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    National Accreditation Board for Hospitals & Healthcare Providers1

    Components of StandardsDevelopment

    Multiple Information Sources Scientific literature JCI Standards

    UK Healthcare Quality Standards Thailand Standards AHA Draft Standards JCI Survey compliance data Research Findings Individual input from field experts and key stakeholders ISO 9001-2000

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    National Accreditation Board for Hospitals & Healthcare Providers2

    Hospital Standards

    Organized around important functions

    Focus on patient and staff safety

    Set standards that all organizations must pass

    To be revised periodically and raise the bar

    Achieve International recognition

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    National Accreditation Board for Hospitals & Healthcare Providers3

    NABH Standards

    10 Chapters

    100 Standards

    503 Objective Elements

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    National Accreditation Board for Hospitals & Healthcare Providers4

    Standards and ObjectiveElements

    A standard is a statement that defines thestructures and processes that must besubstantially in place in an organization toenhance the quality of care

    Objective element is a measurable componentof a standard

    Acceptable compliance with objectiveelements determines the overall compliance

    with a standard

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    National Accreditation Board for Hospitals & Healthcare Providers5

    Section I:Patient-Centered Standards

    STD OE Access, Assessment and Continuity of Care (AAC) 15 78

    Patients Rights and Education (PRE) 5 29

    Care of Patients (COP) 18 105

    Management of Medications (MOM) 13 61

    Hospital Infection Control (HIC) 9 44

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    National Accreditation Board for Hospitals & Healthcare Providers6

    Section II:Health Care Organization

    Management StandardsSTD OE

    Continuous Quality Improvement (CQI) 6 37

    Responsibilities of Management (ROM) 5 20

    Facility Management & Safety (FMS) 9 41

    Human Resource Management (HRM) 13 47

    Information Management Systems (IMS) 7 41100 503

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    NABH STANDARDS

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    Introduction

    NABH standards for hospitals have beenprepared by Technical Committee of NABH andcontain complete set of standards for evaluation

    of hospitals for grant of accreditation. Thestandards provide framework for qualityassurance and quality improvement for hospitals

    NABH Standards contains 10 chapters,100standards and 503 objective elements.

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    Details of chapters.1) Access ,Assessment and continuity of care (AAC)2) Patient Right and Education (PRE).3) Care of Patients(COP).

    4) Management of Medication (MOM).5) Hospital Infection Control (HIC).6) Continuous Quality Improvement(CQI)7) Responsibility of Management (ROM).8) Facility Management and Safety (FMS).9) Human Resource Management (HRM)10) Information Management System (IMS).

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    Chapter 1. ACCESS,ASSESSMENT

    AND CONTINIUITY OF CARE(AAC)

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    AAC.1The organization defines anddisplays the services that it canprovide Objective Elements

    a) The services being provided are clearlydefined.

    b) The defined services are prominentlydisplayed.

    c) The staff is oriented to these services

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    AAC.2The organization has a well defined

    registration and admission process Objective elementsa) Standardized policies and procedures

    are used for registering and admittingpatients

    b) The policies and procedures addressout- patients, in-patients and emergencypatients

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    Cont

    c) Patients are accepted only if theorganization can provide the requiredservice

    d) The policies and procedures alsoaddress managing patients during nonavailability of beds

    e) The staff is aware of these processes

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    AAC.3There is an appropriate mechanism

    for transfer or referral of patientswho do not match the organizationalresources

    Objective elementsa) Policies guide the transfer of unstable

    patients to another facility in an

    appropriate mannerb) Policies guide the transfer of stable

    patients to another facility

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    Cont

    c) Procedures identify staff responsibleduring transfer

    d) The organization gives a summary ofpatients condition and the treatmentgiven

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    AAC.4During admission the patient and /orthe family members are educated to

    make informed decisions

    Objective elementsa) The patients and/or family members

    are explained about the proposed careb) The patients and/or family members

    are explained about the expected results

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    Cont

    c) The patients and/or family membersare explained about the possiblecomplications

    d) The patients and/or family members areexplained about the expected costs.

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    AAC.5Patients cared for by theorganization undergo anestablished initial assessment Objective elementsa) The organization defines the content of

    the assessments for the out patients, in-patients and emergency patients.

    b) The organization determines who canperform the assessments.

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    cont c) The organization defines the time frame

    within which the initial assessment iscompleted.

    d) The initial assessment for in-patients is

    documented within 24 hours or earlier asper the patients condition or hospitalpolicy.

    e) Initial assessment includes screening fornutritional and psychosocial needs.

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    Cont

    f) The initial assessment results in adocumented plan of care.

    g) The plan of care also includes preventiveaspects of the care

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    AAC.6All patients cared for by the

    organization undergo a regularreassessment Objective elements.

    a) All patients are reassessed atappropriate intervals.

    b) Staff involved in direct clinical care

    document reassessments.c) Patients are reassessed to determine

    their response to treatment and to plan

    further treatment or discharge.

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    AAC.7Laboratory services are provided

    as per the requirements of thepatients Objective elementsa) Scope of the laboratory services are

    commensurate to the services providedby the organization

    b) Adequately qualified and trainedpersonnel perform and/or supervise theinvestigations.

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    AAC 8

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    National Accreditation Board for Hospitals & Healthcare Providers24

    AAC.8There is an established

    laboratory quality assuranceprogramme Objective elements

    a) The laboratory quality assuranceprogramme is documented.

    b) The programme addresses verification

    and validation of test methods.c) The programme addresses surveillance

    of test results.

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    National Accreditation Board for Hospitals & Healthcare Providers25

    cont

    d) The programme includes periodiccalibration and maintenance of allequipments.

    e) The programme includes thedocumentation of corrective andpreventive actions

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    National Accreditation Board for Hospitals & Healthcare Providers26

    AAC.9There is an established

    laboratory safety programme Objective elements.

    a) The laboratory safety programme isdocumented.b) This programme is integrated with the

    organizations safety programme.

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    National Accreditation Board for Hospitals & Healthcare Providers27

    cont

    c) Written policies and procedures guidethe handling and disposal of infectiousand hazardous materials.

    d) Laboratory personnel are appropriatelytrained in safe practices.

    e) Laboratory personnel are provided withappropriate safety equipment / devices.

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    National Accreditation Board for Hospitals & Healthcare Providers28

    AAC.10Imaging services are provided as

    per the requirements of the patients Objective elements

    a) Imaging services comply with legal andother requirements.b) Scope of the imaging services are

    commensurate to the services providedby the organization.c) Adequately qualified and trained

    personnel perform and/or supervise theinvesti ations.

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    National Accreditation Board for Hospitals & Healthcare Providers29

    cont d) Policies and procedures guide

    identification and safe transportation ofpatients to imaging services.

    e) Imaging results are available within a

    defined time frame.f) Critical results are intimated immediatelyto the concerned personnel.

    g) Imaging tests not available in theorganization are outsourced toorganization(s) based on their qualityassurance system.

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    National Accreditation Board for Hospitals & Healthcare Providers30

    AAC.11There is an established Quality

    assurance programme forimaging services

    Objective elementsa) The quality assurance programme for

    imaging services is documented.b) The programme addresses verification

    and validation of imaging methodsc) The programme addresses surveillance

    of imaging results

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    National Accreditation Board for Hospitals & Healthcare Providers31

    cont

    d) The programme includes periodiccalibration and maintenance of allequipments.

    e) The programme includes thedocumentation of corrective andpreventive actions

    AAC 12

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    National Accreditation Board for Hospitals & Healthcare Providers32

    AAC.12There is an established radiation

    safety programmeObjective elementsa) The radiation safety programme is

    documented.b) This programme is integrated with the

    organizations safety programme.

    c) Written policies and procedures guidethe handling and disposal of radio-activeand hazardous materials.

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    National Accreditation Board for Hospitals & Healthcare Providers33

    cont

    d) Imaging personnel are provided withappropriate radiation safety devicese) Radiation safety devices are periodically

    tested and documented.f) Imaging personnel are trained in radiationsafety measures.

    g) Imaging signage are prominentlydisplayed in all appropriate locations.h) Policies and procedures guide the safe

    use of radioactive isotopes for imaging

    AAC 13

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    National Accreditation Board for Hospitals & Healthcare Providers34

    AAC.13Patient care is continuous and

    multidisciplinary in natureObjective elements

    a) During all phases of care, there is aqualified individual identified asresponsible for the patients care.

    b) Care of patients is coordinated in all caresettings within the organization.

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    National Accreditation Board for Hospitals & Healthcare Providers35

    cont c) Information about the patients care and

    response to treatment is shared amongmedical, nursing and other care providers.

    d) Information is exchanged and documentedduring each staffing shift, between shifts,and during transfers betweenunits/departments.

    e) The patients record (s) is available to the

    authorized care providers to facilitate theexchange of information.f) Policy and procedures guide the referral of

    patients to other department / specialty.

    AAC 14

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    National Accreditation Board for Hospitals & Healthcare Providers36

    AAC.14The organization has a

    documented discharge process Objective elementsa) The patients discharge process is

    planned.b) Policies and procedures exist for

    coordination of various departments and

    agencies involved in the dischargeprocess (including medico-legal cases

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    National Accreditation Board for Hospitals & Healthcare Providers37

    cont

    c) Policies and procedures are in place forpatients leaving against medical advice

    d) A discharge summary is given to all thepatients leaving the organization(including patients leaving againstmedical advice)

    AAC 15

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    National Accreditation Board for Hospitals & Healthcare Providers38

    AAC.15Organisation defines the content

    of the discharge summary Objective elementsa) Discharge summary is provided to the

    patients at the time of dischargeb) Discharge summary contains the

    reasons for admission, significant

    findings and diagnosis and the patientscondition at the time of discharge.

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    National Accreditation Board for Hospitals & Healthcare Providers39

    cont

    c) Discharge summary contains informationregarding investigation results, anyprocedure performed, medication andother treatment given

    d) Discharge summary contains follow upadvice, medication and other instructionsin an understandable manner.

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    National Accreditation Board for Hospitals & Healthcare Providers41

    Chapter .2PATIENT RIGHT AND

    EDUCATION (PRE)

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    National Accreditation Board for Hospitals & Healthcare Providers42

    PRE.1

    The organization protects patientand family rights during care

    Objective elementa) Patient and family rights are

    documented.

    b) Patients and families are informed oftheir rights in a format and language thatthey can understand

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    National Accreditation Board for Hospitals & Healthcare Providers43

    cont

    c) The organizations leaders protectpatients rights

    d) Staff is aware of their responsibility inprotecting patients rights

    e) Violation of patient rights is reviewed andcorrective/preventive measures taken

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    National Accreditation Board for Hospitals & Healthcare Providers44

    PRE.2.Patient rights support individual

    beliefs, values and involve thepatient and family in decision

    making processes Objective elementsa) Patient rights include respect for

    personal dignity and privacy duringexamination, procedures and treatmentb) Patient rights include protection from

    physical abuse or neglect

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    National Accreditation Board for Hospitals & Healthcare Providers45

    cont

    c) Patient rights include treating patientinformation as confidential

    d) Patient rights include refusal of treatmente) Patient rights include informed consent

    before anesthesia, blood and bloodproduct transfusions and any invasive /high risk procedures / treatment

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    National Accreditation Board for Hospitals & Healthcare Providers47

    PRE.3A documented process for

    obtaining patient and / orfamilies consent exists for

    informed decision making abouttheir care

    Objective elementsa) General consent for treatment is

    obtained when the patient enters theorganization

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    National Accreditation Board for Hospitals & Healthcare Providers48

    cont

    b) Patient and/or his family members are informedof the scope of such general consent

    c) The organization has listed those proceduresand treatment where informed consent isrequired

    d) Informed consent includes information on risks, benefits, alternatives and as to who willperform the requisite procedure in a languagethat they can understand

    e) The policy describes who can give consentwhen patient is incapable of independentsdecision making.

    PRE 4

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    National Accreditation Board for Hospitals & Healthcare Providers49

    PRE.4Patient and families have a right

    to information and educationabout their healthcare needs

    Objective elementsa) When appropriate, patient and families

    are educated about the safe andeffective use of medication and thepotential side effects of the medication

    b) Patient and families are educated aboutdiet and nutrition

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    cont

    c) Patient and families are educated aboutimmunizations

    d) Patient and families are educated about

    their specific disease process,complications and prevention strategiese) Patient and families are educated about

    preventing infectionsf) Patients are taught in a language and

    format that they can understand

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    National Accreditation Board for Hospitals & Healthcare Providers51

    PRE.5.

    Patient and families have a rightto information on expected costs

    Objective elementsa) There is uniform pricing policy in a given

    setting (out-patient and ward category)b) The tariff list is available to patientsc) Patients are educated about the

    estimated costs of treatment

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    National Accreditation Board for Hospitals & Healthcare Providers52

    cont

    d. Patients are informed about theestimated costs when there is a changein the patient condition or treatmentsetting

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    National Accreditation Board for Hospitals & Healthcare Providers53

    Chapter 3.Care of Patients (COP)

    COP 1

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    COP.1Uniform care of patients is

    guided by the applicable lawsand regulations

    Objective elementsa) Care delivery is uniform when similar

    care is provided in more than one settingb) Uniform care is guided by policies and

    procedures which reflect applicable lawsand regulations

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    National Accreditation Board for Hospitals & Healthcare Providers55

    cont

    c) The care and treatment orders aresigned, named, timed and dated by theconcerned doctor

    d) The care plan is countersigned by theclinician in-charge of the patient within 24hours

    e) Evidence based medicine and clinicalpractice guidelines are adopted to guidepatient care whenever possible

    COP 2

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    National Accreditation Board for Hospitals & Healthcare Providers56

    COP.2Emergency services are guided

    by policies, procedures,applicable laws and regulations

    Objective elementsa) Policies and procedure for emergency

    care are documented

    b) Policies also address handling ofmedico-legal casesc) The patients receive care in consonance

    with the policies

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    National Accreditation Board for Hospitals & Healthcare Providers57

    cont

    d) Policies and procedures guide the triageof patients for initiation of appropriatecare

    e) Staff is familiar with the policies andtrained on the procedures for care ofemergency patients

    f) Admission or discharge to home ortransfer to another organization is alsodocumented

    COP 3

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    National Accreditation Board for Hospitals & Healthcare Providers58

    COP.3The ambulance services are

    commensurate with the scope ofthe services provided by the

    organization Objective elementsa) There is adequate access and space for

    the ambulance(s)b) Ambulance(s) is appropriately equippedc) Ambulance(s) is manned by trained

    personnel

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    National Accreditation Board for Hospitals & Healthcare Providers59

    cont

    d) There is a checklist of all equipment andemergency medications

    e) Equipment are checked on a daily basisf) Emergency medications are checked

    daily and prior to dispatchg) The ambulance(s) has a proper

    communication system

    COP 4

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    COP.4Policies and procedures guide

    the care of patients requiringcardio-pulmonary resuscitation

    Objective elementsa) Documented policies and procedures

    guide the uniform use of resuscitationthroughout the organization

    b) Staff providing direct patient care istrained and periodically updated in cardiopulmonary resuscitation

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    National Accreditation Board for Hospitals & Healthcare Providers61

    cont

    c) The events during a cardio-pulmonaryresuscitation are recorded

    d) An analysis of all cardiac arrests is donee) A multidisciplinary committee monitors

    the effectiveness of cardio-pulmonaryresuscitation

    COP.5

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    COP.5Policies and procedures define

    rational use of blood and bloodproducts Objective elementsa) Documented policies and procedures are

    used to guide rational use of blood andblood products

    b) The transfusion services are governedby the applicable laws and regulations

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    National Accreditation Board for Hospitals & Healthcare Providers63

    Cont c) Informed consent is obtained for donation

    and transfusion of blood and bloodproducts

    d) Informed consent also includes patientand family education about donation

    e) Staff is trained to implement the policiesf) Transfusion reactions are analyzed for

    preventive and corrective actions

    COP 6

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    COP.6Policies and procedures guide the

    care of patients in the Intensivecare and high dependency units

    Objective elementsa) The organization has documented

    admission and discharge criteria for its

    intensive care and high dependencyunitsb) Staff is trained to apply these criteria

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    National Accreditation Board for Hospitals & Healthcare Providers65

    cont

    c) Adequate staff and equipment areavailable

    d) Defined procedures for situation of bed

    shortages are followede) Infection control practices are followedf) The unique needs of end of life patients

    are identified and cared forg) A quality assurance program isimplemented

    COP.7

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    National Accreditation Board for Hospitals & Healthcare Providers66

    Policies and procedures guide

    the care of vulnerable patients(elderly, children, physicallyand/or mentally challenged)

    Objective elementsa) Policies and procedures are documented

    and are in accordance with the prevailinglaws and the national and internationalguidelines

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    cont b) Staff is trained to care for this vulnerable groupc) Care is organized and delivered in accordance

    with the policies and proceduresd) The organization provides for a safe and

    secure environment for this vulnerable groupe) A documented procedure exists for obtaining

    informed consent from the appropriate legalrepresentative

    COP.8

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    National Accreditation Board for Hospitals & Healthcare Providers68

    Policies and procedures guide

    the care of high risk obstetricalpatients Objective elements.a) The organization defines and displays

    whether high risk obstetric cases can becared for or not

    b) Persons caring for high risk obstetriccases are competent

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    cont

    c) High risk obstetric patients assessmentalso includes maternal nutrition

    d) The organization has the facilities to takecare of neonates of high risk pregnancies

    COP.9

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    COP.9Policies and procedures guide

    the care of pediatric patients Objective elements .a) The organization defines and displays

    the scope of its pediatric servicesb) The policy for care of neonatal patients is

    in consonance with the national/international guidelines

    c) Those who care for children have agespecific competency

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    National Accreditation Board for Hospitals & Healthcare Providers71

    cont

    d) Provisions are made for special careof children

    e) Patient assessment includesdetailed nutritional, growth,psychosocial and immunizationassessment

    f) Policies and procedures preventchild/ neonate abduction and abuse

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    cont

    g) The childrens family members areeducated about nutrition,immunization and safe parentingand this is documented in themedical record

    COP.10

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    CO . 0Policies and procedures guide

    the care of patients undergoingmoderate sedation

    Objective elementsa) Competent and trained persons perform

    sedationb) The person administering and monitoring

    sedation is different from the personperforming the procedure

    cont

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    c) Intra-procedure monitoring includes at aminimum the heart rate, cardiac rhythm,respiratory rate, blood pressure, oxygensaturation, and level of sedation

    d) Patients are monitored after sedatione) Criteria are used to determineappropriateness of discharge from therecovery area

    f) Equipment and manpower are availableto rescue patients from a deeper level ofsedation than that intended

    COP.11

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    Policies and procedures guide

    the administration of anesthesia Objective elementsa) There is a documented policy and

    procedure for the administration ofanesthesia

    b) All patients for anesthesia have a pre-

    anesthesia assessment by a qualifiedindividual

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    cont c) The pre-anesthesia assessment results in

    formulation of an anesthesia plan which isdocumented

    d) An immediate preoperative reevaluation isdocumented

    e) Informed consent for administration ofanesthesia is obtained by the anesthetist

    f) During anesthesia monitoring includesregular and periodic recording of heart rate,cardiac rhythm, respiratory rate, bloodpressure, oxygen saturation, airway securityand patency and level of anesthesia

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    cont

    g) Each patients post -anesthesia status ismonitored and documented

    h) A qualified individual applies definedcriteria to transfer the patient from therecovery area

    i) All adverse anesthesia events arerecorded and monitored

    COP.12

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    Policies and procedures guide

    the care of patients undergoingsurgical procedures Objective elements

    a) The policies and procedures aredocumented

    b) Surgical patients have a preoperativeassessment and a provisional diagnosisdocumented prior to surgery

    cont

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    cont c) An informed consent is obtained by a

    surgeon prior to the procedured) Documented policies and procedures

    exist to prevent adverse events like

    wrong site, wrong patient and wrongsurgerye) Persons qualified by law are permitted to

    perform the procedures that they areentitled to perform

    f) An operative note is documented prior totransfer out of patient from recovery area

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    cont

    g) The operating surgeon documents thepost-operative plan of care

    h) A quality assurance program is followed

    for the surgical servicesi) The quality assurance program includes

    surveillance of the operation theatreenvironment

    j) The plan also includes monitoring ofsurgical site infection rates

    COP.13

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    Policies and procedures guide the

    care of patients under restraints(physical and / or chemical) Objective elements.a) Documented policies and procedures

    guide the care of patients underrestraints

    b) These include both physical andchemical restraint measures

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    National Accreditation Board for Hospitals & Healthcare Providers82

    cont

    c) These include documentation of reasonsfor restraints

    d) These patients are more frequentlymonitored

    e) Staff receive training and periodicupdating in control and restrainttechniques

    COP.14

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    Policies and procedures guide

    appropriate pain management Objective elementsa) Documented policies and procedures

    guide the management of painb) The organization respects and supports

    the appropriate assessment andmanagement of pain for all patients

    c) Patient and family are educated onvarious pain management techniques

    COP.15

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    Policies and procedures guide

    appropriate rehabilitative services Objective elementsa) Documented policies and procedures

    guide the provision of rehabilitativeservices

    b) These services are commensurate withthe organizational requirements

    c) Rehabilitative services are provided by amultidisciplinary team

    COP.16l d d d

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    Policies and procedures guideall research activities

    Objective elements.a) Documented policies and procedures

    guide all research activities in compliancewith national and international guidelines

    b) The organization has an ethics committeeto oversee all research activities

    c) The committee has the powers todiscontinue a research trial when risksoutweigh the potential benefits

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    cont

    d) Patients informed consent is obtainedbefore entering them in researchprotocols

    e) Patients are informed of their right towithdraw from the research at any stageand also of the consequences (if any) ofsuch withdrawal

    f) Patients are assured that their refusal toparticipate or withdrawal fromparticipation will not compromise theiraccess to the organizations services

    COP.17P li i d d id

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    Policies and procedures guidenutritional therapy

    Objective elementsa) Documented policies and procedures

    guide nutritional assessment andreassessmentb) Patients receive food according to their

    clinical needsc) There is a written order for the dietd) Nutritional therapy is planned and

    provided in a collaborative manner

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    cont

    e) When families provide food, they areeducated about the patients dietlimitations

    f) Food is prepared, handled, stored anddistributed in a safe manner

    COP.18

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    Policies and procedures guide

    the end of life care Objective elementsa) Documented policies and procedures

    guide the end of life careb) These policies and procedures are in

    consonance with the legal requirements

    c) These also address the identification ofthe unique needs of such patient andfamily

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    Chapter4.

    MANAGEMENT OFMEDICATION (MOM)

    MOM.1

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    Policies and procedures guide the

    organization of pharmacyservices and usage of medication Objective elementsa) There is a documented policy and

    procedure for pharmacy services andmedication usage

    b) These comply with the applicable lawsand regulations

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    c) A multidisciplinary committee guides theformulation and implementation of thesepolicies and procedures

    MOM.2

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    There is a hospital formulary Objective elementsa) A list of medication appropriate for the

    patients and organizations resources is

    developedb) The list is developed collaboratively bythe multidisciplinary committee

    c) There is a defined process for acquisitionof these medications

    d) There is a process to obtain medicationsnot listed in the formulary

    MOM.3P li i d d i f

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    Policies and procedures exist forstorage of medication.

    Objective elementsa) Documented policies and procedures

    exist for storage of medicationb) Medications are stored in a clean, well lit

    and ventilated environment

    c) Sound inventory control practices guidestorage of the medications

    t

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    cont d) Medications are protected from loss or

    thefte) Sound alike and look alike medications

    are stored separately

    f) There is a method to obtain medicationwhen the pharmacy is closed

    g) Emergency medications are available all

    the timeh) Emergency medications are replenishedin a timely manner when used

    MOM.4

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    Policies and procedures guide

    the prescription of medications Objective elementsa) Documented policies and procedures

    exist for prescription of medicationsb) The organization determines who can

    write orders

    c) Orders are written in a uniform location inthe medical records

    t

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    d) Medication orders are clear, legible,dated, named and signed

    e) Policy on verbal orders is documentedand implemented

    f) The organization defines a list of highrisk medication

    g) High risk medication orders are verifiedprior to dispensing

    MOM.4

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    Policies and procedures guide the

    safe dispensing of medications Objective elementsa) Documented policies and procedures

    guide the safe dispensing of medicationsb) The policies include a procedure for

    medication recall

    c) Expiry dates are checked prior todispensingd) Labeling requirements are documented

    and implemented by the organization

    MOM.5h d f d d

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    There are defined procedures

    for medication administration Objective elementsa) Medications are administered by those

    who are permitted by law to do sob) Prepared medication are labeled prior to

    preparation of a second drug

    c) Patient is identified prior to administration

    cont

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    cont

    d) Medication is verified from the order priorto administration

    e) Dosage is verified from the order prior toadministration

    f) Route is verified from the order prior toadministration

    g) Timing is verified from the order prior toadministration

    cont

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    cont

    h) Medication administration is documentedi) Polices and procedures govern patients

    self administration of medications j) Polices and procedures govern patients

    medications brought from outside theorganization

    MOM.7

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    Patients and family members are

    educated about safe medicationand food-drug interactions Objective elementsa) Patient and family are educated about

    safe and effective use of medicationb) Patient and family are educated about

    food-drug interactions

    MOM.8

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    Patients are monitored after

    medication administration Objective elementsa) Patients are monitored after medication

    administration and this is documentedb) Adverse drug events are defined

    c) Adverse drug events are reported withina specified time frame

    cont

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    cont

    d) Adverse drug events are collected andanalysed

    e) Policies are modified to reduce adversedrug events when unacceptable trendsoccur

    MOM.9l d d d

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    Policies and procedures guide

    the use of narcotic drugs andpsychotropic substances Objective elementsa) Documented policies and procedures

    guide the use of narcotic drugs andpsychotropic substances

    b) These policies are in consonance withlocal and national regulations

    cont

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    cont

    c) A proper record is kept of the usage,administration and disposal of thesedrugs

    d) These drugs are handled by appropriatepersonnel in accordance with policies

    MOM.10

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    Policies and procedures guide

    the usage of chemotherapeuticagents

    Objective elementsa) Documented policies and procedures

    guide the usage of chemotherapeuticagents

    b) Chemotherapy is prescribed by thosewho have the knowledge to monitor andtreat the adverse effect of chemotherapy

    cont

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    cont

    c) Chemotherapy is prepared andadministered by qualified personnel

    d) Chemotherapy drugs are disposed off inaccordance with legal requirements

    MOM.11P li i d d g

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    Policies and procedures govern

    usage of radioactive orinvestigational drugs Objective elements.

    a) Documented policies and proceduresgovern usage of radioactive orinvestigational drugs

    b) These policies and procedures are inconsonance with laws and regulations

    cont

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    cont

    c) The policies and procedures include thesafe storage, preparation, handling,distribution and disposal of radioactiveand investigational drugs

    d) Staff, patients and visitors are educatedon safety precautions

    MOM.12P li i d d id h

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    Policies and procedures guide the

    use of implantable prosthesis Objective elements.

    a) Documented policies and proceduresgovern procurement and usage ofimplantable prosthesis

    b) Selection of implantable prosthesis isbased on scientific criteria andinternationally recognized approvals

    cont

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    cont

    c) The batch and serial number of theimplantable prosthesis are recorded inthe patients medical record and the

    master logbook

    MOM.13Policies and procedures guide

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    Policies and procedures guide

    the use of medical gases Objective elementsa) Documented policies and procedures

    govern procurement, handling, storage,distribution, usage and replenishment ofmedical gases.

    b) The policies and procedures address thesafety issues at all levels

    Cont

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    Cont

    c) Appropriate records are maintained inaccordance with the policies, proceduresand legal requirements.

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    Chapter 5

    HOSPITAL INFECTIONCONTROL (HIC)

    HIC.1

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    The organization has a well-designed, comprehensive andcoordinated Hospital Infection

    Control (HIC) programme aimedat reducing/ eliminating risks topatients, visitors and providers

    of care.

    Objective elements

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    Objective elementsa) The hospital has a multi-disciplinary

    infection control committee.b) The hospital has an infection control

    team.c) The hospital has designated and

    qualified infection control nurse(s) for thisactivity

    d) The hospital infection control programmeis documented.

    HIC.2

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    The hospital has an infection

    control manual, which isperiodically updated.

    Objective elementsa) The manual identifies the various high-

    risk areas.

    b) It outlines methods of surveillance in theidentified high-risk areas.

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    Cont

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    Cont

    g) Kitchen sanitation and food handlingissues are included in the manual

    h) Engineering controls to prevent

    infections are includedi) Mortuary practices and procedures are

    included as appropriate to the

    organization

    HIC.3Th i f ti t l t i

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    The infection control team is

    responsible for surveillanceactivities in identified areas ofthe hospital.

    Objective elementsa) Surveillance activities are appropriately

    directed towards the identified high-riskareas.

    b) Collection of surveillance data is anongoing process.

    Cont

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    Cont

    c) Verification of data is done on regularbasis by the infection control team.

    d) In cases of notifiable diseases,

    information (in relevant format) is sent toappropriate authorities.

    e) Scope of surveillance activities

    incorporates tracking and analyzing ofinfection risks, rates and trends.

    HIC.4h h i l k i

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    The hospital takes actions to

    prevent or reduce the risks ofHospital Associated Infections

    (HAI) in patients and employees. Objective elementsa) The organization monitors urinary tract

    infections.b) The organization monitors respiratory

    tract infections.

    Cont

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    Cont

    c) The organization monitors intra-vasculardevice infections.

    d) The organization monitors surgical site

    infections.e) Appropriate feedback regarding HAI

    rates are provided on a regular basis to

    medical and nursing staff.

    HIC.5

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    Proper facilities and adequate

    resources are provided to supportthe infection control programme

    Objective elementsa) Hand washing facilities in all patient care

    areas are accessible to health care

    providers.b) Compliance with proper hand washing ismonitored regularly.

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    HIC.6Th h i l k i i

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    The hospital takes appropriate action

    to control outbreaks of infections. Objective elementsa) Hospital has a documented procedure

    for handling such outbreaks.b) This procedure is implemented during

    outbreaks.c) After the outbreak is over appropriate

    corrective actions are taken to preventrecurrence

    HIC.7There are documented procedures

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    pfor sterilisation activities in the

    hospital. Objective elementsa) There is adequate space available for

    sterilization activitiesb) Regular validation tests for sterilisation

    are carried out and documented.c) There is an established recall procedure

    when breakdown in the sterilisationsystem is identified

    HIC.8Statutory provisions with regard

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    Statutory provisions with regardto Bio-medical Waste (BMW)

    management are complied with Objective elements

    a) The hospital is authorised by prescribedauthority for the management andhandling of Bio-medical Waste.

    b) Proper segregation and collection of Bio-medical Waste from all patient careareas of the hospital is implemented andmonitored.

    Cont

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    c) The organization ensures that Bio-medical Waste is stored and transportedto the site of treatment and disposal inproper covered vehicles within stipulatedtime limits in a secure manner.

    d) Bio-medical Waste treatment facility ismanaged as per statutory provisions (if

    in-house) or outsourced to authorisedcontractor(s).

    Cont

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    e) Requisite fees, documents and reportsare submitted to competent authoritieson stipulated dates.

    f) Appropriate personal protectivemeasures are used by all categories ofstaff handling Bio-medical Waste

    HIC.9The infection control programme

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    The infection control programme

    is supported by hospitalmanagement and includes trainingof staff and employee health

    Objective elementsa) Hospital management makes available

    resources required for the infection

    control programmeb) The hospital regularly earmarks

    adequate funds from its annual budget in

    this regard

    Cont

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    c) It conducts regular pre-induction trainingfor appropriate categories of staff before

    joining concerned department(s).

    d) It also conducts regular in-service training sessions for all concernedcategories of staff at least once in a year.

    e) Appropriate pre and post exposureprophylaxis is provided to all concernedstaff members

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    Chapter 6CONTINUOUS QUALITY

    IMPROVEMENT (CQI)

    CQI.1There is a structured quality

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    There is a structured quality

    assurance and continuousmonitoring programme in theorganization

    Objective elementsa) The quality assurance programme is

    developed, implemented and maintainedby a multi-disciplinary committee.

    b) The quality assurance programme isdocumented.

    Cont

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    c) There is a designated individual forcoordinating and implementing thequality assurance programme

    d) The quality assurance programme iscomprehensive and covers all the majorelements related to quality assurance

    and risk management.

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    Cont

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    g) The quality assurance programme is acontinuous process and updated at leastonce in a year.

    CQI.2The organization identifies key

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    indicators to monitor the clinicalstructures, processes and

    outcomes Objective elementsa) Monitoring includes appropriate patient

    assessment.b) Monitoring includes diagnostics services

    safety and quality control programmes.c) Monitoring includes all invasive

    procedures.

    Cont

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    d) Monitoring includes adverse drug events.e) Monitoring includes use of anaesthesia.f) Monitoring includes use of blood and

    blood products.g) Monitoring includes availability and

    content of medical records.

    h) Monitoring includes infection controlactivities.i) Monitoring includes clinical research.

    CQI.3The organisation identifies key

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    g yindicators to monitor the

    managerial structures, processesand outcomes

    Objective elements Monitoring includes procurement of

    medication essential to meet patient

    needs. Monitoring includes reporting of activities

    as required by laws and regulations.

    Cont

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    Monitoring includes risk management. Monitoring includes utilisation of facilities. Monitoring includes patient satisfaction.

    Monitoring includes employee satisfaction. Monitoring includes adverse events. Monitoring includes data collection to

    support further study for improvements. Monitoring includes data collection to

    support evaluation of the improvements.

    .The quality improvement

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    programme is supported by themanagement

    Objective elementsa) Hospital Management makes available

    adequate resources required for qualityimprovement programme.

    b) Hospital earmarks adequate funds fromits annual budget in this regard.

    c) Appropriate statistical and managementtools are applied whenever required

    CQI.5There is an established system

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    yfor audit of patient care services

    Objective elementsa) Medical staff participates in this system.

    b) The parameters to be audited aredefined by the organisation.

    c) Patient and clinician anonymity is

    maintained.d) All audits are documented.e) Remedial measures are implemented.

    CQI.6Sentinel events are intensively

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    analysed Objective elementsa) The organisation has defined sentinel

    events.b) The organisation has established processes

    for intense analysis of such events.c) Sentinel events are intensively analysed

    when they occur.d) Actions are taken upon findings of such

    analysis

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    Chapter 7

    RESPONSIBILITIES OFMANAGEMENT (ROM)

    ROM.1The responsibilities of the

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    p

    management are defined Objective elementsa) The organization has a documented

    organogramb) Those responsible for governance

    appoint the senior leaders in the

    organizationc) Those responsible for governance

    support the quality improvement plan

    Cont

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    d) The organization complies with the laiddown and applicable legislations andregulations

    e) Those responsible for governanceaddress the organizations socialresponsibility

    ROM.2The services provided by each

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    department are documented Objective elementsa) Each organizational program, service, site or

    department has effective leadershipb) Scope of services of each department is

    definedc) Administrative policies and procedures for

    each department is maintainedd) Departmental leaders are involved in quality

    improvement

    ROM.3The organization is managed by

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    g g y

    the leaders in an ethical manner Objective elementsa) The leaders make public the mission

    statement of the organizationb) The leaders establish the organizations

    ethical managementc) The organization discloses its ownership

    Cont

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    d) The organization honestly portrays theservices which it can and cannot provide

    e) The organization accurately bills for its

    services

    ROM.4A suitably qualified and experienced individual heads

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    A suitably qualified and experienced individual heads

    the organisation Objective elementsa) The designated individual has requisite

    and appropriate administrativequalifications.

    b) The designated individual has requisite

    and appropriate administrativeexperience.

    ROM.5Leaders ensure that patient

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    p

    safety aspects and riskmanagement issues are anintegral part of patient care and

    hospital management Objective elements

    a) The organization has an interdisciplinarygroup assigned to oversee the hospitalwide safety programme.

    Cont

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    b) The scope of the programme is definedto include adverse events ranging fromno harm to sentinel events .

    c) Management ensures implementation ofsystems for internal and externalreporting of system and process failures.

    d) Management provides resources forproactive risk assessment and riskreduction activities.

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    Chapter 8FACILITY MANAGEMENT AND

    SAFETY (FMS)

    FMS.1The organization is aware of and

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    g

    complies with the relevant rulesand regulations, laws andbyelaws and requisite facility

    inspection requirements Objective elementsa) The management is conversant with the

    laws and regulations and knows theirapplicability to the organization.

    Cont

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    b) Management regularly updates anyamendments in the prevailing laws of theland.

    c) The management ensuresimplementation of these requirements.

    d) There is a mechanism to regularly

    update licenses/registrations/certifications

    FMS.2The organizations environment

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    The organization s environment

    and facilities operate to ensuresafety of patients, staff and

    visitors

    Objective elementsa) There is a documented operational and

    maintenance (preventive andbreakdown) plan.

    Cont

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    b) Up-to-date drawings are maintainedwhich detail the site layout, floor plansand fire escape routes.

    c) The provision of space shall be in

    accordance with the available literatureon good practices (Indian or InternationalStandards) and directives fromgovernment agencies.

    d) There are designated individualsresponsible for the maintenance of all thefacilities.

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    FMS.3The organization has a programf li i l d i

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    for clinical and support serviceequipment management

    Objective elementsa) The organization plans for equipment in

    accordance with its services andstrategic plan

    b) Equipment is selected by a collaborativeprocess.

    c) All equipment is inventoried and properlogs are maintained as required.

    Cont

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    d) Qualified and trained personnel operateand maintain the equipment.

    e) Equipment are periodically inspected and

    calibrated for their proper functioning.f) There is a documented operational and

    maintenance (preventive and

    breakdown) plan.

    FMS.4The organization has provisions

    f f l i i di l

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    for safe water, electricity, medicalgases and vacuum systems

    Objective elementsa) Potable water and electricity are available

    round the clock.b) Alternate sources are provided for in case of

    failure.

    c) The organisation regularly tests the alternatesources.d) There is a maintenance plan for piped

    medical gas and vacuum installation.

    FMS.5The organization has plans for

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    fire and non-fire emergencieswithin the facilities

    Objective elementsa) The organization has plans andprovisions for early detection, abatementand containment of fire and non-fireemergencies.

    Cont

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

    c) The organization has a documented safe

    exit plan in case of fire and non-fireemergencies.

    d) Mock drills are held at least twice in a

    year

    FMS.6The organization has a smoking

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    limitation policy Objective elementsa) The organization defines its polices to

    reduce or eliminate smokingb) The policy has provisions for granting

    exceptions for patients and families to

    smoke

    FMS.7The organization plans for handling

    it g i id i

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    community emergencies, epidemicsand other disasters

    Objective elementsa) The hospital identifies potential

    emergencies.b) The organization has a documented

    disaster management plan.

    Cont

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    c) Provision is made for availability ofmedical supplies, equipment andmaterials during such emergencies.

    d) Hospital staff is trained in the hospitalsdisaster management plane) The plan is tested at least twice in a

    year.

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    Cont

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    c) Requisite regulatory requirements aremet in respect of radioactive materials.

    d) There is a plan for managing spills ofhazardous materials

    e) Staff is educated and trained for

    handling such materials.

    FMS.9The hospital has system in place

    id f d

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    to provide a safe and secureenvironment

    Objective elements

    a) The hospital has a safety committee toidentify the potential safety and securityrisks.

    b) This committee coordinates development,implementation, and monitoring of thesafety plan and policies.

    Cont

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    c) Facility inspection rounds to ensuresafety are conducted at least twice in ayear in patient care areas and at leastonce in a year in non-patient care areas.

    d) Inspection reports are documented andcorrective and preventive measures areundertaken.

    e) There is a safety education programmefor all staff.

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    Chapter9

    HUMAN RESOURCEMANAGEMENT

    HRM.1The organization has a

    d t d t f h

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    documented system of humanresource planning

    Objective elementsa) The organization maintains an adequate

    number and mix of staff to meet the care,treatment and service needs of thepatient.

    Cont

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

    c) The organization verifies the antecedentsof the potential employee with regards to

    criminal/negligence background.

    HRM.2The staff joining the organization

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    The staff joining the organization

    is socialized and oriented to thehospital environment

    Objective elementsa) Each staff member, employee, student

    and voluntary worker is appropriatelyoriented to the organizations missionand goals.

    Cont b) E h t ff b i d f

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    b) Each staff member is made aware ofhospital wide policies and procedures aswell as relevant department / unit /service / programmes policies andprocedures.

    c) Each staff member is made aware ofhis/her rights and responsibilities.

    d) All employees are educated with regardto patients rights and responsibilities.

    e) All employees are oriented to the servicestandards of the organisation

    HRM.3There is an ongoing programme

    for professional training and

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    for professional training anddevelopment of the staff

    Objective elementsa) A documented training and development

    policy exists for the staff.b) Training also occurs when job

    responsibilities change/ new equipment

    is introduced.c) Feedback mechanisms for assessmentof training and development programmeexist.

    HRM.4Staff members, students and

    volunteers are adequately

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    volunteers are adequatelytrained on specific job duties orresponsibilities related to safety

    Objective elementsa) All staff is trained on the risks within the

    hospital environment.

    b) Staff members can demonstrate andtake actions to report, eliminate /minimize risks.

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    HRM.5 An appraisal system for evaluating

    the performance of an employee

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    the performance of an employeeexists as an integral part of the

    human resource management

    process Objective elementsa) A well-documented performance

    appraisal system exists in theorganization.

    Cont

    b) Th l d f h

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    b) The employees are made aware of thesystem of appraisal at the time ofinduction.

    c) Performance is evaluated based on the

    performance expectations described in job description.d) The appraisal system is used as a tool

    for further development.e) Performance appraisal is carried out at

    pre defined intervals and is documented.

    HRM.6The organization has a well-

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    documented disciplinaryprocedure

    Objective elementsa) A written statement of the policy of the

    organization with regard to discipline is inplace.

    b) The disciplinary policy and procedure isbased on the principles of natural justice.

    Cont

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    c) The policy and procedure is known to allcategories of employees of theorganization.

    d) The disciplinary procedure is inconsonance with the prevailing laws.e) There is a provision for appeals in all

    disciplinary cases.

    HRM.7A grievance handling mechanism

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    exists in the organization Objective elementsa) The employees are aware of the

    procedure to be followed in case theyfeel aggrieved.

    b) The redress procedure addresses thegrievance.

    c) Actions are taken to redress thegrievance

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    Cont

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    c) Regular physical and medical checks aredone at-least once a year and thefindings/ results are documented.

    d) Occupational health hazards areadequately addressed.

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    Cont

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    c) All records of in-service training andeducation are contained in the personalfiles.

    d) Personal files contain results of allevaluations

    HRM 10

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    HRM.10There is a process for collecting, verifyingand evaluating the credentials(education, registration, training and

    experience) of medical professionalspermitted to provide patient care without

    supervision

    Objective elementsa) Medical professionals permitted by law,

    regulation and the hospital to provide

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    regulation and the hospital to providepatient care without supervision isidentified.

    b) The education, registration, training and

    experience of the identified medicalprofessionals is documented andupdated periodically.

    c) All such information pertaining to themedical professionals is appropriatelyverified when possible.

    HRM.11There is a process for authorising

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    p g

    all medical professionals to admitand treat patients and provide

    other clinical servicescommensurate with their

    qualifications

    Objective elementsa) Medical professionals admit and care for

    patients as per the laid down policies

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    patients as per the laid down policiesand authorisation procedures of theorganization

    b) The services provided by the medical

    professionals are in consonance withtheir qualification, training andregistration.

    c) The requisite services to be provided bythe medical professionals are known tothem as well as the various departments/ units of the hospital.

    HRM.12There is a process for collecting,

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    verifying and evaluating thecredentials (education,registration, training and

    experience) of nursing staff Objective elements

    a) The education, registration, training andexperience of nursing staff isdocumented and updated periodically.

    Cont

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    b) All such information pertaining to thenursing staff is appropriately verifiedwhen possible

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    HRM.13There is a process to identify jobresponsibilities and make clinical work

    assignments to all nursing staff memberscommensurate with their qualifications

    and any other regulatory requirements

    Objective elementsa) The clinical work assigned to nursing

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    a) The clinical work assigned to nursingstaff is in consonance with theirqualification, training and registration.

    b) The services provided by nursing staff

    are in accordance with the prevailinglaws and regulations.c) The requisite services to be provided by

    the nursing staff are known to them aswell as the various departments / units ofthe hospital

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    Chapter.10INFORMATION

    MANAGEMENT SYSTEM (IMS)

    IMS.1

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    Policies and procedures exist to meet theinformation needs of the care providers,management of the organization as wellas other agencies that require data andinformation from the organization

    Objective elementsa) The information needs of the

    organization are identified and are

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    organization are identified and areappropriate to the scope of the servicesbeing provided by the organization andthe complexity of the organization

    b) Policies and procedures to meet theinformation needs are documented.c) These policies and procedures are in

    compliance with the prevailing laws andregulations.

    Cont

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    d) All information management andtechnology acquisitions are inaccordance with the policies andprocedures.

    e) The organization contributes to externaldatabases in accordance with the lawand regulations

    IMS.2The organization has processesin place for effective

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    pmanagement of data

    Objective elements

    a) Formats for data collection arestandardized

    b) Necessary resources are available for

    analyzing data

    Cont

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    c) Documented procedures are laid downfor timely and accurate dissemination ofdata

    d) Documented procedures exist for storingand retrieving datae) Appropriate clinical and managerial staff

    participates in selecting, integrating andusing data.

    IMS.3The organization has a complete

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    and accurate medical record forevery patient

    Objective elements a) Every medical record has a unique

    identifier.b) Organization policy identifies those

    authorized to make entries in medicalrecord.

    Cont

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    c) Every medical record entry is dated andtimed.d) The author of the entry can be identified

    e) The contents of medical record areidentified and documented

    f) The record provides an up-to-date and

    chronological account of patient care

    IMS.4The medical record reflects

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    continuity of care Objective elementsa) The medical record contains information

    regarding reasons for admission,diagnosis and plan of care.

    b) Operative and other proceduresperformed are incorporated in themedical record

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    Cont

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    e) In case of death, the medical recordcontains a copy of the death certificateindicating the cause, date and time ofdeath.

    f) Whenever a clinical autopsy is carriedout, the medical record contains a copyof the report of the same.

    g) Care providers have access to currentand past medical record.

    IMS.5Policies and procedures are in place formaintaining confidentiality integrity and

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    maintaining confidentiality, integrity and

    security of information

    Objective elementsa) Documented policies and procedures

    exist for maintaining confidentiality,

    security and integrity of information

    Cont

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    b) Policies and procedures are inconsonance with the applicable lawsc) The policies and procedures incorporate

    safeguarding of data/ record againstloss, destruction and tamperingd) The hospital has an effective process of

    monitoring compliance of the laid downpolicy

    Cont

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    e) The hospital uses developments inappropriate technology for improving,confidentiality, integrity and security

    f) Privileged health information is used forthe purposes identified or as required bylaw and not disclosed without the

    patients authorization

    Cont

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    g) A documented procedure exists on howto respond to patients / physicians andother public agencies requests foraccess to information in the clinicalrecord in accordance with the local andnational law.

    IMS.6Policies and procedures exist for

    retention time of records data

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    retention time of records, dataand information

    Objective elements

    a) Documented policies and procedures arein place on retaining the patients clinicalrecords, data and information

    b) The policies and procedures are inconsonance with the local and nationallaws and regulations

    Cont

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    c) The retention process provides expectedconfidentiality and securityd) The destruction of medical records, data

    and information is in accordance with thelaid down policy

    IMS.7The organization regularly

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    carries out medical audits Objective elementsa) The medical records are reviewed

    periodicallyb) The review uses a representative sample

    c) The review is conducted by identifiedcare providers.

    Cont

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    d) The review focuses on the timeliness,legibility and completeness of themedical records

    e) The review process includes records ofboth active and discharged patients

    f) The review points out and documentsany deficiencies in records

    g) Appropriate corrective and preventivemeasures undertaken are documented.

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    Thank you