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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

AAC2a Process addresses registering and admitting outpatients, inpatients, and

emergency patients.

AAC2b Process addresses mechanism for transfer or referral of patients who do

not match the SHCO’s resources.

3 AAC3 Patients cared for by the SHCO undergo an established initial assessment

AAC3a The SHCO defines the content of the assessments for inpatients and

emergency patients.

4 AAC5 Laboratory services are provided as per the scope of the $HCO’s services and laboratory safety requirements.

AAC5b Procedures guide collection, identification, handling, safe transportation,

processing, and disposal of specimens.

5 AAC7 The SHCO has a defined discharge process

AAC7a Process addresses discharge of all patients including medico-legal cases

and patients leaving against medical advice.

AAC7c

Discharge summary contains the reasons for admission, significant findings, investigation results, diagnosis, procedure performed (if any>, treatment given, and the patients condition at the time of discharge.

Chapter2.CARE OF PATIENTS(COP)

6 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

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.

9 COP5 Documented procedures guide the care of obstetrical patients as per the scope of services provided by the SHCO.

COP5a The SHCO defines the scope of obstetric services.

10 COP6 Documented procedures guide the care of pediatric patients as per the scope of services provided by the SHCO

COP6a The SHCO defines the scope of its pediatric services.

COP6d Procedure addresses identification and security measures to prevent child

or neonate abduction and abuse.

11 COP7 Documented procedures guide the administration of anesthesia

COP7a There is a documented policy and procedure for the administration of

anesthesia

12 COP8 Documented procedures guide the care of patients undergoing surgical procedures

COP8c Documented procedures address the prevention of adverse events like

wrong site, wrong patient and wrong surgery.

Chapter 3.MANAGEMENT OF MEDICATION (MOM).

13 MOM1 Documented procedures guide the organization of pharmacy services and usage of medication.

MOM1a Documented procedures incorporate purchase, storage, prescription and

dispensation of medications

MOM1e Documented procedures address procurement and usage of implantable

prosthesis.

14 MOM2 Documented procedures guide the prescription of medications

MOM2d The SHCO defines a list of high-risk medication and the process to

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).

16 CQI2 The SHCO identifies key indicators to monitor the structures, processes and outcomes which are used as tools for continuous improvement.

CQI2a The SHCO identifies the appropriate key performance indicators in both

clinical and managerial areas.

Chapter 6. RESPONSIBILITIES OF MANAGEMENT(ROM)

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)

19 FMSI The SHCO’s environment and facilities operate to ensure safety of patients, their families) staff, and visitors.

FMS1c The SHCO has a system to identify the potential safety and security risks

including hazardous materials.

20 FMS2 The SHCO has a program for clinical and support service equipment management.

FMS2b There is a documented operational and maintenance (preventive and

breakdown) plan.

21 FMS3 The SHCO has provisions for safe water, electricity, medical gas and 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

FMS4a The SHCO has plans and provisions for detection, abatement, and

containment of fire and non fire emergencies.

FMS4b The SHCO has a documented safe exit plan in case of fire and non fire emergencies.

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

HRM2a A documented procedure regarding disciplinary and grievance handling is in

place.

HRM2b The documented procedure is known to all categories of employees in the

SHCO.

24 HRM3 The SHCO addresses the health needs of its employees

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.

26 IMS3 Documented policies and procedures are in place for maintaining confidentiality, security, and integrity of records, data, and information.

IMS3a Documented procedures exist for maintaining confidentiality, security, and

integrity of information.

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

IMS4a Documented procedures are in place regarding retention of the patient’s

clinical records, data, and information.

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

with the laid down procedure

APPENDIXES 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

1A 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. 2An 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)

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,

Mammogram

Medical Records Department

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

ii Define the departmental scope of service Top management in consultation with the specific department head

iii

Document the above into a policy on ‘scope of services’ and place the same in an SOP manual

Assigned staff

iv Availability of the valid license related to the specific department Administrative department

v Display prominently the scope of services in two languages

Administrative department! Engineering department

vi Update the scope of service Top management! Head of the concerned department

vii Staff orientation to the scope of service Quality team/training cell

IV.AUDIT CHECKLIST

No. Checkpoint Yes 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 developing their own customized documents.

I. OVERVIEW

Scope: To guide the SHCO on preparing a process for registering and admitting outpatients, inpatients, and emergency patients.


• 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

No. Process Responsibility Supporting Document

For OPD Registration

A OPD registration shall be done on first-come first-served basis. Registration clerk Register

B

The following details are taken from the patient or relative: Name, age, sex, occupation, annual income, address, phone (mobile/land line).

Registration clerk Registration form

C

The referral slip, if present, should be checked to identify the specialty, If there is no referral slip, the patient shall be registered as specified by herself/ himself

Registration clerk Referral slip

D

The details are entered into the OPD slip and the bill is raised. Registration clerk Register/OPD

slip

E The patient is directed towards the concerned OPD consultation area. Registration clerk

F After the consultation, if there is any change in the specialty, the patient is referred to the concerned specialty OPD.

Consultant

OPD slip/referral book

C Emergency registration is done 24 hours a day.

Registration clerk/Emergency Register

registration counter

H For unidentified patients, registration shall be done as a medico-legal case (MIC).

Registration clerk Register

I Patients revisiting the OPD for a follow-up consultation shill be re-registered; however, the same Unique Hospital Identifier (UHID) will continue.

Registration clerk

Register

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

No. Process Responsibility Supporting

document

A

Inpatient admission shall be done through the OPD or the Emergency department or the NICU/Labour ward as applicable.

Admission Clerk Admission Register

B

The decision regarding admission shall be made by the consultant and an admission slip or order issued by her/him.

Treating Doctor Admission slip/order

C General consent for admission and treatment is obtained from the patient and the patient’s relative.

Treating Doctor General consent form Admission note

D

The order for admission shall be written in the OPO book with the ward name, date time, name and signature of the consultant. The patient or patient’s relative shall be directed to the admission counter to complete all

Treating Doctor

Admission note

the admission formalities

E At the admission counter the consultant’s note is checked for admission.

Admission Clerk Admission note

F

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

Admission clerk Admission file and receipt

G

The patient is directed to the concerned ward, where the bed will be allotted.

Treating doctor/staff nurse/ward attendant Bed allotment record

H

The patient is received at the ward by the ward nurse and allotted a bed. Treatment is initiated as per the order. The patient is oriented to the ward.

Staff nurse Medical record

iii.TASKS AND RESPONIBILITIES

NO. Task Responsibility

i Define the registration, admission and transfer process.

Top Management

ii Define the department policy on admission and transfer process

Top Management in 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 through ORD or through Emergency ward

Admission clerk Register

2 The Treating Doctor shall decide transfer-out/referral-out and explain the reason and plan of transfer to the patient and relative.

Treating Doctor Medical record

3 Consent for transfer-out/referral-out is obtained from the patient and relative.

Treating Doctor Consent

4 The order for transfer-out/referral-out shall be written in the transfer out register with the patient’s name, date, time

Treating Doctor Transfer-out register

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.


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

Doctor Immediately Immediately within 24 hours of admission

Nurse Immediately Immediately within 4 hours of 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 Nursing

Registered with INC/State Nursing council

III. REQUIRED DOCUMENTS

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

Policy on initial assessment

All patients registered in the hospital will undergo an established initial assessment.

SOP on initial assessment Initial Assessment at Emergency

Patients who come directly to the emergency department and need emergency care are received by the staff nurse; the EMO will attend to the patient immediately.

NO Process Responsibility Supporting Document

1 All patients who come to the emergency

department shall be assessed

EMO/Treating Doctor/Staff nurse

Medical record

2 The following parameters shall be assessed in detail: • Chief complaints • History of illness • Allergies or any associated disease • Temperature, Pulse, Blood Pressure, and Respiration • Physical examination


Medical record

3 In case of mass casualties, triage shall be completed first, and then


Medical record

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 medical record with name, time, date and signature.

Treating Doctor /Doctor on Duty

Medical record

2 The assessment shall include the following parameters:

• Temperature, pulse, blood pressure and Respiration

• Physical examination.

Treating Doctor

Medical record

3 The initial nursing assessment is done in the prescribed format.

Staff nurse Medical record

Assessment of obstetric and high-risk obstetric patients

1 (This includes pregnancies with diabetes, HTN, Asthma, Eclampisa, convulsions, multiple pregnancies, elderly primi(>30 years),bad obstetric history(abortion)

Consultant Medical record

2 The assessment shall include:

• Weight, height

Medical record

• 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 explanations about their conditions ,Descriptions of the following should be shared:

• The diagnosis or provisional diagnosis as applicable

• Plan of treatment as decided by the treating consultant

Treating Doctor / staff nurse

Medical record

4 Special needs of the vulnerable patients who are receiving treatment will be assessed.

Treating Doctor / staff nurse

Medical record

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

Sample collection shall be carried out on a 24 hours basis either in the samples collection room or in the laboratory

Technician

Lab Sample book

2 Sample identification

• 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

Technician

the register.

3 Sample Handling

• All samples will be handled as per the infection control guidelines

• Universal precautions are to be observed while handling samples

Technician

4 Safe Transportation of Samples

• 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.

Technician

5 Processing of Samples

• 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.

Technician

Procedure or Lab Manual

6 Disposal of specimens

• 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.

Technician

III.TASKS AND RESPONSIBILITIES

NO Task Responsibility

Define the content of the Lab Department heads/Quality team

i Manual

ii Define the content of the tab Safety Manual

Top management in consultation with the specific department head

iii Preparation of lab related policy Quality team

iv Staff orientation to the safety aspects and SOPs Quality team/Training cell

IV.AUDIT CHECKLIST

No checkpoint yes NO Remarks


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 their own customized documents.

I. Overview

Scope: To guide the SHCO to develop a documented discharge process, to observe that patient care is multidisciplinary in nature, and to encourage continuity of care through a well-defined discharge

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 department-wise discharge summary.

Head of the Department / Quality team

Discharge summary

2 Treating Consultant decides to discharge the patient

Treating Doctor

3 Development of a care plan for post-discharge care.

Treating Doctor

4 Arranging for the provision of services, including patient or family education

Staff Nurse/CHD

5 Coordination related to discharge with specialty Consultants if cross-consultation was obtained

Treating/Referral Doctor/Staff Nurse

6 Preparation of final discharge summary. Treating Doctor

7 Preparation of account settlement form or final bill.

Staff Nurse/Billing section

8

Discharge summary handed over to the patient along with guidance on post discharge medication, follow-up and information regarding how to obtain urgent care.

Treating Doctor/Staff Nurse

Discharge summary

9 A copy of the discharge summary is Staff Nurse Discharge

attached to the patient case sheet. summary

10 Patient is accompanied till the hospital 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 including display of the billing tariff

Administrative department

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 summary

Treating doctor

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 including handling of medico-legal cases.

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 including handling of medico-legal cases.

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 department for policies and SOPs in handling emergency patients

HR and Quality team

3 Induction and ongoing training for emergency department for policies and SOPs in handling MLCs

Superintendent/Head of hospital; EMO on duty/Consultant on duty

4 Ensuring required documentation process including maintenance of different registers for emergency and MLCs

MO and Quality person /consultant involved.

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 emergency medical services shall be screened and first aid care and stabilizing treatment be provided, if required.

Doctor on duty Casualty register {Casualty register format}

The patient must receive stabilizing treatment within

Doctor on duty and Nurse Patient case record and

the capabilities and resources of the HCO.

on duty Casualty register

Should the stabilizing treatment require a specialist physician, the physician must be available to respond in a timely manner.

Consultant on duty (full time or visiting)

Patient case record/Referral form

The doctor on duty shall decide whether a case is an MLC

Doctor on duty MLC register

All MLCs shall be notified to the police as per SOP following the guidelines provided by legal authority or MCI guidelines; that is, treatment first and other administrative/clerical work later, but mandatory to document.

Doctor on duty and Nurse on duty

MLC notification book and MLC register.

If the doctor on duty concludes, based on the results of the screening examination, that the patient does not have an emergency medical condition, the patient may be treated as OPD or referred to a specific OPD

Doctor on duty Casualty register- column which states where patient is sent after primary treatment.

If inpatient treatment is required as per clinical conditions, the patient shall be transferred to the designated ward/OT/ICU/HDU after primary treatment.

Doctor on duty Casualty register- column which states where patient is sent after primary treatment.

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

Nurse on duty in emergency

The copies of the emergency department records are sent with the patient including any test results.

Doctor and nurse on duty Transfer record

In case there are more than two or three patients, triaging and prioritization for management shall be done based on the acuity and complexity of the clinical condition. Such triaging is known to all on emergency duty.

Doctor on duty

Nurse on duty

Triage record / casualty register

If after stabilizing, the patient refuses to be admitted in the hospital, and wants a transfer to another hospital or wants to go home, she/he should understand the ri4s and benefits.

Doctor on duty Transfer / DAMA / register

If patient’s clinical condition requires treatment that is not within the scope of hospital 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.

Doctor on duty

Nurse on duty

Transfer register

Call the respective hospital to ask about bed availability, brief staff about the patient’s condition on the phone, and confirm whether HCO can receive the patient.

Doctor on duty

Nurse on duty

Transfer register

Paramedical staff shall accompany stable patients and a trained nurse/medical officer shall accompany unstable patients.

Doctor on duty

Nurse on duty

Transfer register

A critical patient shall not be left unattended either inside the hospital or while

Doctor on duty Transfer register

transferring to another HCO. Nurse on duty

Transfer will be done in a suitable ambulance(stable patient in general ambulance or critical patient in cardiac ambulance)depending on availability.

Doctor on duty

Nurse on duty

Ambulance driver/staff of the ambulance if the ambulance is from the receiving hospital.

Ambulance register

All documentation shall be complete in the patient record.

Doctor on duty

Nurse on duty

Patient case file

List of cases that should be considered as MLC (cases may include and not be limited to):

i. All suspected accidental, suicidal and homicidal cases that may include

Poisoning

Road traffic accidents

Falls from a height

Sharp edged injuries

Near drowning

Blunt injuries

fire-arm injuries

burn injuries

ii. Sexual assault/rape

iii. Brought-dead Patients

iv. when clinical findings do not correspond with history (suspected foul play)

v. Any accidental or domestic injury to any female within seven years of marriage.

SOP for handling MLC

No Procedural steps Responsibility Supporting Document

1 All complaints and events shall be recorded. EMO/Nursing Patient record/MLC register

2 Each event shall be recorded in detail including the date, time and place of the event and involvement of person and vehicle during the event.

EMO Patient record/MLC register

3 Each case should be intimated to the relevant police station by phone after counseling the patient and relatives about the hospital policy and procedures. The name and buckle number with designation of the police personnel who has taken down the information along with date and time shall be noted.

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).

EMO/Nursing Patient record/MLC register

4 All MLCs after registration are to be issued for OPD /IPD cases and should be marked “MLC’. MLC number shall be stamped on all paper and patient records


5 Clinical notes shall be entered in IPD / 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

EMO/Nursing MLC book

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 MLC with the required data at emergency

Nursing Patient record/MLC register

7 A counter signature from the police station shall be taken from the representative in a patients MLC form / book


8 The time of informing the police and time of arrival of the police shall be entered in the MLC form


9 In case the police do not arrive within 24 hours of the MLC report a reminder shall be sent asking for an acknowledgment.


10 If any patient refuses to be registered as an MLC, the Medical Superintendent should be immediately informed for a further line of procedural action.


11 All MLCs registered with the hospital shall be intimated to the consultant on duty and the medical superintendent.


12 In case of any doubt regarding registering a case as an MLC, the medical superintendent shall be consulted.


13 If any patient registered under MIC dies during hospitalization, postmortem is a mandatory procedure and the patient’s body shall not be handed over to the patient’s relative but to the respective police station in order for the postmortem to be conducted at the district hospital.


14 A case summary shall be provided to the police at the time of handing over the dead body for submission to the district hospital.


15 When MLC5 are discharged, the relevant police station shall be notified.


16 All medico-legal discharge cases should be registered in the same way at all stages, as recorded at the time of admission.


17 A copy of all the reports of the investigation shall be kept in the MRD file before discharging the patient


18 After handing over the documents and reports to the patient, the patient’s or relative’s signature shall be obtained for the MRD file.


19 After discharge, MRD files of all MLCs shall be stored separately and be under the control of a designated person

MRD Patient record/MLC register

20 The responsible MO/Consultant shall arrange to prepare the injury certificate with the help of the

MRD Patient record/MLC

CMOs register

21 MRD shall preserve a copy of the signed certificate in the patient record


22 At the time of handling over the certificate to police the designation and buckle number of the police representative shall be noted in the second copy and the signature of the police taken.


23 All MLCs shall be reported to the medical superintendent on a monthly basis.


24 The original injury certificate shall only be issued to the police and not to the patient or relatives.

MO/ MRD Patient record/MLC register

Exhibit 1

Format of 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.

Note: Sections II, Ill, and IV below are provided as samples to guide SHCOs in developing 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/Standards% Zofor%ZOBlood%2OBanks%Zoand%2OBIood%2oTransfusion%zoservices.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 component services

Blood bank officer/Pathologist/Medical superintendent/ Incharge consultant/person

ii Procuring or maintaining MOUs Medical superintendent/person in charge

iii Induction and ongoing training for blood and blood component related policies and SOPs

Superintendent/ Head of hospital

iv Ensuring required documentation process including informed consent, blood and component transfusion monitoring, blood reaction monitoring and reporting

MO and/or Quality person/ consultant involved

v Audit and monitoring quality standards for blood transfusion services

Superintendent / 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 admitted as per clinical need.

ICU in charge/Doctor Patient record/ICU register

All patients shall undergo an initial assessment by the ICU doctor on duty and nurse on duty.

ICU doctor and Nurse on duty

Patient case record

In case of non availability of beds,the ICU doctor will find out whether any settled patient can step down or space be created to accommodate the new patient based on available human and

ICU doctor and doctor in casualty

ICU register/transfer register/patient record

other resources.

If it is not possible the patient shall be transferred to another hospital as per the transfer-out procedure.

Doctor on duty

Nurse on duty

All patients shall receive care as per their clinical need.

Doctor on duty

Nurse on duty

Patient case record

All staff doctors, nurses and attendants must maintain hand hygiene as per WHO Hand Hygiene Guidelines.

Doctor on duty

Nurse on duty

HIC Manual

All staff should follow universal precautions while managing the patient.

Doctor on duty

Nurse on duty

Patient record

ICU register

Staff must prevent the patient from falls

Doctor on duty

Nurse on duty

Patient record

ICU register

Staff must provide general nursing care and care for the general hygiene of the patient

Doctor on duty

Nurse on duty

Patient record

ICU register

Bundle care guidelines must be followed for all IV lines, catheters, endotracheal tubes, and other tubes.

Doctor on duty

Nurse on duty

Patient record

ICU register

Monitoring, patient assessment, and treatment should be documented in the designated format and patient case file and ICU register.

Doctor on duty

Nurse on duty

Patient record

ICU register

Handing over, taking over between shifts, and transfers to other wards should be appropriately documented.

Doctor on duty

Nurse on duty

Patient record

ICU register

The patient may be discharged o stepped down to a ward as per clinical need.

Doctor on duty

Nurse on duty

Patient record

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

Note: Sections II, Ill, and IV below are provided as samples to guide SHCOs in developing their own customized documents. 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 SHCO can provide to community.

Gynecology HOD/Medical superintendent or consultant in-charge/Nursing head

ii Finalize the services which will not be provised either due to lack of human resources, expertise, infrastructure or other logistical problems


iii Disseminate the scope of services to all staff members

HR and Gynecology department

iv Prepare a board to display scope of services publicly

Management

v Annual review of scope of services an amendment when any addition or removal is required.


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 preventive action

Audit team

IV. AUDIT CHECKLIST

No. Checkpoint Yes No Comments

i Documented procedures are in place for the prevention of child abduction and abuse.

ii Procedures documented are implemented

iii Infrastructure and manpower are provided as per the procedure

iv Staff in ICU/Pediatric care are aware of the policy and procedure.

v Mock drills are conducted (if code pink is followed), deviations pointed out, corrective and preventive actions are undertaken.

Note: Samples may be used as templates to guide the SHCO to develop customized SOPs.

NO Process flow Responsibility Supporting Document

1 Once the child is admitted, or neonate is born, identification bands are tied.

Nurses SOP/identification band

2 One parent is allowed to be with the patient at all times or allowed to visit the patient frequently in the ICU.

Security personnel/Nurse

3 Footprints of the newborn are imprinted on the bedside record and on the mother’s case sheet.

Nurses Medical records

4 The mother’s identification tag includes the baby’s UHID and name and vice versa.

Nurses

5 Infants are kept in direct, line-of-site supervision at all times by an authorized staff member and the mother.

Nurses

6 Infants are transported only by authorized staff along with the mother or father.

Nurses

7 Strict vigilance is maintained for the movement of children and infants in NICU/PICU and that of bystanders.

Security Staff

8 Movement of unrelated/unidentified attendants is restricted

Security Staff

9 The hospital staff and the parents 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.

Audit/HRD

10 Code pink protocol (if defined) is checked periodically and corrective action and preventive actions undertaken.

Quality team Mock drill record

STANDARD COP7. DOCUMENTED PROCEDURES GUIDE THE ADMINISTRATION OF ANESTHESIA.

Objective Elements

COP7a. There is a documented policy and procedure for the administration of anesthesia. COP7b. All patients for anesthesia have a preanesthesia assessment by a qualified or trained individual.* COP7c. The preanesthesia assessment results in formulation of an anesthesia plan which is documented.*

CPO7d. An immediate preoperative reevaluation is documented.*

COP7e. Informed consent for administration of anesthesia is obtained by the anesthetist.*

COP7f. Anesthesia monitoring includes regular and periodic recording of heart rate, cardiac rhythm, respiratory rate, blood pressure, oxygen saturation, airway security, and potency and level of anesthesia. *

COP7g. Each patient’s postanesthesia status is monitored and documented.* objective Elements COP7b, COP7c, COP7d, COP7e, 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 team as per the policy

HR/Superintendent/Head of SHCO

iii Develop SOPs for different anesthesia related activities

Anesthetist, OT nurse, Quality team/designated person

iv Training related to theses SOPs is provided for all stakeholders

HR/Quality team/consultant in-charge

v Day-to-Day activity and documentation Anesthetist/OT Nurse

vi Regular documentation audit for adherence to SOPs

Quality team/designated person/Consultant in-charge

IV.Audit Checklist

Policy and SOPs for anesthesia services are available Further, to check the implementation of the service the following can be helpful

No Checkpoint Yes 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 local use; prepare other checklist formats for shifting patient from ward to OT,SOPs for patient

Surgical head/Anesthetist/Nurse 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 checklists

Quality team/designated 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


1 Scheduling: The following information is a must when scheduling an invasive/surgical procedure: • Correct spelling of the patient’s full name

Primary nurse and surgical team

OT list, consent form

• Inpatient number • Consent for procedure to be performed

2 Preprocedure/preoperative verification 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.

Physician and Anesthetist

Surgical safety checklist

3 Site mark: This should be completed before the patient enters the procedure or operating room.The site mark is required in invasive or surgical procedures that involve

• Laterality (for example, right, left)

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

• Multiple levels (for example, spine)

This includes bedside invasive procedures.

Physician and Anesthetist, Primary nurse, OR Nurse/Register


4 Before making the site-mark, the Consultant performing the procedure 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.

Physician and Anesthetist

5 There should be standardized marking for all procedures (for example, SS - surgical site). The marker should be hype-allergenic,

Infection control Nurse, OR nurse/Doctor

latex-free, and sterile. The marking should be clear and unambiguous.

6 The site-mark should not be removed tint the procedure is over.

Physician and Anesthetist OR Nurse/Doctor

7 Time-out procedure: Time-out is required to confirm the

• Correct patient • Correct side or site • Correct procedure • Correct patient position • Correct radiographs • Correct implants and equipment

OR Nurse Surgical safety checklist

8 A verbal time-out or pause is called by the OR Nurse or Registrar immediately before the procedure or surgery in the operating room or procedure room.

OR Nurse/Doctor Surgical safety checklist

9 The patient doses not have to be awake for the time-out! Site-marking must be visible at time-out or pause.

OR Nurse/Doctor

10 As soon as the patient enters the 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.

OR Nurse/Doctor

11 The Scrub Nurse, Anesthetist and Surgeon will say ‘yes’ to all the details. The time-out will be 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

If any discrepancy is found at any point, the case must not proceed until completely resolved.


13 All team members and the patient (if possible) must agree on the resolution of the identified discrepancy. The attending Consultant in the patient’s medical records must document the discrepancy and its resolution

Attending consultant (Physician and Anesthetist)

V REFERENCES

Resources for SOPs and formats taken from H. M. Patel Center for Medical Care and Education; and 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=2s26&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/9s3s223249GuidelinesandProtocolsorsexua 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_Guidehliness

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 included in this Guidebook.

MOM1a. Documented procedure shall incorporate purchase, storage, prescription and dispensation of medications.


I OVERVIEW

Scope: To guide the SHCO on procedures to be followed for purchase, storage, prescription and dispensation of drugs in a safe manner and to avoid medication errors.

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 note is raised. Pharmacy staff

4 The order note contains the following: 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

HOD/staff

5 Once the order note is written, the signature from the person in-charge, and person ordering is obtained.

Pharmacy/Purchase in-charge

6 The order is placed with different stock lists or company representatives over the phone according to the order note.


7 Items are received from the stock list as per the agreed turnaround time.


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


9 Quantities, batch number, expiry date, any breakage of items are checked before accepting from the stock list or company representatives.


10 A copy of the order note along with the bill is sent to the Accounts department after getting the signature of the person in charge.

Pharmacy/Purchase staff

11 Payment is made by the Accounts department. Accounts department

Procedure of storage of Medication

NO Procedure Responsibility

1 Medications are stored in the pharmacy or in the Ward or OT stocks (at the point of care).

Pharmacy in-charge and person in charge of the patient care area

2 Only authorized staff are allowed access to the stored medication

Pharmacy staff,Nursing staff in patient care areas

3 The area is clean and well ventilated Pharmacy staff,Housekeeping

4 The medications are protected from direct sunlight and the ambient temperature is maintained as per the manufactures specification


5 Medications with “Cold chain” requirements are kept in the refrigerator.

Temperature is monitored at least once every shift.


6 LASA medications are identified Pharmacy in-charge

7 Individual LASA medications are stored with a separation between the items in each of the LASA pairs


8 Medications are checked every month to identify those due to expire within the next one/two/three months.


9 The near-expiry items are returned to the vendor for exchange.

Pharmacy in-charge

Procedure of prescription of Medication


1 Registered doctors are authorized to prescribe medications in the SHCO.

Medical Profesionals (Consultants/ Residents/Medical Officers)

2 The prescription will contain the type of preparation, name of the drug, dose, route of administration, frequency, and duration of usage.


3 Medication orders are written clearly and legibly in capitals dated, timed, signed, and named


4 Medication orders are written only in the designated locations in the medical record.


5 A list of high-risk medications used in the hospital is maintained

Pharmacy in-charge with inputs from the consultants

SOPs on Dispensing Medication]


1 Dispensing of medication is done by a qualified Pharmacist Pharmacist

2 The pharmacist cross-verifies the medication with the prescription prior to dispensing it with double verification for high-risk medication.

Pharmacist

3 As per prescription, the correct drug and is expiry date are checked by the pharmacist Pharmacist

IV. TASKS AND RESPONSIBILITIES

No Tasks Responsibility

i Define list of medications used in the SHCO List approved vendors

Pharmacist / Doctors

ii List approved vendors Purchase/Pharmacist

iii Storage conditions of medications Management / Quality team/Pharmacist

iv Prescription Format Quality team /Pharmacist/Doctors

v Applicable Policies and SOPs

Quality team /Pharmacist/ 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 maintained.

Purchase/pharmacy in-charge

2 Evidence-based medicine supports the usage of the implant

Clinician using the implant purchase/pharmacy in-charge

3 Implants which are used frequently are stored in the hospital.

Purchase/pharmacy in-charge

4 The following information is recorded in the order note: Name of the item Quantity of the item Order date Name of the company Last order date Present stock

HOD / Staff

5 Once the order note is written, signatures are obtained from the in-charge and the person ordering

Purchase/Pharmacy in-charge

6 Order for items is placed with different stock lists or company representatives over the phone as

Purchase/Pharmacy in-charge

per the order note

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

8 Items are checked according to the bill and the order note


9 Quantities, batch number, expiry date, any breakage, relating to all the items are checked before accepting from the stock list or company representatives


10 A copy of the order note along with the bill is sent to the Accounts department after getting the signature of the person in charge


11 Payment is made by the Accounts department Accounts Department

12 implants are supplied to the point of care on request

Pharmacy/store

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

OT staff

pharmacy staff



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 included in this Guidebook.

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.



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

ii. Define the storage and usage precautions or identifiers for high-risk medications

Management/Pharmacists/ Doctors

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

N. AUDIT CHECKLIST

No Checkpoint Yes No Remarks 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 their own customized documents. I. OVERVIEW Scope: To guide both staff and patients in the SHCO on the standard precautions to be followed in order to:

i. Reduce and prevent the incidence of hospital acquired infections in the SHCO. ii. Identify high-risk areas where active surveillance should be practiced in an SHCO

so as to reduce the rate of infections.

iii. Develop policies and procedures for standards of cleanliness, sanitation, and asepsis in the SHCO.

Hospital Infection Control (HIC) Manual It is recommended that the SHCO have an HIC Manual on standard precautions that staff should follow to prevent patients from acquiring infections within the SHCO. It is recommended that the HIC Manual:

i. Explains to staff the standard precautions and the universal precautions that should be ideally practiced in the SHCO.

ii. Focuses on the importance of hand hygiene as this is one of the root causes for all hospital acquired infections.

iii. Provides guidelines for the care to be taken in high-risk areas like OT (Operation Theatre), CSSD (Central Sterile Supply Department), and (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 and procedures

Designated HIC staff

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 quality improvement)

Administration

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 identified KPI Quality team

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

5. collection of data using standardized format identified by the Quality team Quality team/personnel

6. Verification and validation of data Quality team

7. Analysis of data stakeholders Quality team with the

8. Identification of variation in trends Quality team

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

Quality team and stakeholders

10. Review of the KPI Administration, Quality team and stakeholders

11. Inclusion of new KPI team Administration and Quality



i Form a Quality team with representation from various key areas

Top management

ii Identify KPI Departmental heads, Quality team, Top management

iii Agree on sample size and data collection format Quality team

iv Collect data Selected personnel from Quality team

v Validate data Quality team

vi Present data in a common forum (quality committee meeting or KPI meeting)

Quality team/Administration

vii Compile the data in a presentation Quality team

viii Presentation and analysis of KPI All stakeholders, Top management, Quality team

ix Conduct root-cause analysis User departments and Quality team

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

xi Periodic review of quality function Quality team, Top management

IV.Audit Checklist


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

No Procedure Responsibility Supporting Documents

i The organogram is prepared and authorized by the SHCO management

Top management Organogram

ii All staff are aware of the organogram and the organizational structure it represents. This is done through • Induction program at the time of joining

• Regular training for existing staff

HR staff or Quality department staff or Heads of respective departments

Induction training material

Training material on SHCO-wide policies and procedures

Tasks and Responsibilities

No.

Task Responsibility

i Prepare the draft organogram HR in-charge

ii

Review the draft organogram

• Practice on the ground should reflect what the management planned.

• Opportunities for streamlining the hierarchy are identified and suitable changes made.

Top management and HR department

iii

Authorizing the organogram

• Signature of the Head of the SHCO is affixed.

• The date from which it is effective is mentioned.

Head of the SHCO

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

Sub- Sub-

Departmen

Departmen

Departmen

Departmen

Departmen

Sub- Sub-

Departmen

Departmen

Departmen

Departmental structure(This is optional.The hospital may replace the prompts with actual designations and names of unit or subunits)

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.

Departmental Head

Sub-unit Sub-unit

Section In- Section In-

Staff Category Staff Category Staff Category Staff Category

Section In-

Staff Category Staff Category

Section In-

Staff Category Staff Category

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 the mission statement

Top Management Mission statement

2 This is made public in the following locations: Entrance lobby Foundation stone In all common waiting areas

Operations Head and Maintenance/Facility in-charge

Plaque(e.g. brass or marble).

Boards and framed statements.slide presentation.

Inhouse documents as applicable. Online content if present. Others(the SHCO shall specify other modalities).

3 All the staff are aware of the mission statement. This is done through

• The induction program at the time of joining

• Regular training for existing staff

HR staff, or quality department staff or heads of respective department

Induction training material,Training material on SHCO wide policies and procedures.

4 The mission statement is included in all the manuals in the SHCO

HR department,Quality department

All manuals,Hospital brochure.

III.TASKSAND RESPONSIBILITIES


i List out the words that best describe the purpose, strategy, values and behavioral standards of the SHCO.

Top Management, senior leaders or HODs

ii Discuss the relationship of these elements for both organizational success and employee motivation.


iii The list of descriptive words is clear and final, avoiding duplication and exaggeration.


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


v Ensure that the mission statement is authorized by the top management. The signatory is identifiable or it may simply mention “Management “or “Board of trustees” or the like.

Top Management

vi Incorporate the mission statement in the SHCO’s documentation, such as manuals, brochures, training material.

Quality Department or HR department

vii Display the mission statement to the public at the entrance lobby and in prominent common areas across the SHCO and online media.

Operations Head and Maintenance /Facility in-charge IT dept

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 including hazardous materials.

FMS1d. Facility inspection rounds to ensure safety are conducted periodically.*

FMS1e. There is a safety education programme for relevant staff.*

Objective Elements FMS1a, FMS1b, FMS1d, and 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 including hazardous materials.

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

Scope: To ensure the safety of patients, families, staff and visitors to the SHCO by identifying all the 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 safety and security risks in the SHCO.

HR/Training department

Training records

Any staff member who identifies a potential risk should immediately call (Front Desk/Reception/any 24 hour area), or fill the online reporting form and submit it.

All staff members Reporting forms/Register

If the risk is of immediate concern, it should be addressed through the SHCO phone number.


While calling the number, the reporter must identify himself/herself, the identified risk,and the location.


The designated person along with the engineer/concerned person should visit the spot and ensure that the complaint is addressed.1

Designate person/concerned departments

Reporting forms/Register

On receiving the call,the information should be recorded in the incident register with the date,time,caller details and the reported incident.

Front desk/Reception


The information should be passed on to the designated person concerned, who in turn will have to contact groups responsible for addressing the complaint.

Front desk/Reception/ Designate person/concerned departments


Once rectified, the designated person should conduct a random inspection and see if similar problems exist in other places in the SHCO, and if so, address them.

Designated person Inspection report

Sample protocol for managing different risks when they occur

Some of the common risks in a hospital environment include:

a. Chemical hazards- hazardous chemicals (including blood, and their spillage)

b. Security risks-theft, abduction, sabotage

c. Fire risks due to smoking, short circuits

d. Risk to building and infrastructure - lightning, termites

e. Risk to patient like infections, falls, medication errors, cautery burns

a) Risks due to Hazardous Chemicals

There are many hazardous chemicals in the SHCO environment such as mercury, 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 risks, identification, management and reporting of risks

Training records- yes/No

iii Documentation of reported potential risks

iv Protocol followed to address the reported incident or potential risk

v Analysis of the reported risks

vi Risk mitigation in terms of corrective and preventive action taken

Available / Not available

vii If there was any change in protocol, awareness of staff on the recent protocol.

STANDARD FMS2. THE SHCO HAS A PROGRAM FOR 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.


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 DocumentsThe operational plan should be as per the instructions of the manufacturer as each manufacturer and each model of equipment will have different operating instructions.

Engineering Operational plan for each equipment

Staff handling the equipment must be trained by the supplier of the machine and the instructions strictly followed by personnel operating the machine for its safe operation.

Engineering / Staff handling the equipment

Training records/checklist and records

The equipment must be operated based on the operating instructions or plan.

Staff handling the equipment

Operational plan for the equipment

The operating instructions should be available with the operator or hung on

Staff handling the equipment

Operational plan for the equipment

the machine.

Sample operational plan user checklist


Procedure Responsibility Supporting documents

A preventive maintenance schedule must be prepared by the engineering team.

Engineering

Preventive maintenance schedule

The planned preventive maintenance schedule may vary for different equipment quarterly, semi- annually or annually, depending on the manufacturer.

Engineering

Operators Manual

PPM can be carried out by the engineering staff or outsourced.

Engineering

Records of preventive maintenance

The operator or user must be informed in advance about the scheduled preventive maintenance, so that appropriate arrangements are made by the users to keep the equipment free of use.

Engineering

Intimation to the users

Records of preventive maintenance must be maintained for each equipment

Engineering

Records of preventive maintenance

Sample protocol for handling breakdown repairs of equipment

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

Staff who handles the equipment

Complaint register

The repair may include spare part replacement and small component replacement

Engineer/outsources engineer

Receipts

After the machine is brought back to normal working condition, complete calibration and testing has to be

Engineer/outsources engineer

Records of repair done

performed, including electrical safety, before it is handed over to the user department The breakdown of life saving equipment,surgical equipment and critical care equipment, may be considered as Emergency breakdown and priority given for such breakdown.

Engineer Complaint register

Records of the time of raising the complaint, the person who raised the complaint, the job completion, and equipment handling over time along with the types of repair done should be maintained

Engineer Complaint register



i Inventory of all equipment Engineer

ii Training of the technician operating the equipment Engineer

iii Operational plan for every machine based on the operator’s manual

Engineer / staff handling the equipment

iv Preventive maintenance schedule for each machine based on the operator’s manual

Engineer

v Addressing breakdown and repairs Engineer

vi Records of preventive and breakdown maintenance

Engineer

IV AUDIT CHECKLIST


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 operation of the equipment

Training 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-addressing and recording of time for repairs

Available/Not 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 their own customized documents.

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 installations shall be managed by adequate staff.

HR/Engineering Personal Files

Appropriate backup (cylinders) shall be made available to handle any emergencies that arise out of the failure of piped medical gases.

Engineering Records of backup cylinders

Appropriate personal protective devices such as earmuffs and rubber gloves should be used by the staff

Engineering Actual availability/Inspections at random

Medical gas and vacuum installations shall be maintained as per protocol.

Engineering Daily,weekly,monthly and annual maintenance schedule,records of maintenance.

Daily, weekly, monthly and annual maintenance schedule

No Daily check Parameters to be checked 1 LMO tank(if available) Tank level, pressure 2 Vacuum pump Pressure, machine running

status(lead,standby,last),oil level,belt tension, loading and unloading pressure range, auto drain

3 Air compressor Pressure, machine running status(lead,standby,last),oil level,belt tension,temperature,water pressure,cooling tower working,loading and unloading pressure range

4 Nitrous oxide,carbon dioxide,oxygen manifold

Line pressure,heater coil,cyclinder stock.

Weekly Maintenance

All Medical gas outlets of the clinical area to be checked for pressure range and leaks.If the pressure drops,the outlet needs to be scanned.

Monthly Maintenance

No Daily check Parameters to be checked

1 Vacuum pump Cleaning, oil level and quality, belt tension check for faserners,auto drain and check for silencer cleaning, loading and unloading pressure range.

2 Manifolds Line pressure, heater coil, cylinders stock, leak test.

3 Air compressors

Cleaning, oil level and quality, belt tension check for fasteners, auto drain and check for silencer cleaning, water pressure, temperature sensor, cooling tower, loading and unloading pressure range, servicing suction and discharge valves, and servicing of Non Return Valve.

Annual Maintenance



i Procure license for the LMO Engineer

ii Ensure daily, weekly, monthly and annual checks are done as Engineer per requirement

Engineer

iii Uniformly colour code in a standardized manner (as per international colour coding of medical gas

Engineer

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 containment of fire and non fire emergencies.

FMS4b. The SHCO has a documented safe exit plan in case of fire and nonfire emergencies.

FMS4c. Staff is trained for their role in case of such emergencies.*

FMS4d. Mock drills are held at least twice in a year*

*Objective Elements FMS4c and FMS4d are self-explanatory and therefore not included in this Guidebook.

FMS4a. The SHCO has plans and provisions for detection, abatement and containment of fire and non fire emergencies.


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 systems in the SHCO should be kept 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

Engineering Maintenance records and checklists

The systems should be tested frequently Engineering Maintenance records and checklists

All staff should be trained in handling fire and nonfire emergencies in the SHCO


Training records

Any person who witnesses a fire or leak or any other emergency should immediately call for help

All staff

The staff member should immediately try to fight the fire or handle the situation based on the training provided

staff

The team set for the purpose should be present and take over the situation immediately

Designated team

Based on the situation, the team leader should decide if additional help is required from outside such as the fire department or police

Designated team



i Fire detection systems as per National Building Code (NBC)

Head of SHCO

ii Fire fighting systems as per NBC Head of SHCO

iii Leak detection system of LPC bank, medical gas bank as per norms

Engineer

iv Protocol for emergency contact Designated team

v Staff awareness of their role in reporting or escalation of any potential emergencies


vi Staff awareness of their role in early containment 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.


No Task

Disciplinary procedures Responsibility

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

ii Composition of the team or the designated individual who reviews the offence(s)

Authorized by Top management

iii. List quantum of action to be taken, ensuring that it is commensurate to the offence


iv. Hearing of both parties Disciplinary committee or designated individual

v. Decision on action to be taken against the erring member of staff

Disciplinary committee or designated individual

vi. Opportunity given to staff member to appeal to a designated individual


vii. Implementation of action against staff HR department

viii. Constitution of an Internal Complaints Committee (ICC) to address complaints of sexual harassment at the workplace


ix. Making available the name of the person that the alleged victim should contact in order to present a written complaint.

Any member of ICC or any senior staff in whom the victim confides

x. Acknowledgment of receipt of the complaint by the alleged offender Member Secretary of ICC

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

HR department (on the written instruction of the Member Secretary of ICC)

xii Proceedings of ICC Member Secretary of ICC

xiii. Action taken against the erring staff member

Member Secretary of ICC HR department Top management

Grievance Handling procedure

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

ii. Appointment of grievance handling officers Head of the department Senior HR staff or Top management

iii Proceedings of the grievance handling procedure documented and decision implemented

HR department

iv The written document for disciplinary action and grievance handling is finalized

HR department

Quality department

IV. Audit checklist Frequency of audit: At least once a year as part of hospital-wide audit. No Checkpoint Yes No Remarks

i Procedure for disciplinary action is available

ii Procedure is available for addressing complaints of sexual harassment in the workplace

iii Procedure is available for addressing grievance-handling

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 their own customized documents.

I. OVERVIEW

Scope: To make staff aware of the disciplinary procedure so that they are less likely to err since they know the consequences. Staff also become aware that the disciplinary proceedings are free of bias or prejudice as well as how to access the grievance handling mechanism in a timely manner.

It is important for the staff to know the procedures that will be followed both for disciplinary action and grievance redressal. It is recommended that the management should take the time and make the effort to conduct training for the staff right from the time they join the SHCO, and also ft periodically retrain them on the same.

II. TASKS AND RESPONSIBILITIES


i The written document for disciplinary action and grievance handling is included in

• The compilation of SOPs in the HR department

• The material for training staff on

HR department

Quality department

hospital-wide policies and procedures

ii Make staff aware of the procedures concerning disciplinary action and grievance handling. This is done through training programs such as.

• Training for new staff

• Retraining for staff - Retraining of staff on the hospital-wide policies and procedures is done at least once a year. This may be done by the HR department or the respective department heads.

HR department HOD of respective departments

Quality department

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

No Procedure Responsibility Supporting

Documents

1. Identification of all staff who are eligible under the ES! Act HR staff List of staff under

ESI

2. Enrollment of eligible staff under ESI with all relevant supporting evidences in exchange for an ESI card

HR staff ESI correspondence files

3

Financial contribution made by the hospital and the staff towards enlisting the eligible staff under the ESI: Employees contribute 1.75 percent and employers contribute 4.75 percent

HR/Accounts department

Accounts statement ESI statement

4. The required amount is remitted into the ESI account within 21 days from the end of the due month.

Accounts department

Accounts statement [SI statement

5. Separate training classes are held and handouts listing the benefits under the ESI are given to the staff.

HR staff HR training material

6 Staff may access investigations and treatment at ESI-empanelled hospitals as needed.

Concerned staff

Medical records Billing details

Health and Treatment Benefits for Staff

The following are some of the health benefits which the SCHO may provide to the staff. This is optional and entirely at the discretion of the management of the SCHO. Relevant areas may be modified or deleted.

Type of benefit Eligibility Benefit

General health insurance

For staff not covered under ESI optional for the staff

percentage contribution from the staff and rest from the hospital

OPD investigations All staff Percentage of discount

Staff dependents Percentage of discount

OPD Consultations All staff Percentage of discount

Staff dependents Percentage of discount

inpatient stay All staff

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

Staff dependents

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

Procedure No Procedure Responsibility Supporting

Documents 1 The details of the health benefits

for staff and their dependents is listed and maintained by the HR department

HR staff List of health benefits

2 The staff are made aware of the benefits at the time of joining the SHCO

HR staff HR training material

3 The front office, billing and admission desk staff are responsible for extending the benefits to the staff in times of need.

HOD of front office, billing, admission

Internal communication

4 Staff should contact the HR in-charge in case of difficulty in accessing the health benefits

HR in-charge

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 applicability in the SHCO

HR staff

b List of staff whose gross salary is less than Rs.15,000 per month

HR staff

c Enrollment under ESI with all relevant supporting evidences with local ESI office

HR staff

d ESI card for the eligible staff HR staff

e Calculation of contribution to ESI HR department or Pay and Accounts department

f Remittance of amount to ESI Accounts department

g Separate training classes and handouts for ESI beneficiaries regarding provisions under ESI

HR staff

h Pre-exposure prophylaxis Hospital management extends free/concession/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 protective equipment

A sufficient quantity of personal 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 for general illness at the SHCO.Health insurance cover for staff.

Authorized by the management.

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


1 All the medical records shall have the UHID number.

Registration counter/MRD

Medical record

2 Required medical documentation shall be completed by doctors/ nurses/dietitians/ physiotherapists, as applicable.

Doctors/nurses/ dietitians/ physiotherapists, as applicable

Medical record

3 All the entries shall be dated, timed, signed and named.

Doctors/nurses/ dietitians/ physiotherapists, as

Medical record

applicable

4 The contents of the hospital record shall be defined as per the clinical requirement.

Top management and Quality team

Hospital formats

5 All the formats shall be assembled Medical records officer Medical record according to the sequence decided.

Medical records officer

Medical record

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


Medical record

7 Deficiencies shall be identified in the deficiency checklist and corrective actions taken.


Deficiency checklist

Sequence in which medical records should be stored:

(The list may be expanded or trimmed as per the hospital policy)

i. Mandatory documented requirements: admission record, discharge summary or death summary, clinical information such as the reason(s) for admission, initial diagnosis, findings of assessments and reassessments (by doctors/nurses/dietician/ physiotherapist), allergies, results of diagnostic and therapeutic tests and procedures, final diagnosis, treatment goals, plan of care, revisions to the plan of care, progress notes, any medications ordered or prescribed, other orders, any medications administered including the strength, dose, frequency and route, any adverse drug reactions, consultation reports, consent forms, 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 records, formats and contents of the discharge summary

Administrative in-charge, MRD and Medical records officer

ii To complete the sequencing of the medical records formats


iii To check for completeness of the medical records

Medical officers,nurses,physiotherapists, dietitians(where applicable)

iv Deficiency check at the submission of the record to M RD


v Corrections of the deficiencies Medical officer

vi Getting the deficiencies corrected by the 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 corrected, the records are stored in the medical records as per the UHID or the SHCO policy.

MRO MRD receiving register

2 Only the relevant care providers have access to the medical records.

MRO/Security staff

3 A tracer card process shall be followed when a medical record is retrieved. The tracer card is prepared with the patient’s name and hospital number, the requesting person’s name, ward and the date.

MRO Tracer card

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

MRO Tracer card/medical record

5 Once the medical records are returned, the records are checked for integrity or tampering of information and stored in place The tracer card is then closed

MRO Medical records

6 The medical records stored in the MRD shall be protected from loss due to humidity, adverse environmental conditions, and fire with adequate measures being taken to safeguard against these safety threats.

MRO Pest control records/fire safety plan

7 Whenever privileged health information is required by law, the SHCO will provide the information.

Top management MRO

Privileged communication record

III. Tasks and Responsibility

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

confidentiality and security of the record. MRO

ii Tracer cards/tracer methodology implementation MRO

iii Retrieval of medical records MRO

iv Pest/rodent control Administration in-charge/MRO:

v Security and access control Security staff

IV Audit checklist

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

the confidentiality, security and integrity of information

ii The documented procedures are implemented.

iii The audited sample of case sheets are well- protected from loss, theft and tampering.

iv The process of retrieval of files is implemented.

v Missing files are traced.

vi Adequate fire detection and firefighting equipment is available and mock drills are conducted.

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

Quality team SOP

2 Medical records are retained safely and securely as per the policy

MRO Medical records

3 Medical records are verified for their retention before destruction

MRO Verification list

Policy: The SHCO defines the process of the destruction of medical records in a safe and secure manner after the completion of the retention period without compromising on the confidentiality privacy of the information.

No Process flow Responsibility Supporting Department

1 The retention policy for the medical records, data and information is defined as per the regulatory requirements.

Quality team SOP

2 Medical records which have been stored beyond the retention period are selected for destruction

MRO

List of medical records to be destroyed (recorded in the register)

3 The SHCO may display the UHID numbers of the medical records being selected for destruction for the information of the public

MRO

Notification

4 Medical records are verified for their retention before destruction.

MRO

Verification list

5 Written permission is obtained from the MS before destruction

MRO

Permission letter

6 The selected medical records are destroyed by shredding.

MRO

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

MRO

MOU with vendor

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: [email protected]; [email protected] Website: www.nabh.co

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