nabh manual

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

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

Objective Element Interpretation Remarks

a) The services being 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.


a) 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.


a) 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.


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.


d) The organization gives a summary of patient’s 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.


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

Patients Right Policy

1

patient/attendant can understand. The above information is to be documented and signed by the concerned doctor.

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

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


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.


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.


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


a) The organization defines the content of the assessments for the out–patients, 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.


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

d) The initial assessment for in-patients is documented within 24 hours or earlier as per the patient’s

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


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condition or hospital policy.

e) Initial assessment includes screening for nutritional needs.

The protocol for patient’s 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.


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.


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.


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


a) 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.


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.


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.


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

Laboratory Manual

3

management (RBS, ABG etc) must be available within its premises. See also (f) below for outsourced lab facilities.

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

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

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a) The laboratory quality assurance programme is documented.

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

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.


a) 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 organization’s safety programme.

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


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

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


d) Laboratory personnel are appropriately trained in safe practices.

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


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


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a) 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


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.


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

Refer to AERB guidelines.Imaging QA Programme

6

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

Programme

d) 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.


a) The radiation safety programme is documented.

Refer to AERB guidelinesImaging Safety

Manual

b) This programme is integrated with the organization’s safety programme.

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

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.


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.


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

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a) During all phases of care, there is a qualified individual identified as responsible for the patient’s 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


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


Emergency Room (Causality) Related



(Read responsibility)c) Information about the

patient’s 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 patient’s 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.


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

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a) The patient’s 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.


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

Self explanatory.Discharge Summary

b) Discharge summary contains the reasons for admission, significant findings and diagnosis and the patient’s 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.


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


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,

Discharge Summary

9

bleeding/discharge from site.f) In case of death the

summary of the case also includes the cause of death.


CHAPTER 2 : Care of Patients (COP)

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

Objective Element Interpretation 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

Emergency Suite Related Process

10

a MLC (in accordance with statutory rules).

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 organization’s 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.


e) Equipments are checked on a daily basis.

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


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

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


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.

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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.


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

Self explanatory. Consent form

12

family education about donation.

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

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

13

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

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 patient’s assessment also

Self explanatory.Obstetric Dept

14

includes maternal nutrition.

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.

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.


d) Provisions are made for special care of children.

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


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 children’s 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

15

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

d) Patients are monitored after sedation.

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

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.


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 Manual

16

e) 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

g) Each patient’s 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 patient’s 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.



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

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

Wrong Patient wrong side Policy

17

like wrong site, wrong patient and wrong surgery.

suitable mechanism.

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

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.


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.


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).


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

Self explanatory.Training records

18

control and restraint techniques.

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


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

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.


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.


19

a) 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

d) Patient’s 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 organization’s services.

Self explanatory.NA

COP.17. Policies and procedures guide nutritional therapy.


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.


d) Nutritional therapy is planned and provided in a

The dietician shall ensure that this is planned in consultation with the Dietary, Nutrition and

20

collaborative manner. treating doctor and the patient/patient’s relative after taking into regard the patient’s food habits (veg/ non-veg) and likes and dislikes.

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.


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


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.


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.


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.


21

a) 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.

Objective Element Interpretation Remarksa) A list of medication

appropriate for the patients and organization’s 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.


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 Physical examination.

22

nature, the organization shall follow the manufacturer’s recommendation. This shall be applicable to all areas where medications are stored including wards.

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

Self explanatory. 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

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.


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

23

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 dispensing.

These medications shall preferably be given only after written orders and it should be verified by the staff before dispensing.

High Risk Medication

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


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.

24

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.


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


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


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


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.


i) Policies and procedures govern patient’s 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 patient’s 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.)

25

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.

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.


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).


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

Self explanatory. Adverse drug Reaction

policy

26

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


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.


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.


procedures govern usage of radioactive drugs.

Self explanatory. Radioactive material

policy

27

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.


procedures govern procurement and usage of implantable prosthesis.

Self explanatory.Implant Policy

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 patient’s medical record and the master logbook.

Self explanatory.Implant Policy

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


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 Masifold 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.

Gas Manifold Process

28

Appropriate safety measures shall be developed and implemented for all levels.

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 patient’s 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

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 organization’s leaders protect patient’s rights.

Protection also includes addressing patient’s 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


29

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 patient’s privacy and dignity is maintained. The organization shall develop the necessary guidelines for the same. During procedures the organization shall ensure that the patient is exposed just before the actual procedure is undertaken. With regards to photographs/recording procedures; the organization shall ensure that consent is taken and that the patient’s identity is not revealed.


c) Patient rights include 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.


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 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.


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.


30

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 language that the patient understands.

Informed Consent

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

31

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.


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 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.

Tariff List

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

Self explanatory. Infection Control Manual

32

at preventing and reducing risk of nosocomial infections.

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.


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.


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.


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

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.


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

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


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

Self explanatory.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


33

different departments within the organization. The Manual should include sterilization and disinfection policy, chemicals used/ methods and procedures followed in wards and critical areas. Special focus on critical equipments like ventilators, nebulizers etc.

e) An appropriate antibiotic policy is established and implemented.

The HCO shall develop a 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.


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.


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 organization must have a documented policy on the updation Infection Control Manual

34

the infection control manual.

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.

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.


b) Collection of surveillance data is an ongoing process.

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

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

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

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

This would include categorization of areas/ surfaces; general

35

effectiveness of housekeeping services.

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

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

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


36

providers. 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.


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.).


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 hospital takes appropriate action to control outbreaks of infections.

Objective Element Interpretation Remarksa) Hospital has a

documented procedure for handling such outbreaks.

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


b) This procedure is implemented during outbreaks.

The organization should be able to identify the outbreak, describe the outbreak by developing a case definition, designing a data collection form, collecting data from the affected, constructing an epidemic curve.


c) After the outbreak is over appropriate corrective actions are taken to prevent recurrence.

The organization should be able to implement basic procedures to prevent recurrence such as source control if source identified, review of all infection control policies, loopholes and compliance gaps, strengthening infection control policies etc.


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

Objective Element Interpretation Remarksa) There is adequate space

available for sterilization activities.

Adequacy of space refers to the CSSD which should have an area of 0.7sqm/bed, suitable location, proper layout (unidirectional flow,

CSSD Policy

37

zoning) and separation of clean and dirty areas.

b) Regular validation tests for sterilization are carried out and documented.

This shall be done by accepted methods e.g. bacteriologic, strips etc.Engineering validations like Bowie Dick tape test and leak rate test need to be carried out.

CSSD Policy

c) There is an established recall procedure when breakdown in the sterilization system is identified.

The organization shall ensure that the sterilization procedure is regularly monitored and in the eventuality of a breakdown it has a procedure for withdrawal of such items.

CSSD Policy

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

Objective Element Interpretation Remarksa) The hospital is authorized

by prescribed authority for the management and handling of Bio-medical Waste.

The occupier shall apply in the prescribed form and get approval from the prescribed authority e.g. Pollution control board/committee.

Copy of FORM I

b) Proper segregation and collection of Bio-medical Waste from all patient care areas of the hospital is implemented and monitored.

Wastes to be segregated and collected in different colour coded bags and containers as per statutory provisions. Monitoring shall be done by members of the infection control committee/team.

Evident on Site

c) The organization ensures that Bio-medical Waste is stored and transported to the site of treatment and disposal in proper covered vehicles within stipulated time limits in a secure manner.

The waste is transported to the pre-defined site at definite time intervals (maximum within 48hours) through proper transport vehicles in a safe manner. If this activity is outsourced the organization shall ensure that it is done to an authorized contractor. Monitoring of this activity should be done by Infection Control team.

Evident on SiteWaste transportation trolley

d) Bio-medical Waste treatment facility is managed as per statutory provisions (if in-house) or outsourced to authorized contractor(s).

If the hospital has waste treatment facility within its premises then they have to be in accordance with statutory provisions or they can outsource it to a central facility.

MOU between the hospital and the Outsourced agency

e) Requisite fees, documents and reports are submitted to competent authorities on stipulated dates.

The HCO shall ensure that the fees are deposited in a timely manner. In addition the annual reports have to be submitted by the 31st of January of every year and accident reporting has to be carried out in the prescribed form.

Copy of FORM II

38

f) Appropriate personal protective measures are used by all categories of staff handling Bio-medical Waste.

Self explanatory.

Evident on site

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

Objective Element Interpretation Remarksa) Hospital management

makes available resources required for the infection control programme.

The HCO shall ensure that the resources required by the personnel should be available in a sustained manner. This includes both men and materials.

Copy of the budget

b) The hospital regularly earmarks adequate funds from its annual budget in this regard.

There shall be a separate budget demarcated for HIC activity. This shall be prepared taking into consideration the scope of the activity and previous years’ experience.

Copy of the budget

c) It conducts regular pre-induction training for appropriate categories of staff before joining concerned department(s).

There must be a documented evidence of pre induction training for appropriate categories of staff before joining concerned department(s). It should include the policies, procedures and practices of the infection control programme.

Training Records

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

Self explanatory.

Training Records

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

Self explanatory.

CHAPTER 6 : Continuous Quality Improvement (CQI)

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


a) The quality improvement programme is developed, implemented and maintained by a multi-disciplinary committee.

This committee shall have representation from management, various clinical and support departments of the HCO. This programme shall be developed, implemented and maintained in a structured manner.

39

b) The quality improvement programme is documented.

This should be documented as a manual. The manual shall incorporate the mission, vision, quality policy, quality objectives, service standards, important indicators as identified etc. The manual could be stand alone and should have cross linkages with other manuals.


c) There is a designated individual for coordinating and implementing the quality improvement programme.

This should preferably be a person having a good knowledge of accreditation standards, statutory requirements, hospital quality improvement principles and evaluation methodologies, hospital functioning and operations.

Accreditation Coordinator

d) The quality improvement programme is comprehensive and covers all the major elements related to quality improvement and risk management.

This shall preferably cover all aspects including documentation of the programme, monitoring it, data collection, review of policy and corrective action. Also refer to CQI 1b.

Quality Management PlanRisk Management

e) The designated programme is communicated and coordinated amongst all the employees of the organization through proper training mechanism.

Self explanatory.

Traning Records

f) The quality improvement programme is reviewed at predefined intervals and opportunities for improvement are identified.

As quality improvement is a dynamic process, it needs to be reviewed at regular pre-defined intervals (as defined by the HCO in the quality improvement manual but at least once in four months) by conducting internal audits. This audit shall be done by a multi-disciplinary team (preferably trained in NABH standards) including all the applicable standards and objective elements. At the end of the audit there shall be a formal meeting to summarise the findings and identify areas for improvement. During this meeting there shall be an analysis of key indicators as identified and determined by the organization including the mandatory indicators as laid down in CQI 2 and 3. The minutes of the review meetings should be recorded and maintained.

Quality Committee

40

g) The quality improvement programme is a continuous process and updated at least once in a year.

Self explanatory. The inputs for updation could be based on the review carried out by the quality improvement committee.


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


a) Monitoring includes appropriate patient assessment.

The HCO shall develop appropriate key performance indicators suitable to it. The following is however mandatory:i. Time for initial assessment

of indoor and emergency patients.

i. Percentage of cases wherein care plan is documented and counter-signed by the clinician.

ii. Percentage of cases wherein screening for nutritional needs has been done.

iii. Percentage of cases wherein the pre-defined initial nursing assessment is completed within 30 minutes.

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

The HCO shall develop appropriate key performance indicators suitable to it. The following is however mandatory:i. Number of reporting

errors/1000 investigations.ii. Percentage of re-dos. iii. Percentage of reports Co-

relating with clinical diagnosis.iv. Percentage of adherence to

safety precautions by employees working in diagnostics.

c) Monitoring includes all invasive procedures.

The HCO shall develop appropriate key performance indicators suitable to it. The following is however mandatory:i. Re-exploration rate.ii. Percentage of accidental

removal of tubes and catheters.

iii. Incidence of haematoma at puncture site.

iv. Percentage of re-scheduling of procedures.

d) Monitoring includes adverse drug events.

The HCO shall develop appropriate key performance indicators suitable to it. The following is however mandatory:i. Percentage of medication

errors.

41

ii. Incidence of adverse drug reactions.

iii. Percentage of medication charts with illegible writing over a given period.

iv. Percentage of contrast related reactions.

e) Monitoring includes use of anaesthesia.

The HCO shall develop appropriate key performance indicators suitable to it. The following is however mandatory:i. Percentage of modification of

anaesthesia plan.ii. Percentage of unplanned

ventilation following anaesthesia.

iii. Percentage of adverse anaesthesia events.

iv. Anaesthesia related mortality rate.

f) Monitoring includes use of blood and blood products.

The HCO shall develop appropriate key performance indicators suitable to it. The following is however mandatory:i. Percentage of transfusion

reactions.ii. Percentage of wastage of

blood and blood products.iii. Percentage of blood

component usage.iv. Turnaround time for issue of

blood and blood componentsg) Monitoring includes

availability and content of medical records.

The HCO shall develop appropriate key performance indicators suitable to it. The following is however mandatory:i. Percentage of medical records

not having discharge summary.

ii. Percentage of medical records not having initial assessment and the plan of care.

iii. Percentage of medical records having incomplete and/or improper consent.

iv. Percentage of missing records.

h) Monitoring includes infection control activities.

The HCO shall develop appropriate key performance indicators suitable to it. The following is however mandatory:i. Urinary tract infection rate.ii. Respiratory infection rate.iii. Intra-vascular device infection

rate.iv. Surgical site infection rate.

Infection Control Committee

i) Monitoring includes clinical research.

The HCO shall develop appropriate key performance indicators suitable to it. The following is however mandatory:

NA

42

i. Number of research activities being carried out.

ii. Percentage of patients withdrawing from the study.

iii. Percentage of protocol violations/deviations reported.

iv. Percentage of serious adverse events (which have occurred in the HCO) reported to the ethics committee within the defined timeframe.

j) Monitoring includes data collection to support further improvements.

The data could be collected at pre-defined intervals e.g. monthly/quarterly. This data is analysed for improvement opportunities and the same are carried out. Also refer to CQI 1f

Infection Control Committee

k) Monitoring includes data collection to support evaluation of these improvements.

All improvement activities carried out by the HCO shall have an evaluable outcome. The same shall be captured and analysed.

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


a) Monitoring includes procurement of medication essential to meet patient needs.

The HCO shall develop appropriate key performance indicators suitable to it. The following is however mandatory:i. Percentage of drugs procured by

local purchase.ii. Percentage of stock outs

including emergency drugs.iii. Percentage of consumables

rejected before preparation of Goods Receipt Note.

iv. Incidence of variations from the procurement process.

Drugs and Therapeutic Committee

Drug Formulary

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

The HCO shall develop appropriate key performance indicators suitable to it. The following is however mandatory:i. Number of births and deaths. ii. Number of notifiable diseases. iii. Submission of report/ data/form

pertaining to bio-medcial waste, PNDT act and radiation safety within the defined timeframe.

iv. Submission of tax returns and deduction of taxes at the specified time frame.

MRD Policy

c) Monitoring includes risk management.

The HCO shall develop appropriate key performance indicators suitable to it. The following is however mandatory:i. Number of variations observed in

mock drills.


43

ii. Incidence of falls.iii. Incidence of bed sores after

admission.iv. Percentage of employees

provided pre-exposure prophylaxis.

d) Monitoring includes utilisation of space, manpower and equipment.

The HCO shall develop appropriate key performance indicators suitable to it. The following is however mandatory:i. Bed occupancy rate and average

length of stay.ii. OT and ICU utilization rate.iii. Equipment down time.iv. Nurse-patient ratio.

Quality Committee

e) Monitoring includes patient satisfaction which also incorporates waiting time for services.

The HCO shall develop appropriate key performance indicators suitable to it. The following is however mandatory:i. Out patient satisfaction index.ii. In patient satisfaction index.iii. Waiting time for services including

diagnostics and out patient. iv. Time taken for discharge.

Quality Committee

f) Monitoring includes employee satisfaction.

The HCO shall develop appropriate key performance indicators suitable to it. The following is however mandatory:i. Employee satisfaction index.ii. Employee attrition rate.iii. Employee absenteeism rate.iv. Percentage of employees who

are aware of employee rights, responsibilities and welfare schemes.

Employee Satisfaction Survey

g) Monitoring includes adverse events and near misses.

The HCO shall develop appropriate key performance indicators suitable to it. The following is however mandatory:i. Number of sentinel events.ii. Percentage of near misses

analysed.iii. Number of security related

incidents including thefts.iv. Incidence of needle stick injuries.

Sentinel Event Policy

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

The data could be collected at pre-defined intervals e.g. monthly/ quarterly. This data is analysed for improvement opportunities and the same are carried out. Also refer to CQI 1f

MRD Policy

i) Monitoring includes data collection to support evaluation of the improvements.

Self explanatory. The inputs for updation could be based on the review carried out by the quality improvement committee.

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

44


a) Hospital Management makes available adequate resources required for quality improvement programme.

This shall include the men, material, machine and method. These should be in steady supply so as to ensure that the programme functions smoothly.

Budget Report

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

Appropriate fund allocation is done by the organization for the smooth functioning of the programme.

Budget

c) Appropriate statistical and management tools are applied whenever required.

Self explanatory.

Monthly report of MRD

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


a) Medical and nursing staff participates in this system.

The HCO shall identify such personnel. It could be a mix of clinicians, administrators and nurses.

Medical Audit Committee

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

As these audits are retrospective/concurrent in nature, it is imperative that this be done using predefined parameters so that there is no bias. The parameters could be disease based, cost based, community based or based on length of stay.

Parameters for medical AUDIT

c) Patient and staff anonymity is maintained.

This means that the names of the patients and the hospital staff who may figure in the audit documents must not be disclosed nor any reference be made to them in public discussions/ conferences.

YES

d) All audits are documented.

Self explanatory. Medical Audit Report

e) Remedial measures are implemented

All remedial measures as ascertained should be documented and implemented and improvements thereof recorded to complete the audit cycle.

Action taken Report of the Medical Audit

CQI.6. Sentinel events are intensively analyzed.


a) The organization has defined sentinel events.

The sentinel events relating to system or process deficiencies that Sentinel Event Policy

45

are relevant and important to the organization must be clearly defined.

b) The organization has established processes for intense analysis of such events.

The established processes should include reporting the occurrence of such events on standardised incident report forms.


c) Sentinel events are intensively analysed when they occur.

Root cause analysis of all such events should be carried out by a multi-disciplinary committee taking inputs from the concerned units/ discipline/ departments.


d) Actions are taken upon findings of such analysis.

The findings and recommendations arrived at after the analysis should be communicated to all concerned personnel to correct the systems and processes to prevent recurrences.


CHAPTER 7 : Responsibilities of Management (ROM)

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

Objective Element Interpretation Remarksa) Those responsible for

governance lay down the organization’s mission statement.

It is not only the head of the HCO but the members of the board of governors (where applicable) who need to define it.


b) Those responsible for governance lay down the strategic and operational plans commensurate to the organization’s mission in consultation with the various stake holders.

The Governing board and the leaders of HCO shall define and develop the process for strategic and operation plans so as to achieve the organizational mission statement.


c) Those responsible for governance approve the organization’s budget and allocate the resources required to meet the organization’s mission.

The Governing board and the Head of HCO shall have the policy for budgeting and resource allocation for attaining its mission and periodically review it.

Budget

d) Those responsible for governance monitor and measure the performance of the organization against the stated mission.

The governing board and the Head of the HCO shall develop quarterly (at least) performance reports based on the strategic and operational plans.


e) Those responsible for governance establish the organization’s organogram.

The HCO shall have a well defined organization structure/chart and this shall clearly document the hierarchy, line of control, along with the functions at various levels.

Organization structure

46

f) Those responsible for governance appoint the senior leaders in the organization.

Self explanatory.

Organization structure

g) Those responsible for governance support research activities and quality improvement plans.

Self explanatory.

NA

h) The organization complies with the laid down and applicable legislations and regulations.

Self explanatory. The responsibility of compliance lies with the first two level of the hierarchy.

Licenses COPY

i) Those responsible for governance address the organization’s social responsibility.

The Governing board and Head of the HCO shall willfully develop social responsibility policy and accordingly address it.

Marketing Dept.

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

Objective Element Interpretation Remarksa) Each organizational

programme, service, site or department has effective leadership.

There needs to be a minimum essential qualification and relevant experience of the leader. The leader should have domain knowledge of that particular department.

HR Department have all the records of it

b) Scope of services of each department is defined.

Each department's activity is to be predefined. This could be documented either at individual department level or the HCO could have a brochure detailing the scope of each department.

Scope of Services

Evident on Site

c) Administrative policies and procedures for each department is maintained.

This shall include administrative procedures like attendance, leave, conduct, replacement etc.

HR Department

d) Departmental leaders are involved in quality improvement.

Self explanatory.Quality Committee

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

Objective Element Interpretation Remarksa) The leaders make public

the mission statement of the organization.

The HCO shall have a mission statement and the same shall be displayed prominently.

Quality Management PlanMission statement as

evidence.b) The leaders establish the

organization’s ethical management.

The HCO shall function in an ethical manner. Ethics Committee

47

c) The organization discloses its ownership.

The ownership of the hospital e.g. trust, private, public has to be disclosed.

Private

d) The organization honestly portrays the services which it can and cannot provide.

Self explanatory.Scope of Services

e) The organization honestly portrays its affiliations and accreditation.

Here portrays implies that the HCO convey its affiliations, accreditations for specific departments or whole hospital wherever applicable.

f) The organization accurately bills for its services based upon a standard billing tariff.

Self explanatory.

Tariff List

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

Objective Element Interpretation Remarksa) The designated individual

has requisite and appropriate administrative qualifications.

Self explanatory.YES

b) The designated individual has requisite and appropriate administrative experience.

Self explanatory.16 Years Exp.

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

Objective Element Interpretation Remarksa) The organization has an

interdisciplinary group assigned to oversee the hospital wide safety programme.

Self explanatory.

Hospital Safety Committee

b) The scope of the programme is defined to include adverse events ranging from “no harm” to “sentinel events”.

The HCO shall have a system of reporting of all the incident/accident. Sentinel Event Policy

c) Management ensures implementation of systems for internal and external reporting of system and process failures.

The HCO has a system in place for internal and external reporting of system and process failures.Contingency plan shall be in place to deal with the situation of system and process failure anticipated within the organization.


d) Management provides There shall be sufficient resources

48

resources for proactive risk assessment and risk reduction activities.

kept as contingency to address the risk reduction activities as and when the leaders proactively suggest.The end result of these shall result in preventive actions.


CHAPTER 8: Facility Management and Safety (FMS)

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


a) The management is conversant with the laws and regulations and knows their applicability to the organization.

A designated management functionary has been given the responsibility to enlist the laws and regulation as applicable to the HCO. This functionary has identified the appropriate personnel in the HCO who are supposed to implement the respective laws and regulations.

Licenses & Act approval copy as evidence

b) Management regularly updates any amendments in the prevailing laws of the land.

Self explanatory. Copies available with MS

(Process for Compliance and Updating of Regulatory & Statutory requirements)

c) The management ensures implementation of these requirements.

Self explanatory.Copies available with MS(Process for Compliance

and Updating of Regulatory & Statutory requirements)

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

Self explanatory.Copies available with

MS(Process for Compliance and Updating of Regulatory & Statutory

requirements)

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


a) There is a documented operational and maintenance (preventive and breakdown) plan.

Self explanatory.

Bio-Medical Engg.

b) Up-to-date drawings are maintained which detail the site layout, floor plans and fire escape

A designated person maintains the drawings.

Document with Engineering Department

49

routes.c) There is internal and

external sign posting in the organization in a language understood by patient, families and community.

Self explanatory.

Evident at Site

d) The provision of space shall be in accordance with the available literature on good practices (Indian or International Standards) and directives from government agencies.

Self explanatory. Engineering / Facilities Dept.

e) There are designated individuals responsible for the maintenance of all the facilities.

A person in the HCO management is designated to be in-charge of maintenance of facilities. The HCO has the required number of supervision and tradesmen to manage the facilities.

Roster of Engineering department

f) Maintenance staff is contactable round the clock for emergency repairs.

Self explanatory.Roster as Evidence

g) Response times are monitored from reporting to inspection and implementation of corrective actions.

A complaint attendance register is to be maintained to indicate the date and time of receipt of complaint, allotment of job and completion of job.

Records of the Engineering Department

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


a) The organization plans for equipment in accordance with its services and strategic plan.

Self explanatory. This shall also take into consideration future requirements. Material Management

b) Equipment is selected by a collaborative process.

Collaborative process implies that during equipment selection there is involvement of end user, management, finance, engineering and bio-medical departments.

Purchase Committee

c) All equipment are inventoried and proper logs are maintained as required.

Self explanatory.Bio-Medical Engg.

Registers of the BME Department

d) Qualified and trained personnel operate and maintain the equipment

Self explanatory. Bio Medical Engineer

e) Equipment are periodically inspected and calibrated for their

The HCO has weekly / monthly / annual schedules of inspection and calibration of equipment which Calibration Process

50

proper functioning. involve measurement, in an appropriate manner. The HCO either calibrates the equipment in house or out sources; maintaining traceability to national or international or manufacturer’s guidelines/standards.

Calibration records of equipments

f) There is a documented operational and maintenance (preventive and breakdown) plan.

Self explanatory.Bio-Medical Engg.

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


a) Potable water and electricity are available round the clock.

The HCO shall make arrangements for supply of adequate potable water and electricity.

Engineering / Facilities Dept.

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

Alternate electric supply could be from DG Sets, solar energy, UPS and any other suitable source.

Engineering / Facilities Dept.

c) The organization regularly tests the alternate sources.

Self explanatory.Engineering / Facilities

Dept.d) There is a maintenance

plan for piped medical gas, compressed air and vacuum installation.

Self explanatory.Gas Manifold

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


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

The HCO has a fire and non-fire emergency committee (FNEC) to review the HCO’s preparedness. The HCO has conducted an exercise of hazard identification and risk analysis (HIRA) and accordingly taken all necessary steps to eliminate or reduce such hazards and associated risks. The HCO has:a) a fire plan covering fire arising

out of burning of inflammable items, explosion, electric short circuiting or acts of negligence or due to incompetence of the staff on duty;

b) deployed adequate and qualified personnel for this;

c) acquired adequate fire fighting equipment for this which

Sprinklers and smoke detectors,

Evident on site.

Disaster Mgt. Plan

51

records are kept up-to-date;d) adequate training plans; e) schedules for conduct of mock

fire drills;f) mock drill records;g) exit plans well displayed.

The HCO has a dedicated emergency illumination system which comes into effect in case of a fire. The HCO takes care of non-fire emergency situations by identifying them and by deciding appropriate course of action. These may include :a) terrorist attackb) invasion of swarms of insects

and pestsc) earthquaked) invasion of stray animalse) hysteric fits of patients and/ or

relativesf) civil disorders effecting the

HCOg) anti-social behaviour by

patients/ relativesh) temperamental disorders of

staff causing deterioration in patient care

i) spillage of hazardous (acids, mercury, etc.), infected materials (used gloves, syringes, tubing, sharps, etc.) medical wastes (blood, pus, amniotic fluid, vomits, etc.)

j) building or structural collapsek) fall or slips (from height or on

floor) or collision of personnel in passageway

l) fall of patient from bed m) bursting of pipe linesn) sudden flooding of areas like

basements due to clogging in pipe lines

o) sudden failure of supply of electricity, gas, vacuum, etc

p) bursting of boilers and/ or autoclaves.

The HCO has established liaison with civil and police authorities and fire brigade as required by law for enlisting their help and support in case of an emergency.

b) The organization has a documented safe exit plan in case of fire and non-fire emergencies.

Fire exit plan shall be displayed on each floor particularly close to the lifts. Exit doors should remain open on all the time.

Fire Exit Plan Displayed on each floor

52

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

In case of fire designated person are assigned particular work.

Fire fighting team formedTraining Records

d) Mock drills are held at least twice in a year.

Self explanatory. Records of Drills

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


a) The organization defines and implements its policies to reduce or eliminate smoking.

Smoking in public places including hospitals has been banned in this country.

Smoking Policy

b) The policy has provisions for granting exceptions for patients and families to smoke.

In view of the law permission to smoke within the campus of hospital may not be granted.

Smoking Policy

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


a) The hospital identifies potential emergencies.

The HCO has a documented plan and procedure for handling the situations like sudden rush of victims ofa) earthquakeb) floodc) train accidentd) Civil unrest outside the HCO

premisese) Major firef) Invasion by enemy, etc.g) These plans and procedures

cover ensuring adequacy of medical supplies, equipment, materials, identified trained personnel, transportation aids, communication aids and mock drill methodology.

Disaster Mgt. Plan

b) The organization has a documented disaster management plan.

The disaster plan must incorporate essential elements of alert code, information and communication, action cards for each of the staff, availability and earmarking of resources, establishment of command nucleus, training and mock drills

Disaster Mgt. Plan

c) Provision is made for availability of medical supplies, equipment and materials during such emergencies.

Resource availability should be according to threat perception. Disaster Mgt. Plan

d) Hospital staff is trained in the hospital’s disaster

Mock drills with and without patients have to be carried out. Training Records

53

management plan. Only communication exercise may also be undertaken.

e) The plan is tested at least twice in a year.

Self explanatory. Disaster Mgt. Plan

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


a) Hazardous materials are identified within the organization.

The HCO has identified and listed the hazardous materials and has a documented procedure for their sorting, storage, handling, transpirations, disposal mechanism, and method for managing spillages and adequate training of the personnel for these jobs.


b) The hospital implements processes for sorting, labelling, handling, storage, transporting and disposal of hazardous material.

The HCO has conducted an exercise of hazard identification and risk analysis (HIRA) associated with handling of hazardous materials and accordingly taken all necessary steps to eliminate or reduce such hazards and associated risks. The HCO has ensured display of Material Safety Data Sheets (MSDS) for all hazardous materials and has accordingly arranged associated training of personnel who handle such materials. The situational hazards also need to be covered in HIRA so that any emergency situation arising out of process of storing, handling, storage, transportation and disposal of such hazardous materials are met effectively. Sharp bends in passages, protruding or dangling elements in passage ways, sudden swing of swing doors, ramps, entry and exit from lifts, are situations which need to be taken care of. See FMS 5 also. The HCO has the requisite training need identification for material handling and those trainings are included in the HCO training calendar.

Waste Mgt. Process

MSDS available on site

c) Requisite regulatory requirements are met in respect of radioactive materials.

The appropriate personnel in the HCO are aware about the rules and regulations such as the Atomic Energy Act, the norms issued by Atomic Energy Regulatory Board (AERB) and the directives from the Health Physics Division of Bhaba Atomic Research Centre (BARC).

As per biomedical waste management rule

54

d) There is a plan for managing spills of hazardous materials.

Self explanatory.MSDS

e) Staff is educated and trained for handling such materials.

Self explanatory.Training Record of Medical

& Paramedical Staffs.

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


a) The hospital has a safety committee to identify the potential safety and security risks.

The HCO has a duly constituted safety committee which has identified the potential safety and security risks to staff, patients and visitors.

HospitaL Safety Committee

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

The HCO ensures that the above Committee functions on a regular basis to coordinate development, implementation and monitoring of the plans and policies.


c) Patient safety devices are installed across the organization and inspected periodically.

Self explanatory.

Evident on site

d) Facility inspection rounds to ensure safety are conducted at least twice in a year in patient care areas and at least once in a year in non-patient care areas.

Rounds to be carried out by safety committee.

Facility round conducted by Safety Committee

e) Inspection reports are documented and corrective and preventive measures are undertaken.

Self explanatory.Inspection Rounds

f) There is a safety education programme for all staff.

Self explanatory.Training Record

CHAPTER 9 : Human Resource Management (HRM)

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

Objective Element Interpretation Remarksa) The organization

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

The staff should be commensurate with the workload and the clinical requirement of the patients.

Manpower Planning

55

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

The content of each job should be well defined and the qualifications, skills and experience required for performing the job should be clearly laid down. The job description should be commensurate with the qualification.

Job Specifications

c) The organization verifies the antecedents of the potential employee with regards to criminal/negligence background.

Self explanatory.Antecedent Verification

Service Rule 74

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

Objective Element Interpretation Remarksa) Each staff member,

employee student and voluntary worker is appropriately oriented to the organization’s mission and goals.

The organization's staff including the outsourced staff should be aware and should correctly interpret the mission and goals of the organization.

Employee Guide Book

b) Each staff member is made aware of hospital wide policies and procedures as well as relevant department/ unit/ service/ programme’s policies and procedures.

The organization's staff including the outsourced staff should be aware and should correctly interpret the policies and operating procedures of the organization as well as that of the department/ unit/ service in which he is performing the requisite duties.

Employee Guide Book

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

The HCO shall define the same in consonance with statutory requirements and the same shall be communicated to the employees.

Employee Guide Book

d) All employees are educated with regard to patients’ rights and responsibilities.

The employees should be able to identify and report violation of patient rights as and when the same occurs.

Employee Guide Book

e) All employees are oriented to the service standards of the organization.

The HCO shall develop benchmarks for different services being provided. This shall be based on the HCO's values and focus on development of soft skills: behaviour, attitude, communication skills, etc.

Induction Manual

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

Objective Element Interpretation Remarksa) A documented training A training manual incorporating the

56

and development policy exists for the staff.

procedure for identification of training needs, the training methodology, documentation of training, training assessment, impact of training and the training calendar should be prepared.

Training and Development policy

b) Training also occurs when job responsibilities change/ new equipment is introduced.

The training should focus on the revised job responsibilities as well as on the newly introduced equipment and technology. In case of new equipment the operating staff should receive training on operational as well as daily maintenance aspects.

Training and Development Policy

Record with HRD and respective Deptt.

c) Feedback mechanisms for assessment of training and development programme exist.

This shall include both internal & external training. For external training it could be done either by the HCO itself or by the external agency which imparted the training. Impact of training at user level should also be documented

Record with HRD and respective Deptt.

HRM.4. Staff members, students and volunteers are adequately trained on specific job duties or responsibilities related to safety.

Objective Element Interpretation Remarksa) All staff is trained on the

risks within the hospital environment.

The HCO shall define such risks which shall include patient, visitors and employee related risks.

Hospital Safety manual

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

Self explanatory.

Records of Drills

c) Staff members are made aware of procedures to follow in the event of an incident.

Self explanatory. Training Records

d) Reporting processes for common problems, failures and user errors exist.

The HCO has a defined procedure for reporting of these events. Quality Committee

HRM.5. An appraisal system for evaluating the performance of an employee exists as an integral part of the human resource management process.

Objective Element Interpretation Remarksa) A well-documented

performance appraisal system exists in the organization.

Self explanatory.Performance Appraisal

System

b) The employees are made aware of the system of appraisal at

Self explanatory.Induction Training

Programme

57

the time of induction.c) Performance is

evaluated based on the performance expectations described in job description.


System

d) The appraisal system is used as a tool for further development.

Self explanatory. This can be done by identifying training requirements and accordingly providing for the same (wherever possible).

Performance Appraisal System

e) Performance appraisal is carried out at pre defined intervals and is documented.


System

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

Objective Element Interpretation Remarksa) A written statement of

the policy of the organization with regard to discipline is in place.

Self explanatory.Disciplinary Procedure

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

This implies that both parties (employee and employer) are given an opportunity to present their case and decision is taken accordingly.

Disciplinary Procedure

c) The policy and procedure is known to all categories of employees of the organization.

Self explanatory.Induction Training Records

d) The disciplinary procedure is in consonance with the prevailing laws.

Self explanatory.Disciplinary Procedure

e) There is a provision for appeals in all disciplinary cases.

The HCO shall designate an appellate authority to consider appeals in disciplinary cases.

Disciplinary Procedure

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

Objective Element Interpretation Remarksa) The employees are

aware of the procedure to be followed in case they feel aggrieved.

For definition of "grievance handling" refer to glossary. The HCO has a written procedure for handling grievances of employees. Employee Grievance Policy

b) The redress procedure addresses the grievance.

Self explanatory.

Employee Grievance Policy

c) Actions are taken to redress the grievance.

Self explanatory.Employee Grievance Policy

58

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

Objective Element Interpretation Remarksa) A pre-employment

medical examination is conducted on all the employees.

Self explanatory. This shall however be in consonance with the law of the land.

Evidenced on Personal File

b) Health problems of the employees are taken care of in accordance with the organization’s policy.

Self explanatory. This shall be in consonance with the law of the land and good clinical practices.

Medical Benefit

c) Regular health checks of staff dealing with direct patient care are done at-least once a year and the findings/ results are documented.

Self explanatory. The results should be documented in the personal file.

Medical Benefit

Records in Personal file

d) Occupational health hazards are adequately addressed.

Self explanatory.

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

Objective Element Interpretation Remarksa) Personal files are

maintained in respect of all employees.

Self explanatory.HR Department

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

Self explanatory.Personal File as Evidence.

c) All records of in-service training and education are contained in the personal files.

Self explanatory.Training record kept

separately

d) Personal files contain results of all evaluations.

Evaluations would include performance appraisals, training assessment and outcome of health checks.

YES

HRM.10. There is a process for collecting, verifying and evaluating the credentials (education, registration, training and experience) of medical professionals permitted to provide patient care without supervision.

Objective Element Interpretation Remarksa) Medical professionals The HCO identifies the individuals

59

permitted by law, regulation and the hospital to provide patient care without supervision are identified.

who have the required qualification (s), training and experience to provide patient care in consonance with the law.

Credentialing Committee

b) The education, registration, training and experience of the identified medical professionals is documented and updated periodically.

Self explanatory. Updation is done after acquisition of new skills and/or qualification.


c) All such information pertaining to the medical professionals is appropriately verified when possible.

The HCO shall do the same by verifying the credentials from the organization which has awarded the qualification/training.


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

Objective Element Interpretation Remarksa) Medical professionals

admit and care for patients as per the laid down policies and authorization procedures of the organization.

The HCO shall identify as to what each medical professional is authorized to do.

b) The services provided by the medical professionals are in consonance with their qualification, training and registration.

Self explanatory.

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

Self explanatory.

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


60

a) The education, registration, training and experience of nursing staff is documented and updated periodically.

The HCO identifies the individuals who have the required qualification (s), training and experience to provide nursing care to patients in consonance with the law. Updation is done after acquisition of new skills and/or qualification.

Registration from Nursing Counsil

b) All such information pertaining to the nursing staff is appropriately verified when possible.

The HCO shall do the same by verifying the credentials from the organization which has awarded the qualification/training.

HR Department

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

Objective Element Interpretation Remarksa) The clinical work

assigned to nursing staff is in consonance with their qualification, training and registration.

The HCO shall identify as to what each nurse is authorized to do. Privileging

b) The services provided by nursing staff are in accordance with the prevailing laws and regulations.

Self explanatory.Privileging

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

Self explanatory.Nursing Manual

CHAPTER 10 : Information Management System (IMS)

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


a) The information needs of the organization are identified and are appropriate to the scope of the services being provided by the organization and the complexity of the organization.

The HCO has manual and/or electronic Hospital Information System and/or Management Information System which provides relevant information to all concerned stakeholders.

Medical Records Department

61

b) Policies and procedures to meet the information needs are documented.

A policy document is available where the HIS/MIS is described. HIS

c) These policies and procedures are in compliance with the prevailing laws and regulations.

Self explanatory.Evidenced at respective

Deptt.

d) All information management and technology acquisitions are in accordance with the policies and procedures.

The HCO shall define the needs for software and hardware solutions as per the information requirements and future necessities.

HISPrimus%20Hospital%20Manual.doc#BACKUP

e) The organization contributes to external databases in accordance with the law and regulations.

The HCO shall define the system of releasing the relevant information to the authority as per statutory norms.


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


a) Formats for data collection are standardized.

MIS/HIS data is collected in standardised format from all areas/services in the HCO.


b) Necessary resources are available for analyzing data.

The HCO shall make available men, material, space and budget.

Budget

c) Documented procedures are laid down for timely and accurate dissemination of data.

Self explanatory.Medical Records

Department

d) Documented procedures exist for storing and retrieving data.

The HCO shall define data management policy and ensure adequate safeguards for protection of data, where ever physical or electronic data is stored.


e) Appropriate clinical and managerial staff participates in selecting, integrating and using data.

There is a multi-disciplinary committee which is responsible for the appropriate selection of indicators, measurement of trends and initiating action wherever required.

Medical Audit committee scope.

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


a) Every medical record has a unique identifier.

This shall also apply to records on digital media.


b) Organization policy identifies those

HCO has a written policy stating who all can make entries.


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authorized to make entries in medical record.

c) Every medical record entry is dated and timed.

Self explanatory. Medical Records Department

d) The author of the entry can be identified.

This could be by writing the full name or by mentioning the employee code number, with the help of stamp, etc. In case of electronic based records, authorised e-signature provision as per statutory requirements must be kept.


e) The contents of medical record are identified and documented.

The HCO identifies which documents form part of the medical records, documents and implements the same.


f) The record provides an up-to-date and chronological account of patient care.

The HCO shall decide the format for maintaining the continuity in the medical records.

Medical Record file as an Evidence

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


a) The medical record contains information regarding reasons for admission, diagnosis and plan of care.


Department

b) Operative and other procedures performed are incorporated in the medical record.


Department

c) When patient is transferred to another hospital, the medical record contains the date of transfer, the reason for the transfer and the name of the receiving hospital.

Self explanatory. It is mandatory to mention the clinical condition of the patient before transfer is effected.


d) The medical record contains a copy of the discharge note duly signed by appropriate and qualified personnel.

Self explanatory. Medical Records

Department

e) In case of death, the medical record contains a copy of the death certificate indicating the cause, date and time of death.

Self explanatory. The HCO provides the death certificate as per the International Certification of cause of death.


Death certificate evident

f) Whenever a clinical autopsy is carried out, the medical record contains a copy of the

Self explanatory.

Not Applicable

63

report of the same.g) Care providers have

access to current and past medical record.

The HCO provides access to medical records to designated health care providers (those who are involved in the care of that patient).


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


a) Documented policies and procedures exist for maintaining confidentiality, security and integrity of information.

The HCO shall control the accessibility to the MRD department. It shall ensure the usage of tracer card for movement of the file in and out of the MRD so as to maintain confidentiality, security, safety and integrity of information.This is applicable for both manual and electronic records.

HIS

HISTracer card available.

b) Policies and procedures are in consonance with the applicable laws.

This is in the context of Indian Evidence Act, Indian Penal Code and Code of medical Ethics.

Process for Compliance and Updating of Regulatory & Statutory Requirements

c) The policies and procedures incorporate safeguarding of data / record against loss, destruction and tampering.

For physical records the HCO shall ensure that there is adequate pest and rodent control measures. For electronic data there should be protection against virus/trojans and also a proper backup procedure. To prevent tampering, for physical records access shall be limited only to the concerned health care provider. In electronic format this could be done by adequate passwords.

HIS

HIS

d) The hospital has an effective process of monitoring compliance of the laid down policy.

The HCO carries out regular audits/rounds to check compliance with policies.


HIS

e) The hospital uses developments in appropriate technology for improving confidentiality, integrity and security.

The HCO shall review and update its technological features so as to improve confidentiality, integrity and security of information.


f) Privileged health information is used for the purposes identified or as required by law and not disclosed without the patient’s authorization.

The HCO shall define the procedure for privileged communication.


g) A documented procedure exists on how to respond to patients/ physicians

Self explanatory. In this context, the release of information in accordance with the Code of

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and other public agencies requests for access to information in the medical record in accordance with the local and national law.

Medical Ethics 2002 should be kept in mind. Report to Health Authority

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


a) Documented policies and procedures are in place on retaining the patient’s clinical records, data and information.

The HCO shall define the retention period for each category of medical records:Out-patient, in-patient and MLC.


b) The policies and procedures are in consonance with the local and national laws and regulations.

Some of the related laws in this context are Code of Medical Ethics 2002, Consumer protection act 1987 and relevant state legislation, if any.


c) The retention process provides expected confidentiality and security.

This is applicable for both manual and electronic system. Medical Records

Department

d) The destruction of medical records, data and information is in accordance with the laid down policy.

Destruction can be done after the retention period is over and after taking approval of the competent authority.


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


a) The medical records are reviewed periodically.


Department

b) The review uses a representative sample based on statistical principles.

The HCO shall define the principles on which sampling is based. For example, simple random, systemic random sampling etc.Review shall be based on conditions of clinical and/or community importance, total discharges including deaths, total indoor patients, etc.


c) The review is conducted by identified care providers.

Self explanatory. Medical Audit CommitteeMedical Records

Department

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


Department

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e) The review process includes records of both active and discharged patients.


Department

f) The review points out and documents any deficiencies in records.

Self explanatory. Medical Audit ReportMedicall Records

Department

g) Appropriate corrective and preventive measures undertaken are documented.

Self explanatory. Action Taken Report

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