NABH Manual

Embed Size (px)

DESCRIPTION

NABH MANUAL FOR HOSPITAL RECOGNITION

Citation preview

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

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

    Objective Element Interpretation Remarksa) The services being

    provided are clearly defined and are in consonance with the needs of the community.

    A policy to be framed clearly stating the services the hospital can provide. Scope of Services

    b) The defined services are prominently displayed.

    The services so defined should be displayed prominently in an area visible to all patients entering the organization. The display could be in the form of boards, citizen's charter, scrolling messages etc. Care should be taken to ensure that these are displayed in the language(s) the patient understands.

    Evident on Site

    c) The staff is oriented to these services.

    All the staff in the Hospital mainly in the reception/registration, OPD, IPD are oriented to these facts through training programme regularly or through manuals.

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

    Objective Element Interpretation Remarksa) Standardized policies and

    procedures are used for registering and admitting patients.

    Health Care Organization (HCO) has prepared document (s) detailing the policies and procedures for registration and admission of patients which should also include unidentified patients.

    Registration process

    Admission Process

    b) The policies and procedures address out- patients, in-patients and emergency patients.

    Self explanatoryAdmission Process

    c) Patients are accepted only if the organization can provide the required service.

    The staff handling admission and registration needs to be aware of the services that the organization can provide. It is also advisable to have a system wherein the staff is aware as to whom to contact if they need any clarification on the services provided.

    Admission Process

  • d) The policies and procedures also address managing patients during non availability of beds.

    The HCO is aware of the availability of alternate HCO's where the patients may be directed in case of non-availability of beds.

    Policy for non availability of beds

    e) The staff is aware of these processes.

    All the staff handling these activities should be oriented to these policies and procedures.

    Induction Manual

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

    Objective Element Interpretation Remarksa) Policies guide the transfer

    of unstable patients to another facility in an appropriate manner.

    The organization shall at the outset define as to who is an unstable patient. The documented policy and procedure should address the methodology of safe transfer of the patient in a life threatening situation (like those who are on ventilator) to another HCO. There should be availability of an appropriate ambulance fitted with life support facilities and accompanied by trained personnel.

    Patient Transfer Policy

    b) Policies guide the transfer of stable patients to another facility.

    Patients not in a life threatening situation (stable) should also be transported in a safe manner.

    Patient Transfer Policy

    c) Procedures identify staff responsible during transfer.

    The staff shall at least be a trained trauma/emergency technician/nurse. He/she shall have undergone training in BLS and/or ACLS.

    Patient Transfer Policy

    d) The organization gives a summary of patients condition and the treatment given.

    The HCO gives a case summary mentioning the significant findings and treatment given in case of patients who are being transferred from emergency. For admitted patients a discharge summary has to be given (refer AAC15).The same shall also be given to patients going against medical advice.

    Discharge Summary

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

    Objective Element Interpretation Remarks

    2

  • a) The patients and/or family members are explained about the proposed care.

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

    Patients Right Policy

    b) The patients and/or family members are explained about the expected results.

    The patients and family are explained in detail by the treating physicians or his/her team about the outcomes of such treatment.

    Patients Right Policy

    c) The patients and/or family members are explained about the possible complications.

    Possible complications of the treatment, if any, are clearly communicated to the patient.

    Patients Right Policy

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

    Patients should be given an estimate of the expenses on account of the treatment preferably in a written form.

    Patients Right Policy

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

    Objective Element Interpretation Remarksa) The organization defines

    the content of the assessments for the outpatients, in-patients and emergency patients.

    The hospital shall have a protocol/policy by which a standardized initial assessment of patients is done in the OPD, emergency and in-patients. The initial assessment could be standardized across the hospital or it could be modified depending on the need of the department. However it shall be the same in that particular area e.g. in a paediatric OPD the weight and height may be a must whereas it may not be so for orthopaedics OPD. The organization can have different assessment criteria for the first visit and for subsequent visits. In emergency department this shall include recording the vital parameters. The initial assessment should also include the nursing assessment for in-patients.

    Initial Assessment Policy

    b) The organization determines who can perform the assessments.

    The assessment should be done by the treating doctor, junior doctor or a nurse. The organization determines who can do what assessment and it should be the same across the hospital.

    Initial Assessment Policy

    c) The organization defines the time frame within which the initial assessment is completed.

    The HCO has defined and documented the time frame within which the initial assessment is to be completed with respect to OPD/ emergency/indoor patients.

    I Initial Assessment Policy

    3

  • d) The initial assessment for in-patients is documented within 24 hours or earlier as per the patients condition or hospital policy.

    This should cover history, progress notes, investigation ordered and treatment ordered and all these are to be authenticated by treating doctor.

    Initial Assessment Policy

    e) Initial assessment includes screening for nutritional needs.

    The protocol for patients initial assessment should cover his/her nutritional needs. In case of Out patients this should be done where ever applicable. For example diabetics, CRF patients.

    Initial Assessment Policy

    f) The initial assessment results in a documented plan of care which is monitored.

    This shall be documented by the treating doctor or by a member of his team in the case sheet. This plan is monitored by the treating doctor for its effectiveness, and wherever required by a clinical audit.

    Initial Assessment Policy

    g) The plan of care also includes preventive aspects of the care.

    The documented plan of care should cover preventive actions as necessary in the case and should include diet, drugs etc.

    Initial Assessment Policy

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

    Objective Element Interpretation Remarksa) All patients are

    reassessed at appropriate intervals.

    After the initial assessment, the patient is reassessed periodically and this is documented in the case sheet. The frequency maybe different for different areas based on the setting and the patient's condition e.g. patients in ICU need to reassessed more frequently compared to a patient in the ward.

    Initial Assessment Policy

    b) Staff involved in direct clinical care document reassessments.

    Actions taken under reassessment are documented. The staff could be the treating doctor or any member of the team as per their domain of responsibility of care.

    Initial Assessment Policy

    c) Patients are reassessed to determine their response to treatment and to plan further treatment or discharge.

    Self explanatory.Initial Assessment

    Policy

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

    Objective Element Interpretation Remarks

    4

  • a) Scope of the laboratory services are commensurate to the services provided by the organization.

    The HCO should ensure availability of laboratory services commensurate with the health care services offered by it either by providing the same in house or by outsourcing. However, test results required for emergency management (RBS, ABG etc) must be available within its premises. See also (f) below for outsourced lab facilities.

    Laboratory Manual

    b) Adequately qualified and trained personnel perform and/or supervise the investigations.

    The staff employed in the lab should be suitably qualified (appropriate degree) and trained to carry out the tests. Pathologist, microbiologist and biochemist supervise the staff.

    Laboratory Manual

    c) Policies and procedures guide collection, identification, handling, safe transportation, processing and disposal of specimens.

    The HCO has documented procedures for collection, identification, handling, safe transportation, processing and disposal of specimens, to ensure safety of the specimen till the tests and retests (if required) are completed.

    Laboratory Manual

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

    The HCO shall define the turnaround time for all tests. The HCO should ensure availability of adequate staff, materials and equipment to make the laboratory results available within the defined time frame.

    Laboratory Manual

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

    The laboratory shall establish its biological reference intervals for different tests. The laboratory shall establish critical limits for tests which require immediate attention for patient management. The test results in the critical limits shall be communicated to the concerned after proper documentation.

    Laboratory Manual

    f) Laboratory tests not available in the organization are outsourced to organization(s) based on their quality assurance system.

    The HCO has documented procedure for outsourcing tests for which it has no facilities. This should include: a) list of tests for out sourcing. b) identity of personnel in the out

    sourced facilities to ensure safe transportation of specimens and completing of tests as per requirements of the patient concerned and receipt of results at HCO.

    c) manner of packaging of the specimens and their labelling for identification and this package should contain the test requisition with all details as required for testing.

    d) a methodology to check the performance of service rendered by the out sourced laboratory as per the requirements of the HCO.

    Laboratory Manual

    5

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

    Objective Element Interpretation Remarksa) The laboratory quality

    assurance programme is documented.

    The HCO has a documented quality assurance programme (preferably as per ISO 15189 Medical laboratories Particular requirements for quality and competence).

    Laboratory QA Manual

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

    This holds true for any laboratory developed methods. Laboratory QA Manual

    c) The programme addresses surveillance of test results.

    The laboratory director shall periodically assess the test results. Laboratory QA Manual

    d) The programme includes periodic calibration and maintenance of all equipments.

    Refer to ISO 15189.Laboratory QA Manual

    e) The programme includes the documentation of corrective and preventive actions.

    Self explanatory.Laboratory QA Manual

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

    Objective Element Interpretation Remarksa) The laboratory safety

    programme is documented.

    A well documented lab safety manual is available in the lab. This takes care of the safety of the workforce as well as the equipments available in the lab.

    Laboratory Safety Manual

    b) This programme is integrated with the organizations safety programme.

    Lab safety programme is incorporated in the safety programme of the hospital. Laboratory Safety

    Manual

    c) Written policies and procedures guide the handling and disposal of infectious and hazardous materials.

    The lab staff should follow standard precautions. The disposal of waste is according to Biomedical waste management and handling rules, 1998.

    Laboratory Safety Manual

    d) Laboratory personnel are appropriately trained in safe practices.

    All the lab staff undergo training regarding safe practices in the lab. Laboratory Safety

    Manual

    e) Laboratory personnel are provided with appropriate safety equipment / devices.

    Adequate safety devices are available in the lab e.g. fire extinguishers, dressing materials, standard precautions, disinfectants, etc.

    Laboratory Safety Manual

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

    6

  • Objective Element Interpretation Remarksa) Imaging services comply

    with legal and other requirements.

    The HCO is aware of the legal and other requirements of imaging services and the same are documented for information and compliance by all concerned in the HCO. The HCO maintains and updates its compliance status of legal and other requirements in a regular manner.

    Imaging Department

    b) Scope of the imaging services are commensurate to the services provided by the organization.

    Self explanatory.Imaging Department

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

    As per AERB guidelines.Imaging Department

    d) Policies and procedures guide identification and safe transportation of patients to imaging services.

    The HCO has documented policies and procedures for informing the patients about the imaging activities, their identification and safe transportation to the imaging services. This should also address transfer of unstable patients to imaging services.

    Imaging Department

    Patient Transfer Policy

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

    The organization shall document turnaround time of imaging results. Imaging Department

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

    Critical results shall be intimated to the treating clinician at the earliest on phone, followed by written report.

    Imaging Department

    g) Imaging tests not available in the organization are outsourced to organization(s) based on their quality assurance system.

    The HCO has documented procedure for outsourcing tests for which it has no facilities. This should include: a) list of tests for out sourcing, b) identity of personnel in the out sourced facilities to ensure safe transportation of specimens and completing of imaging results, c) manner of identification of patients and the test requisition with all details as required for testing andd) a methodology to check the selection and performance of service rendered by the outsourced imaging facility as per the requirements of the HCO.

    Imaging Department

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

    Objective Element Interpretation Remarks

    7

  • a) The quality assurance programme for imaging services is documented.

    Refer to AERB guidelines.Imaging QA Programme

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

    A document for verification and validation of imaging methods shall be available.

    Imaging QA Programme

    c) The programme addresses surveillance of imaging results.

    HOD shall periodically assess the imaging results. Imaging QA

    Programmed) The programme includes

    periodic calibration and maintenance of all equipments.

    Calibration and maintenance of all equipment shall be carried out by competent persons.

    Imaging QA Programme

    e) The programme includes the documentation of corrective and preventive actions.

    Self explanatory.Imaging QA Programme

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

    Objective Element Interpretation Remarksa) The radiation safety

    programme is documented.

    Refer to AERB guidelinesImaging Safety Manual

    b) This programme is integrated with the organizations safety programme.

    The safety programme of the imaging department has reference in the hospital safety manual.

    Hospital Safety Manual

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

    Radioactive and hazardous materials shall be disposed off as per bio-medical waste management and handling rules, 1998.

    Imaging Safety Manual

    d) Imaging personnel are provided with appropriate radiation safety devices.

    Self explanatory.Imaging Safety Manual

    e) Radiation safety devices are periodically tested and documented.

    Protective devices e.g. lead aprons should be exposed to X-ray for verification of cracks and damages.

    Imaging Safety Manual

    f) Imaging personnel are trained in radiation safety measures.

    Self explanatory.Training Records

    g) Imaging signage are prominently displayed in all appropriate locations

    Self explanatory.Evidence on side

    h) Policies and procedures guide the safe use of radioactive isotopes for imaging services.

    Document on safe use of radioactive isotopes for imaging services shall be available and implemented.

    Imaging Safety Manual

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

    8

  • Objective Element Interpretation Remarksa) During all phases of care,

    there is a qualified individual identified as responsible for the patients care.

    The HCO to ensure that the care of patients is always given by appropriately qualified medical personnel (resident doctor, consultant and/or nurse).

    In Patient Care Medical Care Related

    Process (Read responsibility)

    Emergency Room (Causality) Related

    Process (Read responsibility)

    IP Care Surgical Care Related Process

    (Read responsibility)b) Care of patients is

    coordinated in all care settings within the organization.

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

    In Patient Care Medical Care Related

    Process (Read responsibility)

    Emergency Room (Causality) Related

    Process (Read responsibility)

    IP Care Surgical Care Related Process

    (Read responsibility)c) Information about the

    patients care and response to treatment is shared among medical, nursing and other care providers.

    The HCO ensures periodic discussions about each patient (covering parameters like patient care, response to treatment, unusual developments if any, etc) amongst medical, nursing and other care providers.

    Inpatient Care

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

    Self explanatory.Inpatient Care

    e) The patients record (s) is available to the authorized care providers to facilitate the exchange of information.

    Self explanatory.Medical Record Dept

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

    The HCO has clearly defined and documented the policies and procedures to be adopted to guide the personnel dealing with referral of patients to other departments or specialties or even other health care providers out side the HCO.

    Patient Transfer Policy

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

    9

  • Objective Element Interpretation Remarksa) The patients discharge

    process is planned in consultation with the patient and/or family.

    The patient's treating doctor determines the readiness for discharge during regular reassessments. The same is discussed with the patient and family.

    Discharge Process

    b) Policies and procedures exist for coordination of various departments and agencies involved in the discharge process (including medico-legal cases).

    The discharge policies and procedures are documented to ensure coordination amongst various departments including accounts so that the discharge papers are complete well within time. For MLC the organization shall ensure that the police are informed.

    Discharge Process

    c) Policies and procedures are in place for patients leaving against medical advice.

    The HCO has a documented policy for the LAMA cases. The treating doctor should explain the consequences of this action to the patient/attendant.

    Discharge Process

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

    The HCO hands over the discharge papers to the patient/attendant in all cases and copy retained. In LAMA cases, the declaration of the patient/attendant is to be recorded on proper format.

    Discharge Process

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

    Objective Element Interpretation Remarksa) Discharge summary is

    provided to the patients at the time of discharge.

    Self explanatory.Disc harge Summary

    b) Discharge summary contains the reasons for admission, significant findings and diagnosis and the patients condition at the time of discharge.

    Self explanatory.

    Discharge Summary

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

    Self explanatory.Discharge Summary

    d) Discharge summary contains follow up advice, medication and other instructions in an understandable manner.

    Self explanatory.Discharge Summary

    e) Discharge summary incorporates instructions about when and how to obtain urgent care.

    The HCO should outline conditions regarding when to obtain urgent care. For example, a post op patient should report when having fever, bleeding/discharge from site.

    Discharge Summary

    10

  • f) In case of death the summary of the case also includes the cause of death.

    Self explanatory.Discharge Summary

    CHAPTER 2 : Care of Patients (COP)

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

    Objective Element Interpretation Remarksa) Care delivery is uniform

    when similar care is provided in more than one setting.

    The organization shall ensure that patients with the same health problems and care needs, receive the same quality of healthcare throughout the organization irrespective of the category of ward.

    Uniform Care Policy

    b) Uniform care is guided by policies and procedures which reflect applicable laws and regulations.

    Self explanatory. Care provision vide Nursing Council of India Act and Medical Council of India at.

    c) The care and treatment orders are signed, named, timed and dated by the concerned doctor.

    Self explanatory. Treatment orders must be written daily. InPatient Dept

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

    The treatment of the patient could be initiated by a junior doctor but the same should be countersigned and authorized by the treating doctor within 24hrs.

    Authorisation of prescription by resident doctor

    e) Evidence based medicine and clinical practice guidelines are adopted to guide patient care whenever possible.

    The organization could develop clinical protocols based on these and the same could be followed in management of patients. These could then be used as parameters for audit of patient care.

    Within scope of Medical audit committee.

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

    Objective Element Interpretation Remarksa) Policies and procedure for

    emergency care are documented.

    These could include SOPs/protocols to provide either general emergency care or management of specific conditions e.g. poisoning.

    Emergency Suite related Process

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

    The policy shall be in line with statutory requirements w.r.t. documentation and intimation to police. The organization shall also define as to what constitutes a MLC (in accordance with statutory rules).

    Emerg ency Suite Related Process

    11

  • c) The patients receive care in consonance with the policies.

    Self explanatory. Practice Objective

    d) Policies and procedures guide the triage of patients for initiation of appropriate care.

    Self explanatory. Admission and discharge protocol in ICU

    e) Staff is familiar with the policies and trained on the procedures for care of emergency patients.

    All the staff working in the casualty should be oriented to the policies and practices through training/documents. Staff should preferably be trained/well versed in ACLS and BLS.

    CPR Training Records

    f) Admission or discharge to home or transfer to another organization is also documented.

    Self explanatory. Patient Transfer Policy

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

    Objective Element Interpretation Remarksa) There is adequate access

    and space for the ambulance(s).

    The organization shall demarcate a proper space for ambulance(s).This shall be demarcated keeping in mind easy accessibility for receiving patients and to enable the ambulance(s) to turn around/exit quickly.

    Sufficient area available for parking of

    ambulances as per Policy.

    b) Ambulance(s) is appropriately equipped.

    This shall be done based on the organizations scope.

    Hospital Ambulance Services

    c) Ambulance(s) is manned by trained personnel.

    The ambulance should be manned by a trained driver, technician/nurse and/or doctor depending on the situation. Personnel shall be trained in ACLS and/or BLS.

    BLS Trained Driver

    d) There is a checklist of all equipment and emergency medications.

    The organization shall develop a checklist and ensure that the ambulance is equipped as per the checklist.

    Hospital Ambulance Services

    e) Equipments are checked on a daily basis.

    This shall include both the ambulance and the equipments within it.

    Hospital Ambulance Services

    f) Emergency medications are checked daily and prior to dispatch.

    Self explanatory. This also includes checking the expiry date of drugs.

    Hospital Ambulance Services

    g) The ambulance(s) has a proper communication system.

    The ambulance shall be connected with the hospital/control room by wireless/mobile phones.

    (By Physical Inspection)

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

    12

  • Objective Element Interpretation Remarksa) Documented policies and

    procedures guide the uniform use of resuscitation throughout the organization.

    The organization shall document the procedure for same. This shall be in consonance with accepted practices.

    CPR Policy

    b) Staff providing direct patient care is trained and periodically updated in cardio pulmonary resuscitation.

    These aspects shall be covered by hands on training. If the organization has a CPR team (e.g. code blue team) it shall ensure that they are all trained in ALS and are present in all shifts.

    CPR Training Record

    c) The events during a cardio-pulmonary resuscitation are recorded.

    In the actual event of a CPR or a mock drill of the same, all the activities along with the personnel attended should be recorded.

    CPR Recording form

    d) A post-event analysis of all cardiac arrests is one by a multi-disciplinary committee.

    The analysis shall include the cause, steps taken to resuscitate and the outcome. Multidisciplinary committee shall include physicians, anaesthetists and nurses

    Code Blue Committee Meeting Records

    e) Corrective and preventive measures are taken based on the post-event analysis.

    Self explanatory. Code Blue Committee Meeting Records

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

    Objective Element Interpretation Remarksa) Documented policies and

    procedures are used to guide rational use of blood and blood products.

    This shall address the conditions where blood and conditions where blood products can be used.

    b) The transfusion services are governed by the applicable laws and regulations.

    Refer to Drugs and Cosmetics act. Drugs And Cosmetic Act (ORIGINAL)

    c) Informed consent is obtained for donation and transfusion of blood and blood products.

    Consent should be taken for every transfusion. However, with the same consent you can give multiple transfusions in the same sitting. For example, 2 pints of blood may be transfused serially using the same consent. However, if the same is given over two days or hours apart, then a separate consent is required.

    Consent form

    d) Informed consent also includes patient and family education about donation.

    Self explanatory. Consent form

    e) Staff is trained to implement the policies.

    This shall include doctors and be done either by training and/or by providing written instructions.

    Training records

    13

  • f) Transfusion reactions are analyzed for preventive and corrective actions.

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

    Transfusion reaction form

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

    Objective Element Interpretation Remarksa) The organization has

    documented admission and discharge criteria for its intensive care and high dependency units.

    The organization should develop objective criteria and adhere to it. Admission & Discharge in

    MICU/HDU

    b) Staff is trained to apply these criteria.

    This shall be done by training and/or by displaying the criteria. Training Records

    c) Adequate staff and equipment are available.

    The ICU should be equipped with all necessary life saving and monitoring equipments as well as suitably manned by trained staff. The exact requirements shall be decided by the organization. However the organization is expected to follow best clinical practices.

    Equipment Evident on site.

    d) Defined procedures for situation of bed shortages are followed.

    As and when there are no vacant beds in the ICU and there is a requirement of such bed, a detailed policy and procedure should be in place to address the situation.

    Policy for non availability of beds

    e) Infection control practices are followed.

    These could be developed individually or it could be a part of the Hospital infection control manual. The organization shall ensure that the practices are in consonance with good clinical practices.

    Infection Control Manual

    f) A quality assurance programme is implemented.

    These could be developed individually or it could be a part of the Hospital quality assurance programme. The organization shall ensure that the programme is in consonance with good clinical practices.

    Quality Management Plan

    14

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

    Objective Element Interpretation Remarksa) Policies and procedures

    are documented and are in accordance with the prevailing laws and the national and international guidelines.

    Self explanatory.

    b) Care is organized and delivered in accordance with the policies and procedures.

    HCO develops SOP's for delivery of care.

    Policy for Vulnerable patients

    c) The organization provides for a safe and secure environment for this vulnerable group.

    The organization shall provide proper environment taking into account the requirement of the vulnerable group.

    Policy for Vulnerable patients

    d) A documented procedure exists for obtaining informed consent from the appropriate legal representative.

    The informed consent for this group of people should be obtained from their family or legal representative.

    General Consent

    e) Staff is trained to care for this vulnerable group.

    All Staff involved in the care of this group shall be adequately trained in identifying and meeting their needs.

    Training Records

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

    Objective Element Interpretation Remarksa) The organization defines

    and displays whether high risk obstetric cases can be cared for or not.

    The organization shall define as to what constitutes high risk obstetric case in consonance with best clinical practices.

    Obstetric Dept

    b) Persons caring for high risk obstetric cases are competent.

    These shall not just be doctors but shall include nursing staff also. The competency shall be based on qualification, experience and training.

    Obstetric Dept

    c) High risk obstetric patients assessment also includes maternal nutrition.

    Self explanatory.Obstetric Dept

    d) The organization has the facilities to take care of neonates of high risk pregnancies.

    The organization shall have a NICU with proper equipments and staff. Policy Of Paediatric Deptt .

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

    15

  • Objective Element Interpretation Remarksa) The organization defines

    and displays the scope of its pediatric services.

    The scope shall also include neonatal services, if any. Policy Of Paediatric Deptt .

    b) The policy for care of neonatal patients is in consonance with the national/ international guidelines.

    Self explanatory.Policy Of Paediatric Deptt .

    c) Those who care for children have age specific competency.

    These shall not just be for doctors but shall include nursing staff also. The competency shall be based on qualification, experience and training.

    Policy Of Paediatric Deptt .

    d) Provisions are made for special care of children.

    Adequate amenities for the care of infants and children to be available in the hospital.

    Policy Of Paediatric Deptt .

    e) Patient assessment includes detailed nutritional, growth, psychosocial and immunization assessment.

    Self explanatory.Paediatric Assessment Sheet

    f) Policies and procedures prevent child/ neonate abduction and abuse.

    The HCO shall ensure that there is an adequate security/surveillance to prevent such happenings.

    Policy Of Neonatal Child/ Abuse

    g) The childrens family members are educated about nutrition, immunization and safe parenting and this is documented in the medical record.

    Self explanatory.Policy Of Paediatric Deptt .

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

    Objective Element Interpretation Remarksa) Competent and trained

    persons perform sedation.Whenever parenteral route is used this shall be carried out by a doctor/nurse.

    Sedation policy

    b) The person administering and monitoring sedation is different from the person performing the procedure.

    Self explanatory.Sedation policy

    c) Intra-procedure monitoring includes at a minimum the heart rate, cardiac rhythm, respiratory rate, blood pressure, oxygen saturation, and level of sedation.

    Self explanatory. The same should be documented. Sedation policy

    16

  • d) Patients are monitored after sedation.

    The patients vitals shall be monitored at regular intervals (as decided by the organization) till he/she recovers completely from the sedation. The same should be documented.

    Sedation policy

    e) Criteria are used to determine appropriateness of discharge from the recovery area.

    These shall be developed by the organization in consonance with good clinical practices.

    Sedation policy

    f) Equipment and manpower are available to rescue patients from a deeper level of sedation than that intended.

    The equipments shall include emergency resuscitation equipments. An anaesthesiologist shall be available in the hospital.

    To be verified by Physical Examination.

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

    Objective Element Interpretation Remarksa) There is a documented

    policy and procedure for the administration of anaesthesia.

    HCO shall document on the indications, the type of anaesthesia and procedure for the same.

    Pre-operative Evaluation

    b) All patients for anaesthesia have a pre-anaesthesia assessment by a qualified individual.

    This shall be done before the patient is wheeled into the OT complex. It shall be applicable for both routine and emergency cases. This assessment shall be done by an anaesthesiologist .It is preferable to do assessment in a standardized format.

    Pre-operative Evaluation

    c) The pre-anaesthesia assessment results in formulation of an anaesthesia plan which is documented.

    Self explanatory. Pre-operative Evaluation

    d) An immediate preoperative re-evaluation is documented.

    This shall be done by an anaesthesiologist just before the patient is wheeled in to the respective OT.

    Anaesthesia and Pain Management

    OT Manuale) Informed consent for

    administration of anaesthesia is obtained by the anaesthetist.

    Self explanatory. Informed Consent

    f) During anaesthesia monitoring includes regular and periodic recording of heart rate, cardiac rhythm, respiratory rate, blood pressure, oxygen saturation, airway security and patency and level of anaesthesia.

    Self explanatory. Anaesthesia and Pain

    Management

    OT Manual

    17

  • g) Each patients post-anaesthesia status is monitored and documented.

    This shall be done in the recovery area/OT and at least include monitoring of vitals till the patient recovers completely from anaesthesia and shall be done by an anaesthesiologist. If the patients condition is unstable and he/she requires ICU care the same shall be monitored there.

    PAC Form Evidenced on site

    h) A qualified individual applies defined criteria to transfer the patient from the recovery area.

    The organization documents these criteria which should be in consonance with good clinical practices. These criteria shall be applied by a designated individual as decided by the HCO.

    Signed by anaesthesist

    i) All adverse anaesthesia events are recorded and monitored.

    All such events are documented and monitored for the purpose of taking corrective and preventive action.

    In Practice.

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

    Objective Element Interpretation Remarksa) The policies and

    procedures are documented.

    This shall include the list of surgical procedures as well as competency level for performing these procedures.

    OT Manual

    b) Surgical patients have a preoperative assessment and a provisional diagnosis documented prior to surgery.

    All patients undergoing surgery are assessed pre operatively and a provisional diagnosis is made which is documented. This shall be applicable for both routine and emergency cases.

    IP Care Surgical Care Related Process

    Pre-operative Evaluation

    c) An informed consent is obtained by a surgeon prior to the procedure.

    Self explanatory. General Consent

    d) Documented policies and procedures exist to prevent adverse events like wrong site, wrong patient and wrong surgery.

    Procedure should be available for preventing adverse events like wrong patients, wrong site by a suitable mechanism.

    Wrong Patient wrong side Policy

    e) Persons qualified by law are permitted to perform the procedures that they are entitled to perform.

    The HCO identifies the individuals who have the required qualification (s), training and experience to perform procedures in consonance with the law.

    Personnel file as evidences

    f) A brief operative note is documented prior to transfer out of patient from recovery area.

    This note provides information about the procedure performed, post operative diagnosis and the status of the patient before shifting and shall be documented by the surgeon/member of the surgical team.

    OT Manual

    18

  • g) The operating surgeon documents the post-operative plan of care.

    Self explanatory.OT Manual

    h) A quality assurance programme is followed for the surgical services.

    This shall be an integral part of the HCO's overall quality assurance programme. It shall focus on post operative complications e.g. bleeding, rational use of antibiotics, etc.

    IP Care Surgical Care Related Process

    i) The quality assurance programme includes surveillance of the operation theatre environment.

    Surveillance activities include monitoring the quality of air provided, rate of air exchange , cleaning and disinfection processes, etc.

    Infection Control Manual

    j) The plan also includes monitoring of surgical site infection rates.

    Self explanatory. To be covered by the internal audit under the scope of

    medical audit

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

    Objective Element Interpretation Remarksa) Documented policies and

    procedures guide the care of patients under restraints.

    This shall clearly state the conditions/circumstances under which restraints shall be used. It shall also specify as to who can authorize the use of restraints.

    Restraint Policy

    b) These include both physical and chemical restraint measures.

    Physical restraints include boxer's bandage, use of cuffs etc. Chemical restraints include sedatives.

    Restraint Policy

    c) These include documentation of reasons for restraints.

    Self explanatory.Restraint Policy

    d) These patients are more frequently monitored.

    The organization shall specify the parameters and frequency of monitoring and accordingly implement the same.

    Restraint Policy

    e) Staff receive training and periodic updating in control and restraint techniques.

    Self explanatory.Training records

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

    Objective Element Interpretation Remarksa) Documented policies and

    procedures guide the management of pain.

    The HCO shall define the group of patients for whom this is applicable. A good reference point for defining these patients could be those having pain as the predominant debilitating symptom.

    Pain management

    19

  • b) The organization respects and supports the appropriate assessment and management of pain for all patients.

    Self explanatory.Pain management

    c) Patient and family are educated on various pain management techniques.

    Self explanatory.Pain management

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

    Objective Element Interpretation Remarksa) Documented policies and

    procedures guide the provision of rehabilitative services.

    Self explanatory.Physiotherapy Dept.

    b) These services are commensurate with the organizational requirements.

    The scope of the departments is in consonance with the scope of the hospital.

    Self explanatory.

    c) Rehabilitative services are provided by a multidisciplinary team.

    The team shall have treating doctor, rehabilitation therapist, rehabilitation nurses and other professional experts.

    Physiotherapy Dept.

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

    Objective Element Interpretation Remarksa) Documented policies and

    procedures guide all research activities in compliance with national and international guidelines.

    Self explanatory.NA

    b) The organization has an ethics committee to oversee all research activities.

    An ethics committee should be framed in the hospital to monitor activities undertaken by various providers. Any research undertaken in the hospital falls under its ambit. This includes both funded and non-funded and also student studies.

    NA

    c) The committee has the powers to discontinue a research trial when risks outweigh the potential benefits.

    Self explanatory.NA

    20

  • d) Patients informed consent is obtained before entering them in research protocols.

    Self explanatory.NA

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

    Self explanatory.NA

    f) Patients are assured that their refusal to participate or withdrawal from participation will not compromise their access to the organizations services.

    Self explanatory.NA

    COP.17. Policies and procedures guide nutritional therapy.

    Objective Element Interpretation Remarksa) Documented policies and

    procedures guide nutritional assessment and reassessment.

    Self explanatory.Dietary, Nutrition and Food

    Services

    b) Patients receive food according to their clinical needs.

    A dietician shall do the assessment of the patient in consultation with the clinician and advice regarding food.

    Dietary, Nutrition and Food Services

    Nutritional assement form

    c) There is a written order for the diet.

    The dietician shall prepare this in the form of a diet sheet and patient shall receive food accordingly.

    Dietary, Nutrition and Food Services

    d) Nutritional therapy is planned and provided in a collaborative manner.

    The dietician shall ensure that this is planned in consultation with the treating doctor and the patient/patients relative after taking into regard the patients food habits (veg/ non-veg) and likes and dislikes.

    Dietary, Nutrition and Food Services

    e) When families provide food, they are educated about the patient's diet limitations.

    The dietician/nurse shall ensure this during planning. Dietary, Nutrition and Food

    Services

    f) Food is prepared, handled, stored and distributed in a safe manner.

    The dietary services to be designed in a manner that there is no criss cross of traffic. All the activities fall in a sequence. The organization shall ensure that hygienic conditions are followed all throughout.

    Dietary, Nutrition and Food Services

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

    21

  • Objective Element Interpretation Remarksa) Documented policies and

    procedures guide the end of life care.

    The HCO has a documented policy for providing care to terminally ill admitted patients. This shall include providing appropriate pain and palliative care according to the wishes of the family and patient.

    End of Life Care Operational Policy

    b) These policies and procedures are in consonance with the legal requirements.

    Self explanatory.End of Life Care

    Operational Policy

    c) These also address the identification of the unique needs of such patient and family.

    The religious and socio-cultural beliefs of patients/ family shall be addressed and respected.

    End of Life Care Operational Policy

    d) These also include sensitively addressing issues such as autopsy and organ donation.

    If the body of the deceased is subjected to an autopsy or for organ donation, it should be discussed with the family in a very courteous manner.

    End of Life Care Operational Policy

    e) Staff is educated and trained in end of life care.

    Self explanatory. Training Records

    CHAPTER 3 : Management of Medication (MOM)

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

    Objective Element Interpretation Remarksa) There is a documented

    policy and procedure for pharmacy services and medication usage.

    The policies and procedures shall address the issues related to procurement, storage, formulary, prescription, dispensing, administration, monitoring and use of medications.

    Material Management

    Pharmacy

    b) These comply with the applicable laws and regulations.

    Self explanatory.Drugs And Cosmetics Act

    c) A multidisciplinary committee guides the formulation and implementation of these policies and procedures.

    This shall be representative of major clinical departments, administration and shall include a pharmacist/ clinical pharmacologist.

    Records Of Drugs and Therapeutics Committee

    MOM.2. There is a hospital formulary.

    22

  • Objective Element Interpretation Remarksa) A list of medication

    appropriate for the patients and organizations resources is developed.

    The hospital formulary shall be prepared and be preferably updated at regular intervals.

    Drug formulary

    b) The list is developed collaboratively by the multidisciplinary committee.

    Refer to MOM 1c.Records Of Drugs and

    Therapeutics Committee

    c) There is a defined process for acquisition of these medications.

    The process should address the issues of vendor selection, vendor evaluation, generation of purchase order and receipt of goods as per rules.

    Pharmacy

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

    Self explanatory. Local Purchase Policy

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

    Objective Element Interpretation Remarksa) Documented policies and

    procedures exist for storage of medication.

    These should address issues pertaining to temperature (refrigeration), light, ventilation, preventing entry of pests/ rodents and vermins.

    Policy on Storage Of Medication

    b) Medications are stored in a clean, well lit and ventilated environment.

    The organization shall also ensure that the storage requirements of the drug as specified by the manufacturer are adhered to. If the recommendations are conflicting in nature, the organization shall follow the manufacturers recommendation. This shall be applicable to all areas where medications are stored including wards.

    Physical examination.

    c) Sound inventory control practices guide storage of the medications.

    Self explanatory. ABC Analysis

    d) Medications are protected from loss or theft.

    The organization shall ensure that it develops proper mechanisms to prevent pilferage. The organization could conduct audits at regular intervals (as defined by the organization) to detect such instances.

    Regular AUDIT

    e) Sound alike and look alike medications are stored separately.

    Many drugs in ampoules, vials or tablets may look-alike or sound-alike. They should be segregated and stored separately.

    Demonstrated in practice

    23

  • f) There is a method to obtain medication when the pharmacy is closed.

    When pharmacy is closed, there should be a SOP to procure the drugs.

    24 hours pharmacy is available.

    g) Emergency medications are available all the time.

    Adequate amount of emergency medicines should be stocked at all times. Re-order level at definite quantity should be done.

    Stock maintenance register &records to be produced as

    evidences.

    h) Emergency medications are replenished in a timely manner when used.

    Self explanatory. Relevant register as evidence.

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

    Objective Element Interpretation Remarksa) Documented policies and

    procedures exist for prescription of medications.

    Self explanatory. Policy on prescription of

    medication

    b) The organization determines who can write orders.

    This shall be done by the treating doctor.

    Policy on prescription of medication

    Policy on Verbal Orders for Medication

    c) Orders are written in a uniform location in the medical records.

    All the orders for medicines are recorded on a uniform location of the case sheet. Electronic orders when typed shall again follow the same principles.

    Medical Records

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

    Self explanatory. Medical Records

    e) Policy on verbal orders is documented and implemented.

    The organization shall ensure that it has a policy to address this issue and it shall address as to who can give verbal orders and how these orders will be validated.

    Policy on Verbal Orders for Medication

    f) The organization defines a list of high risk medication.

    High risk medications are medications involved in a high percentage of medication errors or sentinel events and medications that carry a high risk for abuse, error, or other adverse outcomes. Examples include medications with a low therapeutic window, controlled substances, psychotherapeutic medications, and look-alike and sound-alike medications.

    High Risk Medication

    g) High risk medication orders are verified prior to

    These medications shall preferably be given only after written orders High Risk Medication

    24

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

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

    Objective Element Interpretation Remarksa) Documented policies and

    procedures guide the safe dispensing of medications.

    Clear policies to be laid down for dispensing of medication e.g. route of administration, dosage, rate of administration, expiry date, etc.

    Safe Dispensing Of Medicine

    b) The policies include a procedure for medication recall.

    Recall may result based on letters from regulatory authorities or internal feedback (e.g. visible contaminant in IV fluid bottle).

    Drug Labelling Policy

    c) Expiry dates are checked prior to dispensing.

    Self explanatory. Pharmacy

    d) Labelling requirements are documented and implemented by the organization.

    At a minimum, labels must include the drug name, strength frequency of administration (in a language the patient understands) and expiry dates.

    Drug Labelling Policy

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

    Objective Element Interpretation Remarksa) Medications are

    administered by those who are permitted by law to do so.

    Self explanatory.Policy on prescription of

    medication

    b) Prepared medications are labelled prior to preparation of a second drug.

    Self explanatory.Drug Labelling Policy

    c) Patient is identified prior to administration.

    Self explanatory. Safe Dispensing Of Medicine

    d) Medication is verified from the order prior to administration.

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

    Safe Dispensing Of Medicine

    25

  • e) Dosage is verified from the order prior to administration.

    Self explanatory. Safe Dispensing Of Medicine

    f) Route is verified from the order prior to administration.

    Self explanatory. Safe Dispensing Of Medicine

    g) Timing is verified from the order prior to administration.

    Self explanatory. Safe Dispensing Of Medicine

    h) Medication administration is documented.

    The organization shall ensure that this is done in a uniform location and it shall include the name of the medication, dosage, route of administration, timing and the name and signature of the person who has administered the medication.

    Safe Dispensing Of Medicine

    i) Policies and procedures govern patients self administration of medications.

    At the outset the HCO could define if it would permit self administration of medications. In case the HCO permits then the policy shall include the medications which the patient can self administer. It is preferable that the organization also incorporates a method to ensure that the patient is reminded to take the medication (before every dose) and documentation of self administration.

    Organization do not allow self Medication.

    j) Policies and procedures govern patients medications brought from outside the organization.

    These shall address as to what are the pre-requisites for such a medication (e.g. Invoice; Clear label with mention of the name, dose, expiry date etc.)

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

    Objective Element Interpretation Remarksa) Patient and family are

    educated about safe and effective use of medication.

    The organization shall make a list of such drugs and accordingly educate e.g. digoxin. This could also include education regarding the importance of taking a drug at a specific time e.g. sustained release medications.

    Safe Medication And Food Drugs Interactions

    b) Patient and family are educated about food-drug interactions.

    Patient and family should be counselled about their diet during medication e.g. no alcohol when taking metronidazale.

    Safe Medication And Food Drugs Interactions

    MOM.8. Patients are monitored after medication administration.

    26

  • Objective Element Interpretation Remarksa) Patients are monitored

    after medication administration and this is documented.

    This shall be done by anyone involved in direct patient care. The organization could follow either a passive (documenting only if the patient tells) or active (enquiring with every patient) monitoring mechanism.

    In Patient Care Medical Care Related Process

    b) Adverse drug events are defined.

    The organization shall define as to what constitutes an adverse drug event. This shall be in consonance with best practices. Adverse drug events include adverse drug reactions as well as medication errors.

    Adverse drug Reaction policy

    ARD Form

    c) Adverse drug events are reported within a specified time frame.

    Self explanatory. The organization shall define the timeframe for reporting once the adverse drug event has occurred.

    Adverse drug Reaction policy

    d) Adverse drug events are collected and analyzed.

    All the adverse drug reactions are analyzed regularly by the multi-disciplinary committee (Refer to MOM 1C).

    Adverse drug Reaction policy

    e) Policies are modified to reduce adverse drug events when unacceptable trends occur.

    Self explanatory. Adverse drug Reaction

    policy

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

    Objective Element Interpretation Remarksa) Documented policies and

    procedures guide the use of narcotic drugs and psychotropic substances.

    Self explanatory. Refer to MOM 1a.

    Narcotics Policy

    b) These policies are in consonance with local and national regulations.

    This is in the context of Narcotic Drugs and Psychotropic Substances Act.

    Narcotic Drugs and Psychotropic Substances

    Act.

    c) A proper record is kept of the usage, administration and disposal of these drugs.

    These shall be kept in accordance with statutory requirements. Records

    d) These drugs are handled by appropriate personnel in accordance with policies.

    Self explanatory.

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

    27

  • Objective Element Interpretation Remarksa) Documented policies and

    procedures guide the usage of chemotherapeutic agents.

    Self explanatory.Chemotherapy policy

    b) Chemotherapy is prescribed by those who have the knowledge to monitor and treat the adverse effect of chemotherapy.

    This shall preferably be a medical oncologist or a person who has been trained and has achieved competency in the same.

    Chemotherapy policy

    c) Chemotherapy is prepared and administered by qualified personnel.

    This shall preferably be staff who have received special training in preparing and administration.

    Chemotherapy policy

    d) Chemotherapy drugs are disposed off in accordance with legal requirements.

    These shall be disposed off according to BMW management and handling rules 1998 or manufacturer's recommendation.

    Biomedical waste management rule and regulation.

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

    Objective Element Interpretation Remarksa) Documented policies and

    procedures govern usage of radioactive drugs.

    Self explanatory. Radioactive material policy

    b) These policies and procedures are in consonance with laws and regulations.

    Refer to AERB guidelines.Radioactive material policy

    c) The policies and procedures include the safe storage, preparation, handling, distribution and disposal of radioactive drugs.

    Self explanatory. This shall however be in accordance with AERB guidelines.

    Radioactive material policy

    d) Staff, patients and visitors are educated on safety precautions.

    Self explanatory. DEMONSTRATED IN PRACTICE. APPROPRIATE SIGNAGES USED AT ALL THE PLACES.

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

    Objective Element Interpretation Remarksa) Documented policies and

    procedures govern procurement and usage of implantable prosthesis.

    Self explanatory.Implant Policy

    28

  • b) Selection of implantable prosthesis is based on scientific criteria and national /internationally recognized approvals.

    The organization shall ensure that relevant and sufficient scientific data are available before selection. It shall also look for international (e.g.US-FDA) or national notification (Drugs and Cosmetics Act notification October 2005) for approval of the particular product.

    Implant Policy

    c) The batch and serial number of the implantable prosthesis are recorded in the patients medical record and the master logbook.

    Self explanatory.Implant Policy

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

    Objective Element Interpretation Remarksa) Documented policies and

    procedures govern procurement, handling, storage, distribution, usage and replenishment of medical gases.

    This shall be applicable to all gases used in the organization. It shall also address the issue of statutory requirements and approvals wherever applicable. It shall follow a uniform colour coding system.

    Gas Ma sifold Process

    b) The policies and procedures address the safety issues at all levels.

    This shall include from the point of storage/source area, gas supply lines and the end user area. Appropriate safety measures shall be developed and implemented for all levels.

    Gas Manifold Process

    c) Appropriate records are maintained in accordance with the policies, procedures and legal requirements.

    This is the context of the Indian explosives act of 1884, Gas cylinder rules 1981 and Static and mobile pressure vessels (unfired) 1981.

    Gas Manifold Process

    CHAPTER 4 : Patient Rights and Education (PRE)

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

    Objective Element Interpretation Remarksa) Patient and family rights

    and responsibilities are documented.

    Hospital should respect patients rights and inform them of their responsibilities. All the rights of the patients should be displayed in the form of a Citizens Charter which should also give information of the charges and grievance redress mechanism.

    Citizen Charter

    29

  • b) Patients and families are informed of their rights and responsibilities in a format and language that they can understand.

    Self explanatory.

    Citizen Charter

    c) The organizations leaders protect patients rights.

    Protection also includes addressing patients grievances w.r.t rights. Citizen Charter

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

    Training and sensitisation programmes shall be conducted to create awareness among the staff.

    Employee Guide Book

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

    Where patients' rights have been infringed upon, management must keep records of such violations, as also a record of the consequences, e.g. corrective actions to prevent recurrences.

    Patient Grievance Policy

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

    Objective Element Interpretation Remarksa) Patient and family rights

    address any special preferences, spiritual and cultural needs.

    This could include dietary preferences and worship requirements

    Patients Right Policy

    b) Patient rights include respect for personal dignity and privacy during examination, procedures and treatment.

    During all stages of patient care, be it in examination or carrying out a procedure, hospital staff shall ensure that patients privacy and dignity is maintained. The organization shall develop the necessary guidelines for the same. During procedures the organization shall ensure that the patient is exposed just before the actual procedure is undertaken. With regards to photographs/recording procedures; the organization shall ensure that consent is taken and that the patients identity is not revealed.

    Patients Right Policy

    c) Patient rights include protection from physical abuse or neglect.

    Self explanatory. Special precautions shall be taken especially w.r.t vulnerable patients e.g. elderly, neonates etc.

    Policy For Vulnerable Patients

    d) Patient rights include treating patient information as confidential.

    Self explanatory. Statutory requirements w.r.t. privileged communication shall be followed at all times.

    Patients Right Policy

    e) Patient rights include refusal of treatment.

    During management the patients should be given the choice of treatment. The treating doctor shall discuss all the available options and allow the patient to make an informed choice including the option

    Patients Right Policy

    30

  • of refusal.

    f) Patient rights include informed consent before anaesthesia, blood and blood product transfusions and any invasive / high risk procedures / treatment.

    Self explanatory.Informed Consent

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

    The organization shall ensure that International conference on harmonization (ICH) of Good clinical practice (GCP) and Declaration of Helsinki Somerset (1996) and ICMR requirements are followed.

    Informed Consent

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

    Grievance redressal mechanism must be accessible and transparent. Displayed information must be clearly available on how to voice a complaint.

    Patients Right Policy

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

    Refer AAC4d.Patients Right Policy

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

    The organization shall ensure that every patient has access to his/her record. This shall be in consonance with The code of medical ethics and statutory requirements.

    Patients Right Policy

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

    Objective Element Interpretation Remarksa) General consent for

    treatment is obtained when the patient enters the organization.

    Self explanatory.General Consent

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

    The organization shall define as to what is the scope of this consent and the same shall be communicated to the patient and/or his family members.

    General Consent

    c) The organization has listed those procedures and treatment where informed consent is required.

    A list of procedures should be made for which informed consent should be taken.

    Informed Consent

    d) Informed consent includes information on risks, benefits, alternatives and as to who will perform the requisite procedure in a language that they can understand.

    The consent shall have the name of the doctor performing the procedure. If it is a doctor under training the same shall be specified, however the name of the qualified doctor supervising the procedure shall also be mentioned. Consent form shall be in the

    Informed Consent

    31

  • language that the patient understands.

    e) The policy describes who can give consent when patient is incapable of independent decision making.

    The organization shall take into consideration the statutory norms. This would include next of kin/legal guardian. However in case of unconscious/ unaccompanied patients the treating doctor can take a decision in life saving circumstances.

    Informed Consent

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

    Objective Element Interpretation Remarksa) When appropriate, patient

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

    Self explanatory.Policy on Safe Medication

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

    Self explanatory. Dietary, Nutrition and Food Services

    c) Patient and families are educated about immunizations.

    Self explanatory. More applicable for paediatric population. In adults it could be for influenza, Streptococcus pneumoniae, typhoid, hepatitis B, Neisseria meningitides, etc.

    Immunization cards are given in Hospital

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

    Self explanatory. This could also be done through patient education booklets/videos/leaflets etc.

    Patients Right Policy

    e) Patient and families are educated about preventing infections

    Self explanatory. Patients Right Policy

    f) Patients are taught in a language and format that they can understand

    Self explanatory. Patients Right Policy

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

    Objective Element Interpretation Remarksa) There is uniform pricing

    policy in a given setting (out-patient and ward category).

    There should be a billing policy which defines the charges to be levied for various activities.

    Billing Policy

    b) The tariff list is available to patients.

    The organization shall ensure that there is an updated tariff list and that this list is available to patients

    Tariff List

    32

  • when required. The organization shall charge as per the tariff list. Any additional charge should also be enumerated in the tariff and the same communicated to the patients. The tariff rates should be uniform and transparent.

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

    Refer to AAC4d.Patients Right Policy

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

    When patients are shifted from one setting to another, typically to and from ICUs, the financial implications must be clearly conveyed to them.

    Estimated Cost Performa

    CHAPTER 5 : Hospital Infection Control (HIC)

    HIC.1. The organization has a well-designed, comprehensive and coordinated Hospital Infection Control (HIC) programme aimed at reducing/ eliminating risks to patients, visitors and providers of care.

    Objective Element Interpretation Remarksa) The hospital infection

    control programme is documented which aims at preventing and reducing risk of nosocomial infections.

    Self explanatory. Infection Control Manual

    b) The hospital has a multi-disciplinary infection control committee.

    This shall preferably have Hospital Administrator, Microbiologist, Physician, Surgeon, Manager Nursing (Nursing Supervisor), staff from CSSD, and other Support services and the hospital infection control nurse. It should also include invitees from various departments as deemed necessary.

    Infection Control Manual

    c) The hospital has an infection control team.

    The team is responsible for day-to-day functioning of infection control programme. They shall support surveillance process and detect outbreaks. They shall also participate in audit activity and in infection prevention and control on a day-to-day basis.

    Infection Control Manual

    d) The hospital has designated and qualified infection control nurse(s) for this activity.

    The qualification shall be either a graduate nurse or qualified nurse with competence gained by experience.

    Infection Control Manual

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

    33

  • Objective Element Interpretation Remarksa) The manual identifies the

    various high-risk areas and procedures.

    The manual should clearly identify the high risk areas of the hospital e.g. ICU, HDU, OT, Post-operative ward, Blood Bank, CSSD, etc. Similarly, all high risk procedures should be identified from infection control point of view. For example,cardiac catheterization, endoscopies, surgery lasting more than 2 hours, BMT etc.

    Infection Control Manual

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

    It shall define the frequency and mode of surveillance. The surveillance system should meet WHO criteria of simplicity, cost minimization, timeliness of feedback, flexibility, acceptability, consistency (reliability), sensitivity and specificity.

    Infection Control Manual

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

    Self explanatory.Infection Control Manual

    d) Equipment cleaning and sterilization practices are included.

    It shall address this at all levels e.g. ward, OT and CSSD. It is preferable that the organization follows a uniform policy across different departments within the organization. The Manual should include sterilization and disinfection policy, chemicals used/ methods and procedures followed in wards and critical areas. Special focus on critical equipments like ventilators, nebulizers etc.

    Infection Control Manual

    e) An appropriate antibiotic policy is established and implemented.

    The HCO shall develop a system of monitoring drug susceptibility (based on culture sensitivity) and accordingly develop its antibiotic policy, which shall be reviewed at periodic intervals (maybe once in 3 months) for its continuing applicability.

    Antibiotic Policy

    f) Laundry and linen management processes are also included.

    The laundry can be in-house or outsourced. If outsourced the organization shall ensure that it establishes adequate controls to ensure infection control. The linen change policy should be mentioned. Washing protocols for different categories of linen including blankets should be included.

    Laundry Services

    g) Kitchen sanitation and food handling issues are included in the manual.

    Self explanatory. The same shall be applicable even if this activity is outsourced. The organization could refer to ISO 22000:2005 (food safety) while addressing this issue.

    Infection Control Manual

    34

  • h) Engineering controls to prevent infections are included.

    Issues such as Air conditioning plant and equipment maintenance, cleaning of A/c ducts, AHUs, replacement of filters, seepage leading to fungal colonization, replacement/repair of plumbing, sewer lines (in shafts) should be included. Water supply sources and system of supply, testing for water quality must be included. Any renovation work in hospital patient care areas should be planned with Infection Control team with regard to architectural segregation, traffic flow, use of materials.

    Infection Control Manual

    i) Mortuary practices and procedures are included as appropriate to the organization.

    The mortuary services in the hospital should be provided through walk-in cold rooms or mortuary cold cabinets. Mortuary procedures of preserving body, or body parts and safety measures while handing over body to relatives should be in accordance with the policy.

    j) The organization defines the periodicity of updating the infection control manual.

    The organization must have a documented policy on the updation of the infection control manual. It is desirable to update at least once in a year based on its trends & outcomes of the audit processes.

    Infection Control Manual

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

    Objective Element Interpretation Remarksa) Surveillance activities are

    appropriately directed towards the identified high-risk areas.

    The organization must be able to provide evidence of conducting periodic surveillance activities in its identified high risk areas. The specific objectives, case definitions, identification of potential indicators, frequency and duration of monitoring, methods of data collection, along with schedule of rounds should be defined. Confidentiality and anonymity must be ensured. The HCO should clearly mention which specific targeted surveillance (site specific, unit oriented, priority oriented) activities are being carried out.

    Infection Control Manual

    b) Collection of surveillance data is an ongoing process.

    The organization shall ensure that it has a process in place to collect surveillance data and also to ensure that it is able to capture all such data.

    35

  • c) Verification of data is done on regular basis by the infection control team.

    The data so collected shall be authenticated by the team by going through every data or by using random sampling so that the process can be validated. The team shall preferably verify every serious infection (as defined by the organization) report.

    d) In cases of notifiable diseases, information (in relevant format) is sent to appropriate authorities.

    The organization shall identify all notifiable diseases after taking into consideration the local laws, rules, regulations and notifications thereof. The organization shall ensure that this is sent at the specified frequency and in the format as required by statutory authorities.

    Records from Medical Records department

    e) Scope of surveillance activities incorporates tracking and analyzing of infection risks, rates and trends.

    This shall be done at regular intervals (maybe monthly and consolidated into an annual report) and the organization shall take suitable steps based on the analysis.

    f) Surveillance activities include monitoring the effectiveness of housekeeping services.

    This would include categorization of areas/ surfaces; general cleaning procedures for surfaces, furniture/ fixtures, and items used in patient care. It should also include procedures for terminal cleaning, blood and body fluid cleanup, isolation rooms and all high risk (critical) areas. The common disinfectants used, dilution factors, method of use should be specified.

    HIC.4. The hospital takes actions to prevent or reduce the risks of Hospital Associated Infections (HAI) in patients and employees.

    Objective Element Interpretation Remarksa) The organization monitors

    urinary tract infections.This can be done either by sending urine or catheter tip for culture. The organization shall do this for all symptomatic catheterized patients.

    Records

    b) The organization monitors respiratory tract infections.

    This can be done by sending sputum or ET/ tracheostomy secretions (obtained using a suction catheter) or ET/ tracheostomy tip or protected specimen brushing (PSB) or mini broncho-alveolar lavage (BAL) for culture. The organization shall do this for all patients on the ventilator having clinical features suggestive of infection.

    Records

    36

  • c) The organization monitors intra-vascular device infections.

    For patients with symptoms suggestive of intra vascular device infection and having central line the same shall be done by sending the tip for culture. For all peripheral lines clinical evidence of thrombophlebitis would suffice.

    Records

    d) The organization monitors surgical site infections.

    This shall be done by sending pus/ swab for culture. Records

    e) Appropriate feedback regarding HAI rates are provided on a regular basis to medical and nursing staff.

    The feedback shall include the rates, trends and opportunities for improvement. It could also provide specific inputs to reduce the HAI rate.

    Records

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

    Objective Element Interpretation Remarksa) Hand washing facilities in

    all patient care areas are accessible to health care providers.

    The organization shall ensure that it provides necessary infrastructure to carry out the same.

    Infection Control Manual

    Evidence on siteb) Compliance with proper

    hand washing is monitored regularly.

    The organization shall preferably display the necessary instructions near every hand washing area. Compliance could be verified by random checking, observation, etc.

    Infection Control Manual

    Evidence on site

    c) Isolation/ barrier nursing facilities are available.

    The organization shall define the conditions where the same shall be carried out and ensure that it provides the necessary resources to carry out the activity (e.g. clothing, masks, gloves etc.).

    Infection Control Manual

    d) Adequate gloves, masks, soaps, and disinfectants are available and used correctly.

    Self explanatory. They should be available at the point of use and the organization shall ensure that it maintains an adequate inventory.

    Facilities Available

    HIC.6. The ho