NABH Guide

Guide Book to NABH Standards for Hospitals
Suggested Documentation
Like all quality management systems, documentation is an essential component of NABH

accreditation. NABH standards require various documentation. It is suggested that the HCO prepare a
quality manual incorporating the various standards and objective elements and providing appropriate
linkages. The quality manual could be distributed to all individuals in the first rung of the organogram.
It is preferable that procedures ad processes (refer to glossary for definition) are not incorporated in
the quality manual (only linkages to be provided.) The policies (refer to glossary for definition) for
various objective elements could be incorporated in the concerned activities are taking place.
Wherever, the HCO feels that only a policy would not suffice it can instead documentation and
distribution.
A suggested content is given below.
 Introduction of the HCO
 Management including ownership, vision, mission, ethical management etc.
 Quality policy and objectives including service standards.
 Scope of services provided by the HCO and the details of services provided by every
department
 Composition and role of various committees (in alphabetical order)
 CPR analysis
 Ethics
 Infection control
 Medical audit
 Pharmacy
 Quality
 Safety
 Organogram
 Statutory and regulatory requirements
 Various codes like code blue for CPR, code red for fire alert, code purple for grievance etc
 Chapter wise documentation
© National Accreditation Board for Hospitals and Healthcare Providers Page: 1 of 140
 Indicators being monitored by the organization along with their numerator, denominator and
multiplier
 Annexure (if any)
For example., for AAC 2a which states that “Standardized policies and procedures are used for
registering and admitting patients HCO could mention its policy for admission in the quality manual
and for procedure in the quality manual just mention as “Refer to AAC/SOP/01”.
In addition to the quality manual the HCO needs to have the following manuals:
* Infection Control Manual.
* Quality Improvement Manual which is also incorporates the quality assurance activities of lab,
imaging, intensive care and surgical services.
* Safety manual which also incorporates lab safety and radiation safety.
The minimum documentation required by NABH 2nd edition is given below:
CHAPTER 1: Access, Assessment and Continuity of Care (AAC)
AAC.2. The organization has a well defined registration and admission process.
Objective element
Standardized policies and procedures are used for registering and admitting patients
The policies and procedures address out-patients, in-patients and emergency patients.
The policies and procedures also managing patients during non availability of beds.
AAC.3.. There is an appropriate mechanism for transfer or referral of patients who do not match the
organizational resources.
Objective element
Policies guide the transfer of unstable patients to another facility in an appropriate manner.
Policies guide the transfer of stable patients to another facility.
Procedures identify staff responsible during transfer.
AAC.5. Patience cared for by the organization undergo an established initial assessment
Objective element
The organization defines the content of the assessments for the out-patients, in- patients and
emergency patients.
The organization determines who can perform the assessments.

The organization defines the time frame within which the initial assessment is completed.
AAC.6. Laboratory services are provided as per the requirements of the patients.
Objective element
Policies and procedures guide collection, identification, handling, safe transportation, processing and
disposal of specimens.
Laboratory results are available within a defined timeframe. (HCO needs to determine the timeframe).
AAC.8. There is an established laboratory quality assurance programme.
Objective element
a) The laboratory quality assurance programme is documented.
b) The programme addresses verification and validation of test methods.
c) The programme addresses surveillance of test results.
d) The progamme includes periodic calibration and maintenance of all equipments
e) The progamme icludes the documentation of corrective and preventive actions.
AAC.9. There is an established laboratory safety programme.
Objective element
The laboratory safety programme is documented.
This programme is integrated with the organization’s safety programme.
Written policies and procedures guide the handing and disposal of infectious and hazardous materials.
AAC.10. Imaging services are provided as per the requirements of the patients.
Objective element
Policies and procedures guide identification and safe transportation of patients to imaging services.
Imaging results are available within a defined timeframe. (HCO needs to define the timeframe).
AAC.11. There is an established Quality assurance programme for imaiging services.
Objective element
The quality assurance programme for imaging services is documente.
The programme addresses verification and validation of imaging results.
The programme addresses surveillance of imaging results.
The programme includes periodic calibration and maintenance of all equipments.
The programme includes the documentation of corrective and preventive actions.
AAC.12. There is an established radiation safety programme.
Objective element
The radiation safety programme documented.
This programme is integrated with the organization’s safety programme.
Written policies and procedures guide the handing and disposal of radio-active and hazardous
materials.
Policies and procedures guide the safe use of radioactive isotopes for imaging services.
AAC.13. Patient care is continuous and multidisciplinary in nature.
Objective element
Policies and procedures guide the referral of patients to other departments/specialities.
AAC.14. The organization has a documented discharge process.
Policies and procedures exist for coordination of various departments and agencies involved in the
discharge process (including medico-legal cases).
Policies and procedures are in place for patients leving against medical advice.
CHAPTER 2 : Care of Patients (COP)
COP.2. Emergency services are guided by policies, applicable laws and regulations.
Objective element
Policies and procedure for emergency care are documented.
Policies also address handing of medico-legal cases.
Policies and procedures guide the triage of patients for initiation of appropriate care.
COP.4. Policies and procedures guide the care of patients requiring cardio-pulmonary resuscitation.
objective element
Documented policies and procedures guide the uniform use of resuscitation throughout the
organization.
COP.6. Policies and procedures guide the cars of patients in the intensive care and high dependency
units.
Objective element
The organization has documented admission and discharge criteria for its intensive care and high
dependency units.
Defined procedures for situation of bed shortages are followed.
A quality assurance programme is implemented. (HCO needs to document the same).
Day 2:
COP.7. Policies and procedures guide the care of vulnerable patients (elderly, physically and/or
mentally challenged and children).
Objective element
Policies and procedures are documented and are in accordance with the prevailing laws and the
national and international guidelines.
A documented procedure exists for obtaining informed consent from the appropriate legal
representative.
COP.8. Policies and procedures guide the care of high risk obstetrical patients.
COP.9. Policies and procedures guide the care of pediatric patients.
Objective element
The policy for care of neonatal patients in consonance with the national/international guidelines.
Policies and procedures prevent child/neonate abduction
COP.10. Policies and procedures guide the care of patients undergoing moderate sedation.
Objective element
Criteria are used to determine appropriateness of discharge from the recovery area. (HCO needs to
determine the criteria).
COP.11. Policies and procedures guide the administration of anaesthesia
Objective element
There is a documented policy and procedure for the administration of anaesthesia.
A qualified individual applies defined criteria to transfer the patient from the recovery area. (HCO
needs to determine the qualified individual and the criteria.
COP.12. Policies and procedures guide the care of patients undergoing surgical procedures.
Objective element
The policies and procedures are documented.
Documented policies and procedures exist to prevent adverse events like wrong site,#
A quality assurance programme is followed for the surgical services. (HCO needs to document this).
P.S. The quality assurance programme should also address objective elements i and j.
COP.13. Policies and procedure guide the care of the patients under restraints (physical and/or
chemical).
Objective element
Documented policies and procedures guide the care of patients under restraints.
P.S. This should also address objective element b.
COP.14. Policies and procedures guide appropriate pain management.
Objective element
Documented policies and procedures guide the management of pain..
COP.15. Policies and procedures guide appropriate rehabilitative services.
Objective element
Documented policies and procedures guide the provision of rehabilitative services.
COP.16. Policies and procedures guide all research activities.
Objective element
Document Policies and procedures guide all research activities in compliance with national and
international guidelines.
COP.17. Policies and procedures guide nutritional therapy.
Objective element
Documented Policies and procedures guide nutritional assessment and reassessment.
COP.18. Policies and procedures guide the end of life care.
Objective element
Document Policies and procedures guide the end of life care.
P.S. This should also address objective elements b, c, d.
CHAPTER 3 : Management of Medication (MOM)
COM.1. Policies and procedures guide the organization of pharmacy services and usage of
medication.
Objective element
There is a documented policy and procedure for pharmacy services and medication usage.
P.S. This should also address objective elements b.
MOM.2. There is a hospital formulary.
Objective element
There is a defined process for acquisition of these medications.
There is a process to obtain medications not listed in the formulary.
MOM.3. Policies and procedures exist for storage of medication.
Objective element
Documented policies and procedures exist for storage of medication.
MOM.4. Policies and procedures exist for prescription of medications.
Objective element
Documented policies and procedures exist for prescription of medications.
The organization determines who can write orders .
Policy on verbal orders is documented and implemented.
The organization defines a list of high risk medication.
MOM.5. Policies and procedures guide the safe dispensing of medications.
Objective element
Document Policies and procedures guide the safe dispensing of medications.
The policies include a procedure for medication recall.
MOM.6. There are defined procedures for medication administration.
Objective element
Policies and procedures govern patient’s self administration of medications
Policies and procedures govern patient’s medication brought from outside the organization.
MOM.8. Patients are monitored after medication administration.
Objective element
Adverse drug events are define (HCO needs to define the adverse drug events).
Adverse drug events are reported within a specified time frame. (HCO needs to define the timeframe).
MOM.9. Policies and procedures guide the use of narcotic drugs and psychotropic substances.
Objective element
Documented Policies and procedures guide the use of narcotic drugs and psychotropic substances.
P.S. This should be documented keeping in mind objective element b.
MOM.10. Policies and procedures guide the usage of chemotherapeutic agents.
Objective element
Documented Policies and procedures guide the usage of chemotherapeutic agents.
MOM.11. Policies and procedures govern usage of radioactive drugs.
Objective element
Documented . Policies and procedures govern usage of radioactive drugs.
P.S. This should also address objective elements b, c.
MOM.12. Policies and procedures the use of implantable prosthesis.
Objective element
Document policies and procedures govern procurement and usage of implantable prosthesis.
P.S. This should be documented keeping in mind objective element b.
MOM.13. Policies and procedures guide the use of medical gases.
Objective element
Documented policies and procedures govern procurement, handing, storage, distribution, usage and
replenishment of medical gases.
P.S. This should also address objective element b.
CHAPTER 4: Patient Rights and Education (PRE)
PRE.1. The organization protects patients and family rights informs them about their responsibilities
during care.
Objective element
Patient and family rights responsibilities are documented.
P.S. The rights should be in accordance with PRE 2.
PRE. 3. A documented process for obtaining patient and/or families consent exists for informed
decision making about their care.
Objective element
The organization has listed those situations where informed consent is required. ( HCO needs to
document the same).
The policy describes who can give consent when patient is incapable of independent decision making.
CHAPTER 5:Hospital Infection Control (HIC)
HIC.1. The organization has a well-designed, comprehensive and coordinated infection control
programme aimed at reducing/ eliminating risks to patients, visitors and providers of care.
Objective element
The hospital infection control programmeo is documented which aims at preventing and reducing risk
of nosocomial infections.
P.S. The various objective elements of HIC chapter can be incorporated in a single manual.
HIC.2. The hospital has an infection control manual. Which is periodically updated.
Objective element
The manual identifies the various high-risk areas and procedures.
It outlines methods of surveillance in the identified high-risk areas and procedures.
It focuses on adherence to standard precautions at all times.
Equipment cleaning and sterilization practices are included.
An appropriate antibiotic policy is established and implemented.
Laundry and linen management processes are also included.
Kitchen sanitation and food handing issues are included in the manual.
Engineering controls to prevent infections are included.
Mortuary practices and procedures are include as appropriate to the organization
The organization defines the periodicity of updating the infection control manual.
HIC.6. The hospital takes appropriate actions to control outbreaks of infections.
Objective element
Hospital has a documented procedure for handing such outbreaks.
HIC.7. There are documented procedures for sterilisation activities in the organization
Objective element
There is an established recall procedures for sterilisation system is identified.
CHAPTER 6 : Continuous Quality Improvement (CQI)
COI.1. There is a structured quality improvement and continuous monitoring programme in the
organization
Objective element
The quality improvement programme is documented.
P.S. This should be documented keeping in mind requirements of objectives elements d, f, g. It

should also incorporate the various indicators as required by CQI 2 and 3.
CQI.6. Sentinel events are intensively analyzed.
Objective element
The organization has defined sentinel events.(HCO needs to document the various identified sentinel
events)
The organization has established processes for intense analysis of such events. (HCO needs to
document the process).
CHAPTER 7 : Responsibilities of Management (ROM)
ROM.1. The responsibilities of the management are defined.
Objective element
Scope of services of each department is defined.
Administrative policies and procedures for each department is maintained.(HCO needs to document
the same).
ROM.5. Leaders ensure that patient safety aspects and risk management issues are an integral part of
patient care and hospital management.
Objective element
The scope of the programme is defined to include adverse events ranging from “no harm” to “sentinel
events”.
CHAPTER 8 :Facility Management and Safety
FMS.2 : The organization’s environment and facilities operate to ensure safety of patients, their
families, staff and visitors.
Objective element
There is a documented operational and maintenance (preventive and breakdown) plan.
FMS.3 : The organization has a program for clinical and support service equipment management.
Objective element
There is a documented operational and maintenance (preventive and breakdown) plan.
FMS.6:The organization has a smoking limitation policy.
Objective element
The organization defines and impalements its policies to reduce or eliminate smoking.
The policy has provisions for granting exceptions for patients and families to smoke.
P.S. This has to be documented keeping in mind the statutory requirements.
FMS.7. The organization plans for handing community emergencies, epidemics and other disasters.
Objective element
The hospital identifies potential emergencies. (HCO needs to document the same).
The organization has a documented disaster management plan.
P.S. This should be documented keeping in mind objective element c.
FMS.8. The organization has a plan for management of hazardous materials.
Objective element
Hazardous materials are identified within the organization.(HCO needs to document the same).
The hospital implement processes for sorting, labeling, storage, transporting and disposal of
hazardous material. (HCO needs to document the process).
CHAPTER 9 : Human Resource Management (HRM)
HRM.2. The staff joining the organization is socialized and oriented to the hospital environment.
Objective element.
Each staff member is made aware of his/her rights and responsibilities. (HCO needs to document the
rights and responsibilities).
All employees are oriented to the service standards of the organization. (HCO needs to determine the
service standards of the organization).
HRM.3. There is an ongoing programme for professional training and development of the staff.
Objective element
A document training and development policy exists for the staff.
HRM.5. An appraisal system for evaluating the performance of an employee exists as an integral part
of the human resource management process.
Objective element
A well-documented performance appraisal system exists in the organization.
HRM.6. The organization has a well-documented disciplinary procedure.
Objective element
A written statement of the policy of the organization with regard to discipline is in place.
P.S. This should be documented keeping in mind objective element b, c.
HRM.7. A grievance handling mechanism exists in the organization.
Objective element
The employee are aware of the procedure to be followed in case they feel aggrieved.
CHAPTER 10 : Information Management System (IMS)
Policies and procedures exist to meet the information needs of the care providers, management of the
organization as well as other agencies that require date and information from the organization.
Objective element
The information needs of the organization are identified and are appropriate to the scope of the
services being provided by the organization and the complexity of the organization. (HCO needs to
document to the information needs).
Policies and procedures to meet the information needs are documented.
P.S. This has to be documented keeping in mind objective element c.
IMS.2. The organization has processes in place for effective management of data.
Objective element
Documented procedures are laid down for timely and accurate dissemination of data.
Documented procedures exist for storing and retrieving data.
IMS.3. The organization has a complete and accurate medical record for every parient.
Objective elementc
Organization policy identifies those authorized to make entries in medical record.
The contents of medical record are identified and documented.
IMS.5. Policies and procedures are in place for maintaining. confidentiality, integrity and security of
information.
Objective element
Documented policies and procedures exist for maintaining confidentiality, security and integrity of
information.
P.S. This has to be documented keeping in mind objective element b.
The policies and procedures incorporate safeguarding of data / record against loss, destruction and
tampering.
A documented procedure exists on how to respond to patients / physicians and other public agencies
requests for access to information in the medical record in accordance with the local and national law.
IMS.6. Policies and procedures exists for retention time of records, data and information.
Objective element
Documented policies and procedures are in place on retaining the patient’s clinical records. data and
information.
P.S. This has to document keeping in mind objective element b.
CHAPTER 1 : Access, Assessment and Continuity of Care (AAC)
AAC.1. The organization defines and displays the services that it can provide.
Objective Element Interpretation Remark (S)
A policy to be framed clearly stating the services The needs of the

the hospital can provide. community should be
a) The services being considered especially
provided are clearly when planning a new
defined and are in HCO or adding new
consonance with services.
the needs of the
community
b) The defined The services so defined should be displayed Claims of services and
services are prominently in an area visible to all patients expertise being
prominently entering the organization. The display could be in available should
displayed. the form of boards, citizen’s charter, scrolling actually be available.
messages etc. Care should be taken to ensure Display in the form of
that these are displayed In the language(s) the brochures only is NOT
patient understands. acceptable. Display
should be at least bi-
lingual.
c) The staff is oriented All the staff in the Hospital mainly in the
to these services reception/registration, OPD, IPD are oriented to
these facts through training programme
conducted regularly or through manuals.
AAC.2. The organization has a well defined registration and admission process.
a) Standardized policies Health Care Organization (HCO) has Admission must be authorized
and procedures are prepared document (S) detailing the
used for registering policies an procedures for registration and by a doctor.
and admitting patients. admission of patients which should also
GS1 standards in barcoding
include unidentified patients.
can be used to
identify and track the patient

within
and outside
the hospital
b) The policies and Self explanatory. It is preferable if each one of

procedures address these is.
out-patients, in-
patients an separately addres
emergency patients.
c) Policies are accepted The staff handing admission and

only if the organization registration needs to be aware of the
can provide the services that the organization can
required service. provide. It is also advisable to have a
system wherein the staff is aware as to
whom to contact if they need any
clarification on the services provided.
d) The policies and The HCO is aware of the availability of Also refer to AAC 3.
procedures also alternate HCO’s where the patients may
address managing be directed in case of non-availability of
patients during non beds.
availability of beds.
e) The staff is aware of All the staff handing these activities Orientation can be provided by
these processes. should be oriented to these policies and documentation/by training.
procedures.
AAC.3. There is an appropriate mechanism for transfer or referral of patients who do not match
the organizational resources.
a) Policies guide the The organization shall at the outset define

transfer of unstable as to who is an unstable patient. The
transfer of unstable documented policy and procedure should
patients to another address the methodology of safe transfer of
facility in an the patient in a life threatening situation
appropriate manner. (like those who are on ventilator) to another
HCO. There should be availability of an
appropriate ambulance fitted with life
support facilities and accompanied by
trained personnel.
b) Policies guide the Patients not in a life threatening situation Also refer to COP 3.
transfer of stable (stable) should also be transported in a
patients to another safe manner.
facility
c) Procedures identify The staff shall at least be a trained A doctor should accompany
staff responsible trauma/emergency technician/nurse. an unstable patient.
during transfer. He/she shall have undergone training in
BLS and/or ACLS.
d) The organization The HCO gives a case summary This shall include patients
gives a summary of mentioning the significant findings and being transferred both for
patients condition treatment given in case of patients who are diagnostic and/or therapeutic
and the treatment being transferred from emergency. For purpose.
given. admitted patients a discharge summary has
to be given (refer AAC 15). The same shall
also be given to patients going against
medical advice.
AAC.4.During admission the patient and/ or the family members are educated to make
informed decisions.
a) The patients and/ or The plan of care as decided by the doctor

family members are on duty or the patient management team
explained about the (as the case may be) is to be discussed
proposed care. with the patient and/ or family members.
This should be done in a language the
patient/attendant can understand. The
above information is to be documented
and signed by the concerned doctor.
b) The patients and/or The patients and family are explained in

family members are detail by the treating physicians or his/her
explained about the team about the outcomes of such
expected results. treatment.
c) The patients and/or Possible complications of the treatment, if

family members are any, are clearly communicated to the
explained about the patient.
possible
complications.
d) The patients and/or Patients should be given an estimate of With regards to expected costs,
family members are the expenses on account of the treatment an estimate could be prepared
explained about the preferably in a written form. and the same given to the
expected costs. patient. This estimate shall be
prepared on the basis of the
treatment plan. It could be
prepared by the
OPD/Registration/Admission staff
in consultation with the treating
doctor. In case of packages it

should clearly state the terms and
condition and also the exceptions
if any.
AAC.5. Patients cared for by the organization undergo an established initial assessment.
a) The organization The hospital shall have a protocol/policy by

defines the content which a standardized initial assessment could
of the assessments be standardized across the hospital or it could
for the out-patients, be modified depending on the need of the
In-patients and department.
emergency patients.
However it shall be the same in that particular
area e.g. in a paediatric OPD the weight and
height may be a must whereas it may not be so
for orthopaedics OPD. The organization can
have different assessment subsequent visits. In
emergency department this shall include
recording the vital parameters. The initial
assessment should also include the nursing
assessment for in-patients.
b) The organization The assessment should be done by the treating Also refer to HRM 10a.
determines who can doctor, junior doctor or a nurse. The
perform the organization determines who can do what
assessments. assessment and it should be the same across
the hospital.
c) The organization The HCO has defined and documented the time
defines the time frame within which the initial assessment is to be
frame within which completed with respect to
the initial OPD/emergency/indoor patients.
assessment is
completed.
d) The initial This should cover history, progress notes,

assessment for in- investigation ordered and treatment ordered and
patients is all these are to be authenticated by treating
documented within doctor.
24 hours or earlier as
per the patient’s
condition or hospital
policy.
e) Initial assessment The protocol for patient’s initial assessment This could be done by the
include screening for should cover his/her nutritional needs. In case of treating doctor and/or
nutritional needs. out patients this should be done where ever dietician.
applicable. For example diabetics, CRF patients.
f) The initial This shall be documented by the treating doctor For definition of “plan of
assessment results or by a member of his team in the case sheet. care” and “clinical
in a documented This plan is monitored by the treating doctor for audit” refer to
plan of care which is its effectiveness, an wherever required by a glossary
monitored. clinical audit.
The documented plan of care should cover This could also be done
preventive actions as necessary in the case and through
g) The plan of care also should include diet, drugs etc. booklets/patient
includes preventive information leaflets
aspects of the care. etc. e.g. diabetes,
hypertension.
AAC.6. All patients cared for by the organization undergo a regular reassessment.
a) All patients are After the initial assessment, the patient is Every patient shall be
reassessed at reassessed periodically and this is documented in reassessed at least once
appropriate the case sheet. The frequency may be different for every day by the treating
intervals. different areas based on condition e.g. patients in doctor.
ICU need to reassessed more frequently compared
to a patient in the ward.
b) Staff involved in Actions taken under reassessment are documented. The nursing staff can
direct clinical The staff could be the treating doctor or any member document patient’s vitals.
care document of the team as per their domain of responsibility of
reassessments. care.
c) Patients are Self explanatory

reassessed to
determine their
response to
treatment and to
plan further
treatment or
discharge.
AAC.7. Laboratory services are provided as per the requirements of the patients
a) Scope of the laboratory The HCO should ensure availability of laboratory For example, a
services are services commensurate with the health care cardiac care HCO
commensurate to the services offered by it either by providing the same must necessarily
services provided by the in house or by outsourcing. However, test results have facilities for
organization. required for emergency management (RBS,ABG cardiac enzyme
etc) must be available within its premises. See testing.
also (f) below for outsourced lab facilities.
b) Adequately qualified and The staff employed in the lab should be suitably For adequacy of
trained personnel perform qualified (appropriate degree) and trained to carry qualification refer to
and/ or supervise the out the tests. Pathologist, microbiologist and NABL 112.
investigations. biochemist supervise the staff.
c) Policies and procedures The HCO has documented procedures for The policy should be
guide collection, collection, identification, handing, safe in line with standard
identification, handing, transportation, processing and disposal of precautions. The
safe transportation, specimens, to ensure safety of the specimen till disposal of waste
processing and disposal the tests and rests (if required) are completed. shall be as per the
of specimens. statutory
requirements (Bio-
medical waste
management and
handing rules, 1998.)
d) Laboratory results are The HCO shall define the turnaround time for all The turnaround time
available within a defined tests. The HCO should ensure materials and could be different for
time frame. equipment to make the laboratory results available different tests and
within the defined time frame. could be decided
based on the nature
of test and criticality
of test.
e) Critical results are The laboratory shall establish its biological It is not practical to
intimated immediately to reference intervals for different tests. The establish the biology
the concerned personnel. laboratory shall establish critical limits for rests reference interval for
which require immediate attention for patient a particular analyte,
management. The test results in the critical limits the laboratory should
shall be communicated to the concerned after carefully evaluate the
proper documentation. published data for its
own reference
intervals.
f) Laboratory tests not The HCO has a documented procedure for MOU should be
available in the outsourcing tests for which it has no facilities. This available for all
organization are should include: outsourced activities.
outsourced to
organization(S) based on a) List of tests for out sourcing. The authority for
their quality assurance control and the
b) Identify of personnel in the out methods for control,
system.
sourced facilities to ensure safe of such outsourcing
transportation of specimens and shall ne defined and
completing of the patient concerned documented.
and receipt of results at HCO.
c) Manner of packaging of the

specimens and their labeling for
identification and this package should
contain the test requisition with all
details as required for testing.
d) a methodology to check the

performance of service rendered by
the requirements of the HCO.
AAC.8. There is an established laboratory quality assurance programme.
a) The laboratory quality The HCO has a documented

assurance programme is quality assurance programme
documented. (preferably as per ISO 15189
Medical laboratories –
Particular requirements for

quality and competence).
b) The programme This holds true for any

addresses verification and laboratory developed
validation of test methods. methods.
c) The programme The laboratory director (or in-

addresses surveillance of charge) shall periodically
test results. assess the test results.
d) The programme includes Refer to ISO 15189..

periodic calibration and
maintenance of all
equipments.
e) The programme includes Self explanatory

the documentation of
corrective and preventive
actions.
AAC.9. There is an established laboratory safety programme.
a) The laboratory safety A well documented lab safety manual is This could be as per
programme is available in the lab. This takes care of the Occupational Health
documented. safety of the workforce as well as the and Safety
equipments available in the lab. Management
System –OHSAS
18001:2007.
b) This programme is Lab safety programme is incorporated in the

integrated with the safety programme of the hospital.
organization’s safety
programme.
c) Written policies and The lab staff should follow standard
procedures guide the precautions. The disposal of waste is

handing and disposal of according to Biomedical waste management
infectious and hazardous and handing rules, 1998.
materials.
d) Laboratory personnel are All the lab staff undergo training regarding
appropriately trained is safe practices in the lab.
safe practices.
e) Laboratory personnel are Adequate safety devices are available in the

provided with appropriate lab e.g. fire extinguishers, dressing
safety equipment/ materials, disinfectants,etc.
dervices.
AAC.10. Imaging services are provided as per the requirements of the patients.
a) Imaging services comply The HCO is aware of the legal and All the statutory
with legal and other other requirements of imaging services requirements are met
requirements. and the same are documented for with, like BARC
information and complimented for clearance, dosimeters,
information and compliance by all lead sheets lead
concerned in the HCO. The HCO aprons, signages,
maintains and updates its compliance display as per PNDT
status of legal and other requirements act, reports to
in a regular manner. competent authority,
etc.
b) Scope of the imaging Self explanatory. For example, a neuro-

services are commensurate science centre shall
to the services provided by have CT and MRI.
the organization.
c) Adequately qualified and As per AERB guidelines.

trained personnel perform,
supervise and interpret. The
investigations.
d) Policies and procedures The HCO has documented policies and
guide identification and safe procedures for informing the patients

transportation of patients to about the imaging activities, their
imaging services. identification and safe transportation to
the imaging services. This should also
address transfer of unstable patients to
imaging services.
e) Imaging results are The organization shall document The defined timeframe
available within a defined turnaround time of imaging results. could be different for
time frame. different type of tests.
f) Critical results are intimated Critical results shall document The HCO shall define
immediately to the turnaround time of imaging results. the critical results
concerned personnel. which require
immediate attention of
clinician e.g. ectopic
pregnancy.
g) Imaging tests not available The HCO has documented procedure MOU should be
in the organization are for outsourcing tests for which available for all
outsourced to it has no facilities. This should outsourced activities.
organization(s) based on include: a) list of tests for See AAC 7 f also.
their quality assurance outsourcing,
system.
a) Identify of personnel in the
outsourced facilities to ensure
safe transportation of
specimens and completing of
imaging results.
b) Manner of identification of
patients and the test requisition
with all details as required for
testing and
c) A methodology to check the

selection and performance of
service rendered by the
outsourced imaging facility as
per the requirements of the
HCO.
AAC.11. There is a established Quality assurance programme for imaging services.
a) The quality assurance Refer to AERB guidelines. Some examples include

programme for congruence of optical and
imaging services is radiation field; focal spot size;
documented. output consistency; leakage rate
etc.
b) The programme A document for verification and

addresses verification validation of imaging methods
and validation of shall be available.
imaging methods.
c) The programme HCO (or in-charge) shall

addresses surveillance periodically assess the imaging
of imaging results. results.
d) The programme Calibration and maintenance of all

includes periodic equipment shall be carried out by
calibration and competent persons.
maintenance of all
equipments.
e) The programme Self explanatory.

includes the
documentation of
corrective and
preventive actions.
AAC.12. There is an established radiation safety programme.
a) The radiation safety Refer to AERB guidelines.

programme is documented.
b) This programme is The safety programme of the imaging

integrated with the department has reference in the hospital
organization’s safety safety manual.
programme.
c) Written policies and Radioactive and hazardous materials

procedures guide the shall be disposed off as per bio-medical
handing and disposal of waste management and handing
radio-active and hazardous rules,1998.

materials.
d) Imaging personal are Self explanatory.

providing with appropriate
radiation safety devices.
e) Radiation safety devices Protective devices e.g. lead aprons

are periodically tested and should be exposed to X-ray for
documented. verification of cracks and damages.
f) Imaging personnel are Self explanatory.

trained in radiation safety
measures.
g) Imaging signage are Self explanatory.

prominently displayed in all
appropriate locations.
Document on safe use of radioactive

isotopes for imaging services shall be
h) Policies and procedures available and implemented.
guide the safe use of
radioactive isotopes for
imaging services.
AAC.13. Patient care is continuous and multidisciplinary in nature.
a) During all phases of care, The HCO to ensure that the care of
there is a qualified patients is always given by
individual identified as appropriately qualified medical
responsible for the personnel (resident doctor, consultant
patient’s care. and/or nurse).
b) Care of patients is Care of patients is co-ordinated

coordinated in all care among various care providers in a
settings within the given setting viz OPD, emergency,
organization. IP,ICU, etc. The organization shall
ensure that there is effective
communication of patient
requirements amongst the care

providers in all settings.
c) Information about the The HCO ensures periodic This could be done on
patient’s care and discussions about each patient the basis of entries
response to treatment is (covering parameters like patient care, either on case sheet or
shared among medical, response to treatment, unusual electronic patient
nursing and other care developments if any,etc) amongst records (EPR).
providers. medical, nursing and other care
providers.
d) Information is exchanged Self explanatory. For example,

and documented during
each staffing shift, 1) Nurses’
between shifts, and during handling-taking
transfers between over notes.
units/departments.
2) Transfer
summary.
e) The patient’s record (s) is Self explanatory.

available to the authorized
care providers to facilitate
the exchange of
information.
f) Policies and procedures The HCO has clearly defined and Referral could be for
guide the referral of documented the policies and opinion, co-
patients to other procedures to be adopted to guide the management, take over.
departments/ specialities. personnel dealing with referral of It could be graded into
patients to other departments or immediate, urgent,
specialties or even other health care priority or routine
providers outside the HCO. cartegories.
AAC.14. The organization has a documented discharge process.
Objective element Interpretation Remark (S)
a) The patient’s discharge The patient’s treating doctor determines

process is planned in the readiness for discharge during
consultation with the patient regular reassessments. The same is
and/or family discussed with the patient and family.
b) Policies and procedures exist The discharge policies and procedures

for coordination of various are documented to ensure coordination
departments and agencies amongst various departments including
involved in the discharge accounts so that the discharge papers
process (including medico- are complete well within time. For MLC
legal cases). the organization shall ensure that the
police are informed.
c) Policies and procedures are in The HCO has a documented policy for
place for patients leaving the LAMA cases. The treating doctor
against medical advice. should explain the consequences of this
action to the patient/attendant.
d) A discharge summary is given The HCO hands over the discharge

to all the patients leaving the papers to the patient/attendant in all
organization (including cases and a copy is retained. In LAMA
patients against medical cases, the declaration of the
advice). patient/attendant is to be recorded on
proper format.
AAC.15. Organization defines the content of the discharge summary.
Discharge summary is provided to the Self explanatory.

patients at the time of discharge.
Discharge summary contains the Self explanatory.

reason for admission, significant
findings and diagnosis and the patient’s
condition at the time of discharge.
Discharge summary contains Self explanatory.

information regarding investigation
results, any procedure performed,
medication and other treatment given.
Discharge summary contains follow up Self explanatory. The instructions shall be in a

advice, medication and other manner that the patient can
instructions in an understandable easily understand and avoid use
manner. of medical terms e.g. BID, TID
etc.
Discharge summary incorporates Self explanatory. This could be in the form of

instructions about when and how to what medicines to take, when to
obtain urgent care. consult a doctor or how to seek
medical help and contact
number of thehospital/doctor.
In case of death the summary of the Self explanatory.

case also includes the cause of death.
CHAPTER 2 : Care of Patients (COP)
COP.1. Uniform care of patients is provided in all settings of the organization and is guided by
the applicable laws, regulations and guidelines.
Care delivery is uniform when The organization shall ensure that

similar care is provided in patients with the same health problems
more than one setting. and care needs, receive the same
quality of healthcare throughout the
organization irrespective of the
category of ward.
Uniform care is guided by Self explanatory. For example, consent

policies and procedures which before surgery, providing
reflect applicable laws and first aid to emergency
regulations. patients and police
intimation in cases of
medico-legal cases.
The care and treatment orders Self explanatory. Treatment orders For electronic records the
are signed, named, timed and must be written daily. organization shall ensure
dated by the concerned that the same is captured in
doctor. the system.
The care plan is The treatment of the patient could be The Clinician in charge
countersigned by the clinician initiated by a junior doctor but the same implies the treating doctor.
in-charge of the patient within should be countersigned and
24hrs. authorized by the treating doctor within
24hrs.
Evidence based medicine and The organization could develop clinical For definitions of evidence
clinical practice guidelines are protocols based on these and the same based medicine and clinical
adopted to guide patient care could be followed in management of practice guidelines, refer to
whenever possible. patients. These could then be used as glossary.
parameters for audit of patient care.
COP.2. Emergency services are guided by policies, procedures, applicable laws and
regulations.
There is adequate access and The organization shall demarcate a

space for the ambulance (s). proper space for ambulance(s).
This shall be demarcated keeping in

mind easy accessibility for receiving
patients and to enable the ambulance(s)
to turn around/exit quickly.
Ambulance(s) is appropriately This shall be done based on the This shall be in

equipped. organization’s scope. consonance with ACLS
or BLS guidelines. It is
expected that any
ambulance shall be
equipped with at least
basic life support.
There is a checklist of all The ambulance should be manned by a

equipment and emergency trained driver, technician/nurse and/or
medications. doctor depending on the situation.
Personnel shall be trained in ACLS
and/or BLS.
There is a check list of all The organization shall develop a

equipment and emergency checklist and the ensure that the
medications. ambulance is equipped as per the
checklist.
Equipments are checked daily This shall include both the ambulance
and prior to dispatch. and the equipments within it.
Emergency medications are Self explanatory. This also includes In case a rapid turn
checked daily and prior to checking the expiry date of drugs. around of the
dispatch. ambulance is required
(Where checking may
not be possible prior to
dispatch), only the
medications used could
be topped up or the
HCO could keep an
additional set of drugs
as stand by.
COP.3. The ambulance services are commensurate with the scope of the services provided by
the organization.
Policies and procedure for These could include SOPs/protocols to Also refer to AAC5a.
emergency care are provide either general emergency care or
documented. management of specific conditions e.g.
poisoning.
Policies also address The policy shall be in line with statutory

handling of medico-legal requirements W.R.T. documentation and
cases. intimation to police. The organization shall
also define as to what constitutes a MLC (in
accordance with statutory rules).
The patients receive care in Self explanatory. Poisoning cases, road

consonance with the traffic accidents, patients
policies. with coronary disease,
etc. shall be dealt as per
hospital policies and
procedures.
Policies and procedures Self explanatory This should be based on

guide the triage of patients good clinical practices.
for initiation of appropriate For triage refer to
care. glossary.
Staff is familiar with the All the staff working in the casualty should
policies and trained on the be oriented the policies and practices
procedures for care of through training/documents. Staff should
emergency patients. preferably be trained/well versed in ACLS
and BLS.
Admission or discharge to Self explanatory. Also refer to AAC 14 and

home or transfer to another 15.The discharge note
organization is also shall incorporate salient
documented. features of investigations
done and treatment.
The ambulance(s) has a The ambulance shall be connected with the

proper communication hospital/control room by wireless/mobile
system. phones.
COP.4. Policies and procedures guide the care of patients requiring cardio-pulmonary
resuscitation.
Documented policies and The organization shall document the The document could be
procedures guide the procedure for same. This shall be in displayed prominently in
uniform use of consonance with accepted practices. critical areas such as
resuscitation throughout emergency, ICU, OT etc.
the organization.
Staff providing direct These aspects shall be covered by hands All doctors and nursing staff
patient care is trained and on training. If the organization has a CPR must at least be trained to
periodically updated in team (e.g. code blue team) it shall ensure provide BLS.
cardio pulmonary that they are all trained in ALS and are
resuscitation. present in all shifts.
The events during a In the actual event of a CPR or a mock This could be done using the
cardio-pulmonary drill of the same, all the activities along pre-defined procedural
resuscitation are with the personnel attended should be checklist and by monitoring if
recorded. recorded. the prescribed activity has
been performed property and
in the right sequence.
A post-event analysis of The analysis shall include the cause,

all cardiac arrests is one steps taken to resuscitate and the
by a multi-disciplinary outcome. Multidisciplinary committee shall
committee. include physicians, anaesthetists and
nurses.
Corrective and preventive Self explanatory. During subsequent

measures are taken base resuscitations it is preferable
on the post-event it is preferable that
analysis. implementation of these
actions is noted and training
be modified if necessary.
COP.5. Policies and procedures define rational use of blood and blood products.
Documented policies and This shall addresses the conditions where A good reference
procedures are used to guide blood and conditions where blood products guide is the NABH
rational use of blood and blood can be used. standards for blood
products. banks.
The transfusion services are Refer to Drugs and Cosmetics act.

governed by the applicable
laws and regulations.
Informed consent is obtained Consent should be taken for every Also refer to PRE 3 d
for donation and transfusion of transfusion. However, with the same and e.
blood and blood products. consent you can give multiple transfusions
in the same sitting. For example, 2 pints of Consent for blood

blood may be transfused serially using the transfusion during
same consent. However, if the same is surgery shall be taken
given over two days or hours apart, then a separately. It should
separate consent is required. not be clubbed with
the surgery consent
form.
Informed consent also includes Self explanatory. This could be in the

patient and family education form of booklet/leaflet.
about donation.
Staff is trained to implement This shall include doctors and be done Records of the same
policies. either by training and/or by providing written should be available.
instructions.
Transfusion reactions are The organization shall ensure that any For transfusion
analyzed for preventive and transfusion reaction is reported. It is reactions refer to
corrective actions. preferable that the organization capture glossary.
feedback regarding every transfusion
(including the ones without reaction) as this
would enable it to capture all transfusion
reactions. These are then analyzed (by
individual/committee as decided by the
organization) and appropriate
corrective/preventive action is taken. The
organization shall maintain a record of
transfusion reactions.
COP.6. Policies and procedures guide the care of patients in the Intensive care and high
dependency units.
The organization has The organization should develop A good starting point could be
documented admission objective criteria and adhere to it. various national and
and discharge criteria for international critical care
its intensive care and high society guidelines.
dependency units.
Staff is trained to apply This shall be done by training and/or

these criteria. by displaying the criteria.
Adequate staff and The ICU should be equipped with all

equipment are available. necessary life saving and monitoring
equipments as well as suitably

manned by trained staff. The exact
requirements shall be decided by the
organization. However the organization
is expected to follow best clinical
practices.
Defined procedures for As and when there are no vacant beds

situation of bed shortages in the ICU and there is a requirement
are followed. of such bed, a detailed policy and
procedure should be in place to
address the situation.
Infection control practices These could be developed individually

are followed. or it could be a part of the hospital
infection control manual. The
organization shall ensure that the
practices are in consonance with good
clinical practices.
A quality assurance These could be developed individually Good clinical practices include
programme is or it could be a part of the Hospital monitoring infection rates, re-
implemented. quality assurance programme. The admission rates, re-intubation
organization shall ensure that the rates etc.
programme is in consonance with
good clinical practices.
COP.7. Policies and procedures guide the care of vulnerable patients (elderly, physically and/or
mentally challenged and children).
Policies and procedures are Self explanatory. Refer to disability act, mental
documented and are I act.
accordance with the
prevailing laws ad the
national and international
guidelines.
Care is organized and HCO develops SOP’s for delivery of

delivered in accordance care.
with the policies and
procedures.
The organization provides The organization shall provide proper For example, play room for
for a safe and secure environment taking into account the children, anti-skid titles for
environment for this requirement of the vulnerable group. elderly, ramps with railings for
vulnerable group. disabled, etc.
A documented procedure The informed consent for this group of Refer to PRE 3e.
exists for obtaining informed people should be obtained from their
consent from the family or legal representative.
appropriate legal
representative.
Staff is trained to care for All staff involved in the care of this Records of the same should
this vulnerable group. group shall be adequately trained in be available.
identifying and meeting their needs.
COP.8. Policies and procedures guide the care of high risk obstetrical patients.
Objective Element Interpretations Remark (S)
The organization The organization shall define as to The display should be in a prominent
defines and displays what constitutes high risk obstetric location Refer to AAC 1b also.
whether high risk case in consonance with best clinical
obstetric cases can be practices.
cared for or not.
Persons caring for These shall not just be doctors but

high risk obstetric shall include nursing staff also. The
cases are competent. competency shall be based on
qualification, experience and
training.
High risk obstetric Self explanatory. It is preferable that this is done by a

patient’s assessment dietician.
also includes maternal
nutrition.
The organization The organization shall have a NICU

caring for high risk with proper equipments and staff.
obstetric cases has
the facilities to take
care of neonates of
such cases.
COP.9. Policies and procedures guide the care of pediatric patients.
The organization defines The scope shall also include The display should be in a
and displays the scope neonatal services, if any. prominent location. Refer to AAC 1b
of its paediatric services. also.
The policy for care of Self explanatory. There are national and international
neonatal patients is in guidelines available for the case of
consonance with the neonates by WHO, etc. The hospital
national/international should take them into account.
guidelines.
Those who care for These shall not just be for doctors
children have age but shall include nursing staff also.
specific care of children. The competency shall be based on
qualification, experience and
training.
Provisions are made for Adequate amenities for the care of For example, playroom and breas
special care of children. infants and children to be available feeding room.
in the hospital.
Patient assessment Self explanatory. The same needs to be documented.

includes detailed
nutritional, growth,
psychosocial and
immunization
assessment.
Policies and procedures The HCO shall ensure that there is Examples could include
prevent child/neonate an adequate security/surveillance to identification tag, unsupervised
abduction and abuse. prevent such happenings. phototherapy leading to burns, etc.
The children’s family Self explanatory. For example, growth chart,

members are educated immunization chart, etc. This
about nutrition, (original/copy) should be a part of
immunization and safe the medical record. The education
parenting and this is should preferably be in the
documented in the language that the family
medical record. understands.
COP.10. Policies and procedures guide the care of patients undergoing moderate sedation.
Competent and trained Whenever parenteral route is used this Technical shall not administer
persons perform sedation. be carried out by a doctor/nurse. sedation.
The person administering Self explanatory.

and monitoring sedation is
different from the person
performing the procedure.
Intra-procedure monitoring Self explanatory. The same should be In addition, certain other
includes at a minimum the documented. parameters may be monitored
heart rate, cardiac rhythm, on a care to case basis.
respiratory rate, blood
pressure, oxygen
saturation, and level of
sedation.
Patients are monitored after The patient’s vitals shall be monitored

sedation. at regular intervals (as decided by the
organization) till he/she recovers
completely from the sedation. The
same should be documented.
Criteria are used to These shall be developed by the

determine appropriateness organization in consonance with good
of discharge from the clinical practices.
recovery area.
Equipment and manpower The equipments shall include

are available to rescue emergency resuscitation equipments.
patients from a deeper level An anaesthesiologist shall be available
of sedation than that in the hospital.
intended.
COP.11. Policies and procedures guide the administration of anaesthesia.
There is a documented HCO shall document on the For definition of anaesthesia
policy and procedures for indications, the type of anaesthesia refer to glossary. The standard
the administration of and procedure for the same. is not applicable for local
anaesthesia. anaesthesia.
All patients for anaesthesia This shall be done before the patient is
have a pre-anaesthesia wheeled into the OT complex. It shall
assessment by a qualified be applicable for both routine and
individual. emergency cases. This assessment
shall be done by an anaesthesialogist.
It is preferable to do assessment is a
standardized format.
The pre-anaesthesia Self explanatory. The plan should mention the

assessment results in type of anaesthesia, the
formulation of an drug(s) to be used for
anaesthesia plan which is induction and the drug to be
documented. used for maintenance.
An immediate preoperative This shall be done by an

re-evaluation is anaesthesiologist just before the
documented. patient is wheeled in to the respective
OT.
Informed consent for Self explanatory. Also refer to PRE 3d.

administration of
anaesthesia is obtained by
the anaesthetist.
During anaesthesia Self explanatory. The same should be

monitoring includes regular documented.
and periodic recording of
heart rate, cardiac rhythm,
respiratory rate, blood
pressure, oxygen
saturation, airway security
and patency and level of
anaesthesia.
Each patient’s post- This shall be done in the recovery

anaesthesia status is area/OT and at least include
monitored and monitoring of vitals till the patient
documented. recovers completely from anaesthesia
and shall be done by an
anaesthesiologist. If the patient’s
codition is unstable and he/she
requires ICU care the same shall be
monitored there.
A qualified individual The organization documents these

applies defined criteria to criteria which should be in consonance
transfer the patient from the with good clinical practices . These
recovery area. criteria shall be applied by a
designated individual as decide by the
HCO.
All adverse anaesthesia All such events are documented and

events are recorded and monitored for the purpose of taking
monitored. corrective and preventive action.
COP.12. Policies and procedures guide the care of patients undergoing surgical procedures.
The policies and This shall include the list of surgical

procedures are procedures as well as competency
documented. level for performing these procedures.
Surgical patients have a All patients undergoing surgery are This shall be done by the
preoperative assessment assessed pre operatively and a operating surgeon.
and a provisional diagnosis provisional diagnosis is made which is
documented prior to documented. This shall be applicable
surgery. for both routine and emergency cases.
An informed consent is Self explanatory. Also refer to PRE 3d.

obtained by a surgeon prior
to the procedure.
Documented policies and Procedure should be available for The HCO should be able to
procedure exist to prevent preventing adverse events like wrong demonstrate methods to
adverse events like wrong patients, wrong site by a suitable prevent these events. e.g.
site, wrong patient and mechanism. Identification tags, badges,
wrong surgery. cross checks, etc. Refer to
WHO “Safe surgery saves
lives” initiative.
Persons qualified by law The HCO identifies the individuals who Also refer to HRM 11b.
are permitted to perform have the required qualification (s),
the procedures that they training and experience to perform
are entitled to perform. procedures in consonance with the

law.
A brief operative note is This note provides information about If it is documented by a person
documented prior to the procedure performed, post other than the chief operating
transfer out of patient from operative diagnosis and the status of surgeon the same shall be
recovery area. the patient before shifting and shall be countersigned by the chief
documented by the surgeon/member surgeon within 24 hours.
of the surgical team.
The operating surgeon Self explanatory. The plan shall include advice
documents the post- on IV fluids, medication, care
operative plan of care. of wound, nursing care,
observing for any
complications, etc.
A quality assurance This shall be an integral part of the

programme is followed for HCO’s overall quality assurance
the surgical services. programme. It shall focus on post
operative complications e.g. bleeding,
rational use of antibiotics, etc.
The quality assurance Surveillance activities include For air conditioning of OT refer
programme includes monitoring the quality of air provided, to the glossary.
surveillance of the rate of air exchange, cleaning and
operation theatre disinfection processes, etc.
environment.
The plan also includes Self explanatory. All the post operative patients
monitoring of surgical site shall be screened for the
infections rates. same.
Cop.13. Policies and procedures guide the care of patients under restraints (physical and/or
chemical).
Objective element Interpretation Remark(S)
Documented policies This shall clearly state the

and procedures guide conditions/circumstances under which
the care of patients restraints shall be used. It shall also specify
under restraints. as to who can authorize the use of
restraints.
These include both Physical restraints include boxer’s

physical and chemical bandage, use of cuffs etc. Chemical
restraint measures. restraints include sedatives.
These include Self explanatory.

documentation of
reasons for restraints.
These patients are more The organization shall specify the

frequently monitored. parameters and frequency of monitoring
and accordingly implement the same.
Staff receive training Self explanatory. Records of the same should

and periodic updating in be available.
control and restraint
techniques.
COP.14. Policies and procedures guide appropriate pain management.
Documented policies and The HCO shall define the group of For example, cancer pain,
procedures guide the patients for whom this is applicable. A neuralgias and arthralgia.
management of pain. good reference point for defining
these patients could be those having
pain as the predominant debilitating
symptom.
The organization respects and Self explanatory. Pain assessment and

supports the appropriate management could be
assessment and management carried out using a pain
of pain for all patients. rating scale.
Patient and family are Self explanatory.

educated on various pain
management techniques.
COP.15. Policies and procedures guide appropriate rehabilitative services.

Documented policies Self explanatory.

and procedures guide
the provision of
rehabilitative services.
These services are The scope of the departments is in For example, provision of
commensurate with the consonance with the scope of the hospital. ante natal and post natal
organizational exercises could form a part
requirements. of obstetric rehabilitation
programme.
Rehabilitative services The team shall have treating doctor.,

are provided by a rehabilitation therapist, rehabilitation nurses
multidisciplinary team. and other professional experts.
COP.16. Policies and procedures guide all research activities.
Documented policies Self explanatory. For example, International

and procedures guide all conference on
research activities in harmonization (ICH) of
compliance with national Good clinical practice
and international (GCP) and Declaration of
guidelines. Helsinki Somerset (1996)
and Ethical Guidelines for
Biomedical Research on
Human Subjects (ICMR-
2000).
The organization has an An ethics committee should be framed in the Refer to Schedule Y of
ethics committee to hospital to monitor activities undertaken by Drugs and Cosmetics act
oversee all research various providers. Any research undertaken and to ICMR guidelines.
activities. in the hospital falls under its ambit. This
includes both funded and non-funded and
also student studies.
The committee has the Self explanatory.
powers to discontinue a
research trial when risks
outweigh the potential
benefits.
Patient’s informed Self explanatory.

consent is obtained
before entering them in
research protocols.
Patients are informed of Self explanatory.

their right to withdraw
from the research at any
stage and also of the
consequences. (if any)
of such withdrawal.
Patients are assured Self explanatory.

that their refusal to
participate or withdrawal
from participation will
not compromise their
access to the
organization’s services.
COP.17. Policies and procedures guide nutritional therapy.

and procedures guide
nutritional assessment
and reassessment.
Patients receive food A dietician shall do the assessment of the For example, diabetic diet,
according to their clinical patient in consultation with the clinician and high protein diet, total
needs. advice regarding food. parenteral nutrition.
There is a written order The dietician shall prepare this in the form of
for the diet. a diet sheet and patient shall receive food
accordingly.
Nutritional therapy is The dietician shall ensure that this is planned

planned and provided in in consultation with the treating doctor and
a collaborative manner. the patient/patient’s relative after taking into
regard the patient’s food habits (veg/non-veg)
and likes and dislikes.
When families provide The dietician/nurse shall ensure this during

food, they are educated planning.
about the patient’s diet
limitations.
Food is prepared, The dietary services to be designed in a

handled, stored and manner that there is no criss cross of traffic.
distributed in a safe All the activities fall in a sequence. The
manner. organization shall ensure that hygienic
conditions are followed all throughout.
COP.18. Policies and procedures guide the end of life care.
Documented policies and The HCO has a documented policy Refer to glossary for
procedures guide the end of life for providing care to terminally ill definition of end of life.
care. admitted patients. This shall include
providing appropriate pain and
palliative care according to the
wishes of the family and patient.
These policies and procedures Self explanatory.

are in consonance with the legal
requirements.
These also address the The religious and socio-cultural

identification of the unique needs beliefs of patients/family shall be
of such patient and family. addressed and respected.
These also include sensitively If the body of the deceased is

addressing issues such as subjected to an autopsy or for organ
autopsy and organ donation. donation, it should be discussed
with the family in a very courteous
manner.
Staff is educated and trained in Self explanatory. Records of the same

end of life care. should be available.
CHAPTER 3: Management of Medication (MOM)
MOM.1. Policies and procedures guide the organization of pharmacy services and usage of
medication.
There is a documented policy The policies and procedures shall

and procedure for pharmacy address the issues related to
services and medication usage. procurement, storage, formulary,
prescription, dispensing, and use of
medications.
These comply with the Self explanatory. Relevant legislations

applicable laws and include Drugs and
regulations. Cosmetics Act, Narcotic
Drugs and Psychotropic
Substances Act, Drugs and
Magical Remedies
(Objectionable
Advertisement) Act, etc.
A multidisciplinary committee This shall be representative of major For example, pharmaco-

guides the formulation and clinical departments, administration therapeutic committee.
implementation of these and shall include a pharmacist/ clinical
policies and procedures. pharmacologist.
MOM.2. There is a hospital formulary.
A list of medication appropriate The hospital formulary shall be prepared

for the patients and and be preferably updated at regular
organization’s resources is intervals.
developed.
The list is developed Refer to MOM 1c.
collaboratively by the
multidisciplinary committee.
There is a defined process for The process should address the issues
acquisition of these of vendor selection, vendor evaluation,
medications. generation of purchase order and receipt
of goods as per rules.
There is a process to obtain Self explanatory. For example, local

medications not listed in the purchase.
formulary.
MOM.3. Policies and procedures exist for storage of medication.
Documented policies and These should address issues pertaining to

procedures exist for temperature (refrigeration). Light,
storage of medication. ventilation, preventing entry of
pests/rodents and vermins.
Medications are stored in The organization shall also ensure that the Vaccines should
a clean, well lit and storage requirements of the drug as preferably be kept in
ventilated Medications specified by the manufacturer are adhered vaccine refrigerators (Ice
environment . to. If the recommendations are conflicting in Lined Refrigerator).
nature, the organization shall follow the
manufacturer’s recommendation. This shall
be applicable to all areas where
medications are stored including wards.
Sound inventory control Self explanatory. The organization shall

practices guide storage of follow inventory control
the medications. practices like first in and
first out, ABC,etc.
Medications are protected The organization shall ensure that it

from loss or theft. develops proper mechanisms to prevent
pilferage. The organization could conduct
audits at regular intervals (as defined by the
organization) to detect such instances.
Sound alike and look alike Many drugs in ampoules, vials or tablets The organization can
medication when the may look-alike or sound-alike. They should follow a method of storing
pharmacy is closed. be segregated and stored separately. drugs by generic name in
an alphabetical order to
address this issue.
There is a method to obtain When pharmacy is closed, there should be It is preferable that the
medication when the a SOP to procure the drugs. HCO has a 24 hours
pharmacy is closed. pharmacy.
Emergency medications Adequate amount of emergency medicines

are available all the time. should be stocked at all times. Re –order
level at definite quantity should be done.
Emergency medications Self explanatory.

are replenished in a timely
manner when used.
MOM.4. Policies and procedures exist for prescription of medications.
Documented policies and Self explanatory. Refer to MOM 1a.

procedures exist for
prescription of medications.
The organization determines This shall be done by the treating

who can write orders. doctor.
Orders are written in a All the orders for medicines are

uniform location in the recorded on a uniform location of the
medical records. case sheet. Electronic orders when
typed shall again follow the same
principles.
Medication orders are clear, Self explanatory. The organization can

legible, dated, timed, named explore the possibility of
and signed. writing orders in block
letters so that the issue of
legibility is addressed.
Policy on verbal orders is The organization shall ensure that is Verbal orders should be
documented and has a policy to address this issue and it followed by written orders.
implemented. shall address as to who can give verbal
orders and how these orders will be
validated.
The organization defines a High risk medications are medications

list of high risk medication. involved in a high percentage of
medications errors of sentinel events an

medications that carry a high risk for
abuse, error, or other adverse
outcomes.
Examples include medications with a

low therapeutic window, controlled
substances, psychotherapeutic
medications, an look-alike and sound-
alike medications.
High risk medication orders There medications shall preferably be

are verified prior to given only after written orders and it
dispensing. should be verified by the staff before
dispensing.
MOM.5. Policies and procedures guide the safe dispensing of medications.
Documented policies and Clear policies to be laid down for

procedures guide the safe dispensing of medication e.g. route
dispensing of medications. of administration, dosage, rate of
administration, expiry date, etc.
The policies include a Recall may result based on letters

procedure for medication from regulatory authorities or
recall. internal feedback (e.g. visible
contaminant in IV fluid bottle).
Expiry dates are checked prior Self explanatory. This shall be done at all levels
to dispensing. e.g. pharmacy, ward, etc.
Labelling requirements are At a minimum, labels must include This is applicable to all
documented and implemented the drug name, strength, frequency dispensing areas wherein
by the organization. of administration (in a language the medicines are dispensed
patient understands) and expiry either as cut strips or from
dates. bulk containers.
MOM.6.There are defined procedures for medication administration.
Medications are administered Self explanatory. Refer to statutory requirements. In

by those who are permitted by addition to doctors, nursing staff
law to do so. may also administer.
Prepared medications are Self explanatory. Applicable for parenteral drugs.

labeled prior to preparation of
a second drug.
Patient is identified prior to Self explanatory. Identification shall be done by

administration. unique identification number (e.g.
hospital number/IP number, etc.)
with/without name.
Medication is verified from the Staff administering

order prior to administration. medications should go through
the treatment orders before
administration of the
medication and then only
administer them. It is
preferable that they also check
the general appearance of the
medication (e.g. melting,
clumping etc.) before
dispensing.
Dosage is verified from the Self explanatory.

order prior to administration.
Route is verified from the order Self explanatory.

prior to administration.
Timing is verified from the Self explanatory.

order prior to administration.
Medication administration is The organization shall ensure The records shall reflect the actual
documented. that this is done in a uniform administration. For example, if
location and it shall include the brand Y was given in place of
name of the medication. brand X (same generically) the
documentation shall be of brand Y.
Similarly if the order was for a
tablet of 250mg but the
administration was ½ a tablet of
500mg the latter shall be
documented.
Policies and procedures At the outset the HCO could For example, self administration of
govern patient’s self define if it would permit self insulin.
administration of medications. administration of medications.

In case the HCO permits then
the policy shall include the
medications which the patient
can self administer. It is
preferable that the organization
also incorporates a method to
ensure that the patient is
reminded to take the
medication (before every dose)
and documentation of self
administration.
Policies and procedures These shall address as to what

govern patient’s medications are the pre-requisites for such
brought from outside the a medication (e.g. Invoice,
organization. Clear label with mention of the
name, dose, expiry date etc.
MOM.7. Patients and family members are educated about safe medication and food-drug
interactions.
Objective element interpretation Remark (S)
Patient and family are The organization shall make a

educated about safe and list of such drugs and
effective use of medication. accordingly educate e.g.
digoxin. This could also include
education regarding the
importance of taking a drug at
a specific time e.g. sustained
release medications.
Patient and family are Patient and family should be

educated about food-drug counseled about their diet
interactions. during medication e.g. no
alcohol when taking
metronidazale.
MOM.8.Patients are monitored after medication administration.
Patients are monitored This shall be done by anyone involved

after medication in direct patient care. The organization
administration and this is could follow either a passive
documented. (documenting only if the patient tells) or
active (enquiring with every patient)
monitoring mechanism.
Adverse drug events are The organization shall define as to what Refer to glossary for “adverse
defined. constitutes an adverse drug event. This drug event”.
shall be in consonance with best
practices. Adverse drug events include
adverse drug reactions as well as
medication errors.
Adverse drug events are Self explanatory. The organization shall

reported within a specified define the timeframe for reporting once
time frame. the adverse drug event has occurred.
Adverse drug events are All the adverse drug reactions are
collected and analyzed. analyzed regularly by the multi-
disciplinary committee (Refer to MMC
1c.)
Policies are modified to Self explanatory.

reduce adverse drug
events when unacceptable
trends occur.
MOM.9. Policies ad procedures guide the use of narcotic drugs and psychotropic substances.
Documented policies and Self explanatory. Refer to

procedures guide the use of MOM 1a.
narcotic drugs and
psychotropic substances.
These policies are in This is in the context of

consonance with local and Narcotic Drugs and
national regulations. Psychotropic Substances Act.
A proper record is kept of the These shall be kept in

usage, administration and accordance with statutory
disposal of these drugs. requirements.
These drugs are handled by Self explanatory.

appropriate personal in
accordance with policies.
MOM.10.Policies and procedures guide the usage of chemotherapeutic agents.

and procedures
guide the usage of
chemotherapeutic
agents.
Chemotherapy is This shall preferably be a medical

prescribed by those oncologist or a person who has been
who have the trained and has achieved competency
knowledge to in the same.
monitor and treat the
adverse effect of
chemotherapy.
Chemotherapy is This shall preferably be staff who have

prepared and received special training in preparing
administered by and administration.
qualified personnel.
Chemotherapy drugs These shall be disposed off according

are disposed off in to Bio-medical waste management and
accordance with handing rules 1998 or manufacture’s
legal requirements. recommendation.
MOM.11. Policies and procedures govern usage of radioactive drugs.
Documented policies and Self explanatory.

procedures govern usage of
radioactive drugs.
These policies and procedures Refer to AERB guidelines.

are in consonance with laws
and regulations.
The policies and procedures Self explanatory. This shall

include the safe storage, however be in accordance with
preparation, handling, AERB guidelines.
distribution and disposal of
radioactive drugs.
Staff, patients and visitors are Self explanatory. This refers to the layout/location of
educated on safety radiation waste pipes, delay tanks,
precautions. etc.
MOM.12. Policies and procedures guide the use of implantable prosthesis.
Documented policies and Self explanatory.

procedures govern
procurement and usage of
implantable prosthesis.
Selection of implantable The organization shall ensure

prosthesis is based on that relevant and sufficient
scientific criteria and national/ scientific data are available
internationally recognized before selection. It shall also
approvals. look for international (e.g. US-
FDA) or national notification
(Drugs and Cosmetics Act
notification October 2005) for
approval of the particular
product.
The batch and serial number of Self explanatory.

the implantable prosthesis are
recorded in the patient’s
medical record and the master
logbook.
MOM.13.Policies and procedures guide the use of medical gases.
Documented policies and This shall be applicable to all

procedures govern gases used in the organization.
procurement, handing, It shall also address the issue
storage, distribution, usage of statutory requirements and
and replenishment of medical approvals wherever applicable.
gases. It shall follow a uniform colour

coding system.
The policies and procedures This shall include from the

address the safety issues at all point of storage/source area,
levels. gas supply lines and the end
user area. Appropriate safety
measures shall be developed
and implemented for all levels.
Appropriate records are This is the context of the Indian

maintained in accordance with explosives act of 1884, Gas
the policies, procedures and cylinder rules 1981 and Static
legal requirements. and mobile pressure vessels
(unfired) 1981.
CHAPTER 4 : Patient Rights and Education (PRE)
PRE.!. The organization protects patient and family rights and informs them about their
responsibilities during care.
Patient and family rights and Hospital should respect For an example of “patient
responsibilities are patient’s rights and inform responsibility” refer to glossary.
documented. them of their responsibilities.
All the rights of the patients

should be displayed in the form
of a Citizens’ Chapter which
should also give information of
the charges and grievance
redressal mechanism.
Patients and families are Self explanatory.

informed of their rights and
responsibilities in a format and
language that they can
understand.
The organization’s leaders Protection also includes

protect patient’s and family addressing patient’s
rights. grievances w.r.t. rights..
Staff is a ware of their Training and sensitization

responsibility in protecting programmes shall be
patients and family rights. conducted to create
awareness among the staff.
Violation of patient and family Where patient’s rights have

rights is recorded, reviewed been infringed upon,
and corrective/ preventive management must keep
measures taken. records of such violations, as
also a record of the
consequences, e.g. corrective
actions to prevent recurrences.
PRE.2. Patient and family rights support individual beliefs, values and involve the patient and
family in decision making processes.
Patient and family rights This could include dietary

address any special preferences and worship
preferences, spiritual and requirements.
cultural needs.
Patient and family rights During all stages of patient

include respect for personal care, be it in examination or
dignity and privacy during carrying out a procedure,
examination, procedures and hospital staff shall ensure that
treatment. patient’s privacy and dignity is
maintained. The organization
shall develop the necessary
guidelines for the same. During
procedures the organization
shall ensure that the patient is
exposed just before the actual
procedure is undertaken. With
regards to
photographs/recording
procedures, the organization
shall ensure that consent is
taken and that the patient’s
identity is not revealed.
Patient and family rights Self explanatory. Special Examples of this include falling
include protection from precautions shall be taken from the bed/trolley due to
physical abuse or neglect. especially w.r.t. vulnerable negligence, assault, repeated
patients e.g. elderly, neonates internal examinations, manhanding
etc. etc.
Patient and family rights Self explanatory. Statutory Examples of this include MTP,
include treating patient requirements w.r.t. privileged patients of tuberculosis or any
information as confidential. communication shall be other infectious disease.
followed at all times.
Patient and family rights During management the In case of refusal the treating
include refusal of treatment. patients should be given the doctor shall explain the
choice of treatment. The consequences of refusal of
treating doctor shall discus all treatment and document the same.
the available options and allow
the patient to make an
informed choice including the
option of refusal.
Patient and family rights Self explanatory. Informed consent of the patient is
include informed consent mandatory for doing HIV test.
before anaesthesia, blood and
blood product transfusions and
any invasive/ high risk
procedures/treatment.
Patient and family rights The organization shall ensure

include information and that International conference
consent before any research on harmonization (ICH) of
protocol is initiated. Good clinical practice (GCP)
and Declaration of Helsinki
Somerset (1996) and ICMR
requirements are followed.
Patient and family rights Grievance redressal

include information on how to mechanism must be
voice a complaint. accessible and transparent.
Information must be clearly
available on how to voice a
complaint.
Patient and family rights Refer AAC4d.

include information on the
expected cost of the treatment.
Patient and family have a right The organization shall ensure

to have an access to his/ her that every patient has access
clinical records. to his/her record. This shall be
in consonance. With the code
of medical ethics and statutory
requirements.
PRE.3. A documented process for obtaining patient and/ or family’s consent exists for
informed decision making about their care.
General consent for treatment Self explanatory.

is obtained when the patient
enters the organization.
Patient and family members The organization shall define The cannot include consent for
are informed of the scope of as to what is the scope of this invasive procedures or other
such general consent. consent and the same shall be procedures for which consent is
communicated to the patient required as per this standard.
and/or his family members.
The organization has listed A list of procedures should be The policy for HIV testing should
those situations where made for which informed follow the national policy on HIV
informed consent is required. consent should be taken. testing (NACO).
Informed consent includes The consent shall have the

information on risks, benefits, name of the doctor performing
alternatives and as to who will the procedure. If it is a “doctor
perform the requisite under training” the same shall
procedure in a language that be specified, however the
they can understand. name of the qualified doctor
supervising the procedure shall
also be mentioned. Consent
form shall be in the language
that the patient understands.
The policy describes who can The organization shall take into
give consent when patient is consideration the statutory
incapable of independent norms. This would include next
decision making. of kin/legal guardian. However

in case of
unconscious/unaccompanied
patients the treating doctor can
take a decision in life saving
circumstances.
PRE.4. Patient and families have a right to information and education about their healthcare
needs.
When appropriate, patient and Self explanatory.

families are educated about
the safe and effective use of
medication and the potential
side effects of the medication.
Patient and families are Self explanatory.

educated about diet ad
nutrition.
Patient and families are Self explanatory. More

educated about immunizations. applicable for paediatric
population. In adults it could be
for influenza. Streptococcus
pneumonia, typhoid, hepatitis
B, Neisseria meningitides, etc.
Patient and families are Self explanatory. This could

educated about their specific also be done through patient
disease process, complications education booklets/ videos/
and prevention strategies. leaflets etc.
Patient and families are Self explanatory. For example, hand washing and
educated about preventing avoiding overcrowding near the
infections. patient.
Patient and family are taught in Self explanatory.

a language and format that
they can understand.
PRE.5. Patient and families have a right to information on expected costs.
There is uniform pricing policy There should be a billing policy

in a given setting (out-patient which defines the charges to
and ward category). be levied for various activities.
The tariff list is available to The organization shall ensure

patients. that there is an updated tariff
list and that this list is available
to patients when required. The
organization shall charge as
per the tariff list. Any additional
charge should also be
enumerated in the tariff and
the same communicated to the
patients. The tariff rates should
be uniform and transparent.
Patients and family are Refer to AAC4d.

educated about the estimated
costs of treatment.
Patients and family are When patients are shifted from

informed about the financial one setting to another, typically
implications when there is a to and from ICUs, the financial
change in the patient condition implications must be clearly
or treatment setting. conveyed to them.
CHAPTER 5 : Hospital Infection Control (HIC)
HIC.1. The organization has a well-designed, comprehensive and coordinated infection control
programme aimed at reducing/ eliminating risks to patients, visitors and providers of care.
Objective Element Interpretation Remark(S)
The hospital infection control Self explanatory. Reference documents could

programme is documented include Prevention of hospital
which aims at preventing and acquired infections- a practical
reducing risk of nosocomial guide (2nd edition, 2002) by WHO,
infections. CDC Guidelines and Manual for
control of Hospital Associated
Infections, Standard Operative
procedures by NACO, Ministry of
Health and family Welfare, Govt. of

India.
The hospital has a multi- This shall preferably have

disciplinary infection control Hospital Administrator,
committee. Microbiologist, Physician,
Surgeon, Manager-Nursing
(Nursing Supervisor), staff
from CSSD, and other support
services and the hospital
infection control nurse. It could
also include invitees from
various departments as
deemed necessary.
The hospital has an infection The team is responsible for For the composition of the team
control team. day-to-day functioning of refer to WHO, APIC and CDC
infection control programme. guidelines.
They shall support surveillance
process and detect outbreaks.
They shall also participate in
audit activity and in infection
prevention an control on a day-
to-day basis.
The hospital has designed and The qualification shall be either It is preferable for them to have
qualified infection control nurse a graduate nurse or qualified undergone a short term training
(s) for his activity. nurse with competence gained progrmme on infection control
by experience. nursing by a recognized institute.
HIC.2.The organization has an infection control manual, which is periodically updated.
The manual identifies the The manual should clearly identify the high
various high-risk areas and risk areas of the hospital e.g. ICU, HDU,
procedure. OT, Post-operative ward, Blood Bank,
CSSD, etc.
Similarly, all high risk procedures should

be identified from infection control point of
view. For example, cardiac catheterization,
endoscopies, surgery lasting more than 2
hours, BMT etc.
It outlines methods of It shall define the frequency and mode of

surveillance in the surveillance.
identified high-risk areas.
The surveillance system should meet
WHO criteria of simplicity, cost
minimization, timeliness of feedback,
flexibility, acceptability, consistency
(reliability), sensitivity and specificity.
It focuses on adherence to Self explanatory. Refer to glossary for

standard precautions at all standard precautions.
times.
Equipment cleaning and It shall address this at all levels e.g. ward,
sterilization practices are OT and CSSD. It is preferable that the
included. organization follows a uniform policy
across different departments within the
organization.
The manual should include sterilization

and disinfection policy, chemicals used/
methods and procedures followed in
wards and critical areas. Special focus on
critical equipments like ventilators,
nebulizers etc.
An appropriate antibiotic The HCO shall develop a system of The HCO could also refer
policy is established and monitoring drug susceptibility (based on to international guidelines
implemented. culture sensitivity) and accordingly while framing the policy.
develop its antibiotic policy, which shall be
reviewed at periodic intervals (maybe once Use of WHO reference
in 3 months) for its continuing applicability. document Global strategy
for containment of
antimicrobial resistance,
2001[WHO/CDS/CSR/DRS
/2001.2] can be a good
starting point.
Laundry and linen The laundry can be in-house or

management processes outsourced. If outsourced the organization
are also included. shall ensure that it establishes adequate
controls to ensure infection control. The
linen change policy should be mentioned.
Washing protocols for different categories
of linen including blankets should be
included.
Kitchen sanitation and food Self explanatory. The same shall be

handing issues are applicable even if this activity is
included in the manual. outsourced. The organization could refer
to ISO 22000:2005 (food safety) while
addressing this issue.
Engineering controls to Issues such as air conditioning plant and Refer to glossary for air
prevent infections are equipment maintenance; cleaning of AC conditioning in OT.
included. ducts, AHUS; replacement of filters;
seepage leading to fungal colonization;
replacement/repair of plumbing, sewer
lines (in shafts) should be included. Water
supply sources and system of supply,
testing for water quality must be included.
Any renovation work in hospital patient
care areas should be planned with
Infection Control team with regard to
architectural segregation, traffic flow, use
of materials etc.
Mortuary practices and The mortuary services in the hospital

procedures are included as should be provided through walk-in cold
appropriate to the rooms or mortuary cold cabinets. Mortuary
organization. procedures of preserving body, or body
parts and safety measures while handing
over body to relatives should be in
accordance with the policy.
The organization defines The organization must have a documented

the periodicity of updating policy on the updation of the infection
the infection control control manual. It is desirable to update at
manual. least once in a year based on its trends
and outcomes of the audit processes.
HIC.3. The infection control team is responsible for surveillance activities in identified areas of
the hospital.
Surveillance activities are The organization must be able The HCO should use a judicious
appropriately directed towards to provide evidence of mix of active and passive
the identified high-risk areas. conducting periodic surveillance.
surveillance activities in its
identified high risk areas.
The specific objectives, case
definitions, identification of
potential indicators, frequency
and duration of monitoring,
methods of data collection,
along with schedule of rounds
should be defined.
Confidentiality and anonymity
must be ensured. The HCO
should clearly mention which
specific targeted surveillance
(site specific, unit oriented,
priority oriented) activities are
being carried out.
Collection of surveillance data The organization shall ensure

is an ongoing process. that it has a process in place to
collect surveillance data and
also to ensure that it is able to
capture all such data.
Verification of data is done on The data so collected shall be

regular basis by the infection authenticated by the team by
control team. going through every data or by
using random sampling so that
the process can be validated.
The team shall preferably
verify every serious infection
(as defined by the
organization) report.
In cases of notifiable diseases, The organization shall identify Refer to glossary for notifiable
information (in relevant format) all notifiable diseases after diseases.
is sent to appropriate taking into consideration the
authorities. local laws, rules, regulations
and notifications shall ensure
that this is sent at the specified
frequency and in the format as
required by statutory
authorities.
Scope of surveillance activies This shall be done at regular A simple calculation of infected
incorporates tracking and intervals (may be monthly and patients (numerator) provides only
analyzing of infection risks, consolidated into an annual limited information which would be
rates and trends. report) and the organization difficult to interpret. Risk factor
shall take suitable steps based analysis would require information
on the analysis. for both infected and non infected
patients, in order to calculate

infection and risk adjusted rates.
Surveillance activities include This would include This is applicable even if the
monitoring the effectiveness of categorization of housekeeping services are
housekeeping services. areas/surfaces; general outsourced.
cleaning, blood and body fluid
cleanup, isolation rooms and
all high risk (critical) areas. The
common disinfectants used,
dilution factors, method of use
should be specified.
HIC.4. The organization takes actions to prevent to reduce the risk of Hospital Associated
Infections (HAI) in patients and emplioyees.
The organization monitors This can be done either by The HCO may extend this activity
urinary tract infections. sending urine or catheter tip for to asymptomatic catheterised
culture. The organization shall patients also. It is preferable to use
do this for all symptomatic CDC definirions.
catheterized patients.
The organization monitors This can be done by sending It is preferable to use CDC
respiratory tract infections. sputum or ET/ tracheostomy definitions.
secretions (obtained using a
suction catheter) or ET/
tracheostomy tip or protected
specimen brushing (PSB) or
mini broncho-alveolar lavage
(BAL) for culture. The
organization shall do this for all
patients on the ventilator
having clinical features
suggestive of infection.
The organization monitors For patients with symptoms It is preferable to use CDC
intra-vascular device suggestive of intra vascular definitions.
infections. device infection and having
central line the same shall be
done by sending the tip for
culture. For all peripheral lines
clinical evidence of
thrombophlebitis would suffice.
The organization monitors This shall be done by sending It is preferable to use CDC
surgical site infections. pus/swab for culture. definitions.
Appropriate feedback The feedback shall include the This could be in the form of a
regarding HAI rates are rates, trends and opportunities bulletin/newsletter.
provided on a regular basis to for improvement. It could also
medical and nursing staff. provide specific inputs to
reduce the HAI rate.
HIC.5. Proper facilities and adequate resources are provided to support the infection control
programme.
Hand washing facilities in all The organization shall ensure Optimal hand hygiene
patient care areas are that it providers necessary requirements include large
accessible to health care infrastructure to carry out the washbasins, hands free control,
providers. same. soap and facility for drying hands
without contamination. The hand
hygiene guidelines shall be based
on WHO 2007 guidelines on
patient safety (website:
www.who.int/patientsafety)
Compliance with proper hand The organization shall

washing is monitored regularly. preferably display the
necessary instructions near
every hand washing area.
Compliance could be verified
by random checking.
Observation, etc.
Isolation/ barrier nursing The organization shall be Refer to glossary for

facilities are available. display the isolation/barrier nursing.
Adequate gloves, masks, Self explanatory. They should

soaps, and disinfectants are be available at the point of use
available and used correctly. and the organization shall
ensure that it maintains an
adequate inventory.
HIC.6. The hospital takes appropriate action to control outbreaks of infections.
Hospital has a documented This shall incorporate To define as to what constitutes

procedure for handing such definitions as to what an outbreak the HCO should have
outbreaks. constitutes an outbreak, baseline rates.
identification and investigation
of such outbreaks and the
procedure for management.
This shall be in accordance
with good clinical practices.
Standard Case definitions shall

include a unit of time and place
along with specific biological
and/or clinical criteria.
This procedure is implemented The organization should be

during outbreaks. able to identify the outbreak,
describe the outbreak by
developing a case definition,
designing a data collection
form, collecting data from the
affected, constructing an
epidemic curve.
After the outbreak is over The organization should be

appropriate corrective actions able to implement basic
are taken to prevent procedures to prevent
recurrence. recurrence such as source
control if source identified,
review of all infection control
policies, loopholes and
compliance gaps, strength
evening infection control
policies etc.
HIC.7. There are documented procedures for sterilization activities in the organization.
There is adequate space Adequate of space refers to The HCO shall provide for the
available for sterilization the CSSD which should have same in all areas where
activities. an area of0.7sq. m/bed, sterilization activities are carried
suitable location, proper layout out. It is preferable to have
(unidirectional flow, zoning) separate areas for receiving,
and separation of clean and washing, cleaning, packing,
dirty areas. sterilization, sterile storage and

issue.
Regular validation tests for This shall be done by accepted WHO recommends each load to
sterilization are carried out and methods e.g. bacteriologic, have a number, content
documented. strip etc. description, temp and time record
chart, physical/ chemical tests
Evening validations like Bowie daily, weekly biological tests,
Dick tape test and leak rate steam processing, and ETO
test need to be carried out. processing.
There is an established recall The organization shall ensure The HCO could have a batch
procedure when breakdown in that the sterilization procedure processing system with date and
the sterilization system is is regularly monitored and in machine number for effective
identified. the eventuality of a breakdown recall.
it has a procedure for
withdrawal of such items.
HIC.8. Statutory provisions with regard to Bio-Medical Waste (BMW) management are complied
with.
The hospital is authorized by The occupier shall apply in the

prescribed authority for the prescribed from and get
management and handing of approval from the prescribed
Bio-medical Waste. authority e.g. Pollution control
board/ committee.
Proper segregation and Wastes to be segregated and

collection of Bio-medical collected in different colour
Waste from all patient care coded bags and containers as
areas of the hospital is per statutory provisions.
implemented and monitored. Monitoring shall be done by
members of the infection
control committee/team.
The organization ensures that The waste is transported to the

Bio-medical Waste is stored pre-defined site at definite time
and transported to the site of intervals (maximum within 48
treatment and disposal in hours) through proper
proper covered vehicles within transport vehicles in a safe
stipulated time limits in a manner. If this activity is
secure manner. outsourced the organization
shall ensure that it is done to
an authorized contractor.
Monitoring of this activity

should be done by infection
Control team.
Bio-medical Waste treatment If the hospital has waste

facility is managed as per treatment facility within its
statutory provisions (if in- premises then they have to be
house) or outsourced to in accordance with statutory
authorized contractor(s). provisions or they can
outsource it to a central facility.
Requisite fees, documents and The HCO shall ensure that the
reports are submitted to fees are deposited in a timely
competent authorities on manner. In addition the annual
stipulated dates. reports have to be submitted
by the 31st of January of every
year and carried out in the
prescribed form.
Appropriate personal Self explanatory. For example, gloves and masks,

protective measures are used protective glasses, gown, etc.
by all categories of staff
handling Bio-medical Waste.
HIC.9. The infection control programme is supported by organization’s management and

includes training of staff and employee health.
Hospital management makes The HCO shall ensure that the

available resources required resources required by the
for the infection control personnel should be available
programme. in a sustained manner. This
includes both men and
materials.
The hospital regularly There shall be a separate

earmarks adequate funds from budget demarcated for HIC
its annual budget in this activity. This shall be prepared
regard. taking into consideration the
scope of the activity and
previous year’s experience.
It conducts regular pre- There must be a documented Doctors also need to be trained.
induction training for evidence of pre-induction
appropriate categories of staff training for appropriate
before joining concerned categories of staff before
joining concerned
Department(s). department(s). it should
include the policies,
procedures and practices of
the infection control
programme.
It also conducts regular “in- Self explanatory.

service” training sessions for
all concerned categories of
staff at least once in a year.
Appropriate pre an post Self explanatory. For example, hepatitis B

exposure prophylaxis is vaccination and PEP for needle
provided to all concerned staff stick injury.
members.
CHAPTER 6 : Continuous Quality Improvement (CQI)
CQI.1. There is a structured quality improvement and continuous monitoring programme in

the organization.
The quality improvement This committee shall have For example, core committee,
programme is developed, representation from quality improvement committee,
implemented and maintained management, various clinical etc.
by a multi-disciplinary and support departments of
committee. the HCO. This programme
shall be developed,
implemented and maintained
in a structured manner.
The quality improvement This should be documented as Refer to AAC 8, AAC 11, COP 6,
programme is documented. a manual. The manual shall COP 12 and HIC 2 ALSO.
incorporate. The mission,
vision, quality policy, quality Refer to guidelines for
objectives, service standards, documentation.
important indicators as
identified etc. the manual could
be stand alone and should
have cross linkages with other
manuals.
There is a designated This should preferably be a For example, accreditation co-

individual for coordinating and person having a good ordinator, quality management
implementing the quality knowledge of accreditation representative, quality manager.
improvement programme. standards, statutory
requirements, hospital quality
improvement principles and
evalution methodologies,
hospital functioning and
operations.
The quality improvement This shall preferably cover all Refer to glossary for definition of
programme is comprehensive aspects including Risk management and Quality
and covers all the major documentation of the improvement.
elements related to quality programme, monitoring it, data
improvement and risk collection, review of policy and
management. corrective action. Also refer to
CQI 1b.
The designated programme is Self explanatory. This could be done through regular
communicated and training programme or printed
coordinated amongst all the materials.
employees of the organization
through proper training
mechanism.
The quality improvement As quality improvement is a The assessors shall be either

programme is reviewed at dynamic process, it needs to trained internally or externally in
predefined intervals and be reviewed at regular pre- NABH standards. They shall
opportunities for improvement defined intervals (as defined by assess areas independent of their
are identified. the HCO in the quality area of work.
improvement manual but at
least once in four months) by
conducting internal audits. This
audit shall be done by a multi-
disciplinary team (preferably
trained in NABH standards)
including all the applicable
standards and objective
elements. At the end of the
audit there shall be a formal
meeting to summarise the

findings and identify areas for
improvement. During this
meeting there shall be an
analysis of key indicators as
identified and determined by
the organization including the
mandatory indicators as laid
down in CQI 2 and 3. The
minutes of the review meetings
should be recorded and
maintained.
The quality improvement Self explanatory. The inputs for

programme is a continuous updation could be based on
process and updated process the review carried out by the
and updated at least once in a quality improvement
year. committee.
CQI.2. The organization identifies key indicators to monitor the clinical structures, processes
and outcomes which are used as tools for continual improvement.
Monitoring includes The HCO shall develop

appropriate patient appropriate key performance
assessment. indicators suitable to it. The
following is however
mandatory:
Time for initial assessment of

indoor and emergency
patients.
Percentage of cases wherein

care plan is documented and
counter-signed by the clinician.

screening for nutritional needs
has been done.

the pre-defined initial nursing
assessment is completed
within 30 minutes.
Monitoring includes safety and The HCO shall develop Reporting errors need to be
quality control programmes of appropriate key performance captured. It is better if the
control programmes of the indicators suitable to it. The organization captures these errors
diagnostics services. following is however as errors picked up before
mandatory: dispatching the reports and errors
picked after the dispatch of reports.
Number of reporting This includes transcription errors
errors/1000 investigations. also.
Percentage of re-dos.
Percentage of reports co- Re-dos include tests which needed

relating with clinical diagnosis. to be repeated in view of poor
sample or improper positioning and
Percentage of adherence to
in case of radiology also includes
safety precautions by
films wastage.
employees working in
diagnostics.
To capture co-relation it becomes

mandatory that all investigation
forms have a provisional
diagnosis/relevant clinical details
written on them.
The HCO could decide as to which

tests will be monitored.
To capture adherence to safety

precautions the organization needs
to do a random check of all
employees per month (working in
these areas and including all
categories of staff) and capture
data.
Monitoring includes all invasive The HCO shall develop

procedures. appropriate key performance
indicators suitable to it. The
mandatory:
Re-exploration rate.
Percentage of accidental
removal of tubes and

catheters.
Incidence of haematoma at
puncture site.
Percentage of re-scheduling of
procedures.
Monitoring includes adverse The HCO shall develop

drug events. appropriate key performance
mandatory:
Percentage of medication
errors.
Incidence of adverse drug

reactions.
Percentage of medication
charts with illegible writing over
a given period.
Percentage of contrast related

reactions.
Monitoring includes adverse The HCO shall develop Adverse anaesthesia events
drug events. appropriate key performance include events which happen
indicators suitable to it. The during the procedure like hypoxia,
following is however arrhythmias, cardiac arrest etc.
mandatory:
Percentage of modification of
anaesthesia plan.
Percentage of unplanned
ventilation following
anaesthesia.
Percentage of adverse
anaesthesia.
Anaesthesia related mortality

rate.
Monitoring includes use of The HCO shall develop

blood and blood products. appropriate key performance
mandatory:
Percentage of transfusion
reactions.
Percentage of wastage of
blood and blood products.
Percentage of blood
component usage.
Turnaround time for issue of

blood and blood components.
Monitoring includes availability The HCO shall develop Missing records include records
and content of medical appropriate key performance within the retention time only.
records. indicators suitable to it. The
mandatory:
Percentage of medical records

not having discharge
summary.

not having initial assessment
and the plan of care.

having incomplete and/or
improper consent.
Percentage of missing records.
Monitoring includes infection The HCO shall develop Refer to HIC 4

control activities. appropriate key performance
mandatory:
Urinary tract infection rate.
Respiratory infection rate.
Intra-vascular device infection

rate.
Surgical site infection rate.
Monitoring includes clinical The HCO shall develop Refer to ICMR guidelines and GCP
research. appropriate key performance for reporting time of serious
indicators suitable to it. The adverse events.
mandatory:
Number of research activities

being carried out.
Percentage of patients
withdrawing from the study.
Percentage of protocol
violations/deviations.
Percentage of serious adverse

events (which have occurred in
the HCO) ethics committee
with in the defined timeframe.
Monitoring includes data The data could be collected at For example, data can be collected
collection to support further pre-defined intervals e.g. to study the reasons for “Re Do’s”
improvements. monthly/quarterly. This data is in surgical patients
analysed for improvement
opportunities and the same are Data could be represented
carried out. Also refer to CQI 1f graphically e.g. bar chart, pie chart,
etc.
Monitoring includes data All improvement activities For example, once the reasons for
collection to support evaluation carried out by the HCO shall “Re” Do’s” have been analysed
of these improvements. have an evaluable outcome. and preventive and corrective
The same shall be captured measures undertaken then data
and analysed. can be collected to confirm that
reductions have occurred in the
incidence of “Re Do’s’’.
CQI.3. The organization identifies key indicators to monitor the managerial structures,
processes and outcomes which are used as tools for continual improvement.
Monitoring includes The HCO shall develop Local purchases implies drugs
procurement of medication appropriate key performance purchased outside the formulary.
essential to meet patient indicators suitable to it. The
needs. following is however
mandatory:
Percentage of drugs procured

by local purchase.
Percentage of stock outs

including emergency drugs.
Percentage of consumables
rejected before preparation of
Goods Receipt Note.
Incidence of variations from

the procurement process.
Monitoring includes reporting The HCO shall develop For example, tax, EPF, notifiable
of activities as required by laws appropriate key performance diseases, births and deaths, PNDT
and regulations. indicators suitable to it. The act, AERB guidelines etc.
mandatory:
Number of births and deaths.
Numbers of notifiable
diseases.
Submission of report/ data/

form pertaining to bio-medical
waste, PNDT act and radiation
safety within the defined
timeframe.
Submission of tax returns and

deduction of taxes at the
specified time frame.
Monitoring includes risk The HCO shall develop Mock drills include fire, non-fire
management. appropriate key performance and disaster management.

mandatory: Refer to glossary for definition of
risk management.
Number of variations observed
in mock drills.
Incidence of falls.
Incidence of bed sores after

admission.
Percentage of employees
provided pre-exposure
prophylaxis.
Monitoring includes utilization The HCO shall develop

of space, manpower and appropriate key performance
equipment. indicators suitable to it. The
mandatory:
Bed occupancy rate and

average length of stay.
OT and ICU utilization rate.
Equipment down time.
Nurse-patient ratio.
Monitoring includes patient The HCO shall develop Waiting time implies the time taken
satisfaction which also appropriate key performance from the time that the patient
incorporates waiting time for indicators suitable to it. The register to the time taken for
services. following is however assessment to be done by the
mandatory: doctor/ diagnostic procedure to be
performed.
Out patient satisfaction index.
In patient satisfaction index.

Time taken for discharge implies
Waiting time for services the time from which the doctor
including diagnostics and out writes for discharge to the time for
patient. final clearance.
Time taken for discharge.
Monitoring includes employee The HCO shall be develop

satisfaction. appropriate key performance
mandatory.:
Employee satisfaction index.
Employee attrition rate.
Employee absenteeism rate.
Percentage of employees who

are aware of employee rights,
responsibilities and welfare
schemes.
Monitoring includes adverse The HCO shall develop

events and near misses. appropriate key performance
mandatory:
Number of sentinel events.
Percentage of near misses

analysed.
Number of security related

incidents including thefts.
Incidence of needle stick

injuries.
Monitoring includes data The data could be collected at For example, waiting time in OPD.
collection to support further pre-defined intervals e.g.
improvements. monthly/ quarterly. This data
is analysed for improvement
opportunities and the same are
carried out. Also refer to CQI
1f.
Monitoring includes data Self explanatory. The inputs for

collection to support updation could be based on
evaluation of these the review carried out by the
improvements. quality improvement
committee.
CQI.4. The quality improvement programme is supported by the management.
Hospital Management makes This shall include the men,

available adequate resources material, machine and method.
required for quality programme. These should be in steady
supply so as to ensure that the
programme functions
smoothly.
Hospital earmarks adequate Appropriate fund allocation is The budget could be earmarked
funds from its annual budget in done by the organization for based on previous year’s
this regard. the smooth functioning of the spending. If no data is available the
programme. HCO could make a beginning by
earmarking a budget but reviewing
it at the end of 6 months to make
any necessary modifications.
Appropriate statistical and Self explanatory. For example, Root Cause Analysis,
management tools are applied FMEA, Project evaluation and
whenever required. review technique (PERT), Critical
path method (CPM), control Charts
etc.
CQI.5. There is an established system for audit of patient care services.
Medical and nursing staff The HCO shall identify such These could be members of the
participates in this system. personnel. It could be a mix of Core committee/quality assurance
clinical, administrators and committee, etc.
nurses.
The parameters to be audited As these audits are The audit shall encompass all
are defined by the retrospective/concurrent in aspects of care including clinical
organization. nature, it is imperative that this and nursing.
be done using predefined
parameters so that there is no
bias. The parameters could be

disease based, cost based,
community based or based on
length of stay.
Patient and staff anonymity is This means that the names of

maintained. the patients and the hospital
staff who may figure in the
audit documents must not be
disclosed or any reference be
made to them in public
discussions/ conferences.
All audits are documented. Self explanatory. The HCO could use a checklist
with the predefined parameters
and the audit findings could be
recorded on this sheet.
Remedial measures are All remedial measures as This should preferably be done
implemented ascertained should be based on root cause analysis.
documented and implemented
and improvements thereof
recorded to complete the audit
cycle.
CQI.6. Sentinel events are intensively analyzed.
The organization has defined The sentinel relating to system Refer to Glossary for definition of
sentinel events. or process deficiencies that are sentinel events.
relevant and important to the
organization must be clearly
defined.
The organization has the established processes

established processes for should be carried out by a
intense analysis of such multi-disciplinary committee
events. taking inputs from the
concerned units / discipline/
departments.
Corrective and preventive The findings and

actions are taken based on the recommendations arrived at
findings of such analysis. after the analysis should be
communicated to all concerned

personnel to correct the
systems and processes to
prevent recurrences.
CHAPTER 7 : Responsibilities of Management (ROM)
ROM.1. The responsibilities of the management are defined.
Objective Element Interpretation Remark (s)
Those responsibilities for it is not only the head of the For definition of mission refer to
governance lay down the HCO but the members of the glossary.
organization’s mission board of governors (where
statement. applicable) who need to define
it.
Those responsible for The Governing board and the Refer to glossary for strategic and
governance lay down the leaders of HCO shall define operational plans.
strategic and operational plans and develop the process for
commensurate to the strategic and operation plans
organization’s mission in so as to achieve the
Stakeholders include the
consultation with the various organizational mission
community the organization
stake holders. statement.
serves.
Those responsible for The Governing board and the

governance approve the Head of HCO shall have the
organization’s budget and policy for budgeting and
allocate the resources required resource allocation for
to meet the organization attaining its mission and
against the stated mission. periodically review it.
Those responsible for The governing board and the

governance monitor and Head of the HCO shall develop
measure the performance of quarterly (at least)
the organization against the performance reports based on
stated mission. the strategic and operational
plans.
Those responsible for The HCO shall have a well

governance appoint the senior defined organization
leaders in the organization. structure/chart and this shall
clearly document the
hierarchy, line of control, along
with the functions at various
levels.
Those responsible for Self explanatory. Senior leaders include the first two
governance appoint the senior rungs of the organogram.
leaders in the organization.
Those responsible for Self explanatory. It is not only the Head of the HCO
governance support research but the members of the Board of
activities and quality governors (where applicable) who
improvement plans. need to support this.
The organization compiles with Self explanatory. This shall include central
the laid down and applicable legislations (e.g. Drugs and
legislations and regulations. Cosmetics act, MTP act, PNDT
Act, 1996), Bio medical waste act,
The responsibility of
Air (Prevention and Control of
compliance lies with the first
Pollution) Act, 1981, Atomic
two level of the hierarchy.
Energy Regulatory Body
Approvals, License under Bio-
medical Management and
Handling Rules, 1998, respective
state legislations (Maharashtra
Maintenance of Clinical Records
act, Clinical establishment of West
Bengal) and local regulations (e.g.
building byelaws).
Those responsible for The Governing board and For example, free camps, outreach
governance address the Head of the HCO shall willfully programmes, adoption of villages,
organization’s social develop social responsibility PHCs, etc.
responsibility. policy and accordingly address
it.
RQM.2. The services provided by each department are documented.
Each organizational There needs to be a minimum

programme, service, site or essential qualification and
department has effective relevant experience of the
leadership. leader. The leader should have

domain knowledge of that
particular department.
Scope of services of each Each department’s activity is to For example, nephrology

department is defined. be predefined. This could be department could do all activities
documented either at individual like biopsy, shunts, fistulas, dialysis
department level or the HCO (haemo, CAPD), etc.
could have a brochure
detailing the scope of each
department.
Administrative policies and This shall include It could be common for the entire
procedures for each administrative procedures like HCO.
department is maintained. attendance, leave, conduce,
replacement etc.
Departmental leaders are Self explanatory. To effectively implement this, each

involved in quality department could have its
improvement. department objectives/ key
performance indicators and the
responsibility of achieving them
could be that of the leader.
ROM.3. The organization is managed by the leaders in an ethical manner.
The leaders make public the The HCO shall have a mission For definition of mission refer to
mission statement of the statement and the same shall glossary.
organization. be displayed prominently.
The leaders establish the The HCO shall function in an A good reference guide is “Code of
organization’s ethical ethical manner. medical ethics-2002” published by
management. MCI.
The organization discloses its The ownership of the hospital The portrays could be in the
ownership. e.g. trust, private, public has to registration certificate/ quality
be disclosed. manual, etc.
The organization honestly Self explanatory. Here portrays implies that the HCO
portrays the services which it conveys to the patients clearly
can and cannot provide. what it can and cannot provide.
The services that it cannot provide
could also be conveyed verbally.
Refer to AAC1also.
The organization honestly Here portrays implies that the

portrays its affiliations and HCO conveys its affiliations,
accreditation. accreditations for specific
departments or whole hospital
wherever applicable.
The organization accurately Self explanatory. Also refer to PRE 5. The tariff
bills for its services based upon could be devised by a tariff
a standard billing tariff. committee.
Rom.4. A suitably qualified and experienced individual heads the organization.
The designed individual has Self explanatory. This implies to the individual
requisite and appropriate looking after the day to day
administrative qualifications. operations and not to the chairman
of the Board of Governs.
Appropriate implies qualification in
hospital management/
administration.
The designated individual has Self explanatory. Appropriate implies administrative

requisite and appropriate experience in a HCO.
administrative experience.
ROM.5. Leaders ensure that patient safety aspects and risk management issues are an integral
part of patient care and hospital management.
The organization has an Self explanatory. This group could have a mix of
interdisciplinary group administrators, engineers, doctors,
assigned to oversee the and nurses. Refer to glossary for
hospital wide safety definition of safety programme.
programme.
The scope of the programme is The HCO shall have a system Refer to glossary for definition of
defined to include adverse of reporting of all the adverse events and sentinel
events ranging from ‘no harm’ incidents/accidents. events.
to ‘sentinel events’.
Reporting of incident/accident
should not just be based on
severity of the incident. In fact, all

incident must be reported.
Management ensures The HCO has a system in For example, MRI machine of the
implementation of systems for place for internal and external HCO breaks down.
internal and external reporting reporting of system and
of system and process failures. process failures. In this case internal reporting to be
done to the patients.
Contingency plan shall be in
place to deal with the situation
of system and process failure
anticipated within the
organization.
Management provides There shall be sufficient Refer to glossary for definition of

resources for proactive risk resources kept as contingency risk assessment and risk reduction.
assessment and risk reduction to address the risk reduction
activities. activities as and when the
leaders proactively suggest.
The end result of these shall

result in preventive actions.
CHAPTER 8.: Facility Management and Safety (FMS)
FMS.1. The organization is aware of and complies with the relevant rules and regulations,
laws and byelaws and requisite facility inspection requirements.
The management is A designated management For example, the protection

conversant with the laws and functionary has been given the guidelines give in national building
regulations and knows their responsibility to enlist the laws code of India, relevant regulations
applicability to the and regulation as applicable to (Kerala state building rules).
organization. the HCO. This functionary has
identified the appropriate
personnel in the HCO who are
supposed to implement the
respective laws and
regulations.
Management regularly updates Self explanatory.

any amendments in the
preventing laws of the land.
The management ensures Self explanatory.

implementation of these
requirements.
There is a mechanism to Self explanatory. For example, license for lifts, DG

regularly update licenses/ sets, etc.
registrations/ certifications.
FMS.2. The organization’s environment and facilities operate to ensure safety of patients, their
families, staff and visitors.
There is a documented Self explanatory. Refer glossary for definition of

operational and maintenance preventive and breakdown
(preventive and breakdown) maintenance.
plan.
Up-to-date drawings are A designed person maintains

maintained which detail the the drawings.
site layout, floor plans and fire
escape routes.
There is internal and external Self explanatory. These signages shall guide
sign posting in the organization patients and visitors. It is
in a language understood by preferable that signages are bi-
patient, families and lingual.
community.
Statutory requirements shall be
met.
The provision of space shall be Self explanatory. For example, Indian Standards (IS
in accordance with the 12433) formulated by Bureau of
available literature on good Indian Standards (for 30 and 100
practices (Indian or bedded hospitals and other
International Standards) and standards), IS 10905 for basic
directives from government requirements for general hospital
agencies. buildings.
There are designated A person in the HCO

individuals responsible for the management is designated to
maintenance of all the be in-charge of maintenance of
facilities. facilities. The HCO has the

required number of supervisors
and tradesmen to manage the
facilities.
Maintenance staff is Self explanatory.

contactable round the clock for
emergency repairs.
Response times are monitored A complaint attendance

from reporting to inspection register is to be maintained to
and implementation of indicate the date and time of
corrective actions. receipt of complaint, allotment
of job and completion of job.
FMS.3. The organization has a programme for clinical and support service equipment
management.
The organization plans for Self explanatory. This shall

equipment in accordance with also take into consideration
its services and strategic plan. future requirements.
Equipment is selected by a Collaborative process implies

collaborative process. that during equipment
selection there is involvement
of end user, management,
finance, engineering and bio-
medical departments.
All equipment is inventoried Self explanatory.

and proper logs are maintained
as required.
Qualified and trained Self explanatory.

personnel operate and
maintain the equipment.
Equipment are periodically The HCO has weekly/ monthly/

inspected and calibrated for annual schedules of inspection
their proper functioning. and calibration of equipment
which involve measurement in
an appropriate manner. The

HCO either calibrates the
equipment in house or out
sources, maintaining
traceability to national or
international or manufacture’s
guidelines/ standards.
There is a documented Self explanatory.

operational and maintenance
(preventive and breakdown)
plan.
FMS.4. The organization has provisions for safe water, electricity, medical gases and vacuum
system.
Potable water and electricity The HCO shall make For water quality, refer to IS 10500.
are available round the clock. arrangements for supply of
adequate potable water and
electricity.
Alternate sources are provided Alternative electric supply

for in case of failure. could be from DG Sets, solar
energy, UPS and any other
suitable source.
The organization regularly Self explanatory.

tests the alternative sources.
There is a maintenance plan Self explanatory.

for piped medical gas,
compressed air and vacuum
installation.
FMS.5. The organization has plans for fire and non-fire emergencies within the facilities.
The organization has plans The HCO has a fire and non-fire
and providers for early emergency committee (FNEC) to
detection, containment and review the HCO’s preparedness.
abatement of fire and non-fire The HCO has conducted an

emergences. exercise of hazard identification
and risk analysis (HIRA) and
accordingly taken all necessary
steps to eliminate or reduce such
hazards and associated risks. The
HCO has:
a fire plan covering fire arising out

of burning of inflammable items,
explosion, electric short circuiting
or acts of negligence or due to
incompetence of the staff on duty;
deployed adequate and qualified

personnel for this;
acquired adequate fire fighting

equipment for this which records
are kept up –to-date;
adequate training plans;
schedules for conduct of mock

drills;
mock drill records;
exit plans well displayed.
The HCO has a decided

emergency illumination system
which comes into effect in case of
a fire. The HCO takes care of
non-fire emergency situations by
identifying them and by deciding
appropriate course of action.
These may include:
terrorist attack:
invasion of swarms of insects and

pests:
earthquake:
invasion of stray animals:
hysteric fits of patients and/or
relatives:
civil disorders effecting the HCO:
anti-social behavior by patients/

relatives:
temperamental disorders of staff

causing deterioration in patient
care;
spillage of hazardous (acids,

mercury, etc)., infected materials
(used gloves, syringes, tubing,
sharps, etc.) medical wastes
(blood, pus, amniotic fluid, vomits,
etc.);
building or structural collapse;
fall or slips (from height or on

floor) or collision of personnel in
passageway;
fall of patient from bed;
bursting of pipe lines;
sudden flooding of areas like

basements due to clogging in pipe
lines;
sudden failure of supply of

electricity, gas, vacuum, etc,;
bursting of boilers and/ or

autoclaves.
The HCO has established liaison

with civil and police authorities
and fire brigade as required by
law for enlisting their help and
support in case of an emergency.
The organization has a Fire exit plan shall be displayed

documented safe exit plan in on each floor particularly close to
case of fire and non-fire the lifts. Exit doors should remain
emergencies. open on all the time.
Staff is trained for their role in In case of fire, designated person

case of such emergencies. are assigned particular work.
Mock drills are held at least Self explanatory.

twice in a year.
FMS.6. The organization has a smoking limitation policy.
The organization defines and Smoking in public places

implements its policies to including hospitals has been
reduce or eliminate smoking. banned in this country.
The policy has provisions for In view of the law, permission

granting exceptions for to smoke within the campus of
patients and families to smoke. hospital may not be granted.
FMS.7. The organization plans for handling community emergencies, epidemics and other
disasters.
The hospital identifies potential The HCO has a documented

emergencies. plan and procedure for
handling the situations like
sudden rush of victims of
Earthquake;
Flood;
Train accident;
Civil unrest outside
the HCO premises;
major fire;
invasion by enemy, etc.
These plans and procedures

cover ensuring adequacy of
medical supplies, equipment,
materials, identifying trained
personnel, transportation aids,
communication aids and mock

drill methodology.
The organization has a The disaster plan must Refer to National Disaster
documented disaster incorporate essential elements Management Authority guidelines.
management plan. of alert code, information and
communication, action cards
for each of the staff, availability
and earmarking of resources,
establishment of command
nucleus, training and mock
drills.
Provision is made for Resource availability should be Quantity of resources i.e. medical
availability of medical supplies, according to threat perception. stores etc. should match with the
equipment and materials expected workload.
during such emergencies.
Hospital staff is trained in the Mock drills with and without

hospital’s disaster patients have to be carried out.
management plan.
Only communication exercise
may also be undertaken.
The plan is tested at least Self explanatory. This is only the minimum frequency
twice in a year. and this may be increased.
FMS.8. The organization has a plan for management of hazardous materials.
Objective Element Interpretation Remark(s)
Hazardous materials are The HCO has identified and The hazardous materials could be
identified with the organization. listed the hazardous materials identified as per part II of
and has a documented Manufacture, Storage and Import
procedure for their sorting, of Hazardous Chemical
storage , handling, (Amendment) Rules, 2000.
transpirations, disposal
mechanism, and method for
managing spillages and
In addition biological materials
adequate training of the
like blood, body fluids and
personnel for these jobs.
microbiological cultures, mercury,
nuclear isotopes, medical gases,
LPG gas, steam, ETO etc are
some of the other common

hazardous materials.
The hospital implements The HCO has conducted an

processes for sorting, labeling, exercise of hazard
handling, storage, transporting identification and risk analysis
and disposal of hazardous (HIRA) associated with
material. handling of hazardous
materials and accordingly
taken all necessary steps to
eliminate or reduce such
hazards and associated risks.
The HCO has ensured display
of Material Safety Data Sheets
(MSDS) for all hazardous
materials and has accordingly
arranged associated training of
personnel who handle such
materials. The situational
hazards also need to be
covered in HRA so that any
emergency situation arising out
of process of storing, handling,
storage, transportation and
disposal of such hazardous
materials are met effectively.
Sharp bends in passages,
protruding or dangling
elements in passage ways,
sudden swing of swing doors,
ramps, entry and exit from lifts,
are situations which need to be
taken care of. See FMS 5 also.
The HCO has the requisite
training need identification for
material handling and those
trainings are included in the
HCO training calendar.
Requisite regulatory The appropriate personnel in

requirements are met in respect the HCO are aware about the
of radioactive materials. rules and regulations such as
the Atomic Energy Act, the
norms issued by Atomic
Energy Regulatory Board
(AERB) and the directives from
the Health Physics Division of
Bhabha Atomic Research

Centre (BARC).
There is a plan for managing Self explanatory.

spills of hazardous materials.
Staff is educated and trained for Self explanatory.

handling such materials.
FMS.9. The organization has systems in place to provide a safe and secure environment.
The hospital has a safety The HCO has a duly The safety committee must include
committee to identify the constituted safety committee representatives from facility
potential safety and security which has identified the management, clinicians,
risks. hospital safety and security administrator, nursing and
risks to staff, patients and paramedical staff.
visitors.
It is preferable that the HCO
conducts an exercise of Hazard
Identification and Risk Analysis
(HIRA) and accordingly takes all
necessary steps to eliminate or
reduce such hazards and
associated risks.
This committee coordinates The HCO ensures that the

development, implementation, above committee functions on
and monitoring of the safety a regular basis to coordinate
plan and policies. development, implementation
and monitoring of the plans
and policies.
Patient safety devices are Self explanatory. For example, grab bars, bed rails,
installed across the sign posting, safety belts in
organization and inspected stretchers and wheel chairs,
periodically. alarms both visual and auditory
where applicable, warning signs
like radiation or biohazard. Call
bells, fire safety devices etc.
Facility inspection rounds to Rounds to be carried out by During these rounds potential
ensure safety are conducted at safety committee. safety risks are identified.
least twice in a year in patient
care areas and at least once in
a year in non-patient care

areas.
Inspection reports are Self explanatory. Before and after evidence may be
documented and corrective maintained.
and preventive measures are
undertaken.
There is a safety education Self explanatory.

programme for all staff.
CHAPTER 9: Human Resource Management (HRM)
HRM.1. The organization has a documented system of human resource planning.
a) The organization maintains The staff should be A good reference could be the MCI
an adequate number and mix commensurate with the and INC guidelines.
of staff to meet the care, workload and the clinical
treatment and service needs of requirement of the patients.
the patient.
b) The required job The content of each job should Refer to glossary for definition of
specifications and job be well defined and the job description and job
description are well defined for qualifications, skills and specification.
each category of staff. experience required for
performing the job description
should be commensurate with
the qualification.
c) The organization verifies the Self explanatory. This report and could be got from
antecedents of the potential the district magistrate (s) if the
employee with regards to district (s) where the employee has
criminal/ negligence served earlier and/ or from the
background. previous employer.
It could also be obtained from the

regulatory bodies like MCI (Good
Conduct Certificate).
HRM.2. The staff joining the organization is socialized and oriented to the hospital
environment.
Each staff member, employee The organization’s staff This could be done as a part of the
student and voluntary worker is including the outsourced staff induction training.
appropriately oriented to the should be aware and should
organization’s mission and correctly interpret the mission
goals. and goals of the organization.
Each staff member is made The organization’s staff This could be done as a part of the
aware of hospital wide policies including the outsourced staff induction training and the same
and procedures as well as should be aware and should could be provided in the form of a
relevant department/ unit/ correctly interpret the mission booklet. It also requires continuous
service/ programme’s policies and goals of the organization on the job training to reinforce the
and procedures. as well as that of the correct interpretation of policies
department/ unit/ service in and procedures.
which he is performing the
requisite duties.
Each staff member is made The HCO shall define the This could be done as a part of the
aware of his/ her rights and same in consonance with induction training and the same
responsibilities. statutory requirements and the could be provided in the form of a
same shall be communicated booklet.
to the employees.
All employees are educated The employees should be able For patient rights refer to PRE 2.
with regard to patients’ rights to identify and report violation
and responsibilities. of patient rights as and when
the same occurs.
All employees are oriented to The HCO shall develop The employees should be trained
the service standards of the benchmarks for different to implement the service standards
organization. services being provided. This of the organization.
shall be based on the HCO’s
values and focus on
development of soft skills, etc.
HRM.3. There is an ongoing programme for professional training and development of the
staff.
Objective element Interpretation Remark (s)
A documented training and A training manual incorporating The training shall be for all
development policy exists for the procedure for identification categories of staff including doctors
the staff. of training needs, the training and outsourced staff (wherever
methodology, documentation applicable).
of training, training
assessment, impact calendar
should be prepared.
Training also occurs when job The training should focus on

responsibilities change/ new the revised job responsibilities
equipment is introduced. as well as on the newly
introduced equipment and
technology. In case of new
equipment the operating staff
should receive training on
operational as well as daily
maintenance aspects.
Feedback mechanisms for This shall include both internal

assessment of training and and external training. For
development programme exist. external training it could be
done either by the HCO it self
or by the external agency
which imparted the training.
Impact of training at user level
should also be documented.
HRM.4. Staff members, students and volunteers are adequately trained on specific job duties
or responsibilities related to safety.
All staff is trained on the risks The HCO shall define such For example, fire and non fire
within the hospital risks which shall include emergency, needle stick injury, etc.
environment. patient, visitors and employee
related risks.
Staff members can Self explanatory. Staff should be able to practically

demonstrate and take actions demonstrate actions like taking
to report, eliminate/ minimize care of blood spills, medication
risks. errors and other adverse event
reporting systems.
Staff members are made Self explanatory. The staff should be able to intimate
aware of procedures to follow the sequence of events that they
in the event of an incident. will undertake in the eventuality of
occurrence of any adverse event.
Reporting procedures for The HCO has a defined Reporting processes could be
common problems, failures procedure for reporting of checked from time to time by the
and user errors exist. these events. management to ensure their
implementation.
HRM.5. An appraisal system for evaluating the performance of an employee exists as an

integral part of the human resource management process.
A well-documented Self explanatory. For definition of performance

performance appraisal system appraisal refer to glossary.
exists in the organization.
The employees are made Self explanatory. To be incorporated in the service

aware of the system of booklet and included in the
appraisal at the time of induction training.
induction.
Performance is evaluated Self explanatory. This can be

based on the performance done by identifying training
expectations described in job requirements and accordingly
description. providing for the same
(wherever possible).
Performance appraisal is Self explanatory. This shall be done at least once a

carried out at pre defined year.
intervals and is documented.
HRM.6. The organization has a well-documented disciplinary procedure.
Objective Element interpretation Remark (s)
A written statement of the Self explanatory. For definition of disciplinary

policy of the organization with procedure refer to glossary.
regard to discipline is in place.
The disciplinary policy and This implies that both parties

procedure is based on the (employee and employer) are
principles of natural justice. given an opportunity to present
their case and decision is
taken accordingly.
The policy and procedure is Self explanatory. This could be in the form of service
known to all categories of
employees of the organization. rules.
The disciplinary procedure is in Self explanatory. Refer to relevant labour laws and
consonance with the prevailing CCS (CCA) rules.
laws.
There is a provision for The HCO shall designate an Appellate authority should be
appeals in all disciplinary appellate authority to consider higher than the disciplinary
cases. appeals in disciplinary cases. authority.
HRM.7. A grievance handing mechanism exists in the organization.
The employees are aware of For definition of grievance The HCO could address all points
the procedure to be followed in handling refer to glossary. The in HRM 2, HRM 4,HRM 5, HRM 6
case they feel aggrieved. HCO has a written procedure AND HRM 7 by providing every
for handling grievances of employee with a manual
employees. incorporating the various policies
and procedures
The redress procedure Self explanatory.

addresses the grievance.
Actions are taken to redress Self explanatory.

the grievance.
HRM 8. The organization addresses the health needs of the employees.
A pre-employment medical Self explanatory. This shall For example, performing pre-
examination is conducted on however be in consonance employment HIV testing is illegal.
all the employees. with the law of the land.
Health problems of the Self explanatory. This shall For example, employee health and
employees are taken care of in however be in consonance safety policy.
accordance with the with the law of the land and
organization’s policy. good clinical practices.
Regular health checks of staff Self explanatory. The results The HCO could define the
dealing with direct patient care should be documented in the parameters and it could be
are done at-least once a year personal file. different for different categories of
and the findings/ results are personnel. The HCO could also
documented. identify competent individuals to
perform the same.
Occupational health hazards Self explanatory. For definition of occupational

are adequately addressed. health hazard refer to glossary.
HRM.9. There is a documented personal record for each staff member.
Personal files are maintained Self explanatory.

in respect of all employees.
The personal files contain Self explanatory.

personal information regarding
the employees qualification,
disciplinary background and
health status.
All records of in-service Self explanatory.

training and education are
contained in the personal files.
Personal files contain results of Evaluations would include

all evaluations. performance appraisals,
training assessment and
outcome of health checks.
HRM.10. There is a process for collecting, verifying and evaluating the credentials (education,
registration, training and experience) of medical professionals permitted to provide patient
care without supervision.
Medical professionals The HCO identifies the For definition of credentialing refer
permitted by law, regulation individuals who have the to glossary.
and the hospital to provide required qualification (s),
patient care without training and experience to
supervision are identified. provide patient care in
consonance with the law.
The education, registration, Self explanatory. Updation is

training and experience of the done after acquisition of new
identified medical skills and/or qualification.

professionals is documented
and updated periodically.
All such information pertaining The HCO shall do the same by A good reference could be MCI’s
to the medical professionals is verifying the credentials from website.
appropriately verified when the organization which has
possible. awarded the
qualification/training.
HRM.11.There is a process for authorizing all medical professionals to admit ad treat patients
and provide other clinical services commensurate with their qualifications.
Medical professionals admit The HCO shall identify as to For example, radiotherapy can only
and care for patient as per the what each medical be given by a radiation oncologist.
laid down policies and professional is authorized to
authorization. do.
The services provided by the Self explanatory. Where authorization is provided on

medical professional are in the basis of training the HCO shall
consonance with their maintain a copy of the training
qualification, training and record and verify it.
registration.
The requisite services to be Self explanatory. The HCO could incorporate this in
provided by the medical the brochure itself.
professionals are known to
them as well as the various
departments/ units of the
hospital.
HRM.12. There is a process for collecting, verifying and evaluating the credentials (education,
registration, training and experience) of nursing staff.
The education, registration, The HCO identifies the Refer to Indian Nursing Council
training and experience of individuals who have the Act, 1947.
nursing staff is documented required qualification (s),
and updated periodically. training and experience to
provide nursing care to
patients in consonance with
the law. Updation is done after
acquisition of new skills and/or

qualification.
All such information pertaining The HCO shall do the same by

to the nursing staff is verifying the credentials from
appropriately verified when the organization which has
possible. awarded the
qualification/training.
HRM.13. There is a process to identify job responsibilities and make clinical work assignments
to all nursing staff members commensurate with their qualifications and any other regulatory
requirements.
The clinical work assigned to The HCO shall identify as to For example, an infection Control
nursing staff is in consonance what each nurse is authorized Nurse should have had requisite
with their qualification, training to do. in-house/ external training and
and registration. experience and the aptitude and
knowledge to perform the tasks
required of her.
The services provided by Self explanatory.

nursing staff are in accordance
with the prevailing laws and
regulations.
The requisite services to be Self explanatory.

provided by the nursing staff
are known to them as well as
the various departments / units
of the hospital.
CHAPTER 10 ; Information Management System (IMS)
IMS. 1. Policies and procedures exist to meet the information needs of the care providers,
management of the organization as well as other agencies that require date and information
from the organization.
The information needs of the The HCO has manual and/ or For example, daily census report,
organization are identified and electronic Hospital Information utilization rates, etc, Also refer to
are appropriate to the scope of System and/or Management CQI 2 and CQI 3.
the services being provided by Information System which
the organization and the provides relevant information
complexity of the organization. to all concerned stakeholders.
Policies and procedures to A policy document is available

meet the information needs are where the HIS/ MIS is
documented. described.
These policies and procedures Self explanatory. Some of these include:- IT Act
are in compliance with the 2000 for computer based records,
prevailing laws and PNDT Act for relevant details of all
regulations. patients undergoing ultrasound,
Code of Medical Ethics, 2002, RTI
Act 2005, etc. Relevant state
legislation e.g. Maintenance of
Clinical Records Act (MOCRA) in
Maharashtra.
All information management The HCO shall define the

and technology acquisitions needs for software and
are in accordance with the hardware solutions as per the
policies and procedures. information requirements and
future necessities.
The organization contributes to The HCO shall define the For example, sending birth and
external databases in system of releasing the death statistics, notifiable diseases
accordance with the law and relevant information to the (refer to glossary) and pulse polio
regulations. authority as per statutory programme.
norms.
IMS.2. The organization has processes in place for effective management of data.
Formals for data collection are MIS/HIS data are collected in This is in the context of frequency
standardized. standardized format from all of capturing data namely daily,
areas/ services in the HCO. weekly, monthly, quarterly, yearly
etc. (Statistical bulletin).
Necessary resources are The HCO shall make available
available for analyzing data. men, material, space and

budget.
Documented procedures are Self explanatory. The organization could decide on

laid down for timely and which data needs to be shared with
accurate dissemination of data. whom and also the modalities (e.g.
memos, circulars etc.) for
dissemination of such data.
Documented procedures exist The HCO shall define data Storage could be physical or
for storing and retrieving data. management policy and electronic. Wherever electronic
ensure adequate safeguards storage is done the HCO shall
for protection of data, wherever ensure that there are adequate
physical or electronic data is safeguards for protection of data.
stored.
Appropriate clinical and There is a multi-disciplinary

managerial staff participates in committee which is responsible
selecting, integrating and using for the appropriate selection of
data. indicators, measurement of
trends and initiating action
wherever required.
IMS. 3. The organization has a complete and accurate medical record for every patient.
Every medical record has a This shall also apply to records For example, CR number, hospital
unique identifier. on digital media. number.etc. Gs1 standards and
numbering system can be used to
identify and track the patient record
within and outside the hospital.
Organization policy identifies HCO has a written policy This could be different category of
those authorized to make stating who all can make personnel for different entries, but
entries in medical record. entries. it shall be uniform across the HCO.
For example, progresses record by
doctor and medication
administration chart by nurse.
Every medical record entry is Self explanatory. For needs on electronic media it is
dated and timed. preferable that the date and time is
automatically generated by the
system.
The author of the entry can be This could be by writing the full
identified. name or by mentioning the
employee code number, with
the help of stamp, etc. In case
of electronic based records,
authorized e-signature
provision as per statutory
requirements must be kept.
The contents of medical record The HCO identifies which For example, admission order, face
are identified and documented. documents form part of the sheet, IP sheet, discharge
medical records, documents summary, doctor’s order sheet,
and implements the same. TPR Chart, consent form etc.
The record provides and up-to- The HCO shall decide the
date and chronological account format for maintaining the
of patient care. continuity in the medical
records.
IMS.4. The medical record reflects continuity of care.
The medical record contains Self explanatory. For definition of plan of care refer
information regarding reasons to glossary. After the initial visit it
for admission, diagnosis and shall at least have a provisional
plan of care. diagnosis. The final diagnosis (IP)
must be is as per ICD10.
Operative and other Self explanatory. Also refer to COP 12f.

procedures performed are
incorporated in the medical
record.
When patient is transferred to Self expalanatory. It is If the patient has been transferred
another hospital, the medical mandatory to mention the at his/her request a note may be
contains the date of transfer, clinical condition of the patient added to chat effect. In such
the reason for the transfer and before transfer is effected. instances the name of the
the name of the receiving receiving hospital could be the
hospital. name the patient desires to go to.
However, if the patient has been
transferred by the HCO it shall
have an acknowledgement from
the receiving hospital.
The medical record contains a Self explanatory. Discharge note is the same as
copy of the discharge note duly discharge summary.
signed by appropriate and
qualified personnel. Also refer to AAC 15.
In case of death, the medical Self explanatory. The HCO Also refer to AAC 15g.
record contains a copy of the provides the death certificate
death certificate indicating the as per the International
cause, date and time of death. Certification of Cause of
Death.
Whenever a clinical autopsy is Self explanatory. For definition of autopsy refer to

carried out, the medical record glossary.
contains a copy of the report of
the same.
Care providers have access to The HCO provides access to

current and past medical medical records to designated
record. healthy care providers (those
who are involved in the care of
that patient).
IMS.5. Policies and procedures are in place for maintaining confidentiality, integrity and
security of information.
Objective Element interpretation Remark(s)
Documented policies and The HCO shall control the

procedures exist for accessibility to the MRD
maintaining confidentially, department. It shall ensure the
security and integrity of usage of tracer card for
information. movement of the file in and out
of the MRD so as to maintain
confidentiality, security, safety
and integrity of information.
This is applicable for both

manual and electronic records.
Policies and procedures are in This is in the context of Indian For example, privileged
consonance with the Evidence Act, Indian Penal communication.
applicable laws. Code and Code of Medical
Ethics.
The policies and procedures For physical records the HCO It is preferable that softwares when
incorporate safeguarding of shall ensure that there is used shall be validated and duly
data/ record against loss, adequate pest and rodent authenticated.
destruction and tampering. control measures. For
electronic data there should be
protection against virus/trojans
and also a proper backup
procedure. To prevent
tampering, for physical records
access shall be limited only to
the concerned health care
provider. In electronic format
this could be done by
adequate passwords.
The hospital has an effective The HCO carries out regular Refer to IMS 7.
process of monitoring audits/rounds to check
compliance of the laid down compliance with policies.
policy.
The hospital uses The HCO shall review and For example, moving from physical
developments in appropriate update its technological to electronic format, remote backup
technology for improving features so as to improve of data, etc.
confidentiality, integrity and confidentiality, integrity and
security. security of information.
Privileged health information is The HCO shall define the Special care should be taken in
used for the purposes procedure for privileged medico-legal cases.
identified or as required by law communication.
and not disclosed without the
patient’s authorization.
A documented procedure Self explanatory. In this

exists on how to respond to context, the release of
patients/ physicians and other information in accordance with
public agencies requests for the Code of Medical Ethics
access to information in the 2002 should be kept in mind.

medical record in accordance
with the local and national law.
IMS.6. Policies and procedures exist for retention time of records, data and information.
Documented policies and The HCO shall define the

procedures are in place on retention period for each
retaining the patient’s clinical category of medical records:
records, data and information.
Out –patient, in-patient and
MLC.
The policies and procedures Some of the related laws in

are in consonance with the this context are Code of
local and national laws and Medical Ethics 2002,
regulations. Consumer Protection Act 1987
and relevant state legislation, if
any.
The retention process provides This is applicable for both

expected confidentiality and manual and electronic system.
security.
The destruction of medical Destruction can be done after

records, data and information the retention period is over and
is in accordance with the laid after taking approval of the
down policy. competent authority.
IMS.7. The organization regularly carries out review of medical records.
The medical records are Self explanatory. The HCO could define the
reviewed periodically. periodicity.
The review uses a The HCO shall define the

representative sample based principles on which sampling is
on statistical principles. based. For example, simple
random, systemic random
sampling etc.
Review shall be based on

conditions of clinical and/or
community importance, total
discharges including deaths,
total indoor patient, etc.
The review is conducted by Self explanatory. The HCO shall identify and
identified care providers. authorize such individuals.
The review focuses on the Self explanatory.

timeliness, legibility and
completeness of the medical
records.
The review process includes Self explanatory. An adequate mix of both active and
records of both active and discharged patients should be
discharged patients. used.
The review points out and Self explanatory. For example, missing final
documents any deficiencies in diagnosis, absence of OT notes in
records. an operated patient, etc.
Appropriate corrective and Self explanatory.

preventive measures
undertaken are documented.
GLOSSARY
The commonly used terminologies in the NABH standards are briefly described and explained
herein to remove any ambiguity regarding their comprehension. The definitions narrated have
been taken from various authentic sources as stated where ever possible. Notwithstanding the
accuracy of the explanations given, in the law of the land, the provisions of the latter shall
apply.
Accreditation A process of external review of the quality of the health care being provided
by a health care organization. This is generally carried out by a non-
governmental organization
It also represents the outcome of the review and the decision that an
eligible organization meets an applicable set of standards.
Accreditation The evaluation process for assessing the compliance of an organization

assessment with the applicable standards for determining its accreditation status.
NABH assessment includes the following:-
Documentation review
Facility tour
Interview of staff, patients and visitors
On-site observations by assessors
Education about standards compliance
Advance life support Emergency medical care for sustaining life, including defibrillation, airway
management and drug and medications.
The main algorithm of ALS, which is invoked when actual cardiac arrest has
been established, relies on the monitoring of the electrical activity of the
heart on a cardiac monitor. Depending on the type of cardiac arrhythmia,
defibrillation is applied and medication is administered. Oxygen is
administered and endotracheal intubation may be attempted to secure the
airway. At regular intervals, the effect of the treatment on the heart rhythm,
as well as the presence of cardiac output, is assessed.
Medication that may be administered may include adrenaline (epinephrine),

amiodarne, atropine, bicarbonate, calcium, potassium and magnesium.
Saline or colloids may be administered to increase the circulating volume.
While CPR is given (either manually, or through automated equipment such
as AutoPulse), members of the team consider eight forms of potentially

reversible causes for cardiac arrest, commonly abbreviated as “:
Hypoxia (low oxygen levels in the blood)
Hypovolemia (low amount of circulating blood, either absolutely due to

blood loss or relatively due to vasodilation)
Hyperkalemia or hypokalemia (disturbances in the level of potassium in the

blood) and related disturbances of calcium or magnesium levels and
hypoglycemia (low glucose levels).
Hypothermia (undercooling)
Tension poneumothorax (tear in the lung leading to collapsed lung and

twisting of the large blood vessels)
Tamponade (fluid or blood in the pericardium, compressing the heart)
Toxic and / or therapeutic (chemicals, whether medication or poisoning)
Thromboembolism and related mechanical obstruction (blockage of the

blood vessels to the lungs or the heart by a blood clot or other material)
Adverse drug event Adverse drug event:- Any untoward medical occurrence that may present
during treatment with a pharmaceutical product but which does not
necessarily have a causal relationship with this treatment.
Adverse drug reaction:- A response to a drug which is noxious and

unintended and which occurs at doses normally used in man for
prophylaxis, diagnosis or therapy of disease or for the modification of
physiologic function.
Therefore ADR= adverse event with a causal link to a drug.
Adverse drug event:- The FDA recognizes the term adverse drug event to
be a synonym for adverse event.
In the patient safety literature, the terms adverse drug event and adverse
event usually denote a causal association between the drug and the event,
but there is a wide spectrum of definitions for these terms, including harm
caused by a
Drug
Harm caused by drug use, and
A medication error with or without harm
Institute of Medicine: “an injury resulting from medical intervention related to

a drug”, which has been simplified “an injury resulting from the use of a
drug”
Adverse drug events extend beyond adverse drug reactions to include harm
from overdoses and under- doses usually related to medication errors.
A minority of adverse drug events are medication errors, and medication

errors rarely result in adverse drug events.
Air conditioning of OT Operation Theatres of all HCOs, should have Central Air Conditioning Unit
as per the criteria laid down under IPHS standards. The air conditioning
system should address the following 5 parameters:
Air movement
Air charges
Air ventilation (positive or pressure)
Temperature
Humidity
For super specialized OT:
Positive pressure ventilation to prevent mixing of air in various zones
Fresh air allowance -100% with no recirculation of air.
Air filtration through HEPA filters with filtration levels upto 0.3 microns and
99.97% efficiency.
Relative humidity 40-60% with variation +- 5%
Air charges 5-10/hr
Air changes not to exceed 25/hour.
Ambulance A patient carrying vehicle having facilities to provide unless otherwise

indicated at least basic life support during the process of transportation of
patient. There are various types of ambulances that provide special
services viz. coronary care ambulance, trauma ambulance, air ambulance,
etc.
Anaestheisa It consists of general anaesthesia and spinal or major regional anaesthesia

and does not include local anaesthesia. General anaesthesia is a drug-
induced loss of consciousness during which patient cannot be aroused
even by painful stimulation. The ability to independently maintain
ventilatory function is often impaired.
Assessment All activities including history taking, physical examination, laboratory

investigations that contribute towards determining the prevailing clinical
status of the patient.
Autopsy An examination of a cadaver in order to determine the cause of death or to

study pathologic changes.
A surgical procedure performed after death to examine body tissues and

determine the cause of death.
Barrier nursing Type of nursing for immune- compromised patients with a view to prevent
any secondary infections e.g. use of gloves, masks and relatively
disinfected environment.
Basic life support Emergency procedures performed to sustain life that include
cardiopulmonary resuscitation, control of bleeding, treatment of shock,
stabilization of injures and wounds and first aid.
Basic life support consists of a number of life-saving techniques which are

focused on the “ABC”s of pre-hospital emergency care:
Airway : the protection and maintenance of patient airway including the use
of airway adjuncts such as an oral or nasal airway
Breathing : the actual flow of air through respiration, natural or artificial

respiration, often assisted by emergency oxygen
Circulation : the movement of blood through the beating of the heart or the
emergency measure of CPR
BLS may also include considerations of patient transport such as the

protection of the cervical spine and avoiding additional injures through
splinting and immobilization.
Bylaws A rule governing the internal management of an organization. It can

supplement or complement the government law but cannot countermand it.
For example, municipal bylaws for construction of hospitals/ nursing homes,
for disposal of hazardous and/or infectious waste.
Clinical audit Analysis of clinical aspects of patient care for improving the quality of health
care services e.g. tissue audit, X-Ray audit, lab investigation audit, etc.
Clinical practice Guidelines that assist practitioners to provide appropriate clinical care for
guidelines specific clinical conditions, for example recommendation on management of
cerebral malaria. The guideline includes relevant history taking, physical
signs to look for, lab investigations to be carried out and treatment to be
prescribed.
Competence Demonstrated ability to apply knowledge and skills (para 3.9.2 of ISO
9000:2000).
Knowledge is the understanding of facts and procedures. Skill is the ability

to perform specific action. For example, a competent gynaecologist knows
about the patho-physiology of the female genitaila and can conduct both
normal as well as abnormal deliveries.
Confidentiality Restricted access to information to individuals who have a need, a reason

and permission for such access. It also includes an individual’s right to
personal privacy as well as privacy of information related to his/her health
care records.
Consent Willingness of a party to undergo examination/ procedure/ treatment by a

health care provider. It may be implied (e.g. patient registering in OPD),
expressed which may be written or verbal. Informed consent is a type of
consent in which the health care provider has a duty to inform his/her
patient about the procedure, its potential risk and benefits, alternative
procedure with their risk and benefits so as to enable the patient to take an
informed decision of his/her health care.
In law, it means active acquiescence or silent compliance by a person

legally capable of consenting. In India legal age of consent is 18 years. It
may be evidenced by words or acts or by silence when silence implies
concurrence. Actual or implied consent is necessarily an element in every
contract and every agreement.
Credentialing The process of obtaining, verifying and assessing the qualification of a

health care provider.
Data Raw facts, clinical observations, or measurements collected during an

assessment activity.
Discharge summary A part of a patient record that summarizes the reasons for admission,
significant clinical findings, procedures performed, treatment rendered,
patient’s condition on discharge and any specific instructions given to the
patient or family (for example follow-up medications).
Disciplinary proceedings Sequence of activities to be carried out when staff does not conform to the
laid down norms, rules and regulations of the health care organization.
Employees All members of the health care organization who are employed full time and
are paid suitable remuneration for their services as per the laid down policy.
End of life Period of time marked by disability or disease that is progressively worse
until death.
Ethics Medical ethics is the discipline of evaluating the merits, risks, and social
concerns of activities in the field of medicine.(en. Wikipedia.org/wiki/Medical
ethics).
Evidence based It is the conscientious, explicit and judicious use of current best evidence in
medicine marking decisions about the care of individual patient.
It also implies making medical decisions and applying the same to patient
based on the best external evidence combined with the physician’s clinical
expertise and the patient’s desires.
Family The person(s) with a significant role in the patient’s life. It mainly includes
spouse, children and parents. It may also include a person(s) not legally
related to the patient but can make health care decisions for a patient if the
patient loses decision making ability.
Formulary An approved list of prescription drugs that a health care facility may provide
to their clientele. Some plans restrict prescriptions to those contained on the
formulary are generally those that are determined to be cost effective and
medically effective.
The list is complied by professionals and physicians in the field and is

updated preferably each year. Changes may be made depending on
availability or market.
Grievance handling Sequence of activities carried out to address the grievances of patients,
procedures visitors, relatives and staff.
Hazardous materials Substances dangerous to human and other living organisms. They include
radioactive or chemical materials.
Hazardous waste Waste materials dangerous to living organisms. Such materials require
special precautions for disposal. They include biologic waste that can
transmit disease (for example, blood, tissues ) radioactive materials, and
toxic chemicals. Other examples are infectious waste such as used
needles, used bandages and fluid soaked items.
Health care organization Generic term is used to describe the various types of organization that
provide health care services. This includes ambulatory care centres,
hospitals, laboratories, etc.
High dependency unit A high dependency unit (HDU) is an area for patient who require more
intensive observation, treatment and nursing care that are usually provided
for in a word. It is a standard of care between the ward and full intensive
care.
In service education/ Organized education/training usually provided in the workplace for

training enhancing the skills of staff members or for teaching them new skills
relevant to their jobs/tasks.
Indicator A statistical measure of the performance of functions, systems or processes

overtime. For example,. Hospital acquired infection rate, mortally rate,
caesarean section rate, absence rate, etc.
Information Processed data which lends meaning to the raw data.
Intent A brief explanation of the rational, meaning and significance of the

standards laid down in a particular chapter.
Inventory control The method of supervising the intake, use and disposal of various goods in
hands. It relates to supervision of the supply, storage and accessibility of
items in order to ensure adequate supply without stock outs/ excessive
storage. It is also the process of balancing ordering costs against carrying
costs of the inventory so as to minimize total costs.
Isolation Separation of an ill person who has a communicable disease(e.g., Measles,

chickenpox, mumps, SARS) from those who are healthy. isolation prevents
transmission of infection to others and also allows the focused delivery of
specialized health care to ill parents. The period of isolation varies from
disease to disease. Isolation facilities can also be extended to patients ofor
fulfilling their individual, unique needs.
Job description it entails an explanation pertaining to duties, responsibilities and conditions

required to perform a job.
A summary of the most important features of a job, including the general
nature of the work performed (duties and responsibilities) and level (i.e.,
skill, effort, responsibility and working conditions) of he work performed. It
typically includes job specifications that include employee characteristics
required for competent performance of the job. A job description should
describe and focus on the job itself and not on any specific individual who
might fill the job.
Job specification The qualifications/ physical requirements, experience and skills required to
perform a particular job/task.
A statement of the minimum acceptable qualifications that an incumbent

must possess to perform a given job successfully.
Laws Legal document setting forth the rules of governing a particular kind of
activity. For example organ transplantation act which governs the rules for
undertaking organ transplantation.
Medical audit A peer review carried out by analysis of medical records with a
view to Improve the quality of the patient care.
Medical equipment Any fixed or portable non drug item or apparatus used for diagnosis,
treatment, monitoring and direct care of patient.
Mission A written expression that sets forth the purpose of the organization. It
usually precedes the formation of goals and objectives.
Multi -disciplinary A generic term which includes representatives from various disciplines,
professions or service areas.
Nosocomial/ hospital An infection occurring in a patient in a hospital or other healthcare facility in

associated infection (s) whom it was not present or incubating at the time of admission or the
residual of an infection acquired during a previous admission. Includes
infections acquired in the hospital but appearing after discharge and also
such infections among the staff of the facility (Synonym: hospital- acquired-
infection). (www. Hardudiagnostics.com/ Glossary N. html).
Notifiable disease Certain specified diseases which are required by law to be notified to the
public health authorities. Under the international health regulation the
following diseases are notifiable to WHO:-
Cholera
Plague
Yellow fever
In India the following diseases are also notifiable and may vary from state to
state:
Polio
Influenza
Malaria
Rabies
HIV/AIDS
Louse –borne typhus
Tuberculosis
Leprosy
Viral hepatitis
Dengue fever
Leptospirosis
The various diseases notifiable under the factories act are lead poisoning,
byssinosis, anthrax, asbestosis and silicosis.
Objective element It is that component of 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.
Occupational health The hazards to which an individual is exposed during the course of
hazard performance of his job. These include physical, chemical, biological,
mechanical and psychosocial hazards.
Operational plan Operational Plan is the part of your strategic Plan. It defines how you will
operate in practice to implement your action and monitoring plans – what
your capacity needs are, how you will ensure sustainability of the HCO’s
achievements.
Organaogram A graphic representation of reporting relationship in an organization.
Outsourcing Hiring of services and facilities from other organization based upon one’s
own requirement in areas where such facilities are either not available or
else are not cost-effective. e.g. outsourcing of house keeping, security,
laboratory/ certain special diagnostic facilities with other institutions after
drawing a memorandum of understanding that clearly lays down the

obligations of both the organizations, the one which is outsourcing and the
one which is providing the outsourced facility. It also addresses the quality
related aspects.
Patient care setting The location where a patient is provided health care as per his needs e.g.
ICU, speciality ward, private ward and general ward.
Patient record/ medical A document which contains the chronological sequence of events that a
record/ clinical record patient undergoes during his stay in the health care organization. It includes
demographic data of the patient, assessment findings, diagnosis,
consultations, procedures undergone, progress notes and discharge
summary (Death certificate where required).
Patient responsibility Provide complete and accurate information about his/her health, including
(indicative) present condition, past illnesses, hospitalizations, medications, natural
products and vitamins and any other matters that pertain to his/ her health.
Provide complete and accurate information including full name, address

and other information.
To ask questions when he / she does not understand the doctor or other
member of the health care team tells about diagnosis or treatment. He / she
should also inform the doctor if he / she anticipate problems in following
prescribed treatment or considering alternative therapies.
Abide by all hospital rules and regulations.
Comply with the NO SMOKING policy.
Comply with visitor policies to ensure the rights and comfort of all patients.
Be considerate of noise levels, privacy, and safety Weapons are prohibited
on premises.
Treat hospital staff, other patients, and visitors with courtesy and respect.
To be on time in case of appointments. To cancel or reschedule as far in

advance as possible in case o cancellation or rescheduling of the
appointments.
Not to give medication prescribed for him / her to others.
Provide complete and accurate information for insurance claims and work
with the hospital and physician billing offices to make payment
arrangements.
To communicate with the health care provider if his / her condition worsens
or does not follow the expected course.
To pay for services billed for in a timely manner as per the hospital policies.
To respect that some other patent’s medical condition may be more urgent
than yours and accept that your doctor may need to attend them first.
To respect that admitted patient and patients requiring emergency care take
priority for your doctor.
To follow the prescribed treatment plan and carefully comply with the
instructions given.
To accept, where applicable, adaptations to the environment to ensure a

safe ad secure stay in hospital.
To accept the measures taken by he hospital to ensure personal privacy

and confidentiality of medical records.
To attend follow up appointment as requested.
Not to take any medications without the knowledge of doctor and health
care professionals.
To provide correct and truthful history.
To understand the charter of rights and seek clarification if any.
Performance It is the process of evaluating the performance o employees during a

defined period of time with the aim of ascertaining heir suitability for the job,
Appraisal potential for growth as well as determining training needs.
Plan of care A plan that identifies patient care needs, lists the strategy to meet those
needs, documents treatment goals and objectives, outlines the criteria for
ending interventions and documents the individual’s progress in meeting
specified goals and objectives. The format of the plan may be guided by
specific policies and procedures, protocols, practice guidelines or a
combination of these. It includes preventive, promotive, curative and
rehabilitative aspects of care.
Policies They are he guidelines for decision making, e.g. admission, discharge
policies, antibiotic policy, etc.
Privileging It is the process for authorising all medical professionals to admit and treat
patients and provide other clinical services commensurate with their
qualifications and skills.
Procedure A specified way to carry out an activity or a process (Para 3.4.5 of ISO
9000: 2000).
A set of activities for carrying out work which when observed by all help to
ensure the maximum use of resources and efforts to achieve the desired
output.
Process A set of interrelated or interacting activities which transforms inputs into

outputs (Para 3.4.1 of ISO 9000:2000).
Programme A sequence of activities designed to implement policies and accomplish

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

intervention.
Quality Degree to which a set of inherent characteristics fulfil requirement s (Para

3.1.1 of ISO 9000:2000).
Characteristics imply a distinguishing feature (Para 3.5. 1 of ISO

9000:2005)
Requirements are a need or expectation that is stated, generally implied or

obligatory (Para 3.1.2 of ISO 9000:2000).
Degree of adherence to pre-established criteria or standards.
Quality assurance Part of quality management focused on providing confidence that quality
requirements will be fulfilled (Para 3.2.11 of ISO 9000:2005).
Quality improvement Ongoing response to quality assessment data about a service in ways that
improve the process by which services are provided to consumers/patients.
Re- assessment It implies continuous and ongoing assessment of the patient which is
recorded in the medical records as progress notes.
Resources It implies all inputs in terms of men, material, money, machines, minutes
(time), methods, meters (space), skills, knowledge and information that are
needed for efficient and effective functioning of an organization.
Restraints Devices used to ensure safety by restricting and controlling a person’s

movement. Many facilities are “restraint free” or use alternative methods to
help modify behavior. www.alz.org/Resources/Glossary .asp. Restraint may
be physical or chemical (by use of sedatives).
Risk assessment Risk assessment is a step in the risk management process. Risk
assessment is the determination of quantitative or qualitative value of risk
related to a concrete situation and recognized threat (also called hazard) in

a HCO.
Risk reduction Clinical and administrative activities to identify, evaluate and reduce the risk
of injury.
Safety The degree to which the risk of an intervention/procedure, in the care

environment are reduce for a patient, visitors and health care providers.
Scope of services Range of clinical and supportive activities that are provided by a health care
organization.
Security Protection from loss, destruction, tampering, and unauthorized access or

use.
Sedation The administration to an individual, in any setting for any purpose, by any
route, moderate or deep sedation. There are three levels of sedation:
Minimal sedation (anxiolysis) – A drug induced state during which patients

respond normally to verbal commands. Although cognitive function and
coordination may be impaired, ventilator and cardiovascular functions are
not affected.
Moderate sedation/ analgesia (Conscious sedation) – A drug induced

depression of consciousness during which patients respond purposefully to
verbal commands either alone or accompanied by light tactile stimulation.
No interventions are needed to maintain a patient airway.
Deep sedation/ Analgesia – A drug induced depression of consciousness

during which patients cannot be easily aroused but respond purposefully
after repeated or painful stimulation. Patients may need help in maintaining
a patent airway.
“Self Assessment” as in Definition as per ISO 9000:2005 clause 2.8.4

“Self Assessment
Toolkit” to be submitted An hco’s self – assessment is a comprehensive and systematic review of all
prior to Pre Assessment its activities and results, referenced against the NABH Quality System.
Self – assessment provides an overall view of the performance of the HCO

and the degree of maturity of the Quality System. It helps to identify areas
of processes requiring improvement and to determine priorities.
Sentinel events* A relatively infrequent, unexpected incident, related to system or process

deficiencies, which leads to death or major and enduring loss of function
for a recipient of health care services.
Major and enduring loss of function refers to sensor, motor,
physiological, or psychological impairment not present at the time services

were sought or begun. The impairment not present at the time services
were sought or begun. The impairment lasts for a minimum period of two
weeks and is not related to an underlying condition.
Social responsibility A balanced approach for organization to address economic, social and
environmental issues in way that aims to benefit people, communities and
society, e.g. adoption of villages for providing health care, holding of
medical camps and proper disposal of hospital wastes.
Staff All personnel working in the organization either as full paid employees or as
consultants on honorarium basis
Standard precautions 1. A method of infection control in which all human blood and other
bodily fluids are considered infections for HIV, HBV and other
bloodborne pathogens, regardless of patient history. It
encompasses a variety of practices to prevent occupational
exposure, such as the use of personal protective equipment (PPE),
disposal of sharps and safe housekeeping.
2. A set of guidelines protecting first aiders or healthcare

professionals from pathogens. The main message is “Don’t touch
or use anything that has the victim’s body fluid on it without a
barrier.” It also assumes that all body fluid of a patient is infectious,
and must be treated accordingly.
Standard Precautions apply to blood, all body fluids, secretions, and

excretions (expect sweat) regardless of whether or not they contain visible
blood, non-intact skin and mucous membranes.
Standards 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.
Sterilization It is the process of killing or removing microorganisms including their spores

by thermal, chemical or irradiation means.
Strategic plan Strategic planning is an HCO’s process of defining its strategy or direction
and making decisions on allocating its resources to pursue this strategy,
including its capital and people. Various business analysis techniques can
be used in strategic planning, including SWOT analysis (Strengths,
Weaknesses, Opportunities, and Threats) e.g. HCO can have strategic plan
to become market leader in provision of cardiothoracic and vascular
services. The resource allocation will have to follow the pattern to achieve
the target.
Surveillance The continuous scrutiny of factors that determines the occurrence and
distribution of diseases and other conditions of ill health. It implies watching
over with great attention, authority and often with suspicion. It requires
professional analysis and sophisticated interpretation of data leading to
recommendations for control activities.
Unstable patient A patient whose vital parameters need external assistance for their
maintenance.
Validation 1. Confirmation through the provision of objective evidence that the

requirements for a specific intended use or application have been
fulfilled (Para 3.8.5 of ISO 9000:2000).
Objective Evidence – Data supporting the existence or variety of

something (Para 3.8.1 of ISO 9000:2005).
2. The checking of data for correction or for compliance with

applicable standards, rules or conventions. These are the tests to
determine whether an implemented system fulfills its requirements.
It also refers to what extent does a test accurately measures what it
purports to measure.
Vulnerable patient Those patients who are prone to injury and disease by virtue of their age,
sex physical, mental and immunological status, e.g. infants, elderly,
physically and mentally challenged, those on immunosuppressive and/or
chemotherapeutic agents.
*Reference Guide on Sentinel Events
Definition:
An unexpected incident, related to system or process deficiencies, which leads to death or major and
enduring loss of function * for a recipient of health care services.
Major and enduring loss of function refers to sensory, motor, physiological, or psychological
impairment not present at the time services were sought or begun. The impairment lasts for a
minimum period of two weeks and is not related to an underlying condition.
Event type description
1. Surgical events
 Surgery performed on the wrong body part
 Surgery performed on the wrong patient
 Wrong surgical procedure performed on the wrong patient
 Retained instruments in patient discovered after surgery/procedure
 Patient death during or immediately post surgical procedure
 Anesthesisa related event
2. Device or product events
Patient death or serious disability associated with:
 The use of contaminated drugs, devices, products supplied by the organization
 The use of function of a device in a manner other than the device’s intended use
 The failure or breakdown of a device or medical equipment
 Intravascular air embolism
3. Patient protection events
 Discharge of an infant to the wrong person
 Patient death or serious disability associated with elopement from the health care
facility
 Patient suicide, attempted suicide, or deliberate self-harm resulting in serious

disability
 Intentional injury to a patient by a staff member, another patient, visitor, or other
 Any incident in which a line designated for oxygen or other came to be delivered to a
patient and contains the wrong gas or is contaminated by toxic substances
 Nosocomial infection or disease causing patient death or serious disability
4. Environmental events
Patient death or serious disability while being cared for in a health care facility associated with:
 A burn incurred from any source
 A slip, trip, or fall
 An electric shock
 The use of restraints or bedrails
5. Care management events
 Patient death or serious disability associated with a hemolytic reaction due to the
administration of ABO- incompatible blood products
 Maternal death or serious disability associated with labour or delivery in a low- risk
pregnancy
 Medication error leading to the death or serious disability of patient due to incorrect
administration of drugs, for example:
a) Omission error
b) Dosage error
c) Dose preparation error
d) Wrong time error
e) Wrong rate of administration error
f) Wrong administrative technique error
g) Wrong patient error
Patient death or serious disability associated with an avoidable delay in treatment or

response to abnormal test results.
6. Criminal events
 Any instance of care ordered by or provided by an individual impersonating a clinical

member of staff
 Abduction of a patient
 Sexual assault on a patient within or on the grounds of the health care facility
 Death or significant injury of a patient or staff member resulting from a physical

assault or other crime that occurs within or on the grounds of the health care facility
Medical/ Clinical Audit
A write up for carrying out clinical/ medical audit is given below for comprehending the
process of auditing of the health care services. The text has been simplified so as to explain all
aspects of the subject without compromising the basic tenants of the audit.
What is Audit?
It is the process of reviewing of delivery of care to identify deficiencies so that they may be remedied.
What is Medical Audit (MA)?
It may be defined as ‘Peer Review for evaluation of medical care through retrospective and
concurrent analysis of medical record.
What is the Primary Aim of MA?
 A fault finding mission
 A punitive action
 An External Quality Control method
 To be conducted by any professional other than medical professional.
Who will carry out MA?
Medical Audit Committee
 MS/ Coordinator? Hospital Administrator
 Representative of all disciplines
 Nursing representative
What are the Pre – requisite?
 Good record keeping system
 Should be carried out by fair and impartial professionals
 Clinicians, nursing and other staff as well as patient anonymity to be maintained
 Initiative should come from within
 Purpose should be simple and clearly stated
 Infection should be to effect change for the better
How to audit?
The Audit Cycle
Measure Baseline
Review Standard if
required
Set Standards
Evaluate change
Measure Practice
through data collection
and analysis
Assessment of
performance against
standard
Implement change
Identify opportunity
for improvement
Suggest change
Methodology
1. Selection of topic
a) Should be common because it is common or high risk or bears high cost
b) Should be having local clinical concern or known wide variance in clinical practice
c) Topic should be well defined, focused and amenable to standard setting
2. Some topics
a) Long/ short stay cases
b) Specific disease/ specific operations
c) Vulnerable groups
d) Increase incidence of a disease
e) Post operative infection/ complications
f) All deaths
3. Setting of standard
a) To be set prior to the study
b) Criteria to be based on objective measures
Criterion is an item of care or sure aspect of care that can be used to assess quality. It is a
written statement.
e.g.
i. All patients requiring urgent appointment will be seen that day only.
ii. All patients with epilepsy should be seen once a year.
iii. All patients on oral anticoagulants should have their INR within recommended
limits.
c) Criteria should be well justified
d) Target should be set at realistic level for defined patient groups and take into account
local circumstances
A target describes the level of care to be achieved for any particular criteria.
e.g.
i. 98% of patients requesting for urgent appointment will be seen on that day.
ii. 90% of patients with epilepsy must be seen at least once a year.
iii. 100% of patients on oral anticoagulants will have the INR within recommended
level.
e.g. of Criteria and Target applicable to Structure, Process and Outcome
variables
Structure Process outcome
Criteria Staffing of ICU BT during surgery Case fatality
Target Not <1 per two Not <5% and not> Not to exceed
occupied beds 20% of average cases 0.1% for
specified
procedures
e) Objective criteria are explicit but clinical judgment can be used to answer the question
“Was the management of this case satisfactory”? This is an implicit criteria.
f) Use of explicit criteria should be preferred. The problem with implicit criteria is that
important deficiencies in care may be overlooked and rates may offer in their
assessments of the acceptability of management.
4. Worksheet preparation and methodology of administration
a) Simplest for the purpose
b) Only essential data is collected
c) Suitable sample size is to be selected
 Random sampling – generate
 Stratified samples
 Systematic sampling
 Cluster sampling
d) Probability of bias is to be considered
 Non response to a survey
 Unavailability of certain type of case note
 Selective referral of certain types of patients
 Failure of patient to turn up for follow up
5. Tabulation of Evaluation
6. Interpretations
a) Deficiency of care recognized
b) Specific solutions are proposed. They may not be possible every time.
c) Education impact is appreciated
7. Effecting change
a) Planned programme for change
b) All staff is involved
c) Active feedback
d) Audit is evaluated
Certain additional questions related to Clinical Audit
Q) What to check in Medical Record
 Completeness and adequacy of the record
 Check issues related to the diagnosis
 Investigation and treatment
 Referral and consultations
 Treatment and plan of care with justification
 Operation – justification
 End result
 Administrative lapses for undesirable results
 Calculation of various statistics
Q) Why Audit
 It improves Quality of Care
 It is an aid to Continuous Medical Education
 There is a sense of personal and professional achievement
Q) what are the Motives for doing Audit
They can be broadly categorized as under.
 Professional
 Social
 Pragmatic
 Legal
A diagrammatic representation of the motives is given below
Professional Motives Pragmatic Motives

Social Motives
a) To identify a) To ensure safety of To reduce patients
deficiencies public suffering
b) Educational need b) To present patient
c) Self correction & self from inappropriate
regulation or suboptimal care
Legal motives
CPA Negligence Malpractice
Q) What are the Key Questions to be asked while doing Clinical Audit?
 What do we do?
 Do we do what we think we do?
 What should we do?
 Are we doing what we should be doing?
 How can we improve what we do?
 How me improve?
Q) What are the Benefits of Audit.
a) Professional benefits
 Change in prescribing behavior
 Updation of clinical knowledge
 Increase in staff enthusiasm and satisfaction
 Teamwork
b) Patient care and service delivery
 Improvements in patient care
 Improved patient satisfaction
 Better patient feedback
Q) What are the perceived Disadvantages?
 Increase in workload
 Restriction of clinical feedback
 Professional threat
Q) What are the Barriers to Audit?
 Lack of resources
 Lack of expertise in design and analysis
 Lack of an overall plan for audit
 Relationships problem
 Organizational impediments – disputes between views of clinical and managers
Q) What are the Factors which promote success?
 Supportive organizational environment
 Sound leadership and direction of audit programme
 Strategy and operational planning in audit programme
 Resource and support for audit programme
 Monitoring and reporting of audit activity
 Commitment and participation
Q) What are the Key Lessons from Various Audit?
1. Foster an environment for Audit
 Audit is a valued activity
 Can augment both career and professional development
 Provision of protected time for ausit
 Commitment from staff to provide a request and act on the study findings
2. Tackle the problems of Multidisciplinary Audit
 Can be seen as threatening
 Exposing one mistakes to another
 Staff training in interpersonal skills and in dealing with conflict
 Benefits outweigh disadvantage
3. Review staff training programme
 Importance of planning
 Benefits of pilot study
4. Emphasise audit facilitation
5. Establish confidentiality of finding
6. Ensure all relevant staff are involved
7. Establish evaluation programme
Checklist
Question Criteria
1. Why was the Audit done? Reason for choice
a) Should be clearly defined
b) Should include potential for change
2. How was the Audit done? a) criteria choice
- Should be relevant to the subject
- Should be justified e.g. Literature surveys
c) Preparation and planning should show

adequate teamwork and methodology in
carrying out the audit
d) If standards are set they should be appropriate

and justifiable
3. What was found? Interpretation of the data
Should use all relevant data to allow
appropriate conclusion to be draw
4. What next? Detailed proposal for change should show
explicit details of the proposed change.
Conclusion
Audit appears deceptively simple. Current care is observed so that it can be compared with standards
and the necessary charges in patient care are implemented.
In practice
 Topics for audit need to be chosen with care and refined to make them suitable
 Standard setting requires clarity of thought and careful definition
 Data collection to observe practice can consume endless time and money
 Lasing change is notoriously difficult to achieve
Not withstanding the above, once audit is understood and planned it is one of the best ways for
monitoring the quality of care being rendered and for bringing about the requisite changes for
improving care, professional development and, patient and employee satisfaction.
Further reading:
‘Principles for Best Practice in Clinical Audit’ – published by NICE/RCN and University of Leicester in
2002 and available in PDF via the NHS library website www.library.nhs.uk
‘A Practical Handbook for Clinical Audit’ _ available to download from the Clinical Governance Support
Team website – www.cgsupport.nhs.uk.
www.clinicalauditsupport.com – the Clinical Audit Support Centre offer a range of accredited training
courses in clinical audit and supply a variety of materials, including electronic validation tools that
assist practices in developing accurate practice disease registers – an essential starting point for
undertaking a high quality clinical audit project.
www.cgsupport.nhs.uk – the Clinical Governance Support Team website is a fantastic resource and
house a wide range of clinical governance – related materials. Although the CGST closed its doors in
March 2008, the website is still accessible and contains a range of useful relating to clinical audit.
www.library.nhs.uk – the National Library for Health is intended to act as a source of authoritative
evidence and best practice to support health care in the NHS. The resource can be used to search
expert libraries, books and journals, etc for best practice and other resources relating to clinical audit.
www.nice.org.uk – The National Institute for Clinical Excellence develop a series of national clinical
guidelines to secure consistent, high quality, evidence – based care. NICE also develop audit criteria
that enables healthcare professionals to assess how well guidance is being implemented.
www.healthcarecommission.org.uk – The Healthcare Commission is the independent watchdog for

healthcare in England. The Commission promote continuous improvement in the services provided by
the NHS and are also responsible for reviewing complaints. The Commission have been involved in
the delivery of the national clinical audit programme.
www.cg4cp.org.uk – although this website is aimed primarily at community pharmacists it houses a

range of clinical governance resources, including a basic training session on clinical audit. Those who
want to utilize the site must register their details, but there are no restrictions on who can sign in.
www.rcn.org.uk – The Royal College of Nursing represents nurses and nursing, promotes excellence
in practice and shapes health policies. By accessing the website RCN members can go directly to a
list of recent articles on audit and clinical governance via the RCN library pages.
www.rsmpress.co.uk – this website includes back issues of the Clinical Governance Bulletin. Although
the bulletin is longer published practice staff may find the site useful for looking at previously
conducted clinical governance and audit initiatives.
List of Licenses and Statutory Obligations
All of them might not be applicable to all the Hospitals:
1. Building Permit (From the Municipality).
2. No objection certificate from the Chief Fire officer.
3. Bio – medical Management and handling Rules, 1998.
4. No objection certificate under Pollution Control Act.
5. Radiation Protection Certificate in respect of all X-ray, Cath lab and CT Scanners from BARC.
6. Atomic energy regulatory body approvals.
7. Excise permit to store Spirit.
8. Income tax PAN.
9. Permit to operate lifts under the Lifts and Escalators Act.
10. Narcotics and Psychotropic substances Act and License.
11. Sales Tax Registration certificate.
12. Vehicle registration certificates for Ambulances.
13. Retail and Bulk drug license (Pharmacy).
14. Wireless operation certificate from Indian post and telegraphs. (if applicable)
15. Air (prevention and control of pollution) Act, 1981 and License
16. Arms Act, 1950.(if guards have weapons)
17. Boilers Act, 1923.
18. Cable television networks Act,1995

19. Central sales tax Act, 1956.
20. Consumer protection Act, 1986.
21. Contract Act, 1982.
22. Copyright Act, 1982.
23. Customs Act, 1962.
24. Dentist regulations, 1976.
25. Drugs and cosmetics Act,1940.
26. Electricity Act, 1998.
27. Electricity rules, 1956.
28. Employees provident fund Act, 1952.
29. ESI, Act,1948
30. Employment exchange Act, 1969.
31. Environment protection Act, 1986.
32. Equal remuneration Act, 1976.
33. Explosives Act,1884.
34. Fatal accidents Act, 1855.
35. Gift tax Act, 1958.
36. Hire Purchase Act, 1972.
37. Income Tax Act, 1961.
38. Indian Lunacy Act, 1912.
39. Indian Medical Council Act and Code of Medical Ethics, 1956.
40. Indian Nursing council Act, 1947.
41. Indian penal code, 1860.
42. Indian trade unions Act, 1926.
43. Industrial disputes Act, 1947.
44. Insecticides Act, 1968.
45. Lepers Act
46. Maternity benefit Act, 1961.
47. MTP Act, 1971.
48. Minimum wages Act, 1948.
49. National building code.
50. National holidays under shops Act.
51. Negotiable instruments Act, 1881.
52. Payment of bonus Act, 1965.
53. Payment of gratuity Act,1972.
54. Payment of wages Act, 1936.
55. Persons with disability Act,1995.
56. Pharmacy Act, 1948.
57. PNDT Act, 1996.
58. Prevention of food adulteration Act, 1954.
59. Protection of human rights Act, 1993.
60. PPF Act, 1968.
61. Registration of births and deaths Act, 1969.
62. Sale of goods Act, 1930.
63. Tax deducted at source Act.
64. Sales tax Act.
65. SC and ST Act, 1989.
66. License for the blood bank
67. Companies Act, 1956.
68. Constitution of India
69. Insurance Act, 1938.
70. Transplantation of human organs Act 1994 and License (if applicable)
71. Workers compensation Act. 1923
72. Urban land Act, 1976.

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Guide Book to NABH Standards for Hospitals

Like all quality management systems, documentation is an essential component of NABH

A suggested content is given below.

 Introduction of the HCO

 Management including ownership, vision, mission, ethical management etc.

 Quality policy and objectives including service standards.

 Composition and role of various committees (in alphabetical order)

 Statutory and regulatory requirements

 Chapter wise documentation

 Annexure (if any)

* Infection Control Manual.

The minimum documentation required by NABH 2nd edition is given below:

CHAPTER 1: Access, Assessment and Continuity of Care (AAC)

Policies guide the transfer of stable patients to another facility.

Procedures identify staff responsible during transfer.

The organization determines who can perform the assessments.

AAC.8. There is an established laboratory quality assurance programme.

a) The laboratory quality assurance programme is documented.

b) The programme addresses verification and validation of test methods.

c) The programme addresses surveillance of test results.

d) The progamme includes periodic calibration and maintenance of all equipments

e) The progamme icludes the documentation of corrective and preventive actions.

AAC.9. There is an established laboratory safety programme.

The laboratory safety programme is documented.

This programme is integrated with the organization’s safety programme.

AAC.11. There is an established Quality assurance programme for imaiging services.

The quality assurance programme for imaging services is documente.

The programme addresses verification and validation of imaging results.

The programme addresses surveillance of imaging results.

The programme includes periodic calibration and maintenance of all equipments.

The programme includes the documentation of corrective and preventive actions.

AAC.12. There is an established radiation safety programme.

The radiation safety programme documented.

This programme is integrated with the organization’s safety programme.

AAC.13. Patient care is continuous and multidisciplinary in nature.

Policies and procedures guide the referral of patients to other departments/specialities.

AAC.14. The organization has a documented discharge process.

CHAPTER 2 : Care of Patients (COP)

Policies and procedure for emergency care are documented.

Policies also address handing of medico-legal cases.

Defined procedures for situation of bed shortages are followed.

A quality assurance programme is implemented. (HCO needs to document the same).

COP.9. Policies and procedures guide the care of pediatric patients.

Policies and procedures prevent child/neonate abduction

COP.11. Policies and procedures guide the administration of anaesthesia

There is a documented policy and procedure for the administration of anaesthesia.

The policies and procedures are documented.

P.S. This should also address objective element b.

COP.14. Policies and procedures guide appropriate pain management.

Documented policies and procedures guide the management of pain..

COP.15. Policies and procedures guide appropriate rehabilitative services.

Documented policies and procedures guide the provision of rehabilitative services.

COP.16. Policies and procedures guide all research activities.

COP.17. Policies and procedures guide nutritional therapy.

Documented Policies and procedures guide nutritional assessment and reassessment.

COP.18. Policies and procedures guide the end of life care.

Document Policies and procedures guide the end of life care.

P.S. This should also address objective elements b, c, d.

CHAPTER 3 : Management of Medication (MOM)

P.S. This should also address objective elements b.

MOM.2. There is a hospital formulary.

There is a defined process for acquisition of these medications.

There is a process to obtain medications not listed in the formulary.

MOM.3. Policies and procedures exist for storage of medication.