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

)

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

Objective Element a) The services being provided are clearly defined and are in consonance with the needs of the community. The defined services are prominently displayed.

Interpretation A policy to be framed clearly stating the services the hospital can provide.

Remarks Scope of Services

b)

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. 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.

Evident on Site

c)

The staff is oriented to these services.

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

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

Interpretation 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. Self explanatory

Remarks Registration process Admission Process

b)

c)

The policies and procedures address outpatients, in-patients and emergency patients. Patients are accepted only if the organization can provide the required service.

Admission Process 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 staff is aware of these processes.

The HCO is aware of the availability of alternate HCO's where the patients may be directed in case of non-availability of beds. All the staff handling these activities should be oriented to these policies and procedures.

Policy for non availability of beds

e)

Induction Manual

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

Objective Element a) Policies guide the transfer of unstable patients to another facility in an appropriate manner.

Interpretation 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. Patients not in a life threatening situation (stable) should also be transported in a safe manner. The staff shall at least be a trained trauma/emergency technician/nurse. He/she shall have undergone training in BLS and/or ACLS. 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.

Remarks Patient Transfer Policy

b)

Policies guide the transfer of stable patients to another facility. Procedures identify staff responsible during transfer. The organization gives a summary of patient’s condition and the treatment given.

Patient Transfer Policy

c)

Patient Transfer Policy

d)

Discharge Summary

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

Objective Element

Interpretation

Remarks

2

a)

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

b)

The patients and/or family members are explained about the expected results. The patients and/or family members are explained about the possible complications. The patients and/or family members are explained about the expected costs.

The plan of care as decided by the doctor on duty or the patient management team (as the case may be) is to be discussed with the patient and/or family members. This should be done in a language the patient/attendant can understand. The above information is to be documented and signed by the concerned doctor. The patients and family are explained in detail by the treating physicians or his/her team about the outcomes of such treatment. Possible complications of the treatment, if any, are clearly communicated to the patient. Patients should be given an estimate of the expenses on account of the treatment preferably in a written form.

Patients Right Policy

Patients Right Policy

c)

Patients Right Policy

d)

Patients Right Policy

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

Objective Element a) The organization defines the content of the assessments for the out– patients, in-patients and emergency patients.

Interpretation 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. 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. 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.

Remarks Initial Assessment Policy

b)

The organization determines who can perform the assessments.

Initial Assessment Policy

c)

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

IInitial Assessment Policy

3

Interpretation After the initial assessment. Objective Element Interpretation Remarks 4 . This shall be documented by the treating doctor or by a member of his team in the case sheet. The staff could be the treating doctor or any member of the team as per their domain of responsibility of care. This plan is monitored by the treating doctor for its effectiveness. CRF patients. Laboratory services are provided as per the requirements of the patients. All patients cared for by the organization undergo a regular reassessment. Actions taken under reassessment are documented.7. The frequency maybe different for different areas based on the setting and the patient's condition e.6. Initial Assessment Policy c) Patients are reassessed to determine their response to treatment and to plan further treatment or discharge. drugs etc. Initial assessment includes screening for nutritional needs.g. The plan of care also includes preventive aspects of the care.d) e) The initial assessment for in-patients is documented within 24 hours or earlier as per the patient’s condition or hospital policy. investigation ordered and treatment ordered and all these are to be authenticated by treating doctor. This should cover history. The protocol for patient’s initial assessment should cover his/her nutritional needs. Initial Assessment Policy g) Initial Assessment Policy AAC. Initial Assessment Policy AAC. Initial Assessment Policy Initial Assessment Policy f) The initial assessment results in a documented plan of care which is monitored. patients in ICU need to reassessed more frequently compared to a patient in the ward. In case of Out patients this should be done where ever applicable. Objective Element a) All patients are reassessed at appropriate intervals. Remarks Initial Assessment Policy b) Staff involved in direct clinical care document reassessments. the patient is reassessed periodically and this is documented in the case sheet. progress notes. The documented plan of care should cover preventive actions as necessary in the case and should include diet. and wherever required by a clinical audit. For example diabetics. Self explanatory.

The test results in the critical limits shall be communicated to the concerned after proper documentation. Laboratory Manual 5 . ABG etc) must be available within its premises. identification. safe transportation. d) a methodology to check the performance of service rendered by the out sourced laboratory as per the requirements of the HCO. 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. safe transportation. processing and disposal of specimens. identification. to ensure safety of the specimen till the tests and retests (if required) are completed. processing and disposal of specimens. See also (f) below for outsourced lab facilities. Laboratory Manual Laboratory Manual Laboratory Manual d) Laboratory Manual e) Critical results are intimated immediately to the concerned personnel. The HCO has documented procedure for outsourcing tests for which it has no facilities. b) Adequately qualified and trained personnel perform and/or supervise the investigations. The HCO has documented procedures for collection. materials and equipment to make the laboratory results available within the defined time frame. This should include: a) list of tests for out sourcing. However. The HCO shall define the turnaround time for all tests. 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. handling. Pathologist.a) Scope of the laboratory services are commensurate to the services provided by the organization. c) 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. Laboratory results are available within a defined time frame. The laboratory shall establish its biological reference intervals for different tests. The HCO should ensure availability of adequate staff. microbiologist and biochemist supervise the staff. test results required for emergency management (RBS. The laboratory shall establish critical limits for tests which require immediate attention for patient management. handling. Laboratory Manual f) Laboratory tests not available in the organization are outsourced to organization(s) based on their quality assurance system. Policies and procedures guide collection. The staff employed in the lab should be suitably qualified (appropriate degree) and trained to carry out the tests.

Lab safety programme is incorporated in the safety programme of the hospital. disinfectants.9. There is an established laboratory quality assurance programme.10. Imaging services are provided as per the requirements of the patients.8. 6 . All the lab staff undergo training regarding safe practices in the lab. fire extinguishers. Laboratory personnel are provided with appropriate safety equipment / devices. standard precautions.AAC. Laboratory QA Manual AAC. Laboratory personnel are appropriately trained in safe practices. Interpretation The HCO has a documented quality assurance programme (preferably as per ISO 15189 Medical laboratories – Particular requirements for quality and competence). The lab staff should follow standard precautions. The laboratory director shall periodically assess the test results. Laboratory Safety Manual Laboratory Safety Manual Laboratory Safety Manual Laboratory Safety Manual e) AAC. This takes care of the safety of the workforce as well as the equipments available in the lab. The disposal of waste is according to Biomedical waste management and handling rules.g. Refer to ISO 15189. Adequate safety devices are available in the lab e. 1998. safety is Interpretation A well documented lab safety manual is available in the lab. The programme addresses surveillance of test results. The programme includes periodic calibration and maintenance of all equipments. dressing materials. Laboratory QA Manual Laboratory QA Manual Laboratory QA Manual Self explanatory. Written policies and procedures guide the handling and disposal of infectious and hazardous materials. Objective Element a) The laboratory programme documented. Objective Element a) The laboratory quality assurance programme is documented. Remarks Laboratory Safety Manual b) c) d) This programme is integrated with the organization’s safety programme. etc. Remarks Laboratory QA Manual b) c) d) e) The programme addresses verification and validation of test methods. There is an established laboratory safety programme. The programme includes the documentation of corrective and preventive actions. This holds true for any laboratory developed methods.

Critical results shall be intimated to the treating clinician at the earliest on phone. The HCO has documented procedure for outsourcing tests for which it has no facilities. Policies and procedures guide identification and safe transportation of patients to imaging services. This should include: a) list of tests for out sourcing. Remarks Imaging Department b) c) d) Scope of the imaging services are commensurate to the services provided by the organization. Adequately qualified and trained personnel perform and/or supervise the investigations. Interpretation 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 organization shall document turnaround time of imaging results. b) identity of personnel in the out sourced facilities to ensure safe transportation of specimens and completing of imaging results. Critical results are intimated immediately to the concerned personnel. This should also address transfer of unstable patients to imaging services. Imaging Department As per AERB guidelines. their identification and safe transportation to the imaging services. There is an established Quality assurance programme for imaging services. Imaging Department Patient Transfer Policy e) Imaging results are available within a defined time frame. c) manner of identification of patients and the test requisition with all details as required for testing and d) a methodology to check the selection and performance of service rendered by the outsourced imaging facility as per the requirements of the HCO. followed by written report. Imaging Department f) Imaging Department g) Imaging Department AAC. Imaging Department The HCO has documented policies and procedures for informing the patients about the imaging activities.Objective Element a) Imaging services comply with legal and other requirements. Imaging tests not available in the organization are outsourced to organization(s) based on their quality assurance system. Objective Element Interpretation Remarks 7 . The HCO maintains and updates its compliance status of legal and other requirements in a regular manner.11. Self explanatory.

Interpretation Refer to AERB guidelines Remarks Imaging Safety Manual b) The safety programme of the imaging department has reference in the hospital safety manual. The programme addresses surveillance of imaging results. Radiation safety devices are periodically tested and documented. Imaging Safety Manual AAC. HOD shall periodically imaging results. Radioactive and hazardous materials shall be disposed off as per bio-medical waste management and handling rules.12. Objective Element a) The radiation safety programme is documented. The programme includes the documentation of corrective and preventive actions.a) The quality assurance programme for imaging services is documented. This programme is integrated with the organization’s safety programme. Imaging personnel are trained in radiation safety measures. Refer to AERB guidelines. The programme addresses verification and validation of imaging methods. e) Imaging Safety Manual f) g) Evidence on side h) Document on safe use of radioactive isotopes for imaging services shall be available and implemented. Patient care is continuous and multidisciplinary in nature. Imaging personnel are provided with appropriate radiation safety devices. The programme includes periodic calibration and maintenance of all equipments.g. Self explanatory. Hospital Safety Manual c) Imaging Safety Manual d) Imaging Safety Manual Protective devices e. 8 . There is an established radiation safety programme. Training Records Self explanatory. assess the Imaging QA Programme Imaging QA Programme Imaging QA Programme Imaging QA Programme b) c) d) Calibration and maintenance of all equipment shall be carried out by competent persons.13. Imaging signage are prominently displayed in all appropriate locations Policies and procedures guide the safe use of radioactive isotopes for imaging services. 1998. Imaging QA Programme A document for verification and validation of imaging methods shall be available. Self explanatory. e) AAC. Self explanatory. Written policies and procedures guide the handling and disposal of radio-active and hazardous materials. lead aprons should be exposed to X-ray for verification of cracks and damages.

The organization has a documented discharge process. The organization shall ensure that there is effective communication of patient requirements amongst the care providers in all settings. c) d) e) f) Information about the patient’s care and response to treatment is shared among medical. etc. between shifts. The patient’s record (s) is available to the authorized care providers to facilitate the exchange of information. nursing and other care providers. IP. Self explanatory. Remarks In Patient Care Medical Care Related Process (Read responsibility) Emergency Room (Causality) Related Process (Read responsibility) IP Care Surgical Care Related Process (Read responsibility) In Patient Care Medical Care Related Process (Read responsibility) Emergency Room (Causality) Related Process (Read responsibility) IP Care Surgical Care Related Process (Read responsibility) b) Care of patients is coordinated in all care settings within the organization. response to treatment. Inpatient Care Inpatient Care Self explanatory. and during transfers between units/ departments. The HCO ensures periodic discussions about each patient (covering parameters like patient care. consultant and/or nurse).Objective Element a) During all phases of care. Interpretation The HCO to ensure that the care of patients is always given by appropriately qualified medical personnel (resident doctor. emergency.14. unusual developments if any. nursing and other care providers. Policies and procedures guide the referral of patients to other departments/ specialities. ICU. Information is exchanged and documented during each staffing shift. etc) amongst medical. there is a qualified individual identified as responsible for the patient’s care. 9 . Care of patients is co-ordinated among various care providers in a given setting viz OPD. Patient Transfer Policy AAC. Medical Record Dept 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.

bleeding/discharge from site. For example. any procedure performed. Organization defines the content of the discharge summary. Policies and procedures are in place for patients leaving against medical advice. medication and other instructions in an understandable manner. a post op patient should report when having fever. Interpretation Self explanatory. For MLC the organization shall ensure that the police are informed. Remarks Discharge Process b) Discharge Process c) Discharge Process d) Discharge Process AAC. Discharge Summary e) The HCO should outline conditions regarding ‘when’ to obtain urgent care. significant findings and diagnosis and the patient’s condition at the time of discharge. Discharge summary contains follow up advice. Discharge Summary d) Self explanatory.Objective Element a) The patient’s discharge process is planned in consultation with the patient and/or family. In LAMA cases. Discharge summary contains information regarding investigation results. the declaration of the patient/attendant is to be recorded on proper format. Discharge summary incorporates instructions about when and how to obtain urgent care. Discharge summary contains the reasons for admission.15. The HCO hands over the discharge papers to the patient/attendant in all cases and copy retained. Discharge Summary 10 . Discharge Summary c) Self explanatory. Remarks Discharge Summary b) Self explanatory. 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. Objective Element a) Discharge summary is provided to the patients at the time of discharge. Policies and procedures exist for coordination of various departments and agencies involved in the discharge process (including medico-legal cases). The treating doctor should explain the consequences of this action to the patient/attendant. The same is discussed with the patient and family. medication and other treatment given. A discharge summary is given to all the patients leaving the organization (including patients leaving against medical advice) Interpretation The patient's treating doctor determines the readiness for discharge during regular reassessments. The HCO has a documented policy for the LAMA cases.

COP.r.g. The organization shall also define as to what constitutes a MLC (in accordance with statutory rules). procedures. These could then be used as parameters for audit of patient care. Policies also address handling of medico-legal cases. receive the same quality of healthcare throughout the organization irrespective of the category of ward. a) Objective Element Policies and procedure for emergency care are documented. timed and dated by the concerned doctor. documentation and intimation to police. The policy shall be in line with statutory requirements w. poisoning. Uniform care is guided by policies and procedures which reflect applicable laws and regulations. applicable laws and regulations. InPatient Dept c) Self explanatory. Discharge Summary CHAPTER 2 : Care of Patients (COP) COP. Emergency services are guided by policies.1. Self explanatory. The care plan is countersigned by the clinician in-charge of the patient within 24 hours. b) Interpretation The organization shall ensure that patients with the same health problems and care needs. Treatment must be written daily.f) In case of death the summary of the case also includes the cause of death. Authorisation of prescription by resident doctor e) Within scope of Medical audit committee. Self explanatory. orders d) 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. Uniform care of patients is provided in all settings of the organization and is guided by the applicable laws. The care and treatment orders are signed. Evidence based medicine and clinical practice guidelines are adopted to guide patient care whenever possible. Remarks Emergency Suite related Process Emergency Suite Related Process 11 . named. a) Objective Element Care delivery is uniform when similar care is provided in more than one setting. regulations and guidelines. The organization could develop clinical protocols based on these and the same could be followed in management of patients.2.t. Remarks Uniform Care Policy Care provision vide Nursing Council of India Act and Medical Council of India at. b) Interpretation These could include SOPs/protocols to provide either general emergency care or management of specific conditions e.

a) Objective Element There is adequate access and space for the ambulance(s). Emergency medications are checked daily and prior to dispatch. This shall be done based on the organization’s scope.4. Hospital Ambulance Services BLS Trained Driver c) d) There is a checklist of all equipment and emergency medications. Practice Objective d) Self explanatory. b) Ambulance(s) is appropriately equipped.c) The patients receive care in consonance with the policies. 12 . Remarks Sufficient area available for parking of ambulances as per Policy.3. Hospital Ambulance Services e) Hospital Ambulance Services Hospital Ambulance Services (By Physical Inspection) f) g) COP. Staff should preferably be trained/well versed in ACLS and BLS. Staff is familiar with the policies and trained on the procedures for care of emergency patients. Self explanatory. Admission and discharge protocol in ICU CPR Training Records e) All the staff working in the casualty should be oriented to the policies and practices through training/documents. technician/nurse and/or doctor depending on the situation. The ambulance should be manned by a trained driver. f) Patient Transfer Policy COP.This shall be demarcated keeping in mind easy accessibility for receiving patients and to enable the ambulance(s) to turn around/exit quickly. Self explanatory. The ambulance shall be connected with the hospital/control room by wireless/mobile phones. Policies and procedures guide the triage of patients for initiation of appropriate care. Equipments are checked on a daily basis. Personnel shall be trained in ACLS and/or BLS. This shall include both the ambulance and the equipments within it. The ambulance services are commensurate with the scope of the services provided by the organization. The organization shall develop a checklist and ensure that the ambulance is equipped as per the checklist. Self explanatory. Admission or discharge to home or transfer to another organization is also documented. The ambulance(s) has a proper communication system. Ambulance(s) is manned by trained personnel. This also includes checking the expiry date of drugs. Interpretation The organization shall demarcate a proper space for ambulance(s). Policies and procedures guide the care of patients requiring cardio-pulmonary resuscitation.

This shall be in consonance with accepted practices. Staff is trained to implement the policies. In the actual event of a CPR or a mock drill of the same. The analysis shall include the cause. Policies and procedures define rational use of blood and blood products. Remarks b) Drugs And Cosmetic Act (ORIGINAL) c) d) Informed consent also includes patient and family education about donation.g. For example. Corrective and preventive measures are taken based on the post-event analysis.5. However. Remarks CPR Policy CPR Training Record c) CPR Recording form d) Code Blue Committee Meeting Records e) Code Blue Committee Meeting Records COP. Consent form Consent form This shall include doctors and be done either by training and/or by providing written instructions. anaesthetists and nurses Self explanatory. e) Training records 13 . then a separate consent is required. a) Objective Element Documented policies and procedures are used to guide rational use of blood and blood products. Consent should be taken for every transfusion. However. code blue team) it shall ensure that they are all trained in ALS and are present in all shifts. 2 pints of blood may be transfused serially using the same consent. Self explanatory. The transfusion services are governed by the applicable laws and regulations. The events during a cardio-pulmonary resuscitation are recorded. Staff providing direct patient care is trained and periodically updated in cardio pulmonary resuscitation. all the activities along with the personnel attended should be recorded.a) b) Objective Element Documented policies and procedures guide the uniform use of resuscitation throughout the organization. Refer to Drugs and Cosmetics act. with the same consent you can give multiple transfusions in the same sitting. if the same is given over two days or hours apart. Interpretation This shall address the conditions where blood and conditions where blood products can be used. steps taken to resuscitate and the outcome. Informed consent is obtained for donation and transfusion of blood and blood products. A post-event analysis of all cardiac arrests is one by a multi-disciplinary committee. Multidisciplinary committee shall include physicians. If the organization has a CPR team (e. Interpretation The organization shall document the procedure for same. These aspects shall be covered by hands on training.

These are then analyzed (by individual/ committee as decided by the organization) and appropriate corrective/preventive action is taken. a) b) Objective Element The organization has documented admission and discharge criteria for its intensive care and high dependency units. Interpretation The organization should develop objective criteria and adhere to it. Infection Control Manual f) A quality programme implemented. 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.6. The organization shall ensure that the practices are in consonance with good clinical practices. a detailed policy and procedure should be in place to address the situation. assurance is Quality Management Plan 14 . However the organization is expected to follow best clinical practices. The organization shall ensure that any transfusion reaction is reported. These could be developed individually or it could be a part of the Hospital infection control manual. Remarks Admission & Discharge in MICU/HDU This shall be done by training and/or by displaying the criteria. Transfusion reaction form COP. Adequate staff and equipment are available. Training Records c) Equipment Evident on site. As and when there are no vacant beds in the ICU and there is a requirement of such bed. These could be developed individually or it could be a part of the Hospital quality assurance programme. Policy for non availability of beds e) Infection control practices are followed. Policies and procedures guide the care of patients in the Intensive care and high dependency units. The organization shall maintain a record of transfusion reactions. d) Defined procedures for situation of bed shortages are followed. Staff is trained to apply these criteria. The exact requirements shall be decided by the organization.f) Transfusion reactions are analyzed for preventive and corrective actions. The ICU should be equipped with all necessary life saving and monitoring equipments as well as suitably manned by trained staff. The organization shall ensure that the programme is in consonance with good clinical practices.

Interpretation Self explanatory. children. COP. Care is organized and delivered in accordance with the policies and procedures. Policies and procedures guide the care of high risk obstetrical patients. Policies and procedures guide the care of vulnerable patients (elderly. High risk obstetric patient’s assessment also includes maternal nutrition. Policy for Vulnerable patients Policy for Vulnerable patients General Consent All Staff involved in the care of this group shall be adequately trained in identifying and meeting their needs. Interpretation The organization shall define as to what constitutes high risk obstetric case in consonance with best clinical practices. These shall not just be doctors but shall include nursing staff also. The informed consent for this group of people should be obtained from their family or legal representative. The organization shall provide proper environment taking into account the requirement of the vulnerable group. a) b) c) d) e) Objective Element Policies and procedures are documented and are in accordance with the prevailing laws and the national and international guidelines. The competency shall be based on qualification. a) Objective Element The organization defines and displays whether high risk obstetric cases can be cared for or not. physically and/or mentally challenged).8. The organization has the facilities to take care of neonates of high risk pregnancies. Self explanatory. experience and training.9. d) Policy Of Paediatric Deptt.COP. Remarks HCO develops SOP's for delivery of care. Training Records COP. A documented procedure exists for obtaining informed consent from the appropriate legal representative. Staff is trained to care for this vulnerable group.7. Persons caring for high risk obstetric cases are competent. Policies and procedures guide the care of pediatric patients. The organization provides for a safe and secure environment for this vulnerable group. 15 . Remarks Obstetric Dept b) Obstetric Dept c) Obstetric Dept The organization shall have a NICU with proper equipments and staff.

Policy Of Paediatric Deptt. Policies and procedures guide the care of patients undergoing moderate sedation. c) Sedation policy 16 . blood pressure. Policies and procedures prevent child/ neonate abduction and abuse. Policy Of Paediatric Deptt. if any. Remarks include Policy Of Paediatric Deptt. oxygen saturation. Self explanatory. The policy for care of neonatal patients is in consonance with the national/ international guidelines. The children’s family members are educated about nutrition. Adequate amenities for the care of infants and children to be available in the hospital. experience and training. cardiac rhythm. The person administering and monitoring sedation is different from the person performing the procedure.10. psychosocial and immunization assessment. immunization and safe parenting and this is documented in the medical record. b) Interpretation Whenever parenteral route is used this shall be carried out by a doctor/nurse. Those who care for children have age specific competency. Patient assessment includes detailed nutritional. Intra-procedure monitoring includes at a minimum the heart rate. Policy Of Neonatal Child/ Abuse g) Policy Of Paediatric Deptt. The competency shall be based on qualification.a) b) Objective Element The organization defines and displays the scope of its pediatric services. The same should be documented. Policy Of Paediatric Deptt. and level of sedation. a) Objective Element Competent and trained persons perform sedation. Paediatric Assessment Sheet f) The HCO shall ensure that there is an adequate security/surveillance to prevent such happenings. Self explanatory. COP. respiratory rate. Interpretation The scope shall also neonatal services. Remarks Sedation policy Sedation policy Self explanatory. Self explanatory. Self explanatory. These shall not just be for doctors but shall include nursing staff also. growth. c) d) e) Provisions are made for special care of children.

Sedation policy Sedation policy f) To be verified by Physical Examination. All patients for anaesthesia have a preanaesthesia assessment by a qualified individual. monitored e) Criteria are used to determine appropriateness of discharge from the recovery area. Self explanatory. COP. Interpretation HCO shall document on the indications. It shall be applicable for both routine and emergency cases. These shall be developed by the organization in consonance with good clinical practices. This assessment shall be done by an anaesthesiologist . Anaesthesia and Pain Management OT Manual Informed Consent f) Self explanatory. An anaesthesiologist shall be available in the hospital. An immediate preoperative re-evaluation is documented. The equipments shall include emergency resuscitation equipments. respiratory rate.d) Patients are after sedation. Informed consent for administration of anaesthesia is obtained by the anaesthetist. Self explanatory. airway security and patency and level of anaesthesia. The same should be documented.It is preferable to do assessment in a standardized format. During anaesthesia monitoring includes regular and periodic recording of heart rate. Pre-operative Evaluation e) This shall be done by an anaesthesiologist just before the patient is wheeled in to the respective OT. Policies and procedures guide the administration of anaesthesia. Remarks Pre-operative Evaluation b) Pre-operative Evaluation c) d) The pre-anaesthesia assessment results in formulation of an anaesthesia plan which is documented. The patient’s vitals shall be monitored at regular intervals (as decided by the organization) till he/she recovers completely from the sedation. the type of anaesthesia and procedure for the same. Equipment and manpower are available to rescue patients from a deeper level of sedation than that intended. This shall be done before the patient is wheeled into the OT complex.11. Anaesthesia and Pain Management OT Manual 17 . a) Objective Element There is a documented policy and procedure for the administration of anaesthesia. cardiac rhythm. oxygen saturation. blood pressure.

a) Objective Element The policies procedures documented. PAC Form Evidenced on site Signed by anaesthesist In Practice. These criteria shall be applied by a designated individual as decided by the HCO. and are b) Surgical patients have a preoperative assessment and a provisional diagnosis documented prior to surgery. wrong patient and wrong surgery. post operative diagnosis and the status of the patient before shifting and shall be documented by the surgeon/member of the surgical team. A brief operative note is documented prior to transfer out of patient from recovery area. Remarks OT Manual IP Care Surgical Care Related Process Pre-operative Evaluation General Consent d) Procedure should be available for preventing adverse events like wrong patients. This note provides information about the procedure performed. If the patient’s condition is unstable and he/she requires ICU care the same shall be monitored there. i) 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. Policies and procedures guide the care of patients undergoing surgical procedures. All adverse anaesthesia events are recorded and monitored. All such events are documented and monitored for the purpose of taking corrective and preventive action. This shall be applicable for both routine and emergency cases. Persons qualified by law are permitted to perform the procedures that they are entitled to perform. h) A qualified individual applies defined criteria to transfer the patient from the recovery area.g) Each patient’s postanaesthesia status is monitored and documented. Documented policies and procedures exist to prevent adverse events like wrong site. c) Interpretation This shall include the list of surgical procedures as well as competency level for performing these procedures. Wrong Patient wrong side Policy e) Personnel file as evidences f) OT Manual 18 . All patients undergoing surgery are assessed pre operatively and a provisional diagnosis is made which is documented. training and experience to perform procedures in consonance with the law.12. wrong site by a suitable mechanism. The HCO identifies the individuals who have the required qualification (s). The organization documents these criteria which should be in consonance with good clinical practices. An informed consent is obtained by a surgeon prior to the procedure. Self explanatory. COP.

Policies and procedures guide the care of patients under restraints (physical and/ or chemical). Physical restraints include boxer's bandage. etc. bleeding. Self explanatory. d) Restraint Policy e) Staff receive training and periodic updating in control and restraint techniques. Training records COP. These patients are more frequently monitored. use of cuffs etc. The plan also includes monitoring of surgical site infection rates.g. Remarks Pain management 19 .g) The operating surgeon documents the postoperative plan of care. Chemical restraints include sedatives. etc. It shall focus on post operative complications e. It shall also specify as to who can authorize the use of restraints.13. rate of air exchange . OT Manual This shall be an integral part of the HCO's overall quality assurance programme. These include documentation of reasons for restraints. Interpretation The HCO shall define the group of patients for whom this is applicable. Surveillance activities include monitoring the quality of air provided. Interpretation This shall clearly state the conditions/circumstances under which restraints shall be used. These include both physical and chemical restraint measures. A good reference point for defining these patients could be those having pain as the predominant debilitating symptom. a) Objective Element Documented policies and procedures guide the management of pain. Self explanatory. Remarks Restraint Policy b) Restraint Policy c) Restraint Policy The organization shall specify the parameters and frequency of monitoring and accordingly implement the same. Self explanatory. a) Objective Element Documented policies and procedures guide the care of patients under restraints. rational use of antibiotics. h) IP Care Surgical Care Related Process i) j) The quality assurance programme includes surveillance of the operation theatre environment. Policies and procedures guide appropriate pain management. A quality assurance programme is followed for the surgical services.14. cleaning and disinfection processes. Infection Control Manual To be covered by the internal audit under the scope of medical audit COP. Self explanatory.

These services are commensurate with the organizational requirements. Rehabilitative services are provided by a multidisciplinary team. Pain management c) Self explanatory. a) Objective Element Documented policies and procedures guide all research activities in compliance with national and international guidelines. Interpretation Self explanatory. c) The team shall have treating doctor. COP. Pain management COP. The organization has an ethics committee to oversee all research activities. This includes both funded and non-funded and also student studies. Self explanatory. Physiotherapy Dept. Policies and procedures guide appropriate rehabilitative services. a) b) Objective Element Documented policies and procedures guide the provision of rehabilitative services.16. NA NA 20 .15. Any research undertaken in the hospital falls under its ambit. rehabilitation therapist. Remarks NA b) c) The committee has the powers to discontinue a research trial when risks outweigh the potential benefits. Self explanatory. Patient and family are educated on various pain management techniques. rehabilitation nurses and other professional experts. Remarks Physiotherapy Dept. An ethics committee should be framed in the hospital to monitor activities undertaken by various providers. The scope of the departments is in consonance with the scope of the hospital. Interpretation Self explanatory. Self explanatory.b) The organization respects and supports the appropriate assessment and management of pain for all patients. Policies and procedures guide all research activities.

NA Self explanatory. NA f) Self explanatory. NA COP. The dietician shall prepare this in the form of a diet sheet and patient shall receive food accordingly. Nutrition and Food Services Dietary. Nutrition and Food Services COP. Food is prepared. Policies and procedures guide nutritional therapy.17. Nutrition and Food Services d) e) f) When families provide food. The dietician shall ensure that this is planned in consultation with the treating doctor and the patient/patient’s relative after taking into regard the patient’s food habits (veg/ non-veg) and likes and dislikes. 21 . There is a written order for the diet. Dietary. Patients are assured that their refusal to participate or withdrawal from participation will not compromise their access to the organization’s services. The dietary services to be designed in a manner that there is no criss cross of traffic. Interpretation Self explanatory. Dietary. All the activities fall in a sequence.d) e) Patient’s informed consent is obtained before entering them in research protocols. Patients receive food according to their clinical needs. Remarks Dietary. a) b) Objective Element Documented policies and procedures guide nutritional assessment and reassessment. handled. The organization shall ensure that hygienic conditions are followed all throughout. Nutrition and Food Services A dietician shall do the assessment of the patient in consultation with the clinician and advice regarding food. they are educated about the patient's diet limitations. Policies and procedures guide the end of life care. Nutritional therapy is planned and provided in a collaborative manner.18. Nutrition and Food Services Dietary. Self explanatory. Nutrition and Food Services Nutritional assement form c) Dietary. Patients are informed of their right to withdraw from the research at any stage and also of the consequences (if any) of such withdrawal. stored and distributed in a safe manner. The dietician/nurse shall ensure this during planning.

These also include sensitively addressing issues such as autopsy and organ donation. storage. This shall include providing appropriate pain and palliative care according to the wishes of the family and patient.1. Remarks End of Life Care Operational Policy b) c) d) These policies and procedures are in consonance with the legal requirements. Interpretation The HCO has a documented policy for providing care to terminally ill admitted patients. a) Objective Element There is a documented policy and procedure for pharmacy services and medication usage. Self explanatory. Staff is educated and trained in end of life care. formulary. administration and shall include a pharmacist/ clinical pharmacologist. c) This shall be representative of major clinical departments. End of Life Care Operational Policy The religious and socio-cultural beliefs of patients/ family shall be addressed and respected. Training Records End of Life Care Operational Policy End of Life Care Operational Policy e) CHAPTER 3 : Management of Medication (MOM) MOM.2. Interpretation The policies and procedures shall address the issues related to procurement. prescription. administration. These also address the identification of the unique needs of such patient and family. A multidisciplinary committee guides the formulation and implementation of these policies and procedures. There is a hospital formulary.a) Objective Element Documented policies and procedures guide the end of life care. Self explanatory. Records Of Drugs and Therapeutics Committee MOM. Remarks Material Management Pharmacy Drugs And Cosmetics Act b) These comply with the applicable laws and regulations. dispensing. Policies and procedures guide the organization of pharmacy services and usage of medication. Self explanatory. 22 . it should be discussed with the family in a very courteous manner. monitoring and use of medications. If the body of the deceased is subjected to an autopsy or for organ donation.

Interpretation These should address issues pertaining to temperature (refrigeration). There is a defined process for acquisition of these medications. Self explanatory. Medications are protected from loss or theft. ventilation. Remarks Drug formulary b) Records Of Drugs and Therapeutics Committee c) d) There is a process to obtain medications not listed in the formulary. If the recommendations are conflicting in nature. a) Objective Element Documented policies and procedures exist for storage of medication. The organization shall also ensure that the storage requirements of the drug as specified by the manufacturer are adhered to. vials or tablets may look-alike or soundalike. well lit and ventilated environment. d) Regular AUDIT e) Sound alike and look alike medications are stored separately. The process should address the issues of vendor selection. Refer to MOM 1c. the organization shall follow the manufacturer’s recommendation. Demonstrated in practice 23 . Interpretation The hospital formulary shall be prepared and be preferably updated at regular intervals. generation of purchase order and receipt of goods as per rules. Physical examination. Self explanatory. Many drugs in ampoules. Remarks Policy on Storage Of Medication b) Medications are stored in a clean. ABC Analysis The organization shall ensure that it develops proper mechanisms to prevent pilferage.a) Objective Element A list of medication appropriate for the patients and organization’s resources is developed. c) Sound inventory control practices guide storage of the medications. preventing entry of pests/ rodents and vermins. light.3. vendor evaluation. This shall be applicable to all areas where medications are stored including wards. Pharmacy Local Purchase Policy MOM. The list is developed collaboratively by the multidisciplinary committee. Policies and procedures guide the storage of medication. The organization could conduct audits at regular intervals (as defined by the organization) to detect such instances. They should be segregated and stored separately.

f)

There is a method to obtain medication when the pharmacy is closed. Emergency medications are available all the time.

When pharmacy is closed, there should be a SOP to procure the drugs. Adequate amount of emergency medicines should be stocked at all times. Re-order level at definite quantity should be done. Self explanatory.

24 hours pharmacy is available.

g)

Stock maintenance register &records to be produced as evidences.

h)

Emergency medications are replenished in a timely manner when used.

Relevant register as evidence.

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

a)

Objective Element Documented policies and procedures exist for prescription of medications. The organization determines who can write orders. Orders are written in a uniform location in the medical records.

Interpretation Self explanatory.

Remarks Policy on prescription of medication

b)

This shall be done by the treating doctor.

Policy on prescription of medication Policy on Verbal Orders for Medication

c)

d)

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

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. Self explanatory.

Medical Records

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. 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. These medications shall preferably be given only after written orders

Policy on Verbal Orders for Medication

f)

The organization defines a list of high risk medication.

High Risk Medication

g)

High risk medication orders are verified prior to

High Risk Medication

24

dispensing.

and it should be verified by the staff before dispensing.

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

a)

Objective Element Documented policies and procedures guide the safe dispensing of medications.

Interpretation Clear policies to be laid down for dispensing of medication e.g. route of administration, dosage, rate of administration, expiry date, etc. Recall may result based on letters from regulatory authorities or internal feedback (e.g. visible contaminant in IV fluid bottle). Self explanatory. At a minimum, labels must include the drug name, strength frequency of administration (in a language the patient understands) and expiry dates.

Remarks Safe Dispensing Of Medicine

b)

The policies include a procedure for medication recall. Expiry dates are checked prior to dispensing. Labelling requirements are documented and implemented by the organization.

Drug Labelling Policy

c) d)

Pharmacy

Drug Labelling Policy

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

a)

Objective Element Medications are administered by those who are permitted by law to do so. Prepared medications are labelled prior to preparation of a second drug. Patient is identified prior to administration.

Interpretation Self explanatory.

Remarks Policy on prescription of medication

b)

Self explanatory. Drug Labelling Policy Self explanatory. Safe Dispensing Of Medicine

c)

d)

Medication is verified from the order prior to administration.

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

Safe Dispensing Of Medicine

25

e)

f)

g)

h)

Dosage is verified from the order prior to administration. Route is verified from the order prior to administration. Timing is verified from the order prior to administration. Medication administration is documented.

Self explanatory.

Safe Dispensing Of Medicine Safe Dispensing Of Medicine Safe Dispensing Of Medicine Safe Dispensing Of Medicine

Self explanatory.

Self explanatory.

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. 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. 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.)

i)

Policies and procedures govern patient’s self administration of medications.

Organization do not allow self Medication.

j)

Policies and procedures govern patient’s medications brought from outside the organization.

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

a)

Objective Element Patient and family are educated about safe and effective use of medication.

b)

Patient and family are educated about food-drug interactions.

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

Remarks Safe Medication And Food Drugs Interactions

Safe Medication And Food Drugs Interactions

MOM.8. Patients are monitored after medication administration.

26

a) b) Objective Element Documented policies and procedures guide the use of narcotic drugs and psychotropic substances. The organization shall define as to what constitutes an adverse drug event. Adverse drug Reaction policy Adverse drug Reaction policy d) e) Policies are modified to reduce adverse drug events when unacceptable trends occur. Narcotic Drugs and Psychotropic Substances Act. Adverse drug Reaction policy ARD Form c) Adverse drug events are reported within a specified time frame. administration and disposal of these drugs. Interpretation This shall be done by anyone involved in direct patient care. Policies and procedures guide the usage of chemotherapeutic agents. Policies and procedures guide the use of narcotic drugs and psychotropic substances. Self explanatory. Records c) d) MOM.10. All the adverse drug reactions are analyzed regularly by the multidisciplinary committee (Refer to MOM 1C). Remarks Narcotics Policy This is in the context of Narcotic Drugs and Psychotropic Substances Act. The organization could follow either a passive (documenting only if the patient tells) or active (enquiring with every patient) monitoring mechanism. This shall be in consonance with best practices. Adverse drug events are collected and analyzed. Refer to MOM 1a. The organization shall define the timeframe for reporting once the adverse drug event has occurred. Self explanatory. Remarks In Patient Care Medical Care Related Process b) Adverse drug events are defined. These shall be kept in accordance with statutory requirements. Self explanatory.9. These policies are in consonance with local and national regulations. A proper record is kept of the usage. Adverse drug Reaction policy MOM. These drugs are handled by appropriate personnel in accordance with policies. Interpretation Self explanatory. 27 . Adverse drug events include adverse drug reactions as well as medication errors.a) Objective Element Patients are monitored after medication administration and this is documented.

This shall however be in accordance with AERB guidelines. Interpretation Self explanatory. The policies and procedures include the safe storage. These shall be disposed off according to BMW management and handling rules 1998 or manufacturer's recommendation. distribution and disposal of radioactive drugs. Chemotherapy policy Chemotherapy policy Biomedical waste management rule and regulation. Chemotherapy is prepared and administered by qualified personnel. Remarks Radioactive material policy b) Refer to AERB guidelines. Policies and procedures guide the use of implantable prosthesis. Interpretation Self explanatory. Policies and procedures govern usage of radioactive drugs. Chemotherapy is prescribed by those who have the knowledge to monitor and treat the adverse effect of chemotherapy. Staff. MOM. a) Objective Element Documented policies and procedures govern usage of radioactive drugs. Remarks Chemotherapy policy This shall preferably be a medical oncologist or a person who has been trained and has achieved competency in the same. Interpretation Self explanatory. Remarks Implant Policy 28 . c) Radioactive material policy d) Self explanatory. a) Objective Element Documented policies and procedures govern procurement and usage of implantable prosthesis.12. Chemotherapy drugs are disposed off in accordance with legal requirements. These policies and procedures are in consonance with laws and regulations.11. patients and visitors are educated on safety precautions. Radioactive material policy Self explanatory.a) b) c) d) Objective Element Documented policies and procedures guide the usage of chemotherapeutic agents. handling. DEMONSTRATED IN PRACTICE. MOM. APPROPRIATE SIGNAGES USED AT ALL THE PLACES. This shall preferably be staff who have received special training in preparing and administration. preparation.

It shall also look for international (e. a) Objective Element Patient and family rights and responsibilities are documented.g. Remarks Citizen Charter 29 . The organization shall ensure that relevant and sufficient scientific data are available before selection. usage and replenishment of medical gases.1. This is the context of the Indian explosives act of 1884. This shall include from the point of storage/source area. procedures and legal requirements. 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. gas supply lines and the end user area. Gas Manifold Process CHAPTER 4 : Patient Rights and Education (PRE) PRE. Policies and procedures guide the use of medical gases. It shall also address the issue of statutory requirements and approvals wherever applicable. The organization protects patient and family rights and informs them about their responsibilities during care. Interpretation This shall be applicable to all gases used in the organization.13. The policies and procedures address the safety issues at all levels. It shall follow a uniform colour coding system. c) The batch and serial number of the implantable prosthesis are recorded in the patient’s medical record and the master logbook. Appropriate safety measures shall be developed and implemented for all levels. storage. Remarks Gas Masifold Process Gas Manifold Process c) Appropriate records are maintained in accordance with the policies.b) Selection of implantable prosthesis is based on scientific criteria and national /internationally recognized approvals. Implant Policy Implant Policy MOM. distribution. Gas cylinder rules 1981 and Static and mobile pressure vessels (unfired) 1981. Interpretation Hospital should respect patient’s rights and inform them of their responsibilities. handling.US-FDA) or national notification (Drugs and Cosmetics Act notification October 2005) for approval of the particular product. a) b) Objective Element Documented policies and procedures govern procurement. Self explanatory.

management must keep records of such violations. e. The treating doctor shall discuss all the available options and allow the patient to make an informed choice including the option Patients Right Policy Policy For Vulnerable Patients Patients Right Policy Patients Right Policy 30 . The organization shall develop the necessary guidelines for the same.r. neonates etc. values and involve the patient and family in decision making processes. Patient rights include treating patient information as confidential.b) c) Patients and families are informed of their rights and responsibilities in a format and language that they can understand. Self explanatory.r. privileged communication shall be followed at all times. Patient rights include respect for personal dignity and privacy during examination. During management the patients should be given the choice of treatment. a) b) Objective Element Patient and family rights address any special preferences. as also a record of the consequences. Citizen Charter Protection also includes addressing patient’s grievances w.2. spiritual and cultural needs. hospital staff shall ensure that patient’s privacy and dignity is maintained. Patient rights support individual beliefs. Interpretation This could include preferences and requirements Remarks dietary worship Patients Right Policy c) Patient rights include protection from physical abuse or neglect.g. Patient rights include refusal of treatment.t. With regards to photographs/recording procedures. Statutory requirements w. d) e) During all stages of patient care. The organization’s leaders protect patient’s rights. During procedures the organization shall ensure that the patient is exposed just before the actual procedure is undertaken. procedures and treatment. Training and sensitisation programmes shall be conducted to create awareness among the staff. Where patients' rights have been infringed upon. Special precautions shall be taken especially w. Violation of patient rights is reviewed and corrective/preventive measures taken.r. Self explanatory. the organization shall ensure that consent is taken and that the patient’s identity is not revealed. Citizen Charter d) Employee Guide Book e) Patient Grievance Policy PRE. elderly.t vulnerable patients e.g. Staff is aware of their responsibility in protecting patients rights. Self explanatory.t rights. corrective actions to prevent recurrences. be it in examination or carrying out a procedure.

blood and blood product transfusions and any invasive / high risk procedures / treatment. A list of procedures should be made for which informed consent should be taken.of refusal. Refer AAC4d. Displayed information must be clearly available on how to voice a complaint. Informed Consent h) Patient rights include information on how to voice a complaint. Remarks General Consent c) 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. j) Patients Right Policy PRE. This shall be in consonance with The code of medical ethics and statutory requirements. Patient rights include information and consent before any research protocol is initiated. benefits. The organization has listed those procedures and treatment where informed consent is required. Informed Consent Patients Right Policy Patients Right Policy The organization shall ensure that every patient has access to his/her record. A documented process for obtaining patient and / or families consent exists for informed decision making about their care. a) b) Objective Element General consent for treatment is obtained when the patient enters the organization. alternatives and as to who will perform the requisite procedure in a language that they can understand. Self explanatory. The consent shall have the name of the doctor performing the procedure. Informed consent includes information on risks. Grievance redressal mechanism must be accessible and transparent. i) 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. If it is a “doctor under training” the same shall be specified. Patient has a right to have an access to his / her clinical records. f) g) Patient rights include informed consent before anaesthesia. Patient and/or his family members are informed of the scope of such general consent.3. Consent form shall be in the 31 General Consent Informed Consent d) Informed Consent . Interpretation Self explanatory. however the name of the qualified doctor supervising the procedure shall also be mentioned. Patient rights include information on the expected cost of the treatment.

complications and prevention strategies. Remarks Policy on Safe Medication Self explanatory. Patient and families have a right to information on expected costs.5. the patient The organization shall take into consideration the statutory norms. The tariff list is available to patients. Patient and families are educated about preventing infections Patients are taught in a language and format that they can understand Self explanatory. This could also be done through patient education booklets/videos/leaflets etc. a) b) Objective Element When appropriate. etc. Informed Consent PRE. Neisseria meningitides. More applicable for paediatric population. Self explanatory. Patient and families are educated about diet and nutrition. Nutrition and Food Services Immunization cards are given in Hospital c) d) e) Patient and families are educated about their specific disease process.language that understands. However in case of unconscious/ unaccompanied patients the treating doctor can take a decision in life saving circumstances. Patient and families are educated about immunizations. The organization shall ensure that there is an updated tariff list and that this list is available to patients Remarks Billing Policy Tariff List 32 . Patients Right Policy PRE. Patients Right Policy Patients Right Policy f) Self explanatory.4. Interpretation Self explanatory. patient and families are educated about the safe and effective use of medication and the potential side effects of the medication. Dietary. hepatitis B. a) b) Objective Element There is uniform pricing policy in a given setting (out-patient and ward category). Self explanatory. typhoid. Patient and families have a right to information and education about their healthcare needs. In adults it could be for influenza. e) The policy describes who can give consent when patient is incapable of independent decision making. Interpretation There should be a billing policy which defines the charges to be levied for various activities. This would include next of kin/legal guardian. Streptococcus pneumoniae.

Any additional charge should also be enumerated in the tariff and the same communicated to the patients. Refer to AAC4d. The qualification shall be either a graduate nurse or qualified nurse with competence gained by experience. visitors and providers of care. comprehensive and coordinated Hospital Infection Control (HIC) programme aimed at reducing/ eliminating risks to patients. They shall also participate in audit activity and in infection prevention and control on a day-to-day basis. Physician. The organization shall charge as per the tariff list. Surgeon. The team is responsible for day-today functioning of infection control programme. Patients are informed about the estimated costs when there is a change in the patient condition or treatment setting. Infection Control Manual Infection Control Manual Infection Control Manual HIC. This shall preferably have Hospital Administrator. the financial implications must be clearly conveyed to them. when required. Microbiologist. Remarks Infection Control Manual b) c) The hospital has infection control team. Manager – Nursing (Nursing Supervisor). Patients Right Policy When patients are shifted from one setting to another. staff from CSSD. a) Objective Element The hospital infection control programme is documented which aims at preventing and reducing risk of nosocomial infections. which is periodically updated.2. The hospital has a multidisciplinary infection control committee. The organization has a well-designed. The tariff rates should be uniform and transparent. d) Estimated Cost Performa CHAPTER 5 : Hospital Infection Control (HIC) HIC. typically to and from ICUs. an d) The hospital has designated and qualified infection control nurse(s) for this activity. It should also include invitees from various departments as deemed necessary. Interpretation Self explanatory. They shall support surveillance process and detect outbreaks.c) Patients are educated about the estimated costs of treatment. 33 . The hospital has an infection control manual. and other Support services and the hospital infection control nurse.1.

Remarks Infection Control Manual Infection Control Manual Infection Control Manual It shall address this at all levels e. surgery lasting more than 2 hours. which shall be reviewed at periodic intervals (maybe once in 3 months) for its continuing applicability. cost minimization. The HCO shall develop a system of monitoring drug susceptibility (based on culture sensitivity) and accordingly develop its antibiotic policy. Equipment cleaning and sterilization practices are included. If outsourced the organization shall ensure that it establishes adequate controls to ensure infection control. sensitivity and specificity. CSSD. BMT etc. ICU. d) Infection Control Manual e) An appropriate antibiotic policy is established and implemented. The surveillance system should meet WHO criteria of simplicity. c) It focuses on adherence to standard precautions at all times. ward. endoscopies. The laundry can be in-house or outsourced. Infection Control Manual 34 .cardiac catheterization. Laundry Services g) Kitchen sanitation and food handling issues are included in the manual. Post-operative ward. Washing protocols for different categories of linen including blankets should be included. The organization could refer to ISO 22000:2005 (food safety) while addressing this issue. HDU. Antibiotic Policy f) Laundry and linen management processes are also included. Blood Bank. For example. OT and CSSD.g. Interpretation The manual should clearly identify the high risk areas of the hospital e.a) Objective Element The manual identifies the various high-risk areas and procedures.g. b) It outlines methods of surveillance in the identified high-risk areas. It is preferable that the organization follows a uniform policy across different departments within the organization. Self explanatory. The Manual should include sterilization and disinfection policy. Special focus on critical equipments like ventilators. OT. The same shall be applicable even if this activity is outsourced. chemicals used/ methods and procedures followed in wards and critical areas. The linen change policy should be mentioned. etc. It shall define the frequency and mode of surveillance. acceptability. timeliness of feedback. flexibility. all high risk procedures should be identified from infection control point of view. nebulizers etc. consistency (reliability). Self explanatory. Similarly.

Any renovation work in hospital patient care areas should be planned with Infection Control team with regard to architectural segregation.h) Engineering controls to prevent infections are included. replacement/repair of plumbing. Issues such as Air conditioning plant and equipment maintenance. frequency and duration of monitoring. It is desirable to update at least once in a year based on its trends & outcomes of the audit processes. The specific objectives. b) Collection of surveillance data is an ongoing process. Remarks Infection Control Manual 35 . cleaning of A/c ducts. AHUs. The mortuary services in the hospital should be provided through walk-in cold rooms or mortuary cold cabinets. replacement of filters. i) Mortuary practices and procedures are included as appropriate to the organization. Interpretation The organization must be able to provide evidence of conducting periodic surveillance activities in its identified high risk areas. case definitions. identification of potential indicators. The infection control team is responsible for surveillance activities in identified areas of the hospital. use of materials. j) The organization defines the periodicity of updating the infection control manual. methods of data collection. 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. Infection Control Manual Infection Control Manual HIC. priority oriented) activities are being carried out. The HCO should clearly mention which specific targeted surveillance (site specific. Mortuary procedures of preserving body. Water supply sources and system of supply. seepage leading to fungal colonization.3. The organization must have a documented policy on the updation of the infection control manual. or body parts and safety measures while handing over body to relatives should be in accordance with the policy. unit oriented. a) Objective Element Surveillance activities are appropriately directed towards the identified highrisk areas. sewer lines (in shafts) should be included. along with schedule of rounds should be defined. testing for water quality must be included. traffic flow. Confidentiality and anonymity must be ensured.

4. information (in relevant format) is sent to appropriate authorities. method of use should be specified. regulations and notifications thereof. furniture/ fixtures. Records from Medical Records department e) Scope of surveillance activities incorporates tracking and analyzing of infection risks. 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. rates and trends. 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 organization shall identify all notifiable diseases after taking into consideration the local laws. 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. Surveillance activities include monitoring the effectiveness of housekeeping services. The organization shall do this for all patients on the ventilator having clinical features suggestive of infection. The organization shall do this for all symptomatic catheterized patients. rules. The hospital takes actions to prevent or reduce the risks of Hospital Associated Infections (HAI) in patients and employees.c) Verification of data is done on regular basis by the infection control team. The organization monitors respiratory tract infections. The common disinfectants used. blood and body fluid cleanup. The organization shall ensure that this is sent at the specified frequency and in the format as required by statutory authorities. f) HIC. isolation rooms and all high risk (critical) areas. The team shall preferably verify every serious infection (as defined by the organization) report. dilution factors. It should also include procedures for terminal cleaning. a) Objective Element The organization monitors urinary tract infections. general cleaning procedures for surfaces. b) Interpretation This can be done either by sending urine or catheter tip for culture. and items used in patient care. d) In cases of notifiable diseases. This would include categorization of areas/ surfaces. Remarks Records Records 36 .

Remarks Infection Control Manual 37 . Facilities Available HIC. a) b) Objective Element Hand washing facilities in all patient care areas are accessible to health care providers. Compliance with proper hand washing is monitored regularly.6. d) The organization monitors surgical site infections. It could also provide specific inputs to reduce the HAI rate. The hospital takes appropriate action to control outbreaks of infections.5. and disinfectants are available and used correctly. observation. 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. They should be available at the point of use and the organization shall ensure that it maintains an adequate inventory. 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. a) Objective Element Hospital has a documented procedure for handling such outbreaks. Records Records e) Records HIC.g. soaps. masks. Compliance could be verified by random checking. Isolation/ barrier nursing facilities are available. The organization shall preferably display the necessary instructions near every hand washing area. Remarks Infection Control Manual Evidence on site Infection Control Manual Evidence on site c) Infection Control Manual d) Adequate gloves. Interpretation The organization shall ensure that it provides necessary infrastructure to carry out the same. Proper facilities and adequate resources are provided to support the infection control programme. gloves etc.c) The organization monitors intra-vascular device infections. The feedback shall include the rates. Self explanatory. masks. clothing. For all peripheral lines clinical evidence of thrombophlebitis would suffice. This shall be done by sending pus/ swab for culture. etc. trends and opportunities for improvement. identification and investigation of such outbreaks and the procedure for management. This shall be in accordance with good clinical practices. Interpretation This shall incorporate definitions as to what constitutes an outbreak. Appropriate feedback regarding HAI rates are provided on a regular basis to medical and nursing staff. Standard Case definitions shall include a unit of time and place along with specific biological and/or clinical criteria.).

review of all infection control policies. c) After the outbreak is over appropriate corrective actions are taken to prevent recurrence. 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. bacteriologic. constructing an epidemic curve.g. Proper segregation and collection of Bio-medical Waste from all patient care areas of the hospital is implemented and monitored. Monitoring shall be done by members of the infection control committee/team.7sqm/bed. This shall be done by accepted methods e. a) Objective Element There is adequate space available for sterilization activities. strengthening infection control policies etc. There are documented procedures for sterilization activities in the hospital. suitable location. proper layout (unidirectional flow. Wastes to be segregated and collected in different colour coded bags and containers as per statutory provisions. a) b) Objective Element The hospital is authorized by prescribed authority for the management and handling of Bio-medical Waste.b) This procedure is implemented during outbreaks. The organization should be able to identify the outbreak. describe the outbreak by developing a case definition. Engineering validations like Bowie Dick tape test and leak rate test need to be carried out. collecting data from the affected. zoning) and separation of clean and dirty areas. Pollution control board/committee.8. Interpretation The occupier shall apply in the prescribed form and get approval from the prescribed authority e. loopholes and compliance gaps. The organization should be able to implement basic procedures to prevent recurrence such as source control if source identified. Remarks Copy of FORM I Evident on Site 38 . designing a data collection form.7. strips etc. Statutory provisions with regard to Bio-medical Waste (BMW) management are complied with. c) There is an established recall procedure when breakdown in the sterilization system is identified. Infection Control Manual Infection Control Manual HIC.g. Remarks CSSD Policy CSSD Policy CSSD Policy HIC. Interpretation Adequacy of space refers to the CSSD which should have an area of 0. b) Regular validation tests for sterilization are carried out and documented.

Evident on Site Waste transportation trolley MOU between the hospital and the Outsourced agency e) Copy of FORM II f) Appropriate personal protective measures are used by all categories of staff handling Bio-medical Waste. Evident on site HIC. documents and reports are submitted to competent authorities on stipulated dates. The HCO shall ensure that the fees are deposited in a timely manner. It should include the policies. If this activity is outsourced the organization shall ensure that it is done to an authorized contractor. d) The waste is transported to the predefined site at definite time intervals (maximum within 48hours) through proper transport vehicles in a safe manner. The hospital regularly earmarks adequate funds from its annual budget in this regard. There shall be a separate budget demarcated for HIC activity. Self explanatory.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. Monitoring of this activity should be done by Infection Control team. This includes both men and materials. Self explanatory. It also conducts regular “in-service” training sessions for all concerned categories of staff at least once in a year. a) Objective Element Hospital management makes available resources required for the infection control programme. This shall be prepared taking into consideration the scope of the activity and previous years’ experience. Bio-medical Waste treatment facility is managed as per statutory provisions (if in-house) or outsourced to authorized contractor(s). d) Interpretation The HCO shall ensure that the resources required by the personnel should be available in a sustained manner. 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.9. The infection control programme is supported by hospital management and includes training of staff and employee health. b) c) It conducts regular preinduction training for appropriate categories of staff before joining concerned department(s). Requisite fees. 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. There must be a documented evidence of pre induction training for appropriate categories of staff before joining concerned department(s). Remarks Copy of the budget Copy of the budget Training Records Training Records 39 . procedures and practices of the infection control programme.

CHAPTER 6 : Continuous Quality Improvement (CQI) CQI. hospital quality improvement principles and evaluation methodologies. Traning Records Remarks b) Quality Management Plan c) There is a designated individual for coordinating and implementing the quality improvement programme. This programme shall be developed. Self explanatory. monitoring it. implemented and maintained by a multidisciplinary committee. statutory requirements. Accreditation Coordinator d) e) The quality improvement programme is comprehensive and covers all the major elements related to quality improvement and risk management. quality objectives. This shall preferably cover all aspects including documentation of the programme.1. This should be documented as a manual. vision. review of policy and corrective action. Interpretation This committee shall have representation from management. implemented and maintained in a structured manner.e) Appropriate pre and post exposure prophylaxis is provided to all concerned staff members. service standards. Objective Element a) The quality improvement programme is developed. There is a structured quality improvement and continuous monitoring programme in the organization. The manual could be stand alone and should have cross linkages with other manuals. Also refer to CQI 1b. Self explanatory. various clinical and support departments of the HCO. hospital functioning and operations. The quality improvement programme is documented. The manual shall incorporate the mission. data collection. Quality Management Plan Risk Management 40 . quality policy. The designated programme is communicated and coordinated amongst all the employees of the organization through proper training mechanism. important indicators as identified etc. This should preferably be a person having a good knowledge of accreditation standards.

Number of reporting errors/1000 investigations. The following is however mandatory: i. As quality improvement is a dynamic process. Time for initial assessment of indoor and emergency patients. includes patient Interpretation The HCO shall develop appropriate key performance indicators suitable to it. ii. Percentage of cases wherein screening for nutritional needs has been done. 41 . This audit shall be done by a multidisciplinary team (preferably trained in NABH standards) including all the applicable standards and objective elements. iii. At the end of the audit there shall be a formal meeting to summarise the findings and identify areas for improvement. i. ii. Objective Element a) Monitoring appropriate assessment.f) The quality improvement programme is reviewed at predefined intervals and opportunities for improvement are identified. Percentage of reports CoRemarks b) Monitoring includes safety and quality control programmes of the diagnostics services. The following is however mandatory: i. Quality Committee Quality Management Plan CQI. The HCO shall develop appropriate key performance indicators suitable to it. g) The quality improvement programme is a continuous process and updated at least once in a year. Percentage of cases wherein care plan is documented and counter-signed by the clinician. The minutes of the review meetings should be recorded and maintained. The inputs for updation could be based on the review carried out by the quality improvement committee. processes and outcomes which are used as tools for continual improvement. iii.2. The organization identifies key indicators to monitor the clinical structures. Self explanatory. Percentage of re-dos. 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. 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. Percentage of cases wherein the pre-defined initial nursing assessment is completed within 30 minutes.

The HCO shall develop appropriate key performance indicators suitable to it. The following is however mandatory: i. ii. ii. iii. Percentage of adherence to safety precautions by employees working in diagnostics. Anaesthesia related mortality rate. Percentage of medication charts with illegible writing over a given period. The following is however mandatory: i. iv. Percentage of adverse anaesthesia events. The following is however mandatory: i.relating with clinical diagnosis. all The HCO shall develop appropriate key performance indicators suitable to it. The HCO shall develop appropriate key performance indicators suitable to it. c) Monitoring includes invasive procedures. Percentage of medication errors. The following is however mandatory: i. The following is however mandatory: i. Percentage of contrast related reactions. iv. Incidence of adverse drug reactions. Incidence of haematoma at puncture site. Percentage of medical records d) Monitoring includes adverse drug events. Percentage of accidental removal of tubes and catheters. f) Monitoring includes use of blood and blood products. iii. Percentage of transfusion reactions. iii. ii. g) Monitoring includes availability and content of medical records. Percentage of blood component usage. Percentage of unplanned ventilation following anaesthesia. e) Monitoring includes use of anaesthesia. Re-exploration rate. iv. iv. Turnaround time for issue of blood and blood components The HCO shall develop appropriate key performance indicators suitable to it. iv. Percentage of wastage of blood and blood products. 42 . The HCO shall develop appropriate key performance indicators suitable to it. iii. Percentage of re-scheduling of procedures. ii. Percentage of modification of anaesthesia plan.

The following is however mandatory: i. Percentage of consumables rejected before preparation of Goods Receipt Note. iii. The HCO shall develop appropriate key performance indicators suitable to it. Percentage of serious adverse events (which have occurred in the HCO) reported to the ethics committee within the defined timeframe. iv. Percentage of protocol violations/deviations reported. Number of research activities being carried out. Infection Control Committee NA Infection Control Committee CQI. The same shall be captured and analysed. ii. monthly/quarterly. k) Monitoring includes data collection to support evaluation of these improvements. Urinary tract infection rate. iv. ii. j) Monitoring includes data collection to support further improvements. Percentage of patients withdrawing from the study. Percentage of medical records having incomplete and/or improper consent. Percentage of medical records not having initial assessment and the plan of care. The following is however mandatory: i. iv. ii. Percentage of missing records. ii. iii. Surgical site infection rate. Percentage of stock outs including emergency drugs. processes and outcomes which are used as tools for continual improvement. The HCO shall develop appropriate key performance indicators suitable to it. iii.h) Monitoring includes infection control activities. The organization identifies key indicators to monitor the managerial structures.3. not having discharge summary. iii. The following is however mandatory: i. The data could be collected at predefined intervals e. Interpretation The HCO shall develop appropriate key performance indicators suitable to it. Incidence of variations from the Remarks Drugs and Therapeutic Committee Drug Formulary 43 . i) Monitoring includes clinical research. Objective Element a) Monitoring includes procurement of medication essential to meet patient needs. iv. This data is analysed for improvement opportunities and the same are carried out. Intra-vascular device infection rate.g. Also refer to CQI 1f All improvement activities carried out by the HCO shall have an evaluable outcome. Percentage of drugs procured by local purchase. Respiratory infection rate.

ii. MRD Policy Quality Management Plan Quality Committee Quality Committee f) Monitoring includes employee satisfaction. iv. responsibilities and welfare schemes. d) Monitoring utilisation manpower equipment. Out patient satisfaction index. The HCO shall develop appropriate key performance indicators suitable to it. The following is however mandatory: i. Number of sentinel events. Nurse-patient ratio. Submission of tax returns and deduction of taxes at the specified time frame. c) Monitoring includes risk management. 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. The HCO shall develop appropriate key performance indicators suitable to it.procurement process. Percentage of employees provided pre-exposure prophylaxis. Number of births and deaths. Submission of report/ data/form pertaining to bio-medcial waste. iii. iv. The following is however mandatory: i. Employee Satisfaction Survey g) Monitoring includes adverse events and near misses. ii. Incidence of falls. PNDT act and radiation safety within the defined timeframe. The HCO shall develop appropriate key performance indicators suitable to it. ii. iii. Employee satisfaction index. Employee attrition rate. The following is however mandatory: i. In patient satisfaction index. ii. iii. The HCO shall develop appropriate key performance indicators suitable to it. Percentage of employees who are aware of employee rights. ii. The HCO shall develop appropriate key performance indicators suitable to it. Sentinel Event Policy 44 . iii. Percentage of near misses analysed. Number of variations observed in mock drills. iv. Time taken for discharge. iii. Number of notifiable diseases. Bed occupancy rate and average length of stay. Incidence of bed sores after admission. The following is however mandatory: i. and e) Monitoring includes patient satisfaction which also incorporates waiting time for services. Waiting time for services including diagnostics and out patient. of includes space. Employee absenteeism rate. The following is however mandatory: i. ii. OT and ICU utilization rate. iv. Equipment down time. iv.

g. As these audits are retrospective/concurrent in nature. This data is analysed for improvement opportunities and the same are carried out. Monitoring includes data collection to support evaluation of the improvements. iv. administrators and nurses. material. 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. The data could be collected at predefined intervals e. These should be in steady supply so as to ensure that the programme functions smoothly. Appropriate fund allocation is done by the organization for the smooth functioning of the programme. YES 45 . Number of security related incidents including thefts.5. It could be a mix of clinicians. Remarks Medical Audit Committee b) Parameters for medical AUDIT c) Patient and staff anonymity is maintained. monthly/ quarterly. Objective Element a) Hospital Management makes available adequate resources required for quality improvement programme. Hospital earmarks adequate funds from its annual budget in this regard. Interpretation This shall include the men. Self explanatory. it is imperative that this be done using predefined parameters so that there is no bias.4. Incidence of needle stick injuries. i) iii. community based or based on length of stay. There is an established system for audit of patient care services. The parameters could be disease based. machine and method. Remarks Budget Report b) Budget c) Monthly report of MRD CQI. Appropriate statistical and management tools are applied whenever required.h) Monitoring includes data collection to support further study for improvements. MRD Policy CQI. Also refer to CQI 1f Self explanatory. cost based. Interpretation The HCO shall identify such personnel. The quality improvement programme is supported by the management. The parameters to be audited are defined by the organization. Objective Element a) Medical and nursing staff participates in this system. The inputs for updation could be based on the review carried out by the quality improvement committee.

Actions are taken upon findings of such analysis. Interpretation The sentinel events relating to system or process deficiencies that are relevant and important to the organization must be clearly defined. The Governing board and the Head of HCO shall have the policy for budgeting and resource allocation for attaining its mission and Remarks Quality Management Plan Quality Management Plan Budget 46 . Medical Audit Report All remedial measures as ascertained should be documented and implemented and improvements thereof recorded to complete the audit cycle. The established processes should include reporting the occurrence of such events on standardised incident report forms. 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.d) e) All audits documented. Sentinel Event Policy Sentinel Event Policy d) Sentinel Event Policy CHAPTER 7 : Responsibilities of Management (ROM) ROM. Those responsible for governance lay down the strategic and operational plans commensurate to the organization’s mission in consultation with the various stake holders. Sentinel events are intensively analyzed. Sentinel events are intensively analysed when they occur.6. Those responsible for governance approve the organization’s budget and allocate the resources Interpretation It is not only the head of the HCO but the members of the board of governors (where applicable) who need to define it. Action taken Report of the Medical Audit Remedial measures are implemented CQI. a) b) c) Objective Element Those responsible for governance lay down the organization’s mission statement. Root cause analysis of all such events should be carried out by a multi-disciplinary committee taking inputs from the concerned units/ discipline/ departments. Remarks Sentinel Event Policy b) c) The organization has established processes for intense analysis of such events. Objective Element a) The organization has defined sentinel events. 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. are Self explanatory.1. The responsibilities of the management are defined.

Those responsible for governance establish the organization’s organogram. service. h) Licenses COPY i) Marketing Dept. Self explanatory.d) e) required to meet the organization’s mission. The governing board and the Head of the HCO shall develop quarterly (at least) performance reports based on the strategic and operational plans. Scope of services of each department is defined. The HCO shall have a well defined organization structure/chart and this shall clearly document the hierarchy. The organization complies with the laid down and applicable legislations and regulations. replacement etc. The services provided by each department are documented. Remarks HR Department have all the records of it Scope of Services Evident on Site HR Department d) Quality Committee 47 . along with the functions at various levels. The leader should have domain knowledge of that particular department. periodically review it. This could be documented either at individual department level or the HCO could have a brochure detailing the scope of each department. b) c) Administrative policies and procedures for each department is maintained. Interpretation There needs to be a minimum essential qualification and relevant experience of the leader. NA Self explanatory. This shall include administrative procedures like attendance. Those responsible for governance support research activities and quality improvement plans. Those responsible for governance appoint the senior leaders in the organization. Departmental leaders are involved in quality improvement. line of control. Quality Management Plan Organization structure f) Organization structure g) Self explanatory. ROM. Each department's activity is to be predefined. The Governing board and Head of the HCO shall willfully develop social responsibility policy and accordingly address it. Self explanatory. leave. site or department has effective leadership.2. The responsibility of compliance lies with the first two level of the hierarchy. Those responsible for governance address the organization’s social responsibility. conduct. Those responsible for governance monitor and measure the performance of the organization against the stated mission. a) Objective Element Each organizational programme.

The ownership of the hospital e. private. accreditations for specific departments or whole hospital wherever applicable. The organization honestly portrays the services which it can and cannot provide. Remarks YES b) Self explanatory. The organization discloses its ownership. public has to be disclosed. The organization honestly portrays its affiliations and accreditation. ROM. a) Objective Element The leaders make public the mission statement of the organization.5. Interpretation The HCO shall have a mission statement and the same shall be displayed prominently. 16 Years Exp.g. trust. a) Objective Element The designated individual has requisite and appropriate administrative qualifications.3. Interpretation Self explanatory.ROM. Interpretation Self explanatory. The leaders establish the organization’s ethical management. Leaders ensure that patient safety aspects and risk management issues are an integral part of patient care and hospital management. The organization is managed by the leaders in an ethical manner.4. Tariff List f) ROM. Self explanatory. Self explanatory. The organization accurately bills for its services based upon a standard billing tariff. b) Ethics Committee c) d) Private Scope of Services e) Here portrays implies that the HCO convey its affiliations. The designated individual has requisite and appropriate administrative experience. A suitably qualified and experienced individual heads the organization. Remarks Quality Management Plan Mission statement as evidence. The HCO shall function in an ethical manner. a) Objective Element The organization has an interdisciplinary group assigned to oversee the hospital wide safety programme. Remarks Hospital Safety Committee 48 .

There shall be sufficient resources kept as contingency to address the risk reduction activities as and when the leaders proactively suggest. staff and visitors.2. Sentinel Event Policy c) d) The HCO has a system in place for internal and external reporting of system and process failures. 49 . Objective Element a) The management is conversant with the laws and regulations and knows their applicability to the organization. There is a mechanism to regularly update licenses/ registrations/ certifications.1. Copies available with MS (Process for Compliance and Updating of Regulatory & Statutory requirements) Self explanatory. Copies available with MS (Process for Compliance and Updating of Regulatory & Statutory requirements) Self explanatory. their families. The management ensures implementation of these requirements. The end result of these shall result in preventive actions. Contingency plan shall be in place to deal with the situation of system and process failure anticipated within the organization. laws and byelaws and requisite facility inspection requirements. Management ensures implementation of systems for internal and external reporting of system and process failures. The organization’s environment and facilities operate to ensure safety of patients. The organization is aware of and complies with the relevant rules and regulations. Interpretation A designated management functionary has been given the responsibility to enlist the laws and regulation as applicable to the HCO.b) The scope of the programme is defined to include adverse events ranging from “no harm” to “sentinel events”. Self explanatory. Copies available with MS(Process for Compliance and Updating of Regulatory & Statutory requirements) c) d) FMS. The HCO shall have a system of reporting of all the incident/accident. This functionary has identified the appropriate personnel in the HCO who are supposed to implement the respective laws and regulations. Hospital Safety Committee Hospital Safety Committee CHAPTER 8: Facility Management and Safety (FMS) FMS. Remarks Licenses & Act approval copy as evidence b) Management regularly updates any amendments in the prevailing laws of the land. Management provides resources for proactive risk assessment and risk reduction activities.

Self explanatory. b) Document with Engineering Department c) Self explanatory. floor plans and fire escape routes. Evident at Site d) Self explanatory. Roster as Evidence A complaint attendance register is to be maintained to indicate the date and time of receipt of complaint. The provision of space shall be in accordance with the available literature on good practices (Indian or International Standards) and directives from government agencies. Remarks Bio-Medical Engg. Roster of Engineering department f) g) Maintenance staff is contactable round the clock for emergency repairs. Interpretation Self explanatory. e) A person in the HCO management is designated to be in-charge of maintenance of facilities. Remarks Material Management 50 . allotment of job and completion of job. Records of the Engineering Department FMS. Up-to-date drawings are maintained which detail the site layout.Objective Element a) There is a documented operational and maintenance (preventive and breakdown) plan.3 The organization has a programme for clinical and support service equipment management. Response times are monitored from reporting to inspection and implementation of corrective actions. There is internal and external sign posting in the organization in a language understood by patient. Objective Element a) The organization plans for equipment in accordance with its services and strategic plan. Engineering / Facilities Dept. This shall also take into consideration future requirements. The HCO has the required number of supervision and tradesmen to manage the facilities. A designated person maintains the drawings. families and community. There are designated individuals responsible for the maintenance of all the facilities. Interpretation Self explanatory.

management. medical gases and vacuum system. Self explanatory. Remarks Engineering / Facilities Dept. Self explanatory. The HCO either calibrates the equipment in house or out sources. FMS. b) c) Engineering / Facilities Dept.5 The organization has plans for fire and non-fire emergencies within the facilities. e) Calibration Process Calibration records of equipments f) There is a documented operational and maintenance (preventive and breakdown) plan. Self explanatory. Objective Element Interpretation Remarks 51 . electricity. There is a maintenance plan for piped medical gas. Self explanatory. finance. Purchase Committee Bio-Medical Engg. UPS and any other suitable source. engineering and bio-medical departments. Bio Medical Engineer The HCO has weekly / monthly / annual schedules of inspection and calibration of equipment which involve measurement. c) d) All equipment are inventoried and proper logs are maintained as required. Gas Manifold d) FMS. Interpretation The HCO shall make arrangements for supply of adequate potable water and electricity. solar energy. in an appropriate manner. Alternate electric supply could be from DG Sets. Objective Element a) Potable water and electricity are available round the clock. Engineering / Facilities Dept. Collaborative process implies that during equipment selection there is involvement of end user. Qualified and trained personnel operate and maintain the equipment Equipment are periodically inspected and calibrated for their proper functioning. The organization regularly tests the alternate sources. Alternate sources are provided for in case of failure.b) Equipment is selected by a collaborative process. compressed air and vacuum installation. Registers of the BME Department Self explanatory. Bio-Medical Engg. maintaining traceability to national or international or manufacturer’s guidelines/standards.4 The organization has provisions for safe water.

etc. e) schedules for conduct of mock fire drills. Evident on site. infected materials (used gloves. The HCO has: a) a fire plan covering fire arising out of burning of inflammable items.) j) building or structural collapse k) fall or slips (from height or on floor) or collision of personnel in passageway l) fall of patient from bed Sprinklers and smoke detectors. b) deployed adequate and qualified personnel for this. etc. tubing. g) exit plans well displayed. d) adequate training plans. mercury. The HCO has a dedicated emergency illumination system which comes into effect in case of a fire. amniotic fluid. vomits.) medical wastes (blood. Disaster Mgt. abatement and containment of fire and non-fire emergences. etc.a) The organization has plans and provisions for early detection. pus. explosion. These may include : a) terrorist attack b) invasion of swarms of insects and pests c) earthquake d) invasion of stray animals e) hysteric fits of patients and/ or relatives f) civil disorders effecting the HCO g) anti-social behaviour by patients/ relatives h) temperamental disorders of staff causing deterioration in patient care i) spillage of hazardous (acids. syringes. c) acquired adequate fire fighting equipment for this which records are kept up-to-date. Plan 52 . sharps. 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 takes care of non-fire emergency situations by identifying them and by deciding appropriate course of action. f) mock drill records. electric short circuiting or acts of negligence or due to incompetence of the staff on duty. The HCO has a fire and non-fire emergency committee (FNEC) to review the HCO’s preparedness.

Objective Element a) The hospital identifies potential emergencies. Exit doors should remain open on all the time. The organization has a smoking limitation policy.m) bursting of pipe lines n) sudden flooding of areas like basements due to clogging in pipe lines o) sudden failure of supply of electricity. Interpretation The HCO has a documented plan and procedure for handling the situations like sudden rush of victims of Remarks 53 . Staff is trained for their role in case of such emergencies.7. Self explanatory. In view of the law permission to smoke within the campus of hospital may not be granted. Interpretation Smoking in public places including hospitals has been banned in this country. Mock drills are held at least twice in a year. Fire exit plan shall be displayed on each floor particularly close to the lifts. 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.6. gas. vacuum. The organization plans for handling community emergencies. The policy has provisions for granting exceptions for patients and families to smoke. In case of fire designated person are assigned particular work. b) The organization has a documented safe exit plan in case of fire and non-fire emergencies. Fire Exit Plan Displayed on each floor c) Fire fighting team formed Training Records d) Records of Drills FMS. Remarks Smoking Policy b) Smoking Policy FMS. etc p) bursting of boilers and/ or autoclaves. Objective Element a) The organization defines and implements its policies to reduce or eliminate smoking. epidemics and other disasters.

The organization has a plan for management of hazardous materials. etc. establishment of command nucleus. training and mock drills Resource availability should be according to threat perception. Disaster Mgt. g) These plans and procedures cover ensuring adequacy of medical supplies. c) d) Provision is made for availability of medical supplies. communication aids and mock drill methodology. identified trained personnel. and method for managing spillages and adequate training of the personnel for these jobs. Plan Disaster Mgt. storage.a) b) c) d) b) The organization has a documented disaster management plan. disposal mechanism. Waste Mgt. transporting and disposal of hazardous material. The disaster plan must incorporate essential elements of alert code. The plan is tested at least twice in a year. availability and earmarking of resources. transportation aids. handling. Plan e) Mock drills with and without patients have to be carried out. storage. equipment. equipment and materials during such emergencies. labelling. Training Records Disaster Mgt.8. 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. earthquake flood train accident Civil unrest outside the HCO premises e) Major fire f) Invasion by enemy. action cards for each of the staff. Only communication exercise may also be undertaken. Objective Element a) Hazardous materials are identified within the organization. Interpretation The HCO has identified and listed the hazardous materials and has a documented procedure for their sorting. Process MSDS available on site 54 . The HCO has ensured display of Material Safety Data Sheets (MSDS) for all hazardous materials and has accordingly arranged associated training of personnel Remarks Infection Control Manual b) The hospital implements processes for sorting. transpirations. Plan FMS. materials. Plan Disaster Mgt. Self explanatory. information and communication. Hospital staff is trained in the hospital’s disaster management plan. handling.

FMS. Training Record of Medical & Paramedical Staffs. As per biomedical waste management rule d) There is a plan managing spills hazardous materials. protruding or dangling elements in passage ways.c) Requisite regulatory requirements are met in respect of radioactive materials. Interpretation The HCO has a duly constituted safety committee which has identified the potential safety and security risks to staff. implementation. who handle such materials. The appropriate personnel in the HCO are aware about the rules and regulations such as the Atomic Energy Act. ramps. This committee coordinates development. The HCO ensures that the above Committee functions on a regular basis to coordinate development. are situations which need to be taken care of. the norms issued by Atomic Energy Regulatory Board (AERB) and the directives from the Health Physics Division of Bhaba Atomic Research Centre (BARC). for of MSDS Self explanatory. The HCO has the requisite training need identification for material handling and those trainings are included in the HCO training calendar. Sharp bends in passages. entry and exit from lifts. The situational hazards also need to be covered in HIRA so that any emergency situation arising out of process of storing. Patient safety devices are installed across the organization and inspected periodically. transportation and disposal of such hazardous materials are met effectively. Self explanatory. e) Staff is educated and trained for handling such materials. Remarks HospitaL Safety Committee b) Hospital Safety Committee c) Evident on site 55 . handling. storage. and monitoring of the safety plan and policies. Self explanatory. patients and visitors. The hospital has system in place to provide a safe and secure environment. sudden swing of swing doors. See FMS 5 also.9. Objective Element a) The hospital has a safety committee to identify the potential safety and security risks. implementation and monitoring of the plans and policies.

The organization verifies the antecedents of the potential employee with regards to criminal/negligence background. The staff joining the organization is socialized and oriented to the hospital environment. Training Record CHAPTER 9 : Human Resource Management (HRM) HRM. Job Specifications Antecedent Verification Service Rule 74 HRM. The job description should be commensurate with the qualification. Facility round conducted by Safety Committee Self explanatory. treatment and service needs of the patient. The required job specifications and job description are well defined for each category of staff. employee student and voluntary worker is appropriately oriented to the organization’s mission and goals. skills and experience required for performing the job should be clearly laid down.1. Objective Element a) Each staff member.d) e) f) 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. Remarks Employee Guide Book 56 . Interpretation The staff should be commensurate with the workload and the clinical requirement of the patients.2. Remarks Manpower Planning b) c) The content of each job should be well defined and the qualifications. Inspection Rounds Self explanatory. Rounds to be carried out by safety committee. Objective Element a) The organization maintains an adequate number and mix of staff to meet the care. There is a safety education programme for all staff. Self explanatory. Inspection reports are documented and corrective and preventive measures are undertaken. The Organization has a documented system of human resource planning. Interpretation The organization's staff including the outsourced staff should be aware and should correctly interpret the mission and goals of the organization.

etc. Staff members. training assessment. The HCO shall define the same in consonance with statutory requirements and the same shall be communicated to the employees. For external training it could be done either by the HCO itself or by the external agency which imparted the training. attitude.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. Objective Element Interpretation Remarks 57 . Each staff member is made aware of his/her rights and responsibilities. Impact of training at user level should also be documented Remarks Training and Development policy b) Training also occurs when job responsibilities change/ new equipment is introduced. communication skills. impact of training and the training calendar should be prepared. This shall be based on the HCO's values and focus on development of soft skills: behaviour. Training and Development Policy Record with HRD and respective Deptt. In case of new equipment the operating staff should receive training on operational as well as daily maintenance aspects. the training methodology. There is an ongoing programme for professional training and development of the staff. HRM. The employees should be able to identify and report violation of patient rights as and when the same occurs. documentation of training. students and volunteers are adequately trained on specific job duties or responsibilities related to safety.4. Employee Guide Book Employee Guide Book d) Employee Guide Book e) Induction Manual HRM. c) Feedback mechanisms for assessment of training and development programme exist. Record with HRD and respective Deptt. All employees are educated with regard to patients’ rights and responsibilities. c) 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. Objective Element a) A documented training and development policy exists for the staff. The HCO shall develop benchmarks for different services being provided. The training should focus on the revised job responsibilities as well as on the newly introduced equipment and technology.3. All employees are oriented to the service standards of the organization. Interpretation A training manual incorporating the procedure for identification of training needs. This shall include both internal & external training.

The organization has a well-documented disciplinary procedure. visitors and employee related risks.5. Objective Element a) A well-documented performance appraisal system exists in the organization. This can be done by identifying training requirements and accordingly providing for the same (wherever possible). Remarks Performance Appraisal System b) Self explanatory. c) d) Quality Committee HRM. Induction Training Programme Self explanatory. Reporting processes for common problems. The HCO shall define such risks which shall include patient. Self explanatory. Interpretation Self explanatory. The employees are made aware of the system of appraisal at the time of induction. eliminate / minimize risks. Performance is evaluated based on the performance expectations described in job description. The appraisal system is used as a tool for further development.a) All staff is trained on the risks within the hospital environment. failures and user errors exist. c) d) Performance Appraisal System e) Performance Appraisal System HRM. Staff members can demonstrate and take actions to report. Self explanatory. Training Records The HCO has a defined procedure for reporting of these events. Interpretation Self explanatory. Objective Element a) A written statement of the policy of the organization with regard to discipline is in place. Staff members are made aware of procedures to follow in the event of an incident. Hospital Safety manual b) Records of Drills Self explanatory. An appraisal system for evaluating the performance of an employee exists as an integral part of the human resource management process. Remarks Disciplinary Procedure 58 .6. Performance Appraisal System Self explanatory. Performance appraisal is carried out at pre defined intervals and is documented.

Self explanatory.7. Objective Element a) A pre-employment medical examination is conducted on all the employees. The HCO has a written procedure for handling grievances of employees. Regular health checks of staff dealing with direct patient care are done atleast once a year and the findings/ results are documented. Employee Grievance Policy Remarks Employee Grievance Policy b) c) HRM. Employee Grievance Policy Self explanatory.8. This shall however be in consonance with the law of the land.b) The disciplinary policy and procedure is based on the principles of natural justice. The organization addresses the health needs of the employees. Objective Element a) The employees are aware of the procedure to be followed in case they feel aggrieved. d) e) Disciplinary Procedure HRM. The policy and procedure is known to all categories of employees of the organization. Health problems of the employees are taken care of in accordance with the organization’s policy. A grievance handling mechanism exists in the organization. The disciplinary procedure is in consonance with the prevailing laws. Self explanatory. There is a provision for appeals in all disciplinary cases. Self explanatory. Remarks Evidenced on Personal File b) Medical Benefit c) Medical Benefit Records in Personal file 59 . Actions are taken to redress the grievance. Interpretation Self explanatory. Interpretation For definition of "grievance handling" refer to glossary. This implies that both parties (employee and employer) are given an opportunity to present their case and decision is taken accordingly. This shall be in consonance with the law of the land and good clinical practices. Self explanatory. Disciplinary Procedure c) Induction Training Records Self explanatory. The results should be documented in the personal file. Disciplinary Procedure The HCO shall designate an appellate authority to consider appeals in disciplinary cases. The redress procedure addresses the grievance.

YES d) HRM. training and experience) of medical professionals permitted to provide patient care without supervision.10. Credentialing Committee Remarks Credentialing Committee b) c) The HCO shall do the same by verifying the credentials from the organization which has awarded the qualification/training. Credentialing Committee HRM. There is a process for authorizing all medical professionals to admit and treat patients and provide other clinical services commensurate with their qualifications. All such information pertaining to the medical professionals is appropriately verified when possible. HRM.d) Occupational health hazards are adequately addressed. Objective Element a) Medical professionals permitted by law. verifying and evaluating the credentials (education. The personal files contain personal information regarding the employees’ qualification.11. Interpretation The HCO identifies the individuals who have the required qualification (s). All records of in-service training and education are contained in the personal files. 60 . regulation and the hospital to provide patient care without supervision are identified. There is a process for collecting. disciplinary background and health status. Self explanatory. There is a documented personal record for each staff member. Remarks HR Department b) Self explanatory. The education. registration.9. training and experience of the identified medical professionals is documented and updated periodically. Updation is done after acquisition of new skills and/or qualification. Interpretation Self explanatory. training and experience to provide patient care in consonance with the law. Personal File as Evidence. Self explanatory. registration. c) Self explanatory. training assessment and outcome of health checks. Training record kept separately Evaluations would include performance appraisals. Objective Element a) Personal files are maintained in respect of all employees. Personal files contain results of all evaluations.

registration. Objective Element a) The education. training and experience of nursing staff is documented and updated periodically. Privileging 61 .Objective Element a) Medical professionals admit and care for patients as per the laid down policies and authorization procedures of the organization. verifying and evaluating the credentials (education. 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. There is a process for collecting. training and registration. training and registration. The requisite services to be provided by the medical professionals are known to them as well as the various departments / units of the hospital. b) All such information pertaining to the nursing staff is appropriately verified when possible. Interpretation The HCO shall identify as to what each nurse is authorized to do.13. Remarks Privileging b) Self explanatory. training and experience) of nursing staff. Objective Element a) The clinical work assigned to nursing staff is in consonance with their qualification. Interpretation The HCO shall identify as to what each medical professional is authorized to do. Interpretation 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. The services provided by the medical professionals are in consonance with their qualification. The HCO shall do the same by verifying the credentials from the organization which has awarded the qualification/training. Updation is done after acquisition of new skills and/or qualification. Remarks b) Self explanatory. registration. The services provided by nursing staff are in accordance with the prevailing laws and regulations. Remarks Registration from Nursing Counsil HR Department HRM. c) Self explanatory. HRM.12.

management of the organization as well as other agencies that require date and information from the organization. data are Interpretation MIS/HIS data is collected standardised format from areas/services in the HCO. Policies and procedures exist to meet the information needs of the care providers. space and budget. Objective Element 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.doc#BACKUP e) Medical Records Department IMS. Policies and procedures to meet the information needs are documented.2. Nursing Manual CHAPTER 10 : Information Management System (IMS) IMS. The organization contributes to external databases in accordance with the law and regulations. Self explanatory. in all Remarks Medical Records Department Budget b) Necessary resources are available for analyzing data. 62 . Self explanatory. The HCO shall make available men. Objective Element a) Formats for collection standardized. Interpretation The HCO has manual and/or electronic Hospital Information System and/or Management Information System which provides relevant information to all concerned stakeholders. These policies and procedures are in compliance with the prevailing laws and regulations. material. The HCO shall define the needs for software and hardware solutions as per the information requirements and future necessities.1. HIS c) Evidenced at respective Deptt. The HCO shall define the system of releasing the relevant information to the authority as per statutory norms. All information management and technology acquisitions are in accordance with the policies and procedures.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. The organization has processes in place for effective management of data. d) HISPrimus%20Hospital %20Manual. Remarks Medical Records Department b) A policy document is available where the HIS/MIS is described.

etc. documents and implements the same. with the help of stamp. Interpretation Self explanatory. IMS. The author of the entry can be identified. This could be by writing the full name or by mentioning the employee code number. HCO has a written policy stating who all can make entries. Appropriate clinical and managerial staff participates in selecting. Medical Records Department f) Medical Record file as an Evidence IMS. Self explanatory. The medical record reflects continuity of care. measurement of trends and initiating action wherever required. The organization has a complete and accurate medical record for every patient. The HCO identifies which documents form part of the medical records. where ever physical or electronic data is stored. Medical Records Department e) Medical Audit committee scope. Organization policy identifies those authorized to make entries in medical record.4. Medical Records Department The HCO shall define data management policy and ensure adequate safeguards for protection of data. diagnosis and plan of care. Every medical record entry is dated and timed. There is a multi-disciplinary committee which is responsible for the appropriate selection of indicators. Self explanatory. integrating and using data. Remarks Medical Records Department Medical Records Department Medical Records Department Medical Records Department c) d) e) The contents of medical record are identified and documented. The record provides an up-to-date and chronological account of patient care. Objective Element a) The medical record contains information regarding reasons for admission. Objective Element a) b) Every medical record has a unique identifier. Documented procedures exist for storing and retrieving data.3. The HCO shall decide the format for maintaining the continuity in the medical records.c) d) Documented procedures are laid down for timely and accurate dissemination of data. Medical Records Department Remarks 63 . In case of electronic based records. authorised e-signature provision as per statutory requirements must be kept. Interpretation This shall also apply to records on digital media.

safety and integrity of information. b) Policies and procedures are in consonance with the applicable laws. Self explanatory.5. Self explanatory. the medical record contains a copy of the death certificate indicating the cause. the medical record contains a copy of the report of the same. It shall ensure the usage of tracer card for movement of the file in and out of the MRD so as to maintain confidentiality. Indian Penal Code and Code of medical Ethics. Medical Records Department Self explanatory. security and integrity of information. Objective Element a) Documented policies and procedures exist for maintaining confidentiality. When patient is transferred to another hospital. integrity and security of information. Remarks HIS HIS Tracer card available. Care providers have access to current and past medical record. Medical Records Department Self explanatory. Medical Records Department Death certificate evident Not Applicable The HCO provides access to medical records to designated health care providers (those who are involved in the care of that patient). The medical record contains a copy of the discharge note duly signed by appropriate and qualified personnel. Process for Compliance and Updating of Regulatory & Statutory Requirements 64 . This is applicable for both manual and electronic records. Whenever a clinical autopsy is carried out. date and time of death. In case of death. Interpretation The HCO shall control the accessibility to the MRD department. the reason for the transfer and the name of the receiving hospital. This is in the context of Indian Evidence Act.b) c) d) e) f) g) Operative and other procedures performed are incorporated in the medical record. Medical Records Department IMS. It is mandatory to mention the clinical condition of the patient before transfer is effected. the medical record contains the date of transfer. The HCO provides the death certificate as per the International Certification of cause of death. security. Policies and procedures are in place for maintaining confidentiality. Patient Transfer Policy Self explanatory.

In this context. integrity and security of information. the release of information in accordance with the Code of Medical Ethics 2002 should be kept in mind. The hospital uses developments in appropriate technology for improving confidentiality. For electronic data there should be protection against virus/trojans and also a proper backup procedure. Report to Health Authority IMS. To prevent tampering. Privileged health information is used for the purposes identified or as required by law and not disclosed without the patient’s authorization. The HCO carries out regular audits/rounds to check compliance with policies. Some of the related laws in this context are Code of Medical Ethics 2002. data and information. Medical Records Department HIS e) The HCO shall review and update its technological features so as to improve confidentiality. define the privileged Medical Records Department f) Medical Records Department g) Self explanatory. For physical records the HCO shall ensure that there is adequate pest and rodent control measures. The HCO shall procedure for communication. Consumer protection act 1987 and relevant state legislation. In electronic format this could be done by adequate passwords. This is applicable for both manual and electronic system. for physical records access shall be limited only to the concerned health care provider. A documented procedure exists on how to respond to patients/ physicians and other public agencies requests for access to information in the medical record in accordance with the local and national law. Interpretation The HCO shall define the retention period for each category of medical records: Out-patient.6.c) The policies and procedures incorporate safeguarding of data / record against loss. in-patient and MLC. The retention process provides expected confidentiality and security. Remarks Medical Records Department b) Medical Records Department c) Medical Records Department 65 . integrity and security. data and information. Policies and procedures exist for retention time of records. if any. destruction and tampering. HIS HIS d) The hospital has an effective process of monitoring compliance of the laid down policy. Objective Element a) Documented policies and procedures are in place on retaining the patient’s clinical records. The policies and procedures are in consonance with the local and national laws and regulations.

total discharges including deaths. simple random. Destruction can be done after the retention period is over and after taking approval of the competent authority. systemic random sampling etc. etc. The review representative based on principles. uses a sample statistical Interpretation Self explanatory. The review focuses on the timeliness. For example. Objective Element a) The medical records are reviewed periodically. Medical Audit Committee Medical Records Department Medical Records Department d) Self explanatory. e) Self explanatory. The review process includes records of both active and discharged patients. Medical Records Department Remarks b) c) The review is conducted by identified care providers. Medical Audit Report Medicall Records Department f) g) Self explanatory. Appropriate corrective and preventive measures undertaken are documented. Medical Records Department The HCO shall define the principles on which sampling is based. legibility and completeness of the medical records. The review points out and documents any deficiencies in records.7. Medical Records Department IMS. Action Taken Report 66 . data and information is in accordance with the laid down policy. Self explanatory. Medical Records Department Self explanatory. Review shall be based on conditions of clinical and/or community importance. The organization regularly carries out review of medical records.d) The destruction of medical records. total indoor patients.

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