SHCO shall decide the sequence in which these records can be stored. It may be as
follows: (The list may be expanded or trimmed as per the hospital policy)
• Mandatory documented requirements; Admission record, discharge summary or

death summary, initial assessment, consultations, lab reports, reassessment,
doctors’ orders, nursing assessment, nurses’ record, TPR/BP chart.
• Where applicable, the record may include; consent forms, hemodialysis,

chemotherapy, diabetic charts, diet, pain assessment sheets, PAC/Anesthesia
consent monitoring forms, recovery charts, pre-op checklist, OT records, post-op
records, surgical safety checklist, intake-output chart, fluid chart, ICU monitoring
chart, trauma/emergency sheet.
SOP on providing a complete and accurate medical record for every patient

Document
1 All the medical records shall have Registration Medical record

the UHID number. counter/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, timed, Doctors/nurses/ Medical record

signed and named. dietitians/
physiotherapists, as
applicable
4 The contents of the hospital record Top management Hospital formats

shall be defined as per the clinical and Quality team
requirement.
5 All the formats shall be assembled Medical records Medical record

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

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

the deficiency checklist and officer
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, counseling 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)
6. Consultation sheets
7. Lab report master
8. Progress sheet
9. Doctors1 orders
10. Hemodialysis/chemotherapy/diabetic charts/diet/pain assessment sheets
11. PAC/Anesthesia consent monitoring/recovery charts
12. Pre op 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
i To decide on the content of the medical Administrative in-charge, MRD

records, formats and contents of the discharge and Medical records officer
summary
ii To complete the sequencing of the medical Medical records officer

records formats
iii To check for completeness of the medical Medical

officers,nurses,physiotherapists,
records
dietitians(where applicable)
iv Deficiency check at the submission of the Medical records officer
record to M RD
v Corrections of the deficiencies Medical officer
vi Getting the deficiencies corrected by the Medical records officer

nursing! medical officers within the target time
IV. AUDIT CHECKLIST
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.
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 information.
Note: Sections II, Ill, and IV below are provided as samples to guide SE-ICOs in
developing their customized documents.
I. OVERVIEW
Scope: To guide the SHCO on the safe management of confidentiality, integrity and
security information stored in medical records such that loss, theft, and tampering are
prevented.
i. The patient is the owner of his or her medical record and no form of it should be
available to any third party without written authorization from the patient. Access to
Medical Records Department (MRD) is limited to authorized department staff.
ii. The patient’s relatives require written authorization from the patient to information
from the medical records. The administrator or members of the Quality (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 and
the TPAs (for financial reasons, such information should not be given in its o form; a
photocopy of the same may be handed over to the patient after obtaining approved
authorization.
iii. Once the patient is discharged from the SHCO, the medical records can reach the
MRD stipulated time fame (defined by the SHCO).
iv. The MRD is responsible for proper storage, retrieval, and maintenance of
confidentiality and security of the record.
v. The Medical Records Officer (MRO} is the overall supervisor of the medical records
from when they are generated, through storing, until destruction. However, it is the
responsibility of every doctor/nurse/administrator to take care of the medical
records at their level --in the wards or in the billing section--to maintain the
confidentiality and privacy of information.
vi. This is also applicable to all electronic information such as discharge summaries,
cath lab reports, lab reports, digitized X-Rays, electronic medical records, and any
other electronic
information.
The policy on maintaining confidentiality, security and integrity of information.
Policy: The SHCO is committed to maintaining the confidentiality, integrity and security of
vital information of the patient contained in the medical record and to prevent its loss, theft
or tampering.
i. The MRD is responsible for the proper storage and retrieval of the record as well
as the maintenance of confidentiality and security. During normal working hours,
the SHCO shall have at least one member of staff available in the department.
ii. Atracer 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
• Maintain records in a proper and accessible manner.
• Hand over the records as and when required by the chief administrator for
administrative purposes by getting a written requisition form duly signed.
• Provide records required for MLCs in a court of law by the Consultant or MOs.
• Provide inpatient records for the follow-up of inpatients by the Consultant as
well as by the patients.
• Provide a discharge summary, investigation reports, as and when required.
iv. In case the patient’s medical record data is lost or tampered with, the MRO shall
immediately inform the chief administrator, who is responsible for taking
appropriate action.
v. At the end of the workday, the MRO is responsible for locking up the
department. The key should be handed over to the security post. Thereafter, the
security department is responsible for the protection of the medical record room.
vi. If a medical record is requested by a doctor outside working hours, an MRO or a

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, requesting doctor’s name, retrieving doctor’s/officer’s
name, employee code, purpose c 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 upon 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 art 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 MRO MRD receiving

corrected, the records are register
stored in the medical records as
per the UHID or the SHCO
policy.
2 Only the relevant care providers MRO/Security

have access to the medical staff
records.
3 A tracer card process shall be MRO Tracer card
followed when a medical record
is retrieved. The tracer card is
prepared with the patient’s
name and hospital number, the
requesting person’s name,
ward and the date.
4 The records are retrieved from MRO Tracer card/medical

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

returned, the records are
checked for integrity or
tampering of information and
stored in place The tracer card
is then closed
6 The medical records stored in MRO Pest control

the MRD shall be protected records/fire safety
from loss due to humidity, plan
adverse environmental
conditions, and fire with
adequate measures being
taken to safeguard against
these safety threats.
7 Whenever privileged health Top management Privileged

information is required by law, MRO communication
the SHCO will provide the record
information.
III. Tasks and 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 Administration in-
Pest/rodent control
charge/MRO:
v Security and access control Security staff
IV Audit checklist

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.
STANDARD IMS4. DOCUMENTED PROCEDURES TIME OF THE PATIENT’S

RECORDS, DATAAND 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.*
lMS4c. 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 lair down procedure.
I. OVERVIEW
Scope: To guide the SHCO on the retention of medical records as per legal and regulatory
requirements and on the destruction of records when they are not required.
i. The records are stored in the MRD for the following retention period as per the
requirements.
Inpatient Record: Minimum of three years (as per MCI requirements)
Outpatient Record: As per the state law and hospital policy
Medico-Legal Record: Lifetime
Birth and Death Record: Lifetime
ii. After the retention period, the medical record may be destroyed unless a competent
authority approves its further retention.
iii. The destruction of medical records is achieved by shredding them.
iv. If the process of destruction is outsourced, the hospital should take adequate
measures to safeguard against the leaking of information from these records.
i. Policy and SOP on retention period of medical records.
ii. Policy and SOP on destruction of medical records.
Policy: The SHCO retains its medical records (both outpatient and inpatient) as per the
applicable legal and regulatory requirements
Inpatient Record: Minimum of three years (as per MCI requirements)
Outpatient Record: As per the state law and hospital policy
Medico-Legal Record: Lifetime

Birth and Death Record: Lifetime
No Processflow Responsibility Supporting

Department
1 The retention policy for the medical Quality team SOP

records, data and information is
defined as per the regulatory
requirements.
2 Medical records are retained safely MRO Medical records

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 privacy of the information.
No Process flow Responsibility Supporting

Department
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

stored beyond the retention period are records to be
destroyed (recorded
selected for destruction 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 MRO Verification list

Medical records are verified for their
retention before destruction.
5 MRO Permission letter
Written permission is obtained from
the MS before destruction
6 MRO
The selected medical records are
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
IV. AUDIT CHECKLIST
i Documented procedures are in place for retaining the

patients clinical records, data and information.
ii The documented a 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

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

ittp://www.the-h ospita list. org/article/code-pin k/
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
APPENDIXES
Appendix 1
FORMATION OF HOSPITAL COMMITTEES
Hospital committees (or hospital teams, in case of limited human resources) can p
for multidisciplinary stakeholders to work together in implementing high-quality
SHCOs, and to conduct periodic evaluations for continuous improvement. The appoint re-
appointment of members to these committees or teams will be made by the Unless
otherwise stated, the committees or teams will include a broad renre &
stakeholders and shall consist of an appropriate number of individuals to be of an
manageable, size.
The membership to a committee or team is determined by a nomination process

year The committee/team chairperson may co-opt additional members on aaccording to
need, and will inform the Medical Director of any additional
committees/teams are required to meet as per calendars planned, monthly or
if there are issues that require attention). If a member does not attend three consecutive
he or she will automatically lose membership and be replaced. Each committee/team the
minutes of each meeting, including the list of attendees. Actions will be closed manner The
list of the various medical committees/teams is given below, along with a detail 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 IMPROVEMENTAND 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
• To monitor, evaluate and improve care of patients so as to ensure

high quality and safety for patients. To ensure the protection of patient
rights and ethical practices across the organization.
• To hold leaders, work groups, departmental heads and managers

accountable for the application of performance improvement
principles and the aggressive pursuit & improved performance.
• To define the accreditation roadmap of the organization and ensure

compliance to NABJ-t accreditation standards.
• To review the quality measurement reports of the hospital and of

departments at services as well as to benchmark data from external
sources.
• To ensure that staff education plans are in accordance with quality

improvement priorities.
• To oversee risk management activities for the hospital, such as

training programs in fire safety and biomedical waste management.
• To oversee and review the effectiveness of other medical committees.

• To review or delegate to other appropriate committees or
departments, the examination or 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 have been identified. This includes but is not limited to:
Appropriateness of care
Medical assessment and treatment of patients
Critical Incident Review
Effectiveness of care
Use of clinical guidelines
Clinical audits against established standards and clinical

indicators
Morbidity and mortality reviews
• To evaluate patient satisfaction and the quality of patient care through

an objective systematic monitoring of services, complaints and MLCs,
and to recommend and corrective and preventive actions.
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. INFCCTION CONTROLCOMMITTEE/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
• To oversee the infection control program of the SHCO, so as to ensure that the best
standards are in place and that risks of infection are minimized.
• To ensure that infection control policies and procedures are being consistently
followed throughout the SHCO.
• To assess hospital-acquired infection rates through regular surveillance, and to

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

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

hand hygiene or biomedical waste segregation) are held for staff on a regular basis.
Sample composition
1 HOD Anesthesia/ Internal medicine/Microbiology Chairperson
2 Quality Manager Coordinator
3 Medical Administration(MS) Member
4 3-4 HODs (Clinical) 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
• To ensure that policies and procedures related to CPR are consistently

throughout the organization.
• To ensure CPR training for all staff in CPR, training for selected staff, and to
ensure they understand their roles and responsibilities for code blue.
• To use simulation in the form of mock drills in order to assess the

responsiveness competence of the CPR Team.
• To advise on the design and implementation of the audit process that monitors
the incidence and outcomes of cardiac arrest/medical emergency calls.
• To ensure the availability and maintenance of the equipment and drugs

required.
• To advise on the appropriate choice of equipment and medicines for use in

resuscitation procedures.
• To offer guidance on the minimum level of resuscitation training for individual

staff groups based on their role and exposure to cardiac arrest/emergency
situations.
• To review all cardiac arrest case files to assess the adequacy of response and
to evaluate the scope of improvement for the same.
Sample composition
1 HOD emergency Chairperson
2 Medical Administrator (MS) coordinator
3 Medical Quality Member
5 Emergency Doctor Member
6 Anesthesia Representative Member
7 ICU Representative Member
8 HID security Member
4. PHARMACYAND THERAPEUTIC COMMITTEE /TEAM
Purpose
To ensure that the selection, compliance, distribution, storage, safe use, and
administration of drugs within the SHCO are as perstandards laid down.
Responsibilities
• To ensure that policies and procedures related to medication management are

consistently being followed throughout the SHCO.
• To manage the drug formulary system by evaluating the usage of medications

periodical and requesting additions or deletions.
• To move the SHCO towards a generic drug regime and away from the branded
drug system.
• To monitor adverse drug events and ensure that corrective and preventive actions
are taken.
Sample composition
1 Clinical HOD Chairperson
2 Pharmacy Head coordinator
3 Medical Administrator(MS) Member
4 3-4 Clinical HODs Member
5 Quality Manager Member
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
provide 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
c 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 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 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
assessment includes activities such as history-taking, a physical examination, and
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
Assessment is documented by the treating consultant or nurse. The SHCO shall define
frame for the Initial Assessment based on the organizational resources/patient load)
condition.
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
Unique Identification Number
Dateand time of admission and discharge
Reason for admission
Significant findings
Information regarding investigation results

Diagnosis and any procedure performed
Medication administered
Other treatment given
Patient condition at the time of discharge
Follow-up advice
Medication and other instructions in an understandable manner
How and when to obtain urgent care
Name and signature of the doctor
CARE OF PATIENTS (COP)
Is it mandatory to have Code Pink?
It is not mandatory, but it is preferable to have a Code Pink protocol.
What constitutes an MLC (Medico-Legal Case)?
An MLC can be defined as a case of injury or ailment in which investigations by law-

enforcement agencies are essential to fix the responsibility regarding the causation of the
said injury or ailment. In other words, it is a medical case with legal implications for the
attending doctor where the 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=J4N4h9lBYqc
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, life saving
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:
• Patient’s name, age and sex
• IP/OP number
• Date of prescription
• Ward or department name
• Form of the drug: tablet injection or syrup
• Name of the drug (generic name) written in block letters
• Dosage of the drug (500mg, 1g. etc.)
• Route of administration (oral,etc.)
• Time and frequency of administration (before food, once a day, etc.)
• Duration of treatment (for one week, two weeks, etc.)

• 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 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). No immune 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 C5SD.
CSSD stands for Central Sterile Supply Department. The purpose of CSSD is to provide
all the required sterile items required in a hospital in orderto meetthe needs of all patient
care areas.
CSSD is divided into 3 zones: sled (decontamination), clean zone (packaging), and sterile
zone (sterilization and storage).
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 pr
outcome. These indicators are important as they affect the quality of care, performance,
and safety in an SHCO.
Is measuring the KPls the responsibility of the Quality Officer?
The Quality Officer should ensure that the KPls 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.
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 perform
There should be no bias in data collection. The formula used should be correct and the
data be validated by an authorized person. The proper root cause has to be identified, and
corrective preventive action implemented. There should be a constant collection of data to
see effectiveness of implementation of actions. If these points are not taken care of, KPIs
may 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.

be updated at least once a year, or as and when there are changes made in the organi2
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 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 SH follow for colour coding?
Since health risks can result from using the wrong medical gas, medical gas pipelines
should colour coded. This will also help in identifying problems in different lines and
isolating them 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 befound?
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.
Appendix 3
GLOSSARY
• Assessment -- All activities including history-taking, physical examination, and

laboratory investigations that contribute towards determining the prevailing
clinical status of the patient.
• Biomedical equipment - Any fixed or portable non-drug item or apparatus used

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

need, a reason and permission for such access. It also includes an individual’s
right to personal
privacy and privacy of information related to his/her healthcare records.
• Hazardous material - Substances dangerous to human and other living

organisms which include radioactive or chemical materials.
• Hazardous waste -Waste materials dangerous to living organisms. Such

materials require special precautions for disposal. They include biologic waste
that can transmit disease (for example, blood and tissues), radioactive
materials, and toxic chemicals. Other examples are infectious waste such as
used needles, used bandages and fluid-soaked items.
• Information: Processed data which lends meaning to the raw data.
• Inventory control: The method of supervising the intake, use and disposal of
various goods in hands. It relates to supervision of the supply, storage and
accessibility of items in order to ensure adequate supply without stock-
outs/excessive storage. It is also the process of balancing ordering costs against
carrying costs of the inventory so as to minimize total costs.
• Maintenance: The combination of all technical and administrative actions,

including supervision action, intended to retain an item in, or restore it to, a state
in which it can perform a required function. (British Standard 3811:1993)
• Patient record/Medical record: A document which contains the chronological

sequence of events that a patient undergoes during his stay in the SHCO.
• Policies: They are the guidelines for decision-making, e.g. admission, discharge
policies, antibiotic policy, etc.
• Procedures: A specified way to carry out an activity or a process (Para 3.4.5 of

ISO 9000:
2000) or a series of activities for carrying out work, which when observed by all,
helps to ensure the maximum use of resources and efforts to achieve the
desired output.
• Process: A set of interrelated or interacting activities which transform inputs into
outputs (Para 3.4.1 of ISO 9000:2000).
• Protocol: A plan or a set of steps to be followed in a study, an investigation or an

intervention.
• Referral-out of patient: Safe transfer of a patient to another organization due to

non- availability of required resources including expert/equipment/facility.
• Risk assessment: Risk assessment is the determination of quantitative or

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

reduce the risk of injury.
• Risk reduction: The conceptual framework of elements considered with the

possibilities to minimize vulnerabilities and disaster risks throughout a society to
avoid (prevention) or to limit (mitigation and preparedness) the adverse impacts
of hazards, within the broad context of sustainable development.
(Source:http://www.preventionweb.net/english/professional/terminology/) It is the
decrease in the risk of a healthcare facility, given activity, and treatment process
with respect to patient, staff, visitors and the community.
• Scope of service: Range of clinical and supportive activities that are provided by
an SHCO, e.g. clinical activities: General medicine, General surgery,
Paediatrics, OBG, etc.; support services: Ambulance, Pharmacy, etc.
• Security: Protection from loss, destruction, tampering, and unauthorized access

or use.
• Unstable patient: A patient whose vital parameters need external assistance for
their maintenance.
Note: The complete glossary is available in the NABH Manual on Accreditation

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

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GUIDEBOOK FOR

PRE-ACCREWTATON ENTRY-LEVEL STANDARDS

NATIONAL ACCREDITATION BOARD FOR HOSPITALS AND

HEALTHCARE PROVIDERS (NABH)

AAC1.a The services being provided are clearly defined.

Process addresses registering and admitting outpatients, inpatients, and

Process addresses mechanism for transfer or referral of patients who do

Procedures guide collection, identification, handling, safe transportation,

5 AAC7 The SHCO has a defined discharge process

Process addresses discharge of all patients including medico-legal cases

Discharge summary contains the reasons for admission, significant findings,

Emergency services including ambulance are guided by documented

Documented procedures address care of patients arriving in the emergency

7 COP3 Documented procedures define rational use of blood products

COP3c Procedures addresses documenting and reporting of transfusion reactions.

COP4a Care of patients is in consonance with the documented procedures.

Documented procedures guide the care of obstetrical patients as per the

COP5a The SHCO defines the scope of obstetric services.

Documented procedures guide the care of pediatric patients as per the

COP6a The SHCO defines the scope of its pediatric services.

Procedure addresses identification and security measures to prevent child

11 COP7 Documented procedures guide the administration of anesthesia

There is a documented policy and procedure for the administration of

Documented procedures guide the care of patients undergoing surgical

Documented procedures address the prevention of adverse events like

Chapter 3.MANAGEMENT OF MEDICATION (MOM).

Documented procedures guide the organization of pharmacy services and

Documented procedures incorporate purchase, storage, prescription and

Documented procedures address procurement and usage of implantable

14 MOM2 Documented procedures guide the prescription of medications

The SHCO defines a list of high-risk medication and the process to

Chapter4.HOSPITAL INFECTION CONTROL.(HIC)

Hospital Infection Control Manual (as Annexure)

Chapter 5 . CONTINUOUS QUALITY IMPROVEMENT(CQI).

The SHCO identifies the appropriate key performance indicators in both

Chapter 6. RESPONSIBILITIES OF MANAGEMENT(ROM)

17 ROM1 The responsibilities of the management are defined.

ROM1a The SHCO has a documented organogram.

18 ROM2 The SHCO is managed by the leaders in an ethical manner

The SHCO’s environment and facilities operate to ensure safety of patients,

There is a documented operational and maintenance (preventive and

A documented procedure regarding disciplinary and grievance handling is in

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

24 HRM3 The SHCO addresses the health needs of its employees

IMS1e The contents of medical records are identified and documented.

Documented policies and procedures are in place for maintaining

Documented procedures exist for maintaining confidentiality, security, and

Documented procedures exist for retention time of records data, and

Documented procedures are in place regarding retention of the patient’s

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

The Collaborative has embarked on several initiatives aimed at contributing to healthcare

The NABH Pre-Accreditation Entry-Level Standards for SHCOs consist of 41 standards1

This Guidebook for Pre-Accreditation Entry-Level Standards for SHCOs contains

NABH’s pre-accreditation entry-level standards will soon be followed by pre-accreditation

Somil Nagpat, Senior Health Specialist, World Bank.

List of Contributors and Co-Authors

Dr. Alexander Thomas, President, Consortium of Accredited Healthcare Organizations

Dr. Antony Lazar Basile, Medical Director, STAR Hospitals, Hyderabad.

Ms. Lallu Joseph, Quality Manager, Christian Medical College, Vellore.

Ms. Beenamma Kurien, QualityAssurance Coordinator, Karnataka Health System

World Bank facilitation team

Dr. Somil Nagpal, Senior Health Specialist, World Bank.

Dr. Abha Mehndiratta, Consultant, World Bank.