Clinical Draft

8/12/2019 Clinical Draft

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FIRSTEDITION:JUNE2010

STANDARDS FOR

ACCREDITATION OF

CLINICS Practicing Modern

System of Medicine(ALLOPATHY)

By NABH

NATIONAL ACCREDITATION BOARD FOR HOSPITALS

AND HEALTHCARE PROVIDERS


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DEFINITION OF CLINIC:

A standalone healthcare faci li ty that provides allopathic services by Doctors registeredwith Medical Council of India or State Medical Council.

The Clinic may be located in the community or in the premises of an organization,such as school, factory, etc.

and includes healthcare facilities:

Sl.no. Healthcare facility Definit ion1. Clinic A standalone healthcare facility for services (other than

OPD of a hospital).

2. Polyclinic A Clinic which provides services in 2 or more

specialties, working in cooperation and sharing the samefacilities

3. Dispensary A Clinic, which in addition to care, provides facilities fordispensing medicines. .

In addition a clinic may have add on services as follows:

Diagnostic services such as:

Clinical examination

Procedures Laboratory- pathology, imaging,etc

Therapeutic services such as:

Intervention

Pharmacy etc

Support services such as:

Physiotherapy

Nutrition

Counselling etc.

In the Standards, the Dispensary/Polyclinic/ Clinic hereinafter will

be referred to as Clinic


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Exclusions:

1. Day-care Centres:Day Care will include facilities that have admitting beds for treating patients,

other than for overnight s tay.

The services may, in addition, include services, diagnostics and treatments

such as ambulatory surgical procedures, dialysis, chemotherapy etc.

These Standards are NOT APPLICABLE for non allopathic systems of

medicine such as Ayurvedic, AYUSH, homeopathic, wellness centres

Al ternative medicine streams etc

S.No Chapter Standards Objective Elements

1 Access, Assessment & Continuity ofCare(AAC)

7 33

2 Care of Patients (COP) 7 26

3 Patient Rights and Education(PRE) 5 26

4 Infection Control (IC) 3 10

5 Continuous Quality Improvement (CQI) 4 25

6 Responsibilities of Management (ROM) 3 16

7 Facilities Management and Safety(FMS) 3 12

8 Community Participation and Integration 6 23

Total 38 171


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Table of Contents

Sr. No. Particulars Page No.

01. Access, Assessment and Continuity of Care (AAC)

02. Care of Patients (COP)

03. Patient Rights and Education (PRE)

04. Infection Control (HIC)

05. Continuous Quality Improvement (CQI)

06. Responsibilities of Management (ROM)

07. Facility Management and Safety (FMS)

08. Community Participation and Integration (CPI)

Glossary

List of Licenses and Statutory Obligations


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Chapters & Standard

CHAPTER 1 : Access, Assessment and Continuity ofCare (AAC)

AAC.1. The Clinic defines and displays the services that it can provide.AAC.2. The Clinic has a well defined patient registration process and appropriatemechanism for referral of patients who do not match the Clinics resources.

AAC.3. Patients initial and continuing healthcare needs are identified through anestablished assessment process.

AAC 4: The Clinic has a process to identify those patients who may need additionalcare that is beyond the scope and mission of the Clinic and advises thosepatients to seek additional care , treatment or follow-up

AAC 5: The Clinic has a process to identify the transportation needs of the patientsand facilitate the same as applicable.

AAC.6. Laboratory services if provided are as per the mission and scope of the Clinic.

AAC.7. Imaging services if provided are as per the mission and scope of the Clinic.

CHAPTER 2 : Care of Patients and (COP)COP.1 Care and treatment is provided in a uniform manner to ensure high level of

patient care.

COP 2 Policies and procedures guide the care & treatment of patients with specialidentified needs

COP 3: Medication use is organized to meet patient needs and complies withapplicable laws and regulations

COP 4 The medications available are organized efficiently and effectively and the useis guided by policies and procedures

COP.5. Medication prescription, dispensing and administration follow standardizedprocesses to ensure patient safety.

COP.6 Medications are monitored for patient compliance, clinical appropriateness

and adverse effects and the medication errors are appropriately addressed.COP.7. Policies and procedures guide all research activities.

CHAPTER 3 : Patient Rights and Education (PRE)PRE.1 The Clinic protects patient and family rights and informs them about their

responsibilities during care.

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

PRE.3 A documented process for obtaining patient and / or families consent exists forinformed decision making about their care.

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

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

CHAPTER 4: Infection Control (IC)IC.1. The Clinic has a well-designed, comprehensive and coordinated Infection

Control programme aimed at reducing / eliminating risks to patients, visitorsand providers of care.

IC 2: The Clinic ensures a staff is trained in infection control and occupationalsafety practices.


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IC.3 The Clinic complies with Bio Medical Waste regulations as applicable

CHAPTER 5: Continuous Quality Improvement (CQI)CQI.1 There is a structured quality improvement and continuous monitoring

programme.

CQI.2. The clinic identifies key indicators to monitor the Clinical structures,

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

processes and outcomes which are used as tools for continual improvement.

CQI.4 There is an established system for audit of patient care services.

CHAPTER6:Responsibil it ies of Management (ROM)ROM.1 The responsibilities of the management are defined.

ROM.2. The Clinic is managed by the leaders in an ethical manner.

ROM 3: Those responsible for management have addressed all applicable aspects ofhuman resource management.

CHAPTER 7: Facili ty Management and Safety FMS.1 . The Clinics environment and facilities operate to ensure safety of patients,their families, staff and visitors.

FMS.2 The Clinic has a programme for equipment management, safe water,electricity, medical gases and vacuum system as applicable.

FMS.3 The Clinic has plans for emergencies (fire and non-fire) and hazardousmaterials within the facilities.

CHAPTER 8: Community Participation andIntegrationCPI.1 The clinic cooperates and collaborates with community partners, agencies and

groups to identify the healthcare problems and services needed within thecommunity

CPI.2. The commitment of the Clinic to Health promotion and disease prevention isevident in its mission statement, value statement, collaborative arrangementswith local, regional and national agencies and relevant policies and communityparticipation

CPI. 3 There is a defined mechanism and process for community linkages andoutreach activities, if applicable

CPI. 4 There is a process and mechanism in place to ensure proper and timelycommunication

CPI. 5 The clinic collects, analyze and disseminate public health data

CPI. 6 In conjunction with community planning, clinic defines and measures itsachievements in meeting community goals of care


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Standards & Objective elements

CHAPTER 1 : Access, Assessment and Continuity ofCare (AAC)AAC.1. The Clin ic defines and displays the services that i t can provide.

a) The services provided are clearly defined and are in consonance with theneeds of the community it intends to serve and its mission, resource andscope of services.

b) Clinic identifies barriers to access and implements processes to reduce thosebarriers that have potential to limit access to the Clinic and its services.

c) The services provided are displayed.

AAC.2. The Clinic has a wel l def ined patient regis tration process andappropriate mechanism for referral of patients who do not match theClinics resources.

a) Standardized policies and procedures are used for registering patients.

b) Patients are registered only if their needs match the clinics mission andresources.

c) If the patients needs do not match the clinics mission and resources, the clinicwill assist the patient in identifying and/or obtaining appropriate sources ofcare.

AAC.3. Patients initial and continuing healthcare needs are identified throughan established assessment process.

a) The clinic defines the scope and content of the initial assessments throughpolicy and procedure.

b) The Clinic defines the scope and content of initial assessment conducted bydifferent specialities / providers / disciplines based on applicable laws andregulations.

c) The Clinic defines criteria when additional, specialized, or more in depthspecial needs assessments are required for some patients.

d) Initial assessment may use screening criteria or other mechanisms to identifypatients who may need additional care.

e) The Clinic has a policy and procedure which defines the process for how theoutside assessments are incorporated into the assessment process.

f) There is an established process for meeting patient care needs requiring

continuing care.

g) The assessment findings result in a documented plan of care.

h) The plan of care also includes preventive aspects of the care as applicable.

AAC 4: The Clinic has a process to identify those patients who may needadditional care that is beyond the scope and mission of the Clinic andadvises those patients to seek additional care , treatment or fo llow-up

a) Defined Policies and procedures are used to identify the additional careneeds of the patients and to appropriately refer them to outside healthcare


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providers

b) Written summaries are provided to the patients and referring provider

c) The Clinic attempts to facilitate and coordinate sharing of information andplans of care between referral agencies to ensure proper coordination of carebetween multiple providers, if applicable.

AAC 5: The Clinic has a process to ident ify the transportation needs of the

patients and facili tate the same as applicable.a) Documented policies and procedures address identification of transportation

needs and their facilitation

b) Ambulance or patient transport services, if provided, are organised through

defined policies and procedures for efficient and effective services and comply

with the legal and regulatory requirements.

AAC.6. Laboratory services if provided are as per the mission and scope of theClinic.

a) Lab services, if provided on site are commensurate with the scope of servicesand comply with applicable local and national standards, law and regulations.

b) Lab services if provided on site will have a quality control and laboratorysafety programme.

c) Adequately qualified and trained personnel perform and/or supervise theinvestigations.

d) Policies and procedures guide collection, identification, handling, safetransportation, processing and disposal of specimens.

e) Laboratory results are available within a defined time frame.

f) Critical results are intimated immediately to the concerned personnel.

g) Laboratory tests not available in the Clinic are outsourced or referred tooutside sources to meet patient needs.

AAC.7. Imaging services if provided are as per the miss ion and scope of theClinic.

a) Imaging services if provided are as per applicable local and nationalstandards, law and regulations

b) Imaging services if provided on site will have a quality control and Radiationsafety programme

c) Adequately qualified and trained personnel perform and/or supervise theimaging.

d) Written policies and procedures guide the handling and disposal of radio-active and hazardous materials.

e) Imaging results are available within a defined time frame.f) Critical results are intimated immediately to the concerned personnel.

g) Imaging services if not available in the Clinic are outsourced or referred tooutside resources to meet patient needs.


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CHAPTER 2 : Care of Patients and (COP)COP.1 Care and treatment is provided in a uniform manner to ensure high

level of patient care.

a) Policies and procedures guide the uniform level of care for all patients, whichreflect applicable laws and regulations.

b) Care of patients should be in consonance with the defined scope

c) Evidence based medicine and Clinical practice guidelines are adopted toguide patient care wherever possible.

COP 2 Policies and procedures guide the care & treatment of patients withspecial identified needs

a) Policies and procedures guide the care & treatment of high-risk patientsidentified by the Clinic.

b) Policies and procedures guide the provision of high-risk services.

c) Policies and procedure guide basic and first responder emergency care.

d) Policies also address handling of medico-legal cases.

e) Policies and procedures guide the care & treatment of vulnerable patients andare in accordance with the prevailing laws and the national and internationalguidelines.

f) The policies and procedures guide the care of patients undergoing minorprocedures (e.g. stitching of wound, removal of stitches etc).

g) Documented policies and procedures guide the provision of rehabilitativeservices and commensurate with the clinical requirements

h) Documented policies and procedures guide the management of pain

i) Policies and procedures guide patients undergoing sedation.


a) Policies and procedures guide how the Clinic will meet medication needs ofthe patient.

b) The medication use meets applicable laws & regulations.

COP 4 The medications available are organized effic iently and effectively andthe use is guided by policies and procedures

a) The medications available are appropriate to the Clinics mission, scope ofservices and patient needs.

b) Policies and procedures guide the procurement process, storage labelling andmanagement of Samples

COP.5. Medication prescription, dispensing and administration followstandardized processes to ensure patient safety.

a) Those prescribing medications must be familiar with the details of the drugs

b) Medications are prescribed in a clear legible manner, dated and timed

c) In case medications are dispensed at the Clinic, standardized policies andprocedures are used for safe dispensing

d) Medication administration is guided by standardized policies and procedures

COP.6 Medications are monito red for patient compliance, clinicalappropriateness and adverse effects and the medication errors are


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CHAPTER 3 : Patient Rights and Education (PRE)PRE.1 The Clinic protects patient and family rights and informs them about

their responsibili ties during care.

a) Patient and family rights and responsibilities are documented.

b) Patients and families are informed of their rights and responsibilities in a

format and language that they can understand.

c) The Clinics leaders protect patients rights.

d) A staff is aware of their responsibility in protecting patients rights.

e) Violation of patient rights is reviewed and corrective/preventive measurestaken.

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

a) Patient and family rights address any special preferences, spiritual andcultural needs.

b) Patient rights include respect for personal dignity and privacy during

examination, procedures and treatment.c) Patient rights include protection from physical abuse or neglect.

d) Patient rights include treating patient information as confidential.

e) Patient has the right to make an informed choice including the option ofrefusal.

f) Patient rights include informed consent for any invasive / high risk procedures/ treatment.

g) Patient rights include information and consent before any research protocol isinitiated.

h) Patient rights include information on how to voice a complaint.

i) Patient rights include information on the expected cost of the treatment.

j) Patient has a right to have an access to his / her Clinical records.

PRE.3 A documented process for obtaining patient and / or families consentexists fo r informed decision making about their care.

a) The Clinic has listed those procedures and treatment where informed consentis required.

b) Informed consent includes information on risks, benefits, alternatives and asto who will perform the requisite procedure in a language that they canunderstand.

c) The policy describes who can give consent when patient is incapable of

independent decision making.PRE.4 Patient and families have a right to information and education about

their healthcare needs.

a) When appropriate, patient and families are educated about the safe andeffective use of medication and the potential side effects of the medication.

b) Patient and families are educated about diet and nutrition.

c) Patient and families are educated about immunizations.


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d) Patient and families are educated about their specific disease process,prognosis, complications and prevention strategies.

e) Patient and families are educated about preventing infections

PRE.5 Patient and families have a right to information on expected costs .a) The tariff list is available to patients.

b) Patients are educated about the estimated costs of treatment.

c) Patients are informed about the estimated costs when there is a change in thepatient condition or treatment setting.


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CHAPTER 4: Infection Control (IC)IC.1. The Clinic has a well-designed, comprehensive and coordinated

Infection Control programme aimed at reducing / eliminating risks topatients, visitors and providers of care.

a) The Clinic has documented policies and procedures for infection control asapplicable to its scope.

b) It focuses on adherence to standard precautions at all times.

c) Cleaning, Disinfection of surfaces, equipment cleaning and sterilizationpractices are included.

d) Antibiotic use is guided by evidence based guidelines.

e) Laundry and linen management processes are also included.

f) In cases of notifiable diseases, information (in relevant format) is sent toappropriate authorities.

IC 2: The Clinic ensures staff is trained in infection control and occupationalsafety practices.

a)Staff in Clinic receive regular training in infection control practices

b) Occupational risks are known to staff and they are trained to prevent these;and to take corrective and preventive actions in case of exposure.


a) Bio Medical waste is collected, handled, segregated and disposed of as perthe regulations

b) Staff is trained to handle BMW, and follow precautions


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CHAPTER 5: Continuous Quality Improvement (CQI)CQI.1 There is a struc tured quality improvement and continuous monitor ing

programme.

a) The quality improvement programme is documented.

b) The quality improvement programme is comprehensive and covers all themajor elements related to quality improvement and risk management.

c) The designated programme is communicated and coordinated amongst all theemployees of the Clinic through proper training mechanism.

d) The quality improvement programme is reviewed at predefined intervals andopportunities for improvement are identified.

CQI.2. The clinic identifies key indicators to monitor the Clinical structures,processes and outcomes which are used as tools for continualimprovement

a) Monitoring includes appropriate patient assessment.

b) Monitoring includes safety and quality control programmes of the diagnosticsservices.

c) Monitoring includes all procedures. (invasive and non invasive)

d) Monitoring includes adverse drug events.

e) Monitoring includes content of medical records.f) Monitoring includes infection control activities.

g) Monitoring includes Clinical research.

h) Monitoring includes data collection to support further improvements.

i) Monitoring includes data collection to support evaluation of theseimprovements.

CQI.3. The Clinic identifies key indicators to monitor the managerial struc tures,processes and outcomes which are used as tools for continualimprovement.

a) Monitoring includes procurement of medication essential to meet patientneeds.

b) Monitoring includes reporting of activities as required by laws and regulations.

c) Monitoring includes risk management.

d) Monitoring includes patient satisfaction which also incorporates waiting timefor services.

e) Monitoring includes employee satisfaction.

f) Monitoring includes sentinel events, adverse events and near misses.

g) Monitoring includes data collection to support further study for improvements.


a) Medical and nursing staff participates in this system.

b) The parameters to be audited are defined by the clinic.

c) Patient and staff anonymity is maintained.

d) All audits are documented.

e) Remedial measures are implemented


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CHAPTER 6:Responsibil it ies of Management (ROM)ROM.1 The responsib ili ties of the management are defined.

a) Those responsible for governance lay down the clinics mission statement,budget and resources

b) Those responsible for governance establish the Clinics organogram, asapplicable.

c) Administrative policies and procedures for each section are maintained.d) The organisation complies with the laid down and applicable legislations and

regulations.

e) Those responsible for governance address the organisations socialresponsibility.


a) The Clinic functions in an ethical manner.

b) The Clinic discloses its ownership.

c) The Clinic honestly portrays its affiliations and accreditation.

d) The Clinic accurately bills for its services based upon a standard billing tariff.

ROM 3: Those responsib le for management have addressed all applicableaspects of human resource management.

a) The Clinic maintains an adequate number and mix of staff to meet the care,treatment and service needs of the patient.

b) The required job specifications and job description are well defined for eachcategory of staff.

c) The Clinic verifies the antecedents of the potential employee with regards tocriminal/negligence background, training, education and skills.

d) The Clinic maintains an adequate number and mix of staff to meet the care,treatment and service needs of the patient.

e) Each staff member, employee and voluntary worker is appropriately orientedto the mission of the Clinic, policies and procedures as well as relevantdepartment / unit / service/ programmes policies and procedures

f) Performance evaluation systems are in place

g) Staff Health Problems are addressed


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CHAPTER 7: Facili ty Management and Safety FMS.1 . The Clinics environment and facilities operate to ensure safety of

patients, their families, staff and visi tors.

a) Up-to-date drawings are maintained which detail the site layout, floor plansand fire escape routes.

b) There is internal and external sign posting in the Clinic in a languageunderstood by patient, families and community.

c) The provision of space shall be in accordance with the available literature ongood practices (Indian or International Standards)

FMS.2 The Clinic has a programme for equipment management, safe water,electric ity, medical gases and vacuum system as applicable.

a) The Clinic plans for equipment in accordance with its services and strategicplan.

b) Potable water and electricity are available.

c) Alternate sources are provided for in case of failure.

d) The organisation regularly tests the alternate sources.e) There is a maintenance plan for piped medical gas, compressed air andvacuum installation if applicable

FMS.3 The Clinic has plans for emergencies (fire and non-fi re) and hazardousmaterials wi thin the facilit ies.

a) The Clinic has plans and provisions for early detection, abatement andcontainment of fire and non-fire emergences.

b) Staff is trained for their role in case of such emergencies.

c) The Clinic has addressed identification, spill management, training of staffstorage and disposal of Hazardous materials

d) The Clinic defines and implements its policies to reduce or eliminate smoking


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CHAPTER 8: Community Participation andIntegrationCPI.1 The clinic cooperates and collaborates with communi ty partners,

agencies and groups to identify the healthcare problems and servicesneeded within the communi ty

a) The clinic fosters collaborative partnerships with community partners,agencies, groups as per its scope

b) One or more member have defined responsibility for speaking on behalf of the

clinic to its community and provide quality services to the community

CPI.2. The commitment of the Clinic to Health promotion and diseaseprevention is evident in its mission statement, value statement,collaborative arrangements with local, regional and national agenciesand relevant policies and community partici pation

a) The clinic participates in a variety of health promotion / wellness and diseaseprevention / control programs and provides appropriate care and services toits community

b) The clinic defines Policies and procedures for each program / service it willparticipate

c) The clinic defines preventive and promotive services it provides

d) Identified resources for participating in above programs

e) Clinic provides education, counselling and information to community partnersand priority population on variety of topics for health promotion, Healthprotection, and disease prevention and control

f) The staff involved in counselling and IEC are well trained

g) Clinic cooperates and collaborates with the community partners in provision ofsurveillance, epidemiological investigations

h) There is an process in place for reporting notifiable diseases as per prevailinglaw and regulations

i) Policy and procedures

CPI. 3 There is a defined mechanism and process for communi ty linkages andoutreach activities, if applicable

a) There is a defined mechanism and process for community linkages andoutreach activities

b) The Identified staff is assigned specific area and specific responsibilities

c) The staff is supervised

CPI. 4 There is a process and mechanism in place to ensure proper and timelycommunication

a) The clinic has a process in place to disseminate accurate and appropriateinformation related to public health concerns to various audiences

b) There is an established mechanisms to ensure changes in programs andservices are communicated to relevant staff

c) There is an established mechanism and processes to ensure that communitypartners and public are informed of the purposes and activities of the clinicand availability of resources, programs and services.

CPI. 5 The clinic col lects , analyze and disseminate publ ic health data

a) There is a established process or other mechanism to collect reliable and validhealth data

b) The data is analyzed and interpreted

c) The data and findings are disseminated to identified audience at definedfrequency

CPI. 6 In conjunction with communi ty planning, clinic defines and measures its


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achievements in meeting communi ty goals of care

a) The clinic defines as to how it will achieve the goals and objectives of publichealth and other programs and services

b) The clinic regularly reviews its performance and revises the plan

c) The Clinic regularly solicits community and staff inputs


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GUIDEBOOK

CHAPTER 1 : Access, Assessment and Continuity ofCare (AAC)AAC.1. The Clin ic def ines and displays the services that i t can provide.

Sl. no Objective Element Interpretation Remarks

a) The services provided areclearly defined and are inconsonance with theneeds of the community it

intends to serve and itsmission, resource andscope of services.

A policy to be framed clearlystating the services the clinicmay/may not provide.

The needs of thecommunity should beconsidered especiallywhen planning a new

Clinic or adding newservices.

Claims of servicesand expertise beingavailable shouldactually be available

b) Clinic identifies barriers toaccess and implementsprocesses to reduce thosebarriers that have potentialto limit access to the Clinicand its services.

The served community mayhave diverse population withpatients having same healthneeds but quite different interms of language andcultural context. The leaders

of the Clinic recognise thecommon barriers likephysical, language, culturaland others within their patientpopulation, and implementsprocesses to overcome orlimit these barriers to accessand to the delivery ofservices.

c) The services provided aredisplayed

The services so definedshould be displayedprominently in an area visibleto all patients entering the

Clinic. The display could bein the form of boards,citizens charter, scrollingmessages etc. Care shouldbe taken to ensure that theseare displayed in thelanguage(s) the patientunderstands.

Display in the form ofbrochures only isNOT acceptable.

Display should be atleast bi-lingual.


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AAC.2. The Clinic has a well defined patient regis tration process and appropriatemechanism for referral of patients who do not match the Clinic s resources.


a) Standardized policies andprocedures are used forregistering patients.

Clinic has prepareddocument (s) detailing thepolicies and procedures for

registration of patients whichalso address out- patients, /emergency patients/unidentified patients.

.

b) Patients are registeredonly if their needs matchthe Clinics mission andresources.

The staffs handlingregistration needs to beaware of the services that theClinic can provide. It is alsoadvisable to have a systemwherein the staffs aresupported with criteria toidentify patients who may be

in need of immediateassistance and are aware asto whom to notify and alsowho to contact if they needany clarification on theservices provided. The Clinicestablishes criteria forguiding decisions foracceptance and/or referral.

The patientregistration andassessment processis designed to givepriority to those whoare obviously sick orthose with urgentneeds.

c) If the patients needs donot match the Clinicsmission and resources,

the Clinic will assist thepatient in identifyingand/or obtainingappropriate sources ofcare.

Matching patients needs

and condition with the Clinic

mission, resources depends

on information usuallygathered at the time of first

contact through triage, visual

evaluation, a physical

examination, or the results of

previously conducted

physical, psychological,

Clinical laboratory, or

diagnostic imaging

evaluations done outside the

Clinic or from a referral

source. There is anappropriate mechanism for

referral of patients who do

not match the Clinics mission

and resources.

Outpatient clinic shall at theoutset define such patients.The Clinic gives a summary

These patientsinclude those whohave come to the

Clinic but need to bereferred to anotherorganization.

.


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of patients conditionmentioning the significantfindings and treatment given.

AAC.3. Patients initial and continuing healthcare needs are identified through anestablished assessment process.


a) The Clinic defines thescope and content of theinitial assessmentsthrough policy andprocedure.

The Clinic shall have aprotocol / policy andprocedure by which astandardized initialcomprehensive assessmentof all patients is carried out.

These policies andprocedures define the

timeframe within which theinitial assessment is to becompleted and also identifyassessment process forthose patients who do notmeet the criteria fortreatment and care andrequire referral to anotherservice/facility. Clinic

The Clinic can have differentassessment criteria for thefirst visit and for subsequent

visits.

The Policy and proceduresdetermines who can do whatassessment as per theirqualification, experience andtraining and based onapplicable law andregulations.

The initialassessment mayinclude screeningleading to plan ofcare or referral andrecords for the sameshall be maintainedby patient or theClinic for continuingassessment.

In emergency thisshall includerecording the vitalparameters.

b) The Clinic defines thescope and content of initialassessment conducted bydifferent specialities /providers / disciplinesbased on applicable lawsand regulations.

The initial assessment ismodified depending on thetype of patient / serviceprovided however it shall bethe same in that particulararea e.g. in a paediatric OPDthe weight and height maybe a must whereas it maynot be so for orthopaedicsOPD. Appropriate criteriabased on EBM are used asapplicable.


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Assessments are performedby each discipline within itsscope of practice, licensure,applicable laws, andregulations, or certification.

The scope and content ofinitial assessment conductedby different providers /disciplines may be defined ina policy and procedure ormay be identified onassessment form

c) The Clinic defines criteriawhen additional,specialized, or more indepth special needsassessments are required

for some patients.

Some patients like elderly,pregnant women, very youngchildren, patients withinfectious disease may havespecial needs and require

additional assessment. Theassessment process forthese special needs patientsis appropriately modified toreflect their needs and risks.

d) Initial assessment mayuse screening criteria orother mechanisms toidentify patients who mayneed additional care.

Many patients havehealthcare needs that mayseemingly be unrelated tothe reason they came to theClinic. Such needs mayinclude for e.g. screening fornutritional needs,behavioural health needs,

immunization, and pain asapplicable.

The screening criteria orother mechanisms are basedon guidelines / protocolsdeveloped by the relevantprofessional national orinternational bodies

The staff is trained on theprocess for identification ofthese patients with additionalneeds.

Assessment ofnutritional needs maybe done by thetreating doctor and/ordietician.

Since care will

include a large aspectof primary care,which includesdisease preventionand promotion,immunization historyand advice should beincluded whereverapplicable.

e) The Clinic has a policyand procedure whichdefines the process forhow the outsideassessments areincorporated into the

The patient assessmentprocess may include therelevant findings fromoutside assessments(referral source, laboratoryetc). The policy and

For e.g. thelaboratory / imagingreports are acceptedonly if duly signed byqualified / authorisedpersonnel.


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assessment process. procedure will address:

Process of obtaining andusing outside assessmentfindings.

Outside assessmentsrequiring review and

verification. Situations when outside

assessments are notavailable

f) There is an establishedprocess for meetingpatient care needsrequiring continuing care.

The patients visit to theClinic may be one time orongoing. Patientsreassessed based oncontinuing needs, todetermine their response totreatment or to plan furthertreatment.

g) The assessment findingsresult in a documentedplan of care.

The assessment findings aredocumented in a uniformmanner and uniform locationin a patients record and thepatients record is readilyavailable to thoseresponsible for the patientscare.

Assessments findingsof all providers areintegrated egassessments ofnurses, doctors andphysiotherapist.

It is preferable tohave a uniquepersonal healthrecord that is used bymultiple providers fordocumentation.

For definition of planof care refer toglossary.

h) The plan of care alsoincludes preventiveaspects of the care asapplicable.

The documented plan of careshould cover preventiveactions as necessary in thecase and should include diet,drugs etc.

This could also bedone throughcounselling,booklets/patientinformation leafletsetc. e.g. diabetes,hypertension.

AAC 4: The Clinic has a process to identify those patients who may need additionalcare that is beyond the scope and mission of the Clinic and advises those

patients to seek additional care , treatment or fol low-upSl. no Objective Element Interpretation Remarks

a) Defined Policies andprocedures are used toidentify the additional careneeds of the patients andto appropriately refer themto outside healthcareproviders

These additional needs maybe identified at the time ofassessment or reassessment

Referral is based onthe patients healthstatus and need foradditional / continuingcare or services.

Referral may be for


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speciality, diagnostic,rehabilitativepsychological socialand support servicesetc whichorganisation is unableto provide.

It could also be foropinion, co-management, takeover

b) Written summaries areprovided to the patientsand referring provider

The Clinic frequentlyprovides care and services topatients based on referral ofthe patient for specialityservices (for e.g. cardiacevaluation / particular test).The Clinic has a process

through which itcommunicates to patients(when appropriate patientfamily) about the ongoinghealth needs and types ofcare and services theyshould seek in future. Thereferred provider provides awritten summary to conveythe findings back to thereferring provider

The information(written summary)includes asappropriate, amedication list,significant diagnosisand treatments,

follow up instructionsand any test results.

c) The Clinic attempts tofacilitate and coordinate

sharing of information andplans of care betweenreferral agencies to ensureproper coordination ofcare between multipleproviders, if applicable.

The patient care can involvemany care providers. The

care planning and deliveryneeds to be integrated andcoordinated amongst careproviders.

AAC 5: The Clinic has a p rocess to ident ify the t ranspor tat ion needs of the patientsand facilitate the same as applicable.


a) Documented policies andprocedures addressidentification of

transportation needs andtheir facilitation

They should also addressthe methodology of safetransfer of the patient in an

emergency / life threateningsituation to another

Facility.

Tie up withambulance providers/ referral centres

Coordination /

facilitation

b) Ambulance or patient

transport services, if

provided, are organised

through defined policies

and procedures for

Policies and proceduresshall guide themaintenance, readiness,dispatch

There is adequate space

It is expected thatambulance / PTVshall be equippedwith at least basic lifesupport equipment.


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efficient and effective

services and comply with

the legal and regulatory

requirements.

for parking.

Ambulance(s) isappropriately equipped

The ambulance ismanned by the trainedstaff

There is a Checklist ofequipment/medicines

There is a propercommunication system

Licensing of drivers,pollution control,registration of vehicle etc

The staff shall betrained in ACLS and/ or BLS

The Ambulance /

Equipments /EmergencyMedications shall bechecked daily

AAC.6. Laboratory services if provided are as per the miss ion and scope of theClinic.


a) Lab services, if providedon site are commensuratewith the scope of servicesand comply withapplicable local andnational standards, lawand regulations.

The Clinic may haveavailability of laboratoryservices commensurate withthe health care servicesoffered by it and the scope ofthe clinic services either byproviding the same in houseor by outsourcing/referral.See also (g) below foroutsourced lab facilities.

In case the Clinicdoes not have a lab,or in addition to a lab,they may keep somepoint of care testingarrangements-

For example theClinic may haveGlucometer testing ina Diabetic Clinic orother specific testsrelating to the scope

of service, to meetimmediate diagnosticneed.

b) Lab services if provided onsite will have a qualitycontrol and laboratorysafety programme.

The laboratory qualityassurance and safetyprogramme:

Is documented.

Addresses verificationand validation of testmethods.

Addresses surveillance of

test results. Includes periodic

calibration andmaintenance of allequipments.

Includes thedocumentation ofcorrective and preventiveactions.

Forms and formats &adequate recordkeeping areaddressed.


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Addresses handling anddisposal of infectious andhazardous materials andprotective equipment

training of staff

integrates with other

Clinical safety program

c) Adequately qualified andtrained personnel performand/or supervise theinvestigations.

The staff employed in the labshould be suitably qualified)and trained to carry out thetests.

For adequacy ofqualification refer toNABL 112(Annexure).

d) Policies and proceduresguide collection,identification, handling,safe transportation,processing and disposal ofspecimens.

The Clinic has documentedprocedures for collection,identification, handling, safetransportation, processingand disposal of specimens,to ensure safety of thespecimen till the tests and

retests (if required) arecompleted.

The policy should bein line with standardprecautions. Thedisposal of wasteshall be as per thestatutoryrequirements (Bio-

medical wastemanagement andhandling rules, 1998.)

e) Laboratory results areavailable within a definedtime frame.

The Clinic shall define theturnaround time for all tests.The Clinic should ensureavailability of adequate staff,materials and equipment tomake the laboratory resultsavailable within the definedtime frame.

The turnaround timecould be different fordifferent tests andcould be decidedbased on the natureof test and criticalityof test.

f) Critical results areintimated immediately tothe concerned personnel.

The laboratory shall establishits biological referenceintervals for different tests.The laboratory shall establishcritical limits for tests whichrequire immediate attentionfor patient management. Thetest results in the criticallimits shall be communicatedto the concerned after properdocumentation.

If it is not practical toestablish thebiological referenceinterval for aparticular analyte thelaboratory shouldcarefully evaluate thepublished data for itsown referenceintervals.

g) Laboratory tests notavailable in the Clinic are

outsourced or referred tooutside sources to meetpatient needs.

If services are outsourcedadequate Quality Assurance

criteria for selection andmonitoring of the of theoutsourced lab, will beapplied

AAC.7. Imaging services i f provided are as per the miss ion and scope of the Clin ic.


a) Imaging services if The Clinic may have In case the Clinic


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provided are as perapplicable local andnational standards, lawand regulations

availability of Imagingservices commensurate withthe health care servicesoffered by it either byproviding the same in houseor by outsourcing/referral.See also (g) below foroutsourced lab facilities.

The Clinic is aware of thelegal and other requirementsof imaging services and thesame are documented forinformation and complianceby all concerned in the Clinic.The Clinic maintains andupdates its compliancestatus of legal and otherrequirements in a regularmanner.

does not have animaging service theymay keep somepoint of care testingarrangements-

For example USG in

a cardiac Clinic, tomeet immediatediagnostic need.

All the statutoryrequirements are metwith, like BARCclearance,dosimeters, leadsheets, lead aprons,signages, display asper PNDT act, reportsto competentauthority, etc

b) Imaging services ifprovided on site will havea quality control andRadiation safetyprogramme

The Imaging qualityassurance and Radiationsafety programme:

Is documented.

Addresses patient andstaff safety

Addresses verificationand validation of testmethods.

Addresses surveillance oftest results.

Includes periodiccalibration andmaintenance of allequipments.

Includes thedocumentation ofcorrective and preventiveactions.

Addresses handling anddisposal of infectious,radioactive andhazardous materials and

protective equipment Imaging personnel are

provided with appropriateradiation safety devices

training of staff integrateswith other Clinical safetyprogram

Refer AERBguidelines and NABHAccreditationstandard for MedicalImaging serviceswherever applicable

c) Adequately qualified andtrained personnel perform

The staff employed in theimaging should be suitably


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and/or supervise theimaging.

qualified and trained to carryout the procedure.

d) Written policies andprocedures guide thehandling and disposal ofradio-active and

hazardous materials.

Radioactive and hazardousmaterials shall be disposedoff as per bio-medical wastemanagement and handling

rules, 1998.

e) Imaging results areavailable within a definedtime frame.

The Clinic shall define theturnaround time for allprocedures. The Clinicshould ensure availability ofadequate staff, materials andequipment to make theImaging results availablewithin the defined timeframe.

The turnaround timecould be different fordifferent tests andcould be decidedbased on the natureof test and criticalityof test.

f) Critical results areintimated immediately to

the concerned personnel.

The Imaging shall establishcritical limits for the results

which require immediateattention for patientmanagement. The results inthe critical limits shall becommunicated to theconcerned after properdocumentation.

g) Imaging services if notavailable in the Clinic areoutsourced or referred tooutside resources to meetpatient needs.

If services are outsourcedadequate QualityAssurance criteria forselection and monitoringof the of the outsourced

imaging centre, will beapplied

CHAPTER 2 : Care of Patients and (COP)COP.1 Care and treatment is provided in a uniform manner to ensure high level of

patient care.


a) Policies and proceduresguide the uniform level ofcare for all patients,

Self explanatory. Samequality of services(diagnostics and treatment)

The access andappropriateness ofthe care do not vary


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which reflect applicablelaws and regulations.

for patients having samehealth needs / problems

by the ability to pay /source of payment /time of the day etc

b) Care of patients shouldbe in consonance withthe defined scope

The clinic shall haveappropriate Staff, facilities,protocols and procedures in

consonance with the scopeof service.

For example

an obstetric clinicshall have

examination roomalong withappropriate staff butwill not performprocedures givingdeep sedation whenthere is not adequatebackup staff &facilities etc

c) Evidence based medicineand Clinical practiceguidelines are adopted to

guide patient carewherever possible.

The Clinic could developClinical protocols based onthese and the same could be

followed in management ofpatients. These could thenbe used as parameters foraudit of patient care.

e.g. Standardizedprotocols for care ofmalaria, diabetes,

asthma etc(eg standardtreatment guidelines)For definitions ofevidence basedmedicine and Clinicalpractice guidelines,refer to glossary.

COP 2 Policies and procedures guide the care & treatment of patients with specialidentified needs


a) Policies and procedures

guide the care &treatment of high-riskpatients identified by theClinic.

The Clinic identifies & clearly

defines high-risk patients,such as neonates, elderly,patients with psychiatricdisorders, HIV, patients ofinfectious or communicabledisease etc. The policies andprocedures defines thescope of services to berendered to these high riskpatients and includes themechanism of referral toidentified sources for furthermanagement, in a

coordinated and safemanner.The centre should have a listof specialised servicesavailable in the community orbeyond as per the patientneeds.The persons caring for highrisk patients are competent.

Eg: a cardiac Clinic

with TMT facilitiesmay screen patientswho are not fit forTMT at this centreand may refer tohigher centre.


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b) Policies and proceduresguide the provision ofhigh-risk services.

The Clinic identifies & clearlydefines high risk serviceswhich includes handling useand administration of IVmedications, blood productsetc

c) Policies and procedureguide basic and firstresponder emergencycare.

The policies and procedures

are based on the scope of

services and patient needs

and particularly address

The availability of Clinicof basic first aid facilitiesand resuscitativeequipment,

Clinical guidelines /protocols to provide firstaid, resuscitation andmanagement of specificconditions likehypoglycaemia, allergicreaction and otherconditions common in theserved patients etc.

Training of staff to usethe resuscitativeequipment and provideresuscitative services.

The centre must have

the names and

contact details of

ambulance providers

The centre must be

aware of emergency

facilities in

surrounding nearby

areas.

The staff needs to betrained in BCLS

d) Policies also addresshandling of medico-legalcases.

If medico-legal cases arehandled in the clinic thepolicy shall be in line withstatutory requirements

e) Policies and proceduresguide the care &treatment of vulnerablepatients and are inaccordance with theprevailing laws and thenational and internationalguidelines.

Self explanatory.

The vulnerable patientsinclude children, elderly,physically and/or mentallychallenged.

The Clinic provides for a safeand secure environment forthis vulnerable group.

Staffs are trained to care for

this vulnerable group

Refer to disability act,mental act.

The Clinic shallprovide properenvironment takinginto account therequirement of thevulnerable group.

f) The policies andprocedures guide thecare of patientsundergoing minorprocedures (e.g. stitchingof wound, removal ofstitches etc).

This shall include the list ofsurgical procedures as wellas competency level,qualifications for performingthese Procedures.

An informed consent isobtained prior to theprocedure. Persons


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permitted to performprocedure are competentand in consonance with thelaw

g) Documented policies andprocedures guide the

provision of rehabilitativeservices andcommensurate with theclinical requirements

The scope of thedepartments is in

consonance with the scopeof the Clinic

For example,provision of ante

natal and post natalexercises could forma part of obstetricrehabilitationprogramme

h) Documented policies andprocedures guide themanagement of pain

The Clinic shall define thegroup of patients for whomthis is applicable.

A good reference point fordefining these patients couldbe those having pain as thepredominant debilitating

symptom.Patient and family areeducated on various painmanagement techniques

For example, cancerpain, neuralgias andarthralgia.

i) Policies and proceduresguide patientsundergoing sedation.

Competent person willadminister the sedation and

monitoring facilities willbe available

recovery criteria will beused to send the patienthome after period ofmonitoring facility torescue the patient in caseof deeper level ofsedation will be available



a) Policies and proceduresguide how the Clinic willmeet medication needs ofthe patient.

The Clinic may giveprescription to obtainmedication at communitypharmacy or may dispensefrom the pharmacy operatedby Clinic.

The Clinic can also provideon-site pharmacy servicesthrough contracted agencies.

b) The medication usemeets applicable laws &regulations.

Applicable laws & regulationssuch as Pharmacy act, Drug& cosmetic act, narcotic andpsychotropic substances act


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etc ( as in annexure 1)

COP 4 The medications available are organized effic iently and effectively and theuse is guided by pol icies and procedures


a) The medicationsavailable are appropriate

to the Clinics mission,scope of services andpatient needs.

Self explanatory

b) Policies and proceduresguide the procurementprocess, storage labellingand management ofSamples

Inventorymanagement ofMedicine /consumables mayfollow first expiry firstout principle

COP.5. Medication prescription, dispensing and administration follow standardizedprocesses to ensure patient safety.


a) Those prescribingmedications must befamiliar with the details ofthe drugs

b) Medications areprescribed in a clearlegible manner, datedand timed

c) In case medications aredispensed at the Clinic,standardized policies andprocedures are used for

safe dispensing

These should addressidentification, storage, expirydates, sound alike look alikesegregation, licensing

requirements etcd) Medication administration

is guided by standardizedpolicies and procedures

The Clinic shall ensure:

Only authorized staffadminister medications

Staff is familiar with thecomposition, strengths,dilution requirements andbroad indications, drug -drug interactions, sideeffects etc. Verification ofindications,contraindications, andobtaining history of

allergy/adverse reaction

Proper identification ofpatient, and medicationincluding route, dose,expiry dates, physicalverification etc.

Special precautions forhigh risk medicationssuch as narcotics,


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chemotherapy,radioactive drugs.

Knowledge of allergy testif required.

Proper infection controlpractices including gloves asapplicable

COP.6 Medications are monitored for patient compliance, clinical appropriatenessand adverse effects and the medication errors are appropriately addressed.


a) Medication use ismonitored for patientcompliance, clinicaleffectiveness andadverse medicationeffects; and the same isnoted in patients record.

Proper follow up advice topatient.

b) Adverse medicationeffects are defined,

analyzed, documentedand reported to thecollaborating centre asapplicable.

The adverse drug effects thatare to be recorded in the

patients record and thosethat must be reported aredefined.

c) Patients and familymembers are educatedabout safe and effectiveuse of medication andfood-drug interactions.

Methodology of patienteducation may includepatient education pamphletsetc.They are advised to reportany adverse drug reactions.

d) Policies and procedureswill define reporting,analyzing and correctiveand preventive actions formedication error andadverse drug events.

Prescription audit,Medication errors, nearmisses, patient reportedoutcomes, to be carried out.Corrective and preventiveactions to be recorded.The medication errors andadverse drug events shall bedefined and reported using astandardized format.The staff shall be educatedto report

Attempts are madeas per recallmechanisms.Policies are modifiedto reduce adversedrug events whenunacceptable trendsoccur

COP.7. Polic ies and procedures guide all research activ ities.


a) Documented policies andprocedures guide allresearch activities incompliance with theapplicable law andnational and internationalguidelines.

Self explanatory For example:

Internationalconference onharmonization (ICH)of Good Clinicalpractices (GCP) andDeclaration ofHelsinki Somerset(1996) and EthicalGuidelines for


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BiomedicalResearchon HumanSubjects (ICMR-2006).

Also refer Schedule YDrugs and Cosmetics

Act.b) Documented policies and

procedures addressPatients informedconsent, their right towithdraw, their refusal toparticipate in theresearch activities.

Patients are informed of theirright to withdraw from theresearch at any stage andalso of the consequences (ifany) of such withdrawal.Patients are assured thattheir refusal to participate orwithdrawal from participationwill not compromise theiraccess to the Clinicsservices.


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CHAPTER 3 : Patient Rights and Education (PRE)PRE.1 The Clinic protects patient and family rights and informs them about their

responsibilities during care.


a) Patient and family rights

and responsibilities aredocumented.

The Clinic should respect

patients rights and informthem of their responsibilities.

All the rights of the patientsshould be displayed in theform of a Citizens Charterwhich should also giveinformation of the chargesand grievance redressmechanism.

For an example of

patient responsibilityrefer to glossary.

b) Patients and families areinformed of their rightsand responsibilities in a

format and language thatthey can understand.

Self explanatory.

c) The Clinics leadersprotect patients rights.

Protection also includesaddressing patientsgrievances w.r.t rights.

d) Staff is aware of theirresponsibility in protectingpatients rights.

Training and sensitisationprogrammes shall beconducted to createawareness among the staff.

e) Violation of patient rightsis reviewed andcorrective/preventivemeasures taken.

Where patients' rights havebeen infringed upon,management must keeprecords of such violations, asalso a record of theconsequences, e.g.corrective actions to preventrecurrences.

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


a) Patient and family rightsaddress any specialpreferences, spiritual and

cultural needs.b) Patient rights include

respect for personaldignity and privacy duringexamination, proceduresand treatment.

During all stages of patientcare, be it in examination orcarrying out a procedure,staff shall ensure thatpatients privacy and dignityis maintained. The Clinicshall develop the necessaryguidelines for the same.


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During procedures the Clinicshall ensure that the patientis exposed just before theactual procedure isundertaken.

With regards to

photographs/recordingprocedures; the Clinic shallensure that consent is takenand that the patients identityis not revealed.

c) Patient rights includeprotection from physicalabuse or neglect.

Special precautions shall betaken especially w.r.tvulnerable patients e.g.elderly, neonates etc.

Examples of thisinclude falling fromthe bed/trolley due tonegligence, assault,repeated internalexaminations,manhandling etc.

d) Patient rights includetreating patientinformation asconfidential.

The clinic shall keep therecords in a secure mannerand will release only underauthorisation of the patientexcept under statutoryobligation.

e) Patient has the right tomake an informed choiceincluding the option ofrefusal.

During management thepatients should be given thechoice of treatment. Thetreating doctor shall discussall the available options and

allow.

In case of refusal thetreating doctor shallexplain theconsequences ofrefusal of treatment

and document thesame.

f) Patient rights includeinformed consent for anyinvasive / high riskprocedures / treatment.

Self explanatory. Informed consent ofthe patient ismandatory for doingHIV test/TMT test etc

g) Patient rights includeinformation and consentbefore any researchprotocol is initiated.

The Clinic shall ensure thatInternational conference onharmonization (ICH) of GoodClinical practice (GCP) andDeclaration of HelsinkiSomerset (1996) and ICMR

requirements are followed.

h) Patient rights includeinformation on how tovoice a complaint.

Grievance redressalmechanism must beaccessible and transparent.

i) Patient rights includeinformation on theexpected cost of thetreatment.


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j) Patient has a right to havean access to his / herClinical records.

The Clinic shall ensure thatevery patient has access tohis/her record. This shall bein consonance with The codeof medical ethics andstatutory requirements.

PRE.3 A documented process for obtaining patient and / or families consent existsfor informed decision making about their care.


a) The Clinic has listed thoseprocedures and treatment whereinformed consent is required.

A list of proceduresshould be made forwhich informedconsent should betaken.

The policy for HIVtesting shouldfollow the nationalpolicy on HIVtesting (NACO).

b) Informed consent includesinformation on risks, benefits,

alternatives and as to who willperform the requisite procedure ina language that they canunderstand.

The consent shall havethe name of the doctor

performing theprocedure. Consentform shall be in thelanguage that thepatient understands.

c) The policy describes who cangive consent when patient isincapable of independent decisionmaking.

The Clinic shall takeinto consideration thestatutory norms. Thiswould include next ofkin/legal guardian.However in case ofunconscious/

unaccompaniedpatients the treatingdoctor can take adecision in life savingcircumstances.

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


a) When appropriate, patient andfamilies are educated about thesafe and effective use of

medication and the potential sideeffects of the medication.

Self explanatory.

b) Patient and families are educatedabout diet and nutrition.

Self explanatory.

c) Patient and families are educatedabout immunizations.

Self explanatory.

d) Patient and families are educatedabout their specific disease

Self explanatory.


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process, prognosis, complicationsand prevention strategies. This could also be

done through patienteducationbooklets/videos/leafletsetc.

e) Patient and families are educatedabout preventing infections

Self explanatory. For example, handwashing andavoidingovercrowding nearthe patient.

PRE.5 Patient and families have a right to information on expected costs .Sl. no Objective Element Interpretation Remarks

a) The tariff list is available topatients.

Ethical billing practicesare ensured.

The Clinic shall ensure

that there is anupdated tariff list andthat this list is availableto patients.

The Clinic shall chargeas per the tariff list.Additional chargesshould also beenumerated in the tariffand the samecommunicated to thepatients.

The tariff rates shouldbe uniform andtransparent.

b) Patients are educated about theestimated costs of treatment.

c) Patients are informed about theestimated costs when there is achange in the patient condition ortreatment setting.


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CHAPTER 4: Infection Control (IC)IC.1. The Clinic has a well-designed, comprehensive and coordinated Infection

Control programme aimed at reducing / eliminating risks to patients, visitorsand providers o f care.


a) The Clinic has documentedpolicies and procedures forinfection control as applicable toits scope.

Self explanatory

b) It focuses on adherence tostandard precautions at all times.

Hand washingfacilities in allpatient care areasare accessible tohealth careproviders.

Adequate gloves,

masks, soaps, anddisinfectants areavailable and usedcorrectly.

Refer to glossary

For standardprecautions.

c) Cleaning, Disinfection of surfaces,equipment cleaning andsterilization practices areincluded.

As applicable to thetype of Clinic andservices, the policiesand practices willaddress all relevantaspects.

d) Antibiotic use is guided byevidence based guidelines.

Indiscriminateantibiotic usage is to

be avoided/discouraged.

e) Laundry and linen managementprocesses are also included.

Clean, linen andlaundry service asapplicable

In case of minorprocedures wheresterile precautions areneeded, these shouldbe addressed

f) In cases of notifiable diseases,

information (in relevant format) issent to appropriate authorities.

The Clinic shall

identify all notifiablediseases after takinginto consideration thelocal laws, rules,regulations andnotifications thereof.The Clinic shallensure that this issent at the specified

Refer to glossary for

notifiable diseases.


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frequency and in theformat as required bystatutory authorities.

IC 2: The Clinic ensures staff is trained in infection control and occupational safetypractices.


a) Staff in Clinic receive regulartraining in infection controlpractices

Example Training onHand hygiene, BMW,personal protectiveequipment, cleaningdisinfection andsterilization etc

b) Occupational risks are known tostaff and they are trained toprevent these; and to takecorrective and preventive actionsin case of exposure.

Pre exposureprophylaxis isarranged.

Hepatitis Bimmunizations

Staff is trained tohandle spills

Needle sticksinjury prevention,and first aid to begiven in case ofan accident.

Appropriate postexposure

prophylaxis isquickly facilitatedat nearesthealthcare facility.



a) Bio Medical waste is collected,handled, segregated anddisposed of as per the regulations

Self explanatory. Therules for servicesapply.

b) Staff is trained to handle BMW,and follow precautions


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CHAPTER 5: Continuous Quality Improvement (CQI)CQI.1 There is a struc tured quality improvement and continuous monitori ng

programme.


a) The quality improvementprogramme is documented.

This should bedocumented as amanual. The manualshall incorporate themission, vision, quality

policy, qualityobjectives, servicestandards, importantindicators as identifiedetc. The manual couldbe stand alone andshould have crosslinkages with othermanuals.

.

b) The quality improvementprogramme is comprehensiveand covers all the majorelements related to quality

improvement and riskmanagement.

This shall preferablycover all aspectsincludingdocumentation of the

programme,monitoring it, datacollection, review ofpolicy and correctiveaction..

Refer to glossary fordefinition of "Riskmanagement" and"Quality

improvement.

c) The designated programme iscommunicated and coordinatedamongst all the employees of

The clinic staff shallbe familiarised withthe tools & techniques

This could be donethrough regulartraining programme or


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the Clinic through proper trainingmechanism.

of qualitymanagement inhealthcare includingaccreditation.Self explanatory.

printed materials.

d) The quality improvementprogramme is reviewed atpredefined intervals andopportunities for improvementare identified.

As qualityimprovement is adynamic process, itneeds to be reviewedat regular pre-definedintervals (as definedby the Clinic in thequality improvementmanual but at leastonce in a year) byconducting internalaudits.The Clinic, if nothaving a full team, can

organize anassessment usingexternal peers. Thisaudit shall be done bya multi-disciplinaryteam (preferablytrained in NABHstandards) includingall the applicablestandards andobjective elements. Atthe end of the auditthere shall be a formal

meeting to summarisethe findings andidentify areas forimprovement. Duringthis meeting thereshall be an analysis ofkey indicators asidentified anddetermined by theorganisation includingthe mandatoryindicators as laiddown in CQI 2 and 3.

The minutes of thereview meetingsshould be recordedand maintained.

The assessors shallbe either trainedinternally or externallyin NABH standards.They shall assessareas independent oftheir area of work.

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


a) Monitoring includes appropriate The Clinic shall


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patient assessment. develop appropriatekey performanceindicators suitable toit.The following ishowever mandatory:

i. Patients waitingtime

b) Monitoring includes safety andquality control programmes ofthe diagnostics services.

The Clinic shalldevelop appropriatekey performanceindicators suitable toit. The following ishowever mandatory:

i. Number ofreportingerrors/1000

investigations.

Reporting errors needto be captured. It isbetter if theorganisation capturesthese errors as errorspicked up beforedispatching thereports and errorspicked after the

dispatch of reports.This includestranscription errorsalso.

c) Monitoring includes allprocedures. (invasive and noninvasive)


i. Incidence ofhaematoma/absce

ss at puncture site.

d) Monitoring includes adversedrug events.


i. Percentage ofmedication errors(Prescribing,dispensing,

administration)ii. Incidence of

adverse drugreactions.

e) Monitoring includes content ofmedical records.

The Clinic shalldevelop appropriatekey performanceindicators suitable to

Missing recordsinclude records withinthe retention timeonly.


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it. The following ishowever mandatory:

i. Prescribing errorsii. Complete

identification dataon record

f) Monitoring includes infectioncontrol activities.


i. Hand washcompliance

Refer to IC

g) Monitoring includes Clinicalresearch.

The Clinic shalldevelop appropriatekey performanceindicators suitable toit. The following is

however mandatory:i. Number ofresearch activitiesbeing carried out.

ii. Percentage ofpatientswithdrawing fromthe study.

iii. Percentage ofprotocolviolations/deviations reported.

iv. Percentage of

serious adverseevents (whichhave occurred inthe Clinic)reported to theethics committeewithin the definedtimeframe.

Refer to ICMRguidelines and GCPfor reporting time ofserious adverseevents.

h) Monitoring includes datacollection to support furtherimprovements.

The Clinic shalldevelop appropriatekey performanceindicators suitable toit. The following is

however mandatory:iii. Percentage of

medication errors(Prescribing,dispensing,administration)

iv. Incidence ofadverse drugreactions.


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i) Monitoring includes datacollection to support evaluationof these improvements.

The data could becollected at pre-defined intervals e.g.monthly/quarterly.This data is analysedfor improvementopportunities and thesame are carried out.Also refer to CQI

CQI.3. The Clinic identifies key indicators to monito r the managerial structures,processes and outcomes which are used as tools for continualimprovement.


a) Monitoring includes procurementof medication essential to meetpatient needs.

The Clinic shalldevelop appropriatekey performance

indicators suitable toit. The following ishowever mandatory:

i. Availability ofemergencymedications

ii. Stock out.

b) Monitoring includes reporting ofactivities as required by lawsand regulations.


i. Number ofnotifiablediseases.

ii. Submission ofreport/ data/formpertaining to bio-medical waste,PNDT act andradiation safetywithin the definedtimeframe.

iii. Submission oftax returns anddeduction of taxesat the specifiedtime frame.

For example, tax,EPF, notifiablediseases, PNDT act,AERB guidelines etc.

c) Monitoring includes riskmanagement.


Refer to glossary fordefinition of "riskmanagement".


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indicators suitable toit.

d) Monitoring includes patientsatisfaction which alsoincorporates waiting time forservices.


i. Out patientsatisfaction index.

ii. Waiting time forservices includingdiagnostics andoutpatient.

Waiting time impliesthe time taken fromthe time that thepatient registers tothe time taken forassessment to bedone by the doctor/diagnostic procedureto be performed.

e) Monitoring includes employeesatisfaction.


indicators suitable toit. The following ishowever mandatory:

i. Employeesatisfaction index.

ii. Employee attritionrate.

iii. Employeeabsenteeism rate.

iv. Percentage ofemployees whoare aware ofemployee rights,

responsibilitiesand welfareschemes.

f) Monitoring includes sentinelevents, adverse events and nearmisses.

The Clinic shalldevelop appropriatekey performanceindicators suitable toit. The following ishowever mandatory:i. Number of sentinel

events.ii. Percentage of near

misses analysed.

i. Incidences ofneedle stickinjuries.

g) Monitoring includes datacollection to support furtherstudy for improvements.

The data could becollected at pre-defined intervals e.g.monthly/quarterly.This data is analysedfor improvement

For example, waitingtime in OPD.


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opportunities and thesame are carried out.



a) Medical and nursing staff

participates in this system.

The Clinic shall

identify suchpersonnel. It could bea mix of Clinicians,administrators andnurses.

These could be

members of the Corecommittee/qualityassurance committee,etc.

b) The parameters to be auditedare defined by the clinic.

These will addressmedical recorddocumentation andClinical care aspects

The audit shallencompass allaspects of careincluding Clinical andnursing.

c) Patient and staff anonymity ismaintained.

This means that thenames of the patientsand the Clinic staff

who may figure in theaudit documents mustnot be disclosed norany reference bemade to them inpublic discussions /conferences.

d) All audits are documented. Self explanatory. The Clinic could use achecklist with thepredefinedparameters and theaudit findings couldbe recorded on thissheet.

e) Remedial measures areimplemented

All remedial measuresas ascertained shouldbe documented andimplemented andimprovements thereofrecorded to completethe audit cycle.

This should preferablybe done based onroot cause analysis.


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CHAPTER 6:Responsibil it ies of Management (ROM)ROM.1 The responsib ili ties of the management are defined.


a) Those responsible for governancelay down the clinics missionstatement, budget and resources

b) Those responsible for governanceestablish the Clinics organogram,as applicable.

The Clinic shallhave a well definedClinicstructure/chart andthis shall clearlydocument the

hierarchy, line ofcontrol, along withthe functions atvarious levels.

c) Administrative policies andprocedures for each section aremaintained.

This shall includeadministrativeprocedures likeattendance, leave,conduct,replacement etc.

It could be commonfor the entire Clinic.

d) The organisation complies with thelaid down and applicable

legislations and regulations.

Self explanatory.The responsibility of

compliance lies withthe first two level ofthe hierarchy.

This shall includecentral legislations

(e.g. Drugs andCosmetics act,PNDT Act, 1996),bio medical wasteact, Air (Preventionand Control ofPollution) Act,1981,Atomic EnergyRegulatory Body


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Approvals, Licenseunder Bio-medicalManagement andHandling Rules,1998,respectivestate legislations(MaharashtraMaintenance ofClinical Recordsact, Clinicalestablishment ofWest Bengal)andlocal regulations(e.g. buildingbyelaws).

e) Those responsible for governanceaddress the organisations socialresponsibility.

The leader/s of theClinic shall willfullydevelop socialresponsibility policy

and accordinglyaddress it.

For example, freecamps, outreachprogrammes,adoption of villages,

PHCs, etc.



a) The Clinic functions in an ethicalmanner.

It is mandatory tofollow Code ofmedical ethics".

b) The Clinic discloses its ownership. The ownership ofthe Clinic e.g. trust,private, public hasto be disclosed.

The disclosurecould be in theregistrationcertificate/qualitymanual, etc.

c) The Clinic honestly portrays itsaffiliations and accreditation.

Here portraysimplies that theClinic conveys itsaffiliations,accreditations forspecific services orwhole centrewhereverapplicable.

d) The Clinic accurately bills for itsservices based upon a standardbilling tariff.

Self explanatory. Also refer to PRE5.The tariff could bedevised by a tariff

committee.ROM 3: Those responsib le for management have addressed all applicable aspectsof human resource management.


a) The Clinic maintains an adequatenumber and mix of staff to meet thecare, treatment and service needsof the patient.

The staff should becommensurate withthe workload

.


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b) The required job specifications andjob description are well defined foreach category of staff.

The content of eachjob should be welldefined and thequalifications, skillsand experiencerequired forperforming the jobshould be clearlylaid down.The job descriptionshould becommensurate withthe qualification.

Refer to glossary fordefinition of "jobdescription and jobspecification".

c) The Clinic verifies the antecedentsof the potential employee withregards to criminal/negligencebackground, training, education andskills.

MCI/NCIregistration, policeverification asapplicable. Thisshould includeClinical privileges

also.d) The Clinic maintains an adequatenumber and mix of staff to meet thecare, treatment and service needsof the patient.

e) Each staff member, employee andvoluntary worker is appropriatelyoriented to the mission of the Clinic,policies and procedures as well asrelevant department / unit / service/programmes policies andprocedures

This includespatient rights,employee rights andall departmentalpolicies, safety,grievance redressaletc.

f)

Performance evaluation systemsare in place

Appraisal, training

needs identification,support for training,CMES etc isprovided.

g)

Staff Health Problems areaddressed

This includesoccupational healthissues, medicalcheckups asapplicable andpreventiveimmunization.


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CHAPTER 7: Facili ty Management and SafetyFMS.1 . The Clinics environment and facilit ies operate to ensure safety of patients,

their families, staff and visitors.


a) Up-to-date drawings aremaintained which detail the

site layout, floor plans and fireescape routes.

A designated personmaintains the

drawings.

b) There is internal and externalsign posting in the Clinic in alanguage understood by patient,families and community.

Self explanatory. These signages shallguide patients andvisitors. It ispreferable thatsignages are bi-lingual.Statutoryrequirements shall bemet.

c) The provision of space shall bein accordance with the available

literature on good practices(Indian or InternationalStandards)

Self explanatory.

FMS.2 The Clinic has a programme for equipment management, safe water,electric ity, medical gases and vacuum system as applicable.


a) The Clinic plans for equipmentin accordance with its services

Self explanatory. Thisshall also take into


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and strategic plan. consideration futurerequirements.

b) Potable water and electricity areavailable.

The Clinic shall makearrangements forsupply of adequatepotable water andelectricity.

For water qualityrefers to IS 10500.

c) Alternate sources are providedfor in case of failure.

Alternate electricsupply could be fromDG Sets, solarenergy, UPS and anyother suitable source.

d) The organisation regularly teststhe alternate sources.

Self explanatory.

e) There is a maintenance plan forpiped medical gas, compressedair and vacuum installation ifapplicable

Self explanatory.

FMS.3 The Clinic has plans for emergencies (fire and non-fi re) and hazardous

materials within the facilit ies.Sl. no Objective Element Interpretation Remarks

a) The Clinic has plans andprovisions for early detection,abatement and containment offire and non-fire emergences.

The Clinic hasconducted anexercise of hazardidentification and riskanalysis (HIRA) andaccordingly taken allnecessary steps toeliminate or reducesuch hazards andassociated risks. a)fire plan covering firearising out of burningof inflammable items,explosion, electricshort circuiting or actsof negligence or dueto incompetence ofthe staff on duty.b) acquired adequatefire fighting equipmentfor this which recordsare kept up-to-date.

c) Adequate trainingof staff.d) Exit plans welldisplayed.e) Emergencyillumination systemwhich comes intoeffect in case of a fire.Non-fire emergencysituations include :

The National BuildingCode is a goodreference guide.


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a) Spillage ofhazardous (acids,mercury, etc.),infected materials(used gloves,syringes, tubing,sharps, etc.) medicalwastes (blood, pus,amniotic fluid, vomits,etc.)b) fall or slips (fromheight or on floor) orcollision of personnelin passagewayc) fall of patient frombedd) sudden failure ofsupply of electricity,gas, vacuum, etc

e) bursting of boilersand / or autoclavesThe Clinic hasestablished liaisonwith civil and policeauthorities and firebrigade as required bylaw for enlisting theirhelp and support incase of anemergency.

b) A staff is trained for their role incase of such emergencies.

In case of firedesignated person are

assigned particularwork. Mock drills arealso held

c) The Clinic has addressedidentification, spill management,training of staff storage anddisposal of Hazardous materials

The Clinic hasidentified and listedthe hazardousmaterials and has adocumentedprocedure for theirsorting, storage,handling,transpirations,disposal mechanism,

and method formanaging spillagesand adequate trainingof the personnel forthese jobs.

The hazardousmaterials could beidentified as per part IIof Manufacture,Storage and Import ofHazardous Chemical(Amendment) Rules,2000.In addition Biologicalmaterials like blood,

body fluids andmicrobiologicalcultures, mercury,nuclear isotopes,medical gases, LPGgas, steam, ETO etcare some of the othercommon hazardousmaterials.


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d) The Clinic defines andimp

Documents

Clinical Draft