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

AAC.1. The organization defines and displays the services that it can provide.

Objective Element Interpretation Remarks


a) The services being A policy to be framed clearly stating the
provided are clearly services the hospital can provide. Scope of Services
defined and are in
consonance with the
needs of the community.
b) The defined services are The services so defined should be
prominently displayed. displayed prominently in an area visible
to all patients entering the organization. Evident on Site
The display could be in the form of
boards, citizen's charter, scrolling
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 All the staff in the Hospital mainly in the
these services. reception/registration, OPD, IPD are
oriented to these facts through training
programme regularly or through
manuals.

AAC.2. The organization has a well defined registration and admission process.

Objective Element Interpretation Remarks


a) Standardized policies and Health Care Organization (HCO) has
procedures are used for prepared document (s) detailing the Registration process
registering and admitting policies and procedures for registration
patients. and admission of patients which should Admission Process
also include unidentified patients.

b) The policies and Self explanatory


procedures address out- Admission Process
patients, in-patients and
emergency patients.
c) Patients are accepted only The staff handling admission and
if the organization can registration needs to be aware of the Admission Process
provide the required services that the organization can
service. provide. It is also advisable to have a
system wherein the staff is aware as to
whom to contact if they need any
clarification on the services provided.
d) The policies and The HCO is aware of the availability of
procedures also address alternate HCO's where the patients may Policy for non
managing patients during be directed in case of non-availability of availability of beds
non availability of beds. beds.
e) The staff is aware of these All the staff handling these activities
processes. should be oriented to these policies and Induction Manual
procedures.

AAC.3. There is an appropriate mechanism for transfer or referral of patients who do not
match the organizational resources.

Objective Element Interpretation Remarks


a) Policies guide the transfer The organization shall at the outset
of unstable patients to define as to who is an unstable patient. Patient Transfer Policy
another facility in an The documented policy and procedure
appropriate manner. should address the methodology of safe
transfer of the patient in a life
threatening situation (like those who are
on ventilator) to another HCO. There
should be availability of an appropriate
ambulance fitted with life support
facilities and accompanied by trained
personnel.
b) Policies guide the transfer Patients not in a life threatening
of stable patients to situation (stable) should also be Patient Transfer Policy
another facility. transported in a safe manner.
c) Procedures identify staff The staff shall at least be a trained
responsible during trauma/emergency technician/nurse. Patient Transfer Policy
transfer. He/she shall have undergone training in
BLS and/or ACLS.
d) The organization gives a The HCO gives a case summary
summary of patient’s mentioning the significant findings and Discharge Summary
condition and the treatment given in case of patients who
treatment given. are being transferred from emergency.
For admitted patients a discharge
summary has to be given (refer
AAC15).The same shall also be given
to patients going against medical
advice.

AAC.4. During admission the patient and /or the family members are educated to make
informed decisions.

Objective Element Interpretation Remarks

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a) The patients and/or family The plan of care as decided by the
members are explained doctor on duty or the patient
about the proposed care. management team (as the case may
be) is to be discussed with the patient
Patients Right Policy
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 The patients and family are explained in
members are explained detail by the treating physicians or
about the expected his/her team about the outcomes of Patients Right Policy
results. such treatment.

c) The patients and/or family Possible complications of the treatment,


members are explained if any, are clearly communicated to the Patients Right Policy
about the possible patient.
complications.
d) The patients and/or family Patients should be given an estimate of
members are explained the expenses on account of the Patients Right Policy
about the expected costs. treatment preferably in a written form.

AAC.5. Patients cared for by the organization undergo an established initial assessment.

Objective Element Interpretation Remarks


a) The organization defines The hospital shall have a protocol/policy
the content of the by which a standardized initial Initial Assessment
assessments for the out– assessment of patients is done in the Policy
patients, in-patients and OPD, emergency and in-patients. The
emergency patients. 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 subsequent visits. In emergency
department this shall include recording
the vital parameters. The initial
assessment should also include the
nursing assessment for in-patients.
b) The organization The assessment should be done by the
determines who can treating doctor, junior doctor or a nurse. Initial Assessment
perform the assessments. The organization determines who can Policy
do what assessment and it should be
the same across the hospital.
c) The organization defines The HCO has defined and documented
the time frame within the time frame within which the initial IInitial Assessment
which the initial assessment is to be completed with Policy
assessment is completed. respect to OPD/ emergency/indoor
patients.

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d) The initial assessment for This should cover history, progress
in-patients is documented notes, investigation ordered and Initial Assessment
within 24 hours or earlier treatment ordered and all these are to Policy
as per the patient’s be authenticated by treating doctor.
condition or hospital
policy.
e) Initial assessment includes The protocol for patient’s initial
screening for nutritional assessment should cover his/her Initial Assessment
needs. nutritional needs. In case of Out Policy
patients this should be done where ever
applicable. For example diabetics, CRF
patients.
f) The initial assessment This shall be documented by the
results in a documented treating doctor or by a member of his Initial Assessment
plan of care which is team in the case sheet. This plan is Policy
monitored. monitored by the treating doctor for its
effectiveness, and wherever required by
a clinical audit.
g) The plan of care also The documented plan of care should
includes preventive cover preventive actions as necessary Initial Assessment
aspects of the care. in the case and should include diet, Policy
drugs etc.

AAC.6. All patients cared for by the organization undergo a regular reassessment.

Objective Element Interpretation Remarks


a) All patients are After the initial assessment, the patient
reassessed at appropriate is reassessed periodically and this is Initial Assessment
intervals. documented in the case sheet. The Policy
frequency maybe different for 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 Actions taken under reassessment are
clinical care document documented. The staff could be the Initial Assessment
reassessments. treating doctor or any member of the Policy
team as per their domain of
responsibility of care.
c) Patients are reassessed to Self explanatory.
determine their response Initial Assessment
to treatment and to plan Policy
further treatment or
discharge.

AAC.7. Laboratory services are provided as per the requirements of the patients.

Objective Element Interpretation Remarks

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a) Scope of the laboratory The HCO should ensure availability of
services are laboratory services commensurate with Laboratory Manual
commensurate to the the health care services offered by it
services provided by the either by providing the same in house or
organization. by outsourcing. 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 The staff employed in the lab should be
trained personnel perform suitably qualified (appropriate degree) Laboratory Manual
and/or supervise the and trained to carry out the tests.
investigations. Pathologist, microbiologist and
biochemist supervise the staff.
c) Policies and procedures The HCO has documented procedures
guide collection, for collection, identification, handling, Laboratory Manual
identification, handling, safe transportation, processing and
safe transportation, disposal of specimens, to ensure safety
processing and disposal of of the specimen till the tests and retests
specimens. (if required) are completed.

d) Laboratory results are The HCO shall define the turnaround


available within a defined time for all tests. The HCO should Laboratory Manual
time frame. ensure availability of adequate staff,
materials and equipment to make the
laboratory results available within the
defined time frame.
e) Critical results are The laboratory shall establish its
intimated immediately to biological reference intervals for Laboratory Manual
the concerned personnel. different tests. The laboratory shall
establish critical limits for tests which
require immediate attention for patient
management. The test results in the
critical limits shall be communicated to
the concerned after proper
documentation.
f) Laboratory tests not The HCO has documented procedure
available in the for outsourcing tests for which it has no Laboratory Manual
organization are facilities. This should include:
outsourced to a) list of tests for out sourcing.
organization(s) based on b) identity of personnel in the out
their quality assurance sourced facilities to ensure safe
system. 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 labelling for
identification and this package
should contain the test requisition
with all details as required for
testing.
d) a methodology to check the
performance of service rendered by
the out sourced laboratory as per
the requirements of the HCO.

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

Objective Element Interpretation Remarks


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

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

Objective Element Interpretation Remarks


a) The laboratory safety A well documented lab safety manual is
programme is available in the lab. This takes care of Laboratory Safety
documented. the safety of the workforce as well as Manual
the equipments available in the lab.

b) This programme is Lab safety programme is incorporated


integrated with the in the safety programme of the hospital. Laboratory Safety
organization’s safety Manual
programme.
c) Written policies and The lab staff should follow standard
procedures guide the precautions. The disposal of waste is Laboratory Safety
handling and disposal of according to Biomedical waste Manual
infectious and hazardous management and handling rules, 1998.
materials.
d) Laboratory personnel are All the lab staff undergo training
appropriately trained in regarding safe practices in the lab. Laboratory Safety
safe practices. Manual
e) Laboratory personnel are Adequate safety devices are available
provided with appropriate in the lab e.g. fire extinguishers, Laboratory Safety
safety equipment / dressing materials, standard Manual
devices. precautions, disinfectants, etc.

AAC.10. Imaging services are provided as per the requirements of the patients.

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Objective Element Interpretation Remarks
a) Imaging services comply The HCO is aware of the legal and
with legal and other other requirements of imaging services Imaging Department
requirements. and the same are documented for
information and compliance by all
concerned in the HCO. The HCO
maintains and updates its compliance
status of legal and other requirements
in a regular manner.
b) Scope of the imaging Self explanatory.
services are Imaging Department
commensurate to the
services provided by the
organization.
c) Adequately qualified and As per AERB guidelines.
trained personnel perform Imaging Department
and/or supervise the
investigations.
d) Policies and procedures The HCO has documented policies and Imaging Department
guide identification and procedures for informing the patients
safe transportation of about the imaging activities, their Patient Transfer Policy
patients to imaging identification and safe transportation to
services. the imaging services. This should also
address transfer of unstable patients to
imaging services.
e) Imaging results are The organization shall document
available within a defined turnaround time of imaging results. Imaging Department
time frame.
f) Critical results are Critical results shall be intimated to the
intimated immediately to treating clinician at the earliest on Imaging Department
the concerned personnel. phone, followed by written report.
g) Imaging tests not available The HCO has documented procedure
in the organization are for outsourcing tests for which it has no
outsourced to facilities. This should include:
organization(s) based on a) list of tests for out sourcing,
their quality assurance b) identity of personnel in the out Imaging Department
system. 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 performance 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.

Objective Element Interpretation Remarks

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a) The quality assurance Refer to AERB guidelines.
programme for imaging Imaging QA
services is documented. Programme
b) The programme A document for verification and
addresses verification and validation of imaging methods shall be Imaging QA
validation of imaging available. Programme
methods.
c) The programme HOD shall periodically assess the
addresses surveillance of imaging results. Imaging QA
imaging results. Programme
d) The programme includes Calibration and maintenance of all
periodic calibration and equipment shall be carried out by Imaging QA
maintenance of all competent persons. Programme
equipments.
e) The programme includes Self explanatory.
the documentation of Imaging QA
corrective and preventive Programme
actions.

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

Objective Element Interpretation Remarks


a) The radiation safety Refer to AERB guidelines
programme is Imaging Safety Manual
documented.
b) This programme is The safety programme of the imaging
integrated with the department has reference in the Hospital Safety Manual
organization’s safety hospital safety manual.
programme.
c) Written policies and Radioactive and hazardous materials
procedures guide the shall be disposed off as per bio-medical Imaging Safety Manual
handling and disposal of waste management and handling rules,
radio-active and 1998.
hazardous materials.
d) Imaging personnel are Self explanatory.
provided with appropriate Imaging Safety Manual
radiation safety devices.
e) Radiation safety devices Protective devices e.g. lead aprons
are periodically tested and should be exposed to X-ray for Imaging Safety Manual
documented. verification of cracks and damages.
f) Imaging personnel are Self explanatory.
trained in radiation safety Training Records
measures.
g) Imaging signage are Self explanatory.
prominently displayed in Evidence on side
all appropriate locations
h) Policies and procedures Document on safe use of radioactive
guide the safe use of isotopes for imaging services shall be Imaging Safety Manual
radioactive isotopes for available and implemented.
imaging services.

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

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Objective Element Interpretation Remarks
a) During all phases of care, The HCO to ensure that the care of In Patient Care
there is a qualified patients is always given by Medical Care Related
individual identified as appropriately qualified medical Process (Read
responsible for the personnel (resident doctor, consultant responsibility)
patient’s care. and/or nurse).
Emergency Room
(Causality) Related
Process (Read
responsibility)

IP Care Surgical Care


Related Process
(Read responsibility)
b) Care of patients is Care of patients is co-ordinated among In Patient Care
coordinated in all care various care providers in a given setting Medical Care Related
settings within the viz OPD, emergency, IP, ICU, etc. The Process (Read
organization. organization shall ensure that there is responsibility)
effective communication of patient
requirements amongst the care Emergency Room
providers in all settings. (Causality) Related
Process (Read
responsibility)

IP Care Surgical Care


Related Process
(Read responsibility)
c) Information about the The HCO ensures periodic discussions
patient’s care and about each patient (covering Inpatient Care
response to treatment is parameters like patient care, response
shared among medical, to treatment, unusual developments if
nursing and other care any, etc) amongst medical, nursing and
providers. other care providers.
d) Information is exchanged Self explanatory.
and documented during Inpatient Care
each staffing shift,
between shifts, and during
transfers between units/
departments.
e) The patient’s record (s) is Self explanatory.
available to the authorized Medical Record Dept
care providers to facilitate
the exchange of
information.
f) Policies and procedures The HCO has clearly defined and
guide the referral of documented the policies and
patients to other procedures to be adopted to guide the Patient Transfer Policy
departments/ specialities. personnel dealing with referral of
patients to other departments or
specialties or even other health care
providers out side the HCO.

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

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Objective Element Interpretation Remarks
a) The patient’s discharge The patient's treating doctor determines
process is planned in the readiness for discharge during Discharge Process
consultation with the regular reassessments. The same is
patient and/or family. discussed with the patient and family.
b) Policies and procedures The discharge policies and procedures
exist for coordination of are documented to ensure coordination Discharge Process
various departments and amongst various departments including
agencies involved in the accounts so that the discharge papers
discharge process are complete well within time. For MLC
(including medico-legal the organization shall ensure that the
cases). police are informed.
c) Policies and procedures The HCO has a documented policy for
are in place for patients the LAMA cases. The treating doctor Discharge Process
leaving against medical should explain the consequences of this
advice. action to the patient/attendant.
d) A discharge summary is The HCO hands over the discharge
given to all the patients papers to the patient/attendant in all Discharge Process
leaving the organization cases and copy retained. In LAMA
(including patients leaving cases, the declaration of the
against medical advice) patient/attendant is to be recorded on
proper format.

AAC.15. Organization defines the content of the discharge summary.

Objective Element Interpretation Remarks


a) Discharge summary is Self explanatory.
provided to the patients at Discharge Summary
the time of discharge.
b) Discharge summary Self explanatory.
contains the reasons for
admission, significant Discharge Summary
findings and diagnosis and
the patient’s condition at
the time of discharge.

c) Discharge summary Self explanatory.


contains information Discharge Summary
regarding investigation
results, any procedure
performed, medication and
other treatment given.
d) Discharge summary Self explanatory.
contains follow up advice, Discharge Summary
medication and other
instructions in an
understandable manner.
e) Discharge summary The HCO should outline conditions
incorporates instructions regarding ‘when’ to obtain urgent care. Discharge Summary
about when and how to For example, a post op patient should
obtain urgent care. report when having fever,
bleeding/discharge from site.

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f) In case of death the Self explanatory.
summary of the case also Discharge Summary
includes the cause of
death.

CHAPTER 2 : Care of Patients (COP)

COP.1. Uniform care of patients is provided in all settings of the organization and is guided
by the applicable laws, regulations and guidelines.

Objective Element Interpretation Remarks


a) Care delivery is uniform The organization shall ensure that
when similar care is patients with the same health problems Uniform Care Policy
provided in more than one and care needs, receive the same
setting. quality of healthcare throughout the
organization irrespective of the category
of ward.
b) Uniform care is guided by Self explanatory. Care provision vide
policies and procedures Nursing Council of
which reflect applicable India Act and Medical
laws and regulations. Council of India at.
c) The care and treatment Self explanatory. Treatment orders
orders are signed, named, must be written daily. InPatient Dept
timed and dated by the
concerned doctor.
d) The care plan is The treatment of the patient could be Authorisation of
countersigned by the initiated by a junior doctor but the same prescription by
clinician in-charge of the should be countersigned and authorized resident doctor
patient within 24 hours. by the treating doctor within 24hrs.

e) Evidence based medicine The organization could develop clinical Within scope of
and clinical practice protocols based on these and the same Medical audit
guidelines are adopted to could be followed in management of committee.
guide patient care patients. These could then be used as
whenever possible. parameters for audit of patient care.

COP.2. Emergency services are guided by policies, procedures, applicable laws and
regulations.

Objective Element Interpretation Remarks


a) Policies and procedure for These could include SOPs/protocols to Emergency Suite
emergency care are provide either general emergency care related Process
documented. or management of specific conditions
e.g. poisoning.
b) Policies also address The policy shall be in line with statutory Emergency Suite
handling of medico-legal requirements w.r.t. documentation and Related Process
cases. intimation to police. The organization
shall also define as to what constitutes
a MLC (in accordance with statutory
rules).

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c) The patients receive care Self explanatory. Practice Objective
in consonance with the
policies.
d) Policies and procedures Self explanatory. Admission and
guide the triage of patients discharge protocol in
for initiation of appropriate ICU
care.
e) Staff is familiar with the All the staff working in the casualty
policies and trained on the should be oriented to the policies and CPR Training Records
procedures for care of practices through training/documents.
emergency patients. Staff should preferably be trained/well
versed in ACLS and BLS.

f) Admission or discharge to Self explanatory.


home or transfer to Patient Transfer Policy
another organization is
also documented.

COP.3. The ambulance services are commensurate with the scope of the services provided
by the organization.

Objective Element Interpretation Remarks


a) There is adequate access The organization shall demarcate a Sufficient area available
and space for the proper space for ambulance(s).This for parking of
ambulance(s). shall be demarcated keeping in mind ambulances as per
easy accessibility for receiving patients Policy.
and to enable the ambulance(s) to turn
around/exit quickly.
b) Ambulance(s) is This shall be done based on the Hospital Ambulance
appropriately equipped. organization’s scope. Services

c) Ambulance(s) is manned The ambulance should be manned by a BLS Trained Driver


by trained personnel. 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 The organization shall develop a Hospital Ambulance
equipment and emergency checklist and ensure that the Services
medications. ambulance is equipped as per the
checklist.
e) Equipments are checked This shall include both the ambulance Hospital Ambulance
on a daily basis. and the equipments within it. Services

f) Emergency medications Self explanatory. This also includes Hospital Ambulance


are checked daily and checking the expiry date of drugs. Services
prior to dispatch.
g) The ambulance(s) has a The ambulance shall be connected with (By Physical
proper communication the hospital/control room by Inspection)
system. wireless/mobile phones.

COP.4. Policies and procedures guide the care of patients requiring cardio-pulmonary
resuscitation.

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Objective Element Interpretation Remarks
a) Documented policies and The organization shall document
procedures guide the the procedure for same. This shall CPR Policy
uniform use of be in consonance with accepted
resuscitation throughout practices.
the organization.
b) Staff providing direct These aspects shall be covered by
patient care is trained and hands on training. If the CPR Training Record
periodically updated in organization has a CPR team (e.g.
cardio pulmonary code blue team) it shall ensure that
resuscitation. they are all trained in ALS and are
present in all shifts.
c) The events during a In the actual event of a CPR or a
cardio-pulmonary mock drill of the same, all the CPR Recording form
resuscitation are recorded. activities along with the personnel
attended should be recorded.

d) A post-event analysis of all The analysis shall include the Code Blue Committee
cardiac arrests is one by a cause, steps taken to resuscitate Meeting Records
multi-disciplinary and the outcome. Multidisciplinary
committee. committee shall include physicians,
anaesthetists and nurses
e) Corrective and preventive Self explanatory. Code Blue Committee
measures are taken based Meeting Records
on the post-event analysis.

COP.5. Policies and procedures define rational use of blood and blood products.

Objective Element Interpretation Remarks


a) Documented policies and This shall address the conditions
procedures are used to where blood and conditions where
guide rational use of blood blood products can be used.
and blood products.

b) The transfusion services Refer to Drugs and Cosmetics act. Drugs And Cosmetic Act
are governed by the (ORIGINAL)
applicable laws and
regulations.
c) Informed consent is Consent should be taken for every
obtained for donation and transfusion. However, with the Consent form
transfusion of blood and same consent you can give multiple
blood products. transfusions in the same sitting. For
example, 2 pints of blood may be
transfused 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 Self explanatory.
includes patient and family Consent form
education about donation.
e) Staff is trained to This shall include doctors and be
implement the policies. done either by training and/or by Training records
providing written instructions.

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f) Transfusion reactions are The organization shall ensure that
analyzed for preventive any transfusion reaction is reported.
and corrective actions. It is preferable that the organization Transfusion reaction form
capture feedback regarding every
transfusion (including the ones
without reaction) as this would
enable it to capture all transfusion
reactions. These are then analyzed
(by individual/ committee as
decided by the organization) and
appropriate corrective/preventive
action is taken. The organization
shall maintain a record of
transfusion reactions.

COP.6. Policies and procedures guide the care of patients in the Intensive care and high
dependency units.

Objective Element Interpretation Remarks


a) The organization has The organization should develop
documented admission objective criteria and adhere to it. Admission & Discharge in
and discharge criteria for MICU/HDU
its intensive care and high
dependency units.
b) Staff is trained to apply This shall be done by training
these criteria. and/or by displaying the criteria. Training Records

c) Adequate staff and The ICU should be equipped with


equipment are available. all necessary life saving and
monitoring equipments as well as Equipment Evident on site.
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 As and when there are no vacant
situation of bed shortages beds in the ICU and there is a Policy for non availability of
are followed. requirement of such bed, a detailed beds
policy and procedure should be in
place to address the situation.

e) Infection control practices These could be developed


are followed. individually or it could be a part of Infection Control Manual
the Hospital infection control
manual. The organization shall
ensure that the practices are in
consonance with good clinical
practices.
f) A quality assurance These could be developed
programme is individually or it could be a part of Quality Management Plan
implemented. the Hospital quality assurance
programme. The organization shall
ensure that the programme is in
consonance with good clinical
practices.

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COP.7. Policies and procedures guide the care of vulnerable patients (elderly, children,
physically and/or mentally challenged).

Objective Element Interpretation Remarks


a) Policies and procedures Self explanatory.
are documented and are in
accordance with the
prevailing laws and the
national and international
guidelines.
b) Care is organized and HCO develops SOP's for delivery of Policy for Vulnerable
delivered in accordance care. patients
with the policies and
procedures.
c) The organization provides The organization shall provide Policy for Vulnerable
for a safe and secure proper environment taking into patients
environment for this account the requirement of the
vulnerable group. vulnerable group.
d) A documented procedure The informed consent for this group
exists for obtaining of people should be obtained from General Consent
informed consent from the their family or legal representative.
appropriate legal
representative.
e) Staff is trained to care for All Staff involved in the care of this
this vulnerable group. group shall be adequately trained in Training Records
identifying and meeting their needs.

COP.8. Policies and procedures guide the care of high risk obstetrical patients.

Objective Element Interpretation Remarks


a) The organization defines The organization shall define as to
and displays whether high what constitutes high risk obstetric Obstetric Dept
risk obstetric cases can be case in consonance with best
cared for or not. clinical practices.

b) Persons caring for high These shall not just be doctors but
risk obstetric cases are shall include nursing staff also. The Obstetric Dept
competent. competency shall be based on
qualification, experience and
training.
c) High risk obstetric patient’s Self explanatory.
assessment also includes Obstetric Dept
maternal nutrition.
d) The organization has the The organization shall have a NICU
facilities to take care of with proper equipments and staff. Policy Of Paediatric Deptt.
neonates of high risk
pregnancies.

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

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Objective Element Interpretation Remarks
a) The organization defines The scope shall also include
and displays the scope of neonatal services, if any. Policy Of Paediatric Deptt.
its pediatric services.
b) The policy for care of Self explanatory.
neonatal patients is in Policy Of Paediatric Deptt.
consonance with the
national/ international
guidelines.

c) Those who care for These shall not just be for doctors
children have age specific but shall include nursing staff also. Policy Of Paediatric Deptt.
competency. The competency shall be based on
qualification, experience and
training.
d) Provisions are made for Adequate amenities for the care of
special care of children. infants and children to be available Policy Of Paediatric Deptt.
in the hospital.
e) Patient assessment Self explanatory.
includes detailed Paediatric Assessment Sheet
nutritional, growth,
psychosocial and
immunization assessment.
f) Policies and procedures The HCO shall ensure that there is
prevent child/ neonate an adequate security/surveillance to Policy Of Neonatal Child/
abduction and abuse. prevent such happenings. Abuse

g) The children’s family Self explanatory.


members are educated Policy Of Paediatric Deptt.
about nutrition,
immunization and safe
parenting and this is
documented in the medical
record.

COP.10. Policies and procedures guide the care of patients undergoing moderate sedation.

Objective Element Interpretation Remarks


a) Competent and trained Whenever parenteral route is used
persons perform sedation. this shall be carried out by a Sedation policy
doctor/nurse.
b) The person administering Self explanatory.
and monitoring sedation is Sedation policy
different from the person
performing the procedure.
c) Intra-procedure monitoring Self explanatory. The same should
includes at a minimum the be documented. Sedation policy
heart rate, cardiac rhythm,
respiratory rate, blood
pressure, oxygen
saturation, and level of
sedation.

16
d) Patients are monitored The patient’s vitals shall be
after sedation. monitored at regular intervals (as Sedation policy
decided by the organization) till
he/she recovers completely from
the sedation. The same should be
documented.
e) Criteria are used to These shall be developed by the
determine appropriateness organization in consonance with Sedation policy
of discharge from the good clinical practices.
recovery area.
f) Equipment and manpower The equipments shall include
are available to rescue emergency resuscitation To be verified by Physical
patients from a deeper equipments. An anaesthesiologist Examination.
level of sedation than that shall be available in the hospital.
intended.

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

Objective Element Interpretation Remarks


a) There is a documented HCO shall document on the
policy and procedure for indications, the type of anaesthesia Pre-operative Evaluation
the administration of and procedure for the same.
anaesthesia.
b) All patients for This shall be done before the
anaesthesia have a pre- patient is wheeled into the OT Pre-operative Evaluation
anaesthesia assessment complex. It shall be applicable for
by a qualified individual. 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-anaesthesia Self explanatory.
assessment results in Pre-operative Evaluation
formulation of an
anaesthesia plan which is
documented.
d) An immediate preoperative This shall be done by an Anaesthesia and Pain
re-evaluation is anaesthesiologist just before the Management
documented. patient is wheeled in to the
respective OT. OT Manual
e) Informed consent for Self explanatory.
administration of Informed Consent
anaesthesia is obtained by
the anaesthetist.

f) During anaesthesia Self explanatory.


monitoring includes Anaesthesia and Pain
regular and periodic Management
recording of heart rate,
cardiac rhythm, respiratory OT Manual
rate, blood pressure,
oxygen saturation, airway
security and patency and
level of anaesthesia.

17
g) Each patient’s post- This shall be done in the recovery
anaesthesia status is area/OT and at least include PAC Form Evidenced on site
monitored and monitoring of vitals till the patient
documented. 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 The organization documents these
applies defined criteria to criteria which should be in Signed by anaesthesist
transfer the patient from consonance with good clinical
the recovery area. practices. These criteria shall be
applied by a designated individual
as decided by the HCO.
i) All adverse anaesthesia All such events are documented In Practice.
events are recorded and and monitored for the purpose of
monitored. taking corrective and preventive
action.

COP.12. Policies and procedures guide the care of patients undergoing surgical procedures.

Objective Element Interpretation Remarks


a) The policies and This shall include the list of surgical OT Manual
procedures are procedures as well as competency
documented. level for performing these
procedures.
b) Surgical patients have a All patients undergoing surgery are IP Care Surgical Care
preoperative assessment assessed pre operatively and a Related Process
and a provisional provisional diagnosis is made which
diagnosis documented is documented. This shall be Pre-operative Evaluation
prior to surgery. applicable for both routine and
emergency cases.
c) An informed consent is Self explanatory. General Consent
obtained by a surgeon
prior to the procedure.
d) Documented policies and Procedure should be available for Wrong Patient wrong side
procedures exist to preventing adverse events like Policy
prevent adverse events wrong patients, wrong site by a
like wrong site, wrong suitable mechanism.
patient and wrong surgery.
e) Persons qualified by law The HCO identifies the individuals Personnel file as evidences
are permitted to perform who have the required qualification
the procedures that they (s), training and experience to
are entitled to perform. perform procedures in consonance
with the law.
f) A brief operative note is This note provides information
documented prior to about the procedure performed, OT Manual
transfer out of patient from post operative diagnosis and the
recovery area. status of the patient before shifting
and shall be documented by the
surgeon/member of the surgical
team.

18
g) The operating surgeon Self explanatory.
documents the post- OT Manual
operative plan of care.
h) A quality assurance This shall be an integral part of the
programme is followed for HCO's overall quality assurance IP Care Surgical Care
the surgical services. programme. It shall focus on post Related Process
operative complications e.g.
bleeding, rational use of antibiotics,
etc.
i) The quality assurance Surveillance activities include
programme includes monitoring the quality of air Infection Control Manual
surveillance of the provided, rate of air exchange ,
operation theatre cleaning and disinfection
environment. processes, etc.
j) The plan also includes Self explanatory. To be covered by the internal
monitoring of surgical site audit under the scope of
infection rates. medical audit

COP.13. Policies and procedures guide the care of patients under restraints (physical and/ or
chemical).

Objective Element Interpretation Remarks


a) Documented policies and This shall clearly state the
procedures guide the care conditions/circumstances under Restraint Policy
of patients under which restraints shall be used. It
restraints. shall also specify as to who can
authorize the use of restraints.
b) These include both Physical restraints include boxer's
physical and chemical bandage, use of cuffs etc. Chemical Restraint Policy
restraint measures. restraints include sedatives.
c) These include Self explanatory.
documentation of reasons Restraint Policy
for restraints.
d) These patients are more The organization shall specify the
frequently monitored. parameters and frequency of Restraint Policy
monitoring and accordingly
implement the same.
e) Staff receive training and Self explanatory.
periodic updating in control Training records
and restraint techniques.

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

Objective Element Interpretation Remarks


a) Documented policies and The HCO shall define the group of
procedures guide the patients for whom this is applicable. Pain management
management of pain. A good reference point for defining
these patients could be those
having pain as the predominant
debilitating symptom.

19
b) The organization respects Self explanatory.
and supports the Pain management
appropriate assessment
and management of pain
for all patients.
c) Patient and family are Self explanatory.
educated on various pain Pain management
management techniques.

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

Objective Element Interpretation Remarks


a) Documented policies and Self explanatory.
procedures guide the Physiotherapy Dept.
provision of rehabilitative
services.
b) These services are The scope of the departments is in
commensurate with the consonance with the scope of the Self explanatory.
organizational hospital.
requirements.

c) Rehabilitative services are The team shall have treating doctor,


provided by a rehabilitation therapist, Physiotherapy Dept.
multidisciplinary team. rehabilitation nurses and other
professional experts.

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

Objective Element Interpretation Remarks


a) Documented policies and Self explanatory.
procedures guide all NA
research activities in
compliance with national
and international
guidelines.
b) The organization has an An ethics committee should be
ethics committee to framed in the hospital to monitor NA
oversee all research activities undertaken by various
activities. providers. Any research
undertaken in the hospital falls
under its ambit. This includes both
funded and non-funded and also
student studies.
c) The committee has the Self explanatory.
powers to discontinue a NA
research trial when risks
outweigh the potential
benefits.

20
d) Patient’s informed consent Self explanatory.
is obtained before entering NA
them in research
protocols.
e) Patients are informed of Self explanatory.
their right to withdraw from NA
the research at any stage
and also of the
consequences (if any) of
such withdrawal.
f) Patients are assured that Self explanatory.
their refusal to participate NA
or withdrawal from
participation will not
compromise their access
to the organization’s
services.

COP.17. Policies and procedures guide nutritional therapy.

Objective Element Interpretation Remarks


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

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

21
Objective Element Interpretation Remarks
a) Documented policies and The HCO has a documented policy
procedures guide the end for providing care to terminally ill End of Life Care
of life care. admitted patients. This shall include Operational Policy
providing appropriate pain and
palliative care according to the
wishes of the family and patient.
b) These policies and Self explanatory.
procedures are in End of Life Care
consonance with the legal Operational Policy
requirements.
c) These also address the The religious and socio-cultural
identification of the unique beliefs of patients/ family shall be End of Life Care
needs of such patient and addressed and respected. Operational Policy
family.
d) These also include If the body of the deceased is
sensitively addressing subjected to an autopsy or for End of Life Care
issues such as autopsy organ donation, it should be Operational Policy
and organ donation. discussed with the family in a very
courteous manner.
e) Staff is educated and Self explanatory.
trained in end of life care. Training Records

CHAPTER 3 : Management of Medication (MOM)

MOM.1. Policies and procedures guide the organization of pharmacy services and usage of
medication.

Objective Element Interpretation Remarks


a) There is a documented The policies and procedures shall
policy and procedure for address the issues related to
pharmacy services and procurement, storage, formulary,
medication usage. prescription, dispensing, Material Management
administration, monitoring and use
of medications. Pharmacy

b) These comply with the Self explanatory.


applicable laws and Drugs And Cosmetics Act
regulations.
c) A multidisciplinary This shall be representative of
committee guides the major clinical departments, Records Of Drugs and
formulation and administration and shall include a Therapeutics Committee
implementation of these pharmacist/ clinical pharmacologist.
policies and procedures.

MOM.2. There is a hospital formulary.

22
Objective Element Interpretation Remarks
a) A list of medication The hospital formulary shall be
appropriate for the patients prepared and be preferably updated Drug formulary
and organization’s at regular intervals.
resources is developed.

b) The list is developed Refer to MOM 1c.


collaboratively by the Records Of Drugs and
multidisciplinary Therapeutics Committee
committee.
c) There is a defined process The process should address the
for acquisition of these issues of vendor selection, vendor Pharmacy
medications. evaluation, generation of purchase
order and receipt of goods as per
rules.
d) There is a process to Self explanatory. Local Purchase Policy
obtain medications not
listed in the formulary.

MOM.3. Policies and procedures guide the storage of medication.

Objective Element Interpretation Remarks


a) Documented policies and These should address issues
procedures exist for pertaining to temperature
storage of medication. (refrigeration), light, ventilation, Policy on Storage Of
preventing entry of pests/ rodents Medication
and vermins.
b) Medications are stored in The organization shall also ensure
a clean, well lit and that the storage requirements of the
ventilated environment. drug as specified by the
manufacturer are adhered to. If the
recommendations are conflicting in Physical examination.
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 Self explanatory.
practices guide storage of ABC Analysis
the medications.

d) Medications are protected The organization shall ensure that it


from loss or theft. develops proper mechanisms to
prevent pilferage. The organization Regular AUDIT
could conduct audits at regular
intervals (as defined by the
organization) to detect such
instances.
e) Sound alike and look alike Many drugs in ampoules, vials or
medications are stored tablets may look-alike or sound- Demonstrated in practice
separately. alike. They should be segregated
and stored separately.

23
f) There is a method to When pharmacy is closed, there
obtain medication when should be a SOP to procure the 24 hours pharmacy is
the pharmacy is closed. drugs. available.

g) Emergency medications Adequate amount of emergency


are available all the time. medicines should be stocked at all Stock maintenance register
times. Re-order level at definite &records to be produced as
quantity should be done. evidences.

h) Emergency medications Self explanatory.


are replenished in a timely Relevant register as evidence.
manner when used.

MOM.4. Policies and procedures guide the prescription of medications.

Objective Element Interpretation Remarks


a) Documented policies and Self explanatory.
procedures exist for Policy on prescription of
prescription of medication
medications.

b) The organization This shall be done by the treating Policy on prescription of


determines who can write doctor. medication
orders.
Policy on Verbal Orders for
Medication
c) Orders are written in a All the orders for medicines are
uniform location in the recorded on a uniform location of Medical Records
medical records. the case sheet. Electronic orders
when typed shall again follow the
same principles.
d) Medication orders are Self explanatory.
clear, legible, dated, timed, Medical Records
named and signed.

e) Policy on verbal orders is The organization shall ensure that it


documented and has a policy to address this issue Policy on Verbal Orders for
implemented. and it shall address as to who can Medication
give verbal orders and how these
orders will be validated.
f) The organization defines a High risk medications are
list of high risk medication. medications involved in a high High Risk Medication
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 These medications shall preferably
orders are verified prior to be given only after written orders High Risk Medication

24
dispensing. and it should be verified by the staff
before dispensing.

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

Objective Element Interpretation Remarks


a) Documented policies and Clear policies to be laid down for
procedures guide the safe dispensing of medication e.g. route Safe Dispensing Of
dispensing of medications. of administration, dosage, rate of Medicine
administration, expiry date, etc.

b) The policies include a Recall may result based on letters


procedure for medication from regulatory authorities or Drug Labelling Policy
recall. internal feedback (e.g. visible
contaminant in IV fluid bottle).

c) Expiry dates are checked Self explanatory. Pharmacy


prior to dispensing.
d) Labelling requirements are At a minimum, labels must include
documented and the drug name, strength frequency Drug Labelling Policy
implemented by the of administration (in a language the
organization. patient understands) and expiry
dates.

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

Objective Element Interpretation Remarks


a) Medications are Self explanatory.
administered by those who Policy on prescription of
are permitted by law to do medication
so.
b) Prepared medications are Self explanatory.
labelled prior to Drug Labelling Policy
preparation of a second
drug.
c) Patient is identified prior to Self explanatory. Safe Dispensing Of
administration. Medicine

d) Medication is verified from Staff administering medications Safe Dispensing Of


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

25
e) Dosage is verified from the Self explanatory. Safe Dispensing Of
order prior to Medicine
administration.
f) Route is verified from the Self explanatory. Safe Dispensing Of
order prior to Medicine
administration.
g) Timing is verified from the Self explanatory. Safe Dispensing Of
order prior to Medicine
administration.
h) Medication administration The organization shall ensure that
is documented. this is done in a uniform location Safe Dispensing Of
and it shall include the name of the Medicine
medication, dosage, route of
administration, timing and the name
and signature of the person who
has administered the medication.

i) Policies and procedures At the outset the HCO could define


govern patient’s self if it would permit self administration Organization do not allow
administration of of medications. In case the HCO self Medication.
medications. permits then the policy shall include
the medications which the patient
can self administer. It is preferable
that the organization also
incorporates a method to ensure
that the patient is reminded to take
the medication (before every dose)
and documentation of self
administration.
j) Policies and procedures These shall address as to what are
govern patient’s the pre-requisites for such a
medications brought from medication (e.g. Invoice; Clear label
outside the organization. with mention of the name, dose,
expiry date etc.)

MOM.7. Patients and family members are educated about safe medication and food-drug
interactions.

Objective Element Interpretation Remarks


a) Patient and family are The organization shall make a list of
educated about safe and such drugs and accordingly Safe Medication And Food
effective use of educate e.g. digoxin. This could Drugs Interactions
medication. also include education regarding
the importance of taking a drug at a
specific time e.g. sustained release
medications.
b) Patient and family are Patient and family should be
educated about food-drug counselled about their diet during Safe Medication And Food
interactions. medication e.g. no alcohol when Drugs Interactions
taking metronidazale.

MOM.8. Patients are monitored after medication administration.

26
Objective Element Interpretation Remarks
a) Patients are monitored This shall be done by anyone In Patient Care Medical
after medication involved in direct patient care. The Care Related Process
administration and this is organization could follow either a
documented. passive (documenting only if the
patient tells) or active (enquiring
with every patient) monitoring
mechanism.
b) Adverse drug events are The organization shall define as to
defined. what constitutes an adverse drug Adverse drug Reaction
event. This shall be in consonance policy
with best practices.
Adverse drug events include ARD Form
adverse drug reactions as well as
medication errors.
c) Adverse drug events are Self explanatory. The organization
reported within a specified shall define the timeframe for
time frame. reporting once the adverse drug Adverse drug Reaction
event has occurred. policy
d) Adverse drug events are All the adverse drug reactions are
collected and analyzed. analyzed regularly by the multi- Adverse drug Reaction
disciplinary committee (Refer to policy
MOM 1C).

e) Policies are modified to Self explanatory.


reduce adverse drug Adverse drug Reaction
events when unacceptable policy
trends occur.

MOM.9. Policies and procedures guide the use of narcotic drugs and psychotropic
substances.

Objective Element Interpretation Remarks


a) Documented policies and Self explanatory. Refer to MOM 1a.
procedures guide the use
of narcotic drugs and Narcotics Policy
psychotropic substances.
b) These policies are in This is in the context of Narcotic Narcotic Drugs and
consonance with local and Drugs and Psychotropic Psychotropic Substances
national regulations. Substances Act. Act.

c) A proper record is kept of These shall be kept in accordance


the usage, administration with statutory requirements. Records
and disposal of these
drugs.
d) These drugs are handled Self explanatory.
by appropriate personnel
in accordance with
policies.

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

27
Objective Element Interpretation Remarks
a) Documented policies and Self explanatory.
procedures guide the Chemotherapy policy
usage of
chemotherapeutic agents.
b) Chemotherapy is This shall preferably be a medical
prescribed by those who oncologist or a person who has Chemotherapy policy
have the knowledge to been trained and has achieved
monitor and treat the competency in the same.
adverse effect of
chemotherapy.
c) Chemotherapy is prepared This shall preferably be staff who
and administered by have received special training in Chemotherapy policy
qualified personnel. preparing and administration.
d) Chemotherapy drugs are These shall be disposed off Biomedical waste
disposed off in accordance according to BMW management management rule and
with legal requirements. and handling rules 1998 or regulation.
manufacturer's recommendation.

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

Objective Element Interpretation Remarks


a) Documented policies and Self explanatory.
procedures govern usage Radioactive material policy
of radioactive drugs.
b) These policies and Refer to AERB guidelines.
procedures are in Radioactive material policy
consonance with laws and
regulations.
c) The policies and Self explanatory. This shall
procedures include the however be in accordance with Radioactive material policy
safe storage, preparation, AERB guidelines.
handling, distribution and
disposal of radioactive
drugs.
d) Staff, patients and visitors Self explanatory. DEMONSTRATED IN
are educated on safety PRACTICE. APPROPRIATE
precautions. SIGNAGES USED AT ALL
THE PLACES.

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

Objective Element Interpretation Remarks


a) Documented policies and Self explanatory.
procedures govern Implant Policy
procurement and usage of
implantable prosthesis.

28
b) Selection of implantable The organization shall ensure that
prosthesis is based on relevant and sufficient scientific Implant Policy
scientific criteria and data are available before selection.
national /internationally It shall also look for international
recognized approvals. (e.g.US-FDA) or national
notification (Drugs and Cosmetics
Act notification October 2005) for
approval of the particular product.
c) The batch and serial Self explanatory.
number of the implantable Implant Policy
prosthesis are recorded in
the patient’s medical
record and the master
logbook.

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

Objective Element Interpretation Remarks


a) Documented policies and This shall be applicable to all gases
procedures govern used in the organization. It shall Gas Masifold Process
procurement, handling, also address the issue of statutory
storage, distribution, requirements and approvals
usage and replenishment wherever applicable. It shall follow
of medical gases. a uniform colour coding system.
b) The policies and This shall include from the point of
procedures address the storage/source area, gas supply Gas Manifold Process
safety issues at all levels. lines and the end user area.
Appropriate safety measures shall
be developed and implemented for
all levels.

c) Appropriate records are This is the context of the Indian


maintained in accordance explosives act of 1884, Gas Gas Manifold Process
with the policies, cylinder rules 1981 and Static and
procedures and legal mobile pressure vessels (unfired)
requirements. 1981.

CHAPTER 4 : Patient Rights and Education (PRE)

PRE.1. The organization protects patient and family rights and informs them about their
responsibilities during care.

Objective Element Interpretation Remarks


a) Patient and family rights Hospital should respect patient’s
and responsibilities are rights and inform them of their Citizen Charter
documented. responsibilities.
All the rights of the patients should
be displayed in the form of a
Citizens’ Charter which should also
give information of the charges and
grievance redress mechanism.

29
b) Patients and families are Self explanatory.
informed of their rights and
responsibilities in a format Citizen Charter
and language that they
can understand.
c) The organization’s leaders Protection also includes addressing
protect patient’s rights. patient’s grievances w.r.t rights. Citizen Charter

d) Staff is aware of their Training and sensitisation


responsibility in protecting programmes shall be conducted to Employee Guide Book
patients rights. create awareness among the staff.
e) Violation of patient rights is Where patients' rights have been
reviewed and infringed upon, management must Patient Grievance Policy
corrective/preventive keep records of such violations, as
measures taken. also a record of the consequences,
e.g. corrective actions to prevent
recurrences.

PRE.2. Patient rights support individual beliefs, values and involve the patient and family in
decision making processes.

Objective Element Interpretation Remarks


a) Patient and family rights This could include dietary
address any special preferences and worship Patients Right Policy
preferences, spiritual and requirements
cultural needs.
b) Patient rights include During all stages of patient care, be
respect for personal it in examination or carrying out a
dignity and privacy during procedure, hospital staff shall
examination, procedures ensure that patient’s privacy and
and treatment. dignity is maintained. The Patients Right Policy
organization shall develop the
necessary guidelines for the same.
During procedures the organization
shall ensure that the patient is
exposed just before the actual
procedure is undertaken. With
regards to photographs/recording
procedures; the organization shall
ensure that consent is taken and
that the patient’s identity is not
revealed.
c) Patient rights include Self explanatory. Special
protection from physical precautions shall be taken Policy For Vulnerable
abuse or neglect. especially w.r.t vulnerable patients Patients
e.g. elderly, neonates etc.
d) Patient rights include Self explanatory. Statutory
treating patient information requirements w.r.t. privileged Patients Right Policy
as confidential. communication shall be followed at
all times.
e) Patient rights include During management the patients
refusal of treatment. should be given the choice of
treatment. The treating doctor shall
discuss all the available options and Patients Right Policy
allow the patient to make an
informed choice including the option

30
of refusal.

f) Patient rights include Self explanatory.


informed consent before Informed Consent
anaesthesia, blood and
blood product transfusions
and any invasive / high
risk procedures /
treatment.
g) Patient rights include The organization shall ensure that
information and consent International conference on Informed Consent
before any research harmonization (ICH) of Good
protocol is initiated. clinical practice (GCP) and
Declaration of Helsinki Somerset
(1996) and ICMR requirements are
followed.
h) Patient rights include Grievance redressal mechanism Patients Right Policy
information on how to must be accessible and
voice a complaint. transparent. Displayed information
must be clearly available on how to
voice a complaint.
i) Patient rights include Refer AAC4d.
information on the Patients Right Policy
expected cost of the
treatment.
j) Patient has a right to have The organization shall ensure that
an access to his / her every patient has access to his/her Patients Right Policy
clinical records. 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 families consent exists for
informed decision making about their care.

Objective Element Interpretation Remarks


a) General consent for Self explanatory.
treatment is obtained General Consent
when the patient enters
the organization.
b) Patient and/or his family The organization shall define as to
members are informed of what is the scope of this consent General Consent
the scope of such general and the same shall be
consent. communicated to the patient and/or
his family members.
c) The organization has listed A list of procedures should be made
those procedures and for which informed consent should Informed Consent
treatment where informed be taken.
consent is required.
d) Informed consent includes The consent shall have the name of
information on risks, the doctor performing the Informed Consent
benefits, alternatives and procedure. If it is a “doctor under
as to who will perform the training” the same shall be
requisite procedure in a specified, however the name of the
language that they can qualified doctor supervising the
understand. procedure shall also be mentioned.
Consent form shall be in the

31
language that the patient
understands.

e) The policy describes who The organization shall take into


can give consent when consideration the statutory norms. Informed Consent
patient is incapable of This would include next of kin/legal
independent decision guardian. However in case of
making. unconscious/ unaccompanied
patients the treating doctor can take
a decision in life saving
circumstances.

PRE.4. Patient and families have a right to information and education about their healthcare
needs.

Objective Element Interpretation Remarks


a) When appropriate, patient Self explanatory.
and families are educated Policy on Safe Medication
about the safe and
effective use of medication
and the potential side
effects of the medication.
b) Patient and families are Self explanatory. Dietary, Nutrition and Food
educated about diet and Services
nutrition.
c) Patient and families are Self explanatory. More applicable Immunization cards are
educated about for paediatric population. In adults it given in Hospital
immunizations. could be for influenza,
Streptococcus pneumoniae,
typhoid, hepatitis B, Neisseria
meningitides, etc.
d) Patient and families are Self explanatory. This could also be
educated about their done through patient education Patients Right Policy
specific disease process, booklets/videos/leaflets etc.
complications and
prevention strategies.
e) Patient and families are Self explanatory. Patients Right Policy
educated about preventing
infections
f) Patients are taught in a Self explanatory. Patients Right Policy
language and format that
they can understand

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

Objective Element Interpretation Remarks


a) There is uniform pricing There should be a billing policy
policy in a given setting which defines the charges to be Billing Policy
(out-patient and ward levied for various activities.
category).
b) The tariff list is available to The organization shall ensure that
patients. there is an updated tariff list and Tariff List
that this list is available to patients

32
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 are educated Refer to AAC4d.
about the estimated costs Patients Right Policy
of treatment.
d) Patients are informed When patients are shifted from one
about the estimated costs setting to another, typically to and Estimated Cost Performa
when there is a change in from ICUs, the financial implications
the patient condition or must be clearly conveyed to them.
treatment setting.

CHAPTER 5 : Hospital Infection Control (HIC)

HIC.1. The organization has a well-designed, comprehensive and coordinated Hospital


Infection Control (HIC) programme aimed at reducing/ eliminating risks to patients, visitors
and providers of care.

Objective Element Interpretation Remarks


a) The hospital infection Self explanatory.
control programme is Infection Control Manual
documented which aims at
preventing and reducing
risk of nosocomial
infections.
b) The hospital has a multi- This shall preferably have Hospital
disciplinary infection Administrator, Microbiologist, Infection Control Manual
control committee. Physician, Surgeon, Manager –
Nursing (Nursing Supervisor), staff
from CSSD, and other Support
services and the hospital infection
control nurse. It should also include
invitees from various departments
as deemed necessary.
c) The hospital has an The team is responsible for day-to-
infection control team. day functioning of infection control Infection Control Manual
programme. They shall support
surveillance process and detect
outbreaks. They shall also
participate in audit activity and in
infection prevention and control on
a day-to-day basis.
d) The hospital has The qualification shall be either a
designated and qualified graduate nurse or qualified nurse Infection Control Manual
infection control nurse(s) with competence gained by
for this activity. experience.

HIC.2. The hospital has an infection control manual, which is periodically updated.

33
Objective Element Interpretation Remarks
a) The manual identifies the The manual should clearly identify
various high-risk areas the high risk areas of the hospital Infection Control Manual
and procedures. 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 It shall define the frequency and
surveillance in the mode of surveillance. Infection Control Manual
identified high-risk areas. The surveillance system should
meet WHO criteria of simplicity,
cost minimization, timeliness of
feedback, flexibility, acceptability,
consistency (reliability), sensitivity
and specificity.
c) It focuses on adherence to Self explanatory.
standard precautions at all Infection Control Manual
times.
d) Equipment cleaning and It shall address this at all levels e.g.
sterilization practices are ward, OT and CSSD. It is Infection Control Manual
included. 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 The HCO shall develop a system of
policy is established and monitoring drug susceptibility Antibiotic Policy
implemented. (based on culture sensitivity) and
accordingly develop its antibiotic
policy, which shall be reviewed at
periodic intervals (maybe once in 3
months) for its continuing
applicability.
f) Laundry and linen The laundry can be in-house or
management processes outsourced. If outsourced the Laundry Services
are also included. organization shall ensure that it
establishes adequate controls to
ensure infection control. The linen
change policy should be mentioned.
Washing protocols for different
categories of linen including
blankets should be included.
g) Kitchen sanitation and Self explanatory. The same shall be
food handling issues are applicable even if this activity is Infection Control Manual
included in the manual. outsourced. The organization could
refer to ISO 22000:2005 (food
safety) while addressing this issue.

34
h) Engineering controls to Issues such as Air conditioning
prevent infections are plant and equipment maintenance, Infection Control Manual
included. cleaning of A/c ducts, AHUs,
replacement of filters, seepage
leading to fungal colonization,
replacement/repair of plumbing,
sewer lines (in shafts) should be
included. Water supply sources and
system of supply, testing for water
quality must be included. Any
renovation work in hospital patient
care areas should be planned with
Infection Control team with regard
to architectural segregation, traffic
flow, use of materials.
i) Mortuary practices and The mortuary services in the
procedures are included hospital should be provided through
as appropriate to the walk-in cold rooms or mortuary cold
organization. cabinets. Mortuary procedures of
preserving body, or body parts and
safety measures while handing over
body to relatives should be in
accordance with the policy.
j) The organization defines The organization must have a
the periodicity of updating documented policy on the updation Infection Control Manual
the infection control of the infection control manual. It is
manual. desirable to update at least once in
a year based on its trends &
outcomes of the audit processes.

HIC.3. The infection control team is responsible for surveillance activities in identified areas of
the hospital.

Objective Element Interpretation Remarks


a) Surveillance activities are The organization must be able to
appropriately directed provide evidence of conducting Infection Control Manual
towards the identified high- periodic surveillance activities in its
risk areas. 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 The organization shall ensure that it
data is an ongoing has a process in place to collect
process. surveillance data and also to
ensure that it is able to capture all
such data.

35
c) Verification of data is done The data so collected shall be
on regular basis by the authenticated by the team by going
infection control team. 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 The organization shall identify all
diseases, information (in notifiable diseases after taking into
relevant format) is sent to consideration the local laws, rules,
appropriate authorities. regulations and notifications Records from Medical
thereof. The organization shall Records department
ensure that this is sent at the
specified frequency and in the
format as required by statutory
authorities.
e) Scope of surveillance This shall be done at regular
activities incorporates intervals (maybe monthly and
tracking and analyzing of consolidated into an annual report)
infection risks, rates and and the organization shall take
trends. suitable steps based on the
analysis.

f) Surveillance activities This would include categorization of


include monitoring the areas/ surfaces; general cleaning
effectiveness of procedures for surfaces, furniture/
housekeeping services. 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 hospital takes actions to prevent or reduce the risks of Hospital Associated
Infections (HAI) in patients and employees.

Objective Element Interpretation Remarks


a) The organization monitors This can be done either by sending
urinary tract infections. urine or catheter tip for culture. The Records
organization shall do this for all
symptomatic catheterized patients.
b) The organization monitors This can be done by sending
respiratory tract infections. sputum or ET/ tracheostomy
secretions (obtained using a suction
catheter) or ET/ tracheostomy tip or
protected specimen brushing (PSB) Records
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.

36
c) The organization monitors For patients with symptoms
intra-vascular device suggestive of intra vascular device
infections. infection and having central line the
same shall be done by sending the Records
tip for culture. For all peripheral
lines clinical evidence of
thrombophlebitis would suffice.
d) The organization monitors This shall be done by sending pus/
surgical site infections. swab for culture. Records

e) Appropriate feedback The feedback shall include the


regarding HAI rates are rates, trends and opportunities for
provided on a regular improvement. It could also provide Records
basis to medical and specific inputs to reduce the HAI
nursing staff. rate.

HIC.5. Proper facilities and adequate resources are provided to support the infection control
programme.

Objective Element Interpretation Remarks


a) Hand washing facilities in The organization shall ensure that it
all patient care areas are provides necessary infrastructure to Infection Control Manual
accessible to health care carry out the same.
providers. Evidence on site
b) Compliance with proper The organization shall preferably
hand washing is monitored display the necessary instructions Infection Control Manual
regularly. near every hand washing area.
Compliance could be verified by Evidence on site
random checking, observation, etc.
c) Isolation/ barrier nursing The organization shall define the
facilities are available. conditions where the same shall be
carried out and ensure that it Infection Control Manual
provides the necessary resources
to carry out the activity (e.g.
clothing, masks, gloves etc.).

d) Adequate gloves, masks, Self explanatory. They should be


soaps, and disinfectants available at the point of use and the Facilities Available
are available and used organization shall ensure that it
correctly. maintains an adequate inventory.

HIC.6. The hospital takes appropriate action to control outbreaks of infections.

Objective Element Interpretation Remarks


a) Hospital has a This shall incorporate definitions as
documented procedure for to what constitutes an outbreak;
handling such outbreaks. identification and investigation of
such outbreaks and the procedure
for management. This shall be in Infection Control Manual
accordance with good clinical
practices.
Standard Case definitions shall
include a unit of time and place
along with specific biological and/or
clinical criteria.

37
b) This procedure is The organization should be able to
implemented during identify the outbreak, describe the
outbreaks. outbreak by developing a case Infection Control Manual
definition, designing a data
collection form, collecting data from
the affected, constructing an
epidemic curve.
c) After the outbreak is over The organization should be able to
appropriate corrective implement basic procedures to
actions are taken to prevent recurrence such as source Infection Control Manual
prevent recurrence. control if source identified, review of
all infection control policies,
loopholes and compliance gaps,
strengthening infection control
policies etc.

HIC.7. There are documented procedures for sterilization activities in the hospital.

Objective Element Interpretation Remarks


a) There is adequate space Adequacy of space refers to the
available for sterilization CSSD which should have an area CSSD Policy
activities. of 0.7sqm/bed, suitable location,
proper layout (unidirectional flow,
zoning) and separation of clean and
dirty areas.
b) Regular validation tests for This shall be done by accepted
sterilization are carried out methods e.g. bacteriologic, strips CSSD Policy
and documented. etc.
Engineering validations like Bowie
Dick tape test and leak rate test
need to be carried out.
c) There is an established The organization shall ensure that
recall procedure when the sterilization procedure is CSSD Policy
breakdown in the regularly monitored and in the
sterilization system is eventuality of a breakdown it has a
identified. procedure for withdrawal of such
items.

HIC.8. Statutory provisions with regard to Bio-medical Waste (BMW) management are
complied with.

Objective Element Interpretation Remarks


a) The hospital is authorized The occupier shall apply in the
by prescribed authority for prescribed form and get approval Copy of FORM I
the management and from the prescribed authority e.g.
handling of Bio-medical Pollution control board/committee.
Waste.
b) Proper segregation and Wastes to be segregated and
collection of Bio-medical collected in different colour coded
Waste from all patient care bags and containers as per Evident on Site
areas of the hospital is statutory provisions. Monitoring
implemented and shall be done by members of the
monitored. infection control committee/team.

38
c) The organization ensures The waste is transported to the pre-
that Bio-medical Waste is defined site at definite time intervals
stored and transported to (maximum within 48hours) through
the site of treatment and proper transport vehicles in a safe
disposal in proper covered manner. If this activity is outsourced Evident on Site
vehicles within stipulated the organization shall ensure that it Waste transportation trolley
time limits in a secure is done to an authorized contractor.
manner. Monitoring of this activity should be
done by Infection Control team.
d) Bio-medical Waste If the hospital has waste treatment
treatment facility is facility within its premises then they
managed as per statutory have to be in accordance with MOU between the hospital
provisions (if in-house) or statutory provisions or they can and the Outsourced
outsourced to authorized outsource it to a central facility. agency
contractor(s).
e) Requisite fees, documents The HCO shall ensure that the fees
and reports are submitted are deposited in a timely manner. In
to competent authorities addition the annual reports have to
on stipulated dates. be submitted by the 31st of January Copy of FORM II
of every year and accident reporting
has to be carried out in the
prescribed form.
f) Appropriate personal Self explanatory.
protective measures are
used by all categories of Evident on site
staff handling Bio-medical
Waste.

HIC.9. The infection control programme is supported by hospital management and includes
training of staff and employee health.

Objective Element Interpretation Remarks


a) Hospital management The HCO shall ensure that the
makes available resources resources required by the Copy of the budget
required for the infection personnel should be available in a
control programme. sustained manner. This includes
both men and materials.
b) The hospital regularly There shall be a separate budget
earmarks adequate funds demarcated for HIC activity. This
from its annual budget in shall be prepared taking into
this regard. consideration the scope of the Copy of the budget
activity and previous years’
experience.
c) It conducts regular pre- There must be a documented
induction training for evidence of pre induction training
appropriate categories of for appropriate categories of staff
staff before joining before joining concerned Training Records
concerned department(s). department(s). It should include the
policies, procedures and practices
of the infection control programme.
d) It also conducts regular Self explanatory.
“in-service” training
sessions for all concerned Training Records
categories of staff at least
once in a year.

39
e) Appropriate pre and post Self explanatory.
exposure prophylaxis is
provided to all concerned
staff members.

CHAPTER 6 : Continuous Quality Improvement (CQI)

CQI.1. There is a structured quality improvement and continuous monitoring programme in the
organization.

Objective Element Interpretation Remarks


a) The quality improvement This committee shall have
programme is developed, representation from management,
implemented and various clinical and support
maintained by a multi- departments of the HCO. This
disciplinary committee. programme shall be developed,
implemented and maintained in a
structured manner.
b) The quality improvement This should be documented as a
programme is manual. The manual shall Quality Management Plan
documented. incorporate the mission, vision,
quality policy, quality objectives,
service 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 This should preferably be a person
individual for coordinating having a good knowledge of Accreditation Coordinator
and implementing the accreditation standards, statutory
quality improvement requirements, hospital quality
programme. improvement principles and
evaluation methodologies, hospital
functioning and operations.

d) The quality improvement This shall preferably cover all


programme is aspects including documentation of Quality Management Plan
comprehensive and covers the programme, monitoring it, data Risk Management
all the major elements collection, review of policy and
related to quality corrective action. Also refer to CQI
improvement and risk 1b.
management.
e) The designated Self explanatory.
programme is
communicated and
coordinated amongst all Traning Records
the employees of the
organization through
proper training
mechanism.

40
f) The quality improvement As quality improvement is a
programme is reviewed at dynamic process, it needs to be
predefined intervals and reviewed at regular pre-defined
opportunities for intervals (as defined by the HCO in
improvement are the quality improvement manual but Quality Committee
identified. at least once in four months) by
conducting internal audits. This
audit shall be done by a multi-
disciplinary team (preferably trained
in NABH standards) including all
the applicable standards and
objective elements. At the end of
the audit there shall be a formal
meeting to summarise the findings
and identify areas for improvement.
During this meeting there shall be
an analysis of key indicators as
identified and determined by the
organization including the
mandatory indicators as laid down
in CQI 2 and 3. The minutes of the
review meetings should be
recorded and maintained.
g) The quality improvement Self explanatory. The inputs for
programme is a updation could be based on the Quality Management Plan
continuous process and review carried out by the quality
updated at least once in a improvement committee.
year.

CQI.2. The organization identifies key indicators to monitor the clinical structures, processes
and outcomes which are used as tools for continual improvement.

Objective Element Interpretation Remarks


a) Monitoring includes The HCO shall develop appropriate
appropriate patient key performance indicators suitable
assessment. to it. The following is however
mandatory:
i. Time for initial assessment
of indoor and emergency
patients.
i. Percentage of cases wherein
care plan is documented and
counter-signed by the clinician.
ii. Percentage of cases wherein
screening for nutritional needs
has been done.
iii. Percentage of cases wherein
the pre-defined initial nursing
assessment is completed within
30 minutes.
b) Monitoring includes safety The HCO shall develop appropriate
and quality control key performance indicators suitable
programmes of the to it. The following is however
diagnostics services. mandatory:
i. Number of reporting
errors/1000 investigations.
ii. Percentage of re-dos.
iii. Percentage of reports Co-

41
relating with clinical diagnosis.
iv. Percentage of adherence to
safety precautions by
employees working in
diagnostics.

c) Monitoring includes all The HCO shall develop appropriate


invasive procedures. key performance indicators suitable
to it. The following is however
mandatory:
i. Re-exploration rate.
ii. Percentage of accidental
removal of tubes and catheters.
iii. Incidence of haematoma at
puncture site.
iv. Percentage of re-scheduling of
procedures.
d) Monitoring includes The HCO shall develop appropriate
adverse drug events. key performance indicators suitable
to it. The following is however
mandatory:
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 The HCO shall develop appropriate
anaesthesia. key performance indicators suitable
to it. The following is however
mandatory:
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 The HCO shall develop appropriate
blood and blood products. key performance indicators suitable
to it. The following is however
mandatory:
i. Percentage of transfusion
reactions.
ii. Percentage of wastage of blood
and blood products.
iii. Percentage of blood
component usage.
iv. Turnaround time for issue of
blood and blood components
g) Monitoring includes The HCO shall develop appropriate
availability and content of key performance indicators suitable
medical records. to it. The following is however
mandatory:
i. Percentage of medical records

42
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 The HCO shall develop appropriate
infection control activities. key performance indicators suitable Infection Control Committee
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 The HCO shall develop appropriate
clinical research. key performance indicators suitable NA
to it. The 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/deviations 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 The data could be collected at pre-
collection to support defined intervals e.g. Infection Control Committee
further improvements. monthly/quarterly. This data is
analysed for improvement
opportunities and the same are
carried out. Also refer to CQI 1f
k) Monitoring includes data All improvement activities carried
collection to support out by the HCO shall have an
evaluation of these evaluable outcome. The same shall
improvements. be captured and analysed.

CQI.3. The organization identifies key indicators to monitor the managerial structures,
processes and outcomes which are used as tools for continual improvement.

Objective Element Interpretation Remarks


a) Monitoring includes The HCO shall develop appropriate
procurement of key performance indicators suitable to Drugs and Therapeutic
medication essential to it. The following is however mandatory: Committee
meet patient needs. i. Percentage of drugs procured by
local purchase. Drug Formulary
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

43
procurement process.

b) Monitoring includes The HCO shall develop appropriate


reporting of activities as key performance indicators suitable to MRD Policy
required by laws and it. The following is however mandatory:
regulations. i. Number of births and deaths.
ii. Number of notifiable diseases.
iii. Submission of report/ data/form
pertaining to bio-medcial 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 The HCO shall develop appropriate
management. key performance indicators suitable to Quality Management
it. The following is however mandatory: Plan
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 The HCO shall develop appropriate
utilisation of space, key performance indicators suitable to Quality Committee
manpower and it. The following is however mandatory:
equipment. 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 The HCO shall develop appropriate
patient satisfaction which key performance indicators suitable to Quality Committee
also incorporates waiting it. The following is however mandatory:
time for services. 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.

f) Monitoring includes The HCO shall develop appropriate


employee satisfaction. key performance indicators suitable to Employee Satisfaction
it. The following is however mandatory: Survey
i. Employee satisfaction index.
ii. Employee attrition rate.
iii. Employee absenteeism rate.
iv. Percentage of employees who are
aware of employee rights,
responsibilities and welfare
schemes.
g) Monitoring includes The HCO shall develop appropriate
adverse events and near key performance indicators suitable to Sentinel Event Policy
misses. it. The following is however mandatory:
i. Number of sentinel events.
ii. Percentage of near misses
analysed.

44
iii. Number of security related
incidents including thefts.
iv. Incidence of needle stick
injuries.
h) Monitoring includes data The data could be collected at pre-
collection to support defined intervals e.g. monthly/ MRD Policy
further study for quarterly. This data is analysed for
improvements. improvement opportunities and the
same are carried out. Also refer to CQI
1f
i) Monitoring includes data Self explanatory. The inputs for
collection to support updation could be based on the review
evaluation of the carried out by the quality improvement
improvements. committee.

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

Objective Element Interpretation Remarks


a) Hospital Management This shall include the men, material,
makes available adequate machine and method. These should
resources required for be in steady supply so as to ensure Budget Report
quality improvement that the programme functions
programme. smoothly.
b) Hospital earmarks Appropriate fund allocation is done
adequate funds from its by the organization for the smooth Budget
annual budget in this functioning of the programme.
regard.
c) Appropriate statistical and Self explanatory.
management tools are
applied whenever Monthly report of MRD
required.

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

Objective Element Interpretation Remarks


a) Medical and nursing staff The HCO shall identify such
participates in this personnel. It could be a mix of Medical Audit Committee
system. clinicians, administrators and
nurses.
b) The parameters to be As these audits are
audited are defined by the retrospective/concurrent in nature, it
organization. is imperative that this be done using Parameters for medical
predefined parameters so that there AUDIT
is no bias. The parameters could be
disease based, cost based,
community based or based on
length of stay.
c) Patient and staff This means that the names of the
anonymity is maintained. patients and the hospital staff who
may figure in the audit documents YES
must not be disclosed nor any
reference be made to them in public
discussions/ conferences.

45
d) All audits are Self explanatory.
documented. Medical Audit Report
e) Remedial measures are All remedial measures as
implemented ascertained should be documented Action taken Report of the
and implemented and Medical Audit
improvements thereof recorded to
complete the audit cycle.

CQI.6. Sentinel events are intensively analyzed.

Objective Element Interpretation Remarks


a) The organization has The sentinel events relating to
defined sentinel events. system or process deficiencies that Sentinel Event Policy
are relevant and important to the
organization must be clearly
defined.
b) The organization has The established processes should
established processes for include reporting the occurrence of Sentinel Event Policy
intense analysis of such such events on standardised
events. incident report forms.
c) Sentinel events are Root cause analysis of all such
intensively analysed when events should be carried out by a Sentinel Event Policy
they occur. multi-disciplinary committee taking
inputs from the concerned units/
discipline/ departments.
d) Actions are taken upon The findings and recommendations
findings of such analysis. arrived at after the analysis should Sentinel Event Policy
be communicated to all concerned
personnel to correct the systems
and processes to prevent
recurrences.

CHAPTER 7 : Responsibilities of Management (ROM)

ROM.1. The responsibilities of the management are defined.

Objective Element Interpretation Remarks


a) Those responsible for It is not only the head of the HCO
governance lay down the but the members of the board of Quality Management Plan
organization’s mission governors (where applicable) who
statement. need to define it.
b) Those responsible for The Governing board and the
governance lay down the leaders of HCO shall define and Quality Management Plan
strategic and operational develop the process for strategic
plans commensurate to and operation plans so as to
the organization’s mission achieve the organizational mission
in consultation with the statement.
various stake holders.
c) Those responsible for The Governing board and the Head
governance approve the of HCO shall have the policy for
organization’s budget and budgeting and resource allocation Budget
allocate the resources for attaining its mission and

46
required to meet the periodically review it.
organization’s mission.
d) Those responsible for The governing board and the Head
governance monitor and of the HCO shall develop quarterly Quality Management Plan
measure the performance (at least) performance reports
of the organization based on the strategic and
against the stated operational plans.
mission.
e) Those responsible for The HCO shall have a well defined
governance establish the organization structure/chart and this Organization structure
organization’s shall clearly document the
organogram. hierarchy, line of control, along with
the functions at various levels.
f) Those responsible for Self explanatory.
governance appoint the
senior leaders in the Organization structure
organization.

g) Those responsible for Self explanatory.


governance support
research activities and NA
quality improvement
plans.
h) The organization Self explanatory.
complies with the laid The responsibility of compliance Licenses COPY
down and applicable lies with the first two level of the
legislations and hierarchy.
regulations.
i) Those responsible for The Governing board and Head of
governance address the the HCO shall willfully develop Marketing Dept.
organization’s social social responsibility policy and
responsibility. accordingly address it.

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

Objective Element Interpretation Remarks


a) Each organizational There needs to be a minimum
programme, service, site essential qualification and relevant HR Department have all the
or department has experience of the leader. The records of it
effective leadership. leader should have domain
knowledge of that particular
department.
b) Scope of services of each Each department's activity is to be
department is defined. predefined. This could be Scope of Services
documented either at individual
department level or the HCO could Evident on Site
have a brochure detailing the scope
of each department.
c) Administrative policies This shall include administrative
and procedures for each procedures like attendance, leave, HR Department
department is maintained. conduct, replacement etc.
d) Departmental leaders are Self explanatory.
involved in quality Quality Committee
improvement.

47
ROM.3. The organization is managed by the leaders in an ethical manner.

Objective Element Interpretation Remarks


a) The leaders make public The HCO shall have a mission
the mission statement of statement and the same shall be Quality Management Plan
the organization. displayed prominently. Mission statement as evidence.

b) The leaders establish the The HCO shall function in an ethical


organization’s ethical manner. Ethics Committee
management.
c) The organization The ownership of the hospital e.g.
discloses its ownership. trust, private, public has to be Private
disclosed.
d) The organization honestly Self explanatory.
portrays the services Scope of Services
which it can and cannot
provide.
e) The organization honestly Here portrays implies that the HCO
portrays its affiliations and convey its affiliations, accreditations
accreditation. for specific departments or whole
hospital wherever applicable.
f) The organization Self explanatory.
accurately bills for its
services based upon a Tariff List
standard billing tariff.

ROM.4. A suitably qualified and experienced individual heads the organization.

Objective Element Interpretation Remarks


a) The designated individual Self explanatory.
has requisite and YES
appropriate administrative
qualifications.
b) The designated individual Self explanatory.
has requisite and 16 Years Exp.
appropriate administrative
experience.

ROM.5. Leaders ensure that patient safety aspects and risk management issues are an integral
part of patient care and hospital management.

Objective Element Interpretation Remarks


a) The organization has an Self explanatory.
interdisciplinary group
assigned to oversee the Hospital Safety Committee
hospital wide safety
programme.

48
b) The scope of the The HCO shall have a system of
programme is defined to reporting of all the
include adverse events incident/accident. Sentinel Event Policy
ranging from “no harm” to
“sentinel events”.
c) Management ensures The HCO has a system in place for
implementation of internal and external reporting of
systems for internal and system and process failures.
external reporting of Contingency plan shall be in place Hospital Safety Committee
system and process to deal with the situation of system
failures. and process failure anticipated
within the organization.
d) Management provides There shall be sufficient resources
resources for proactive kept as contingency to address the
risk assessment and risk risk reduction activities as and
reduction activities. when the leaders proactively Hospital Safety Committee
suggest.
The end result of these shall result
in preventive actions.

CHAPTER 8: Facility Management and Safety (FMS)

FMS.1. The organization is aware of and complies with the relevant rules and regulations, laws
and byelaws and requisite facility inspection requirements.

Objective Element Interpretation Remarks


a) The management is A designated management
conversant with the laws functionary has been given the
and regulations and responsibility to enlist the laws and
knows their applicability to regulation as applicable to the Licenses & Act approval
the organization. HCO. This functionary has copy as evidence
identified the appropriate personnel
in the HCO who are supposed to
implement the respective laws and
regulations.
b) Management regularly Self explanatory.
updates any amendments Copies available with MS
in the prevailing laws of (Process for Compliance
the land. and Updating of Regulatory
& Statutory requirements)
c) The management Self explanatory.
ensures implementation Copies available with MS
of these requirements. (Process for Compliance
and Updating of Regulatory
& Statutory requirements)
d) There is a mechanism to Self explanatory.
regularly update licenses/ Copies available with
registrations/ MS(Process for Compliance
certifications. and Updating of Regulatory
& Statutory requirements)

FMS.2. The organization’s environment and facilities operate to ensure safety of patients, their
families, staff and visitors.

49
Objective Element Interpretation Remarks
a) There is a documented Self explanatory.
operational and
maintenance (preventive Bio-Medical Engg.
and breakdown) plan.

b) Up-to-date drawings are A designated person maintains the Document with


maintained which drawings. Engineering Department
detail the site layout, floor
plans and fire escape
routes.
c) There is internal and Self explanatory.
external sign posting in
the organization in a Evident at Site
language understood by
patient, families and
community.
d) The provision of space
shall be in accordance
with the available Self explanatory. Engineering / Facilities
literature on good Dept.
practices (Indian or
International Standards)
and directives from
government agencies.
e) There are designated A person in the HCO management
individuals responsible for is designated to be in-charge of Roster of Engineering
the maintenance of all the maintenance of facilities. The HCO department
facilities. has the required number of
supervision and tradesmen to
manage the facilities.

f) Maintenance staff is Self explanatory.


contactable round the Roster as Evidence
clock for emergency
repairs.
g) Response times are A complaint attendance register is
monitored from reporting to be maintained to indicate the Records of the
to inspection and date and time of receipt of Engineering Department
implementation of complaint, allotment of job and
corrective actions. completion of job.

FMS.3 The organization has a programme for clinical and support service equipment
management.

Objective Element Interpretation Remarks


a) The organization plans for Self explanatory. This shall also
equipment in accordance take into consideration future
with its services and requirements. Material Management
strategic plan.

50
b) Equipment is selected by Collaborative process implies that
a collaborative process. during equipment selection there is
involvement of end user, Purchase Committee
management, finance, engineering
and bio-medical departments.
c) All equipment are Self explanatory.
inventoried and proper Bio-Medical Engg.
logs are maintained as Registers of the BME
required. Department
d) Qualified and trained Self explanatory.
personnel operate and Bio Medical Engineer
maintain the equipment
e) Equipment are The HCO has weekly / monthly /
periodically inspected and annual schedules of inspection and
calibrated for their proper calibration of equipment which Calibration Process
functioning. involve measurement, in an
appropriate manner. The HCO Calibration records of
either calibrates the equipment in equipments
house or out sources; maintaining
traceability to national or
international or manufacturer’s
guidelines/standards.
f) There is a documented Self explanatory.
operational and Bio-Medical Engg.
maintenance (preventive
and breakdown) plan.

FMS.4 The organization has provisions for safe water, electricity, medical gases and vacuum
system.

Objective Element Interpretation Remarks


a) Potable water and The HCO shall make arrangements Engineering / Facilities
electricity are available for supply of adequate potable Dept.
round the clock. water and electricity.
b) Alternate sources are Alternate electric supply could be Engineering / Facilities
provided for in case of from DG Sets, solar energy, UPS Dept.
failure. and any other suitable source.
c) The organization regularly Self explanatory.
tests the alternate Engineering / Facilities
sources. Dept.
d) There is a maintenance Self explanatory.
plan for piped medical Gas Manifold
gas, compressed air and
vacuum installation.

FMS.5 The organization has plans for fire and non-fire emergencies within the facilities.

Objective Element Interpretation Remarks

51
a) The organization has The HCO has a fire and non-fire
plans and provisions for emergency committee (FNEC) to Sprinklers and smoke
early detection, review the HCO’s preparedness. detectors,
abatement and The HCO has conducted an Evident on site.
containment of fire and exercise of hazard identification and
non-fire emergences. risk analysis (HIRA) and
accordingly taken all necessary
steps to eliminate or reduce such
hazards and associated risks. The Disaster Mgt. Plan
HCO has:
a) a fire plan covering fire arising
out of burning of inflammable
items, explosion, electric short
circuiting or acts of negligence
or due to incompetence of the
staff on duty;
b) deployed adequate and
qualified personnel for this;
c) acquired adequate fire 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. These 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
relatives
f) civil disorders effecting the
HCO
g) anti-social behaviour 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 bed

52
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 Fire exit plan shall be displayed on


documented safe exit each floor particularly close to the Fire Exit Plan Displayed on
plan in case of fire and lifts. Exit doors should remain open each floor
non-fire emergencies. on all the time.

c) Staff is trained for their In case of fire designated person Fire fighting team formed
role in case of such are assigned particular work. Training Records
emergencies.
d) Mock drills are held at Self explanatory.
least twice in a year. Records of Drills

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

Objective Element Interpretation Remarks


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

FMS.7. The organization plans for handling community emergencies, epidemics and other
disasters.

Objective Element Interpretation Remarks


a) The hospital identifies The HCO has a documented plan
potential emergencies. and procedure for handling the
situations like sudden rush of
victims of

53
a) earthquake
b) flood Disaster Mgt. Plan
c) train accident
d) Civil unrest outside the HCO
premises
e) Major fire
f) Invasion by enemy, etc.
g) These plans and procedures
cover ensuring adequacy of
medical supplies, equipment,
materials, identified trained
personnel, transportation aids,
communication aids and mock
drill methodology.
b) The organization has a The disaster plan must incorporate
documented disaster essential elements of alert code, Disaster Mgt. Plan
management plan. 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 Resource availability should be
availability of medical according to threat perception. Disaster Mgt. Plan
supplies, equipment and
materials during such
emergencies.
d) Hospital staff is trained in Mock drills with and without patients
the hospital’s disaster have to be carried out. Only Training Records
management plan. communication exercise may also
be undertaken.
e) The plan is tested at least Self explanatory. Disaster Mgt. Plan
twice in a year.

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

Objective Element Interpretation Remarks


a) Hazardous materials are The HCO has identified and listed
identified within the the hazardous materials and has a Infection Control Manual
organization. documented procedure for their
sorting, storage, handling,
transpirations, disposal mechanism,
and method for managing spillages
and adequate training of the
personnel for these jobs.
b) The hospital implements The HCO has conducted an
processes for sorting, exercise of hazard identification and
labelling, handling, risk analysis (HIRA) associated with
storage, transporting and handling of hazardous materials Waste Mgt. Process
disposal of hazardous and accordingly taken all necessary
material. steps to eliminate or reduce such MSDS available on site
hazards and associated risks. The
HCO has ensured display of
Material Safety Data Sheets
(MSDS) for all hazardous materials
and has accordingly arranged
associated training of personnel

54
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 identification
for material handling and those
trainings are included in the HCO
training calendar.
c) Requisite regulatory The appropriate personnel in the
requirements are met in HCO are aware about the rules and
respect of radioactive regulations such as the Atomic
materials. Energy Act, the norms issued by As per biomedical waste
Atomic Energy Regulatory Board management rule
(AERB) and the directives from the
Health Physics Division of Bhaba
Atomic Research Centre (BARC).
d) There is a plan for Self explanatory.
managing spills of MSDS
hazardous materials.
e) Staff is educated and Self explanatory.
trained for handling such Training Record of Medical
materials. & Paramedical Staffs.

FMS.9. The hospital has system in place to provide a safe and secure environment.

Objective Element Interpretation Remarks


a) The hospital has a safety The HCO has a duly constituted
committee to identify the safety committee which has HospitaL Safety Committee
potential safety and identified the potential safety and
security risks. security risks to staff, patients and
visitors.
b) This committee The HCO ensures that the above
coordinates development, Committee functions on a regular Hospital Safety Committee
implementation, and basis to coordinate development,
monitoring of the safety implementation and monitoring of
plan and policies. the plans and policies.
c) Patient safety devices are Self explanatory.
installed across the
organization and Evident on site
inspected periodically.

55
d) Facility inspection rounds Rounds to be carried out by safety
to ensure safety are committee.
conducted at least twice Facility round conducted by
in a year in patient care Safety Committee
areas and at least once in
a year in non-patient care
areas.
e) Inspection reports are Self explanatory.
documented and Inspection Rounds
corrective and preventive
measures are
undertaken.
f) There is a safety Self explanatory.
education programme for Training Record
all staff.

CHAPTER 9 : Human Resource Management (HRM)

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

Objective Element Interpretation Remarks


a) The organization The staff should be commensurate
maintains an adequate with the workload and the clinical
number and mix of staff to requirement of the patients. Manpower Planning
meet the care, treatment
and service needs of the
patient.
b) The required job The content of each job should be
specifications and job well defined and the qualifications,
description are well skills and experience required for Job Specifications
defined for each category performing the job should be clearly
of staff. laid down. The job description
should be commensurate with the
qualification.
c) The organization verifies Self explanatory.
the antecedents of the Antecedent Verification
potential employee with Service Rule 74
regards to
criminal/negligence
background.

HRM.2. The staff joining the organization is socialized and oriented to the hospital
environment.

Objective Element Interpretation Remarks


a) Each staff member, The organization's staff including
employee student and the outsourced staff should be
voluntary worker is aware and should correctly interpret Employee Guide Book
appropriately oriented to the mission and goals of the
the organization’s mission organization.
and goals.

56
b) Each staff member is The organization's staff including
made aware of hospital the outsourced staff should be Employee Guide Book
wide policies and aware and should correctly interpret
procedures as well as the policies and operating
relevant department/ unit/ procedures of the organization as
service/ programme’s well as that of the department/ unit/
policies and procedures. service in which he is performing
the requisite duties.
c) Each staff member is The HCO shall define the same in
made aware of his/her consonance with statutory Employee Guide Book
rights and responsibilities. requirements and the same shall be
communicated to the employees.
d) All employees are The employees should be able to
educated with regard to identify and report violation of Employee Guide Book
patients’ rights and patient rights as and when the
responsibilities. same occurs.
e) All employees are The HCO shall develop
oriented to the service benchmarks for different services Induction Manual
standards of the being provided. This shall be based
organization. on the HCO's values and focus on
development of soft skills:
behaviour, attitude, communication
skills, etc.

HRM.3. There is an ongoing programme for professional training and development of the staff.

Objective Element Interpretation Remarks


a) A documented training A training manual incorporating the
and development policy procedure for identification of Training and Development
exists for the staff. training needs, the training policy
methodology, documentation of
training, training assessment,
impact of training and the training
calendar should be prepared.
b) Training also occurs The training should focus on the
when job responsibilities revised job responsibilities as well
change/ new equipment as on the newly introduced Training and Development
is introduced. equipment and technology. In case Policy
of new equipment the operating
staff should receive training on Record with HRD and
operational as well as daily respective Deptt.
maintenance aspects.
c) Feedback mechanisms This shall include both internal &
for assessment of training external training. For external Record with HRD and
and development training it could be done either by respective Deptt.
programme exist. 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.

Objective Element Interpretation Remarks

57
a) All staff is trained on the The HCO shall define such risks
risks within the hospital which shall include patient, visitors Hospital Safety manual
environment. and employee related risks.
b) Staff members can Self explanatory.
demonstrate and take
actions to report, Records of Drills
eliminate / minimize risks.

c) Staff members are made Self explanatory.


aware of procedures to Training Records
follow in the event of an
incident.
d) Reporting processes for The HCO has a defined procedure
common problems, for reporting of these events. Quality Committee
failures and user errors
exist.

HRM.5. An appraisal system for evaluating the performance of an employee exists as an


integral part of the human resource management process.

Objective Element Interpretation Remarks


a) A well-documented Self explanatory.
performance appraisal Performance Appraisal
system exists in the System
organization.

b) The employees are made Self explanatory.


aware of the system of Induction Training
appraisal at the time of Programme
induction.
c) Performance is evaluated Self explanatory.
based on the Performance Appraisal
performance expectations System
described in job
description.
d) The appraisal system is Self explanatory. This can be done
used as a tool for further by identifying training requirements Performance Appraisal
development. and accordingly providing for the System
same (wherever possible).
e) Performance appraisal is Self explanatory.
carried out at pre defined Performance Appraisal
intervals and is System
documented.

HRM.6. The organization has a well-documented disciplinary procedure.

Objective Element Interpretation Remarks


a) A written statement of the Self explanatory.
policy of the organization Disciplinary Procedure
with regard to discipline is
in place.

58
b) The disciplinary policy This implies that both parties
and procedure is based (employee and employer) are given
on the principles of an opportunity to present their case Disciplinary Procedure
natural justice. and decision is taken accordingly.

c) The policy and procedure Self explanatory.


is known to all categories Induction Training Records
of employees of the
organization.
d) The disciplinary Self explanatory.
procedure is in Disciplinary Procedure
consonance with the
prevailing laws.
e) There is a provision for The HCO shall designate an
appeals in all disciplinary appellate authority to consider Disciplinary Procedure
cases. appeals in disciplinary cases.

HRM.7. A grievance handling mechanism exists in the organization.

Objective Element Interpretation Remarks


a) The employees are For definition of "grievance
aware of the procedure to handling" refer to glossary. The
be followed in case they HCO has a written procedure for
Employee Grievance Policy
feel aggrieved. handling grievances of employees.

b) The redress procedure Self explanatory.


addresses the grievance. Employee Grievance Policy

c) Actions are taken to Self explanatory.


Employee Grievance Policy
redress the grievance.

HRM.8. The organization addresses the health needs of the employees.

Objective Element Interpretation Remarks


a) A pre-employment Self explanatory. This shall
medical examination is however be in consonance with the Evidenced on Personal File
conducted on all the law of the land.
employees.
b) Health problems of the Self explanatory. This shall be in
employees are taken care consonance with the law of the land Medical Benefit
of in accordance with the and good clinical practices.
organization’s policy.
c) Regular health checks of Self explanatory. The results should
staff dealing with direct be documented in the personal file. Medical Benefit
patient care are done at-
least once a year and the Records in Personal file
findings/ results are
documented.

59
d) Occupational health Self explanatory.
hazards are adequately
addressed.

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

Objective Element Interpretation Remarks


a) Personal files are Self explanatory.
maintained in respect of HR Department
all employees.
b) The personal files contain Self explanatory.
personal information Personal File as Evidence.
regarding the employees’
qualification, disciplinary
background and health
status.
c) All records of in-service Self explanatory.
training and education Training record kept
are contained in the separately
personal files.
d) Personal files contain Evaluations would include
results of all evaluations. performance appraisals, training YES
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.

Objective Element Interpretation Remarks


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

HRM.11. There is a process for authorizing all medical professionals to admit and treat
patients and provide other clinical services commensurate with their qualifications.

60
Objective Element Interpretation Remarks
a) Medical professionals The HCO shall identify as to what
admit and care for each medical professional is
patients as per the laid authorized to do.
down policies and
authorization procedures
of the organization.
b) The services provided by Self explanatory.
the medical professionals
are in consonance with
their qualification, training
and registration.
c) The requisite services to Self explanatory.
be provided by the
medical professionals are
known to them as well as
the various departments /
units of the hospital.

HRM.12. There is a process for collecting, verifying and evaluating the credentials (education,
registration, training and experience) of nursing staff.

Objective Element Interpretation Remarks


a) The education, The HCO identifies the individuals
registration, training and who have the required qualification
experience of nursing (s), training and experience to
staff is documented and provide nursing care to patients in Registration from Nursing
updated periodically. consonance with the law. Updation Counsil
is done after acquisition of new
skills and/or qualification.
b) All such information The HCO shall do the same by
pertaining to the nursing verifying the credentials from the HR Department
staff is appropriately organization which has awarded the
verified when possible. qualification/training.

HRM.13. There is a process to identify job responsibilities and make clinical work assignments
to all nursing staff members commensurate with their qualifications and any other regulatory
requirements.

Objective Element Interpretation Remarks


a) The clinical work The HCO shall identify as to what
assigned to nursing staff each nurse is authorized to do. Privileging
is in consonance with
their qualification, training
and registration.
b) The services provided by Self explanatory.
nursing staff are in Privileging
accordance with the
prevailing laws and
regulations.

61
c) The requisite services to Self explanatory.
be provided by the Nursing Manual
nursing staff are known to
them as well as the
various departments /
units of the hospital.

CHAPTER 10 : Information Management System (IMS)

IMS.1. Policies and procedures exist to meet the information needs of the care providers,
management of the organization as well as other agencies that require date and information
from the organization.

Objective Element Interpretation Remarks


a) The information needs of The HCO has manual and/or
the organization are electronic Hospital Information Medical Records
identified and are System and/or Management Department
appropriate to the scope Information System which provides
of the services being relevant information to all
provided by the concerned stakeholders.
organization and the
complexity of the
organization.
b) Policies and procedures A policy document is available
to meet the information where the HIS/MIS is described. HIS
needs are documented.
c) These policies and Self explanatory.
procedures are in Evidenced at respective
compliance with the Deptt.
prevailing laws and
regulations.
d) All information The HCO shall define the needs for
management and software and hardware solutions as HISPrimus%20Hospital
technology acquisitions per the information requirements %20Manual.doc#BACKUP
are in accordance with and future necessities.
the policies and
procedures.
e) The organization The HCO shall define the system of
contributes to external releasing the relevant information to Medical Records
databases in accordance the authority as per statutory Department
with the law and norms.
regulations.

IMS.2. The organization has processes in place for effective management of data.

Objective Element Interpretation Remarks


a) Formats for data MIS/HIS data is collected in
collection are standardised format from all Medical Records
standardized. areas/services in the HCO. Department
b) Necessary resources are The HCO shall make available
available for analyzing men, material, space and budget. Budget
data.

62
c) Documented procedures Self explanatory.
are laid down for timely Medical Records
and accurate Department
dissemination of data.
d) Documented procedures The HCO shall define data
exist for storing and management policy and ensure Medical Records
retrieving data. adequate safeguards for protection Department
of data, where ever physical or
electronic data is stored.
e) Appropriate clinical and There is a multi-disciplinary
managerial staff committee which is responsible for Medical Audit committee
participates in selecting, the appropriate selection of scope.
integrating and using indicators, measurement of trends
data. and initiating action wherever
required.

IMS.3. The organization has a complete and accurate medical record for every patient.

Objective Element Interpretation Remarks


a) Every medical record has This shall also apply to records on Medical Records
a unique identifier. digital media. Department
b) Organization policy HCO has a written policy stating Medical Records
identifies those who all can make entries. Department
authorized to make
entries in medical record.
c) Every medical record Self explanatory. Medical Records
entry is dated and timed. Department
d) The author of the entry This could be by writing the full
can be identified. name or by mentioning the Medical Records
employee code number, with the Department
help of stamp, etc. In case of
electronic based records,
authorised e-signature provision as
per statutory requirements must be
kept.
e) The contents of medical The HCO identifies which
record are identified and documents form part of the medical Medical Records
documented. records, documents and Department
implements the same.
f) The record provides an The HCO shall decide the format
up-to-date and for maintaining the continuity in the Medical Record file as an
chronological account of medical records. Evidence
patient care.

IMS.4. The medical record reflects continuity of care.

Objective Element Interpretation Remarks


a) The medical record Self explanatory.
contains information Medical Records
regarding reasons for Department
admission, diagnosis and
plan of care.

63
b) Operative and other Self explanatory.
procedures performed Medical Records
are incorporated in the Department
medical record.
c) When patient is Self explanatory. It is mandatory to
transferred to another mention the clinical condition of the Patient Transfer Policy
hospital, the medical patient before transfer is effected.
record contains the date
of transfer, the reason for
the transfer and the name
of the receiving hospital.
d) The medical record Self explanatory.
contains a copy of the Medical Records
discharge note duly Department
signed by appropriate
and qualified personnel.
e) In case of death, the Self explanatory. The HCO
medical record contains a provides the death certificate as per Medical Records
copy of the death the International Certification of Department
certificate indicating the cause of death. Death certificate evident
cause, date and time of
death.
f) Whenever a clinical Self explanatory.
autopsy is carried out, the
medical record contains a Not Applicable
copy of the report of the
same.
g) Care providers have The HCO provides access to
access to current and medical records to designated Medical Records
past medical record. health care providers (those who Department
are involved in the care of that
patient).

IMS.5. Policies and procedures are in place for maintaining confidentiality, integrity and
security of information.

Objective Element Interpretation Remarks


a) Documented policies and The HCO shall control the
procedures exist for accessibility to the MRD
maintaining department. It shall ensure the HIS
confidentiality, security usage of tracer card for movement
and integrity of of the file in and out of the MRD so HIS
information. as to maintain confidentiality, Tracer card available.
security, safety and integrity of
information.
This is applicable for both manual
and electronic records.
b) Policies and procedures This is in the context of Indian Process for Compliance and
are in consonance with Evidence Act, Indian Penal Code Updating of Regulatory &
the applicable laws. and Code of medical Ethics. Statutory Requirements

64
c) The policies and For physical records the HCO shall
procedures incorporate ensure that there is adequate pest
safeguarding of data / and rodent control measures. For
record against loss, electronic data there should be
destruction and protection against virus/trojans and
tampering. also a proper backup procedure. To HIS
prevent tampering, for physical
records access shall be limited only HIS
to the concerned health care
provider. In electronic format this
could be done by adequate
passwords.
d) The hospital has an The HCO carries out regular
effective process of audits/rounds to check compliance Medical Records
monitoring compliance of with policies. Department
the laid down policy.
HIS

e) The hospital uses The HCO shall review and update


developments in its technological features so as to Medical Records
appropriate technology improve confidentiality, integrity and Department
for improving security of information.
confidentiality, integrity
and security.
f) Privileged health The HCO shall define the
information is used for the procedure for privileged Medical Records
purposes identified or as communication. Department
required by law and not
disclosed without the
patient’s authorization.
g) A documented procedure Self explanatory. In this context, the
exists on how to respond release of information in
to patients/ physicians accordance with the Code of
and other public agencies Medical Ethics 2002 should be kept
requests for access to in mind. Report to Health Authority
information in the medical
record in accordance with
the local and national law.

IMS.6. Policies and procedures exist for retention time of records, data and information.

Objective Element Interpretation Remarks


a) Documented policies and The HCO shall define the retention
procedures are in place period for each category of medical Medical Records
on retaining the patient’s records: Department
clinical records, data and Out-patient, in-patient and MLC.
information.
b) The policies and Some of the related laws in this
procedures are in context are Code of Medical Ethics Medical Records
consonance with the local 2002, Consumer protection act Department
and national laws and 1987 and relevant state legislation,
regulations. if any.
c) The retention process This is applicable for both manual
provides expected and electronic system. Medical Records
confidentiality and Department
security.

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

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

Objective Element Interpretation Remarks


a) The medical records are Self explanatory.
reviewed periodically. Medical Records
Department
b) The review uses a The HCO shall define the principles
representative sample on which sampling is based. For Medical Records
based on statistical example, simple random, systemic Department
principles. 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 Self explanatory. Medical Audit Committee
by identified care Medical Records
providers. Department
d) The review focuses on Self explanatory.
the timeliness, legibility Medical Records
and completeness of the Department
medical records.
e) The review process Self explanatory.
includes records of both Medical Records
active and discharged Department
patients.
f) The review points out and Self explanatory. Medical Audit Report
documents any Medicall Records
deficiencies in records. Department

g) Appropriate corrective Self explanatory.


and preventive measures Action Taken Report
undertaken are
documented.

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