Self Assessment Toolkit

Organisation is required to provide self assessment report in the format 'Self Assessment Toolkit' given below. All the entries are to be properly filled up. Regarding scoring following criteria would
be applicable.

Compliance to the requirement: 10

Partial compliance to the requirement: 5 (if any of the sample is found to be noncomplying out of total samples selected)
Non-compliance to the requirement: 0
Not Applicable: NA

Evaluation Criteria during final assessment:

· No individual standard should have more than one zero to qualify. However, no zero is accepted in the regulatory/ legal requirements.
· The average score for individual standard must not be less than 5.
· The average score for individual chapter must not be less than 7.
· The overall average score for all standards must exceed 7.

Special Note:

Self assessments should be done by the hospital in a stringent manner and if at the time of Pre assessment it is found that there is a significant difference between the
self assessment and the pre assessment report then organisations can apply for final assessment not earlier than six months from the date of completion of Pre
assessment.

SELF ASSESSMENT TOOLKIT

Objective Elements Interpretation Remark

Chapter 1: ACCESS, ASSESSMENT AND CONTINUITY OF CARE (AAC)

AAC.1: The organisation defines and displays the services that it can provide.
a The services being provided are clearly defined and are in consonance with the A policy to be framed clearly The needs of the community
needs of the community. stating the services the hospital should be considered especially
can provide. when planning a new HCO or
adding new services
b The defined services are prominently display. The services so defined should Claims of services and expertise
be visible prominently in an area being available should actually be
visible to all patients entering available. Display in the form of
the organization. The display brochures only is NOT
could be in the form of boards, acceptable. Display should be at
citizen's charter, scrolling least bi-lingual.
messages etc. care should be
taken to ensure that these are
displayed in the language (s) the
patient understands.
c The staff is oriented to these services. All the staff in the Hospital
mainly in the
reception/registration, OPD, IPD
are oriented to these facts
through training programme
conducted regularly or through
manuals.

AAC.2: The organisation has a well defined registration and admission process.
 a. Standardized policies and procedures are used for registering and admitting Health Care Organization (HCO) Admission must be authorized by
patients. has prepared document (s) a doctor.
detailing the policies and GS1 standards in barcoding can
procedures for registration and be used to identify and track the
admission of patients which patient within and outside the
should also include unidentified hospital.
patients.
b. The policies and procedures address out-patients, in-patients and emergency The policies and procedures
patients. address out-patients, in-patients
and emergency
c. Patients are accepted only if the organization can provide the required service. The staff handling admission
and registration needs to be
aware of the services that the
organization can 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 procedures also address managing patients during non The HCO is aware of the Also refer to AAC 3.
availability of beds. availability of alternate HCO’s
where the patients may be
directed in case of non-
availability of beds.
e. The staff is aware of these processes. All the staff handling these Orientation can be provided by
activities should be oriented of documentation/ training.
these policies and procedures.

AAC.3 There is an appropriate mechanism for transfer or referral of patients who do not match the organisation resources.
a. Policies guide the transfer of unstable patients to another facility in an The organization shall at the These patients include those who
appropriate manner. outset define as to who is an have come to the emergency but
unstable patient. The need to be transferred to another
documented policy and organization or those already
procedure should address the admitted but who now require
methodology of safe transfer of care in another organization it also
the patient in a life threatening includes patients being shifted for
situation (like those who are on diagnostic tests.
ventilator) to another HCO. Also refer to COP 3.
There should be availability of
an appropriate ambulance fitted
with life support facilities and
accompanied by trained
personnel.
b. Policies guide the transfer of stable patients to another facility. Patients not in a life threatening Also refer to COP 3.
situation (stable) should also be
transported in a safe manner.
c. Procedures identify staff responsible during transfer. The staff shall at least be a A doctor should accompany an
trained trauma/emergency unstable patient.
technician/nurse/. He/She shall
have undergone training in BLS
and/or ACLS.
d. The organization gives a summary of patient’s condition and the treatment The HCO gives a case summary This shall include patients being
given. mentioning the significant transferred both for diagnostic
findings and treatment given in and/or therapeutic purpose.
case of patients who are being
transferred from emergency. For
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 family members are educated to make informed decision.
a. The patients and/ or family members are explained about the proposed care. The plain of care as decided by
the management team (as the
case may be) is to be discussed
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 family members are explained about the expected results. The patients and family are
explained in detail by the
training physicians or his/her
team about the outcomes of
such treatment.
c. The patients and/ or family members are explained about the possible Possible complications of the
complications. treatment, if any, are clearly
communicated to the patient.
 d. The patients and/ or family members are explained about the expected costs. Patients should be given as
estimate of the expenses on
account of the treatment
preferably in a written form
With regards to expected costs,
an estimate could be prepared
and the same given to the patient.
This estimate shall be prepared
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
conditions and also the exceptions
if any.

AAC.5 Patients cared for by the organisation undergo an established initial assessment.
a. The organisation defines the content of the assessments for the out patients, inThe hospital shall have a
patients and emergency patients. protocol/policy by which a
standardized initial assessment
of patients is done in the OPD.
Emergency and in-patients. The
initial assessment could be
standardized across the hospital
or it could be modified
depending on the need of the
department. 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 criteria for the first
visit and for department the vital
parameters. The initial
assessment should also include
the nursing assessment for in-
patients.
b. The organisation determines who can perform the assessments. The assessment should be done Also refer to HRM 10a.
by the treating doctor, junior
doctor or a nurse. The
organization determines who
can do what assessment and it
should be the same across the
hospital.
c. The organisation defines the time frame within which the initial assessment is The HCO has defined and
completed. documented the time frame
within which the initial
assessment is to be completed
with respect to OPD/
emergency/ indoor patients.
d. The initial assessment for in-patients is documented within 24 hours or earlier The should cover history,
as per the patient's condition or hospital policy. progress notes, investigation
ordered and treatment ordered
and all these are to be
authenticated by treating doctor.
e. Initial assessment includes screening for nutritional needs. The protocol for patient’s initial This could be done by the treating
assessment should cover doctor and/or dietician.
his/her nutritional needs, in case
of Out patients this should be
done where ever applicable. For
example diabetics, CRF
patients.
f. The initial assessment results in a documented plan of care which is monitored. This shall be documented by the For definition of “plan of care” and
treating doctor or by a member “clinical audit’ refer to glossary.
of his team in the case sheet.
This plan is monitored by the
training doctor for its
effectiveness and whenever
required by a clinical audit.
g. The plan of care also includes preventive aspects of the care. The documented plan of care This could also be done through
should cover preventive actions booklets/ patient information
as necessary in the case and leaflets etc. e.g. diabetes,
should include diet, drugs etc. hypertension.

AAC.6 All patients cared for by the organisation undergo a regular reassessment.
a. All patients are reassessed at appropriate intervals. After the initial assessment, the Every patient shall be reassessed
patient is reassessed at least once every day by the
periodically and this is treating doctor.
documented in the case sheet.
The frequency may be different
areas based on the setting and
the patient's condition e.g.
patients in ICU need to
reassessed more frequently
compared to a patient in the
ward.
 b. Staff involved in direct clinical care document reassessments. Actions taken under The nursing staff can document
reassessment are documented. patient's vitals.
the staff could be the treating
doctor or any member of the
learn as per their domain of
responsibility of care.
c. Patients are reassessed to determine their response to treatment and to plan Self explanatory.
further treatment or discharge.

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

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

a. The laboratory quality assurance programme is documented. The HCO has a documented
quality assurance programme
(preferably as per ISO 15189
Medical laboratories - Particular
requirements for quality and
competence).
b. The programme addresses verification and validation of test methods. This holds true for any
laboratory developed methods.
c. The programme addresses surveillance of test results. The laboratory director (or in-
charge) shall periodically assess
the test results.
 d. The programme includes periodic calibration and maintenance of all Refer to ISO 15189.
equipments.
e. The programme includes the documentation of corrective and preventive Self explanatory.
actions.

AAC.9 There is an established laboratory safety programme.

a. The laboratory safety programme is documented. A well documented lab safelty This could be as per Occupational
manual is available in the lab. Health and safety Management
This takes care of the safety of System - OHSAS 18001:2007.
the workforce as well as the
equipments available in the lab.
b. This programme is integrated with the organisation's safety programme. Lab safety programme is
incorporated in the safety
programme of the hospital.
c. Written policies and procedures guide the handling and disposal of infectious The lasb staff should follow
and hazardous materials. standard precautions. The
disposal of waste is according to
Biomedical waste management
and handling rules, 1998.
d. Laboratory personnel are appropriately trained in safe practices. All the lab staff undergo training
regarding safe practices in the
lab.
e. Laboratory personnel are provided with appropriate safety equipment/ devices. Adequate safety devices are
available in the lab e.g. fire
extinguishers, dressing
materials disinfectants, etc.

AAC.10 Imaging services are provided as per the requirement of the patients.
a. Imaging services comply with the legal and other requirement. The HCO is aware of the legal All the statutory requirements are
and other requirements of met with, like BARC clearance,
imaging services and the same dosimeters, lead sheets, lead
are documented for information aprons, signages, display as per
and compliance by all PNDT act, reports to competent
concerned in the HCO. The authority, etc.
HCO maintains and updates its
compliance status of legal and
other requirements in a regular
manner.
b. Scope of the imaging services are commensurate to the services provided by Self explanatory For example, a neuro-science
the organisation. centre shall have CT and MRI.
c. Adequately qualified and trained personnel perform, supervise and interpret the As per AERB guidelines.
investigations.
d. Policies and procedures guide identification and safe transportation of patients The HCO has documented
to imaging services. policies and procedures for
informing the patients about the
imaging activities, their
identification and safe
transportation to the imaging
services. This should also
address transfer of unstable
patients to imaging services.
e. Imaging results are available within a defined time frame. The organization shall document The defined timeframe could be
turnaround time of imaging different for different type of tests.
results.
f. Critical results are intimated immediately to the concerned personnel. Critical results shall be intimated The HCO shall define the critical
to the treating clinician at the results which require immediate
earliest on phone, followed by attention of clinician e.g. ectopic
written report. pregnancy.
g. Imaging tests not available in the organization are outsourced to organization(s) The HCO has documented MOU should be available for all
based on their quality assurance system procedure for outsourcing tests outsourced activities. See AAC 7 f
for which it has no facilities. This also.
should include: a) List of tests
for out sourcing. b) Identity of
personnel in the out sourced
facilities to ensure safe
transportation of specimens and
completing of imaging results. c)
Manner of identification of
patients and the test requisition
with all details as required for
testing and . d) A methodology
to check the selection and
perforance of service rendered
by the outsourced imaging
facility as per the requirements
of the HCO.

AAC.11 There is an established quality assurance programme for imaging services.

a. The quality assurance program for imaging services is documented. Refer to AERB guidelines

b. The programme addresses verification and validation of imaging methods. A document for verification and
validation of imaging methods
shall be available.
c. The programme addresses surveillance of imaging results. HOD (or in-charge) shall
periodically assess the imaging
results.
 d. The programme includes periodic calibration and maintenance of all Calibration and maintenance of
equipments. all equipment shall be carried
out by competent persons.
e. The programme includes the documentation of corrective and preventive Self explanatory.
actions.

AAC.12 There is an established radiation safety programme.

a. The radiation safety programme is documented. Refer to AERB guidelines

b. This programme is integrated with the organization’s safety programme. The safety programme of the
imaging department has
reference in the hospital safety
manual.
c. Written policies and procedures guide the handling and disposal of radio-active Radioactive and hazardous
and hazardous materials. materials shall be disposed off
as per bio-medical waste
management and handling
rules, 1998.
d. Imaging personnel are provided with appropriate radiation safety devices. Self explanatory

e. Radiation safety devices are periodically tested and documented. Protective devices e.g. lead
aprons should be exposed to X-
ray for verification of cracks and
damages.
f. Imaging personnel are trained in radiation safety measures. Sel explanatory.

g. Imaging signage are prominently displayed in all appropriate locations. Self explanatory

h. Policies and procedures guide the safe use of radioactive isotopes for imaging Document on safe use of
services. radioactive isotopes for imaging
services shall be available and
implemented.
AAC.13 Patient care is continuous and multidisciplinary in nature.
a. During all phases of care, there is a qualified individual identified as responsible The HCO to ensure that the
for the patient’s care. care of patients is always given
by appropriately qualified
medical personnel (resident
doctor, consultant and/or nurse).
b. Care of patients is coordinated in all care setting within the organisation. Care of patients is co-ordinated
among various care providers in
a given setting viz OPD,
emergency, IP, ICU etc. The
organization shall ensure that
there is effective communication
of patient requirements amongst
thecare providers in all settings.
c. Information about the patient's care and response to treatment is shared among The HCO ensures periodic This could be done on the basis of
medical, nursing and other care providers. discussions about each patient entries either on case sheet or
(covering parameters like lectronic patient records (EPR).
patient care, response to
treatment, unusual
developments if any. etc)
amongst medical, nursing and
other care providers.
d. Information is exchanged and documented during each staffing shift, between Self explanatory For example 1) Nurses handling
shifts, and during transfers between units/ departments. taking over notes. 2) Transfer
summary.
e. The patient’s record(s) is available to authorized care providers to facilitate the Self explanatory
exchange of information.
f. Policies and procedures guide the referral of patients to other departments/ The HCO has clearly defined Referral could be for opinion, co-
specialities. and documented the policies management, take over. It could
and procedures to be adopted to be graded into immediate, urgent
guide the personnel dealing with priority or routine categories.
referral of patients to other
departments or specialities or
even other health care provider
out side the HCO.
AAC.14 The organisation has a documented discharge process.
a. The patient’s discharge process is planned in consultation with the patient and/ The patient's treating doctor
or family. determines the readiness for
discharge during regular
reassessments. The same is
discussed with the patient and
family.
b. Policies and procedures exist for coordination of various departments and The discharge policies and
agencies involved in the discharge process (including medico-legal cases) procedures are documented to
ensure coordination amongst
various departments including
accounts so that the discharge
papers are complete well within
time. For MLC the organization
shall ensure that the police are
informed.
 c. Policies and procedures are in place for patients leaving against medical The HCO has a documented This policy could address the
advice. policy for the LAMA cases. The reasons of LAMA for any possible
treating doctor should explain corrective and/or preventive action
the consequences of this action by the HCO.
to the patient/attendent.
d. A discharge summary is given to all the patients leaving the organization The HCO hands over the
(including patients leaving against medical advice). discharge papers to the
patient/attendent in all cases
and a copy is retained. In LAMA
cases, the declaration of the
patient/attendent is to be
recorded on proper format.

AAC.15 Organisation define the content of the discharge summary.

a. Discharge summary is provided to the patients at the time of discharge. Self explanatory

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

c. Discharge summary contains information regarding investigation results, any Self explanatory
procedure performed, medication and other treatment given.

d. Discharge summary contains follow up advice, medication and other Self explanatory The instruction shall be in a
instructions in an understandable manner. manner that the patient can easiliy
understand and avoid use of
medical terms e.g. BID, TID etc.
e. Discharge summary incorporates instructions about when and how to obtain The HCO should outline This could be in the form of whiat
urgent care. conditions regarding "when" to medicines to take, when to consult
obtain urgent care, For example, a doctor or bow to seek medical
a post op patient should report help and contact number of the
when having fever, hospital/doctor.
bleeding/discharge from site.
f. In case of death the summary of the case also includes the cause of death. Self explanatory

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.
a Care delivery is uniform when similar care is provided in more than one setting. The organisation shall ensure
that patients with the same
health problems and care
needs, receive the same quality
of healthcare throughout the
organization irrespective of the
category of ward.
b Uniform care is guided by policies and procedures which reflect applicable laws Self explanatory For example, consent before,
and regulations. surgery, providing first aid to
emergency patients and police
intimation in cases of medicolegal
cases.

c The care and treatment orders are signed, named, timed and dated by the Self explanatory, Treatment For electronic records the
concerned doctor. orders must be written daily. organization shall ensure that the
same in captured in the system.

d The care plan is countersigned by the clinician in-charge of the patient within 24 The treatment of the patient The clinician in charge implies the
hours. could be initiated by a junior treating doctor.
doctor but the same should be
countersigned and authorized
by the treating doctor within 24
hrs.
e Evidence based medicine and clinical practise guidelines are adopted to guide The organization could develop For definitions of evidence based
patient care whenever possible. clinical protocols based on these medicine and clinical practise
and the same could be followed guidelines, refer to glossary.
in management of patients.
These could then be used as
parameters for audit of patient
care.

COP.2: Emergency services are guided by policies, procedures and applicable laws and regulations.
a Policies and procedure for emergency care are documented. These could iclude Also refer to AAC5a.
SOPs/protocols to provide either
general emergency care or
management of specific
conditions e.g. poisoning.
 b Policies also address handling of medico-legal cases. The policy shall be in line with
statutary requirements w.r.t.
documentation and intimation to
police. The organization shall
also define as to what
constitutes a MLC (in
accordance with statutory rules).
c The patient receives care in consonance with the policies. Self explanatory Poisoning cases, road traffic
accidents, patients with coronary
disease, etc, shall be deaft as per
hospital policies and procedures.
d Policies and procedures guide the triage of patients for initiation of appropriate Self explanatory This should be based on good
care. clinical practices. For triage refer
to glossary.
e Staff is familiar with the policies and trained on the procedures for care of All the staff working in the
emergency patients. casualty should be oriented to
the policies and practices
through training/documents.
Staff should preferably be
trained/well versed in ACLS and
BLS.
f Admission or discharge to home or transfer to another organisation is also Self explanatory Also refer to AAC 14 and 15. The
documented. discharge note shall incorporate
salient features of investigations
done and treatment.

COP.3: The ambulance services are commensurate with the scope of the services provided by the organisation.
a There is adequate access and space for the ambulance(s). The organization shall
demarcute a 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.
b Ambulance(s) is appropriately equipped. This shall be done based on the
organization's scope.
c Ambulance(s) is manned by the trained personnel The ambulance should be
manned by a trained driver,
technician/nurse and/or doctor
depending on the situation.
Personnel shall be trained in
ACLS and/or BLS.
d There is a checklist of all equipment and emergency medications. The organization shall develop a
checklist and ensure that the
ambulance is equipped as per
the checklist.
e Equipment are checked on a daily basis. This shall include both the
ambulance the equipments
within it.
f Emergency medications are checked daily and prior to dispatch. Self explanatory. This also In case a rapid turn around of the
includes checking the expiry ambulance in required (where
date of drugs. 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.
g The ambulance(s) has a proper communication system. The ambulance shall be
connected with the
hospital/control room by
wireless/mobile phones.

COP.4: Policies and procedures guide the care of patients requiring cardio-pulmonary resuscitation.
a Documented policies and procedures guide the uniform use of resuscitation The organisation shall document The document could be displayed
throughout the organisation. the procedure for same. This prominently in critical areas such
shall be in consonance with as emergency. ICU, OT etc.
accepted practices.
b Staff providing direct patient care is trained and periodically update in cardio These aspects shall be covered
pulmonary resuscitation. by hands on training. If the
organization has a CPR team
(e.g. code blue team) it shall
ensure that they are all trained
in ALS and are present in all
shifts.
c The events during a cardio pulmonary resuscitation are recorded. In the actual event of a CPR or This could be done using the pre-
a mock dril of the same, all the defined procedural checklist and
activities along with the by monitoring if the prescribed
personnel attended should be activity has been performed
recorded. properly and in the right
sequence.
d A post-event analysis of all cardiac asserts is done by a multidisciplinary The analysis shall include the
committee. cause, steps taken to
resuscitate and the outcome.
Multidisciplinary committee shall
include physicians,
anaesthetists and nurses.
 e Corrective and preventive measures are taken based on the post-event Self explanatory During subsequent resuscitations
analysis. it is preferable that 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.
a Documented policies and procedures are used to guide rational use of blood This shall address the A good reference guide is the
and blood products. conditions where blood and NABH standards for blood banks.
conditions where blood products
can be used.
b The transfusion services are governed by the applicable laws and regulations. Refer to Drugs and Cosmatics
act.
c Informed consent is obtained for donation and transfusion of blood and blood Consent should be taken for Also refer to PRE3 d and e.
products. every transfusion. However, with Consent for blood transfusion
the same consent you can give during surgery shall be taken
multiple transfusions in the separately. It should not be
same sitting. For example, 2 clubbed with the surgery consent
pints of blood may be transfused form.
serially using the same consent.
However, if the same is given
over two days or hours apart
then a separate consent is
required.
d Informed consent also includes patient and family education about donation. self explanatory This could be in the form of
booklet/leaflet.
e Staff is trained to implement the policies. This shall include doctors and Records of the same should be
be done either by training and/or available.
by providing written instruction.
f Transfusion reactions are analysed for preventive and corrective actions. The organization shall ensure For transfusion reactions refer to
that any transfusion reaction is glossary.
reported. It is preferable that the
organization capture feedback
regarding every transfusion
(including the ones without
reaction) as this would enable it
to cature all transfusion
analyzed (by
individual/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.
a The organisation has documented admission and discharge criteria for its The organization should develop A good starting point could be
intensive care and high dependency units. objective criteria and adhere to various national and international
it. critical care society guidelines.
b Staff is trained to apply these criteria. This shall be done by training by
deplaying the criteria.
c Adequate staff and equipment are available. The ICU should be equipped
with all necessary life saving
and monitoring equipmebnts 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.
d Defined procedures for situation of bed shortages are followed. As and when there are no
vacant beds in the ICU and
there is a requirement of such
bed, a detailed policy and
procedure should be in place to
address the situation.
e Infection control practices are followed. These could be developed
individually 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.
f A quality assurance programme is implemented. These could be developed Good clinical practices include
individually or it could be a part monitoring infection rates, re-
of the Hospital quality assurance admission rates, re-intubation
programme. The organization rates etc.
shall ensure that the 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).
a Policies and procedures are documented and are in accordance with the Self explanatory Refer to disability act, mental act.
prevailing laws and the national and international guidelines.
 b Care is organised and delivered in accordance with the policies and HCO develops SOP's for
procedures. delivery of care
c The organisation provides for a safe and secure environment for this vulnerable The organization shall provide For example, play room for
group. proper envirnment taking into children, anti-skid tiles for elderly,
account the requirement of the ramps with railings for disabled,
vulnerable group. etc.
d A documented procedure exists for obtaining informed consent from the The informed consent for this Refer to PRE 3e.
appropriate legal representative. group of people should be
obtained from their family or
legal representative.
e Staff is trained to care for this vulnerable group. All staff involved in the care of Records of the same should be
this group shall be adequately available.
trained in identifying and
meeting their needs.

COP.8: Policies and procedures guide the care of high-risk obstetrical patients.
a The organisation defines and displays whether high-risk obstetric cases be The organization shall define as The display should be in a
cared for or not. to what constitutes high risk prominent location. Refer to AAC
obstetric case in consonance 1b also.
with best clinical practices.
b Persons caring for high-risk obstetric cases are competent. These shall not just be doctors
but shall include nursing staff
also. The competency shall be
based on qualification,
experience and training.
c High-risk obstetric patient’s assessment also includes maternal nutrition. Self explanatory It is preferable that this is done by
a dietician.
d The organization caring for high risk obstetric cases has the facilities to take The organization shall have a
care of neonates of such cases. NICU with proper equipments
and staff.

COP.9: Policies and procedures guide the care of paediatric patients.

a The organisation defines and displays the scope of its dediatric services. The scope shall also include
neonatal services, if any.
b The policy for care of neonatal patients is in consonance with the national/ Self explanatory
international guidelines.
c Those who care for children have age specific competency. These shall not just be for
doctors but shall include nursing
staff also. The competency shall
be based on qualification,
experience and training.
d Provisions are made for special care of children. Adequate amentities for the care For example, playroom and breast
of infants and children to be
available in the hospital.
e Patient assessment includes detailed nutritional, growth, psychosocial and Sel explanatory
immunization assessment.
f Policies and procedures prevent child/ neonates abduction and abuse. The HCO shall ensure that there
is an adquate
security/surveillance to prevent
such happenings.
g The children’s family members are educated about nutrition, immunization and self explanatory.
safe parenting and this is documented in the medical record.
The display should be in a
prominent location. Refer to AAC
1b also.
There are national and
international guidelines available
for the cases of neonates by
WHO, etc. The hospital should
take them into account.
feeding room.
The same needs to be
documented.
Examples could include
identification tag, unsupervised
phototherapy leading to nurns,
etc.
For example, growth chart,
immunisation chart, etc. This
(origional/copy) should be a part
of the medical record. The
education should preferably be in
the language that the family
understands.

COP.10: Policies and procedures guide the care of patients undergoing moderate sedation.
a Competent and trained persons perform sedation. Whenever parenteral route is Technician shall not administer
used this shall be carried out by sedation
a doctor/nurse.
b The person administering and monitoring sedation is different from the person self explanatory
performing the procedure.
c Intra – procedure monitoring includes at a minimum the heart rate, cardiac Self explanatory, The same In addition, certain other
rhythm, respiratory rate, blood pressure, and oxygen saturation, and level of should be documented parameters may be monitored on
sedation. a case to case basis.
d Patients are monitored after sedation. The patient's vitals shall be
monitored at regular intervals
(as decided by the organization)
till he/she recovers completely
from the sedation. The same
should be documented.
e Criteria are used to determine appropriateness of discharge from the recovery These shall be developed by the
area. organization in consonance with
good critical practices.
 f Equipment and manpower are available to rescue patients from a deeper level The equipments shall include
of sedation than that intended. emergency resuscitation
equipments. An
anaesthesiologist shall be
available in the hospital.

COP.11: Policies and procedures guide the administration of anesthesia.

a There is a documented policy and procedure for the administration of HCO shall document on the For addition of anaesthesia refer
anesthesia. indications, the type of to glossary. The standard is not
anaesthesia and procedure for applicable for local anaesthesia.
the same.
b All patients for anesthesia have a pre-anesthesia assessment by a qualified This shall be done before the
individual. patient is wheeled into the OT
complex. It shall be applicable
for both routine and emergency
cases. This assessment shall be
done by an anaesthesiologist. It
is preferable to do assessment
in a standardized format
c The pre-anesthesia assessment results in formulation of an anesthesia plan Self explanatory The plan should mention the type
which is documented. of anaesthesia, the drug(s0 to be
used for induction and the drug to
be used for maintenance ..

d An immediate preoperative re-evaluation is documented. this shall be done by an

anaesthesiologist just before the
patient is wheeled in to the
respective OT
e Informed consent for administration of anesthesia is obtained by the anesthetist. Self explanatory Also refer to PRE 3d.

f During anesthesia monitoring includes regular and periodic recording of heart Self explanatory The same should be documented.
rate, cardiac rhythm, respiratory rate, blood pressure, oxygen saturation, airway
security and patency and level of anesthesia.
g Each patient’s post-anesthesia status is monitored and documented. This shall be done in the
recovery area/OT and at least
include monitoring of vitals till
the patient recovers completely
from anaesthesia and shall be
done by an anaesthesiologist. if
the patient's condition is
unstable and he/she requires
ICU care the same shall be
monitored there.
h A qualified individual applies defined criteria to transfer the patient from the The organization documents
recovery area. these criteria which should be in
consonance with good clinical
practices. These criteria shall be
applied by a designated
individual as decided by the
HCO.
i All adverse anesthesia events are recorded and monitored. All such events are documented
and monitored for the purpose
of taking corrective and
preventive action.

COP.12: Policies and procedures guide the care of patients undergoing surgical procedures.
a The policies and procedures are documented. This shall include the list of
surgical procedures as well as
competency level for performing
these procedures.
b Surgical patients have preoperative assessment and a provisional diagnosis All patients undergoing surgery This shall be done by the
documented prior to surgery. are assessed pre operatively operating surgeon.
and a provisional diagnosis is
made which is documented.
This shall be applicable for both
routine and emergency cases.
c An informed consent is obtained by the surgeon prior to the procedure. Self explanatory Also refer to PRE 3d.

d Documented policies and procedure exist to prevent adverse events like wrong Procedure should be available The HCO should be able to
site, wrong patients and wrong surgery. for preventing adverse events demonstrable methods to prevent
like wrong patients, wrong site these events e.g. identification
by a suitable mechanism. tags badgets, cross checks, etc.
Refer to WHO "Safe surgery
saves lives" initiative.
e Persons qualified by law are permitted to perform the procedures that they are The HCO identifies the Also refer to HRM 11b.
entitled to perform. individuals who have the
required qualification (s0,
training and experience to
perform procedures in
cosonance with the law.
 f A brief operative note is documented prior to transfer out of patient from This note provides information If it is documented by a person
recovery area. about the procedure performed, other than the chief operating
post operative diagnosis and the surgeon the same shall be
status and shall be documented countersigned by the chief
by the surgeon/member of the surgeon within 24 hours.
surgical team.
g The operating surgeons documents the post operative plan of care. Self explanatory. The plan shall include advice on
IV fluids, medications, care of
wound, nursing care, observing
for any complication, etc.
h A quality assurance programme is followed for the surgical survices. This be an integral part of the
HCO's overall quality assurance
programme. It shall focus on
post operative complications e.
g. bleeding rational use of
antibiotics, etc.
i The quality assurance program includes surveillance of the operation theatre Surveillance activities include For air conditioning of OT OT refer
environment. monitoring the quality of air to the glossary
provided , rate of air exchange,
cleaning and disinfection
processes , etc.
j The plan also includes monitoring of surgical site infection rates. Self explanatory. All the post operative patients
shall be screened for the same.

COP.13: Policies and procedures guide the care of patients under restraints (physical and/ or chemical).
a Documented policies and procedures guide the care of patients under This shall clearly state the
restraints. conditions/Circumstances under
which restraints shall be used .It
shall also specify as to who can
authorize the use of restrains.
b These include both physical and chemical restraint measures. Physical restraints include
boxer's bandage, use of cuffs
ec. Chemical restraints include
sedatives.
c These include documentation of reasons for restraints. Self explanatory.

d These patients are more frequently monitored. The organization shall specify
the parameters and frequency of
monitoring and accordingly
implement the same.
e Staff receive training and periodic updating in control and restraint techniques. Self explanatory. Records of the same should be
available.

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

a Documented policies and procedures guide the management of pain. The HCO shall define the group For example cancer pain,
of patients for whom this is neuralgias and arthralgia.
applicable. A good reference
point for defining these patients
could be those having pain as
the predominant debilitating
symptom.
b The organization respects and supports the appropriate assessment and Self explanatory. Pain assesssment and
management of pain for all patients. mangement could be carried out
using a pain rating scale.
c Patient and family are educated on various pain management techniques. Self explanatory.

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

a Documented policies and procedures guide the provision of rehabilitative Self explanatory.
services.
b These services are commensurate with the organizational requirements. The scope of the departments is For example,provision of ante
in consonance with the scope of natal and post natal exercises
the hospital. could form a part of obstetric
rehabilitaton programme.
c Rehabilitative services are provided by a multidisciplinary team. The team shall have treating
doctor, rehabilitation therapist,
rehabilitation nurss and other
professional experts.

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

a Documented policies and procedures guide all research activities in compliance Self explanatory. For example, International
with national and international guidelines. conference on harmonization
(ICH) of Good clinical practice
(GCP) and declaration of Helsinki
somerset (1996) and Ethical
Guidelines for Biomedical
Researchon Human Subjects
(ICMR-2000).
 b The organization has an ethics committee to oversee all research activities. An ethics committee should be Refer to schedule Y of Drugs and
framed in the hospital to monitor cosmetics act and ICMR
activities undertaken by various guidelines.
providers. Any research
undertaken in the hospital
fallsunder its ambit. This
includes both funded and non-
fundes and also student studies.
c The committee has the powers to discontinue a research trial when risks outweigh the Self explanatory.
potential benefits.

d Patient’s informed consent is obtained before entering them in research protocols. Self explanatory.

e Patients are informed of their right to withdraw from the research at any stage Self explanatory.
and also of the consequences (if any) of such withdrawal.
f Patients are assured that their refusal to participate or withdrawal from Self explanatory.
participation will not compromise their access to the organization’s services.

COP.17: Policies and procedures guide nutritional therapy.

a Documented policies and procedures guide nutritional assessment and Self explanatory.
reassessment.
b Patients receive food according to their clinical needs. A dietician shall do the For example, diabetic diet high
assessment of the patient in protein diet,total parenteral
consulation with the clinician nutrition, etc.
and advice regarding food.
c There is a written order for the diet. The dietician shall prepare this
in the form of a diet sheet and
patient shall receive food
accordingly.
d Nutritional therapy is planned and provided in a collaborative manner. The dietician shall ensure that
this is planned in consultation
with the treating doctor and the
patient/patient's relative after
taking into regard the patient's
food habitts (veg/ non-veg) and
likes and dislikes.
e When families provide food, they are educated about the patients diet The dietician / nurse shall
limitations. ensure this planning.
f Food is prepared, handled, stored and distributed in a safe manner. The dietary services to be
designed in a manner that there
is no criss cross of traffic. All the
activities fall in a squence. The
organization shall ensure that
hygienic conditions are follwed
all throughout.

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

a Documented policies and procedures guide the end of life care. The HCO has a documented
policy for providing care to
terminallly ill admitted patients.
This shall include providing
appropriate pain and palliative
care according to the wishes of
the family and patient.
b These policies and procedures are in consonance with the legal requirements. Self explanatory.

c These also address the identification of the unique needs of such patient and The religious and socio-cultural
family. beliefs of patients/ family shall
be addresed and respected.
d These also include sensitively addressing issues such as autopsy and organ If the body of the deceased is
donation. subjected to an autopsy or for
argan donation, it should be
discussed with the family in a
very courteous manner.
e Staff is educated and trained in end of life care. Self explanatory. Records of the same should be
available.

Chapter 3: MANAGEMENT OF MEDICATION (MOM)

MOM.1: Policies and procedures guide the organization of pharmacy services and usage of medication.
a There is a documented policy and procedure for pharmacy services and The polices and procedures
medication usage. shall address the issues related
to procurement, storage,
formulary, prescription,
dispensing, administration,
monitoing and use of
medications.
b These comply with the applicable laws and regulations. Self explanatory.
Relevant legislations include
Drugs and cosmetics Act food and
Drugs and Psychotropic
substances Acts,Drugs and
gagical Remedies (Objectionable
Advertisement) Act, etc.
 c A multidisciplinary committee guides the formulation and implementation of This shall be representative of For example, pharmaco-
these policies and procedures. major clinical departments therapeutic committee.
administration and shall include
a pharmacist/ clinical
pharmacologist.

MOM.2: There is a hospital formulary.

a A list of medication appropriate for the patients and organization’s resources is The hospital formulary shall be
developed. prepared and be preferably
updated at regular intervals.
b The list is developed collaboratively by the multidisciplinary committee. Refer to MOM 1c.

c There is a defined process for acquisition of these medications. The process should address the
issues of vendor selection,
vendor evalation,generation of
vendor evaluation,generation of
purchase order and receipt of
goods and receipt of goods as
per rules.
d There is a process to obtain medications not listed in the formulary. Self explanatory For example, local purchase.

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

a Documented policies and procedures exist for storage of medication. These should address issues
pertaining to temperature
(refrigeraion),light, ventilation
preventing entry of
pests/rodents and vermins.
b Medications are stored in a clean, well lit and ventilated environment. The organization shall also Vaccines should preferable be
ensure that the storage kept in vaccine refrigerators (Ice
requirements of he drug as Lined Refrigerator).
specified by the manufacturer
are adhered to.If the
recommendations are
confilicting recommendations in
nature, the organization shall
follow the manufacturer's
recommendation. This shall be
applicable to all areas where
medications are stored including
wards.
c Sound inventory control practices guide storage of the medications. Self explanatory The organization shall follow
inventory control practics like first
in and first out , ABC, etc.
d Medications are protected from loss or theft. The oranization shall ensure
that it develops proper
mechanisums to prevent
pilferage. The organization
could conduct audits at regular
intervals (as defined by the
organiztion) to detect such
instances
e Sound alike and look alike medications are stored separately. Many drugs in ampoules, vials the organization can folllow a
or tablets may look-alike or method of storing drugs by
sound alike. They should be generic name in an alphabetical
segregated and stored order to address this issue .
seperately.
f There is a method to obtain medication when the pharmacy is closed. when pharmacy is closed , there it is preferable that the HCO has a
should be SOP to procure the 24 hours pharmacy.
drugs.
g Emergency medications are available all the time. Adequate amount of emergency
medicines should be stocked at
all times. Re-order level at
definite quantity should be done.
h Emergency medications are replenished in a timely manner when used. self explanatory

MOM.4: Policies and procedures exist for prescription of medications.

a Documented policies and procedures exist for prescription of medications. self explanatory refer to MOM 1a

b The organization determines who can write orders. this shall be done by the treating
doctor.
c Orders are written in a uniform location in the medical records. all the orders for medicines are
recorded on a uniform location
of the case sheet. Electronic
orders when typed shall again
follow the same principles.
d Medication orders are clear, legible, dated, timed, named and signed. Self explanatory The organization can explore the
possibility of writing orders in
block letters so that the issue of
legibility is adderessed.
 e Policy on verbal orders is documented and implemented. The organization shall ensure
that it has a policy to address as
to who can give verbal orders
and how these orders will be
validated
f The organization defines a list of high risk medication. High risk medications are
medications involved in a high
percentage of medication errors
or sentinel events and
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,and look-alike and
sound-alike medications.
g High risk medication orders are verified prior to dispensing. These medications shalll
preferably be given only arter
written orders and it should be
verified by the staff before
dispensing.

MOM.5: Policies and procedures guide the safe dispensing of medications.

a Documented policies and procedures guide the safe dispensing of medications. Clear policies to be laid down for
dispensing of medication e.g.
route of administration, dosage,
rate of administration, expiry
date , etc.
b The policies include a procedure for medication recall. Recall may result based on
letters from regulatory
authoroties or internal feedback(
e.g. visible contaminant in IV
fliud bottle)
c Expiry dates are checked prior to dispensing. Self explanatory This shall be done at alll levels e.
g. pharmacy, ward, etc
d Labeling requirements are documented and implemented by the organization. At a minimum, labels must This is applicable to all dispensing
include the drug name, strenght, areas wherein medicines are
ffrequency of administration ( in dispensed either as cut strips or
a language the patient from bulk containers.
understands ) and expry dates.

MOM.6: There are defined procedures for medication administration.

a Medications are administered by those who are permitted by law to do so. Self explanatory Refer to statutory requiremenys.
in addition to doctors, nursing staff
may also administer.
b Prepared medication are labeled prior to preparation of a second drug. Self explanatory applicable for parenteral drugs

c Patient is identified prior to administration. Self explanatory Identification shall be done by

unique identification number( eg.
hospital number/IP number, etc)
with/without name
d Medication is verified from the order prior to administration. Staff administering medications
should go through the treatent
orders before administration of
the medication and then only
administer them. It is preferable
that they also check the general
appearance of the medication)
eg .melting, clumping etc.)
e Dosage is verified from the order prior to administration. Self explanatory

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

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

h Medication administration is documented. The organization shall ensure
that this is done in a uniform
location and it shall include the
name of medication, dosage,
route of administration, timing
and the name and signature of
the person who has
administered the medication
the records shall reflect the actual
administration.For example, if
brand Y was given in place of
brand X(same gnerically)the
documentation shall be of brand
Y. Similarly if the order was for a
tablet of 250mg but the
administsation was1/2 a tablet of
500mg the latter shall be
documented.
 i Polices and procedures govern patient’s self administration of medications. At the outset the HCO could for example, slf administration of
define if it would permit self insulin.
administration of medications. In
case the HCO permits then the
policy shall include the
medications which the patient
can self administer. If 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
j Polices and procedures govern patient’s medications brought from outside the These shall address ass to what
organization. are the pre-requisites for such a
medication ( eg. invoice, 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.
a Patient and family are educated about safe and effective use of medication. The organization shall make a
list of such drugs and
accordingly educate eg. digoxin.
This could also include
education regarding the
immportance of taking a drug at
a specific time eg. sustained
release medications.
b Patient and family are educated about food-drug interactions. Patient and family should be
counselled about their diet
during medication eg. no alcohol
when taking metronidazle.

MOM.8: Patients are monitored after medication administration.

a Patients are monitored after medication administration and this is documented. This shall be done by anyone
involced in direct patient care.
The organization could follow
either a pasiive ( documenting
only if the patient tellls ) or
active ( enquiring with every
patient ) monitoring mechanism.
b Adverse drug events are defined. The organization shall define as Refer to glossary for "adverse
to what constitutes an adverse drug event"
drug event. This shall be in
consonance with best practices.
Adverse drug events include
adverse drug reactions as well
as medication errors.
c Adverse drug events are reported within a specified time frame. Self explanatory
The organization shall define the
timeframe for reporting once the
adverse drug event has
occured.
d Adverse drug events are collected and analysed. All the adverse drug reaction are
analysed regularly by the multi-
disciplinary committee
e Policies are modified to reduce adverse drug events when unacceptable trends Self explanatory
occur.

MOM.9: Policies and procedures guide the use of narcotic drugs and psychotropic substances.
a Documented policies and procedures guide the use of narcotic drugs and Self explanatory
psychotropic substances.
b These policies are in consonance with local and national regulations. This is in context of narcotic
drugs and psychotropic
substances act.
c A proper record is kept of the usage, administration and disposal of these These shall be kept in
drugs. accordance with statutory
requirements.
d These drugs are handled by appropriate personnel in accordance with policies. Self explanatory

MOM.10: Policies and procedures guide the usage of chemotherapeutic agents.

a Documented policies and procedures guide the usage of chemotherapeutic Self explanatory
agents.
b Chemotherapy is prescribed by those who have the knowledge to monitor and This shall preferably be a
treat the adverse effect of chemotherapy. medical oncologist or a person
who has been trained and had
achieved competency in the
same.
 c Chemotherapy is prepared and administered by qualified personnel. This shall preferable be staff
who have received special
trainig in preparing and
administration.
d Chemotherapy drugs are disposed off in accordance with legal requirements. These shall be disposed off
according to Bio-medical waste
management and handling rules
1998 or manufacturer's
recommendation.

MOM.11: Policies and procedures govern usage of radioactive drugs.

a Documented policies and procedures govern usage of radioactive drugs. Self explanatory

b These policies and procedures are in consonance with laws and regulations. Refer to AERB guidelines.

c The policies and procedures include the safe storage, preparation, handling, Self explanatory. This shall
distribution, and disposal of radioactive drugs. however be in accordance with
AERB guidelines.
d Staff, patients and visitors are educated on safety precautions. Self explanatory This refers to the layout/location of
radiaton waste pipes,delay waste
pipes, delay tanks, etc.

MOM.12: Policies and procedures guide the use of implantable prosthesis.

a Documented policies and procedures govern procurement and usage of Self explanatory
implantable prosthesis.
b Selection of implantable prosthesis is based on scientific criteria and national/ The organisation shall ensure
internationally recognized approvals. that relevant and sufficient
scientic data are available
before selection. It shall also
look for international (e.g. US-
FDA) of national notification
(Drugs and Cosmetics Act
notification october 2005) for
approval of the particular
product.
c The batch and serial number of the implantable prosthesis are recorded in the Self explanatory
patient’s medical record and the master logbook.

MOM.13: Policies and procedures guide the use of medical gases.

a Documented policies and procedures govern procurement, handling, storage, This shall be applicable to all
distribution, usage and replenishment of medical gases. gases used in the organization .
It shall also address the issue of
statutory requirements and
approvals wherever applicable It
shall follow a uniform colour
coding system.
b The policies and procedures address the safety issues at all levels. This shall include from the point
of storage/source area, gas
supply lines and the end user
area.Appropriate safety
measures shall be developed
and implemented for all levels.
c Appropriate records are maintained in accordance with the policies, procedures This is the context of the Indian
and legal requirements. explosives act of 1884, Gas
cylinder rules 1981 and static
and mobile pressure vessels
(unfired) 1981.

Chapter 4: PATIENT RIGHTS AND EDUCATION (PRE)

PRE.1: The organization protects patient and family rights informs them about their responsibilities during care.
a Patient and family rights and responsibilities are documented. Hospital should respect For an example of "patient
patient'srights and inform them responsibility refer to glossary.
of their responsibilites.
All the rights of the patient
should be displye in the form of
a citizens' charter which should
also give information of the
charges and grievance
redressal mechanism.
b Patients and families are informed of their rights and responsibilities in a format self explanatory.
and language that they can understand.
c The organization’s leaders protect patient's and family rights. Protection also includes
addressing patient"s grievances
w.r.t rights.
d Staff is aware of their responsibility in protecting patients and family rights. Traning and sensitisation
programmes shall be conducted
to create aeareness among the
staff.
 e Violation of patient and family rights is recorded, reviewed and corrective/ Where patient"s rights have
preventive measures taken. been infringed upon,
management must keep 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.
a Patient and family rights address any special preferences, spiritual and cultural This could include dietary
needs. preferences and worship
requirements.
b Patient and family rights include respect for personal dignity and privacy during During all stages of patient care,
examination, procedures and treatment. be it in examination or carrying
out a procedure,hospital staff
shall ensure that 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 actualsprocedure 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.
c Patient and family rights include protection from physical abuse and neglect. Self explanotry. Special Examples of this include falling
precautions shall be taken from the bed/trolley due to
especially w.r.t. vulnerable negligence,assaultt,repeated
patients .eg. elderly, neonates internal examinations,
etc. manhandling etc.
d Patient and family rights include treating patient information as confidential. Self explanatory. statutory Example of this include MTP,
requirement w.r.t. privilged patients of tubeculosis or any
communication shall be followed other infections disease
at all times.
e Patient and family rights include refusal of treatment. During management the In case of refusal the treating
patients should be given the doctor shall explain the
choice of treatment .The treating consequences of refusal of
doctor shall discuss all the treatment and document the same
available options and allow the
aptient to make an informed
choice including the option of
refusal.
f Patient and family rights include informed consent before anaesthesia, blood self explanatory Informed consent of the patient is
and blood product transfusions and any invasive/ high-risk procedures/ mandatory for doing HIV test.
treatment.
g Patient and family right include information and consent before any research The organization shall ensure
protocol is initiated. that international conference on
harmonization (ICH) of good
clinical practice (GCP) and
Declaration of Helsinki
Somerset (1996) and ICMR
requirements are followed.
h Patient and family rights include information on how to voice a complaint. Grievance redressal mechanism
must be accesssible and
transparent. Information must be
clearly available on how to voice
a complaint.
i Patient and family rights include information on the expected cost of the Refer AAC4d.
treatment.
j Patient and family have a right to have an access to his/ her clinical records. The organization shall ensur
that every patient has access 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.
a General consent for treatment is obtained when the patient enters the Self explanatory
organisation.
b Patient and / or his family members are informed of the scope of such general The organization shall difine as This cannot include conset for
consent. to what is the scope of this invasive procedures for invasive
consent and the same shall be procedures or other procedures
communicated to the patient for which consent is required as
and /or his family members. per this standard.
c The organisation has listed those situations where informed consent is required. A list of procedures should be The policy for HIV testing should
made for which informed follow the national policy on HIV
consent should be taken. testing (NACO).
 d Informed consent includes information on risks, benefits, alternatives and as to The consent shall have the
who will perform the requisite procedure in a language that they can name of the doctor performing
understand. the procedure. If it is a "doctor
under training" the same shall
be specified, however the name
of the qualified doctor
supervising the procedure shall
also be mentioned consent form
shall be in the language that the
patient understands.
e The policy describes who can give consent when patient is incapable of The organisation shall take into
independent decision-making. consideration the statutory
norms. This would include next
of kin/legal guardian. However
in case of unconscious/
unaccompanied patients the
treating in life saving
circumstances.

PRE.4: Patient and families have a right to information and education about their health care needs.
a When appropriate, patient and families and are educated about the safe and Self explanatory.
effective use of medication and the potential side effects of the medication.

b Patient and families are educated about diet and nutrition Self explanatory.

c Patient and families are educated about immunisations. Self explanatory. More
applicable for paediatric
population. In adults it could be
for influenza, streptococcus
pneumonia, typhoid, hepatitis B,
Neisseria meningitides, etc,
d Patient and families are educated about their specific disease process, Self explanatory. This could also
complications and prevention strategies. be done through patient
education
booklets/videos/leaflets etc.
e Patient and families are educated about preventing infections. Self explanatory. For example, hand washing and
avoiding overcrowding near the
patient.

f Patients and family are taught in a language and format that they can Self explanatory.
understand.

PRE.5: Patient and families have a right to information on expected costs.

a There is uniform pricing policy in a given setting (out-patient and ward There should be a billing policy
category). which defines the charges to be
levied for various activities.

b The tariff list is available to patients. The organization shall ensure

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.

c Patients and family are educated about the estimated cost of treatment. Refer to AAC4d.

d Patients and family are informed about the financial implications when there is a When patients are shifted from
change in the patient condition or treatment setting. one setting to another, typically
to and form ICUs, the financial
implication must be clearly
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.
a The hospital infection control programme is documented which aims at Self explanatory. Reference documents could
preventing and reducing risk of nosocomial infections. include Prevention of hospital
acquired infections- a practical
guide (2nd edition, 2002) by
WHO, CDC Guidelines and
Manual for control of Hospital for
control of Hospital Associated
Infections, Standard Operative
Procedures by NACO, Ministry of
Health and family Welfare, Govt.
of India.
 b The hospital has a multi-disciplinary infection control committee. This shall preferably have
Hospital Administrator, Surgeon,
Manager – Nursing (Nursing
Supervisor(, staff form CSSD,
and the hospital infection control
nurse. It could also include
invitees form various
departments as deemed
necessary.
c The hospital has an infection control team. The team is responsible for day- For the composition of the team
to-day functioning of infection refer to WHO, APIC and CDC
control programme. They shall guidelines.
support surveillance process
and detect outbreaks. They shall
also participate in infection
prevention and control on a day-
today basis.
d The hospital has designated and qualified infection control nurse(s) for this The qualification shall be either It is preferable for them to have
activity. a graduate nurse or qualified undergone a short term training
nurse with competence gained programme on infection control
by experience. nursing by a recognized institute.

HIC.2: The organisation has an infection control manual, which is periodically updated.
a The manual identifies the various high-risk areas and procedures. The manual should clearly
identify the high risk areas of the
hospital e.g. ICU, HDU, 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.
b It outlines methods of surveillance in the identified high-risk areas. It shall define the frequency and
mode of surveillance. The
surveillance system should meet
WHO criteria of simplicity, cost
minimization timeliness of
feedback flexibility, acceptability,
consistency, (reliability),
sensitivity and specificity.
c It focuses on adherence to standard precautions at all times. Self explanatory. Refer to glossary for standard
precautions.

d Equipment cleaning and sterilisation practices are included. It shall address this at all levels
e. g. ward, OT and CSSD. It is
preferable that the 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.
e An appropriate antibiotic policy is established and implemented. The HCO shall develop a The HCO could also refer to
system of monitoring drug international guidelines while
susceptibility (based on culture framing the policy. Use of WHO
sensitivity) and accordingly reference document Global
develop its antibiotic policy, strategy for containment
which shall be reviewed at resistance, 2001
periodic intervals (maybe once [WHO/CDC/CSR/DRS2001.2]can
in 3 months) for its continuing be a good starting point.
applicability.
f Laundry and linen management processes are also included. The laundry can be in-house or
outsourced. If outsourced the
organization shall ensure the 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.
g Kitchen sanitation and food handling issues are included in the manual. Self explanatory. The same
shall be applicable even if this
activity is outsourced. The
organization could refer to ISO
22000:2005 (food safety) while
addressing this issue.
 h Engineering controls to prevent infections are included. Issues such as air conditioning Refer to glossary for air
plant and equipment conditioning in OT.
maintenance; cleaning of AC
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 sources and
water quality must be included.
Any renovation work in hospital
patient with Infection Control
team with regard to architectural
segregation, traffic flow, use of
materials etc.
i Mortuary practices and procedures are included as appropriate to the The mortuary services in the Standard precautions must be
organization. hospital should be provided adhered to.
through walk-in cold rooms or
mortuary cold cabinets.
Mortuary procedures of
preserving body, or body parts
and safety measures while
handling over body to relatives
should be in accordance with
the policy.
j The organization defines the periodicity of updating the infection control manual. The organization must have a
documented policy on the
updation of the infection control
manual. It is desirable to update
at 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.
a Surveillance activities are appropriately directed towards the identified high-risk The organization must be able The HCO should use a judicious
areas to provide evidence of mix of active and passive
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.
b Collection of surveillance data is an ongoing process The organization shall ensure
that it has a process in place to
collect surveillance data and
also to ensure that it is able to
capture all such data.
c Verification of data is done on regular basis by the infection control team The data so collected shall be
authenticated by the team by
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.
d In cases of notifiable diseases, information (in relevant format) is sent to appropriate The organization shall identity Refer to glossary for notifiable
authorities. all notifiable diseases after diseases.
taking into consideration the
local laws, rules, regulations and
notifications thereof. The
organization shall ensure that
this is sent at the specified
frequency and in the format as
required by statutory authorities.
e Scope of surveillance activities incorporates tracking and analyzing of infection This shall be done at regular A simple calculation of infected
risks, rates and trends. intervals (maybe monthly and patients (numerator) provides only
consolidated into an annual limited information which would be
report) and the organization difficult to interpret. Risk factor
shall take suitable steps based analysis would require infected
on the analysis. and non infected patients, in order
to calculate infection and risk
adjusted rates.
 f Surveillance activities include monitoring the effectiveness of housekeeping services.
This would include This is applicable even if the
categorization of areas/surfaces; housekeeping services are
general cleaning procedures for outsourced.
surfaces, furniture/ fixtures, and
items used in patient care. It
should also include procedures
for terminal 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 or reduce the risk of Hospital Associated Infections (HAI) in patients and
employees.
a The organization monitors urinary tract infections. This can be done either by
sending urine or catheter tip for
culture. The organization shall
do this for all symptomatic
catheterized patients.
The HCO may extend this activity
to asymptomatic catheterised
patients also. It is preferable to
also. It is preferable to use CDC
definitions.

b The organization monitors respiratory tract infections. This can be done by sending It is preferable to use CDC
sputum or ET/ tracheostomy definitions.
secretions (obtained using a
suction catheter) of 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.
c The organization monitors intra-vascular device infections. For patients with symptoms It is preferable to use CDC
suggestive of intra vascular definitions.
device infection and having
central line the same shall be
doneby sending the tip for
culture. For all peripheral lines
clinical evidence of
thrombophlebitis would suffice.
d The organization monitors surgical site infections. This shall be done by sending It is preferable to use CDC
pus/swab for culture. definitions.

e Appropriate feedback regarding HAI rates are provided on a regular basis to The feedback shall include the This could be in the form of a
medical and nursing staff. rates. Trends and opportunities bulletin/newsletter.
for improvement. It could also
provide specific inputs to reduce
the HAI rate.

HIC.5: Proper facilities and adequate resources are provided to support the infection control programme.
a Hand washing facilities in all patient care areas are accessible to health care The organization shall ensure
providers. that it provides necessary
infrastructure to carry out the
same.
Optimal hand hygiene
requirements includes large
washbasins, hands free control,
soap and facility for drying hands
without contamination. The hand
hygiene the hand hygiene
guidelines shall be based on
WHO 2007 guidelines on patient
safety (website: www.who.
int/patientsafety)

b Compliance with proper hand washing is monitored regularly. The organization shall
preferably display the necessary
instruction near every had
washing area. Compliance could
be verified by random checking,
observation, etc.
c Isolation/ barrier nursing facilities are available. The organization shall define the Refer to glossary ofr
conditions where the same shall isolation/barrier nursing.
be carried out and ensure that it
provides the necessary
resources to carry out the
activity (e.g. clothing, masks,
gloves etc.).
d Adequate gloves, masks, soaps, and disinfectants are available and used Self explanatory. The should be
correctly. available at the point of use and
the organization shall ensure
that it maintains an adequate
inventory.

HIC.6: The organisation takes appropriate actions to control outbreaks of infections.

 a Hospital has a documented procedure for handling such outbreaks. This shall incorporate definitions To define as to what constitutes
as to what constitutes an an outbreak the HCO should have
outbreak, identification and baseline rates.
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.
b This procedure is implemented during outbreaks. The organization should be able
to identify the outbreak, describe
the outbreak by developing a
case definition, designing a data
collection from, collection data
from the affected, constructing
an epidemic curve.
c After the outbreak is over appropriate corrective actions are taken to prevent The organization should be able
recurrence. to implement basic procedures
to prevent recurrence such as
source control if source
identified, review of all infection
control polices, loopholes and
compliance gaps, strengthening
infection control polices etc.

HIC.7: There are documented procedures for sterilisation activities in the organisation.
a There is adequate space available for sterilization activities. Adequacy of space refers to the
CSSD which should have an
area of 0.7sq. m/bed, suitable
location, proper layout
(unidirectional flow, zoning) and
separation of clean and dirty
areas.
The HCO shall provide for the
same in all areas where
sterilization activities are carried
out. It is preferable to have
separate areas for receiving,
washing, cleaning, packing,
sterilization, sterile storage and
issue.

b Regular validation tests for sterilisation are carried out and documented. This shall be done by accepted
method e.g. bacteriologic, strips
etc. Engineering validations like
Bowie Dick tape test and leak
rate test need to be carried out
WHO recommends each load to
have a number, content
description, temp and time record
chart, physical/chemical tests
daily, weekly biological test, steam
processing, and ETO processing.

c There is an established recall procedure when breakdown in the sterilisation The organization shall ensure
system is identified. that the sterilization procedure is
regularly monitored and in the
eventuality of a breakdown it
has a procedure for withdrawal
of such items.
The HCO could have a batch
processing system with date and
machine number for effective
recall.

HIC.8: Statutory provisions with regard to Bio-medical Waste (BMW) management are complied with.
a The hospital is authorised by prescribed authority for the management and The occupier shall apply in the
handling of Bio-medical Waste. prescribed form and get
approval form the prescribed
authority e.g. Pollution control
board/committee.
b Proper segregation and collection of Bio-medical Waste from all patient care Wastes to be segregated and
areas of the hospital is implemented and monitored. collected in different colour
coded bags and containers as
per statutory provisions.
Monitoring shall be done by
member of the infection control
committee/team.
c The organization ensures that Bio-medical Waste is stored and transported to The waste is transported to the
the site of treatment and disposal in proper covered vehicles within stipulated pre-defined site at definite time
time limits in a secure manner. intervals (Maximum within 48
hours) through proper transport
activity is outsourced the
organization. Monitoring of this
activity should be done by
infection Control team.
d Bio-medical Waste treatment facility is managed as per statutory provisions (if If the hospital has waste
in-house) or outsourced to authorised contractor(s). treatment facility within its
premises the they have to be in
accordance with statutory
provisions or they can outsource
it to a central facility.
e Requisite fees, documents and reports are submitted to competent authorities The HCO shall ensure that the
on stipulated dates. fees are deposited in a timely
manner. In addition the annual
reports have to be submitted by
the 31st of January of every
year and accident reporting has
to be carried out in the
prescribed form.
 f Appropriate personal protective measures are used by all categories of staff Self explanatory. For example, gloves and masks,
handling Bio-medical Waste. protective glasses, gowns, etc.

HIC.9: The infection control programme is supported by the organisation’s management and includes training of staff and
employee health.
a Hospital management makes available resources required for the infection The HCO shall ensure that the
control programme. resources required by the
personnel should be available in
a sustained manner. This
includes both men and
materials.
b The hospital regularly earmarks adequate funds from its annual budget in this There shall be a separate
regard. budget demarcated for HIC
activity. This shall be prepared
taking into consideration the
scope of the activity and
previous years, experience.
c It conducts regular pre-induction training for appropriate categories of staff There must be a documented Doctors also need to be trained.
before joining concerned department(s). evidence of pre-induction
training for appropriate
categories of staff before joining
concerned department(s). it
should include the policies,
procedures and practices of the
infection control programme.
d It also conducts regular “in-service” training sessions for all concerned Self explanatory.
categories of staff at least once in a year.
e Appropriate pre and post exposure prophylaxis is provided to all concerned Self explanatory. For example, hepatitis B
staff members vaccination and PEP for needle
stick injury.

Chapter 6: CONTINUOUS QUALITY IMPROVEMENT (CQI)

CQI.1: There is a structured quality improvement and continuous monitoring programme in the organization.
a The quality improvement programme is developed, implemented and This committee shall have For examples, core committee,
maintained by a multi-disciplinary committee. representation from quality improvement committee,
management, various clinical Etc.
and support departments of the
HCO. This programme shall be
develop, implemented and
maintained in a structured
manner.
b The quality improvement programme is documented. This should be documented as a Refer to AAC 8, AAC 11, COP 6,
manual. The manual shall COP 12 and HIC 2 also.
incorporate the mission,vision, Refer to guidelines for
quality objectives, service documentation.
standards,important indicators
as identified etc. The manual
could be stand alone and should
have cross linkages with other
manuals.

c There is a designated individual for coordinating and implementing the quality For example accreditation co-
improvement programme ordinator, quality management
This should preferably be a
representative, quality manager.
person having a good
knowledge of accreditation
standards, statutory
Requirements, hospital quality
improvement principles and
evaluation methodologies,
hospital functioning and
operations

d The quality improvement programme is comprehensive and covers all the major The shall preferably cover all Refer to glossary for definition of
elements related to quality improvement and risk management. aspects including Risk management and Quality
documentation of the improvement.
programme, monitoring it data
collection, review of policy and
corrective action.Also refer to
CQI 1b.

e The designated programme is communicated and coordinated amongst all the Self explanatory This could be bone throught
employees of the organization through proper training mechanism. regular training programme or
printed materials
 f The quality improvement programme is reviewed at predefined intervals and As quality improvement is a The assessors shall be either
opportunities for improvement are identified. dynamic process, it needs to be trained internally or externall in
reviewed at regular pre-defined NABH standards. They shall
intervals (as defined by the HCO assess areas independent of their
in the quality improvement area of work
manual but at least once in four
months) by conducting internal
audits. This audits shall be done
by a multi-disciplinary team
(preferable trained in NABH
standards) and objective
elements.At the end of the audit
there shall be a formal meeting
to summarise the findings and
identity 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.
g The quality improvement programme is a continuous process and updated at Self explanatory. The inputs for
least once in a year. updation could be based on the
review carried out by the quality
improvement committee.

CQI.2: The organization identifies key indicators to monitor the clinical structures, processes and outcomes which are used as
tools for continual improvement.
a Monitoring includes appropriate patient assessment. The HCO shall develop
appropriate key performance
indicators suitable to it. The
following is however mandatory:
i.Time for initial assessment of
indoor and emergency patients.
ii.Percentage of cases wherein
care plan is documented and
counter-signed by the clinician.
iii.Percentage of cases wherein
screening for nutritional needs
has been done.iv.Percentage of
cases wherein the pre-defined
intial nursing assessment is
completed within 30 monutes.

b Monitoring includes safety and quality control programmes of the diagnostics The HCO shall develop
services. appropriate key performance
indicators suitable to it . The
following is however mansatory :
i.Number of reporting
errors/1000 investigationa ii.
Percentage of re-dos. iii.
Percentage of reports co-
relating with clinical diagnosis.
iv.Percentage of adherence to
safety precautions by
employees working in
diagnostics.
Reporting errors need to be
captured. It is better if the
organization caputers these errors
as errors picked up before
dispatching the reports and errors
picked after the dispatch of
reports.
This includes transcription errors
also.
Re-dos include tests which
needed to be repeated in view of
poor sample or improper
positioning and in case of
radiology also includes radiology
also include films wastage.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
monitered.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.
c Monitoring includes all invasive procedures. The HCO shall develop
appropriate key performance
indicators suitable to it . The
following is however mansatory :
i.Re-exploration rate ii.
Percentage of accidental
remeoval of tubes and catheters
iii.Incidence of haematoma at
puncture site iv.Percentage of
re-scheduling of procedures.

d Monitoring includes adverse drug events. The HCO shall develop

appropriate key performance
indicators suitable to it. The
following is however mndatroy:
i.Percentage of medication
errors.ii.Incidence of adverse
drug reactions iii.Percentage of
medication charts with illegible
writing over a given period. iv.
Percentage of contrast related
reactions.
e Monitoring includes use of anaesthesia. The HCO shall develop Adverse anaesthesia events
appropriate key performance include events which happen
Indicators suitable to it . The during the procedure like hypoxia,
following is however mandatory arrhythmias, cardiac arrest etc.
:

i.Percentage of modification of
anaesthesia plan.
ii.Percentage of unplanned
ventilation following
anaesthesia.
iii.Percentage of adverse
anaesthesia events.
iv.Anaesthesia related mortality
rate.

f Monitoring includes use of blood and blood products. The HCO shall develop Wastage includes blood products
appropriate key performance found unfit for use
indicators suitable to it. The
following is however mansatory :
i.Percentage of transfusion
reactions.
ii.Percentage of wstage of blood
and blood products.
iii.Percentage of blood
component usage.
iv.Turnaround time for issue of
blood and blood components.

g Monitoring includes availability and content of medical records. The HCO shall develop Missing records include records
appropriate key performance within the retention
indicators suitable to it. The
following is however mandatory
i.Percentage of medical records
not having discharge summary.
ii.Percentage of medical records
not having initial assessment
and the plan of care.
iii.Percentage of medical
records having incomplete
and/or improper consent.
iv.Percentage of missing
records.

h Monitoring includes infection control activities. The HCO shall develop Refer to HIC 4
appropriate key performance
indicators suitable to it. The
following is however mandatory:
i.Urinary tract infection rate.
ii.Respiratory infection rate.
iii.Intra-vascular device infection
rate.
iv.Surgical site infection rate
 i Monitoring includes clinical research. The HCO shall develop Refer to ICMR guidelines and
appropriate key performance GCP for reporting time of serious
indicators suitable to it. The adverse events.
following is however mandatory:
i.Number of research activities
being carried out.
ii.Percentage of patients
withdrawing from the study.
iii.Percentage of protocol
violations/deiations reported.
iv.Percentage of serious
adverse events (which have
occurred in the HCO) reported
to the ethics committee within
the defined timeframe
j Monitoring includes data collection to support further improvements. The data could be collected at For example data can be collected
pre-defined intervals e.g. to study the reasons for “Re Do’s
monthly/quaterly. This data is in surgical patients
analysed for improvement Data could be represented
opportunities and the same are graphically e.g. bar chart,pie
carried out.Also refer to CQI 1f chart, etc.

k Monitoring includes data collection to support evaluation of these improvements. All improvement activities
carried out by the HCO shall
have an evaluable outcome.
The same be captured and
analysed.
For example , once the reasons
for “Re Do’s” have been analysed
and preventive and corrective
measures undertaken then data
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.

a Monitoring includes procurement of medication essential to meet patient needs. The HCO shall develop Local purchase implies drugs
appropriate key performace purchased outside the formulary.
indicators suitable to it. The
following is however mandatory:
i.Percentage of drugs procured
by local purchase.
ii.Percentage of stock outs
including emergency drugs.
iii.Percentage of consumables
rejected before preparation of
Goods Receipt Note.
iv.Incidence of variations from
the procurement
b Monitoring includes reporting of activities as required by laws and regulations. The HCO shall develop For example, tax , EPF, notifiable
appropriate key performace diseases,births and deaths,PNDT
indicators suitable to it. The act, AERB guidelines etc.
following is however mandatory:
i.Number of birthes and deaths.
ii.Numberof notifiable diseases.
iii.Submission of
report/data/form pertaining to
bio-medical waste,PNDT act
and radiation safety within the
defined timeframe.
iv.Submission of tax returns and
deduction of taxes at the
specified time frame.

c Monitoring includes risk management. The HCO shall develop Mock drills include fire,nono-fire
appropriate key performace and disaster management.
indicators suitable to it. The Refer to glossary for definition of
following is however mandatory: risk management
i.Number of variations observed
in mock drills.
ii.Incidence of falls.
iii.Incidence of bed sores after
admission.
iv.Percentage of employees
provided pre-exposure
prophylaxis.

d Monitoring includes utilisation of space, manpower and equipment. The HCO shall develop
appropriate key performace
indicators suitable to it. The
following is however mandatory:
i.Bed occupancy rate and
average length of stay.
ii.OT and ICU utilization rate.
iii.Equipment down time.
iv.Nurse-patient ratio
 e Monitoring includes patient satisfaction which also incorporates waiting time for The HCO shall develop
services. appropriate key performace
indicators suitable to it. The
following is however mandatory:
i.Out patient satisfaction index.
ii.In patient satisfaction index.
iii.Waiting time for services
including diagnostics and out
patient.
iv.Time taken for discharge.
Waiting time implies the time
taken from the time that the
patient registers to the time taken
for assessment to be done by the
doctor/ diagnostic procedure to be
performed. Time taken for
discharge implies the time from
which the doctor writes for
discharge to the time for final
clearance

f Monitoring includes employee satisfaction. The HCO shall develop

appropriate key performace
indicators suitable to it. The
following is however mandatory:
i.Employee satisfaction index.
.
ii.Employee attrition rate
iii.Employee absenteeism rate
iv.Percentage of employees who
are aware of employees rights,
responsibilities and welfare
schemes.
.

g Monitoring includes adverse events and near misses. The HCO shall develop
appropriate key performace
indicators suitable to it. The
following is however mandatory:
i.Number of sentinel events.
ii.Percentage of near misses
analysed.
iii.Number of security related
incidents including thefts.
iv.Incidence of needle stick
injuries.

h Monitoring includes data collection to support further study for improvements. The data could be collected at
pre-defined intervals e.g.
monthly/quarterly. This data is
analysed for improvement
opportunities and the same are
carried out.Also refer also refer
to CQI 1f.
i Monitoring includes data collection to support evaluation of these Self explanatory. The inputs for
improvements. updations could be based on the
review carried out by the quality
improvement committee.17

CQI.4: The quality improvement programme is supported by the management.

a Hospital Management makes available adequate resources required for quality This shall include the men,
improvement programme. material,machine and method.
These should so as to ensure
that the programme functions
smoothly.
b Hospital earmarks adequate funds from its annual budget in this regard. Appropriate fund allocation is
done by the organization for the
smooth functioning of the
programme.
c Appropriate statistical and management tools are applied whenever required. Self Explanatory
The bedget could be earmarked
based on previous year’s
spending. If no data is available
the HCO could make a beginning
by earmarking a budget but
reviewing it at the end of 6 months
to make any necessary
modifications.
For example ,Root cause
analysis, FMEA, project evalution
and review technique (PERT),
Critical path method (CPM),
Control charts etc.

CQI.5: There is an established system for audit of patient care services.

a Medical and nursing staff participates in this system. The HCO shall identify such These could be members of the
personnel. It could be a mix of core committee/quality assurance
clinicians, administrators ans committee, etc.
nurse.
b The parameters to be audited are defined by the organisation. As these audits are The auit shall encompass all
retrospective/concurrent in aspects of care including clinical
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
 c Patient and staff anonymity is maintained. This means that the names of
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.
d All audits are documented. Self explanantory The HCO could use a checklist
with the predefined parameters
and the audit findings could be
recorded on this sheet.
e Remedial measures are implemented. All remedial measures as This should preferably be done
ascertained should be based on root cause analysis.
documented and implements
thersof recorded to complete the
audit cycle.
CQI.6: Sentinel events are intensively analysed.
a The organisation has defined sentinel events. The sentinel events relating to Refer to Glossary for definition of
system or process deficiencies sentinel events.
that are relevant and important
to the organization must be
clearly defined.
b The organisation has established processes for intense analysis of such events. The established processes
should include reporting the
occurrence of such events on
standardized incident report
forms.
c Sentinel events are intensively analysed when they occur. Root cause analysis of all such
events should be carried out by
a multi-disciplinary committee
taking inputs from the
concerned
units/discipline/departments
d Corrective and preventive Actions are taken based on the findings of such The findings and
analysis. recommendations arrived at
after the analyses 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.
a Those responsible for governance lay down the organization’s mission It is not only the head of the For definition of mission refer to
statement. HCO but te members of the glossary.
board of governors (where
applicable) who need to define
it.
b Those responsible for governance lay down the strategic and operational plans The Governing boars and the Refer to glossary for strategic and
commensurate to the organization’s mission in consultation with the various leaders of HCO shall define and operational plans.Stakeholders
stake holders. develop the processs for include the community the
strategic and operation plans so organization serves.
as to achieve the organizational
mission statement.

c Those responsible for governance approve the organization’s budget and The Governing boars and the
allocate the resources required to meet the organization’s mission. leaders of HCO shall have the
policy for budgeting and
resource allocation for attaining
its mission and periodically
review it.
d Those responsible for governance monitor and measure the performance of the The Governing boars and the
organization against the stated mission. leaders of HCO shall develop
quarterly (at least) performance
reports based on the strategic
and operational plans.
e Those responsible for governance establish the organization’s organogram. The HCO shall have a well
defined organization
structure/chart and this shall
clearly document the hierarchy,
line of control,along with the
functions at various levels.
f Those responsible for governance appoint the senior leaders in the organization. Self explanatory Senior leaders include the first two
rungs of the organogram
g Those responsible for governance support research activities and quality improvement
Self explanatory
plans. It is not only the Head of the HCO
but the members of the Board of
governors (where applicable) who
need to support this.
 h The organization complies with the laid down and applicable legislations and regulations.
Self explanatory The This shall include central
responsibility of compliance lies
legislations (e.g. Drugs and
with the first two level of the Cosmetics act, MTP act,PNDT
hierarchy Act,1996), Bio medical waste act,
Air (Prevention and control of
pollution) Act, 1981, Atomic
Energy Requlatory Body
Approvals, License under Bio-
medical Manaement 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).
i Those responsible for governance address the organization’s social responsibility.The Governing board and Head For example,free camps outreach
of the HCO shall willfully programmes,adoption of villages,
develop social responsibility PHCs etc.
policy and accordingly address
it.

ROM.2: The services provided by each department are documented.

a Each organizational program, service, site or department has effective There needs to be a minimum
leadership. essential qualification and
relevant experience of the
leader. The leader shoul have
domain knowledge of that
particular department
b Scope of services of each department is defined. Each department’s activity is to For example,nephrology
be predefined. This could be department could do all activities
documented either at individual like biopsy,shunts,listulas,dialysis
department level or the HCO (haemo, CAPD),etc.
could have a brochure detailing
the scope of each department.
c Administrative policies and procedures for each department is maintained. This shall include administrative It could be common for the entire
procedures like attendance, HCO.
leave,conduct replacement etc
d Departmental leaders are involved in quality improvement. Self explanatory To effectively implement this each
department could have its
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.

a The leaders make public the mission statement of the organization. The HCO shall have a mission
statement and the same shall be
displayed prominently.
b The leaders establish the organization’s ethical management. The HCO shall function in an
ethical manner.
c The organization discloses its ownership. The ownership of the hospital e. The disclosure could be in the
g.trust , private ,pulic has to be registration certificate/ quality
disclosed.
d The organization honestly portrays the services which it can and cannot Self explanatory
provide.
e The organization honestly portrays its affiliations and accreditations. Here portrays implies that the
HCO conveys its affilations,
accreditations for specific
departments or whole hospital
wherever applicable.
f The organization accurately bills for it’s services based upon a standard billing Self explanatory
tariff.
For definition of mission refer to
glossary.
A good reference guide is “code of
medical ethics 2002” published by
MCI.
manual , etc.
Here portrays implies that the that
HCO conveys to the patients
clearly what it can and cannot
provide. The services that it
cannot provide could also be
conveyed verbally. Refer to AAC 1
also
Also refer to PRE 5. The tariff
could be devised by a tariff
committee.

ROM.4: A suitably qualified and experienced individual heads the organisation.

a The designated individual has requisite and appropriate administrative Self explanatory This implies to the individual
qualifications. looking after the day to day Board
of Governors. Appropriate implies
qualification in hospital
management/ administration.
b The designated individual has requisite and appropriate administrative Self explanatory Appropriate implies administrative
experience. experience in a HCO.

ROM.5: Leaders ensure that patient safety aspects and risk management issues are an integral part of patient care and
hospital management.
 a The organization has an interdisciplinary group assigned to oversee the hospital Self explanatory
wide safety programme.
b The scope of the programme is defined to include adverse events ranging from The HCO shall have a system of
“no harm” to “sentinel events”. reporting of all the
incidents/accidents.
c Management ensures implementation of systems for internal and external The HCO has a system in place
reporting of system and process failures. for internal and external
reporting of system and process
failures. Contingrncy plan shall
be in place to deal with the
situation of system and process
failure anticipated within the
arganization.
d Management provides resources for proactive risk assessment and risk There shall be sufficient
reduction activities. resources kept as contingency risk definition of risk assessement
to address the risk reduction
activities as and when the
leaders proactively suggest.
The end result of these shall
result of thses shall result of
these shall result in preventive
actions.
The group could have a mix of
administratorsgineers, doctors
and nurses, Refer to glossary for
definition of safety programme.
Refer to glossary for definition of
adverse events and sentinel
events. Reporting
incident/accident should not just
be based on severity of the
incident. In fact, all incidents must
be reported.
for example, MRI machine, of the
HCO breaks down. In this case
internal reporting is to be done to
reporting is to be done to CEO
and external reporting to be done
o the patients.
Refer to glossary for definition of
and risk reduction.

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.
a The management is conversant with the laws and regulations and knows their A designated management For example, the protection
applicability to the organization. functionary has been given the guidelines given in national
responsibility to enlist the laws building code of India,relevant
and regulation as applicable to state and local body regulations
the HCO. This functionary has (Kerala state building rules).
identified the appropriate
personnel in the HCO who are
supposed to implement the
respective laws and regulations.
b Management regularly updates any amendments in the prevailing laws of the Self explanatory
land.
c The management ensures implementation of these requirements. Self explanatory

d There is a mechanism to regularly update licenses/ registrations/certifications. Self explanatory

FMS.2: The organization’s environment and facilities operate to ensure safety of patients, their families, staff and visitors.
a There is a documented operational and maintenance (preventive and Self explanatory Refer glossary for definition of
breakdown) plan. preventive and breakdown
maintenance.
b Up-to-date drawings are maintained which detail the site layout, floor plans and A designated person maintains
fire escape routes. the drawings.
c There is internal and external sign posting in the organisation in a language Self explanatory These signages shall guide
understood by patient, families and community. patients and visitors. It is
preferable that signages are
bilingual. Statutory requirements
shall be met.
d The provision of space shall be in accordance with the available literature on Self explanatory For example Indian standards (IS
good practices (Indian or International Standards) and directives from 12433) formulated by Bureau of
government agencies. Indian standards (for 30 and 100
bedded hospitals and other
standards), IS 10905 for basic
requirements for general hospital
buildings.
e There are designated individuals responsible for the maintenance of all the A Person in the HCO
facilities. management is designated to
be in-charge of maintenance of
facilities.The HCO has the
required number of supervisors
and tradesmen to mnage the
facilities.
f Maintenance staff is contactable round the clock for emergency repairs. Self explanatory

g Response times are monitored from reporting to inspection and implementation A Complaint attendance register
of corrective actions. is to be maintained to indicate
the date and time of receipt of
complaint,allotment of job and
completion of job.

FMS.3: The organization has a program for clinical and support service equipment management.
 a The organization plans for equipment in accordance with its services and Self explanatory. This shall also
strategic plan. take into consideration future
requirements.
b Equipment is selected by a collaborative process. Collaborative process implies
that during equipment selection
there is involvement of end
user, management , finance ,
engineering and bio-medical
departments.
c All equipment is inventoried and proper logs are maintained as required. Self explanatory

d Qualified and trained personnel operate and maintain the equipment. Self explanatory

e Equipment are periodically inspected and calibrated for their proper functioning. The HCO has
weekly/monthly/annual
schedules of inspection and
calibration of equipment which
involve measurement in an
appropriate manner. The
equipment in house or out
sources , Mintaining traceability
to national or intenational or
manufacturer's
guidelines/standards.
f There is a documented operational and maintenance (preventive and Self explanatory
breakdown) plan.

FMS.4: The organization has provisions for safe water, electricity, medical gases and vacuum systems.
a Potable water and electricity are available round the clock. The HCO shall make For water quality, refer to IS
arrangements for supply of 10500.
adequate potable water and
electricity.
b Alternate sources are provided for in case of failure. Alternate electric supply could
be form DG Sets. Solar energy.
UPS and any other suitable
source.
c The organisation regularly tests the alternate sources. Self explanatory.

d There is a maintenance plan for piped medical gas, compressed air and Self explanatory.
vacuum installation.

FMS.5: The organization has plans for fire and non-fire emergencies within the facilities.
 a The organization has plans and provisions for early detection, containment and The HCO has a fire and non-fire The National Building Code is a
abatement of fire and non-fire emergencies. emergency committee (FNEC) good reference guide.
to review the HCO’s
preparedness. The HCO has
conducted an 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) a fire plan covering fore
arising out of burning of
inflammable items, explosion,
electric short circuiting or acts of
negligence of due to
incompetence of the staff on
duty;
b) deployed adequate and
qualified adequate and qualified
personnel for this;
c) acquired adequate fore
fighting equipment for this which
records are kept up-to-date;
d) adequate training plans;
e) schedules for conduct of
mock fire drills;
f) mock drill records;
g) exit plans well displayed.
The HCO has a dedicated
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.
Theses may include:
a) terrorist attack ;
b) invasion of swarms of insects
and pests; c)
earthquake;
d) invasion of stray animals;
e) hysteric fits of patients and/or
relative; f)
civil disorders effecting the
HCO;
g) anti-social behavior by
patients/ relatives;
h) temperamental disorders of
staff causing deterioration in
patient care;
i) spillage of hazardous (acids,
mercury, etc.), infected
materials (used gloves,
syringes, tubing sharps, etc.)
medical wastes (blood, pus,
amniotic fluid, vomits, etc.);
j) building or structural collapse;
k) fall or slips (from height or on
floor) or collision of personnel in
passageway;
l) fall of patient from lines;
m) bursting of pipe lines;
n) sudden flooding of areas like
basements due to clogging in
pipe lines;
o) sudden failure of supply of
electricity, gas, vacuum, etc.;
p) 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.

b The organization has a documented safe exit plan in case of fire and non-fire Fire exit plan shall be displayed
emergencies. on each floor particularly close
to the lifts. Exit doors should
remain open on all the time.
c Staff is trained for their role in case of such emergencies. In case of fire, designated
person are assigned particular
work.
d Mock drills are held at least twice in a year Self explanatory.

FMS.6: The organization has a smoking limitation policy.

 a The organization defines and implement its polices to reduce or eliminate Smoking in public places
smoking. including hospitals has been
banned in this country.
b The policy has provisions for granting exceptions for patients and families to In view of the law, permission to
smoke. smoke within the campus of
hospital may not be granted.

FMS.7: The organization plans for handling community emergencies, epidemics and other disasters.
a The hospital identifies potential emergencies. The HCO has a documented
plan and procedure for handling
the situations like sudden rush
of victims of
a) earthquake;
b) flood;
c) train accident;
d)civil unrest outside the HCO
remises;
e) major fire;
f) invasion by enemy, etc.
Tese plans and procedures
cover ensuring adequacy of
medical supplies, equipment,
materials, identifying trained
personnel, transportation aids,
communication aids and mock
drill methodology.

b The organization has a documented disaster management plan. The disaster plan must Refer to National Disaster
incorporate essential elements Management Authority guidelines.
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.
c Provision is made for availability of medical supplies, equipment and materials Resource availability should be Quantity of resources i.e. medical
during such emergencies. according to threat perception. stores etc. should match with the
expected workload.

d Hospital staff is trained in the hospital’s disaster management plan. Mock drills with and without
patients have to we carried out.
Only communication exercise
may also be undertaken.
e The plan is tested at least twice in a year. Self explanatory. This is only the minimum
frequency and this may be
increased.

FMS.8: The organization has a plan for management of hazardous materials.

a Hazardous materials are identified within the organization. The HCO has identified and
listed the hazardous materials
and has a documented
procedure their sorting, storage,
handling, transpirations,
disposal mechanism, and
method for managing spillages
and adequate training of the
personnel for these jobs.
The hazardous materials could be
identified as per part II of
manufacture, Storage and Import
of Hazardous Chemical
(Amendment) Rules, 2000.
In addition Biological materials like
blood, body fluids and
microbiological cultures, mercury,
nuclear isotopes, medical gases,
LPG gas, steam, ETO etc are
some of the other common
hazardous materials.
 b The hospital implements processes for sorting, labelling, handling, storage, The HCO has conducted an
transporting and disposal of hazardous material. exercise of hazard identification
and risk analysis (HIRA)
associated with handling of
hazardous materials and
according 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
according arranged associated
training of personnel who handle
such materials. The situational
hazards also need to be
covered in HIRA 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
handling and those trainings are
included in the HCO training
calendar.
c Requisite regulatory requirements are met in respect of radioactive materials. The appropriate personnel in the
HCO are aware about the rules
and regulations such as the
Atomic Energy Act, the norms
issued by Atomic Energy
Regulatory Board (AERB) and
the directives form the Health
Physics Division of Bhabha
Atomic Research Center
(BARC).
d There is a plan for managing spills of hazardous materials. Self explanatory.

e Staff is educated and trained for handling such materials. Self explanatory.

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

b This committee coordinates development, implementation, and monitoring of The HCO ensures that the
the safety plan and policies. above committee functions on a
regular basis to coordinate
development, implementation
and monitoring of the plans and
policies.
c Patient safety devices are installed across the organization and inspected Self explanatory For example, grab bars, bed rails,
periodically. sing posting, safety belts in
stretchers and wheel chairs,
alarms both visual and auditory
where applicable, warning signs
like radiation or biohazard, call
bells, fire safety devices etc.

d Facility inspection rounds to ensure safety are conducted at least twice in a year Rounds to be carried out by During these rounds potential
in patient care areas and at least once in a year in non-patient care areas. safety committee. safety risks are identified.

e Inspection reports are documented and corrective and preventive measures are Self explanatory. Before and after evidence may be
undertaken. maintained.

f There is a safety education programme for all staff. Self explanatory.

Chapter 9: HUMAN RESOURCE MANAGEMENT (HRM)

HRM.1: The organization has a documented system of human resource planning.

a The organization maintains an adequate number and mix of staff to meet the The staff should be
care, treatment and service needs of the patient. commensurate with the
workload and the clinical
requirement of the patients.
b The required job specifications and job description are well defined for each The content of each job should
category of staff. be well defined and the
qualifications, skills and
experience required for
performing the job should be
clearly laid down. The job
description should be
commensurate with the
qualification.
c The organization verifies the antecedents of the potential employee with Self explanatory
regards to criminal/negligence background.
A good reference could be the
MCI and INC guidelines.
Refer to glossary for definition of
job description and job
specification.
This report could be got firm the
district magistrate (s) of the district
(s) where the employee has
served earlier and/or from the
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.
a Each staff member, employee, student and voluntary worker is appropriately The organization’s staff This could be done as a part of
oriented to the organization’s mission and goals. including the outsourced staff the induction training .
should be aware and should
correctly interpret the mission
and goals of the organization.
b Each staff member is made aware of hospital wide policies and procedures as The organization’s. staff This could be done as a part of
well as relevant department / unit / service / programme’s policies and including the outsourced staff the induction training and the
procedures. should be aware and should same could be provided in the
correctly interpret the policies form of a booklet. In also reinforce
and operating procedures of the the correct interpretation of
organization as well as that of policies and procedures.
the department/ unit/ service in
which he is performing the
requisite duties.
c Each staff member is made aware of his/her rights and responsibilities. The HCO shall define the same This could be done as a part of
in consonance with statutory the induction training and the
requirements and the same same could be provided in the
shall be communicated to the form of a booklet.
employees.
d All employees are educated with regard to patients’ rights and responsibilities. The employees should be able For patient right refer to PRE 2.
to identify and report violation of
patient rights as and when the
same occurs.
e All employees are oriented to the service standards of the organisation. The HCO shall develop The employees should be trained
benchmarks for different to implement the service
services being provided. This standards of the organization.
shall be based on the HCO’s

HRM.3: There is an ongoing programme for professional training and development of the staff.
a A documented training and development policy exists for the staff. A training manual incorporating The training shall be for all
the procedure for identification categories of staff including
of training needs, the training doctors and outsourced staff
methodology, documentation of (wherever applicable).
training, training assessment,
impact of training and the
training calendar should be
prepared.
b Training also occurs when job responsibilities change/ new equipment is The training should focus on the
introduced. revised job responsibilities 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.
c Feedback mechanisms for assessment of training and development programme This shall include both include
exist. both internal and external
training. For external by the
HCO itself 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.
 a All staff is trained on the risks within the hospital environment. The HCO shall define such risks
which shall include patient,
visitors and employee related
risks.
b Staff members can demonstrate and take actions to report, eliminate / minimize Self explanatory.
risks.
c Staff members are made aware of procedures to follow in the event of an Self explanatory.
incident.
d Reporting processes for common problems, failures and user errors exist. The HCO has a defined
procedure for reporting of these
events.
HRM.5: An appraisal system for evaluating the performance of an employee exists as an integral part of the human resource
management process.
a A well-documented performance appraisal system exists in the organization. Self explanatory.
b The employees are made aware of the system of appraisal at the time of Self explanatory.
induction.
c Performance is evaluated based on the performance expectations described in Self explanatory.
job description.
d The appraisal system is used as a tool for further development. Self explanatory. This can be
done by identifying training
requirements and accordingly
providing for the same
(wherever possible)
e Performance appraisal is carried out at pre defined intervals and is Self explanatory.
documented.
HRM.6: The organization has a well-documented disciplinary procedure.
a A written statement of the policy of the organization with regard to discipline is Self explanatory.
in place.
b The disciplinary policy and procedure is based on the principles of natural This implies that both parties
justice. (employee and employer) are
give an opportunity to present
their case and decision is taken
accordingly.
c The policy and procedure is known to all categories of employees of the Self explanatory.
organization.
d The disciplinary procedure is in consonance with the prevailing laws. Self explanatory.
e There is a provision for appeals in all-disciplinary cases. The HCO shall designate an
appellate authority to consider
appeals in disciplinary cases.
HRM.7: A grievance handling mechanism exists in the organization.
a The employees are aware of the procedure to be followed in case they feel For definition of grievance The HCO could address all points
aggrieved. handling refer to glossary. The in HRM2, HRM4, HRM5, HRM6
HCO has a written procedure for
handing grievance of
employees.
b The redress procedure addresses the grievance. Self explanatory
c Actions are taken to redress the grievance. Self explanatory
HRM.8: The organization addresses the health needs of the employees.
a A pre-employment medical examination is conducted on all the employees. Self explanatory. This shall
however be in consonance with
the low of the land.
b Health problems of the employees are taken care of in accordance with the Self explanatory. The shall be in
organization’s policy. consonance with the low of the
land and good clinical practices.
For example, fire and non fire
emergency, needle stick injury,
etc.
Staff should be able to practically
demonstrate actions like taking
care of blood spills, medication
errors and other adverse event
reporting systems.
The staff should be able to
intimate the sequence of events
the they will undertake in the
eventuality of occurrence of any
adverse event.
Reporting processes could be
checked form time to time by the
management to ensure their
implementation.
For definition of performance
appraisal refer to glossary.
To be incorporated in the service
booklet and included in the
induction training.
For definition of job description
refer to glossary.
This shall be done at least once a
year.
For definition of disciplinary
procedure refer to glossary.
This could be in the form of
service rules.
Refer to relevant labour laws and
CCS (CCA) rules.
Appellate authority should be
higher than the disciplinary
authority.
For example, performing pre-
employment HIV testing is illegal.
For example, employee health
and safety policy.
 c Regular health checks of staff dealing with direct patient care are done at-least Self explanatory. The result
once a year and the findings/ results are documented. should be documented in the
personal file.
The HCO could define the
parameters and it could be
different for different categories of
personnel. The HCO could also
identify competent individuals to
perform the same.

d Occupational health hazards are adequately addressed. Self explanatory. For definition of occupational
health hazard refer to glossary

HRM.9: There is a documented personal record for each staff member.

a Personal files are maintained in respect of all employees. Self explanatory.

b The personal files contain personal information regarding the employees Self explanatory.
qualification, disciplinary background and health status.

c All records of in-service training and education are contained in the personal Self explanatory.
files
d Personal files contain result of all evalutions. Evaluations would include
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.

a Medical professionals permitted by law, regulation and the hospital to provide The HCO identifies the For definition of credentialing refer
patient care without supervision is identified. individuals who have the to glossary.
required qualification (s),
training and experience to
provide patient care in
consonance with the law.
b The education, registration, training and experience of the identified medical Self explanatory. Updation is
professionals is documented and updated periodically. done after acquisition of new
skills and/or qualification.
c All such information pertaining to the medical professionals is appropriately The HCO shall do the same by A good reference could be MCI”s
verified when possible. verifying the credentials from the website.
organization which has awarded
the qualification/training.

HRM.11: There is a process for authorising all medical professionals to admit and treat patients and provide other clinical
services commensurate with their qualifications.
a Medical professionals admit and care for patients as per the laid down policies The HCO shall identify as to For example, radiotherapy can
and authorisation procedures of the organization. what each medical professional only be give by a radiation
is authorized to do. oncologist.

b The services provided by the medical professionals are in consonance with their Self explanatory. Where authorization is provided
qualification, training and registration. on the basis of training the HCO
shall maintain a copy of the
training record and verify it.

c The requisite services to be provided by the medical professionals are known to Self explanatory. The HCO could incorporate this in
them as well as the various departments/ units of the hospital. the brochure itself.

HRM.12: There is a process for collecting, verifying and evaluating the credentials (education, registration, training and
experience) of nursing staff.
a The education, registration, training and experience of nursing staff is The HCO identifies the Refer to Indian Nursing Council
documented and updated periodically. individuals who have the Act, 1947
required qualification (s),
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
b All such information pertaining to the nursing staff is appropriately verified when The HCO shall do the same by
possible. verifying the credentials from the
organization which has awarded
the qualification/training6t

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.
 a The clinical work assigned to nursing staff is in consonance with their The HCO shall identify as to
qualification, training and registration. what each nurse is authorized to Nurse should have had requisite
do.
b The services provided by nursing staff are in accordance with the prevailing Self explanatory
laws and regulations.
c The requisite services to be provided by the nursing staff are known to them as Self explanatory
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 data and information from the Organization.
a The information needs of the organization are identified and are appropriate to The HCO has manual and/or
the scope of the services being provided by the organization and the complexity electronic Hospital Information
of the organization. System and/or Management
Information System information
to all concerned stakeholders.
b Policies and procedures to meet the information needs are documented. A policy document is available
where the HIS/MIS is described.
c These policies and procedures are in compliance with the prevailing laws and Self explanatory.
regulations.
d All information management and technology acquisitions are in accordance with The HCO shall define the needs
the policies and procedures. for software and hardware
solutions as per the information
requirement and future
necessities.
e The organization contributes to external databases in accordance with the law The HCO shall define the
and regulations. system of releasing the relevant
information to the authority as
per statutory norms.
IMS.2: The organization has processes in place for effective management of data.
a Formats for data collection are standardized MIS/HIS data are collected in
standardized format from all
areas/services in the HCO.
b Necessary resources are available for analyzing data. The HCO shall make available
men, material, space and
budget.
c Documented procedures are laid down for timely and accurate dissemination of Self explanatory.
data.
d Documented procedures exist for storing and retrieving data. The HCO shall define data
management policy and ensure
adequate safeguards for
protection of data, wherever
physical of electronic data in
stored.
e Appropriate clinical and managerial staff participates in selecting, integrating There is a multi-disciplinary
and using data. committee which is responsible
for the appropriate selection of
indicators, measurement of
trends and initiating action
wherever required.
IMS.3: The organization has a complete and accurate medical record for every patient.
a Every medical record has a unique identifier. This shall also apply to records
on digital media.
For example. An infection Control
in-house / external training and
experience and the aptitude and
knowledge to perform the tasks
required of her.
For example, daily census report,
utilization rates, etc. Also refer to
CQI 2 and CQI 3.
Some of these include:-IT Act
2000 for computer based records,
PNDT Act for relevant details of all
patients undergoing ultrasound,
Code of Medical Ethics, 2002, RTI
Act 2005, etc. Relevant sate
legislation e.g. Maintenance of
Clinical Records Act (MOCRA) in
Maharashtra.
For example, sending birth and
death statistics, notifiable
diseases (refer to glossary) and
pulse polio programme.
This is in the context of frequency
of capturing data namely daily,
weekly, monthly quarterly, yearly
etc. (Statistical bulletin).
The organization could decide on
which data needs to be shared
with whom and also the modalities
(e.g. memos, circulars etc.) for
dissemination of such data.The
organization could decide on
which data needs to be shared
with whom and also the modalities
(e.g. memos, circulars etc.) for
dissemination of such data.
Storage could be physical of
electronic. Wherever electronic
storage is done the HCO shall
ensure that there ate adequate
safeguards for protection of data.
For example, CR number, hospital
number, etc. GS1 standards and
numbering system can be used to
identify and track the patient
record within and outside the
hospital.
 b Organisation policy identifies those authorized to make entries in medical HCO has a written policy stating This could be different category of
record. who all con make entries. personnel for different entries, but
it shall be uniform across the
HCO. For example. Progress
record by doctor and medication
administration chat by nurse.
c Every medical record entry is dated and timed. Self explanatory. For records on electronic media it
is preferable that the date and
time is automatically generated by
the system.
d The author of the entry can be identified. This could be by writing the full
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 dept.
e The contents of medical record are identified and documented. The HCO identifies which For example, admission order,
documents form part of the face sheet, IP sheet, discharge
medical records, documents and summary, doctor’s order consent
implements the same. form etc.
f The record provides an up-to-date and chronological account of patient care. The HCO shall decide the
format for maintaining the
continuity in the medical
records.
IMS.4: The medical record reflects continuity of care.
a The medical record contains information regarding reasons for admission, Self explanatory. For definition of plan of care refer
diagnosis and plan of care. to glossary. After the initial visit it
shall at least have a provision
diagnosis. The final diagnosis (IP)
must be is as per ICD 10.
b Operative and other procedures performed are incorporated in the medical Self explanatory Also refer to COP 12f.
record.
c When patient is transferred to another hospital, the medical record contains the Self explanatory. It is mandatory If the patient has been transferred
date of transfer, the reason for the transfer and the name of the receiving to mention the clinical condition at his/her request a note may be
hospital. of the patient before transfer is added to that effect. In such
effected. instances the name of the
receiving hospital could be the
name the patient desires to go to.
However, if the patient has been
transferred by the HCO it shall
have an acknowledgement form
the receiving hospital.
d The medical record contains a copy of the discharge note duly signed by Self explanatory Discharge note is the same as
appropriate and qualified personnel. discharge summary. Also refer to
AAC 15.
e In case of death, the medical record contains a copy of the death certificate Self explanatory. The HCO Also refer to AAC 15 g.
indicating the cause, date and time of death. provides the death certificate as
per the international Certification
of Cause of Death.
f Whenever a clinical autopsy is carried out, the medical record contains a copy Self explanatory. For definition of autopsy refer to
of the report of the same. glossary.
g Care providers have access to current and past medical record. The HCO provides access to
medical records to designated
health 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.
a Documented policies and procedures exist for maintaining confidentiality, The HCO shall control the
security and integrity of information. accessibility to the MRD
department. It shall ensure the
usage of tracer card for
movement of the file I and out of
the MRD so as to maintain
confidentiality, security, safety
and integrity of information.
The is applicable for both
manual and electronic records.

b Policies and procedures are in consonance with the applicable laws. This is the context of Indian For example, privileged
Evidence Act, Indian Penal communication.
Code and Code of Medical
Ethics.
 c The policies and procedures incorporate safeguarding of data/ record against For physical records the HCO It is preferable that softwares
loss, destruction and tampering. shall ensure that there is when used shall be validated and
adequate pest and rodent duly authenticated.
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.
d The hospital has an effective process of monitoring compliance of the laid down The HCO carries out regular Refer to IMS 7.
policy. audits/rounds to check
compliance with policies.
e The hospital uses developments in appropriate technology for improving, The HCO shall review and For example, moving form
confidentiality, integrity and security. update its technological features physical to electronic format,
so as to improve confidentiality, remote backup of data, etc.
integrity and security of
information.
f Privileged health information is used for the purposes identified or as required The HCO shall define the Special care should be taken in
by law and not disclosed without the patient’s authorization. procedure for privileged medico-legal cases.
communication.
g A documented procedure exists on how to respond to patients/ physicians and Self explanatory. In this context,
other public agencies requests for access to information in the medical record in the release of information in
accordance with the local and national law. accordance with the Code of
Medical Ethics 2002 should be
kept in mind.

IMS.6: Policies and procedures exist for retention time of records, data and information.
a Documented policies and procedures are in place on retaining the patient’s The HCO shall define the
clinical records, data and information. retention period for each
category of medical records:
Out-patient, in-patient and MLC.

b The policies and procedures are in consonance with the local and national laws Some of the related laws in this
and regulations. context are Code of Medical
Ethics 2002, Consumer
Protection Act 1987 and
relevant state legislation, if any.

c The retention process provides expected confidentiality and security. This is applicable for both
manual and electronic system.

d The destruction of medical records, data and information is in accordance with Destruction can be done after
the laid down policy. the retention period is over and
after taking approval of the
competent authority.

IMS.7: The organization regularly carries out review of medical records.

a The medical records are reviewed periodically. Self explanatory. The HCO could define the
periodicity.

b The review uses a representative sample based on statistical principles. The HCO shall define the
principles on which sampling is
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 patients,
etc.
c The review is conducted by identified care providers. Self explanatory The HCO shall identify and
authorize such individuals.

d The review focuses on the timeliness, legibility and completeness of the medical Self explanatory
records.
e The review process includes records of both active and discharged patients. Self explanatory An adequate mix of both active
and discharged patients should be
used.

f The review points out and documents any deficiencies in records. Self explanatory For example, missing final
diagnosis, absence of OT motes
in an operated patient, etc.

g Appropriate corrective and preventive measures undertaken are documented. Self explanatory