This document provides guidelines for pre-accreditation standards for small healthcare organizations (SHCOs) in India. It outlines 27 standards across 9 areas such as access to care, patient care, medication management, infection control, and information management. The standards require documented policies and procedures to guide key activities like patient registration, assessment, treatment, discharge, equipment management, record keeping, and staff grievance handling. SHCOs must also monitor performance indicators, conduct infection surveillance, and ensure facility safety and staff health. Following these entry-level standards helps SHCOs deliver basic healthcare services systematically and improve quality.

1. GUIDEBOOK FOR
PRE-ACCREDITATION ENTRY-LEVEL STANDARDS
FOR SMALL HEALTHCARE ORGANIZATIONS (SHCOs)
First Edition: May 2015
NATIONAL ACCREDITATION BOARD FOR HOSPITALS AND
HEALTHCARE PROVIDERS (NABH)
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Accreditation
Pre-Accreditation
(Progressive- Level)
Pre-Accreditation
(Entry-Level)

3. NATIONAL ACCREDITATION BOARD FOR HOSPITALS AND
HEALTHCARE PROVIDERS (NABH)
GUIDEBOOK FOR
PRE-ACCREDITATION ENTRY-LEVEL STANDARDS
FOR SMALL HEALTHCARE ORGANIZATIONS (SHCOs)
First Edition: May 2015

4. © All Rights Reserved
No part of this book may be reproduced or transmitted in any form without permission in writing from the author.
First Edition May 2015
National Accreditation Board for Hospitals and Healthcare Providers

5. CONTENTS
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 01
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 03
Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 04
List of Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 06
Chapter 1. ACCESS, ASSESSMENT AND CONTINUITY OF CARE (AAC). . . . . . . . . . . . . . . . . . . . . . . . 09
Chapter 2. CARE OF PATIENTS (COP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
1 AAC1 The SHCO defines and displays the services that it can provide.. . . . . . . . . . . . . . 09
AAC1a The services being provided are clearly defined.
2 AAC2 The SHCO has a documented registration, admission and transfer process. . . . . . 12
AAC2a Process addresses registering and admitting outpatients, inpatients,
and emergency patients.
AAC2b Process addresses mechanism for transfer or referral of patients who
do not match the SHCO's resources.
3 AAC3 Patients cared for by the SHCO undergo an established initial assessment. . . . . . 17
AAC3a The SHCO defines the content of the assessments for inpatients and
emergency patients.
4 AAC5 Laboratory services are provided as per the scope of the SHCO's services . . . . . . 21
and laboratory safety requirements.
AAC5b Procedures guide collection, identification, handling, safe transportation,
processing, and disposal of specimens.
5 AAC7 The SHCO has a defined discharge process. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
AAC7a Process addresses discharge of all patients including medico-legal cases
and patients leaving against medical advice.
AAC7c Discharge summary contains the reasons for admission, significant findings,
investigation results, diagnosis, procedure performed (if any),
treatment given, and the patient's condition at the time of discharge.
6 COP2 Emergency services including ambulance are guided by documented . . . . . . . . . 31
procedures and applicable laws and regulations.
COP2a Documented procedures address care of patients arriving in the
emergency including handling of medico-legal cases.
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6. 7 COP3 Documented procedures define rational use of blood and blood products. . . . . . 41
COP3c Procedure addresses documenting and reporting of transfusion reactions.
8 COP4 Documented procedures guide the care of patients as per the scope of . . . . . . . 44
services provided by the SHCO in Intensive Care and High Dependency Units.
COP4a Care of patient is in consonance with the documented procedures.
9 COP5 Documented procedures guide the care of obstetrical patients as per . . . . . . . . . 48
the scope of services provided by the SHCO.
COP5a The SHCO defines the scope of obstetric services.
10 COP6 Documented procedures guide the care of pediatric patients as per . . . . . . . . . . 50
the scope of services provided by the SHCO.
COP6a The SHCO defines the scope of its pediatric services.
COP6d Procedure addresses identification and security measures to prevent child
or neonate abduction and abuse.
11 COP7 Documented procedures guide the administration of anesthesia. . . . . . . . . . . . . 54
COP7a There is a documented policy and procedure for the administration of
anesthesia.
12 COP8 Documented procedures guide the care of patients undergoing . . . . . . . . . . . . . 57
surgical procedures.
COP8c Documented procedures address the prevention of adverse events like
wrong site, wrong patient, and wrong surgery.
13 MOM1 Documented procedures guide the organization of pharmacy services and . . . . . 63
usage of medication.
MOM1a Documented procedures incorporate purchase, storage, prescription,
and dispensation of medications.
MOM1e Documented procedures address procurement and usage of implantable prosthesis.
14 MOM2 Documented procedures guide the prescription of medications. . . . . . . . . . . . . . 71
MOM2d The SHCO defines a list of high-risk medication and the process to prescribe them.
15 HIC1 The SHCO has an Infection Control Manual which it periodically updates; . . . . . 74
the SHCO conducts surveillance activities.
Hospital Infection Control Manual (as Annexure)
16 CQI2 The SHCO identifies key indicators to monitor the structures, processes, . . . . . . 76
and outcomes which are used as tools for continuous improvement.
CQI2a The SHCO identifies the appropriate key performance indicators in both
clinical and managerial areas.
Chapter 3. MANAGEMENT OF MEDICATION (MOM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Chapter 4. HOSPITAL INFECTION CONTROL (HIC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Chapter 5. CONTINUOUS QUALITY IMPROVEMENT (CQI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
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7. Chapter 6. RESPONSIBILITIES OF MANAGEMENT (ROM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Chapter 7. FACILITY MANAGEMENT AND SAFETY (FMS). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Chapter 8. HUMAN RESOURCE MANAGEMENT (HRM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Chapter 9. INFORMATION MANAGEMENT SYSTEM (IMS). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
17 ROM1 The responsibilities of the management are defined. . . . . . . . . . . . . . . . . . . . . . 80
ROM1a The SHCO has a documented organogram.
18 ROM2 The SHCO is managed by the leaders in an ethical manner. . . . . . . . . . . . . . . . . . 83
ROM2a The management makes public the mission statement of the SHCO.
19 FMS1 The SHCO's environment and facilities operate to ensure safety of patients, . . . . 87
their families, staff, and visitors.
FMS1c The SHCO has a system to identify the potential safety and security
risks including hazardous materials.
20 FMS2 The SHCO has a program for clinical and support service equipment . . . . . . . . . 92
management.
FMS2b There is a documented operational and maintenance
(preventive and breakdown) plan.
21 FMS3 The SHCO has provisions for safe water, electricity, medical gas, . . . . . . . . . . . . . 97
and vacuum systems.
FMS3c There is a maintenance plan for medical gas and vacuum systems.
22 FMS4 The SHCO has plans for fire and nonfire emergencies within the facilities.. . . . . 102
FMS4a The SHCO has plans and provisions for detection, abatement,
and containment of fire and nonfire emergencies.
FMS4b The SHCO has a documented safe exit plan in case of fire and nonfire emergencies.
23 HRM2 The SHCO has a well-documented disciplinary and grievance . . . . . . . . . . . . . . 109
handling procedure.
HRM2a A documented procedure regarding disciplinary and grievance handling is in place.
HRM2b The documented procedure is known to all categories of employees in the SHCO.
24 HRM3 The SHCO addresses the health needs of its employees. . . . . . . . . . . . . . . . . . . 115
HRM3a Health problems of the employees are taken care of in accordance with
the SHCO's policy.
25 IMS1 The SHCO has a complete and accurate medical record for every patient. . . . . . 123
IMS1e The contents of medical records are identified and documented.
26 IMS3 Documented policies and procedures are in place for maintaining. . . . . . . . . . . 128
confidentiality, security, and integrity of records, data, and information.
IMS3a Documented procedures exist for maintaining confidentiality, security,
and integrity of information.
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8. 27 IMS4 Documented procedures exist for retention time of records, data, . . . . . . . . . . 132
and information.
IMS4a Documented procedures are in place regarding retention of the patient's
clinical records, data, and information.
IMS4c The destruction of medical records, data, and information is in accordance
with the laid down procedure.
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APPENDIXES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
1. Formation of Committees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
2. Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
3. Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150

9. Since January 2011, the Forum of Government Sponsored Health Insurance Schemes in India,
organized by World Bank in close partnership with central and state governments, has been a
platform for facilitating knowledge-sharing between key policymakers heading central and state
government health insurance schemes. This practitioner-to-practitioner knowledge exchange
created a subgroup, a Quality and Accreditation Collaborative, which includes Government of India
(GOI) and state government-financed health insurance and health financing programs, commercial
insurers, hospitals, National Accreditation Board for Hospitals and Healthcare Providers (NABH),
industry chambers such as the Federation of Indian Chambers of Commerce and Industry (FICCI),
and other health sector stakeholders. By contributing to overall improvement in the quality of
service delivery, the potential impact of this initiative extends far beyond the 15 or so participating
healthprograms,tothehealthcaresystemasawhole.
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
thestageforsteadyprogresstohigherlevelsofNABHstandards.
1
The NABH Pre-Accreditation Entry-Level Standards for SHCOs consist of 41 standards and 149
2
objectiveelements .
However,thetaskoftheCollaborativedidnotendwhenthepre-accreditationentry-levelstandards
were published. To facilitate the attainment of pre-accreditation entry-level standards by small
FOREWORD
1
A standard is a statement of expectation that defines the structures and process that must be substantially in place in an
organization to enhance the quality of care.
2
An objective element is that component of a standard which can be measured objectively on a rating scale. The acceptable
compliance with the measureable elements will determine the overall compliance with the standard.
National Accreditation Board for Hospitals and Healthcare Providers
1

10. 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 thataspire to improve the quality of their care but lack the internal
capacity to achieve this on their own, will benefit from this document. A team of renowned experts
in healthcare quality, with considerable experience and exposure to accreditation and quality
assessments, joined hands to undertake the development of this Guidebook, which consists of
supporting tools and templates for selected pre-accreditation entry-level standards and objective
elements published by NABH, as prioritized by the Collaborative based on their complexity and
needforfurtherdetailing.
This Guidebook for Pre-Accreditation Entry-Level Standards for SHCOs contains comprehensive
information on the prioritized 27 standards and 34 objective elements (including the Hospital
Infection Control [HIC] Manual included as an Annexure in the soft copy version of this guide). The
Guidebook includes an overview of each objective element, suggestions on how to fulfil the
objective element, tasks and responsibilities of various team members in the hospital to fulfil the
objective element, and various other tools such as audit checklists, training material, sample
StandardOperatingProcedures(SOPs),andothersampletemplatestoassistintheimplementation
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
documentshavebeenusedbyreal-lifehospitals.
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.
SomilNagpal,SeniorHealthSpecialist,WorldBank.
AbhaMehndiratta,Consultant,WorldBank.
Alexander Thomas, President, Consortium of Accredited Healthcare Organizations (CAHO);
Chairman,AdvisoryCommittee,NABHAccreditationofGovernmentHospitals,Govt.ofKarnataka.
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11. Despite the rapid growth of the health industry in India, patient safety and quality care remains a
greatconcern.
NABHhasbeenoperatinganaccreditationandalliedprogramsince2006.Only295hospitalsand49
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
canjoin the quality journey. A step-wise approach to enhance quality was considered more suitable
giventheexistingchallenges.
This Guidebook has been prepared with the objective of enabling SHCOs to prepare for the
accreditation process on their own, without an external agency, thus making the entire
accreditation process more cost-effective and sustainable. The Guidebook is expected to help
SHCOs achieve a proper understanding of the standards and the objective elements and how they
can be implemented. It will also promote uniformity in the interpretation and implementation of
thestandardsacrosshospitals.
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
madeavailableonline.
Dr. K. K. Kalra,
CEO, NABH
PREFACE
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12. 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
providedbytheWorldBank-DFIDTrustFund.
ListofContributorsandCo-Authors
Convener
Dr. Alexander Thomas, President, Consortium of Accredited Healthcare Organizations (CAHO);
Chairman,AdvisoryCommittee,NABHAccreditationofGovernmentHospitals,Govt.ofKarnataka.
Co-Authors
Dr.AntonyLazarBasile,MedicalDirector,STARHospitals,Hyderabad.
Dr.ManjuChacko,TeamLeader,Quality,BangaloreBaptistHospital,Bangalore.
Dr. Badari Datta H.C., Head of Quality and Consultant ENT Surgeon, Bangalore Baptist Hospital,
Bangalore.
Ms.LalluJoseph,QualityManager,ChristianMedicalCollege,Vellore.
Dr.K.Kalra,CEO,NationalAccreditationBoardforHospitalsandHealthcareProviders(NABH).
Ms. Beenamma Kurien, Quality Assurance Coordinator, Karnataka Health System Development and
ReformProject(KHSDRP),GovernmentofKarnataka.
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,ShreeKrishnaHospital,Karamsad.
Dr. Arati Verma, Senior Vice President, Medical Quality, Max Healthcare; Chair, NABH Appeals
Committee;Chair,NABHAssessorManagementCommittee.
WorldBankfacilitationteam
Dr.SomilNagpal,SeniorHealthSpecialist,WorldBank.
Dr.AbhaMehndiratta,Consultant,WorldBank.
ACKNOWLEDGEMENTS
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13. Conceptualization, Review and Guidance: Members of the Quality and Accreditation
Collaborative
Shri Rajeev Sadanandan,JointSecretary,GovernmentofIndia.
Dr.K.Ellangovan,Secretary,DepartmentofHealthandFamilyWelfare,GovernmentofKerala.
Ms.AshaNair,DirectorandGeneralManager,UIIC,Chennai.
Dr.K.PhaniKoteswaraRao,ChiefMedicalAuditor,RajivAarogysri,GovernmentofTelangana.
Ms.ShobhaMishraGhosh,Sr.Director,FICCI,NewDelhi.
Dr.T.S.Selvavinayagam,JointDirectorofHealthServices,GovernmentofTamilNadu.
Dr.RaviBabuShivaraj,JointDirector,CMCHIS,GovernmentofTamilNadu.
Dr.NarayanaSwamy,Dy.Director,SuvarnaArogyaSurakshaTrust,GovernmentofKarnataka.
Mr.VijendraKatre,Addl.CEO,RSBY,GovernmentofChhattisgarh.
Dr.K.Sandeep,Sr.Consultant,M&E,GovernmentofKerala.
MajorAshutoshShrivastava,ChiefOperatingOfficer,GlocalHealthcare.
Dr.K.MadanGopal,Sr.Tech.Advisor,GIZ,andRSBY.
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
finalizetheGuidebookforPre-AccreditationEntry-LevelStandards.
We express our special thanks to Dr. Manju Chacko, Team Leader, Quality, Bangalore Baptist
Hospital, Bangalore; Dr. Nancy Ramya I., Executive Program Manager, Bangalore Baptist Hospital,
Bangalore; and Divya Alexander, Independent Consultant, Bangalore for closely supporting the co-
authors in coordination and finalization of this Guidebook. Last but not the least, our special thanks
to Ms. Usha Tankha for her excellent editorial support at all stages of this Guidebook and for
bringingitoutinitsfinalshape.
We are grateful to the following NABH accredited institutions for allowing their de-identified
documentstobeusedassamplesinthisexercise:
1. BangaloreBaptistHospital
2. MaxHealthcare
3. CimarFertilityClinic
4. GiridharEyeInstitute
5. ShreeKrishnaHospital,HMPatelCentreforMedicalCareandEducation
Note: All diagrams and forms in this document are original unless otherwise stated. Policies and Standard
Operating Procedures (SOPs) shared are samples to guide SHCOs in developing their own customized
documents.
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14. LIST OF ABBREVIATIONS
ACLS AdvancedCardiacLifeSupport
AHPI AssociationofHealthcareProviders,India.
BP BloodPressure
BPL BelowPovertyLine
BT BleedingTime
CCTV Closed-CircuitTelevision
CDC CentersforDiseaseControl
CEO ChiefExecutiveOfficer
CMO ChiefMedicalOfficer
CSSD CentralSterileSupplyDepartment
CT ComputedTomography
CTVS CardiothoracicandVascularSurgeon
DAMA DischargeAgainstMedicalAdvice
EMO EmergencyMedicalOfficer
ENT Ear-Nose-Throat
ER EmergencyRoom
ESI EmployeesStateInsurance
FICCI FederationofIndianChambersofCommerceandIndustry
FOGSI FederationofObstetricandGynaecologicalSocietiesofIndia
HDU HighDependencyUnit
HOD HeadofDepartment
HCO HealthcareOrganization
HR HumanResources
HSG Hysterosalpingogram
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15. ICC InternalComplaintsCommittee
ICN InfectionControlNurse
ICU IntensiveCareUnit
ID Identification
IG Immunoglobulin
IMC IndianMedicalCouncil
INC IndianNursingCouncil
IPD InpatientDepartment
ISMP InstituteforSafeMedicationPractices
KMC KarnatakaMedicalCouncil
KPI KeyPerformanceIndicator
Lab Laboratory
LAMA LeavingAgainstMedicalAdvice
LASA LookAlikeSoundAlike
LMO LiquidMedicalOxygen
LPG LiquefiedPetroleumGas
MCI MedicalCouncilofIndia
MO MedicalOfficer
MRD MedicalRecordsDepartment
MRSA Methicillin-ResistantStaphylococcusAureus
MS MedicalSuperintendent
MTP MedicalTerminationofPregnancy
NABH NationalAccreditationBoardforHospitalsandHealthcareProviders
NABL NationalAccreditationBoardforTestingandCalibrationLaboratories
NACO NationalAIDSControlOrganisation
NALS NeonatalAdvancedLifeSupport
NBM NilbyMouth
NBC NationalBuildingCode
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16. NICU NeonatalIntensiveCareUnit
OBD ObstetricsandGynecology
OPD OutpatientDepartment
OT OperatingTheatre
PA PublicAnnouncement
PAC PreanesthesiaConsent
PALS PediatricAdvancedLifeSupport
PEP Pre-exposureProphylaxis
PICU PediatricIntensiveCareUnit
PNDT PrenatalDiagnosticTechniques
PPE PersonalProtectiveEquipment
PPTCT PreventionofParentToChildTransmission
RCOG RoyalCollegeofObstetriciansandGynecologists
RMO ResidentMedicalOfficer
SHCO SmallHealthcareOrganization
SOP StandardOperatingProcedure
TAT TurnAroundTime
TPA ThirdPartyAdministrator
UHID UniqueHospitalIdentifier
USG Ultrasonography
WHO WorldHealthOrganization
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17. STANDARDAAC1.THESHCODEFINESANDDISPLAYSTHESERVICESTHATITCANPROVIDE.
ObjectiveElements
AAC1a.Theservicesbeingprovidedareclearlydefined.
AAC1b.Thedefinedservicesareprominentlydisplayed.*
AAC1c.Therelevantstaffareorientedtotheseservices.*
AAC1a.Theservicesbeingprovidedareclearlydefined.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope: To guide the SHCO on how to define the scope of services and ensure that these services are
displayedfortheconvenienceandinformationofpatients.
SHCOs may differ in the kind of services theyprovide,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
elementguidestheSHCOonhowtopreparealistofservicesthatitisprovidingtoitspatients.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
onlyiftheSHCOhasalicenceforthesame.
*ObjectiveElementsAAC1bandAAC1careself-explanatoryandthereforenotincludedinthisGuidebook.
AAC1b.Thedefinedservicesareprominentlydisplayed.
Of the list of services that have been defined in the scope, the SHCO can identify those that are relevant to the patients,
and display these bilingually, so that patients are fully informed and can avail of these services. As the method of display
has not been specified by NABH, SHCOs may customize the same. They may use boards placed at the entrance and in
receptionareas,andadditionally,puttheseontheirwebsite,orhavepamphletsfordistributionifneeded.
AAC1c.Therelevantstaffareorientedtotheseservices.
The SHCOshould ensure thatclinicaland nonclinicalstaff are familiar with the services on offer, so thattheycanguide the
patientsaccordingly.Thismaybedonethroughtrainingofstaff.
Chapter 1
ACCESS, ASSESSMENT AND CONTINUITY OF CARE (AAC)
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18. Itisrecommendedthat:
i. The Head of the SHCO take input from other team members and departmental staff to
compilethelistofservices.
ii. The responsibility for ensuring thatthe services are listed correctly lies with the Head of the
SHCOwhoapprovesthesamebysigningoffthepolicydocumentthatliststhescope.
iv. Whenever a new service is introduced, the scope of services policy document is amended
accordingly.
v. The scope of service may be divided as follows (NABH has not specified a template or
minimumstructureforlistingthescopeofservices):
lClinicalservices
lSupportservices
lAdditionalservices
lServiceexclusion,ifany
Note:ThescopeofservicesmaybecustomizedforeachSHCO.
Forexample,thescopeofserviceforageneralhospitalmaybeasfollows:
Clinical Services Support Services
General Medicine Dietary
General Surgery Central Sterile Supply Department
Pediatrics Hospital Laundry
Gynecology & Obstetrics
Dental Medico-social department
Anesthesiology Biomedical Engineering Services
Emergency Department Ambulance
Diagnostic Services
lLaboratory
lRadiology- X-Ray, CT Scan, USG,
Mammogram
Pharmacy
Medical Records Department
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19. Thescopeofserviceforadepartmentmaybeasfollows:
DepartmentofImagingServices:
Thedepartmentprovidesthefollowingtypesofservices:
lGeneralX-Ray
lBariumMealX-Ray
lSpecialX-RaysuchasHSG
lUltrasonography
II.REQUIREDDOCUMENTS
i. Policyonscopeofservices
ii. A valid licence related to the scope of services such as MTP licence, Prenatal Diagnostic
Techniques(PNDT),ifapplicable.
III.TASKSANDRESPONSIBILITIES
No. Task Responsibility
i. Define the general scope of service Head of SHCO
ii. Define the departmental scope of service Top management in consultation
with the specific department head
iii. Document the above into a policy on 'scope of Assigned staff
services' and place the same in an SOP manual
iv. Availability of the valid license related to the Administrative department
specific department
v. Display prominently the scope of services in two Administrative department/
languages Engineering department
vi. Update the scope of service Top management/ Head of the
concerned department
vii. Staff orientation to the scope of service Quality team/ Training cell
IV. AUDIT CHECKLIST
No. Checkpoint Yes No Remarks
i. Availability of scope of service policy
document including licenses
ii. Bilingual display of scope of service in a
prominent area
iii. Staff training records
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20. STANDARD AAC2. THE SHCO HAS A DOCUMENTED REGISTRATION, ADMISSION AND
TRANSFERPROCESS.
ObjectiveElements
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'sresources.
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
customizeddocuments.
I.OVERVIEW
Scope: To guide the SHCO on preparing a process for registering and admitting outpatients,
inpatients,andemergencypatients.
Itisrecommendedthat:
OncethepatientisbroughttotheSHCO,thepatientisregisteredandadmitted,ifrequired.
OnlypatientsthatcanbecaredforbytheSHCOareadmitted.
PatientsthatmatchtheSHCO'sresourcesareregisteredandadmittedusingadefinedprocess.
Thedefinedprocesscoversallpatients–OPD,newandfollow-uppatients,andemergencypatients.
Thedefinedprocess:
i. Providesguidelineinstructionsregardingtheoutpatientregistrationprocess.
ii. Hasauniformregistrationsystemforpatientsandmaintainstherecordsofpatientscoming
tothehospital.
iii. ProvidesregistrationforIPDifitmatchesthescopeofservicesprovided.
iv. Providesamechanismforadmissionsuchthatthepatientcanavailofhealthcareservices.
II.REQUIREDDOCUMENTS
i. PolicyandSOPonregistration
ii. PolicyandSOPonadmission
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21. No. Process Responsibility Supporting Document
For OPD Registration
A OPD registration shall be done on Registration clerk Register
first-come first-served basis.
B The following details are taken Registration clerk Registration form
from the patient or relative:
Name, age, sex, occupation,
annual income, address, phone
(mobile/landline).
C The referral slip, if present, Registration clerk Referral slip
should be checked to identify
the specialty. If there is no
referral slip, the patient shall be
registered as specified by herself/
himself.
D The details are entered into the Registration clerk Register/OPD slip
OPD slip and the bill is raised.
E The patient is directed towards Registration clerk
the concerned OPD consultation
area.
F After the consultation, if there is Consultant OPD slip/referral book
any change in the specialty,
the patient is referred to the
concerned specialty OPD.
G Emergency registration is done Registration Register
24 hours a day. clerk/Emergency
registration counter
H For unidentified patients, Registration clerk Register
registration shall be done as a
medico-legal case (MLC).
I Patients revisiting the OPD for a Registration clerk Register
follow-up consultation shall be
re-registered; however, the same
Unique Hospital Identifier (UHID)
will continue.
i.Policyonregistration
Each patient being assessed at the hospital should be registered and provided with a unique
identificationnumber.
SOPonOPDregistration
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22. ii.Policyonadmission
The hospital shall admit patients in consonance with the scope of services only if the hospital can
providetherequiredservices.
SOPoninpatientadmission
No. Process Responsibility Supporting Document
A Inpatient admission shall be done Admission Clerk Admission Register
through the OPD or the
Emergency department or the
NICU/Labour ward as applicable.
B The decision regarding admission Treating Doctor Admission slip/order
shall be made by the consultant
and an admission slip or order
issued by her/him.
C General consent for admission Treating Doctor General consent form
and treatment is obtained from the
patient and the patient's relative.
D The order for admission shall be Treating Doctor Admission note
written in the OPD book with the
ward name, date, time, name and
signature of the consultant. The
patient or patient's relative shall be
directed to the admission counter
to complete all the admission
formalities.
E At the admission counter, the Admission Clerk Admission note
consultant's note is checked for
admission.
F The IPD number and demographic Admission Clerk Admission file and
details of the patient are put into receipt
the admission register/computer
to generate an admission file
(case sheet). This is handed over
to the patient and the admission
fee is collected.
G The patient is directed to the Treating doctor/ staff Bed allotment record
concerned ward, where the bed nurse/ward attendant
will be allotted.
H The patient is received at the ward Staff nurse Medical record
by the ward nurse and allotted a bed.
Treatment is initiated as per the order.
The patient is oriented to the ward.
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23. III. TASKS AND RESPONSIBILITIES
No. Task Responsibility
i. Define the registration, admission and transfer Top management
process.
ii. Define the department policy on admission and Top management in consultation
transfer process with the specific department head
iii. Preparation of policy Quality team
iv. Staff orientation to the scope of service Quality team /training cell
IV. AUDIT CHECKLIST
No. Checkpoint Yes No Remarks
i. Availability of policy - apex manual
ii. Availability of registration form
iii. Availability of admission form including
consent
iv. Staff awareness
AAC2b. Process addresses mechanism for transfer or referral of patients who do not match the
SHCO'sresources.
Note:SectionsIIandIIIareprovidedassamplestoguidetheSHCOindevelopingitsowncustomized
documents.
I.OVERVIEW
Scope:ToguidetheSHCOontransferorreferralofpatientswhodonotmatchtheSHCO'sresources.
It is recommended that the following standardized approach be used for referring a patient in case
theservicerequireddoesnotmatchwiththeserviceavailableintheHCO:
i. Patients who do not match the SHCO's resources are referred to organizations that have
matchingresources.
ii. All patients reaching the emergency department in critical conditions are provided with
first-aidandallavailablelife-savingmeasures.
iii. In case of non-availability of beds in the inpatient care wards, patients are placed in the
emergencywarduntilbedsareavailable.
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24. iv. In case of absolute non-availability of beds, or if the patient's medical needs are not within
the scopeof the hospital, the doctor on duty makes enquiries about the availability of beds
in the nearest Government facility or at a hospital of the patient's preference, and transfers
the patient in the hospital's ambulance or 108 ambulance. The patient is accompanied by
theappropriate doctoror nurseifrequired.
v. Emergency patients receive life-stabilizing treatment and if resources are not available,
transferredtoanorganizationthathastherequiredresources.
II.REQUIREDDOCUMENTS
i. PolicyandSOPfortransfer-outandreferral-out
ii. Policyonpatienttransferandpatientreferral-outtoanotherorganization
TheSHCOcanreferoutthepatient if
· Themedicalproblemisnotwithinthescopeoftheservicesdefinedbythehospital
· Theresourcesdonotmatch
· Ahigherlevelofcareorspecializedcareisrequired
· Specialinvestigationsarerequiredthatarenotavailableinthehospital
However,thepatientshallbeshiftedonlyafterfirst-aidisprovidedandthepatientisstabilized.
SOPforreferral-outortransfer-out
No. Process Flow Responsibility Supporting Document
1 Transfer-out or referral-out shall be Admission Clerk Register
done through OPD or through
Emergency ward.
2 The Treating Doctor shall decide Treating Doctor Medical record
transfer-out/referral-out and explain
the reason and plan of transfer to
the patient and relative.
3 Consent for transfer-out/referral-out is Treating Doctor Consent
obtained from the patient and relative.
4 The order for transfer-out/referral-out Treating Doctor Transfer-out register
shall be written in the transfer-out
register with the patient's name, date,
time.
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25. III. AUDIT CHECKLIST
No. Checkpoint Yes No Remarks
i. Availability of policy - apex manual
ii. Availability of transfer-out form
iii. Consent form
iv. Staff awareness
v. Transfer-out register/record
STANDARDAAC3.PATIENTSCAREDFORBYTHESHCOUNDERGOANESTABLISHEDINITIAL
ASSESSMENT.
ObjectiveElements
AAC3a.TheSHCOdefinesthecontentoftheassessmentsforinpatientsandemergencypatients.
AAC3b.TheSHCOdetermineswhocanperformtheassessments.*
AAC3c.Theinitialassessmentforinpatientsisdocumentedwithin24hoursorearlier.*
*Objective Elements AAC3b and AAC3c are self-explanatory and therefore not included in this
Guidebook.
AAC3a.TheSHCOdefinesthecontentoftheassessmentsforinpatientsandemergencypatients.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
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
toeachpatientisbasedonanassessmentofthepatient'srelevant medicalneeds.
Itisrecommendedthat:
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
ontheneedsofthedepartment.
iii. Theformatisdesignedsoastoensurethatthelaid-downparametersarecaptured.
iv. Every initial assessment contains the presenting complaint, vital signs, and salient
examinationfindings.
v. Time frame for initial assessment: Every patient of the hospital (IPD and Emergency
services) be appropriately assessed for her/his clinical condition based on standard norms
of medical practice. The initial assessment should be done within a specified time frame to
facilitate the early plan of care. Initial assessments and timelines should be followed for
everypatientadmitted.
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26. Assessment by Unstable Patient Stable Patient Documentation
Doctor Immediately Immediately Within 24 hours of admission
Nurse Immediately Immediately Within 4 hours of admission
Qualifiedandregisteredprofessionalsperformtheassessmentasapplicablebylaw:
Professional Basic Qualification Registration
Medical M.B.B.S. PG in various specialties Registered with MCI
Nursing Diploma/Degree/Postgraduate in Registered with INC/State Nursing
Nursing Council
III.REQUIREDDOCUMENTS
i. PolicyandSOPoninitialassessment
ii. Apexmanual
Policyoninitialassessment
Allpatientsregisteredinthehospitalwillundergoanestablishedinitialassessment.
SOPoninitialassessment
InitialAssessmentatEmergency
Patients who come directly to the emergency department and need emergency care are received
bythestaffnurse;theEMOwillattendtothepatientimmediately.
No. Process Responsibility Supporting Document
1 All patients who come to the emergency EMO/Treating Doctor Medical record
department shall be assessed. /Staff nurse
2 The following parameters shall be EMO/Treating Doctor Medical record
assessed in detail: /Staff Nurse
lChief complaints
lHistory of illness
lAllergies or any associated disease
lTemperature, Pulse, Blood Pressure,
and Respiration
lPhysical examination
3 In case of mass casualties, triage shall be EMO/Treating Doctor Medical record
completed first, and then followed by /Staff Nurse.
assessment.
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27. InitialAssessmentafterAdmission
Each patient upon admission shall be assessed by qualified individuals for appropriate care or
treatmentneedsorneedforfurtherassessment.Thescopeandintensityoftheassessmentshallbe
determinedby
lThepatient'scondition/diagnosis
lThecaresetting
lThepatient'sresponsetoanypreviouscareandthepatient'sconsenttotreatment
Thepatientshallbeassessedandtherecordsshallbedocumented.Thenadocumentedplanofcare
isdrawnup,basedontheinitialassessment.
No. Process Responsibility Supporting Document
Initial assessment of admitted patient
1 Initial assessment is made and Treating Doctor/ Medical record
documented in medical record with Doctor on Duty
name, time, date and signature.
2 The assessment shall include the Treating Doctor Medical record
following parameters:
lTemperature, Pulse, Blood Pressure
and Respiration.
lPhysical examination.
3 The initial nursing assessment is done in Staff Nurse Medical record
the prescribed format.
Assessment of obstetric and high-risk
obstetric patients
1 (This includes pregnancies with diabetes, Consultant Medical record
HTN, asthma, eclampsia, convulsions,
multiple pregnancies, elderly primi
(>30 years), bad obstetric history
(abortions)
2 The assessment shall include: Medical record
lWeight, height
lBP
lRoutine lab investigations
lHb, blood group, urine (routine and
microbiological)
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28. No. Process Responsibility Supporting Document
lBT, CT
lNST (Non-stress test)
lFoetal monitoring
lMonths of pregnancy (regularly noted
on each visit)
lTetanus injections
l2-3 ultrasounds in whole period
(immediately after confirmation of
pregnancy, 20 week anomaly and
32 week growth scan)
lPPTCT counseling
lMultidisciplinary approach for
patients with medical disorders in
pregnancy
3 All patients shall be given appropriate Treating Doctor/Staff Medical record
explanations about their conditions. nurse
Descriptions of the following should be
shared:
lThe diagnosis or provisional diagnosis
as applicable
lPlan of treatment as decided by the
treating consultant
4 Special needs of the vulnerable patients Treating Doctor/Staff Medical record
who are receiving treatment will be nurse
assessed.
IV. TASKS AND RESPONSIBILITIES
No. Task Responsibility
i. Define the content of the initial assessment form Department heads/Quality team
ii. SOP for the initial assessment Department heads/Quality team
iii. Preparation of apex or department manual Quality team
iv. Staff orientation to the initial assessment Quality team /Training cell
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29. IV. AUDIT CHECKLIST
No. Checkpoint Yes No Remarks
i. Availability of policy
ii. Availability of the initial assessment form
iii. Availability of equipment like BP
apparatus, thermometer
iv. Staff awareness
v. Patient case record
STANDARD AAC5. LABORATORY SERVICES ARE PROVIDED AS PER THE SCOPE OF THE
SHCO'SSERVICESANDLABORATORYSAFETYREQUIREMENTS.
ObjectiveElements
AAC5a. Scope of the laboratory services are commensurate with the services provided by the
SHCO.*
AAC5b. Procedures guide collection,identification, handling, safe transportation, processing and
disposalofspecimens.
AAC5c. Laboratory results are available within a defined time frame and critical results are
intimatedimmediatelytotheconcernedpersonnel.*
AAC5d. Laboratory personnel are trained in safe practices and are provided with appropriate safety
equipmentordevices.*
* Objective Elements AAC5a, AAC5c and AAC5d are self explanatory and therefore not included in
thisGuidebook
AAC5b. Procedures guide collection,identification, handling, safe transportation, processing and
disposalofspecimens.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope: To guide the SHCO to prepare a department Lab Manual that incorporates all the
documentedproceduresforcollection.
LabManual
Itisrecommendedthat:
i. The SHCO has a department Lab Manual that incorporates all the documented procedures
for collection, identification, handling, safe transportation, processing and disposal of
specimens.
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30. 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. TheSHCO ensuresthesafetyofthespecimentillthetest(andretest,ifrequired).
iv. The SHCO ensures that a unique hospital identification number (UHID) is used for the
identificationofthepatient.
v. Inaddition,itmayuseanothernumbertoidentifythesample.
vi. The disposal of waste is as per the statutory requirements (Bio-medical Waste
ManagementandHandlingRules).
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
policyforreportingsuchresultvaluesareasfollows:
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
concernedConsultantimmediately.
ix If the consultant is not reachable, the result is brought to the notice of the Medical Officer
onduty.
x. TheconcernedWardnurseisalsoinformedoftheresultifthepatienthasbeenadmitted.
xi. Thelistofvaluesconsideredascriticalmaybedisplayedatprominentlocationsinthelab.
II.REQUIREDDOCUMENTS
Thelistofrecordsorregisters,andformsandformatsshallbeavailableinthelaboratory.
No. Name (Register/Format) Responsible Person
1 Lab Manual Quality team in consultation with the
Department Head-Lab
2 Critical Result Intimation Book Lab Technicians
3 External Quality Register Lab Technicians
4 Internal Quality Register Lab Technicians
5 Refrigerator Temperature Register Lab Technicians
6 Quality Indicator Register Lab Technicians
7 List of hazardous material Quality team in consultation with the
Department Head-Lab or HIC Team
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31. Procedure
Sample Collection, Identification, Handling, and Transportation of Samples, Processing of
Samples,DisposalofSpecimens
No. Process Flow Responsibility Supporting Document
1. Sample Collection Technician LAB Sample Book
Sample collection shall be carried out
on a 24-hour basis either in the sample
collection room or in the laboratory
2. Sample Identification Technician
o All samples will be labeled with the
name, age, sex, lab serial number,
and the unique ID number of the
patient.
o All samples will be accompanied by a
written requisition from the treating
doctor for lab investigation and
necessary payment (if applicable).
o The lab reception receiving the
samples will enter the details into
the register.
3. Sample Handling Technician
lAll samples will be handled as per
the infection control guidelines.
lUniversal precautions are to be
observed while handling samples.
4. Safe Transportation of Samples Technician
lAll measures shall be taken in order
to prevent samples from undergoing
any deterioration.
lNecessary precautions shall be taken
depending on the prevailing
environmental factors.
5. Processing of Samples Technician Procedure or Lab
lThe processing of samples should be Manual
carried out as per the requirements
of individual tests.
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32. No. Process Responsibility Supporting Document
lThe procedure for testing should be
standardized and necessary
instructions issued to all concerned
personnel.
lSamples should be processed
without delay, and on a priority
basis for emergency cases.
6. Disposal of Specimens Technician
lDisposal is to be carried out in
accordance with Biomedical
Waste-Handling Rules.
lPrecautions should be observed in
accordance with the Hospital
Infection Control Manual.
III. TASKS AND RESPONSIBILITIES
No. Task Responsibility
i. Define the content of the Lab Manual Department heads/Quality team
ii. Define the content of the Lab Safety Manual Top management in consultation
with the specific department head
iii. Preparation of lab related policy Quality team
iv. Staff orientation to the safety aspects and SOPs Quality team/Training cell
IV. AUDIT CHECKLIST
No. Checkpoint Yes No Remarks
i. Availability of policy
ii. Availability of the required documents
iii. Availability of equipment as per the scope
iv. Availability of PPE
v. Staff training record
vi. Waste disposal management
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33. STANDARDAAC7.THESHCOHASADEFINEDDISCHARGEPROCESS.
ObjectiveElements
AAC7a. Process addresses discharge of all patients including medico-legal cases (MLCs) and
patientsleavingagainstmedicaladvice.
AAC7b.AdischargesummaryisgiventoallthepatientsleavingtheSHCO(includingpatientsleaving
againstmedicaladvice).*
AAC7c. Discharge summary contains the reasons for admission, significant findings,
investigations results, diagnosis, procedure performed (if any), treatment given, and the
patient'sconditionatthetimeofdischarge.
AAC7d. Discharge summary contains follow-up advice, medication and other instructions in an
understandablemanner.*
*Objective Elements AAC7b, and AAC7d are self-explanatory and therefore not included in this
Guidebook.
AAC7a. Process addresses discharge of all patients including medico-legal cases and patients
leavingagainstmedicaladvice.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope: To guide the SHCO to develop a documented discharge process, to observe that patient care
is multidisciplinary in nature, and to encourage continuity of care through a well-defined discharge
process.
It is recommended thatthe dischargeprocedures are documented as below to ensure coordination
amongvariousdepartments,includingAccounts,sothatthedischargepapersarereadyontime:
i. ForMLCs,theSHCOensuresthatpoliceareinformed.
ii. DischargeplanningbeinitiatedbytheConsultantonthebasisofthepatient'scondition.
iii. The patient be assessed as 'medically stable' and fit for discharge. This may include
assessmentoffunctional,medical,medication,andnutritionalneeds.
iv. Thedischargesummarybeprovidedtoeverypatientatthetimeofdischarge.
v. Acopyofthedischargesummarybekeptinthemedicalrecord.
vi. Atthetimeofdischarge,thereshouldbecoordinationwiththeBillingDepartment.
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34. vii. For MLCs, the treating Consultant should document the discharge in the case sheet, which
is then intimated to the RMO. The RMO endorses it and intimates the nearest police station
throughtheEMObyfillingupthepoliceintimationform.
viii.In case of death of non MLCs, the death summary should also contain the cause of death.
Thebodyshouldbehandedovertotherelativesorshiftedtothemortuary.
ix. IncaseofdeathofMLCs,thebodyshouldbeshiftedtothemortuaryimmediately.TheEMO
informs the nearest police station of the death. The body is later handed over to the police
forfurthernecessaryaction.
x. LEFTAGAINSTMEDICALADVICE(LAMA)
lUnder the scope of patient rights, no patients may be kept in hospital against their will
except in some conditions such as major psychiatric illness, intoxication, or when the
patientisinpolicecustody.
lThenursingstaffandthedoctorconcernedshouldtrytopersuadethepatienttostayand
at the same time try to find out why the patient wishes to leave. If possible, the problem
shouldbeaddressed.
lThe responsibility of the treating consultantis to explain the consequencesof this action
to the patient or attendant, and also that if the patient leaves the hospital against
medicaladvice,thehospitalceasestoberesponsibleforher/hiscare.
lDespite this, if the patient still wishes to be discharged, all possible stepsshould be taken
to ensure the patient or authorized attendant signs a form to this effect before leaving
thehospital.
lIn the event that the patient refuses to sign the form, this should be documented clearly
intheMedicalRecords.
lAlldiscussionsandrisksexplainedshouldberecordedinthepatient'sMedicalRecords.
xi. The discharge summary should be prepared and handed over to the patient and a copy of
thedischargesummaryshouldbeattachedtothepatientcasesheet.
xii. Atthetimeofdischarge,theinvestigationresultsshould alsobehanded overtothepatient
andacopyshouldbekeptbythehospital.
The discharge process should be coordinated with other departments in case the patient had
consultationswithotherdepartments.
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35. Treating Consultant informs Ward nurse about discharging the patient
(evening before the scheduled day of discharge)
Patient's relative informed about discharge by the Ward nurse
Final decision on discharge taken by the treating consultant
(on the scheduled day of discharge)
Check whether BPL card is
verified and seal put on
case sheet. Or that any other
scheme beneficiary seal is
put on case sheet.
Staff Nurse prepares
account settlement form
and hands over to patient's
relatives along with case
sheet.
Discharge summary given
to Patient/relatives &
counseled by ward nurse.
Patient send-off
Patient send-off
Staff Nurse checks for bill settlement
by crosschecking with receipt
and case sheet. Discharge
summary given to Patient/relatives
and counseled by ward nurse.
Patient's relatives hand
over the account settled case
sheet to the ward staff nurse.
Patient's relatives sent to
cash counter for final
bill settlement.
Is the patient
a paying
case? YesNo
Discharge Process
I.REQUIREDDOCUMENTS
i. PolicyonDischarge
ii. Standardizeddischargesummaryform
iii. DAMA/LAMAform
iv. Consentform
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36. Policy
The SHCO shall have a Discharge Plan which is a multidisciplinary, collaborative process involving
thepatient,patient'sfamily,andconcernedteammembersduringaspecificepisodeofillness.
Processofdischarge
No. Process Responsibility Supporting Document
1 Preparation of the contents of the Head of the Discharge summary
department-wise discharge summary. Department/ Quality
team
2 Treating Consultant decides to discharge Treating Doctor
the patient.
3 Development of a care plan for Treating Doctor
post-discharge care.
4 Arranging for the provision of services, Staff Nurse/CHD
including patient or family education.
5 Coordination related to discharge with Treating/Referral
specialty Consultants if cross-consultation Doctor/Staff Nurse
was obtained.
6 Preparation of final discharge summary. Treating Doctor
7 Preparation of account settlement form Staff Nurse/Billing
or final bill. section
8 Discharge summary handed over to the Treating Doctor/Staff Discharge summary
patient along with guidance on post Nurse
discharge medication, follow-up and
information regarding how to obtain
urgent care.
9 A copy of the discharge summary is Staff Nurse Discharge summary
attached to the patient case sheet.
10 Patient is accompanied till the hospital Ward attendant
exit.
No. Task Responsibility
i. Define the discharge process Top Management
ii. Define the time required for each process Top Management in consultation
with the specific department head
or Quality team
iii. Availability of the billing process requirements Administrative department
including display of the billing tariff
iv. Staff orientation to the discharge process Quality team/Training cell
III. TASKS AND RESPONSIBILITIES
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37. IV. AUDIT CHECKLIST
No. Checkpoint Yes No Remarks
i. Availability of policy
ii. Availability of required documents
iii. Standardized discharge form
DAMA form
LAMA form
iv. Patient records for compliance of the policy
v. Medical Record Audit
AAC7c. Discharge summary contains the reasons for admission, significant findings, investigation
results, diagnosis, procedure performed (if any), treatment given, and the patient's condition at
thetimeofdischarge.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.GUIDANCENOTE
To guide the SHCO to prepare a discharge summary which includes adequate information that is
requiredwhenthepatientleavestheSHCO.
After the final decision to discharge the patient is taken, the treating Consultant prepares the
dischargesummaryofthepatientwhichcontainsthefollowinginformation:
i. Reasonsforadmission
ii. Investigations performed and summarized information about the results of the
investigations
iii. Finaldiagnosis
iv. Recordofanyprocedures(operations)performed
v. Conditionofthepatientatthetimeofdischarge
vi. Medicationinstructions
vii. Follow-upadvice
viii. Howtoobtainemergencycontact
ix. Astandardizeddischargesummaryforuniformity
x. Departments shall prepare discharge summary forms based on the content specific to
theirdepartment
xi. Incaseofadeath,thedeathsummaryshallalsocontainthecauseofdeath
xii. Periodic medical record audits shall be conducted to ensure that the discharge summary
complieswiththecontentrequirement.
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38. II.REQUIREDDOCUMENTS
i. Standardized dischargesummary
III.TASKSANDRESPONSIBILITIES
No. Task Responsibility
i. Define the content of discharge summary Top Management or HOD
ii. Preparation of policy Quality team
iii. Accuracy of the content of the discharge Treating doctor
summary
iv. Preparation of standard forms Quality team
IV. AUDIT CHECKLIST
No. Checkpoint Yes No Remarks
i. Availability of policy
ii. Availability of required documents
iii. Standardized discharge form
DAMA form
LAMA form
iv. Patient records for compliance of the policy
v. Medical Record Audit
V.REFERENCES
AccreditationStandardsforHospitals,NABH,3rdEdition,November2011.
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39. Chapter 2
CARE OF PATIENTS (COP)
STANDARD COP2. EMERGENCY SERVICES INCLUDING AMBULANCE ARE GUIDED BY
DOCUMENTEDPROCEDURESANDAPPLICABLELAWSANDREGULATIONS.
ObjectiveElements
COP2a. Documented procedures address care of patients arriving in the emergency including
handlingofmedico-legalcases.
COP2b. Staff should be well versed in the care of Emergency patients in consonance with the scope
oftheservicesofhospital.*
COP2c.Admissionordischargetohomeortransfertoanotherorganizationisalsodocumented.*
*Objective Elements COP2b and COP2c are self-explanatory and therefore not included in this
Guidebook.
COP2a. Documented procedures address care of patients arriving in the emergency including
handlingofmedico-legalcases.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope: To guide the SHCO on the provision of uniform and appropriate care to all patients based on
acuityandpatientneed;andatthesametimetofollowalllegalandpatientsafetyrequirements.
It is recommended that each SHCO be able to provide a defined standard of care to patients
presenting there, within the scope of available staff and resources. These could include SOPs or
protocols to provide either general emergency care or management of specific conditions such as
poisoning, acute abdominal pain (see http://clinicalestablishments.nic.in/En/1068-
downloads.aspx).
i. The procedure for medico-legal cases (MLCs) should be in line with statutory requirements
with respect to documentation and intimation to police. The SHCO should also define what
constitutesanMLC(inaccordancewithstatutoryrules).
ii. AlistofcommonemergenciesthattheSHCOhasreceivedinthelastfiveyearsbeprepared.
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40. iii. Basedonthislist,thesequenceofstepsorprocedurestobefollowedineachcaseshouldbe
definedanddocumented.Staffshouldbetrainedforthesame.
iv. Process to ensure safe transfer of the patient within the hospital and outside the hospital
includinggoodreferralpracticesshouldbeinplace
v. Staff should be aware of their roles and responsibilities in different emergency scenarios
(rolesoftheattendant,nurse,doctor).
vi. Some resources that may be helpful to develop such mechanisms in the hospital are
availableintheReferences.
II.REQUIREDDOCUMENTS
i. Policyforprovidingservicesforemergencypatientandinmedico-legalcases.
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,codeblue/CPR.
iii. SOPforhandlingMLCs.
iv. RequiredregistersforMLC.s
III.TASKSANDRESPONSIBILITIES
Sr. No. Task / assignment Responsibility
1 Preparation of all policies and SOPs Quality team and/or Medical
superintendent
2 Induction and ongoing training for emergency HR and Quality team
department for policies and SOPs in handling
emergency patients
3 Induction and ongoing training for emergency Superintendent/ Head of
department for policies and SOPs in handling MLCs hospital; EMO on duty/
Consultant on duty
4 Ensuring required documentation process including MO and Quality person/
maintanance of different registers for emergency Consultant involved.
and MLCs
5 Audit and monitoring quality standards Quality Team
6 MLC Certificates EMO
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41. IV. AUDIT CHECKLIST
Checkpoint Yes NO Comments
Availability of required Policies and SOPs for
receiving, managing, transfer in ward/
discharge / referral / DAMA; for potential
emergency cases
Availability of required Policies and SOPs for
receiving, managing, transfer in ward/
discharge / referral / DAMA; for potential MLC
Processes are in place to ensure Documentation
related to MLC including MLC registers, Police
intimation and MLC certification
All resources manpower, equipment,
medications and consumables are available
24 x 7 and processes are in place to arrange for
the same in case of mass emergencies.
Doctors and staff training records
Policy
ThefollowingsamplemayguidetheSHCOindevelopingitsowncustomizeddocument.
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 thatis not within the scopeof the services of the hospital, the patient shall be referred or
transferredtothenearestrelevanthealthcaresetupafterprimarymeasuresareundertaken.
SOPforreceivingandmanagingpatientsinemergency
Process Flow Responsibility Supporting Document
Any patient seeking emergency Doctor on duty Casualty register
medical services shall be screened {Casualty register format}
and first aid care and stabilizing
treatment be provided, if required.
The patient must receive stabilizing Doctor on duty and Patient case record and
treatment within the capabilities and Nurse on duty Casualty register
resources of the HCO.
Should the stabilizing treatment Consultant on duty Patient case record/Referral
require a specialist physician, the (full time or visiting) form
physician must be available to
respond in a timely manner.
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42. Process Flow Responsibility Supporting Document
The doctor on duty shall decide Doctor on duty MLC register
whether a case is an MLC.
All MLCs shall be notified to the Doctor on duty and MLC notification book and
police as per SOP following the Nurse on duty MLC register
guidelines provided by legal authority
or MCI guidelines; that is, treatment
first and other administrative/clerical
work later, but mandatory to
document.
If the doctor on duty concludes, Doctor on duty Casualty register - column
based on the results of the screening which states where patient
examination, that the patient does is sent after primary
not have an emergency medical treatment.
condition, the patient may be treated
as OPD or referred to a specific OPD.
If inpatient treatment is required as Doctor on duty Casualty register - column
per clinical conditions, the patient which states where the
shall be transferred to the designated patient is sent after primary
ward/OT/ICU/HDU after primary treatment
treatment.
Prior arrangement for availability of Nurse on duty in
bed in ward/ ICUs must be confirmed emergency
so that the HCO can be prepared for
the arrival of the new patient.
The copies of the emergency Doctor and nurse on Transfer record
department records are sent with the duty
patient including any test results.
In case there are more than two or Doctor on duty Triage record/Casualty
three patients, triaging and Register
prioritization for management shall Nurse on duty
be done based on the acuity and
complexity of the clinical condition.
Such triaging is known to all on
emergency duty.
If after stabilizing, the patient refuses Doctor on duty Transfer/DAMA register
to be admitted in the hospital, and
wants a transfer to another hospital
or wants to go home, she/he should
understand the risks and benefits. Refer to AAC
If patient's clinical condition requires Doctor on duty Transfer register
treatment that is not within the scope
of hospital services, arrangements Nurse on duty
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43. Process Flow Responsibility Supporting Document
shall be made to transfer out the
patient to a nearby healthcare setup
that has a scope of service which
matches the patient's needs.
Call the respective hospital to ask Doctor on duty Transfer register
about bed availability, brief staff
about the patient's condition on the Nurse on duty
phone, and confirm whether HCO can
receive the patient.
Paramedical staff shall accompany Doctor on duty Transfer register
stable patients and a trained nurse/ Nurse on duty
medical officer shall accompany
unstable patients.
A critical patient shall not be left Doctor on duty Transfer register
unattended either inside the hospital
or while transferring to another HCO. Nurse on duty
Transfer will be done in a suitable Doctor on duty Ambulance register
ambulance (stable patient in general
ambulance or critical patient in Nurse on duty
cardiac ambulance) depending on Ambulance driver/
availability. staff of the
ambulance if the
ambulance is from
the receiving hospital.
All documentation shall be complete Doctor on duty Patient case file
in the patient record Nurse on duty
ListofcasesthatshouldbeconsideredasMLC(casesmayincludeandnotbelimitedto):
i. ALLsuspectedaccidental,suicidalandhomicidalcasesthatmayinclude
- poisoning
- roadtrafficaccidents
- fallsfromaheight
- sharp-edgedinjuries
- neardrowning
- bluntinjuries
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44. - fire-arminjuries
- burninjuries
ii. Sexualassault/rape
iii. Brought-deadpatients
iv. Whenclinicalfindingsdonotcorrespondwithhistory (suspectedfoulplay)
v. Anyaccidentalordomesticinjurytoanyfemalewithinsevenyearsofmarriage.
SOPforhandlingMLC
No. Procedural steps Responsibility Supporting Document
1 All complaints and events shall be EMO/Nursing Patient record/MLC
recorded. register
2 Each event shall be recorded in detail EMO Patient record/MLC
including the date, time and place of the register
event and involvement of person and
vehicle during the event.
3 Each case should be intimated to the EMO/Nursing Patient record/MLC
relevant police station by phone after register
counseling the patient and relatives about
the hospital policy and procedures.
The name and buckle number with
designation of the police personnel who
has taken down the information along with
date and time shall be noted.
A written intimation shall be prepared and
given to the police when they come to the
HCO or shall be sent across noting the date
and time of telephonic intimation
(the format is enclosedin Exhibit 1).
4 All MLCs after registration are to be issued EMO/Nursing Patient record/MLC
for OPD /IPD cases and should be marked register
"MLC". MLC number shall be stamped on
all paper and patient records.
5 Clinical notes shall be entered in IPD/OPD EMO/Nursing MLC book
case paper and in an MLC form book
(in duplicate or triplicate).
lExamine the patient for all injuries. Take
a detailed history of the event. Start the
medical management as required.
Inform the concerned Consultant
accordingly; proceed further with the
necessary investigations.
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45. No. Procedural steps Responsibility Supporting Document
lFor all MLCs, the injury sheet must be
filled up and all columns completed.
lWhile filling the injury sheet, place
special emphases on identification
marks, who the patient was brought by,
the site of accident, name, age, sex, date,
time of arrival and detailed examination
of the injury.
lRecord 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.
lAll 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.
lIn 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.
lObtain 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.
lIn all poisoning cases, a gastric lavage
sample (20-50ml) shall be taken and
clothes of the patient preserved, sealed
and handed over to the police as soon as
possible. Till the police receive it, lavage
samples should be stored at 4 to
8 degree celsius.
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46. No. Procedural steps Responsibility Supporting Document
lNo lavage sample should be attempted
in any acid or kerosene oil poisoning or
burn case.
lIn all MLCs, medico-legal
evidence like patient's clothes with
blood stains, stab injury, cut mark and
bullet hole marks shall be encircled,
signed by the examining doctor, and
preserved. Any foreign body recovered
from the patient after an operation, such
as a bullet, shall be sealed and handed
over to the police under receipt.
lClothes/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.
lPicture 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.
lNo 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 Nursing Patient record/MLC
each MLC with the required data at register
emergency.
7 A counter-signature from the police station Nursing Patient record/MLC
shall be taken from the representative in a register
patient's MLC form/book.
8 The time of informing the police and time Nursing Patient record/MLC
of arrival of the police shall be entered in register
the MLC form.
9 In case the police do not arrive within 2 EMO Patient record/MLC
4 hours of the MLC report, a reminder shall register
be sent asking for an acknowledgment.
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47. No. Procedural steps Responsibility Supporting Document
10 If any patient refuses to be registered as an EMO Patient record/MLC
MLC, the Medical Superintendent should be register
immediately informed for a further line of
procedural action.
11 All MLCs registered with the hospital shall EMO Patient record/MLC
be intimated to the consultant on duty and register
the medical superintendent.
12 In case of any doubt regarding registering a EMO
case as an MLC, the medical superintendent
shall be consulted.
13 If any patient registered under MLC dies EMO Patient record/MLC
during hospitalization, postmortem is a register
mandatory procedure and the patient's
body shall not be handed over to the
patient's relative but to the respective
police station in order for the postmortem
to be conducted at the district hospital.
14 A case summary shall be provided to the EMO Patient record/MLC
police at the time of handing over the dead register
body for submission to the district hospital.
15 When MLCs are discharged, the relevant EMO/Nursing Patient record/MLC
police station shall be notified. register
16 All medico-legal discharge cases should be EMO/Nursing Patient record/MLC
registered in the same way at all stages, as register
recorded at the time of admission.
17 A copy of all the reports of the investigation Nursing Patient record/MLC
shall be kept in the MRD file before register
discharging the patient.
18 After handing over the documents and Nursing Patient record/MLC
reports to the patient, the patient's or register
relative's signature shall be obtained for the
MRD file.
19 After discharge, MRD files of all MLCs shall MRD Patient record/MLC
be stored separately and be under the register
control of a designated person.
20 The responsible MO/Consultant shall MRD Pt record /MLC
arrange to prepare the injury certificate register
with the help of the CMO.
21 MRD shall preserve a copy of the signed MRD Patient record/MLC
certificate in the patient record. register
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48. No. Procedural steps Responsibility Supporting Document
22 At the time of handing over the certificate MRD Patient record/MLC
to police, the designation and buckle register
number of the police representative shall
be noted in the second copy and the
signature of the police taken.
23 All MLCs shall be reported to the medical MRD Patient record/MLC
superintendent on a monthly basis. register
24 The original injury certificate shall only be MO/MRD Patient record/MLC
issued to the police and not to the patient register
or relatives.
Exhibit1
FormatofIntimation
To
ThePoliceSub-Inspector,
M.L.C.NOTIFICATION
(ThisformshouldbefilledbytheDoctorwhileadmitting/dischargingthepatient)
PatientName:----------------------------------------------------------------------------------------------
Address:-----------------------------------------------------------------------------------------------------
Age:-------------------- Sex:-------------------- M/F:---------------------- UHID:---------------------
Admittedon :---------------at:--------------------------- IPNo:----------MLCNo.:--------------
Date Time
PatientBrought:--------------------------------------------------------------------------------------------
TreatingDoctors:-------------------------------------------------------------------------------------------
AdmittedbyM.O.:-----------------------------------------------------------------------------------------
Observationofinjuries/Historywhileadmitted:
X-RAY/CTScan/MRI
Date/TimeofAdmission/Discharge/Death:------------------------------------------------
Doctor
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49. STANDARD COP3. DOCUMENTED PROCEDURES DEFINE RATIONAL USE OF BLOOD AND
BLOODPRODUCTS.
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
ClinicalUseofBlood.Availableat:http://www.who.int/bloodsafety/clinical_use/en/).
ObjectiveElements
COP3a.Thetransfusionservicesaregovernedbytheapplicablelawsandregulations.*
COP3b.Informedconsentisobtainedfordonationandtransfusionofbloodandbloodproducts.*
COP3c.Procedureaddressesdocumentingandreportingoftransfusionreactions.
COP3c.Procedureaddressesdocumentingandreportingtransfusionreactions.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
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,
andtheimportanceofreportingitforfurtherimprovement.
Itisrecommendedthat:
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,
rigororfever)tosevere(hemolysis,hemoglobinuria,acuterenalfailure,ordeath).
ii. Allbloodtransfusionmonitoringbedocumentedinthestandardizedformat.
iii. TheSHCOensuresthatanytransfusionreactionisreportedtothebloodbank.
*ObjectiveElementsCOP3aandCOP3bareself-explanatoryandthereforenotincludedinthisGuidebook.
COP3a:Thetransfusionservicesshallbegovernedbyapplicablelawsandregulations.TheSHCOshouldhaveanMoUwith
an accredited blood bank or blood storage center which follows quality practice guidelines. There should be documented
policies for obtaining blood and blood components, including at night, and on holidays, and the staff should be trained on
these. The doctor on duty shall be in charge of arranging for blood components and their safe transportatation.
Transportation should be done with cold chain maintenance and accompanied by all the relevant forms and papers to
ensureacross-matchandpatientidentityandsafety.
COP3b:Informedconsentshallbeobtainedforthedonationandtransfusionofbloodandbloodproducts.Consentshould
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
overtwodays,thenseparateconsentformsarerequired.
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50. iv. Standardsfor bloodbankandbloodtransfusionmaybefoundin:
lNational AIDS Control Organisation (NACO), Ministry of Health and Family Welfare,
Government of India. Standards for Blood Banks and Blood Transfusion Services.
Availableat
http://www.naco.gov.in/upload/Final%20Publications/Blood%20Safety/Standards%
20for%20Blood%20Banks%20and%20Blood%20Transfusion%20Services.pdf
lhttp://www.naco.gov.in/NACO/Quick_Links/Publication/Blood_Safety__Lab_Services/
Operational__Technical_guidelines_and_policies/standards_for_blood_bank/
lNACO, Ministry of Health and Family Welfare, Government of India, Operational and
Technical Guidelines and Policies for Blood Safety and Lab Services. Available at
http://www.naco.gov.in/NACO/Quick_Links/Publication/Blood_Safety__Lab_Service/
II. REQUIRED DOCUMENTS
i. Policy for blood transfusion services.
ii. SOPs for handling blood and blood components including acquisition, storage, transport,
bloodcomponenttransfusion,andmonitoringduringtransfusion.
iii. SOPfordetectingand reportingbloodtransfusionreactionsforimprovingpatientsafety.
iv. LegalpapersandlicensesandapplicableMOUs,whicheverisapplicableasperregulation.
III.TASKSANDRESPONSIBILTIES
·
Sr. No. Task / assignment Responsibility
i. Preparation of all policy and SOPs for blood and Blood bank officer/Pathologist/
blood component services Medical superintendent/In-
charge consultant/person
ii. Procuring or maintaining MOUs Medical superintendent/ person
in charge
iii. Induction and ongoing training for blood and blood Superintendent/Head of
component related policies and SOPs hospital
iv. Ensuring required documentation process including MO and /or Quality person/
informed consent, blood and component Consultant involved
transfusion monitoring, blood reaction monitoring
and reporting
v. Audit and monitoring quality standards for blood Superintendent / responsible
transfusion services person or consultant
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51. IV. AUDIT CHECKLIST
Checkpoint Yes NO Comments
Availability of required policies and SOPs for
blood and blood component transfusion
services
Availability of required documentation, MOUs
Availability of informed consent form for blood
and blood component transfusion
Blood appropriately checked as per SOP and
documented before starting the transfusion and
documented in format for monitoring
transfusion
Availability of transfusion reaction reporting
form
All human resources, equipment, and
consumables are available
Doctors and staff training records
Blood Transfusion Monitoring Chart
Note: Formats or templates can be used as per local requirement and complexity of SHCO
PatientName UHID BloodBankNo.
BloodGroup BloodUnitNo. Alltests-positive/negative
Bloodunitcheckedby Name: Designation: Signature:
Name: Designation: Signature:
Bloodtransfusionstartingtime:
Time Pulse BP RespirationRate BloodDropRate/min Remarks
OHr
15min
30min
1hr
1hr30min
2hr
2hr30min
Bloodtransfusioncompletiontime
Posttransfusionvitals
At30min
At1hr
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52. Blood transfusion monitored by: Name: Signature
Transfusion Reaction Form
Patient Name UHID Blood Group Blood Bank No.
Blood Group Blood Bag No. Date
Type of blood/component:
Time of issue:
Time of starting transfusion :
Time of completion:
Nature of transfusion reaction:
Sign and symptoms to BTR: Fever: Rigors with chills, Pain:Site of pain
Icterus Hemoglobinuria
Allergic symptoms: Urticaria/rash/swelling
Nausea and vomiting:
Any other symptoms:
Vitals :T/pulse/BP/respiration
Samples: Blood in both EDTA and plain bulb; Urine sample (within 6 hours of suspected reaction)
Name: Date: Time: Signature
STANDARDCOP4.DOCUMENTEDPROCEDURESGUIDETHECAREOFPATIENTSASPERTHE
SCOPEOF SERVICES PROVIDED BY THE SHCOIN INTENSIVE CARE AND HIGH DEPENDENCY
UNITS.
ObjectiveElements
COP4a.Careofpatientsisinconsonancewiththedocumentedprocedures.
COP4b.Adequatestaffandequipmentareavailable.*
*ObjectiveElementCOP4bisself-explanatoryandthereforenotincludedinthisGuidebook.
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53. COP4a.Careofpatientsisinconsonancewiththedocumentedprocedures.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope: To instil confidence in the SHCO regarding NABH standards which can be helpful for better
patientmanagementandsatisfaction.
ItisrecommendedthatSHCOspreparewrittenSOPsforallpossiblecommonproceduresinorderto
careforHighDependencyUnit(HDU)andICUpatientssafelyandconsistently.
ItisrecommendedthatSHCOsprepareamanualforICUandHDUwhichcontainsalistofalltheday-
to-day general procedures as well as special procedures within the scope of the hospital services
(cardiac/neuro/obstetric/surgicalICU):
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,extubationandpost-extubationcare.
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.
Fordetails,see:
lMinistry of Health and Family Welfare, Government of India, Standard Treatment
Guidelines,theClinicalEstablishmentsAct,2010.Availableat
http://clinicalestablishments.nic.in/En/1068-downloads.aspx
lCDCGuidelinesforInfectionControl,2003.Availableat
www.cdc.gov/ncidod/hip/enviro/guide.htm
lCriticalCareSocietyGuidelines,2010.Availableat
www.isccm.org/pub-icu—guidelines.aspx
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54. lRoyalCollegeofObstetriciansandGynaecologistsGuidelines,2014.Availableat
https://www.rcog.org.uk/en/guidelines-research-services/guidelines/?p=5
lFOGSIGuidelines.Availableat
http://www.fogsi.org/index.php?option=com_content&view=article&id=84&Itemid=131
lMinistryofHealth,GovernmentofIndia,NACOGuidelines.Availableat
http://www.naco.gov.in/NACO/About_NACO/Policy__Guidelines/Policies__Guidelines1/
II. REQUIREDDOCUMENTS
i. Policy for providing critical care services for medical, surgical, pediatric, obstetrics or
neonatalpatients.
ii. SOPsforholisticcareofcriticallyillpatientsandtheirmanagementinICUsorHDUs.
iii. Forms and formats for informed consent, Procedure checklists, Lab or Imaging
investigations, Monitoring sheets for doctors and and nurses, Blood and blood component
transfusion.
III. TASKSANDRESPONSIBILITIES
i. Key personnel meet and finalize the scope of critical care for different category of patients,
suchassurgical,medical,neonateandpediatricswithinICU/HDU.
ii. Policy and SOPs for admission, discharge, transfer and management of patients in ICU and
HDU.
iii. SOPsfordifferentprocedurestobedonewithinICU/HDU.
iv. Process to ensure regular update of these SOPs as per current evidence-based practices
shouldbeestablished
v. Training of all doctors, nurses and support staff regarding SOPs, clinical and administrative
processesincludinginfectioncontrolpractices.
vi. Ensuring good inventory practices for essential medications, biomedical equipment and
consumables,throughouttheday,everydayandthroughouttheyear.
vii. Provisionforacquiringthemincasetheyareoutofstockinanemergency.
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55. IV. AUDIT CHECKLIST
Checkpoint Yes NO Comments
Updated ICU / HDU Manual available to all
end-users
Manual contains all relevant SOPs
Staff is aware of all SOPs
Informed consent forms, Monitoring sheets,
and Documentation process are in place
Equipment, medications, consumables are
available as per the scope of the ICU/ HDU
services
Training record of doctors, nurses and other
relevant staff
Process Flow Responsibility Supporting Document
All patients in ICUs shall be admitted ICU in charge/ Doctor Patient record/ICU register
as per clinical need.
All patients shall undergo an initial ICU doctor and Nurse Patient case record
assessment by the ICU doctor on duty on duty
and nurse on duty.
In case of non-availability of beds, the ICU doctor and doctor ICU register/transfer
ICU doctor will find out whether any in casualty register/patient record
settled patient can step down or any
space be created to accommodate
the new patient based on available
human and other resources.
If it is not possible, the patient shall
be transferred to another hospital as
per the transfer-out procedure.
All patients shall receive care as per Doctor on duty Patient case record
their clinical need. Nurse on duty
All staff doctors, nurses and Doctor on duty HIC manual
attendants must maintain hand
hygiene as per WHO Hand Hygiene Nurse on duty
Guidelines.
Note: Some samples may be used as templates to develop customized SOPs.
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56. Process Flow Responsibility Supporting Document
All staff should follow universal Doctor on duty Patient record
precautions while managing the
patient. Nurse on duty ICU register
Staff must prevent the patient from Doctor on duty Patient record
falls. Nurse on duty ICU register
Staff must provide general nursing Doctor on duty Patient record
care and care for the general hygiene
of the patient. Nurse on duty ICU register
Nurse and staff must prevent bed Doctor on duty Patient record
sores by frequently changing the
position of the patient. Nurse on duty ICU register
Bundle care guidelines must be Doctor on duty Patient record
followed for all IV lines, catheters,
endotracheal tubes, and other tubes. Nurse on duty ICU register
Monitoring, patient assessment, and Doctor on duty Patient record
treatment should be documented in
the designated format and patient Nurse on duty ICU register
case file and ICU register.
Handing over, taking over between Doctor on duty Patient record
shifts, and transfers to other wards
should be appropriately documented. Nurse on duty ICU register
The patient may be discharged or Doctor on duty Patient record
stepped down to a ward as per
clinical need. Nurse on duty ICU register
STANDARD COP5. DOCUMENTED PROCEDURES GUIDE THE CARE OF OBSTETRICAL
PATIENTSASPERTHESCOPEOFSERVICESPROVIDEDBYTHESHCO.
ObjectiveElements
COP5a.TheSHCOdefinesthescopeofobstetricservices.
COP5b. Obstetric patient's care includes regular antenatal check-ups, maternal nutrition, and
postnatalcare.*
COP5c.TheSHCOhasthefacilitiestotakecareofneonates.*
*Objective Elements COP5b, and COP5c are self-explanatory and therefore not included in this
Guidebook.
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57. I.OVERVIEW
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
Scope: To guide the SHCO on how to clearly communicate the different obstetrical services that the
SHCO can or cannot provide for pregnant women during the antenatal, intranatal and postnatal
period.
ItisrecommendedthattheSHCO:
i. Clearly define and display the services that it can provide such as antenatal services,
intranatalandpostnatalservices.
ii. Listthedifferentdiagnosticfacilitiesavailableforthiscategoryofpatients.
iii. Define and display whether it can cater to high-risk pregnancies such as eclampsia , or
medicaldisorderwithpregnancy.
iv. Provide details on provision for termination of pregnancy and family planning services, if
applicable.
II.REQUIREDDOCUMENTS
i. ScopeofservicesthatSHCOprovidestothecommunity.
ii. ScopeofservicesdisplayedinaprominentareaintheOPD.
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58. Sr. No. Task / assignment Responsibility
i Finalize the scope of maternal services that the Gynecology HOD/ Medical
SHCO can provide to community. superintendent or Consultant
in-charge/Nursing head
ii Finalize the services which will not be provided Gynecology HOD/ Medical
either due to lack of human resources, expertise, superintendent or Consultant
infrastructure, or other logistical problems. in-charge/Nursing head
iii. Disseminate the scope of services to all staff HR and Gynecology department
members.
iv. Prepare a board to display scope of services Management
publicly.
i. Annual review of scope of services and amendment Gynecology HOD/ Medical
when any addition or removal is required. superintendent or Consultant
in-charge/Nursing head
III. TASKS AND RESPONSIBILITIES
IV. AUDIT CHECKLIST
No. Checkpoint Yes NO Comments
i. Availability of scope service policy
document, including licenses if
applicable, such as PNDT, MTP.
ii. Bilingual display of scope of service in a
prominent area.
iii. Staff training records
STANDARD COP6. DOCUMENTED PROCEDURES GUIDE THE CARE OF PEDIATRIC PATIENTS AS PER
THESCOPEOFSERVICESPROVIDEDBYTHESHCO.
ObjectiveElements
COP6a.TheSHCOdefinesthescopeofitspediatricservices.
COP6b.Provisionsaremadeforspecialcareofchildrenbycompetentstaff.*
COP6c.Patientassessmentincludesdetailednutritionalgrowthandimmunizationassessment.*
COP6d. Procedure addresses identification and security measures to prevent child or neonate
abductionandabuse.
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59. COP6e. The children's family members are educated about nutrition, immunization and safe
parenting.*
*Objective Elements COP6b, COP6c, COP6e, are self-explanatory and therefore not included in this
Guidebook.
COP6a.TheSHCOdefinesthescopeofitspediatricservices.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope: To guide the SHCO on how to decide and communicate clearly to the community the
differentpediatricservicesthatcanorcannotbeprovidedforneonates,infantsandchildren.
Thescopeofpediatricservicesisdefinedbythehospitalandmayinclude:
Pediatric/neonatalservices Immunizationservices
Emergencyservices Childguidanceclinics
Wellbabyclinic Developmentalclinic
Anysuperspecialty/subspecialtyservices
Itisrecommendedthat:
i. The scope of services be displayed bilingually (in English and the State language) in
prominentplaces.
ii. In case a change is required in the scope, the HOD Pediatrics requests the same and the MS
approvesit.
II.REQUIREDDOCUMENTS
Definedscopeofpediatricservicesavailablewithinthehospital.
Sr. No. Task Responsibility
i. Formulate the scope of services. HOD Pediatrics
ii. Approval of the scope of services or its correction. MS
iii. Display of scope of pediatric services. MS
III. TASKS AND RESPONSIBILITIES
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60. 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
AbductionandAbuse.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope: To guide the SHCO on the prevention of neonate/child abductions and abuse and to ensure
propersafetyfornewbornsandchildren.
Itisrecommendedthat:
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
timesinwaitingroomsandoutpatientclinics.
ii. Proper security measures are taken to avoid any abduction or abuse of children in the
hospitalpremisesbypostingsecurityguardsoutsideeachdepartmentinthehospital.
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
abductionorabuse.
II.REQUIREDDOCUMENTS
i. PolicyonChildAbductionandAbuse
ii. SOPonChildAbduction
III.TASKSANDRESPONSIBILITIES
No. Task Responsibility
i. Formulate SOP/policies Quality officer
ii. Allocate resources for name tags, CCTV Medical superintendent
iii. Patient education Nurses/Medical officers
iv. Safety and security of NICU/PICU wards Security personnel
v. Code pink mock drill, corrective action, and Audit team
preventive action
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61. 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:SamplesmaybeusedastemplatestoguidetheSHCOtodevelopcustomizedSOPs.
No. Process Flow Responsibility Supporting Document
1. Once the child is admitted, or neonate is Nurses SOP/identification
born, identification bands are tied. band
2. One parent is allowed to be with the Security personnel/
patient at all times or allowed to visit the Nurse
patient frequently in the ICU.
3. Footprints of the newborn are imprinted Nurses Medical records
on the bedside record and on the mother's
case sheet.
4. The mother's identification tag includes Nurses
the baby's UHID and name and vice versa.
5. Infants are kept in direct, line-of-site Nurses
supervision at all times by an authorized
staff member and the mother.
6. Infants are transported only by authorized Nurses
staff along with the mother or father.
7. Strict vigilance is maintained for the Security staff
movement of children and infants in
NICU/PICU and that of bystanders.
8. Movement of unrelated/unidentified Security staff
attendants is restricted.
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62. No. Process Flow Responsibility Supporting Document
9. The hospital staff and the parents are Audit/HRD
trained and educated about the policy and
procedures for preventing infant and child
abduction, and on safety measures and
precautions to be taken to prevent infant
abduction and abuse.
10. Code pink protocol (if defined) is checked Quality team Mock drill record
periodically, and corrective action and
preventive actions undertaken.
STANDARD COP7. DOCUMENTED PROCEDURES GUIDE THE ADMINISTRATION OF
ANESTHESIA.
ObjectiveElements
COP7a.Thereisadocumentedpolicyandprocedurefortheadministrationofanesthesia.
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.Animmediatepreoperativereevaluationisdocumented.*
COP7e.Informedconsentforadministrationofanesthesiaisobtainedbytheanesthetist.*
COP7f.Anesthesiamonitoringincludesregularandperiodicrecordingofheartrate,cardiacrhythm,
respiratory rate, blood pressure, oxygen saturation, airway security, and potency and level of
anesthesia.*
COP7g.Eachpatient'spostanesthesiastatusismonitoredanddocumented.*
*Objective Elements COP7b, COP7c, COP7d, COP7e, COP7f, and COP7g are self-explanatory and
thereforenotincludedinthisGuidebook.
COP7a.Thereisadocumentedpolicyandprocedurefortheadministrationofanesthesia.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
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
ofOT.
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63. 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
helpstheSHCOminimizeadverseeventsandmedico-legalissues.
Itisrecommendedthat:
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
designatedindividual.
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
(thatis,Aldrettecriteria).
iii. Thereisadefinedprocessfortakinginformedconsentfromthepatientandrelatives.
iv. TheSHCOtrainsalldoctorsandsurgicalstaffaccordingtotheWHOsurgicalsafetychecklist.
(WHO Surgical Safety Checklist and Implementation Manual. Available at
http://www.who.int/patientsafety/safesurgery/ss_checklist/en/)
I.REQUIREDDOCUMENTS
i. Policyforproviding safeanesthesiaserviceswithintheSHCO.
ii. SOPsforhandlingday-to-dayfunctioningandprovidinganesthesiaservices.
iii. SOPsforelectiveandemergencysurgeries.
iv. SOPs to handle a potential situation where the patient needs to be referred for further
management.
v. SOPsforpostanesthesiastatusmonitoring.
vi. Informedconsentformats.
vii. Formats for preanesthesia assessment, immediate preoperative re-evaluation, monitoring
duringandafteranesthesia.
viii.WHOsurgicalsafetychecklist(anesthesiarelatedcomponent)
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64. No. Task Responsibility
i. Develop a policy for anesthesia services Management
ii. Appoint or make available anesthetists and teams as per HR / Superintendent/
the policy Head of SHCO
iii. Develop SOPs for different anesthesia-related activities Anesthetist, OT nurse,
Quality team/ designated
person
iv. Training related to these SOPs is provided for all HR/Quality team
stakeholders /Consultant in-charge
v. Day-to-day activity and documentation Anesthetist/OT nurse
vi. Regular documentation audit for adherence to SOPs Quality team/
designated person /
Consultant in-charge
III. TASKS AND RESPONSIBILITIES
IV.AUDITCHECKLIST
PolicyandSOPsforanesthesiaservicesareavailable
Further,tochecktheimplementationoftheservicethefollowingcanbehelpful:
No. Checkpoint Yes NO Comments
i. Policy and SOPs for anesthesia services
are available
ii. PAC documented
iii. Transfer checklist from ward to OT filled
appropriately
iv. Informed Consent documentation obtained
v. Immediate preoperative assessment of
patient done
vi. Anesthesia plan confirmed
vii. All medication and procedure
documented for induction of anesthesia
viii. Intraoperative monitoring chart
documented
ix. Postoperative monitoring done
x. Patient has obtained the discharge
criteria before being shifted
xi. Appropriate handover of patient to
receiving department/ward/ICU is
documented
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65. STANDARD COP8. DOCUMENTED PROCEDURES GUIDE THE CARE OF PATIENTS
UNDERGOINGSURGICALPROCEDURES.
ObjectiveElements
COP8a. Surgical patients have a preoperative assessment and a provisional diagnosis documented
priortosurgery.*
COP8b.Informedconsentisobtainedbyasurgeonpriortotheprocedure.*
COP8c. Documented procedures address the prevention of adverse events like wrong site, wrong
patient,andwrongsurgery.
COP8d. Qualified persons are permitted to perform the procedures that they are entitled to
perform.*
COP8e.Theoperatingsurgeondocumentstheoperativenotesandpostoperativeplanofcare.*
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
notincludedinthisGuidebook.
COP8c. Documented procedure addresses the prevention of adverse events like wrong site,
wrongpatientandwrongsurgery.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope: To guide the SHCO to develop and implement policies and SOPs for conducting safe surgical
proceduresandpreventingpotentialadverseevents.
Itisrecommendedthat:
i. Personnelinvolvedincareofsurgicalpatientstakeallnecessarymeasurestoreducetherisk
ofoccurrenceofadverseeventsinsurgicalpatients.Referto:
WHO,SurgicalSafetyChecklistandImplementationManual.Availableat
http://www.who.int/patientsafety/safesurgery/ss_checklist/en/
WHO,SafeSurgery.Availableat
http://www.who.int/patientsafety/safesurgery/en/
WHO,ToolsandResourcesonPatientSafety.Availableat
http://www.who.int/patientsafety/safesurgery/tools_resources/en/
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66. ii. The SHCO has SOPs to implement and demonstrate methods to prevent adverse surgical
eventssuchasidentificationtags,badges,andcross-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,
beforeincision,andattheendofthesurgery.
v. Proper coordination takes place between ward/ICU staff, OT staff, medical officers,
anesthesiologistandconsultantsurgeon.
vi. Patient participation during the checklist process could help reduce adverse events and
near-misses.
vii. Any adverse event with a surgical patient be reported to hospital management and to the
concerned people. These committees do a root-cause analysis and take appropriate
preventivemeasurestopreventtheoccurrenceofasimilareventinthefuture.
II.REQUIREDDOCUMENTS
i. SHCOpolicytoprovidesafesurgicalservices.
ii. SOPs for surgical services including informed consent process, wheel-in, execution of
surgery,infectioncontrolpractices,andsafehandoverofthepatient.
iii. WHOsurgicalsafetychecklistformat.
iv. Incidentreportformincaseofanyevent.
III.TASKSANDRESPONSIBILITIES
No. Task Responsibility
i. Adopt WHO surgical safety checklist and customize it for Surgical head/
local use; prepare other checklist formats for shifting Anesthetist/ Nurse in-
patient from ward to OT; SOPs for patient identification charge
and side- and site- marking.
ii. Disseminate the checklist to all stakeholders. HR/Quality team /
designated Consultant/
person
iii. Audit of adherence to real-time usage of these checklists. Quality team /
designated Consultant/
person
iv. Reorientation or refresher training for the same. Quality team /
designated Consultant/
person
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67. IV. AUDIT CHECKLIST
No. Checkpoint Yes NO Comments
i. SOP in place to implement surgical safety
checklist
ii. Training record of doctors and staff
iii. All steps taken in order to identify the
patient before wheel-in (transfer from
Ward to OT)
iv. All steps taken by Anesthetist and
Circulating nurse before the induction of
anesthesia (sign-in)
v. All steps of the surgical checklist are
followed before skin incision (time-out)
vi. All steps of the surgical checklist are
followed before sign out (sign-out).
Checklistforreal-timedocumentationofsurgicalsafety
Note: Somesamplescouldbeusefulas templatestocreatecustomizedSOPs.
SOPtopreventwrongsite,wrongpatient,andwrongsurgery
No. Process Flow Responsibility Supporting Document
1. Scheduling: The following information is a Primary Nurse and OT list, Consent form
must when scheduling an invasive/surgical Surgical team
procedure:
lCorrect spelling of the patient's full name
lInpatient number
lConsent for procedure to be performed
2. Preprocedure/preoperative verification Physician and Surgical safety
The physician and anesthetist shall verify Anesthetist checklist
the patient's identity by asking
lPatient's full name and compare with ID
band
lProcedure or surgery to be performed
If the patient is a minor, incompetent, sedated,
or not able to speak, the information should
be obtained from a blood-relative or legal
guardian.
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68. No. Process Flow Responsibility Supporting Document
3. Site mark: This should be completed before Physician and Surgical safety
the patient enters the procedure or Anesthetist, checklist
operating room. The site-mark is required Primary Nurse,
in invasive or surgical procedures that OR Nurse/Registrar
involve
lLaterality (for example, right, left)
lMultiple structures (for example, toes,
fingers, limbs)
lMultiple levels (for example, spine)
This includes bedside invasive procedures.
4. Before making the site-mark, the Physician and
Consultant performing the procedure or Anesthetist
surgery verifies the patient's identity and
medical records. In the case of a minor, the
verification process must involve parents or
the legal guardian.
5. There should be standardized marking for Infection Control
all procedures (for example, SS - Nurse, OR Nurse/
surgical site). The marker should be Doctor
hypo-allergenic, latex-free, and sterile.
The marking should be clear and
unambiguous.
6. The site-mark should not be removed until Physician and
the procedure is over. Anesthetist,
OR Nurse/Doctor
7. Time-out procedure: OR Nurse Surgical safety
Time-out is required to confirm the checklist
following:
lCorrect patient
lCorrect side or site
lCorrect procedure
lCorrect patient position
lCorrect radiographs
lCorrect implants and equipment
8. A verbal time-out or pause is called by the OR Nurse/Doctor Surgical safety
OR Nurse or Registrar immediately before checklist
the procedure or surgery in the operating
room or procedure room.
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69. No. Process Flow Responsibility Supporting Document
9. The patient doses not have to be awake for OR Nurse/Doctor
the time-out. Site-marking must be visible
at time-out or pause.
10. As soon as the patient enters the operating OR Nurse/Doctor
or procedure room, the OR Nurse/Registrar
assigned to call time-out will call for a
pause and loudly call the full name of the
patient, inpatient number, procedure
name, and site.
11. The Scrub Nurse, Anesthetist, and Surgeon Physician and Surgical safety
will say 'yes' to all the details. The time-out Anaesthetist, checklist
will be documented in the medical records. OR Nurse/Doctor
It should include
lPersonnel present at the time-out
lVerification of correct patient
lVerification of correct side and site
lAgreement on the procedure/verification
of radiographs
lVerification of the correct position
lAvailable implants and equipment
12. Discrepancies Physician and
If any discrepancy is found at any point, Anesthetist,
the case must not proceed until completely OR Nurse/Registrar
resolved.
13. All team members and the patient Attending
(if possible) must agree on the resolution Consultant
of the identified discrepancy. The attending (Physician and
Consultant in the patient's medical records Anesthetist)
must document the discrepancy and its
resolution.
V. REFERENCES
Resources for SOPs and formats taken from H. M. Patel Center for Medical Care and Education;
and NABH Standards for Hospitals (3rd Edition), November 2011.
CDC Guidelines for Infection Control. Available at
http://www.cdc.gov/HAI/prevent/prevent_pubs.html.
FOGSI Guidelines. Available at
http://www.fogsi.org/index.php?option=com_content&view=article&id=84&Itemid=131
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70. Gautam Biswas, Recent Advances in Forensic Medicine and Toxicology, Jaypee Brothers, 2015.
Jagdish Singh, Medical Negligence and Compensation, Bharat Law Publishers, 2014.
Medico-legal Forms and Formats, Kerala Medico-Legal Society. Available at
https://sites.google.com/site/keralamedicolegalsociety/medico-legal-certificates
Ministry of Health and Family Welfare Acts, Government of India. Available at
http://www.mohfw.nic.in/index1.php?page=1&ipp=50&lang=1&level=2&sublinkid=2526&lid=18
10
Ministry of Health and Family Welfare, Government of India, Guidelines and Protocols: Medico-
legal Care for Survivors/Victims of Sexual Violence. Available at
http://www.mohfw.nic.in/WriteReadData/l892s/9535223249GuidelinesandProtocolsorsexualvio
lence_MOHFWf.pdf
Ministry of Health and Family Welfare, Government of India, Standard Treatment Guidelines, the
Clinical Establishments Act 2010. Available at
http://clinicalestablishments.nic.in/En/1068-downloads.aspx
Ministry of Health, Government of India, NACO Guidelines. Available at
http://www.naco.gov.in/NACO/About_NACO/Policy__Guidelines/Policies__Guidelines1/
NACO, Ministry of Health and Family Welfare, Government of India, Operational and Technical
Guidelines and Policies for Blood Safety and Lab Services. Available at
http://www.naco.gov.in/NACO/Quick_Links/Publication/Blood_Safety__Lab_Services/
NACO, Ministry of Health and Family Welfare, Government of India. Standards for Blood Banks
and Blood Transfusion Services. Available at
http://www.naco.gov.in/upload/Final%20Publications/Blood%20Safety/Standards%20for%20Blo
od%20Banks%20and%20Blood%20Transfusion%20Services.pdf
Royal College of Obstetricians and Gynaecologists Guidelines. Available at
https://www.rcog.org.uk/guidelines
Satish Tiwari, Textbook on Medico-legal Issues, Jaypee Brothers, 2012.
Society of Critical Care Medicine Guidelines. Available at
http://www.learnicu.org/pages/guidelines.aspx
WHO, Surgical Safety Checklist and Implementation Manual. Available at
http://www.who.int/patientsafety/safesurgery/ss_checklist/en/
WHO, Safe Surgery. Available at
http://www.who.int/patientsafety/safesurgery/en/
WHO, Tools and Resources on Patient Safety. Available at
http://www.who.int/patientsafety/safesurgery/tools_resources/en/
WHO, Safe and Rational Clinical Use of Blood. Available at
http://www.who.int/bloodsafety/clinical_use/en/
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71. Chapter 3
MANAGEMENT OF MEDICATION (MOM)
STANDARD MOM1. DOCUMENTED PROCEDURES GUIDE THE ORGANIZATION OF
PHARMACYSERVICESANDUSAGEOFMEDICATION.
ObjectiveElements
MOM1a. Documented procedures incorporate purchase, storage, prescription, and dispensation
ofmedications.
MOM1b.Thesecomplywiththeapplicablelawsandregulations.*
MOM1c.Soundalikeandlookalikemedicationsarestoredseparately.*
MOM1d.Medicationsbeyondtheexpirydatearenotstoredorused.*
MOM1e.Documentedproceduresaddressprocurementandusageofimplantableprosthesis.
*Objective Elements MOM1b, MOM1c, and MOM1d are self-exlanatory and therefore not
includedinthisGuidebook.
MOM1a. Documented procedure shall incorporate purchase, storage, prescription and
dispensationofmedications.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope: To guide the SHCO on procedures to be followed for purchase, storage, prescription and
dispensationofdrugsinasafemannerandtoavoidmedicationerrors.
Itisrecommendedthat:
i. There is a defined process for the acquisition of medications as per the defined list of the
SHCO.AlistofvendorsisselectedbytheSHCOdependingontheirreputation.
ii. MedicationsareorderedaccordingtothedefinedreorderlevelproposedbytheSHCO.
iii. Medications are stored in a clean and safe environment as recommended by the
manufacturer.
iv. There are some medicines which"look alike", for example, Adrenaline and Atropine. There
are some medicines which"sound alike", for example, Levoflox and Levocet, Depomedrol
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72. and Solumedrol. These types of medications are called "Look-alike Sound-alike"medicines
or LASA medicines (see Annexure). The hospital should consider making special
arrangements for storage of these medications (for example, making a list, educating staff,
and labelling LASA medicines with the help of stickers and avoiding keeping them
together).
v. Allprescriptionsbewrittenbyregisteredmedicalpractitioners.
vi. All prescriptions have the patient's name, admission number, drug name (generic names
written in full), strength and quantity, dosage, treatment duration, that is, days, weeks, or
months,doctor'ssignature,anddate.
vii. Dispensation of medication should be done in a safe manner that ensures quick and
efficientpatientcareandminimizeserrors.
viii.In case of government hospitals, the purchase is usually done by the department or
medicalservicescorporation.
II.REQUIREDDOCUMENTS
i. Procedure forPurchase
ii. ProcedureforStorage
iii. Procedure forPrescription
iv. Procedure forDispensing
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
modifyitaccordingtotheirrequirement.
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73. No. Procedure Responsibility
1. A list of medications used regularly in the SHCO is Pharmacy in-charge
maintained.
2. The stock of medicines is checked every morning. Pharmacy staff
3. If stock is less than minimum stock level, an order Pharmacy staff
note is raised.
4. The order note contains the following: HOD/staff
i. Name of the item
ii. Quantity of the item
iii. Order date
iv. Name of the company
v. Last order date
vi. Present stock
5. Once the order note is written, the signature Pharmacy/Purchase in-charge
from the person in-charge, and person ordering is
obtained.
6. The order is placed with different stockists or Pharmacy/Purchase in-charge
company representatives over the phone according
to the order note.
7. Items are received from the stockist as per the Pharmacy/Purchase in-charge
agreed turnaround time.
8. Items are checked according to the bill and the order Pharmacy/Purchase staff
note.
9. Quantities, batch number, expiry date, any breakage Pharmacy/Purchase staff
of items are checked before accepting from the
stockist or company representatives.
SOP on Procurement of Medication
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74. No. Procedure Responsibility
10. A copy of the order note along with the bill is sent Pharmacy/Purchase staff
to the Accounts department after getting the
signature of the person in charge.
11. Payment is made by the Accounts department. Accounts department
Procedure of Storage of Medication
No. Procedure Responsibility
1. Medications are stored in the pharmacy or in the Pharmacy in-charge and
Ward or OT stocks (at the point of care). person in-charge of the
patient care area
2. Only authorized staff are allowed access to the Pharmacy staff,
stored medication. Nursing staff in patient care
areas
3. The area is clean and well-ventilated. Pharmacy staff, Housekeeping
4. The medications are protected from direct sunlight Pharmacy in-charge and
and the ambient temperature is maintained as per person in charge of the
the manufacturer's specification. patient care area
5. Medications with "cold chain" requirements are Pharmacy in-charge and
kept in the refrigerator. person in charge of the
Temperature is monitored at least once every shift. patient care area
6. LASA medications are identified Pharmacy in-charge
7. Individual LASA medications are stored with a Pharmacy in-charge and
separation between the items in each of the person in charge of the
LASA pairs. patient care area
8. Medications are checked every month to identify Pharmacy in-charge and
those due to expire within the next one/two/three person in charge of the
months. patient care area
9. The near-expiry items are returned to the vendor Pharmacy in-charge
for exchange.
Note:For a list of High-Risk Medications, refer to Annexure.
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75. Procedure of Prescription of Medication
No. Procedure Responsibility
1. Registered doctors are authorized to prescribe Medical Professionals
medications in the SHCO. (Consultants/ Residents/Medical
Officers)
2. The prescription will contain the type of Medical Professionals
preparation, name of the drug, dose, route of (Consultants/ Residents/Medical
administration, frequency, and duration of usage. Officers)
3. Medication orders are written clearly and legibly Medical Professionals
in capitals, dated, timed, signed, and named. (Consultants/ Residents/Medical
Officers)
4. Medication orders are written only in the Medical Professionals
designated locations in the medical record. (Consultants/ Residents/Medical
Officers)
5. A list of high-risk medications used in the hospital Pharmacy in-charge with inputs
is maintained. from the consultants
SOPs on Dispensing Medication
No. Procedure Responsibility
1. Dispensing of medication is done by a qualified Pharmacist
pharmacist
2. The pharmacist cross-verifies the medication with Pharmacist
the prescription prior to dispensing it with double
verification for high-risk medication.
3. As per prescription, the correct drug and its expiry Pharmacist
date are checked by the pharmacist.
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76. III. TASKS AND RESPONSIBILITIES
No. Tasks Responsibility
i. Define list of medications used in the SHCO Pharmacist/Doctors
ii. List approved vendors Purchase/Pharmacist
iii. Storage conditions of medications Management/Quality
team/Pharmacist
iv. Prescription Format Quality
team/Pharmacist/Doctors
v. Applicable Policies and SOPs Quality team/
Pharmacists/Doctors/ Nurse
IV. AUDIT CHECKLIST
No. Checkpoint Yes No Remarks
i. List of medications used in the SHCO
ii. Monitoring of storage conditions
iii. Prescription with patient's name, admission
number, dosage, written in capitals, doctor's
signature, and State Medical Council registration
MOM1e.Documentedproceduresaddressprocurementandusageofimplantableprosthesis.
Note:SectionsII,III,andIVbelowareprovidedassamplestoguideSHCOsindevelopingtheirown
customizeddocuments.
I.OVERVIEW
Scope: To guide the SHCO on how to define the policy and procedure on procurement and usage of
implantableprosthesis.
i. Medical implants are devices or tissues that are placed inside or on the surface of the
body. Many implants are prosthetics, intended to replace missing body parts. Other
implants deliver medication, monitor body functions, or provide support to organs and
tissues.
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77. No. Procedure Responsibility
ii. Some implants are made from skin, bone or other body tissues. Others are made from
metal,plastic,ceramicorothermaterials.
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,andimplantfailure. Somepeoplealsohavereactionstothematerials
usedinimplants.
iv. The selection of implants is based on scientific criteria that are recognized nationally and
internationally.Theprimaryselectionofimplantsisdonebytheconsultants.
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
procuredagainstawrittenprescriptionorder.
viii. The patient and/or family members are counseled before the usage of a particular
implantandurgedtoreportanyadversesituationthatmayarisefollowingimplantation.
ix. The batch and serial numbers of the implants used are recorded in the master file and
patientrecord.
x. Allstandardprecautionarymeasuresintermsofsterilizationshouldbeadheredto.
II REQUIREDDOCUMENTS
Note: The following is a sample list of documents which may be modified by the hospital according
toitsfunction.
1. A list of implants that are used in the SHCO is Purchase/Pharmacy in-charge
maintained.
2. Evidence-based medicine supports the usage of Clinician using the implant
the implant. Purchase/Pharmacy in-charge
3. Implants which are used frequently are stored in Purchase/Pharmacy in-charge
the hospital.
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78. No. Procedure Responsibility
4. The following information is recorded in the HOD/staff
order note: Name of the item
Quantity of the item
Order date
Name of the company
Last order date
Present stock
5. Once the order note is written, signatures are Purchase/Pharmacy in-charge
obtained from the in-charge and the person
ordering
6. Order for items is placed with different Purchase/Pharmacy in-charge
stockists or company representatives
over the phone as per the order note
7. Items are received from the stockist as per agreed Purchase/Pharmacy in-charge
TAT
8. Items are checked according to the bill and the order Pharmacy/Purchase staff
note
9. Quantities, batch number, expiry date, any breakage, Pharmacy/Purchase staff
relating to all the items are checked before accepting
from the stockist or company representatives
10. A copy of the order note along with the bill is sent Pharmacy/Purchase staff
to the Accounts department after getting the
signature of the person in charge
11. Payment is made by the Accounts department Accounts Department
12. Implants are supplied to the point of care Pharmacy/ Store
on request
13. Implant details such as name, model, lot and batch OT staff
number, expiry date, size (label in the pack) are Pharmacy staff
recorded in the medical record and pharmacy
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79. III. TASKS AND RESPONSIBILITIES
No. Task Responsibility
i. Select Implant Treating Doctor
ii. List approved vendors Pharmacy/ Stores
iii. Check availability of the implant Stores
iv. Check supply to the OT Stores
v. Verify implant as per selected implant OT Staff
IV. AUDIT CHECKLIST
No. Checkpoint Yes No Remarks
i. List of implants
ii. Usage of implants
iii. Evidence of documentation of usage of implants
StandardMOM2.Documentedproceduresguidetheprescriptionofmedications.
ObjectiveElements
MOM2a.TheSHCOdetermineswhocanwriteorders.*
MOM2b.Ordersarewritteninauniformlocationinthemedicalrecords.*
MOM2c.Medicationordersareclear,legible,datedandsigned.*
MOM2d.TheSHCOdefinesalistofhigh-riskmedicationandprocesstoprescribethem.
*Objective Elements MOM2a, MOM2b, and MOM2c are self-explanatory and therefore not
includedinthisGuidebook.
MOM2d.TheSHCOdefinesalistofhigh-riskmedicationandprocesstoprescribethem.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
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80. I.OVERVIEW
Scope: To guide the SHCO on how to define the list of high-risk medications and the process to
prescribetheminordertoensurepatientsafety.
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
mayconsiderlabellingthehigh-riskmedicines,keepingthemseperately,andavoidingverbalorders
forthemedicines.
Itisrecommendedthat:
i. TheSCHOpreparealistofhigh-riskmedicationsusedintheSHCO.Thislistshouldbemade
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. Allhigh-riskmedicationsbeadequatelylabelled.
iii. Antidotesforthesedrugsbemadeavailable.Noverbalordersshouldbefollowedforhigh-
riskmedications.
II.REQUIREDDOCUMENTS
Listofhigh-riskmedicinesareavailableintheAnnexure.
III.TASKSANDRESPONSIBILITIES
No. Tasks Responsibility
i. Draw up a list of high-risk medications used in Pharmacist/Doctors
the hospital
ii. Define the storage and usage precautions or Management/Pharmacists/
identifiers for high-risk medications Doctors
iii. Availability of antidotes for high-risk medication, Management/Pharmacist
if available
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81. No. Checkpoint Yes No Remarks
i. List of high-risk medications
ii. Identifiers for high-risk medications
IV. AUDIT CHECKLIST
V.REFERENCES
AccreditationStandardsforHospitals,NABH,3rdEdition,November2011.
de Vries, T.P.G.M., R. H. Henning, H. V. Hogerzeil and D. A. Fresle, A Guide to Good Prescription,
WorldHealthOrganizationActionProgrammeonEssentialDrugs, Geneva,1994.
General Medical Council (GMC), 2013. Good Practice in Prescribing and Managing Medicines and
Devices.Availableat
http://www.gmc-uk.org/Good_practice_in_prescribing.pdf_58834768.pdf
Institute for Safe Medication Practices, 4th April 2013. ISMP's List of High-Alert Medications. ISMP
MedicationSafetyAlert.
WHO, 2003.Guidelines for the Storage of Essential Medicines and Other Health Commodities.
Availableat
http://apps.who.int/medicinedocs/en/d/Js4885e/
ANNEXURES
1. List of high-alert medications. Available at
https://www.ismp.org/tools/highalertmedications.pdf
2. List of look-alike sound-alike (LASA) medications. Available at
https://www.ismp.org/tools/confuseddrugnames.pdf
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82. STANDARD HIC1. THE SHCO HAS AN INFECTION CONTROL MANUAL WHICH IT
PERIODICALLYUPDATES;THESHCOCONDUCTSSURVEILLANCEACTIVITIES*.
ObjectiveElements
HIC1a.Itfocusesonadherencetostandardprecautionsatalltimes.
HIC1b.Cleanlinessandgeneralhygieneoffacilitieswillbemaintainedandmonitored.
HIC1c.Cleaninganddisinfectionpracticesaredefinedandmonitoredasappropriate.
HIC1d.Equipmentcleaning,disinfectionandsterilizationpracticesareincluded.
HIC1e.Laundryandlinenmanagementprocessesarealsoincluded.
*A sample Hospital Infection Control (HIC) manual has been included as an annexure in the soft
copy of thisdocument. Itaddressesalltheobjective elements listedabove. Hence,limiteddetails
ontheHICmanualareprovidedinthischapter.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope: To guide both staff and patients in the SHCO on the standard precautions to be followed in
orderto:
i. ReduceandpreventtheincidenceofhospitalacquiredinfectionsintheSHCO.
ii. Identify high-risk areas where active surveillance should be practiced in an SHCO so as to
reducetherateofinfections.
iii. Develop policies and procedures for standards of cleanliness, sanitation, and asepsis in the
SHCO.
HospitalInfectionControl(HIC)Manual
It is recommended that the SHCO have an HIC Manual on standard precautions that staff should
followtopreventpatientsfromacquiringinfectionswithintheSHCO.
ItisrecommendedthattheHICManual:
i. Explains to staff the standard precautions and the universal precautions that should be
ideallypracticedintheSHCO.
ii. Focuses on the importance of hand hygiene as this is one of the root causes for all hospital
acquiredinfections.
iii. Provides guidelines for the care to be taken in high-risk areas like OT (Operation
Theatre),CSSD(CentralSterileSupplyDepartment),andICU(IntensiveCareUnit).
Chapter 4
HOSPITAL INFECTION CONTROL (HIC)
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83. iv. Definestheprotocoltobefollowedincaseofaneedle-stickinjurytoanystaff.
v. Defines the colour coding for biomedical waste segregation which should be as per the
Stateregulationsorasperstatutoryregulations.
vi. EnliststheconditionstobefollowedbytheSHCOforisolationpractices.
vii. Lists the standard cleaning, disinfection and sterilization practices to be followed in the
HCOtopreventinfections.
viii.Outlinestheprecautionsandthemethodologytobefollowedincaseofspills.
ix. ListsthestandardhousekeepingpracticestobepracticedbytheSHCO.
x Liststhestandardlaundryandlinenmanagementprocesses.
xi. ListsthehygienepracticestobefollowedinthekitchenoftheSHCO.
xii. Defines conditionsthatwillhelp SHCOs to identify an outbreak and the measures thatneed
tobefollowedincaseofanoutbreak.
No. Name (Register/Format) Responsible Person
i. HIC Manual Person designated for HIC activities along
with a dedicated doctor
No. Task Responsibility
i. Define the content of the HIC Manual Clinical Department Heads along with
designated HIC staff
ii. Staff orientation to infection control Designated HIC staff
practices and procedures
II. REQUIRED DOCUMENTS
III. TASKS AND RESPONSIBILITIES
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
IV. AUDIT CHECKLIST
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84. STANDARD CQI2. THE SHCO IDENTIFIES KEY INDICATORS TO MONITOR THE STRUCTURES,
PROCESSES, AND OUTCOMES WHICH ARE USED AS TOOLS FOR CONTINUOUS
IMPROVEMENT.
ObjectiveElements
CQI2a. The SHCO identifies the appropriate key performance indicators in both clinical and
managerialareas.
CQI2b.Theseindicatorsshallbemonitored.*
*ObjectiveElementCQI2bisself-explanatoryandthereforenotincludedinthisGuidebook.
CQI2a. The SHCO identifies the appropriate key performance indicators in both clinical and
managerialareas.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope: To guide the SHCO on how to measure the performance of an SHCO by indicators that
representthefunctioningofvariousservices,personnel,anddepartments.
There are three dimensions of quality, namely, Structures, Processes and Outcomes. Examples of
Structures are infrastructure, number of nurses available, number of doctors available, availability
of biomedical equipment. Examples of Processes include hand washing, administration of
medications, reporting of X-Ray. Examples of Outcomes include Surgical Site Infection Rate,
PatientSatisfactionIndex,numberoffallsinthehospital.
If Structures and Processes are good,the Outcomeswill consequently also be good.For example, to
ensure quality care in the ER, the Structures necessary are availability of doctors and nurses,
availability of equipment and medicines. For Processes, the doctors and nurses should provide the
correct treatment using standard treatment guidelines and protocols. The presence of Structures
alone does not ensure quality. If both Structures and Processes are appropriate, they will lead to
goodOutcomes.
Whenwewanttomeasurequality,wemaymeasureeitherthestructure,processoroutcome. Ifwe
measure outcome,indirectlyweare measuringboth structure and process. But if weare measuring
either structure or process, it is uncertain whethergoodoutcomeswill be achieved. For example, if
Chapter 5
CONTINUOUS QUALITY IMPROVEMENT (CQI)
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85. we measure percentage of beds with hand sanitizer available by the bedside, it does not give us any
idea of how often it is used. If we are measuring a process, for example, compliance with hand
washing, we know that is an important component to control hospital-acquired infection, but we
are still uncertain whether the hospital-acquired infection rate is low. If we measure surgical site
infectionrate,whichisanoutcomeofseveralstructuresandprocesses,weareindirectlymeasuring
structures and processes. Therefore, if the surgical site infection rate has gone up, weneed to look
into individual structures and processes that contribute to the outcome. For example, we may look
into factors such as whether antibiotic prophylaxis was given half an hour before surgery (process),
presence of hand wash facilities in the surgical ward (structure), proper OT air conditioning
(structure),andavailabilityofsterileequipment(structure).
To summarize, we may measure quality by measuring structure, process or outcome by using Key
PerformanceIndicators(KPI).KPIsareindicatorsthathelptoobjectivelydiscernthefunctioningofa
particular process or a system. As the health system is very complex with multiple stakeholders
playing a keyrole in any process, it is very difficult to determinethe performance of a process unless
an indicator which is measurable is developed. For example, if a doctor is asked about the
medicationerrorsinhisworkplace,hemayacceptthatmedicationerrorsdohappen,buthewillnot
be able to identify the nature of medication errors and the measures to be taken to decrease them.
If the number of medication errors are captured as an indicator, they may be classified and a root-
causeanalysisconductedtodecreasethenumberofmedicationerrors.Someindicatorssuchasthe
time taken for the initial assessment, surgical site infection rate, catheter-associated urinary tract
infection rate, are clinical indicators which are directly related to clinicians, which include doctors
and nurses. There are other indicators that are directly related to hospital administration, such as
thenumberofemergencymedicineswhichareoutofstock.
II.REQUIREDDOCUMENTS
The SHCO may choose some indicators from the list of indicators found in NABH Accreditation
Standards,thirdedition,November2011.
i. SOPforCollectionandAnalysisofKPI
Each SHCO can create its own indicators but listed below are some examples of Key
Performance Indicators. There is no ruleon 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
Indicatorsare.
lClinical: mortality rate, percentage of cases where preoperative antibiotic was given,
incidence of catheter-associated UTI, number of surgical site infections, number of
errorsinreportingofLabinvestigations.
lNonclinical: OPD waiting time, patient satisfaction rate, number of stock outs of
emergencymedications,numberoferrorsinbilling.
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86. 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)
1. Identification of KPI Quality team/Administration
2. Identification of personnel to collect the data Quality team
3. Data collection format to be defined for each of the Quality team
identified KPI
4. Periodicity of collection and review to be defined Quality team and administration
5. Collection of data using standardized format Quality team/personnel
identified by the Quality team
6. Verification and validation of data Quality team
7. Analysis of data Quality team with the
stakeholders
8. Identification of variation in trends Quality team
9. Root-cause analysis and corrective and preventive Quality team and stakeholders
action taken wherever necessary (in case of negative
trends or worsening of performance)
10. Review of the KPI Administration, Quality team
and stakeholders
11. Inclusion of new KPI Administration and Quality
team
Administration
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87. III. TASKS AND RESPONSIBILITIES
No. Tasks Responsibility
i. Form a Quality team with representation from
various key areas
ii. Identify KPI Departmental heads,
Quality team, Top management
iii. Agree on sample size and data collection format Quality team
iv. Collect data Selected personnel from Quality
team
v. Validate data Quality team
vi. Present data in a common forum (quality Quality team/Administration
committee meeting or KPI meeting)
vii. Compile the data in a presentation Quality team
viii. Presentation and analysis of KPI All stakeholders, Top
management, Quality team
ix. Conduct root-cause analysis User departments and Quality
team
x. Take corrective and preventive action User departments, Quality team,
Administration
xi. Periodic review of quality function Quality team, Top management
Top management
IV.AUDIT CHECKLIST
No. Checkpoint Yes No Remarks
i. Quality team is formed
ii. Some KPIs are identified
iii. Formula or sample size, and method of
data collection is determined
iv. Indicators are discussed and measures taken
to improve the quality
V. REFERENCES
AccreditationStandardsforHospitals,NABH,3rdEdition,November2011.
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88. STANDARDROM1.THERESPONSIBILITIESOFTHEMANAGEMENTAREDEFINED.
ObjectiveElements
ROM1a.TheSHCOhasadocumentedorganogram.
ROM1b.TheSHCOisregisteredwithappropriateauthoritiesasapplicable.*
ROM1c.TheSHCOhasadesignatedindividual(s)tooverseethehospital-widesafetyprogram.*
*Objective Elements ROM1b and ROM1c are self-explanatory and therefore not included in this
Guidebook.
ROM1a.TheSHCOhasadocumentedorganogram.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope:To guide the SHCO on prepaing a picture of the structure of the SHCO, namely, its leadership,
its functional levels - departments, units, subunits - and the jobs at different levels, as well as the
relationshipbetweenpersonnelandbetweenlevelsofjobs.
Aneffectiveorganogrammaybepreparedwiththehelpofthefollowingstepsandprinciples:
i. Thedifferentfunctionaries(designations)andfunctionalunits(departments)arelisted.
ii. AclearchainofcommandorhierarchyexistsinthefunctioningoftheSCHOwhichprovides:
a. Apathwayfortheflowofinformationfromtoptobottomandviceversa.
b. Anindicationofwhomtoreporttoregardingday-to-dayfunctioning.
c. Anindicationofwhomtoapproachforescalationinproblemresolution.
d. Anindicationofcross-relatedfunctionaldepartmentsandindividuals.
iii. Thisisrepresentedintheformofaflowchart.
iv. Under each functional unit or department, it is possible to similarly list out the different
categoriesof staff in the unit, number of staff in each category, and the hierarchy within the
unitstartingfromthedepartmenthead,andsectionin-charges.Thisisoptional.
v. The organogram forms the framework based on which an adequate mix of staff is made
availabletocatertotheservicesrenderedintheSHCO.
Chapter 6
RESPONSIBILITIES OF MANAGEMENT (ROM)
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89. II.REQUIREDDOCUMENTS
Policy
The SHCO has an up-to-date organogram (see Annexure) that outlines the leadership, the different
functionaldepartments,andhierarchicalrelationshipbetweentheseentities.
Procedure
No. Procedure Responsibility Supporting
Documents
i. The organogram is prepared and authorized
by the SHCO management
ii. All staff are aware of the organogram and the HR staff or Quality Induction training
organizational structure it represents. This is department staff or material
done through Heads of respective
lInduction program at the time of joining departments
lRegular training for existing staff Training material
on SHCO-wide
policies and
procedures
Top management Organogram
No. Task Responsibility
i. Prepare the draft organogram. HR in-charge
ii. Review the draft organogram Top management and
o Practice on the ground should reflect what the HR department
management planned.
o Opportunities for streamlining the hierarchy are
identified and suitable changes made.
iii. Authorizing the organogram Head of the SHCO
o Signature of the Head of the SHCO is affixed.
o The date from which it is effective is mentioned.
III. TASKS AND RESPONSIBILITIES
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90. IV. AUDIT CHECKLIST
Frequency of audit: At least once a year as part of a hospital-wide audit.
No. Checkpoint Yes No Remarks
i. The organogram is present.
ii. The organogram is approved by the Top
management.
iii. All departments are represented in the
organogram.
iv. All management levels are represented.
v. The hierarchy is accurate.
vi. Cross-reporting, if any, is represented.
ANNEXURE
Organogram (This is a representative organogram. The hospital may replace the prompts with
actualdesignationsandsuitablymodifyit.)
Head of the SHCO
(Designation)
Second Level Leaders
Department
Department
Sub-unit Sub-unit
Sub-unit Sub-unitDepartment
Department
Department Department
Department
Department
Department
Second Level Leaders
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Second Level Leaders

91. Departmental structure (This is optional. The hospital may replace the prompts with actual
designationsandnamesofunitorsubunits)
Staff category Staff category
Section In-charge
Department Head
Sub-unitSub-unit
Staff category
Section In-charge
Section In-charge
Staff category Staff category
Staff categoryStaff categoryStaff category
Section In-charge
STANDARDROM2.THESHCOISMANAGEDBYTHELEADERSINANETHICALMANNER.
ObjectiveElements
ROM2a.ThemanagementmakespublicthemissionstatementoftheSHCO.
ROM2b.TheleadersormanagementguidetheSHCOtofunctioninanethicalmanner.*
ROM2c.TheSHCOdisclosesitsownership.*
ROM2d.TheSHCO'sbillingprocessisaccurateandethical.*
*Objective Elements ROM2b, ROM2c, and ROM2dare self-explanatory and therefore not included
inthisGuidebook.
ROM2a.ThemanagementmakespublicthemissionstatementoftheSHCO.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope: To orient the management of the SHCO, and in turn the staff, to the rationale of the SHCO
thatisencapsulatedinthemissionstatement.
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92. The mission statement refers to the overall purpose of an organization. The mission answers the
question,"Whatdoestheorganizationaimtoaccomplish?"
Missionstatementsaredesignedtofulfilthreebasicpurposes:
a. Toinspireandmotivateorganizationalmemberstohigherlevelsofperformance.
b. Toguideresourceallocationinaconsistentmanner.
c. To create a balance among the competing, and often conflicting interests of various
organizationalstakeholders.
The contentofthemissionstatementusuallyincludesthefollowingcomponents:
a. Purpose - defines the patients, stakeholders, markets, and geographical areas served, and
servicesprovided.
b. Strategy - refers to the tools used such as distinctive or core competencies, technologies,
elementsofgrowthandprofitability,andtheself-imageoftheorganization.
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,traininganddevelopment.
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,andcreative.
II.REQUIREDDOCUMENTS
Policy
Thehospitalhasadefinedmissionstatement,displaysthesame,andabidesbyit.
No. Procedure Responsibility Supporting
Documents
1. The Top management enunciates the
mission statement
2. This is made public in the following Operations Head Plaque (e.g. brass or
locations: and Maintenance marble).
Entrance lobby /Facility in-charge Boards and framed
Foundation stone statements. Slide
In all common waiting areas presentation.
Inhouse documents
as applicable. Online
content if present.
Others (the SHCO
shall specify other
modalities).
Top management Mission statement
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93. No. Procedure Responsibility Supporting
Documents
3. All the staff are aware of the mission
statement. This is done through department staff, or material.
lThe induction program at the time Heads of respective Training material on
of joining departments SHCO-wide policies
lRegular training for existing staff and procedures.
4. The mission statement is included HR department, All manuals.
in all the manuals in the SHCO Quality department Hospital brochure.
HR staff , or Quality Induction training
III.TASKSANDRESPONSIBILITIES
No. Task Responsibility
i. List out the words that best describe the
purpose, strategy, values and behavioral HODs
standards of the SHCO.
ii. Discuss the relationship of these elements Top Management, senior leaders or
for both organizational success and employee HODs
motivation.
iii. The list of descriptive words is clear and final, Top Management, senior leaders or
avoiding duplication and exaggeration. HODs
iv Frame a comprehensive statement which Top Management, senior leaders or
incorporates all the descriptive terms in a HODs
logical and meaningful manner. The statement
may be a single, all-inclusive sentence or
broken into simple short multiple sentences.
v Ensure that the mission statement is Top management
authorized by the Top management. The
signatory is identifiable or it may simply
mention "Management" or "Board of Trustees"
or the like.
vi Incorporate the mission statement in the Quality Department or HR
SHCO's documentation, such as manuals, department
brochures, training material.
vii Display the mission statement to the public Operations Head and
at the entrance lobby and in prominent Maintenance/Facility in-charge
common areas across the SHCO, and online IT Dept
media.
Top Management, senior leaders or
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94. IV.AUDITCHECKLIST
Frequency:Onetimeaudit
Onetimeaudit:Presenceorabsenceofamissionstatement.
V.REFERENCES
Forehand, A., "Mission and Organizational Performance in the Healthcare Industry". Journal of
HealthManagement,July-August2000,Vol.45,No.4,pp.267-77.
Pearce, John A. and Fred David, Corporate Mission Statements: The Bottom Line, The Academy of
ManagementExecutives,May1987,Vol.1,No.2,pp.109-115.
Smith, Mark, Ronald B. Heady et al. Do Missions Accomplishtheir Missions? An Exploratory Analysis
ofMissionStatementContentandOrganizationalLongevity.Availableat
http://www.huizenga.nova.edu/Jame/articles/mission-statement-content.cfm
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95. STANDARD FMS1. THE SHCO's ENVIRONMENT AND FACILITIES OPERATE TO ENSURE SAFETY OF
PATIENTS,THEIRFAMILIES,STAFFANDVISITORS.
ObjectiveElements
FMS1a. Internal and external signages shall be displayed in a language understood by the patients
or familiesandcommunities.*
FMS1b.Maintenancestaffiscontactableroundtheclockforemergencyrepairs.*
FMS1c. The SHCO has a system to identify the potential safety and security risks including
hazardousmaterials.
FMS1d.Facilityinspectionroundstoensuresafetyareconductedperiodically.*
FMS1e.Thereisasafetyeducationprogrammeforrelevantstaff.*
*Objective Elements FMS1a, FMS1b, FMS1d, and FMS1e are self-explanatory and therefore not
includedinthisGuidebook.
FMS1c. The SHCO has a system to identify the potential safety and security risks including
hazardousmaterials.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope: To ensure the safety of patients, families, staff and visitors to the SHCO by identifying all the
potentialrisks,andhavingadequatesafetymeasuresinplacetopreventaccidentsandharm.
Risk is a potential threat thataffects 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
recommendedthat
lStaff be educated about the various risks in the hospital environment, identify potential
risks,manageandreportthemimmediately.
lAppropriate mechanisms be implemented for the staff and visitors to report any identified
potentialrisk.
Chapter 7
FACILITY MANAGEMENT AND SAFETY (FMS)
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96. lThe reported risks be addressed immediately and appropriate corrective and preventive
measuresbetakentomitigatetherisk.
II.REQUIREDDOCUMENTS
i. Protocolforreportingpotentialrisks
ii. Protocolformanagingdifferentriskswhentheyoccur
SAMPLEDOCUMENTS
Sampleprotocolforreportingpotentialrisks
Procedure
All staff are trained to identify and report safety and
security risks in the SHCO.
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.
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.
On receiving the call, the information should be
recorded in the Incident Register with the date,
time, caller details and the reported incident.
The information should be passed on to the
designated person concerned, who in turn will have
to contact groups responsible for addressing the
complaint.
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.
Responsibility
HR/Training
department
All staff members
All staff members
All staff members
Designated person/
Concerned
departments
Front desk/ Reception
Front desk/Reception/
Designated person/
Concerned
departments
Designated person
Supporting
Documents
Training records
Reporting forms/
Register
Reporting forms/
Register
Reporting forms/
Register
Reporting forms/
Register
Reporting forms/
Register
Reporting forms/
Register
Inspection
report
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97. Sampleprotocolformanagingdifferentriskswhentheyoccur
Someofthecommonrisksinahospitalenvironmentinclude:
a) Chemicalhazards-hazardouschemicals(includingblood,andtheirspillage)
b) Securityrisks-theft,abduction,sabotage
c) Firerisksduetosmoking,shortcircuits
d) Risktobuildingandinfrastructure-lightning,termites
e) Risktopatientlikeinfections,falls,medicationerrors,cauteryburns
a)RisksduetoHazardousChemicals
There are many hazardous chemicals in the SHCO environment such as mercury, glutaraldehyde,
cleaning chemicals, lab reagents. The primary objective is to identify all the chemicals stored in the
SHCO and guide their storage, usage and spill kits made available as per the MSDS (Material Safety
and Data Sheet) for each chemical. All staff handling these chemicals must be aware of how to
handlethemandwhattodoincaseofaspillorsplashofthechemical.
Example1:Handlingmercuryspillsinhospitals
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
thespilloccurs,thefollowingprotocolmaybeadopted.
lIncreaseventilationintheroombyopeningthewindows.
lPick up the mercury with a dropper or scoop up beads with a piece of heavy paper like
playingcards.
lPlace the mercury-contaminated instruments (dropper/heavy paper) and any broken glass
inaplasticzipperbag.
lDispose of waste mercury as toxic waste. Double-bag the waste and incinerate it; however,
itismoreenvironmentallyacceptabletoforwardthewastetoreclaimthemercury.
lIt is advisable to reduce the usage of mercury-containing equipment. All conventional
mercury thermometers may be replaced with infrared thermometers (non-touch). Hg-
containingBPapparatusmaybereplaced.
Whencleaningupamercuryspill:
lDo not use household cleaning products, particularly products that contain ammonia or
chlorine.Thesechemicalswillreactreleasingatoxicgas.
lDonotuseabroomorpaintbrush.Itwillspreadthemaroundbybreakingthemintosmaller
beads.
lDonotusevacuumasitwilldispersemercuryvapourintotheairandincreasethelikelihood
ofhumanexposure.
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98. b)SecurityRisks
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
theiroccurrenceandtoaddressthem,incasetheyhappen.
Theftinhospital
lAllstaffshouldwearhospitalIDatalltimes.
lStaffmustreportanyunidentifiedindividualsorsuspiciousactivity.
lVisitorswithoutguestpasseswillnotbepermittedinsidetheSHCO.
lCCTVmonitoringofthecorridorsandcommonareasisnecessary.
lPatientstobeinstructedtokeeptheirbelongingssafeandlocked.
lTheftmustbeimmediatelyreportedtothesecuritydepartment.
lSecurity department must take control of the scene and scrutinize all CCTV recordings and
movements.
lAllstaffintheareashouldbeinterrogatedaboutanysuspiciousmovement.
lEvery effort must be made to solve the case. Security department must include the senior
doctororseniornursewhilehandlingtheinvestigation.
c)RiskofFire
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
preventionmeasuresincludethefollowing:
lStrictprohibitiononsmoking.
lPositioningofheatsourcesawayfromcombustiblematerials.
lGoodhousekeepingandpreventionofaccumulationofeasilyignitablerubbishorpaper.
lSupervision and control of contractors or employees using blowlamps, cutting or welding
equipment.
lRisk assessment and control in the purchase of articles and substances to avoid the
introductionoffirehazardswheneverandwhereverpossible.
lStrictpreventive maintenance programs for electrical wiringand appliances, like non use of
loosewires,extensioncords,multipletappingfromasingleload.
lSupervisionofcookingfacilities.
lAvoidinguseofelectricalandelectronicequipmentwithdamagedandtwistedwires.
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
totheirworkplaceaswellas basictechniquesontheuseoffireextinguishers.
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99. d)RiskofElectricalShocks
Although the chance of electrical shock is less common, once it occurs, there is a high chance that it
willresultincasualtiesandpropertydamage.
GeneralPreventionMeasures
lDonotexposethelivepartofawireoranyelectricalappliance.
lAllelectricalappliancesmustbegroundedproperly.
lCircuitbreakersmustbeinstalledforreducingtheseverityofelectricshockaccidents.
lDonottouchelectricalapplianceswithwethands.
lBesuretousestandardregulationfusesforswitchesandnotcopperorsteelwire.
lDonopermituseoffaultyormalfunctioningelectricalproducts.
lDonotusewiringwithalinkinthemiddletoconnecttwoseparatewires.
lDonothaveloosewiresinthefacility.
lHave good standard wiring and do not permit substandard wiring that does not follow
electricalsafetyrequirements.
lStaff operating the equipment must be trained and have adequate knowledge on the use of
equipment.
lConductperiodicsafetyinspectionsinordertodetectpotentialproblems.
e)RiskofFall
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
interventionsarerequiredtopreventfalls.
Topreventfalls,thefollowingmaybeobserved:
lAllwheelchairsandstretchersusedfortransferringpatientsshouldhaverestraintbelts.
lAll roads and corridors must be level and any broken or chipped floor tiles should be
immediatelyreplaced.
lWhile cleaning, the area should be cordoned off with appropriate signage like "wet floor".
Anyspillagemustbecleanedimmediately.
lHandrailsmustbeprovidedforstaircases.
lThe end of a passage and the beginning of the stairs must be demarcated in a different
colour.
lGrabbarsmustbeprovidedinalltoilets.
lAdequatelightingmustbepresentinallareas.
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100. III.TASKSANDRESPONSIBILITIES
No. Task Responsibility
i Train staff on potential risks HR Department / Training department
ii Report any potential risk All staff
iii Analyze the risk Designated person or group
iv Implement risk mitigation strategies Administration, designated person or group
IV.AUDITCHECKLIST
No Checkpoint Yes No Remarks
i Training of staff on risks - identification,
management and reporting of risks
ii Staff interviews that show awareness
of staff on risks, identification,
management and reporting of risks Training records- Yes/ No
iii Documentation of reported
potential risks
iv Protocol followed to address the
reported incident or potential risk
v Analysis of the reported risks
vi Risk mitigation in terms of corrective
and preventive action taken Available/Not available
vii If there was any change in protocol,
awareness of staff on the recent
protocol.
STANDARDFMS2.THESHCOHASAPROGRAMFORCLINICALANDSUPPORTSERVICEEQUIPMENT
MANAGEMENT
ObjectiveElements
FMS2a.TheSHCOplansforequipmentinaccordancewithitsservices.*
FMS2b.Thereisadocumentedoperationalandmaintenance(preventiveandbreakdown)plan.
*ObjectiveElementFMS2aisself-explanatoryandthereforenotincludedinthisMnaual.
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101. FMS2b.Thereisadocumentedoperationalandmaintenance(preventiveandbreakdown)plan.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope: To ensure that equipment is used or operated in the right manner, equipment is checked
periodicallytoavertrepairs,andalsotoaddressrepairsimmediately,iftheyoccur.
SHCO equipment includes biomedical equipment like monitors or infusions, used for direct patient
care and engineering equipment such as generators and motors for the functioning of the hospital.
It is recommended that they be operated and maintained appropriately, otherwise it could
compromisepatientcare.
Operationalplan
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
technicianbetrainedinsafeoperationbytheequipmentcompany.
Maintenanceplan
lMaintenanceplanaddressespreventiveandbreakdownmaintenance.
lTheprimaryaimofpreventivemaintenanceistoavoidormitigatefailureofequipment.Itis
designed to preserve and restore equipment reliability by replacing worn components
before theyactually fail,and includes partial or complete overhaul at specified periods. For
example,oilchanges,lubrication.
lBreakdownmaintenance intends to address the mechanism to get the equipment repaired
properly,andwithoutdelay,iffailureshaveoccurred.
lBoth preventive and breakdown maintenance may be outsourced in the form of Annual
Maintenance Contract (AMC) or Comprehensive Maintenance Contract (CMC) or it could
bedonebyqualifiedinhouseengineers.
II. REQUIREDDOCUMENTS
i. Inventoryofequipment.
ii. Checklistsandoperationalinstructionsforallequipmentbasedonoperator'smanual.
iii. Plannedpreventivemaintenancescheduleforallequipment.
iv. Handlingbreakdownrepairsofequipment.
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102. SAMPLEDOCUMENTS
Sampleinventoryofequipment
lAs good practice, all equipment should be inventoried with a unique numbering system
developed by the SHCO. This could be available on the machine in the form of a sticker or
writtenwithmarkingink.
lExample for inventory number: Simple running numbers like 001, 002 or BBH/ BM/ DEFIB/
003.
nBBH-BangaloreBaptistHospital
nBM-BiomedicalEquipment
nDEFIB-Defibrillator
n003-Runningnumber
lInventory number and serial number (assigned by manufacturer) are the two IDs of the
equipment.
lA database in the form of an excel sheet, or in the form of hard copy as register, or a
softwarecouldbemaintained.
lInventory should be managed and updated by the engineering team when new equipment
isboughtoroldequipmentiscondemned.
Sampleofinventorysoftware
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103. Sample protocol for the operational plan for all equipment
Procedure
The operational plan should be as per the
instructions of the manufacturer as each
manufacturer and each model of equipment will
have different operating instructions.
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.
The equipment must be operated based on the
operating instructions or plan.
The operating instructions should be available with
the operator or hung on the machine.
Responsibility
Engineering
Engineering / Staff
handling the
equipment
Staff handling the
equipment
Staff handling the
equipment
Supporting
Documents
Operational plan
for each
equipment
Training records/
checklist and
records
Operational plan
for the
equipment
Operational plan
for the
equipment
SampleOperationalplan-UserChecklist
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104. Procedure
A preventive maintenance schedule must be
prepared by the engineering team.
The planned preventive maintenance schedule may
vary for different equipment - quarterly, semi-
annually or annually, depending on the
manufacturer.
PPM can be carried out by the engineering staff or
outsourced.
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.
Records of preventive maintenance must be
maintained for each equipment.
Responsibility
Engineering
Engineering
Engineering
Engineering
Engineering
Supporting
Documents
Preventive
maintenance
schedule
Operators
Manual
Records of
preventive
maintenance
Intimation to the
users
Records of
preventive
maintenance
III. TASKS AND RESPONSIBILITIES
If the machine is not functioning, information
should be passed on to the engineer or the
outsourced company handling the equipment.
The repair may include spare part replacement and
small component replacement.
After the machine is brought back to normal
working condition, complete calibration and testing
has to be 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.
Records of the time of raising the complaint, the
person who raised the complaint, the job
completion, and equipment handing over time
along with the types of repair done should be
maintained.
Staff who handles
the equipment
Engineer/ Outsourced
engineer
Engineer/ Outsourced
engineer
Engineer
Engineer
Complaint
register
Receipts
Records of repair
done
Complaint
Register
Complaint
register
Sample protocol for handling breakdown repairs of equipment
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105. STANDARD FMS3. THE SHCO HAS PROVISIONS FOR SAFE WATER, ELECTRICITY, MEDICAL
GAS,ANDVACUUMSYSTEMS.
ObjectiveElements
FMS3a.Potablewaterandelectricityareavailableroundtheclock.*
FMS3b.Alternatesourcesareprovidedforincaseoffailureandtestedregularly.*
TASKS AND RESPONSIBILITIES
No. Tasks Responsibility
i. Inventory of all equipment Engineer
ii. Training of the technician operating the equipment Engineer
iii. Operational plan for every machine based on the Engineer/ Staff handling the
operator's manual equipment
iv. Preventive maintenance schedule for each machine Engineer
based on the operator's manual
v. Addressing breakdown and repairs Engineer
vi. Records of preventive and breakdown maintenance Engineer
IV.AUDITCHECKLIST
No Checkpoint Yes No Remarks
i. Engineer or outsourcing of the
equipment management based on
competency
ii. Updated inventory of all the equipment
iii. Availability of inventory number on
the machines
iv. Training or competency of technician Training records- Yes/ No
on the operation of the equipment
v. Operational plan for the equipment as
per the operator's manual
vi. Preventive maintenance schedule as
per the operator's manual
vii. Breakdown maintenance or complaint Available/ Not available
register - addressing and recording of
time for repairs
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106. FMS3c.Thereisamaintenanceplanformedicalgasandvacuumsystems.
*Objective Elements FMS3a and FMS3b are self-explanatory and therefore not included in this
Guidebook.
FMS3c.Thereisamaintenanceplanformedicalgasandvacuumsystems.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope: To ensure that there is safe and continuous supply of medical gases and vacuum for the
patientsinthewards,ICUs,OTs.
Medical gases form the very backbone of an SHCO. Without them it would be impossible to run a
healthcareorganization,astheyplayanessentialroleinthefunctioningofcriticalcareunitsandkey
operationalareas.
Itisrecommendedthat:
Medical gas installations are constructed as per norms and licenses obtained for Liquid Medical
Oxygen(LMO)asperrequirements.
Strictsafetyrequirementsasperthenormsarefollowed.
Trained medical gas operators or technicians be available in the case of central supply and
continuoussupply.
Maintenanceshouldbedoneregularlyasperrequirements.
II.REQUIREDDOCUMENTS
i. Protocolforoperatingmedicalgasandvacuuminstallationsshallbemanagedasperpolicy.
ii. Daily,weekly,monthlyandannualmaintenanceschedule.
iii. Uniformcolourcodingofmedicalgaspipelines.
SAMPLEDOCUMENTS
Sample Protocols for operating medical gas and vacuum installations shall be managed as per
policy.
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107. Procedure
Medical gas installations and vacuum installations
shall be managed by adequate staff.
Appropriate backup (cylinders) shall be made
available to handle any emergencies that arise out
of the failure of piped medical gases.
Appropriate personal protective devices such as
earmuffs and rubber gloves should be used by the
staff.
Medical gas and vacuum installations shall be
maintained as per protocol.
Responsibility
HR/Engineering
Engineering
Engineering
Engineering
Supporting
Documents
Personal Files
Records of
backup cylinders
Actual
availability/
Inspections at
random
Daily, weekly,
monthly and
annual
maintenance
schedule,
records of
maintenance.
Daily, weekly, monthly and annual maintenance schedule
No. Daily Check Parameters to be checked
1. LMO tank (if available) Tank level, pressure
2. Vacuum pump Pressure, machine running status (lead, standby, last),
oil level, belt tension, loading and unloading pressure
range, auto drain
3. Air compressor Pressure, machine running status (lead, standby), oil level,
belt tension, temperature, water pressure, cooling tower
working, loading and unloading pressure range
4. Nitrous oxide, carbon Line pressure, heater coil, cylinder stock
dioxide, oxygen manifold
Weekly Maintenance
All medical gas outlets of the clinical area to be checked for pressure range and leaks. If the
pressure drops, the outlet needs to be scanned.
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108. Monthly Maintenance
No Daily Check Parameters to be checked
1. Vacuum Pump Cleaning, oil level and quality, belt tension check for fasteners, auto
drain and check for silencer cleaning, loading and unloading
pressure range.
2. Manifolds Line pressure, heater coil, cylinders stock, leak test.
3. Air compressors Cleaning, oil level and quality, belt tension check for fasteners, auto
drain and check for silencer cleaning, water pressure, temperature
sensor, cooling tower, loading and unloading pressure range,
servicing suction and discharge valves, and servicing of NonReturn
Valve.
AnnualMaintenance
Aspertheequipmentrequirementsandmanual,thoroughoverhaulshouldbeperformed.
Colourcodingofmedicalgaspipelines:
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109. III.TASKS AND RESPONSIBILITIES
No Task Responsibility
i. Procure license for the LMO Engineer
ii. Ensure daily, weekly, monthly and annual checks are done as Engineer
per requirement
iii. Uniformly colour code in a standardized manner (as per international Engineer
colour coding of medical gas and vacuum systems)
iv. Update medical gas pipeline drawing Engineer
v. Ensure safety signage Engineer
IV.AUDITCHECKLIST
No Checkpoint Yes No Remarks
i. Safety signage present
ii. Actual storage of empty and filled cylinders
iii. By-pass in case of emergencies and back up
iv. Valves shut off in different loops
v. Chained cylinders
vi. Mechanism of loading and unloading cylinders
vii. Leak detection systems
viii. Daily, weekly and monthly checks by operator
ix. Annual overhaul
x. Standardized colour coding of pipelines
xi. Condition of the cylinders, colour coding.
xii. Personnel protective equipment for the staff
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110. STANDARD FMS4. THE SHCO HAS PLANS FOR FIRE AND NONFIRE EMERGENCIES WITHIN
THEFACILITIES.
ObjectiveElements
FMS4a. The SHCO has plans and provisions for early detection, abatement, and
containmentoffireandnonfireemergencies.
FMS4b. The SHCO has a documented safe exit plan in case of fire and nonfire
emergencies.
FMS4c.Staffistrainedfortheirroleincaseofsuchemergencies.*
FMS4d.Mockdrillsareheldatleasttwiceinayear.*
*Objective Elements FMS4c and FMS4d are self-explanatory and therefore not included in
thisGuidebook.
FMS4a. The SHCO has plans and provisions for detection, abatement and containment of
fireandnonfireemergencies.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing
theirowncustomizeddocuments.
I.OVERVIEW
Scope: To ensure that adequate systems are available for the early detection, abatement
and containment of fire and nonfire emergencies to ensure the safety of the occupants
(patients,relatives,staff)andinfrastructureoftheSHCO.
In an SHCO set-up, potential emergency situations include fire emergencies and nonfire
emergencies such as terrorist attacks, stray animals, earthquakes, antisocial behaviour of
relatives, chemical spillage, structural collapse, patient fall, flooding, and bursting of
pipelines.
Itisrecommendedthat:
i. Smoke detectors, leak detectors, and systems like alarms, hooters, and Public
Address(PA)systemsbeavailableforuseincaseofemergencies.
ii. Thesesystemsbemaintainedandtestedtoensuretheirfunctionalityatalltimes.
iii. A trained multidisciplinary team handle such emergencies wherein a common
telephone number (help line) or other mechanisms be used to alert and activate
thisteam.
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111. II.REQUIREDDOCUMENTS
Protocolforthemanagementoffireandnonfireemergencies.
SAMPLEDOCUMENTS
Sampleprotocolforthemanagementfireandnonfireemergencies.
Procedure
All emergency detection and fighting systems in the
SHCO should be kept active at all times. For
example-
lFire alarm and detection system
lPortable fire extinguishers
lFire hydrants
lFire hose boxes and reels
lFire water pumps
lWater storage and sumps for fire fighting
lLeak detection system. For example, LPG or
medical gas
The systems should be tested frequently
All staff should be trained in handling fire and
nonfire emergencies in the SHCO.
Any person who witnesses a fire or leak or any
other emergency should immediately call for help.
The staff member should immediately try to fight
the fire or handle the situation based on the
training provided.
The team set for the purpose should be present and
take over the situation immediately.
Based on the situation, the team leader should
decide if additional help is required from outside
such as the fire department or police.
Responsibility
Engineering
Engineering
HR/Training
department
All staff
Staff
Designated team
Designated team
Supporting
Documents
Maintenance
records and
checklists
Maintenance
records and
checklists
Training records
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112. III.TASKS AND RESPONSIBILITIES
No Task Responsibility
i. Fire detection systems as per National Building Code (NBC) Head of SHCO
ii. Fire fighting systems as per NBC Head of SHCO
iii. Leak detection system of LPG bank, medical gas bank as per norms Engineer
iv. Protocol for emergency contact Designated
team
v. Staff awareness of their role in reporting or escalation of any HR/ Training
potential emergencies department
vi. Staff awareness of their role in early containment of a potential HR/ Training
emergency department
IV. AUDITCHECKLIST
No Checkpoint Yes No Remarks
i. Fire detection systems as per norms
ii. Fire fighting systems as per norms
iii. Checking or testing records of the detection and
fighting systems
iv. Leak detection systems as per norms
v. Emergency communication systems
vi. Plan for managing fire and nonfire emergencies
vii. Staff training
viii. Awareness of staff on the plan
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113. FMS4b. The SHCO has a documented safe exit plan in case of fire and nonfire
emergencies.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing
theirowncustomizeddocuments.
I.OVERVIEW
Scope: To ensure that the occupants of the SHCO building are evacuated to safety in case of
an emergency situation. In order to do so, it is recommended that the SHCO should have
safeexitplansforitsoccupants.
Itisrecommendedthat:
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
specificationsforbuildingswhichconductevacutionsinanemergency.
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
conductingmockdrills.
II. REQUIREDDOCUMENTS
i. EmergencyFloorPlans
ii. EmergencyEvacuationPlan
SAMPLEDOCUMENTS
SampleofEmergencyFloorPlan
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
orientthepersonlookingatthefloorplan,whichisusuallymarkedas"Youarehere".
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114. ExampleofEmergencyEvacuationPlan
lAll staff in the SHCO should be trained in basic firefighting techniques, like handling fire
extinguishers.
lAllstaffintheSHCOshouldbeawareoftheirroleinanyemergency.
lSignagessuchasemergencyfloorplansandfireexits,shouldbeavailableinallareas.
lEmergency lights should be available for facilitating evacuation in an emergency, as power
supplyisturnedoff.
lThe SHCO may have a central person designated to be the first point of contact in
emergencies.
lIn caseof fire, it couldbe the securityin-chargealong with the engineeringor maintenance
staffwhocouldtakeoverthefirefightingoperation.
lThere should be an established method,like alarms, PA system or central phone to alert the
team.
lThe fire fighting team should immediately proceed to the scene with additional firefighting
equipment,trytoextinguishthefire,orescalatetothecityfiredepartment.
lThe 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
thatthesub-stationisstaffedandthatelectricsupplytothefire-affectedareaiscutoff.
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115. l
that the functioning and movement of the fire fighting team or Fire Brigade personnel are
nothampered.Theycanalsoassisttheteamifrequired.
lThe 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
evacuatedalongwiththeequipment.
lOne staff member should be designated by the Senior Nurse to check toilets and other
roomstomakesurethattherearenopatientshidingortrappedinthoseareas.
The housekeeping staff and other staff may form a ring around the scene of fire and ensure
III. TASKS AND RESPONSIBILITIES
No Task Responsibility
i. Building or Infrastructure facilities Head of SHCO
ii. Signage as per the requirement Designated person
iii. Emergency floor plans Designated person
iv. Emergency lights and availability Engineer
v. Emergency evacuation plan Designated team
vi. Mock drills for safe evacuation Designated team
IV.AUDITCHECKLIST
No Checkpoint Yes No Remarks
i. Green-coloured exit signage is clearly visible.
ii. Emergency lighting.
iii. Emergency floor plans are visible on all the floors
and at conspicuous places.
iv. An emergency evacuation plan exists.
v. Staff are trained in the emergency evacuation plan.
vi. Staff are aware of their roles during an emergency
evacuation.
vii. Mock drills are conducted to test the plan.
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116. V. REFERENCES
Accreditation Standards for Hospitals, NABH, 3rd Edition, November 2011.
Bureau of Indian Standards, National Building Code of India 2005, Group 1, New Delhi.
G. B. Menon, Fire Advisor, Government of India, Handbook on Building Fire Codes, Fire Fighting
and Fire Safety Requirements. Available at
www.urbanindia.nic.in/publicinfo/byelaws/chap-7.pdf
Fire Fighting and Fire Safety Requirements, Chapter 7. Available at
www.urbanindia.nic.in/publicinfo/byelaws/chap-7.pdf
IITK-GSDMA, Fire 05-V3.0. Available at
http://www.iitk.ac.in/nicee/IITK-GSDMA/F05.pdf
Indian Standards, Basic Requirements for Hospital Planning, Part 1 upto 30 bedded hospital, IS
12433 (Part 1): 1988.
Indian Standards, Basic Requirements for Hospital Planning, Part 2 upto 100 bedded hospital, IS
12433 (Part 2): 2001.
Indian Standards, Recommendations for Basic Requirements of General Hospital Buildings,
Part 3, Engineering services department, IS: I0905 (Part 3)-1984.
Medical Equipment Maintenance Program Overview. Available at
http://whqlibdoc.who.int/publications/2011/9789241501538_eng.pdf
NABH & Fire Safety. Available at
http://nabh.co/Images/PDF/Fire_Safety_NABH.pdf
OSHA (Occupational Safety & Health Administration) Technical Manual. Available at
www.osha.gov
R. Craig Schroll, Fire Detection and Alarm Systems: A Brief Guide, Dec. 01, 2007. Available at
http://ohsonline.com/Articles/2007/12/Fire-Detection-and-Alarm-Systems-A-Brief-Guide.aspx
www.bis.org.in
R. R. Nair, Fire Safety Expert and Consultant, Maintenance Schedule, adapted from lecture notes
of 2014.
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117. STANDARDHRM2.THESHCOHASAWELL-DOCUMENTEDDISCIPLINARYANDGRIEVANCE
HANDLINGPROCEDURE
ObjectiveElements
HRM2a.Adocumentedprocedureregardingdisciplinaryandgrievancehandlingisinplace.
HRM2b.ThedocumentedprocedureisknowntoallcategoriesofemployeesintheSHCO.
HRM2c.Actionsaretakentoredressthegrievance.*
*ObjectiveHRM2cisself-explanatoryandthereforenotincludedinthisGuidebook.
HRM2a.Adocumentedprocedurewithregardtotheseisinplace.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope:To guide the SHCO on taking prompt action for disciplinary action and grievance redressal by
designated individuals which helps to avoid bias or prejudice. It is recommended that the
management of the SHCO predefines the mechanism for addressing disciplinary action and
grievanceredressal.
i. Disciplinary action: This is the recommended sequence of activities carried out when staff
do not comply with laid-down norms, service standards, rules and regulations of the SHCO.
Staff should be made aware of the consequencesof not abiding with the applicablepolicies
of the SHCO. A memberof staff who is aware of disciplinary action is less likelyto commitan
offence. The mechanism identifies situations that warrant a review of the event by a
committee.Thequantumofthedisciplinaryactionmaybepredefinedforcertainsituations
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
thelaw.
ii. Grievance redressal: This is the recommended sequence of activities carried out to address
thegrievancesofpatients,visitors,relativesandstaff.ThestaffintheSHCOshouldbeaware
thatthere is a grievance redressal procedure if theydo 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
Chapter 8
HUMAN RESOURCE MANAGEMENT (HRM)
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118. committee rules whether the grievance is genuine or not and gives its recommendations
accordingly.Thereisscopetoappealtoahigherauthority.
II.REQUIREDDOCUMENTS
i.PolicyandSOPonDisciplinaryAction
DisciplinaryPolicyandProcedure
Policy: Staff who do not comply with their job description and other general requirements in the
SHCOwillbesubjecttoanestablisheddisciplinaryhearinganddisciplinaryactionifnecessary.
Procedure
Thisisasampleofadisciplinaryprocedure.
Complaint against staff
Preliminary assessment
of complaint by the HOD
Major offence
Counseling
Warning
or
Hearing in disciplinary
committee
Staff allowed to
present his/her
explanation
Complainant
presents the details
of the offence
Decision of disciplinary
committee
Gross misconduct Offence No Offence
Disciplinary actionTermination
Appeal
Decision reversed
Decision up held
No action
Repeat offender Minor offence No offence
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119. GrievanceHandlingPolicyandProcedure
Policy:Staffareempoweredtouseanestablishedmechanismtoaddressgrievances,ifany.
Procedure
Thisisasampleofagrievancehandlingprocedure.
Staff discusses
grievance with HOD
Resolution of grievance
Yes Discussion with HR
No resolution
No
Hearing in grievance
handling committee
Respondent is allowed
to present his/her
explanation
Complainant
presents the details
of the grievance
Decision of grievance
handling committee
Grievance upheld
Resolution
No cause for
concern
Action takenGrievance resolved
Appeal by any
involved party Decision reversed
Decision upheld
No action
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120. III. TASKS AND RESPONSIBILITIES
No Task Responsibility
Disciplinary procedure
i. Step-by-step description of the disciplinary procedure HR department
ii. Composition of the team or the designated individual who Authorized by Top
reviews the offence(s) management
iii. List quantum of action to be taken, ensuring that it is Authorized by Top
commensurate to the offence management
iv. Hearing of both parties Disciplinary committee
or designated individual
v. Decision on action to be taken against the erring member Disciplinary committee
of staff or designated individual
vi. Opportunity given to staff member to appeal to a Authorized by Top
designated individual management
vii. Implementation of action against staff HR department
viii. Constitution of an Internal Complaints Committee (ICC) to Authorized by Top
address complaints of sexual harassment at the workplace management
ix. Making available the name of the person that the alleged Any member of ICC or
victim should contact in order to present a any senior staff in
written complaint. whom the victim
confides
x. Acknowledgment of receipt of the complaint by the Member Secretary
alleged offender of ICC
xi. Immediate separation of the concerned individuals at the HR department (on the
workplace with stern caution to all concerned not to written instruction of
interact with each other on the complaint the Member Secretary
of ICC)
xii. Proceedings of ICC Member Secretary
of ICC
xiii. Action taken against the erring staff member Member Secretary
of ICC
HR department
Top management
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121. Greivance Handling Procedure
i. A step-by-step description of the grievance HR department
handling procedure
ii. Appointment of grievance handling officers Head of the department
Senior HR staff or Top
management
iii. Proceedings of the grievance handling procedure HR department
documented and decision implemented
iv. The written document for disciplinary action and grievance HR department
handling is finalized Quality department
IV.AUDITCHECKLIST
Frequencyofaudit:Atleastonceayearaspartofhospital-wideaudit.
No Checkpoint Yes No Remarks
i. Procedure for disciplinary action is available
ii. Procedure is available for addressing complaints
of sexual harassment in the workplace
iii. Procedure is available for addressing
grievance-handling
i Grievance handling procedure is reviewed and
approved by Top management on a yearly basis
v. All concerned documents and materials have the
updated procedure
vi. Records of disciplinary proceedings are maintained
vii. Records of grievance handling proceedings
are maintained
viii. Records of proceedings that handle complaints
of sexual harassment in the workplace are
maintained confidentially.
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122. HRM2b.ThedocumentedprocedureisknowntoallcategoriesofemployeesintheSHCO.
Note: Sections II and III below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
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
orprejudiceaswellas howtoaccessthegrievancehandlingmechanisminatimelymanner.
It is important for the staff to know the procedures that will be followed both for disciplinary action
and grievance redressal. It is recommended that the management should take the time and make
the effort to conduct training for the staff right from the time they join the SHCO, and also to
periodicallyretrainthemonthesame.
II. TASKS AND RESPONSIBILITIES
No Task Responsibility
i. The written document for disciplinary action and grievance handling HR department
is included in Quality
department
lThe compilation of SOPs in the HR department
lThe material for training staff on hospital-wide policies and
procedures
ii. Make staff aware of the procedures concerning disciplinary action HR department
and grievance handling. This is done through training HOD of
programs such as: respective
departments
lTraining for new staff Quality
department
lRetraining for staff - Retraining of staff on the
hospital-wide policies and procedures is done at least
once a year. This may be done by the HR department or
the respective department heads.
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123. No Checkpoint Yes No Remarks
i. All relevant documents and materials have the
updated procedure
ii. Staff interviews to check staff awareness and
understanding of the disciplinary procedure
iii. Staff interviews to check if staff show adequate
awareness on the grievance handling procedure
iv. Staff interviews to check staff awareness on
dealing with sexual harassment at the workplace
III.AUDITCHECKLIST
Frequencyofaudit:Atleastonceayearaspartofhospital-wideaudit.
STANDARDHRM3.THESHCOADDRESSESTHEHEALTHNEEDSOFEMPLOYEES.
ObjectiveElements
HRM3a. Health problems of the employees are taken care of in accordance with the SHCO's
policy.
HRM3b.Occupationalhealthhazardsareadequatelyaddressed.*
*ObjectiveElementHRM3bisself-explanatoryandthereforenotincludedinthisGuidebook.
HRM3a. Health problems of the employees are taken care of in accordance with the SHCO's
policy.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
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
servicesrendered.
The extent to which the hospital management supports the healthcare needs of the staff is partly
mandatoryandpartlydiscretionaryasperthefollowingprinciples:
i. Employeehealthbenefitisastatutory requirementiftheSHCOfallswithinthegamutofthe
Employee State Insurance Norms (more than 10 or more staff employed on the rolls). Staff
who earn less than Rs.15,000 gross salary are eligible as per the act and are provided free
treatment at the Employee's State Insurance (ESI) or ESI-empanelled hospitals. There is a
financial contribution from the hospital and the staff towards enlisting the eligible staff
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124. 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
SHCOshouldrefertothelatestnormsissuedundertheESIAct.
ii. Occupational hazards resulting in health problems also should be covered by the SHCO.
Theseinclude:
a. Preventive measures such as pre-exposure prophylaxis when possible - for example,
HepatitisBvaccineorInfluenzavaccineforstaffwhoareatrisk.
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
stafffromacquiringdiseasesintheSHCO.
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 amountof
discountorinsurancepremiumthatiscontributedbythehospitalislefttothediscretion
oftheSHCOmanagement.
II.REQUIREDDOCUMENTS
Policy: The health problems of the staff are addressed through pre- and post-exposure prophylaxis
andotherhealthbenefits.
SOPonEmployeeStateInsurance
No. Procedure Responsibility Supporting
Documents
1. Identification of all staff who are eligible under HR staff List of staff
the ESI Act under ESI
2. Enrollment of eligible staff under ESI with all HR staff ESI
relevant supporting evidences in exchange for correspondence
an ESI card files
3. Financial contribution made by the hospital HR/Accounts Accounts
and the staff towards enlisting the eligible staff department statement
under the ESI: Employees contribute 1.75 ESI statement
percent and employers contribute 4.75 percent
4. The required amount is remitted into the ESI Accounts Accounts
account within 21 days from the end of the department statement
due month. ESI statement
5. Separate training classes are held and HR staff HR training
handouts listing the benefits under the ESI material
are given to the staff.
6. Staff may access investigations and treatment at Concerned staff Medical records
ESI-empanelled hospitals as needed. Billing details
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125. HealthandTreatmentBenefitsforStaff
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
modifiedordeleted.
Type of benefit Eligibility Benefit
General health For staff not covered Percentage contribution from the staff and
insurance under ESI rest from the hospital
Optional for the staff
OPD All staff Percentage of discount
investigations
Staff dependents Percentage of discount
OPD All staff Percentage of discount
consultations
Staff dependents Percentage of discount
Inpatient stay All staff Percentage of discount for eligible room category
Percentage of discount on investigations
Percentage of discount on consultation and
professional fees for procedures
Staff dependents Percentage of discount for eligible room category
Percentage of discount on investigations
Percentage of discount on consultation and
professional fees for procedures
No. Procedure Responsibility Supporting
Documents
1. The details of the health benefits for staff and HR staff List of health
their dependents is listed and maintained by benefits
the HR department.
2. The staff are made aware of the benefits at the HR staff HR training
time of joining the SHCO. material
3. The front office, billing and admission desk HOD of Front Internal
staff are responsible for extending the benefits office, Billing, communication
to the staff in times of need. Admission
4. Staff should contact the HR In-charge in case HR In-charge -
of difficulty in accessing the health benefits.
Procedure
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126. SOPonPre-exposureprophylaxis
Pre-exposureprophylaxisforHepatitisB
1. Members of staff, at the time of joining, are evaluated for need of vaccination and then offered
vaccination.
2. IfthereisnoevidenceofHepatitisBvaccinationinthepast,thevaccineseriesisstarted.
3. If there are low levels of antibody despite previous vaccination, then a booster dose is
indicated.
4. Thevaccinationscheduleusedforadultsisthreeintramuscularinjections,thesecondand third
dosesadministeredat1and6months,afterthefirstdose.
5. Costsfortestingandvaccinationmaybebornebythehospitalatitsdiscretion.
SOPonpost-exposureprophylaxis
The following steps are initiated after a needle-stick injury or exposure of skin and mucous
membranestobloodandbodyfluids.
Apost-exposureprophylaxisisindicatedwhenthestaffmemberisexposedtobloodorbodyfluidor
needle-stickinjury.
lWoundormucousmembranemanagement
- Cleanwoundswithsoapandwater.
- Flushmucousmembraneswithwater.
- No evidence of benefit for application of antiseptics or disinfectants or squeezing
(milking)puncturesite.
- Avoidtheuseofhypoorotheragents.
lImmediate reporting to designated individual (Casualty or Duty medical officer or Infection
Controlofficer).
- Dateandtimeofexposure.
- Proceduredetails:what,where,how,withwhatdevice.
- Exposuredetails:route,bodysubstanceinvolved,volumeordurationofcontact.
- Informationaboutsourcepersonandexposedperson.
lPost-exposuremanagement:Assessmentofinfectionrisk.
- If source person testing is possible: test for presence of HBsAg/HCV antibody/HIV
antibody
- If source person testing is not possible: consider risk factors in the source that predict
higherincidenceofHBV,HCV,HIVinfection.
- Testingofneedlesandothersharpinstrumentsisnotrecommended.
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127. - Followguidelinesforpost-exposureprophylaxisforindividualsituations.
- Medical Officer and Pharmacy In-charge are authorized to provide free evaluation,
testingandmedicationtostaffthathavebeenexposed.
Guidelinesforpost-exposureprophylaxisforHepatitisB
Percutaneous(needle-stick)ormucosalexposuretoHBsAg-positivebloodorbodyfluids:
lUnvaccinated person: Administer Hepatitis B vaccine regimen and Hepatitis B
immunoglobulinwithin24hours.
lVaccinated person: Test exposed person for antibody to HBsAg. If adequate, no treatment
required.Ifnotadequate,administerHBIGand oneHepatitisBvaccineboosterdose.
Percutaneous(needle-stick)ormucosalexposuretoHBsAg-negativebloodorbodyfluids:
lUnvaccinatedperson:AdministerHepatitisBvaccineregimen.
lVaccinatedperson:Notreatmentrequired.
Percutaneous(needle-stick)ormucosalexposuretoHBsAgstatus-unknownbloodorbodyfluids:
lIfknownhigh-risksource,treatasifsourcewerepositive.
lUnvaccinatedperson:StarttheHepatitisBvaccineregimen.Ifknownhigh-risksource,treat
asifsourcewerepositive.
lVaccinated person: Test exposed person for antibody to HBsAg. If adequate, no treatment
required.Ifnotadequate,administeroneHepatitisBvaccineboosterdose.
Guidelinesforpost-exposureprophylaxisforHepatitisC
Thefollowingarerecommendedforfollow-upofoccupationalHCVexposures:
lForthesource,performtestingforanti-HCV.
lForthepersonexposedtoanHCV-positivesource:
- Performbaselinetestingforanti-HCVandALTactivity.
- 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-
6weeks).
- Confirm all anti-HCV results reported positive by enzyme immunoassay using
supplementalanti-HCVtesting.
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
whenstartedearlyinthecourseofHCVinfection.WhenHCVinfectionisidentifiedearly,theperson
shouldbereferredformedicalmanagementtoaspecialistknowledgeableinthisarea.
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128. GuidelinesforpostexposureprophylaxisforHIV
HIVpositivesource:
lLesssevereexposure:Solidneedle-stickorsuperficialinjury.
HIVpositivelowviralloadasymptomaticsource-2drugPEP.
HIVpositivehighviralload,symptomaticsourceAIDS-recommendexpanded3drugPEP.
lMore severe exposure: Large bore hollow needle, deep puncture, visible blood on device,
needle used in patient's artery or vein. HIV positive source. Recommend expanded 3 drug
PEP.
lHIVnegativesource:Nospecifictreatment
lHIV unknown source: Presence of high risk factors for exposure to HIV in the source.
Recommend2drugPEP.
III. TASKS AND RESPONSIBILITIES
No Task Responsibility
a. i. Employee State Insurance Act applicability HR Staff
in the SHCO
b. List of staff whose gross salary is less than HR staff
Rs. 15,000 per month
c. Enrollment under ESI with all relevant supporting HR staff
evidences with the local ESI office
d. ESI card for the eligible staff HR staff
e. Calculation of contribution to ESI HR department or Pay and
Accounts department
f. Remittance of amount to ESI Accounts department
g. Separate training classes and handouts for HR staff
ESI beneficiaries regarding provisions under ESI
h. Pre-exposure prophylaxis Hospital management
extends free/concession/part-
paymentfor vaccines..
Pre- employment check-up
identifies staff for pre-exposure
prophylaxis (HR staff and
Physician/Infection control nurse).
HR creates the process flow for
staff member to be administered
the vaccine.
HR maintains records.
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129. i. Postexposure prophylaxis General physician/ER physician to
identify potential situations for
postexposure prophylaxis and
describe the work flow.
SHCO management authorizes free
and timely treatment in these
situations as well as the procedure
to be followed General
physician/ER physician identify staff
who need post-exposure
prophylaxis after an incident.
Pharmacy staff are authorized to
dispense the required medication
to the caregivers.
HR staff or the Infection control
nurse or officer maintains records.
j. Provision of safety measures - personal A sufficient quantity of personal
protective equipment protective equipment is made
available by the management.
In-charge of clinical areas keeps the
items ready at hand and supervises
its usage.
k. Discounts for investigations or treatment for Authorized by the management.
general illness at the SHCO. Health insurance
cover for staff.
No Checkpoint Yes No Remarks
i. Employee State Insurance Act Applicable/Not
applicability in the SHCO Applicable
ii. List of staff whose gross salary is less than Available - Yes/No
Rs. 15,000 per month Updated every month
- Yes/No
iii. Eligible new staff enrolled under ESI
iv. Remittance of amount to ESI Monthly remittance -
Yes/No
Timely remittance
(within 21 days)
- Yes/No
v. Staff interview shows awareness of the
provisions under ESI
IV. AUDIT CHECKLIST
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130. vi. Pre-exposure prophylaxis given for
concerned staff
vii. Postexposure prophylaxis given following
an incident
viii. Provision of safety measures - personal
protective equipment. Audited during
facility tour.
Accreditation Standards for Hospitals, NABH, 3rd Edition, November 2011.
CDC, Updated U.S. Public Health ServiceGuidelines for the Management of Occupational
Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis. MMWR,
2001, 50(No. RR-11). Available at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5011a1.htm
The Gazette of India, Registered no - DL (N) 04/0007/2003---13. Part II, Section I, No 18, New
Delhi, Tuesday, April 23, 2003 / Visakha 3, 1935 (SAKA).
WHO, Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and
Recommendations for Postexposure Prophylaxis. Available at
http://www.who.int/occupational_health/activities/5pepguid.pdf
V. REFERENCES
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131. Chapter 9
INFORMATION MANAGEMENT SYSTEM (IMS)
STANDARD IMS1. THE SHCO HAS A COMPLETE AND ACCURATE MEDICAL RECORD FOR
EVERYPATIENT.
ObjectiveElements
IMS1a.Everymedicalrecordhasauniqueidentifier.*
IMS1b.TheSHCOidentifiesthoseauthorizedtomakeentriesinmedicalrecord.*
IMS1c.Everymedicalrecordentryisdatedandtimed.*
IMS1d.Theauthoroftheentrycanbeidentified.*
IMS1e.Thecontentsofmedicalrecordsareidentifiedanddocumented.
*Objective Elements IMS1a, IMS1b, IMS1c, and IMS1d are self-explanatory and therefore not
includedinthisGuidebook.
IMS1e.Thecontentsofmedicalrecordsareidentifiedanddocumented.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope: To guide the management on how to ensure medical records are complete, accurate, and
readilyretrievableforreviewbyvariousstakeholderssuchasdoctors,regulators,auditors,patients,
andadministrators.
Itisrecommendedthat:
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
advisedondischarge,deathsummary,dischargeagainstmedicaladvicenote,emergency
caremanagement,amongothers,alsobedocumentedandfiled.
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132. No. Process flow Responsibility Supporting Document
1. All the medical records shall have Registration counter/ Medical record
the UHID number. MRD
2. Required medical documentation Doctors/nurses/ Medical record
shall be completed by doctors/ dietitians/
nurses/dietitians/ physiotherapists, physiotherapists, as
as applicable. applicable
3. All the entries shall be dated, Doctors/nurses/ Medical record
timed, signed and named. dietitians/
physiotherapists, as
applicable
4. The contents of the hospital record Top management and Hospital formats
shall be defined as per the clinical Quality team
requirement.
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. AlltheformatscontaintheUHIDnumberandassembledchronologically.
vi. Allthedocumentationismadebytheidentifiedcareproviderswithdateandtime.
II.REQUIREDDOCUMENTS
PolicyandSOPonhavingacompleteandaccuratemedicalrecordforeverypatient.
Policy:ItisthepolicyoftheSHCOtoprovidecompleteandaccuratemedicalrecordsofthepatient.
TheSHCOshalldecidethesequenceinwhichtheserecordscanbestored.Itmaybeasfollows: (The
listmaybeexpandedortrimmedasperthehospitalpolicy)
lMandatory documented requirements: Admission record, discharge summary or death
summary, initial assessment, consultations, lab reports, reassessment, doctors' orders,
nursingassessment,nurses'record,TPR/BPchart.
lWhere applicable, the record may include: consent forms, hemodialysis, chemotherapy,
diabeticcharts, diet,pain assessment sheets,PAC/Anesthesia consent monitoring forms,
recovery charts, pre-op checklist, OT records, post-op records, surgical safety checklist,
intake-outputchart,fluidchart,ICUmonitoringchart,trauma/emergencysheet.
SOPonprovidingacompleteandaccuratemedicalrecordforeverypatient
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133. No. Process flow Responsibility Supporting Document
5. All the formats shall be assembled Medical records officer Medical record
according to the sequence decided.
6. Once the records are assembled, Medical records officer Medical record
they shall be checked for accuracy
(UHID), and completeness
according to the required
documentation and formats.
7. Deficiencies shall be identified in Medical records officer Deficiency checklist
the deficiency checklist and
corrective actions taken.
Sequenceinwhichmedicalrecordsshouldbestored:
(Thelistmaybeexpandedortrimmedasperthehospitalpolicy)
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,
finaldiagnosis,treatmentgoals,planofcare,revisionstotheplanofcare,progressnotes,
any medications ordered or prescribed, other orders, any medications administered
including the strength, dose, frequency and route, any adverse drug reactions,
consultation reports, consent forms, counselling forms, lab reports, reassessment,
doctors'orders,nursingassessment,nurses'record,TPR/BPchart.
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.
TheSHCOmaydecidethesequenceinwhichtheserecordsareto bestored:
1. Admissionrecord/admissionconsent
2. Consentforms
3. Dischargesummary/deathsummary/deathcertificate
4. Trauma/Emergencysheet
5. Initialassessmentsheet(deliveryreport/partograph)
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134. 6. Consultationsheets
7. Labreportmaster
8. Progresssheet
9. Doctors'orders
10. Hemodialysis/chemotherapy/diabeticcharts/diet/painassessmentsheets
11. PAC/Anesthesiaconsentmonitoring/recoverycharts
12. Preopchecklist
13. OTrecord/post-oprecord
14. Surgicalsafetychecklist/painassessment
15. Intake-outputchart
16. Fluidchart
17. Nursingassessment
18. Nurses'record
19. TPR/BPchart/ICUmonitoringchart.
SampleauditchecklistfordeficiencieswhilesubmittingmedicalrecordstotheMRD
Hospital Name Hospital No. of the Patient UHID
No. Points to check D/C* Responsibility Target Time Comments
1. Final diagnosis in the
admission record
2. Final outcome
3. Signatures with date, name
and time
4. Discharge summary
5. Initial assessment form
6. Consent forms
7. OT/post-operative notes
8. Death case sheet
*D= Deficient ; C = Compliant.
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135. III. TASKS AND RESPONSIBILITIES
No. Tasks Responsibility
i. To decide on the content of the medical records, Administrative in-charge, MRD
formats and contents of the discharge summary and Medical records officer
ii. To complete the sequencing of the medical records Medical records officer
formats
iii. To check for completeness of the medical records Medical officers, nurses,
physiotherapists, dietitians
(where applicable)
iv. Deficiency check at the submission of the record to Medical records officer
MRD
v. Corrections of the deficiencies Medical officer
vi. Getting the deficiencies corrected by the nursing/ Medical records officer
medical officers within the target time
IV. AUDIT CHECKLIST
No. Checkpoint Yes No Remarks
i. The contents of medical records are identified and
documented in the SOP.
ii. Samples of audited medical records have all the
documents, records and formats filed in the
medical records in a chronological manner as per
the SOP.
iii. Date, time, name and signature of the medical
documentations have been accurately recorded.
iv. Medical records are checked for deficiencies in
terms of accuracy and completeness.
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136. STANDARD IMS3. DOCUMENTED POLICIES AND PROCEDURES ARE IN PLACE FOR
MAINTAINING CONFIDENTIALITY, SECURITY, AND INTEGRITY OF RECORDS, DATA AND
INFORMATION.
ObjectiveElements
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
notdisclosedwithoutthepatient'sauthorization.*
*ObjectiveElementIMS3bisself-explanatoryandthereforenotincludedinthisGuidebook.
IMS3a. Documented procedures exist for maintaining confidentiality, security and integrity of
information.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope: To guide the SHCO on the safe management of confidentiality, integrity and security of
informationstoredinmedicalrecordssuchthatloss,theft,andtamperingareprevented.
Itisrecommendedthat:
i. The patient is the owner of his or her medical record and no form of it should be made
available to any third party without written authorization from the patient. Access to the
MedicalRecordsDepartment(MRD)islimitedtoauthorizeddepartmentstaff.
ii. The patient's relatives require written authorization from the patient to obtain
informationfromthemedicalrecords.TheadministratorormembersoftheQualityteam
(for audit reasons), or court-of-law or police (for legal reasons) may have access to
information within medical records with an approved written request form. For patients
and the TPAs (for financial reasons), such information should not be given in its original
form; a photocopy of the same may be handed over to the patient after obtaining the
approvedauthorization.
iii. OncethepatientisdischargedfromtheSHCO,themedicalrecordscanreachtheMRDina
stipulatedtimeframe(definedbytheSHCO).
iv. The MRD is responsible for proper storage, retrieval, and maintenance of confidentiality
andsecurityoftherecord.
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137. 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
privacyofinformation.
vi. This is also applicable to all electronic information such as discharge summaries, cath lab
reports,labreports,digitizedX-Rays,electronicmedicalrecords,andanyotherelectronic
information.
II.REQUIREDDOCUMENTS
Thepolicyonmaintainingconfidentiality,securityandintegrityofinformation.
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
shallhaveatleastonememberofstaffavailableinthedepartment.
ii. Atracercardprocessmaybefollowedwhenamedicalrecordisretrieved.
iii. Regardingcontrolonretrievaloraccessibilityofthemedicalrecord,theSHCOshall
lMaintainrecordsinaproperandaccessiblemanner.
lHand over the records as and when required by the chief administrator for
administrativepurposesbygettingawrittenrequisitionformdulysigned.
lProviderecordsrequiredforMLCsinacourtoflawbytheConsultantorMOs.
lProvide inpatient records for the follow-up of inpatients by the Consultant as well as
bythepatients.
lProvideadischargesummary,investigationreports, asandwhenrequired.
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
responsiblefortheprotectionofthemedicalrecordroom.
vi. If a medical record is requested by a doctor outside working hours, an MRO or a front-
office executive or a medical officer with a security guard may retrieve it from the MRD
after proper documentation in a register including the patient's hospital number, name,
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138. requestingdoctor'sname,retrievingdoctor's/officer'sname,employeecode,purposeof
retrieval, and date and time of retrieval. The same should be verified by the security
guard's counter-signature in the same register. The MRO should subsequently follow up
ontheserecordsforcompletenessandintegrityuntiltheyarereturnedtotheMRD.
vii. ThemedicalrecordsstoredintheMRDarepronetodestructionbyrodents,necessitating
the proper planning and implementation of pest control. A record must be maintained in
thisregard.
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 hospitalmust preservefor the long term(such as medico-legaland
death files) may preferably be segregated, identified and stored in a separate area. The
sameshallberetrievedandtransportedtoasaferplaceincaseofanemergency.
No. Process Flow Responsibility Document/Record
1. Once the deficiencies are corrected, the MRO MRD receiving
records are stored in the medical records register
as per the UHID or the SHCO policy.
2. Only the relevant care providers have MRO/security staff
access to the medical records.
3. A tracer card process shall be followed MRO Tracer card
when a medical record is retrieved.
The tracer card is prepared with the
patient's name and hospital number, the
requesting person's name, ward and
the date.
4. The records are retrieved from the shelf MRO Tracer card/
and a tracer card is maintained after medical record
documenting the movement. The same
is also documented in a register.
5. Once the medical records are returned, MRO Medical records
the records are checked for integrity or
tampering of information and stored in
place. The tracer card is then closed.
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139. No. Process Flow Responsibility Document/Record
6. The medical records stored in the MRD MRO Pest control
shall be protected from loss due to records/fire safety
humidity, adverse environmental plan
conditions, and fire with adequate
measures being taken to safeguard
against these safety threats.
7. Whenever privileged health information Top management/ Privileged
is required by law, the SHCO will provide MRO communication
the information. record
III. TASKS AND RESPONSIBILITIES
No. Tasks Responsibility
i. Proper storage and retrieval, and maintenance of MRO
confidentiality and security of the record.
ii. Tracer cards/tracer methodology implementation MRO
iii. Retrieval of medical records MRO
iv. Pest/rodent control Administration in-charge/MRO
v. Security and access control Security staff
IV. AUDIT CHECKLIST
No. Checkpoint Yes No Remarks
i. Documented procedures are in place to maintain
the confidentiality, security and integrity of
information.
ii. The documented procedures are implemented.
iii. The audited sample of case sheets are well-
protected from loss, theft and tampering.
iv. The process of retrieval of files is implemented.
v. Missing files are traced.
vi. Adequate fire detection and firefighting
equipment is available and mock drills are
conducted.
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140. STANDARD IMS4. DOCUMENTED PROCEDURES EXIST FOR RETENTION TIME OF THE
PATIENT'SRECORDS,DATAANDINFORMATION.
ObjectiveElements
IMS4a. Documented procedures exist for retention time of the patient's clinicalrecords, data and
information.
IMS4b.Theretentionprocessprovidesexpectedconfidentialityandsecurity.*
IMS4c. The destruction of medical records, data, and information is in accordance with the laid
downprocedure.
*ObjectiveElementIMS4bisself-explanatoryandthereforenotincludedinthisGuidebook.
IMS4a. Documented procedures exist for retention time of the patient's clinicalrecords, data and
information.
IMS4c. The destruction of medical records, data and information is in accordance with the laid
downprocedure.
Note: Sections II, III, and IV below are provided as samples to guide SHCOs in developing their own
customizeddocuments.
I.OVERVIEW
Scope: To guide the SHCO on the retention of medical records as per legal and regulatory
requirementsandonthedestructionofrecordswhentheyarenotrequired.
Itisrecommendedthat:
i. The records are stored in the MRD for the following retention period as per the
requirements.
InpatientRecord:Minimumofthreeyears(asperMCIrequirements)
OutpatientRecord:Asperthestatelawandhospitalpolicy
Medico-LegalRecord:Lifetime
BirthandDeathRecord:Lifetime
ii. After the retention period, the medical record may be destroyed unless a competent
authorityapprovesitsfurtherretention.
iii. Thedestructionofmedicalrecordsisachievedbyshreddingthem.
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141. iv. If the process of destruction is outsourced, the hospital should take adequate measures
tosafeguardagainsttheleakingofinformationfromtheserecords.
II.REQUIREDDOCUMENTS
i. PolicyandSOPonretentionperiodofmedicalrecords.
ii. PolicyandSOPondestructionofmedicalrecords.
Policy: The SHCO retains its medical records (both outpatient and inpatient) as per the applicable
legalandregulatoryrequirements
InpatientRecord:Minimumofthreeyears(asperMCIrequirements)
OutpatientRecord:Asperthestatelawandhospitalpolicy
Medico-LegalRecord:Lifetime
BirthandDeathRecord:Lifetime
No. Process Flow Responsibility Supporting Documents
1. The retention policy for the Quality team SOP
medical records, data and
information is defined as per the
regulatory requirements.
2. Medical records are retained MRO Medical records
safely and securely as per the policy.
3. Medical records are verified for their MRO Verification list
retention before destruction.
Policy: The SHCO defines the process of the destruction of medical records in a safe and secure
manner after the completion of the retention period without compromising on the confidentiality
andprivacyoftheinformation.
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142. No. Process Flow Responsibility
i. Preparation policy and SOPs Quality team
ii. Implementation of the retention policy/SOP MRO
No. Process Flow Responsibility Supporting Documents
1. The retention policy for the medical Quality team SOP
records, data and information is
defined as per the regulatory
requirements.
2. Medical records which have been MRO List of medical records
stored beyond the retention period to be destroyed
are selected for destruction. (recorded in the
register)
3. The SHCO may display the UHID MRO Notification
numbers of the medical records
being selected for destruction for
the information of the public.
4. Medical records are verified for their MRO Verification list
retention before destruction.
5. Written permission is obtained from MRO Permission letter
the MS before destruction.
6. The selected medical records are MRO
destroyed by shredding.
7. If medical records are outsourced MRO MOU with vendor
for destruction, they are transported
in a safe manner and shredded in the
presence of the MRO or any other
personnel identified by the MS and
then handed over to the vendor for
disposal.
III.TASKS AND RESPONSIBILITIES
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143. No. Checkpoint Yes No Remarks
i. Documented procedures are in place for retaining
the patients' clinical records, data and information.
ii. The documented procedures are implemented.
iii. The audited sample of case sheets are well-
preserved for the duration of the retention period.
iv. The process of destruction of medical records is
defined and implemented.
v. If the process of destruction is outsourced,
adequate measures are taken to safeguard against
leakage of information from these records.
IV. AUDIT CHECKLIST
V. REFERENCES
Accreditation Standards for Hospitals, NABH, 3rd edition, November 2011.
Code Pink, 2006. Available at
http://www.the-hospitalist.org/article/code-pink/
Edna K. Huffman, Medical Record Management, Physicians' Record Company, 1st edition,1990.
Francis, C.M., C. Mario de Souza, Hospital Administration, Jaypee Brothers, 2004.
Indian Public Health Standards, Guidelines for MRD in Hospitals: Guidelines for District Hospitals,
Revision 2012, DGHS, Ministry of Health and Family Welfare, Government of India.
Preservation of Records, Code of Ethics Regulations, 2002, amended in 2009.
WHO, Medical Records Manual, A Guide for Developing Countries, Revised edition, 2006.
http://www.wpro.who.int/publications/docs/MedicalRecordsManual.pdf
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144. Hospital committees (or hospital teams, in caseof limited human resources) canprovide a platform
for multidisciplinary stakeholders to work together in implementing high-quality care across
SHCOs, and to conduct periodic evaluations for continuous improvement. The appointment and/or
re-appointment of members to these committees or teams will be made by the Medical Director.
Unless otherwise stated, the committees or teams will include a broad representation of
stakeholders and shall consist of an appropriate number of individuals to be of an effective, yet
manageable,size.
The membership to a committee or team is determined by a nomination process for a term of one
year. The committee/team chairperson may co-opt additional members on a temporary basis
according to need, and will inform the Medical Director of any additional members. The
committees/teams are required to meet as per calendars planned, monthly or quarterly (or earlier
if there are issues that require attention). If a member does not attend three consecutive meetings,
he or she will automatically lose membership and be replaced. Each committee/team will record
the minutes of each meeting, including the list of attendees. Actions will be closed in a timely
manner.Thelistofthevariousmedicalcommittees/teamsisgivenbelow,alongwithadetailednote
ontheirpurpose,responsibilitiesandcomposition.
1. PerformanceImprovementandSafetyCommittee
2. InfectionControlCommittee
3. CPRCommittee
4. PharmacyandTherapeuticsCommittee
1.PERFORMANCEIMPROVEMENTANDSAFETYCOMMITTEE/TEAM
Purpose
To develop a Quality Management Program that is systematic, organization-wide and consistent
withthemission,visionandvaluesoftheSHCO.
Responsibilities
lTo monitor, evaluate and improve care of patients so as to ensure high standards of
qualityandsafetyforpatients.
APPENDIXES
Appendix 1
FORMATION OF HOSPITAL COMMITTEES
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145. lToensuretheprotectionofpatientrightsandethicalpracticesacrosstheorganization.
lTo hold leaders, work groups, departmental heads and managers accountable for the
application of performance improvement principles and the aggressive pursuit of
improvedperformance.
lTo define the accreditation roadmap of the organization and ensure compliance to NABH
accreditationstandards.
lTo review the quality measurement reports of the hospital and of departments and
servicesaswellastobenchmarkdatafromexternalsources.
lTo ensure that staff education plans are in accordance with quality improvement
priorities.
lTo oversee risk management activities for the hospital, such as training programs in fire
safetyandbiomedicalwastemanagement.
lTooverseeandreviewtheeffectivenessofothermedicalcommittees.
lTo review or delegate to other appropriate committees or departments, the examination
of patient complaints, incident reports, or other matters involving quality of care and
clinical performance, and ensuring that appropriate action is taken for the problems that
havebeenidentified.Thisincludesbutisnotlimitedto:
vAppropriatenessofcare
vMedicalassessmentandtreatmentofpatients
vCriticalIncidentReview
vEffectivenessofcare
vUseofclinicalguidelines
vClinicalauditsagainstestablishedstandardsandclinicalindicators
vMorbidityandmortalityreviews
lTo evaluate patient satisfaction and the quality of patient care through an objective and
systematicmonitoringofservices, complaintsandMLCs,andtorecommendandoversee
correctiveandpreventiveactions.
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146. 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.INFECTIONCONTROLCOMMITTEE/TEAM
Purpose
To ensure thatthere is an active, effective, institution-wide infection control program thatdevelops
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
infectioncontrolpoliciesandproceduresandensurestheirimplementation.
Responsibilities
lTo oversee the infection control program of the SHCO, so as to ensure that the best
standardsareinplaceandthatrisksofinfectionareminimized.
lTo ensure that infection control policies and procedures are being consistently followed
throughouttheSHCO.
lTo assess hospital-acquired infection rates through regular surveillance, and to ensure
thatinterventionsareprioritizedinordertoreducetheserates.
lTomonitorsurveillancedataandidentifyopportunitiesforimprovement.
lTo advise on matters related to the proper use of antibiotics, to develop antibiotic
policies, and to recommend remedial measures when antibiotic-resistant strains are
detected.
lTo ensure that training programs on infection control-related parameters (such as hand
hygieneorbiomedicalwastesegregation)areheldforstaffon aregularbasis.
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147. Sample Composition
No. Composition Designation
1. HOD Anesthesia/ Internal Medicine/ Chairperson
Microbiology
2. Quality Manager Coordinator
3. Medical Administration (MS) Member
4. 3-4 HODs (Clinical) Member
5. Nursing Head Member
6. Infection Control Nurse Member
7. Staff Representation from CSSD Member
8. Head of Support Services Member
9. Head of Engineering Member
10. Head of Food and Beverages Member
11. Head of Housekeeping Member
3.CPRCOMMITTEE/TEAM
Purpose
Toensureaneffectivehospital-wideCardioPulmonaryResuscitation(CPR)program.
Responsibilities
lTo ensure that policies and procedures related to CPR are consistently followed
throughouttheorganization.
lTo ensure CPR training for all staff in CPR, training for selected staff, and to ensure that
theyunderstandtheirrolesandresponsibilitiesforcodeblue.
lTo use simulation in the form of mock drills in order to assess the responsiveness and
competenceoftheCPRTeam.
lTo advise on the design and implementation of the audit process that monitors the
incidenceandoutcomesofcardiacarrest/medicalemergencycalls.
lToensuretheavailabilityandmaintenanceoftheequipmentanddrugsrequired.
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148. lTo advise on the appropriate choice of equipment and medicines for use in resuscitation
procedures.
lTo offer guidance on the minimum level of resuscitation training for individual staff
groupsbasedontheirroleandexposuretocardiacarrest/emergencysituations.
lTo review all cardiac arrest case files to assess the adequacy of response and to evaluate
thescopeofimprovementforthesame.
Sample Composition
No. Composition Designation
1. HOD Emergency Chairperson
2. Medical Administrator (MS) Coordinator
3. Medical Quality Member
4. Nursing Head Member
5. Emergency Doctor Member
6. Anesthesia Representative Member
7. ICU Representative Member
8. HOD Security Member
4.PHARMACYANDTHERAPEUTICCOMMITTEE/TEAM
Purpose
To ensure that the selection, compliance, distribution, storage, safe use, and administration of
drugswithintheSHCOareasperstandardslaiddown.
Responsibilities
lTo ensure that policies and procedures related to medication management are
consistentlybeingfollowedthroughouttheSHCO.
lTomanagethedrugformularysystembyevaluatingtheusageofmedicationsperiodically
andrequestingadditionsordeletions.
lTo move the SHCO towards a generic drug regime and away from the branded drug
system.
lTo monitor adverse drug events and ensure that corrective and preventive actions are
taken.
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149. Sample Composition
No. Composition Designation
1. Clinical HOD Chairperson
2. Pharmacy Head Coordinator
3. Medical Administrator (MS) Member
4. 3-4 Clinical HODS Member
5. Quality Manager Member
6. Nursing Head Member
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150. Whatisscopeofservice?
The scope of service refers to the range of clinical and supportive activities that are provided by a
healthcare organization. For example, clinical activities: general medicine, general surgery,
paediatrics,OBG;andsupportservices:ambulance,pharmacy.
HowcanthescopeofservicesprovidedbyanSHCObedisplayed?
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.
WhoisresponsiblefordefiningthegeneralscopeofservicesoftheSHCO?
The Administrative Head of the organization in consultation with the department heads will define
thescopeofservices.
While applying for accreditation, is it necessary to mention the scope of all services available,
includingoutsourcedservicessuchaslaboratoryservices?
Yes. While applying for accreditation, the scope of all services available including outsourced
services shallbementioned. Wheneveranewservice isadded,thesameshallbecommunicatedto
theaccreditationauthorityaccordingtotheagreement.
DoallpatientscomingtotheSHCOhavetoberegistered?
Yes, all patients who are assessed in the SHCO, including those in the Emergency department and
OPD,shallberegisteredandgivenauniqueidentificationnumbertoensurecontinuityofcare.
WhatisanInitialAssessment?
This is the first assessment done on the patient within the defined time-frame. The initial
assessment includes activities such as history-taking, a physical examination, and laboratory
investigationsthatcontributetowardsdeterminingtheprevailingclinicalstatusofthepatient.
Whatisthedefinedtime-framefortheInitialAssessment?
The time-frame shall be from the time that the patient has registered until the time that Initial
Assessment is documented by the treating consultant or nurse. The SHCO shall define its time-
frame for the Initial Assessment based on the organizational resources/patient load/patient
condition.
Appendix 2
FREQUENTLY ASKED QUESTIONS (FAQs)
ACCESS, ASSESSMENT AND CONTINUITY OF CARE (AAC)
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151. Whatis'criticalresult'?
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
attentionbytheconsultant/nurse,failingwhichthereisadangerofharmtothepatient.
Shouldadischargesummarybegiventoallpatientsdischargedfromthe SHCO?
Yes. A discharge summary should be given to all patients discharged from the SHCO, including
patientsleavingagainstmedicaladvice(LAMA)/onrequest/MLCpatients.
Whatisthedefinedcontentofadischargesummary?
Adischargesummaryshallcontainthefollowing:
lPatientname
lUniqueIdentificationNumber
lDateandtimeofadmissionanddischarge
lReasonforadmission
lSignificantfindings
lInformationregardinginvestigationresults
lDiagnosisandanyprocedureperformed
lMedicationadministered
lOthertreatmentgiven
lPatientconditionatthetimeofdischarge
lFollow-upadvice
lMedicationandotherinstructionsinanunderstandablemanner
lHowandwhentoobtainurgentcare
lNameandsignatureofthedoctor
IsitmandatorytohaveCodePink?
Itisnotmandatory,butitispreferabletohaveaCodePinkprotocol.
WhatconstitutesanMLC(Medico-LegalCase)?
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
CARE OF PATIENTS (COP)
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152. attending doctor, after eliciting history and examining the patient, believes that some investigation
bylawenforcementagenciesisessential.
HowshouldanMLCcertificatebegiven?
The following link provides examples and formats for different types of MLC:
http://dhs.kerala.gov.in/docs/orders/code.pdf
HowdoesonesealsamplesinMLCsituations?
Thislinkprovidesdetailsonsealingsamples:https://www.youtube.com/watch?v=J4N4h9IBYqc
Whatistriage?
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.
Duringmedicaltriage,thevictims'conditionsareevaluatedandprioritizedintofourcategories:
- Immediate (I): The victim has life-threatening injuries (airway, bleeding, or shock) that
demandsimmediateattentiontosavehisorherlife;rapid,lifesavingtreatmentisurgent.
- Delayed (D): Injuries do not jeopardize the victim's life. The victim may require professional
care,buttreatmentcanbedelayed.
- Minor(M):Walking,woundedandgenerallyambulatory.
- 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
victimsthanrescuers.
Whatisahigh-riskpregnancy?
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
medicalorsurgicalconditions,iscalledhigh-riskpregnancy.
Whataretheminimumrequirementsofaprescriptionorder?
Theprescriptionshallbewrittenbyadoctorandtheminimumrequirementstobeincludedare:
o Patient'sname,ageandsex
o IP/OPnumber
o Dateofprescription
o Wardordepartmentname
o Formofthedrug:tablet,injectionorsyrup
MANAGEMENT OF MEDICATIONS (MOM)
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153. o Nameofthedrug(genericname)writteninblockletters
o Dosageofthedrug(500mg,1g,etc.)
o Routeofadministration(oral,etc.)
o Timeandfrequencyofadministration(beforefood,onceaday,etc.)
o Durationoftreatment(foroneweek,twoweeks,etc.)
o Doctor'sfullnameandsignature
Whatisamedicationrecall?
A medication recall is the removal of a drug from a sub-store/ward because it is either defective or
potentiallyharmful.Thepharmacistisresponsiblefortherecallofmedication.
Whatarethestatutoryrequirementsforahospitalpharmacy?
All laws, regulations, directives, guidelines and licensure requirements of the drugs control
departmentandexcisedepartmentshouldbemet.Thedepartmentshouldhave,atalltimes,avalid
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
PharmacyDepartment,includingNarcoticrequisitions(for1year)withintheirrecordbooks.
a.Licenses: i.Retaillicense-Form20&Form21
ii.Wholesaledruglicense-Form20B&Form21B
iii.Narcoticlicense-FormV(NDV)
b.Registrationcertificates:StatePharmacycouncilregistrationcertificate
c.Acts: i.PharmacyAct,1948
ii.DrugsandCosmeticsAct,1940
iii.NarcoticsandPsychotropicSubstancesAct,1985
iv.DrugsandMagicRemediesAct,1954
Howarepsychotropicandnarcoticdrugsmanaged?
Narcoticdrugs are always keptin a separate almirah under lock and key. The stock/narcoticregister
shouldhavethefollowinginformation:
a. For ward/departments: serial number of the entry register, date, quantity of drugs issued from
pharmacy,serialnumberoftheindent,indentdulysignedbytheMD/DMS.
b. For OP/IP patients: Serial number of the entry register, date, name of the patient, name of the
consultant.
There should be proper handing-over of the stock with signature of the staff who hands over and
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154. takes over. Empty ampules should be returned to the pharmacy against which narcotics will be
issued.Therewillbeaseparateentryregisterforbrokenampules.
Whatareverbalmedicationordersandwhocancarryoutverbalorders?
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
ordermustbesignedbythedoctorassoonaspossible.
Whatarenosocomialinfections?Howaretheytransmitted?
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
infectionscanbetransmittedthroughcontact,droplets,andair.
WhatisMRSA?WhatisthesinglemostimportantfactorincontainingMRSA?
MRSA is Methicillin-Resistant Staphylococcus Aureus. The single most important factor in
containing(preventionof)MRSAismaintaininggoodhandhygiene.
Whatformsofprotectionarenecessarytopreventthespreadofrespiratoryinfections?
Heavy-duty N95 or N97 masks should be used for open pulmonary tuberculosis or suspected
pulmonary tuberculosis, and surgical masks for other common droplet infections, for example,
respiratory viral illness. Surgical masks can also be used to contain transmission of invasive
meningococcal disease (Meningococcal Meningitis and meningococcemia). Nonimmune or
pregnant staff should not enter the room of patients known or suspected to have rubella, varicella,
andmeasles.
Whatarethecommonmodesofsterilizationusedinhospitals?
Common modes of sterilization are steam sterilization (autoclave), gas sterilization (ethylene
oxide),andhotairoven.
WhatisCSSDandwhatisitspurpose?ListthezonesofCSSD.
CSSD stands for Central Sterile Supply Department. The purpose of CSSD is to provide all the
requiredsterileitemsrequiredinahospitalinordertomeettheneedsofallpatientcareareas.
CSSD is divided into 3 zones: soiled (decontamination), clean zone (packaging), and sterile zone
(sterilizationandstorage).
HOSPITAL INFECTION CONTROL (HIC)
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155. WhatisCQI?
ContinuousQualityImprovementisthetermusedforimprovementinthestructuresandprocesses
thatwill lead to improvement in outcomes.Since quality does not have an end point,it is a constant
journeywheretheimprovementprocesshastobecontinuous.
WhatisaKeyPerformanceIndicator(KPI)?
KPIs are measurable indicators that measure the performance of a structure, process or outcome.
These indicators are important as they affect the quality of care, performance, and safety in an
SHCO.
IsmeasuringtheKPIstheresponsibilityoftheQualityOfficer?
The Quality Officer should ensure that the KPIs are collected and analyzed, and that appropriate
actions are taken. But all the stakeholders have to participate and contribute for effective quality
improvement.
HowmanyKPIsshouldbedeveloped?
The SHCO can develop any number of KPIs, but it is imperative to capture at least some common
indicators.Iftheorganizationfeelsthataparticularareaneedsimprovement,theindicatorsforthat
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
thepercentageofsurgeriesthatstartbefore8.30a.m.
Whatshouldthesamplesizebe?
The NABH standards can be referred to for formula and sample size. However, at least 10% of the
totalpopulationisareasonablesamplesize.
WhoshouldanalyzetheKPIs?
All the stakeholders, the Quality officer and a representative from administration should analyze
thedatacollectedinordertoreachtheappropriatecorrectiveandpreventiveactions.
Whatisroot-causeanalysis?
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
findouttherootcause.
WhatisCAPA(CorrectiveandPreventiveAction)?
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
contemplateandimplementpreventiveactions.
CONTINUOUS QUALITY IMPROVEMENT (CQI)
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156. Whatisa"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
qualityjourney,thetrendappearstobedownwardbecauseofimproveddatacollection.
ArethereanyspecialprecautionstobetakenwhilemeasuringKPIs?
Indicators should be carefully chosen so that they really measure the important performance.
There should be no bias in data collection. The formula used should be correct and the data has to
bevalidatedbyanauthorizedperson.Theproperrootcausehastobeidentified,andcorrectiveand
preventive action implemented. There should be a constant collection of data to see the
effectiveness of implementation of actions. If these points are not taken care of, KPIs may give
incorrectinformationregardingperformance,whichmayturnouttobedetrimental.
Whatisanorganogram?Howfrequentlydoesithavetobeupdated?
An organogram is the graphic representation of a reporting relationship in an organization. It has to
be updated at least once a year, or as and when there are changes made in the organizational
structure.
Whatshouldthemissionstatementbecomprisedof?
Themissionshoulddefinethefollowing:
1.Purposeoftheorganization
2.Strategyoftheorganization
3.Valuesoftheorganization
WhatisMSDSandwhyisitrequired?
A Material Safety Data Sheet (MSDS) is a document that contains information on the potential
hazards of a chemical and how to work safely with it. It is an essential starting point for the
development of a complete health and safety program. An MSDS is prepared by the manufacturer
of the material. It should explain the hazards of the product, how to use the product safely, what to
expect if the recommendations are not followed, what to do if accidents occur, how to recognize
symptomsofoverexposure,andwhattodoifsuchincidentsoccur.
Whyshouldmedicalgaspipelineshavestandardizedcolourcoding?WhatstandardshouldSHCOs
followforcolourcoding?
Since health risks can result from using the wrong medical gas, medical gas pipelines should be
colour coded. This will also help in identifying problems in different lines and isolating them if
RESPONSIBILITIES OF MANAGEMENT (ROM)
FACILITIES MANAGEMENT AND SAFETY (FMS)
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157. required. The color coding may follow standards such as IS/ISO 9170-1 : 2008, NFPA 99. HTM, ANSI
andCGAC-9standards.
What building norms should be followed while constructing an SHCO? Where are the fire
protectionanddetectionrequirementsforbuildingstobefound?
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);andbuildingandplumbingservices.
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(NBC2005).ThecomprehensiveNBC2005contains11Partssomeofwhicharefurtherdivided
intoSections,totalling26chapters.
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
protectionfeaturesthatarenecessarytominimizedangertolifeandpropertyfromfire.
Whatisagrievance-handlingmechanism?
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
officerorcommittee.
Isitmandatorytohaveamedicalrecordsofficer?
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 appointa medical records
officer(MRO)totakecareofthesame.
HUMAN RESOURCES MANAGEMENT (HRM)
INFORMATION MANAGEMENT SYSTEM (IMS)
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158. lAssessment - All activities including history-taking, physical examination, and laboratory
investigations that contribute towards determining the prevailing clinical status of the
patient.
lBiomedical equipment - Any fixed or portable non-drug item or apparatus used for
diagnosis,treatment,monitoringanddirectcareofthepatient.
lConfidentiality - Restricted accesses to information to individuals who have a need, a
reason and permission for such access. It also includes an individual's right to personal
privacyandprivacyofinformationrelatedtohis/herhealthcarerecords.
lHazardous material - Substances dangerous to human and other living organisms which
includeradioactiveorchemicalmaterials.
lHazardouswaste-Wastematerialsdangeroustolivingorganisms.Suchmaterialsrequire
special precautions for disposal. They include biologic waste that can transmit disease
(for example, blood and tissues), radioactive materials, and toxic chemicals. Other
examples are infectious waste such as used needles, used bandages and fluid-soaked
items.
lInformation:Processeddatawhichlendsmeaningtotherawdata.
lInventory control: The method of supervising the intake, use and disposal of various
goodsinhands.Itrelatestosupervisionofthesupply,storageandaccessibilityofitemsin
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
minimizetotalcosts.
lMaintenance: The combination of all technical and administrative actions, including
supervision action, intended to retain an item in, or restore it to, a state in which it can
performarequiredfunction. (BritishStandard3811:1993)
lPatient record/Medical record: A document which contains the chronological sequence
ofeventsthatapatientundergoesduringhisstayintheSHCO.
lPolicies: They are the guidelines for decision-making, e.g. admission, discharge policies,
antibioticpolicy,etc.
lProcedures: A specified way to carry out an activity or a process (Para 3.4.5 of ISO 9000:
2000) or a series of activities for carrying out work, which when observed by all, helps to
Appendix 3
GLOSSARY
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159. ensurethemaximumuseofresourcesandeffortstoachievethedesiredoutput.
lProcess: A setof interrelated or interacting activities which transform inputs into outputs
(Para3.4.1ofISO9000:2000).
lProtocol: A plan or a set of steps to be followed in a study, an investigation or an
intervention.
lReferral-out of patient: Safe transfer of a patient to another organization due to non-
availabilityofrequiredresourcesincludingexpert/equipment/facility.
lRisk assessment: Risk assessment is the determination of quantitative or qualitative
value of risk related to a concrete situation and a recognized threat (also called hazard).
Riskassessmentisastepinariskmanagementprocedure.
lRisk management: Clinical and administrative activities to identify, evaluate, and reduce
theriskofinjury.
lRisk reduction: The conceptual framework of elements considered with the possibilities
to minimize vulnerabilities and disaster risks throughout a society to avoid (prevention)
or to limit (mitigation and preparedness) the adverse impacts of hazards, within the
broadcontextofsustainabledevelopment.
(Source:http://www.preventionweb.net/english/professional/terminology/)
It is the decrease in the risk of a healthcare facility, given activity, and treatment process
withrespecttopatient,staff,visitorsandthecommunity.
lScopeofservice: RangeofclinicalandsupportiveactivitiesthatareprovidedbyanSHCO,
e.g. clinical activities: General medicine, General surgery, Paediatrics, OBG, etc.; support
services:Ambulance,Pharmacy,etc.
lSecurity:Protectionfromloss,destruction,tampering,andunauthorizedaccessoruse.
lUnstable patient: A patient whose vital parameters need external assistance for their
maintenance.
Note: The complete glossary is available in the NABH Manual on Accreditation Standards for
Hospitals,3rdEdition,November2011.
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162. National Accreditation Board for Hospitals and Healthcare Providers
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IP Estate, New Delhi 110 002, India
Phone: +91-11-2332 3416/ 17/18/19/20; Fax: 2332 3415
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