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A Guide Book to NABH Standards on Hospital Accreditation

First Edition Issued on August 2006

National Accreditation Board for Hospitals and Healthcare Providers

Amendments

1. Page no.16: Title of PRE 4 may be read as “ Patient and families have a right to information and education about their healthcare needs” 2. Page no.17: PRE 5. d. may be read as “ Patients and family are informed about the financial implications when there is a change in the patient condition or treatment setting” 3. Page no. 21: COP 5.f to be deleted and ‘g’ to be considered as ‘f’ 4. Page no. 56 & 57: FMS 6 to be read as following: FMS. 6 The organization has a smoking policy Objective element a. The organization defines it policies to reduce or eliminate smoking b. The policy has provisions for granting exemptions for patients and families to smoke Interpretation The HCO has a smoking policy to indicate the HCO stand on permitting smoking selectively within its premises and the mechanism to ensure implementation of this policy. Smoking and non-smoking zones are properly displayed as documented. Remarks

5. Page no. 57: Following is to be added: FMS. 7 The organization plans for handling community emergencies, epidemics and other disasters Objective element Interpretation Remarks a. The hospital The HCO has a documented plans and identifies potential procedure for handling the situations like emergencies sudden rush of victims of: a. Earthquake b. Flood c. Train accident d. Civil unrest outside the HCO premises e. Major fire f. Invasion by enemy g. Etc, etc. These plans and procedures cover ensuring adequacy of medical supplies, equipment, materials, identified trained personnel, transportation aids, communication aids and mock drill methodology. b. The Organization as above has documented disaster management plan.

A guide book to NABH standards on hospital accreditation – August 2006

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c. Provision is made as above for availability of medical supplies, equipment and materials during such emergencies d. Hospital staff is as above trained in the hospital’s disaster management plan. e. The plan is tested Self explanatory at least twice in a year FMS. 8 The organization has a plan for management of hazardous materials. a. Hazardous materials are identified within the organization. The HCO has identified & listed the hazardous materials and has a documented procedure for their sorting, storage, handling, transpirations, spillages and adequate training of the personnel for these jobs. The HCO has conducted an exercise of hazard identification and risk analysis (HIRA) associated with handling of hazardous associated with handling of hazardous materials and accordingly taken all necessary steps to eliminate or reduce such hazards and associated risks. The HCO has ensured display of Material Safety Data Sheets (MSDS) for all hazardous materials and has accordingly arranged associated training of personnel who handle such materials. The situational hazards also need to be covered in the HIRA so that any emergency situation arising out of the process of storing, handling, storage, transportation and disposal of such hazardous materials are met effectively. Sharp bends in passages, protruding or dangling elements in passage ways, sudden swing of swing doors, ramps, entry and exit from lifts, are situation which need to be taken care of see FMS 5 also. The HCO has the requisite training need identification for material handling and those trainings are included in the HCO training calendar

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

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

d. There is plan for managing spills of hazardous materials e. Staff is educated Self explanatory and trained for handling such materials. FMS.9 The organization has systems in place to provide a safe and secure environment. a. The hospital has a The HCO has duly contributed safety safety committee committee which has identified the to identify the potential safety and security risks to potential safety staff, patients and visitors. and security risks 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. See FMS 5 and FMS 8 above. b. The committee The HCO ensures that the above coordinates Committee functions on a regular development, basis to coordinate development, implementations, implementation and monitoring of the and monitoring of plans& policies. the safety plan and policies. c. Facility inspection See FMS 5 and FMS 8 above rounds to ensure safety are conducted at least twice in year in patient care areas and at least once in a year in nonpatient care areas. d. Inspection reports See FMS 5 and FMS 8 above are documented and corrective and preventive measures are undertaken. e. There is a safety See FMS 5 and FMS 8 above education programme for all staff. A guide book to NABH standards on hospitals accreditation – August 2006 Page 3of 3

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

INDEX Page Sr. Assessment and continuity of Care (AAC) 3 03 CHAPTER 2 : Patient Rights and Education (PRE) 14 04 CHAPTER 3 : Care of Patient 18 05 CHAPTER 4 : Management of Medication (MOM) 31 06 CHAPTER 5 : Hospital Infection Control 38 07 CHAPTER 6 : Continuos Quality Improvement (CQI) 44 08 CHAPTER 7 : Responsibility of Management (ROM) 49 09 CHAPTER 8 : Facility of Management and Safety 53 10 CHAPTER 9 : Human Resource Management (HRM) 58 11 CHAPTER 10 :Information Management System (IMS) 65 12 Glossary 71 13 List of Licenses 83 . No. Particular 01 Introduction 2 02 CHAPTER 1: Access.

It facilitates hospitals in demonstrating commitment to patient safety and quality of care.qcin. and experts from health industry and NABH secretariat. It raises community confidence in the services provided by the hospital.org www. Institution of Engineers Building Bahadur Shah Zafar Marg New Delhi – 110002 India Tel : Fax : Email : Website: +91 11 23379321/23379621 +91 11 23379321 nabh@qcin. First edition. The present edition of guide book is expected to fulfill this very need. which can facilitate in speedy compliance of accreditation standards. Medical tourism comes as welcome by-product. India health industry has long waiting for this initiative. CEO National Accreditation Board for Hospitals & Healthcare Providers (NABH) 2nd floor.org . Indian health industry has taken the accreditation program in right earnest. The comments from all stake holders are welcome.Foreword NABH standard for hospital accreditation were released in February 2005. empanelled assessors of NABH. The book is result of collaborative effort put in by members of NABH technical committee. This guide book is to be read in conjunction with the NABH Hospital Standards. There has been demand to have some kind of guidance. 2005.

have been laid down for easy comprehension. the initial implementation of the standards and the subsequent monitoring of the same.Introduction The NABH standards have been laid down keeping the Indian ethos and working environment in mind. Each time one has to raise the bar and hence the importance of continual quality improvement. They are not applicable to primary health care institutions and rural hospitals. Finally it must also be understood that accreditation is an ongoing process. While there might be initial expenses for ensuring implementation and monitoring of the standards. in the long term these costs will be recovered by the organization owing to the better and more efficient and effective quality of patient care. We are aware that apart from extra resources needed from implementation. at the time of implementation. Duplication is necessity since it will ensure compliance with the said standards and also emphasize the importance of the standards and the objective elements. employee. a few guidelines. All the standards are core standards would not be applicable to them while assessment. better understanding of the standards and the objective elements. On going through the details during the phase of implementation of the standards on would realize that extra efforts and resources are indeed required for ensuring compliance with the standards. The compliance with these standards will indicate that the hospital is patient. These standards are applicable to multidisciplinary hospitals and single especially hospitals providing secondary. Accreditation is thus journey and not a destination. tertiary and quaternary levels of health/medical care. It may also be observed. The standards deceptively simple. and smoother and more efficient implementation. staff and environment friendly. . that there may be some duplication at few places. chapter-wise in tabulated form. The best way to implement the standards is to have an in-house quality committee/team that will be responsible for making the quality manual based on the NABH standards. removing and clarifying ambiguities uniform application of standards across the organization. visitor and environment safety. The main focus of the standards is on patient.

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. b) The defined services are prominently displayed. Action/ Documentation A Policy to be framed clearly stating the services the hospital can provide 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 that staff is the hospital mainly in the reception/registration, OPD, IPD are oriented to these facts through training program regularly or through manuals. Remarks/ Audit Points See Policy document

Display in the form of brochures only is NOT acceptable

c) The staff is oriented to these services

Interview the staff in these locations

AAC.2 The Organization has 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/ Audit Points See Policy for the same

b) The policies and procedures address outpatients, inpatients and emergency patients c) Patients are accepted only if the organization can provide the required service

Interview staff at these areas

d) The policies and procedures also address managing patients during non-availability of beds e) Staff is aware of these processes

The staff handling admission and registration needs to be aware of the services that the organization can provide. It 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. The HCO is aware of the availability HCO’s where the patients may be directed in case of non-availability of beds Also refer to AAC 3. All the staff handling these activities should be oriented to

Interview staff

Interview staff

See evidence of training programs

these policies and procedures. Orientation can be provided by documentation/training 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 documented policy and procedure should address the methodology of safe transfer of the patient in a life threatening situation (like whose who are on ventilator) to another HC-O. Availability of an appropriate ambulance fitted with life support facilities and accompanied by trained personnel. Remarks/ Audit Points The organization shall at the outset define as to who is an unstable patient. These patients include those who have come to the casualty but need to be transferred to another organization or those already admitted but who now require care in another. Organization. It also includes patients being shifted for diagnostic tests. See the process and policy

b. Policies guide the transfer of stable patients to another facility c. Procedures identify staff responsible during transfer

d. The organization gives a summary of patient’s condition and the treatment given

Patient not in life-threatening situation (stable) should also be transported in a safe manner during transfer. The staff shall at least be trained trauma or emergency technician/ nurse. He/she shall have undergone training in BCLS 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.

It is preferable that a doctor accompanies an unstable patient.

This shall include patients being transferred both for diagnostic and/or therapeutic purposes.

AAC.4 During admission the patient and/or the family members are educated to make informed decisions Objective Element a. The patients and/or family members are explained about the proposed care Interpretation The plan of treatment as decided by the doctor on duty or the patient management team (as the case may be), the expected results, possible complications and the expected cost involved are 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 Remarks/ Audit Points With regards to expected costs, an estimate could be prepared and the same given to the patient. This estimate shall be prepared on the basis of the treatment plan. It could be prepared by the OPD / registration / admission staff in consultation with the treating doctor. In case of packages it should clearly state the terms

documented. b. The patients and/or family members are explained about the expected results c. The patients and/or family members are explained about the possible complications d. The patients and/or family members are explained about the expected costs. The patients and family are expected in detail by the treating physician or his/her team about the outcomes of such treatment. Possible complications of the treatment, if any, are clearly communicated to the patient and their signature taken. Patients should be given an estimate of the expenses on account of the treatment preferably in a written form.

and conditions and also the exceptions, if any. Interview the patients

Interview the patients

See evidence of the estimate.

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 protocol/policy by which a standardized initial assessment of patient is done in the OPD, Emergency and IPD. The initial 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 pediatric OPD the weight and height may be a must whereas it may not be so for orthopedics 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 assessment can be done by the treating doctor, junior doctor or a nurse. The organization shall determine who can do that 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 emergency/indoor patients The HCO’s documented protocol mentions that the initial assessment is to be completed within 24 hours or earlier depending upon the patient’s condition. This should also cover history, progress notes, investigation ordered and Remarks/ Audit Points See the evidence of such practices.

b. The organization determines who can perform the assessments

Interview the staff and observe the practice.

c. The organization defines the time frame within which the initial assessment is completed d. The initial assessment for in-patients is documented within 24 hours or earlier as per the patient’s condition or hospital policy.

See the evidence of such a documents

See the evidence of such practices in the medical records.

e. Initial assessment includes screening for nutritional needs. f. The initial assessment results in a documented plan of care. g. The plan of care also includes preventive aspects

treatment ordered and all these are to be authenticated by treating doctor. The protocol for patients initial assessment should cover his/her nutritional needs This shall be documented by the treating doctor or by a member of his team in the case sheet. The documented plan of care should cover preventive actions as necessary in the case and should include diet, drugs, etc

This could be done by the treating doctor and/or dietitian For definition of “plan of care” refer to glossary. This could also be done through booklet/patient information leaflets, etc. e.g. diabetes, hypertension.

AAC.6. All patients cared for by the organization undergo a regular reassessment Objective Elements a. All the patients are reassessed at appropriate intervals Interpretation After the initial assessment, the patient is reassessed periodically and this is documented in the case sheet. The frequency may be different for different areas based on the setting and the patient’s condition e.g. patients in ICU need to be reassessed more frequency compared to a patient in the ward. Actions taken under reassessment are documented. The staff could be the treating doctor or any member of the team. The nursing staff can document patient’s vitals. Self explanatory Remark/Audit Points Every patient shall be reassessed at least once every day.

b. Staff involved in direct clinical care documents reassessments

Evidence of such documentation to be seen.

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

See evidence of progress notes.

AAC.7. Laboratory services are provided as per the requirements of the patients Objective Elements a. Scope of the laboratory services are commensurate to the services provided by the organization. b. Adequate qualified and trained personnel perform and/or supervise the investigations Interpretation The HCO should ensure availability of laboratory services commensurate with the health care services offered by it. See also (f) below for outsourced lab facilities. The staff employed in the lab should be suitably (appropriate degree) and trained to carry out the tests. Pathologist, microbiologist and biochemist Remark/Audit Points For example a cardiac care HCO must necessarily have facilities for cardiac enzyme

For adequacy of qualification refer to NABL 112 (Annexure)

supervise the staff The HCO has documented procedures for collection. The tests results in the critical limits shall be communicated to the concerned after proper documentation. The turnaround time could be different for different tests and could be decided based on the nature of test and criticality of test. Policies and procedures guide collection.c.8. identification. A methodology to check the performance of service rendered by the outsourced laboratory as per the requirements of the HCO The policy should be in lined with standard precautions. The laboratory shall establish its biological reference intervals for different tests. processing and disposal of specimens to ensure safety of the specimen till the test and retest (if required) are completed The HCO shall define the turn around time for all tests. The disposal of waste shall be as per the statutory requirements (biomedical waste management and handling rules. This should include: a) list of tests for outsourcing b) identity of personnel in the outsourced facilities to ensure safe transportation of specimens and completing of tests as per requirements of the patient concerned and receipt of results at HCO c) manner of packing of the specimens and their labeling for identification and this package should contain the test requisition with all details as required for testing. The laboratory shall establish critical limits for tests which require immediate attention for patient management. AAC. handling. e. The HCO has documented procedure for outsourcing tests for which it has no facilities. The laboratory quality assurance program is documented Interpretation The HCO has documented quality assurance program (preferably as per ISO 15189: Medical laboratories – Particular requirements for quality and Remark/Audit Points Evidence of such program to be seen. safe transportation. If it is not practical to establish the biological reference interval for a particular analyte the laboratory should carefully evaluate the published data for its own reference intervals. See documentation in the form of MOU. There is an established laboratory quality assurance program Objective Elements a. 1998 act). Laboratory tests not available in the organization are outsourced to organization(s) based on their quality assurance system. . identification. safe transportation and disposal of specimens. materials and equipment to make the laboratory results available within the defined time frame. handling. The HCO should ensure availability of adequate staff. d. Critical results are intimated immediately to the concerned personnel f. and terms and condition of the same with an accredited lab. Laboratory results are available within a defined time frame.

See evidence of training program. lead aprons. fire extinguishers. The program includes the documentation of corrective and preventive actions competence) This holds true for any laboratory – developed methods Examine the same The laboratory director shall periodically assess the test results. This program is integrated with the organization’s safety program c.b. Adequate safety devices are available in lab e. etc. lead sheets. AAC. e. Examine the same.10. Written – Policies and procedures guide the handling and disposal of infections and hazardous materials. Imaging services are provided as per the requirements of the patients Objective Elements a. The lab staff should follow standard precautions – The disposal of waste is according to biomedical handling and management rules. . The program addresses verification and validation of test methods c. Remark/Audit Points This could be as per occupational health and safety management system – OHSAS 18001:1999 Cross examine both the documents. The HCO maintains and updates its compliance status of legal and other requirements in a Remark/Audit Points All the statutory requirements are met with like BARC clearance. signage’s. d. The laboratory safety program is documented. Imaging services comply with legal and other requirements 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. display as per PNDT act. e.g. All the lab staff undergo training regarding safe practices in the lab. etc. This takes care of the safety of the workforce as well as the equipment available in the lab. dosimeters. Interpretation A well documented lab safety manual is available in the lab. b. Laboratory personnel are appropriately trained in safe practices.9. disinfections. The program addresses surveillance of tests results d. standard precautions. dressing materials. 1998. The program includes periodic calibration and maintenance of all equipment. There is an established laboratory safety program Objective Elements a. Refer to ISO 15189 Examine the same Examine the same Self explanatory Examine the same AAC. Laboratory personnel are provided with appropriate safety equipment/devices. reports to competent authority. Lab safety program is incorporated in the safety program of the hospital. See evidence of the same.

The organization shall document turnaround time of imaging results. d. There is an established quality assurance program for imaging services Objective Elements a.b. followed by written report.11. Adequately qualified and trained personnel performed/or supervise the investigations. The program addresses verification and validation of imaging methods Interpretation Refer to AERB guidelines Remark/Audit Points See evidence of AERB guidelines in facility. a neoro-science centre shall have CT and MRI. The defined timeframe could be different for different type of tests. The HCO has documented procedure for outsourcing tests for which it has no facilities. The quality assurance program for imaging services is documented b. As per AERB guidelines Interview the HOD. their identification and safe transportation to the imaging services. Imaging results are available within a defined time frame f. c) the 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 and performance of service rendered by the outsourced imaging facility as per the requirements of the HCO Interview the patients. c. e. This should include: a) list of tests for outsourcing b) identity of personnel in the outsourced facilities to ensure safe transportation of specimens and completing of imaging tests. This should also address transfer of unstable patients to imaging services. ectopic pregnancy. Imaging tests not available in the organization are outsourced to organization(s) based on their quality assurance system.g. AAC. regular manner Self Explanatory For example. See evidence of MOU and terms and conditions. The HCO has documented policies and procedures for informing the patients about the imaging – activities. Critical results shall be intimated to the treating clinician at the earliest on phone. Scope of the imaging services are commensurate to the services provided by the organization. Critical results are intimated immediately to the concerned personnel. The HCO shall define critical results which require immediate attention of clinician e. Verify the same A documents for verification and validation of imaging methods shall be available . Policies and procedures guide identification and safe transportation of patients to imaging services. g.

b. 1998. e.13. See evidence AAC. Imaging personnel are provided with appropriate radiation safety devices e. Radioactive and hazardous materials shall be disposal off and per bio-medical waste management and handling rules. The program includes periodic calibration and maintenance of all equipment. Imaging personnel are trained in radiation safety measures. During all phases of care there is a qualified individual identified as response Interpretation The HCO to ensure that the care of patients is always given by appropriately qualified medical personnel (resident doctor. Policies and procedures guide the safe use of radioactive isotopes for imaging services. The program addresses surveillance of imaging results d. Written policies and procedures guide the handling and disposal of radioactive and hazardous materials.c.12. The radiation safety program is documented. Self explanatory. consultant and/or nurse). lead aprons should be exposed to x-ray for verification of cracks and damages. d. Self explanatory Verify the same Verify the same Verify the same AAC. This program is integrated with the organization’s safety program c. See evidence See evidence See evidence Protective devices e. Calibration and maintenance of all equipment shall be carried out by competent persons. Self explanatory See evidence See evidence Self explanatory See evidence Document on safe use of radioactive isoscopes for imaging services shall be available and implemented. Imaging signage are prominently displayed in all appropriate locations h.g. There is an established radiation safety program Objective Elements a. Radiation safety devices are periodically tested and documented f. Interpretation Refer to AERB guidelines Remark/Audit Points See evidence The safety program of the imaging department has reference in the hospital safety manual. g. Patient care is continuous and multidisciplinary in nature Objective Elements a. The program includes the documentation of corrective and preventive actions HOD shall periodically assess the imaging results. Remark/Audit Points Examine records .

The HCO ensures periodic discussions about each patient (covering parameters like patient care. IP.14. Information about the patient’s care and response to treatment is shared among medical. The patient’s record (s) is are available to the authorized care providers to facilitate the exchange of information. and during transfers between units/departments. c. . nursing and other care providers. The organization shall ensure that there effective communication of patient requirements amongst the care providers in all settings. AAC. The organization has a documented discharge process Objective Elements a. ICU. d. co-management. Policies and procedures are in place for patients leaving against medical advice Interview nurses This policy could address the reasons of LAMA for any possible corrective and/or preventive action by the HCO. It could be graded into immediate. etc) amongst medical. Remark/Audit Points Interview nurses b. urgent. Care of patients is coordinated in all care settings within the organization. e. unusual developments if any. Information is exchanged and documented during each staffing shift. Policies and procedures guide the referral of patients to other department / specialities. priority or routine categories. Referral could be for opinion.b. The patients discharge process is planned Interpretation The patient’s treating doctor determines the readiness for discharge during regular reassessments The discharge policies and procedures are documented to ensure coordination amongst various departments including account so that the discharge papers are organization shall ensure that the police is informed. emergency. nursing and other care providers. The HCO has documented policy for the LAMA cases. The treating doctor should explain the consequences of this action to the patient/attendant. f. Policies and procedures exist for coordination of various departments and agencies involved in the discharge process (including medico-legal cases) c. etc. between shifts. Care of patients is co-ordinated among various care providers in a given setting viz OPD. response to treatment. Self explanatory Interview Staff This could be done on the basis of entries on case sheet or electronic patient records (EPR) For example 1) nurses’ handling-taking over notes 2) transfer summary Self explanatory Interview staff 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 specialities or even other health care providers outside the HCO. take over.

any procedure performed. Discharge summary incorporates instructions about when and how to obtain urgent care f. This could be in the form of what medicines to take. BID. Discharge summary is provided to the patients at the time of discharge b. The HCO hands over the discharge papers to the patient/attendant in all cases and copy retained. A discharge summary is given to all the patients leaving against medical advice. Discharge summary contains information regarding investigation results. etc. TID. the recorded on proper format.15. Organization defines the content of the discharge summary Objective Elements a. e. See the evidence AAC. medication and other treatment given d. when to consult a doctor or how to seek medical help and contact number of the hospital/doctor. Discharge summary contains follow up advice. Self explanatory. In LAMA cases. c. medication and other instructions in an understandable manner. Patient records also contain a copy of the discharge/case summary Interpretation Self explanatory Remark/Audit Points See evidence Self explanatory Examine the document Self explanatory Examine the document Self explanatory The instructions shall be in manner that the patient can easily understand and avoid use of medical terms e.g.d. Discharge summary contains the reasons for findings and diagnosis and the patient’s condition at the time of discharge. In case of death the summary of the case also includes the cause of death g. Examine the document Self explanatory Self explanatory Examine the record .

During procedures the organization shall ensure that the patient is exposed just before the actual procedure is undertaken. With regards to photographs/ recording procedures. Staff is aware of their responsibility in protecting patients rights e. The organization’s leaders protect patient’s rights d. All the rights of the patients should be displayed in the form of a citizen’s charter which should also give information of the charges and grievance redressal mechanism. The organization protects patient and family rights during care Objective Elements a.g. hospital staff shall develop the necessary guidelines for the same. Where patients’ rights have been infringed upon.2. Patient and family rights are documented Interpretation Hospital should respect patient’s rights. Corrective actions to prevent recurrences. e. Patient rights support individual beliefs.r. the organization shall ensure that consent is taken and that the patient’s identity is not revealed. management must keep records of such violations. Patients and families are informed of their rights in a format and language that they can understand c.1.CHAPTER 2: Patient Rights and Education (PRE) PRE. Verify the same Examine evidence of training programs Examine the same PRE. Patient rights include respect for personnel dignity and privacy during examination. b. procedures and treatment Interpretation During all stages of patient care. as also a record of the consequences. Special Remark/Audit Points In addition the HCO could also define patient responsibilities. Violation of patient rights is reviewed and corrective/preventive measures taken See evidence Protection also includes addressing patient’s grievances w. Self explanatory.t rights Training and sensitization programs shall be conducted to create awareness among the staff. values and involve the patient and family in decision making process Objective Elements a. Patient rights include Examples of the include falling . be it in examination or carrying out a procedure. Self Explanatory Remark/Audit Points See evidence b. Refer to glossary for details.

elderly.protection from physical abuse or neglect c.3. Self Explanatory from the bed/trolley due to negligence. Patient rights include information on the expected cost of the treatment i. In case of refusal the treating doctor shall explain the consequences of refusal of treatment and document the same. blood and blood product transfusions and any invasive/high risk procedures/treatment f. etc. Refer AAc4d See evidence Examine the process Examine the process The organization shall ensure that every patient has access to his/her record. etc. Informed consent of the patient is mandatory for doing HIV test.r. assault. A documented process for obtaining patient and/or families consent exists for informed decision making about their care Objective Elements a. Displayed information must be clearly available on how to voice a complaint.t privileged communication shall be followed at all times.g. Patient rights include information and consent before any research protocol is initiated precautions shall be taken especially w. patients of tuberculosis or any other infectious diseases.r. Self explanatory. Statutory requirements w. Patient rights include treating patient information as confidential d. This shall be in consonance with the code of medical ethics and statutory requirements Interview the patients PRE. General consent for treatment is obtained when the patient enters the organization b. Patient rights include informed consent before anesthesia. g. neonates. repeated internal examinations. The treating doctor shall discuss all the available options and allow the patient to make an informed choice including the option of refusal. manhandling.t vulnerable patients e. the patients should be given the choice of treatment. Examples of this include MTP. Grievance redressal mechanism must be accessible and transparent. Patient and/or his family Interpretation Self explanatory Remark/Audit Points See evidence The organization shall define as Interview the patient . Patient has right to have an access to hi/her clinical records 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. During management. Patient rights include information on how to voice a complaint h. Patient rights include refusal of treatment e.

complications and preventions strategies e. Self Explanatory. Patient and families are educated preventing infections f. Interview the patient and the family d. The policy describes who can give consent when patient is incapable of independent decision making. There is uniform pricing policy in a given setting (out-patient and ward Interpretation There should be a billing policy which defines the charges to be levied for various activities Remark/Audit Points See the Policy . This could also be done through patient education booklets/videos/leaflets. Patient and families are educated about diet and nutrition Interpretation Self explanatory Remark/Audit Points Interview the patient and the family Self explanatory Interview the patient and the family. Objective Elements a. patient and families are educated about eh safe and effective use of medication and the potential side effects of the medication b.5. etc. A list of procedures should be made for which informed consent should be taken See the list Self explanatory. Self Explanatory Interview the patient and the family Self explanatory For example. etc. streptococcus pneumonia. Patient and families have a right to information on expected costs Objective Elements a. The organization has listed those procedures and treatment where informed consent is required d. Patient and families are educated about diet and nutrition c.4. The organization shall take into consideration the statutory norms. alternatives and as to who will perform the requisite procedure in a language that they can understand to what is the scope of this consent and the same shall be communicated to the patient and/or his family members. benefits. in case of unconscious/unacco mpanied . This would include next of kin/legal guardian.patients the treating doctor can take a decision in life saving circumstances PRE. hand washing and avoiding overcrowding near the patient Interview the patient and the family PRE. Patient and families are educated about their specific disease process. typhoid. In adults it could be for influenza. Patients are taught in a language and format that they can understand Self explanatory more applicable for pediatric population.members are informed of the scope of such general consent c. When appropriate. hepatitis B and neisseria meningitides. However. Informed consent includes information on risks.

Patients are informed about the estimated costs when there is a change in the patient condition or treatment setting The organization shall ensure that there is an updated tariff list and that this list is organization shall charge as per the tariff list.category) b. See evidence When patients are shifted from one setting to another. typically to and from ICUs. Any additional charge should also be enumerated in the tariff and the same communicated to the patients. . the financial implications must be clearly conveyed to them. The tariff rates should be uniform and transparent Refer to AAC4d Interview the patients See the estimate paper randomly. Patients are educated about the estimated costs of treatment d. The tariff list is available to patients c.

The care and treatment orders are signed. Self explanatory Remark/Audit Points See evidence of SOPs b.r. applicable laws and regulations Objective Elements a.1. Policies also address handling of medicolegal cases See the policy c. shall be dealt as per hospital. The policy shall be in line with statutory requirements w. Uniform care is guided by policies and procedures which reflect applicable laws and regulations c. named. For electronic records the organization shall ensure that the same is captured in the system Cross check the evidence of signature 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. etc. Emergency services are guided by policies.CHAPTER 3 : Care of Patient COP. poisoning. patients with coronary disease. Policies and procedure for emergency care are documented Interpretation These could include SOPs/protocols to provide either general emergency care or management of specific conditions e. Also refer to AAC5a. road traffic accidents. The organization could develop clinical protocols based on these and the same could be followed in management of patients For definitions of evidence based medicine and clinical practice guidelines. procedures. The care plan is countersigned by the clinician in-charge of the patient within 24 hours e. timed and dated by the concerned doctor d. refer to glossary COP.t documentation and intimation to police.2.g. The organization shall also define as to what constitutes a MLC (in accordance with statutory rules). . providing first-aid to emergency patients and police intimation in cases of medicolegal cases. Evidence based medicine and clinical practice guidelines are adopted to guide patient care whenever possible Self explanatory For example consent before surgery. Care delivery is uniform when similar care is provided in more than one setting Interpretation The organization shall ensure that patients with the same health problems and care needs receive the same quality of healthcare throughout the organization irrespective of the category of ward. The patients receive care in consonance with the policies Poisoning cases. Self explanatory Remark/Audit Points Interview nurses and examine the records b. Uniform care of patients is guided by the applicable laws and regulations Objective Elements a.

Policies and procedures guide the triage of patient s for initiation of appropriate care e. Verify the same See the checklist See evidence g. Self explanatory. Also refer to AAC 14 and 15. There is adequate access and space for the ambulance(s) Interpretation The organization shall demarcate a proper space for ambulance(s). This shall be done based on the organization’s scope Remark/Audit Points Examine the same b. Admission of discharge to home or transfer to another organization is also documented All the staff working in the casualty should be oriented to the policies and practices through training/documents. This shall be demarcated keeping in mind easy accessibility for receiving patients and to enable the ambulance(s) to turn around/exit quickly. There is a checklist of all equipment and emergency medications e. The organization shall develop a checklist and ensure that the ambulance is equipped as the checklist. only the medications used could be topped up or the HCO could keep an additional set of drugs as standby. Self explanatory. See evidence of training programs See the registers or any other document COP. technician/nurse and/or doctor depending on the situation. Personnel shall be trained in ALS and/or BLS. Ambulance(s) is (are) manned by trained personnel d. Staff should preferably be trained/well versed in ACLS and BCLS. This also includes checking the expiry date of drugs.3. Emergency medications are checked daily and prior to dispatch The ambulance should be manned by a trained driver. Ambulance(s) is (are) appropriately equipped c. This shall be in consonance with ALS or BLS guidelines. See evidence . Equipment is checked on a daily basis f. This shall include both the ambulance and the equipment within it.d. The ambulance services are commensurate with the scope of the services provided by the organization Objective Elements a. Staff is familiar with the policies and trained on the procedures for care of emergency patients Self explanatory For triage refer to glossary f. It is expected that any ambulance shall be equipped with life support. In case a rapid turn around of the ambulance is required (where checking may not be possible prior to dispatch). The ambulance(s) has (have) a proper communication system The ambulance shall be connected with the hospital/control room by wireless/mobile phones.

The transfusion services are governed by the applicable laws and regulations c. Informed consent is obtained for donation and transfusion of blood and blood products d. This shall be in consonance with accepted practices. Documented policies and procedures are used to guide rational use of blood and blood products b. ICU. Staff providing direct patient care is trained and periodically updated in cardiopulmonary resuscitation c.g. Remark/Audit Points The document could be displayed prominently in critical areas such as emergency. steps taken to resuscitate and the outcome. Policies and procedures guide the care of patients requiring cardio-pulmonary resuscitation Objective Elements a.COP. Documented policies and procedures guide the uniform use of resuscitation throughout the organization b. A post-event analysis of all cardiac arrests is done by a multidisciplinary committee e. Multidisciplinary committee shall include physicians. The analysis shall include the cause. Also refer to PRE3 d and e Check the instrument Self explanatory This could be in the form of booklet/leaflet.5. These aspects shall be covered by hands-on training. Informed consent is also includes patient and family education about donation e. The events during a cardio-pulmonary resuscitation are recorded d. . Staff is trained to implement the policies Interpretation This shall address the conditions where blood and conditions where blood products can be used. In the actual event of COR or a mock drill of the same. etc. anaesthetists and nurses Self explanatory. all the activities along with the personnel attended should be recorded. Verify training schedule See the records See evidence Check the record COP. Remark/Audit Points See the Policy Refer to drugs and cosmetics act. code blue team) it shall ensure that they are all trained in ALS and are present in all shifts.4. Evidence of availability of the Act in the facility Self explanatory. If the organization has a CPR team (e. OT. This shall be done either by training and/or by providing written instructions See the evidence of training schedule. Corrective and preventive measures are taken based on the post-event analysis Interpretation The organization shall document the procedure for the same. Policies and procedures define rational use of blood and blood products Objective Elements a.

Infection control practices are followed f. Policies and procedures guide the care of patient in the intensive care and high dependency units Objective Elements a. The exact requirements shall be decided by the organization. The organization shall maintain a record of transfusion reactions See the SOPs For transfusion reactions refer to glossary. the organization is expected to follow best clinical practices As and when there are no vacant beds in the ICU and there is a requirement of such bed. The organization has documented admission and discharge criteria for its intensive care and high dependency units b. Adequate staff and equipment are available Interpretation The organizations shall develop these criteria and adhere to it. Transfusion reactions are analyzed for preventive and corrective actions The organization shall define as to what constitutes emergency use and accordingly develop timeframes. See the SOPs See the SOPs and interview the nurses Examine the manual . The unique needs of end of life patients are identified and cared for g. These could be developed individually or it could be a part of the hospital infection control manual.6. The organization shall ensure that any transfusion reaction is reported. Remark/Audit Points See the policy d. Defined procedures for situation of bed shortages are followed e. detailed policy and procedure should be in place to address the situation. The organization defines the time frame within which blood must be available for emergency use g. The organization shall ensure that the practices are in consonance with good clinical practices. Staff is trained to apply these criteria c. The organization shall Evidence of training and staff interview Examine the facility See the policy and interview staff. These are then analyzed (by individual/committee as decided by the organization) and appropriate corrective/preventive action is taken. A quality assurance program is implemented This shall be done by training and/or by displaying the criteria. However. The ICU should be equipped with all necessary life-saving and monitoring equipment as well as suitably manned by trained staff. These are identified in consultation with patient/patient’s relatives and wherever possible the same are provided These could be developed individually or it could be a part of the hospital quality assurance program.f. COP.

Policies and procedures are documented and are in accordance with the prevailing laws and the national and international guidelines b. Staff is trained to care for this vulnerable group Interpretation Self explanatory Remark/Audit Points Refer to disability HCO develops SOP’s for delivery of care. The organization defines and displays whether high risk obstetric cases can be cared for or not b. etc. Policies and procedures guide the care of vulnerable patients (elderly. Refer to PRE 3e All staff involved in the care of this group shall be adequately trained in identifying and meeting their needs Evidence of such training and staff interview COP. The organization has the facilities to take care of neonates of high risk pregnancies Examine the patients records The organization shall have NICU/PICU with proper equipment and staff Examine the facility . anti-skid titles for elderly. COP. Care is organized and delivered in accordance with the policies and procedures c. ramps with railings for disabled.7. Persons caring for high risk obstetric cases are competent 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. Examine SOPs The organization shall provide proper environment taking into account the requirements of the vulnerable group The informed consent for their group people should be obtained from their family or legal representative. The organization provides for a safe and secure environment for this vulnerable group d. High risk obstetric patient’s assessment also includes maternal nutrition d. play room for children.ensure that the program is in consonance with good clinical practices. children. A documented procedure exists for obtaining informed consent from the appropriate legal representative e. experience and training.8. Self explanatory Remark/Audit Points See the display Interview the HOD c. For example. Policies and procedures guide the care of high risks obstetrical patients Objective Elements a. physically and/or mentally challenged) Objective Elements a. The competency shall be based on qualifications.

certain other parameters may be monitored on a case to case basis. playroom and breast feeding room Examine records The HCO shall ensure that there is an adequate security/surveillance to prevent such happenings Self explanatory Examples could include identification tag. Self explanatory Remark/Audit Points See the policy and the display d. etc. blood pressure.COP. Policies and procedures prevent child/neonate abduction and abuse g. The policy for care of neonatal patients is in consonance with the national/international guidelines c. The hospital should take them into account. Policies and procedures guide the care of Pediatrics Patients Objective Elements a. Interview the HOD and staff For example. Those who care for children have age-specific competency Interpretation The scope also include neonatal services. experience and training. cardiac rhythm. psychological and immunization assessment f. Provisions are made for special care of children e. For example. Intra-procedure monitoring includes at minimum the heart rate. Self explanatory Remark/Audit Points Technician shall not administer sedation.10. The person administering and monitoring sedation is different from the person performing the procedure c. Adequate amenities for the care of infants and children to be available in the hospital Self explanatory There are national and international guidelines available for the case of neonates by WHO. immunization and safe parenting and this is documented in the medical record These shall not just be for doctors but shall include nursing staff also. The organization defines and displays the scope of its pediatric services b. unsupervised phototherapy leading to burns. The children’s family members are educated about nutrition. etc. Competent and trained persons perform sedation b. Patient assessment includes detailed nutritional. it any. immunization chart. etc. respiratory rate.9. Observe the practice and interview staff Self explanatory In addition. growth. . COP. growth chart. Policies and procedures guide the care of Patients undergoing moderate sedation Objective Elements a. The competency shall be based on qualification. oxygen Interpretation Whenever parenteral route is used this shall be carried out by a doctor/nurse.

The standard is not applicable for local anesthesia See the evidence b. Self explanatory Check the records This shall apply to local anesthesia also. This assessment shall be done by an anaesthesiologist. blood pressure. Equipment and manpower are available to rescue patients from a deeper level of sedation than that intended The patient’s vitals shall be monitored at regular intervals (as decided by the organization) till he/she recovers completely from the sedation These shall be developed by the organization in consonance with good clinical practices. Criteria are used to determine appropriateness of discharge from the recovery area f. airway security and potency and level of anaesthesia See the evidence This shall be done by an anesthesiologist just before the patient is wheeled into the respective OT. It is preferable to do assessment in standardized format Self explanatory Remark/Audit Points For definition of anesthesia refer to glossary. During anaesthesia monitoring includes regular and periodic recording of heart rate. The pre-anesthesia assessment results in formulation of an anesthesia plan which is documented. This shall be done before the patient is wheeled into the OR complex. An anaesthesiologist shall be available in the hospital Examine facility COP. All the patients for anesthesia have preanesthesia assessment by a qualified individual Interpretation HCO shall document on the indications.11. Policies and procedures guide the administration of anesthesia Objective Elements There is a documented policy and procedure for the administration of anesthesia a. oxygen saturation. respiratory rate. the type of anesthesia and procedure for the same. d. c. Interview staff and verify the records See the SOPs The equipment shall include emergency resuscitation equipment. It shall be applicable for both routine and emergency cases. (Refer to PRE 3d) Check the records Self Explanatory .saturation and level of sedation d. Patients are monitored after sedation e. Informed consent for administration of anesthesia is obtained by the anesthetist e. cardiac rhythm. An immediate preoperative reevaluation is documented.

All adverse anesthesia events are recorded and monitored 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. observing .f. The policies and procedures are documented b. The plan shall include advice on IV fluids.12. The operating surgeon documents the postoperative plan of care The HCO identities the individuals who have the required qualifications (s). If the patient’s condition is unstable and he/she requires ICU are the same Shall be monitored there. This shall be applicable for both routine and emergency cases Self explanatory Remark/Audit Points See the SOPs This shall be done by the operating surgeon. E. See the evidence Policies should be available for preventing adverse events like wrong patients. care of wound. A brief operative note is documented prior to transfer out of patient from recovery area Interpretation This shall include the list of surgical procedures as well as competency level for performing these procedures. An informed consent is obtained by a surgeon prior to the procedure d. etc. wrong site by a suitable mechanism The HCO should be able to demonstrate methods to prevent these events. COP. Surgical patients have a preoperative assessment and a provisional diagnosis documented prior to surgery c. All patients undergoing surgery are assessed preoperatively and a provisional diagnosis is made which is documented. Self explanatory Check the records See the SOPs All such events are monitored for the purpose of taking corrective and preventive action. Policies and procedures guide the care of patients undergoing surgical procedures Objective Elements a. wrong patient and wrong surgery e.g. This note provides information about the procedure performed. badges. See the document and interview the HOD. Persons qualified by law are permitted to perform the procedures that they are entitled to perform f. g. Each patient’s postanesthesia status is monitored and documented g. Documented policies and procedures exist to prevent adverse events like wrong site. This shall be done by a designated individual as decided by the HCO and shall be in consonance with best clinical practices. training and experience to perform procedures in consonance with the law. post operative diagnosis and the status of the patient before shifting and shall be documented by the surgeon/member of the surgical team. nursing care. A qualified individual applies defined criteria to transfer the patient from the recovery area h. identification tags. medication. Self explanatory If it is documented by a person other then the chief operating surgeon the same shall be countersigned by the chief surgeon. cross checks.

for any complications. and arthralgia b. These patients are more frequently monitored Interpretation This shall clearly state the conditions/circumstances under which restraints shall be used. Chemical restraints include sedatives. A good reference point for defining these patients could be those having pain as the predominant debilitating symptom. it shall focus on post operative complications e. Surveillance activities include monitoring the quality of air provided. These includes both physical and chemical restraint measures c. cancer pain. COP. Physical restraints include boxer’s bandage. The organization respects and supports the appropriate assessment and Pain assessment and management carried out using a pain rating scale. rate of air exchange. Self explanatory See the records See the training schedule COP. These includes documentation of reasons for restraints d. Self explanatory Remark/Audit Points See the policy See the policy See the Policy e. Policies and procedures appropriate pain management Objective Elements a. A quality assurance program is followed for the surgical services This shall be an integral part of the HCO’s overall quality assurance program. neuralgias. Self explanatory See the manual i. bleeding . . The plan also includes monitoring of surgical site infection rates See the manual All the post operative patients shall be screened for the same. etc. It shall also specify as to who can authorize the use of restraints. Documented policies and procedures guide the management of pain Interpretation The HCO shall define the group of patients for whom this is applicable. Self explanatory` Remark/Audit Points For example. A quality assurance program includes surveillance of the operation theatre environment j. rational use of antibiotics.14. Documented policies and procedures guide the care of patients under restraints b. etc. Policies and procedures guide the care of patients under restraints (physical and/or chemical) Objective Elements a.g. etc. cleaning and disinfection processes.13. use of cuffs. etc. h. Staff receive training and periodic updating in control and restraint techniques The organization shall specify the parameters and frequency of monitoring and accordingly implement the same.

International conference on harmonization (ICH) of good clinical practice (GCP) and declaration of Helsinki Somerset (1996) and ethical guidelines for biomedical research on human subjects (ICMR-2000) Refer to ICMR guidelines c. provision of antenatal and postnatal and postnatal exercise could form a part of obstetric rehabilitation program. The organization has an ethics committee to oversee all research activities Interpretation Self explanatory Remark/Audit Points For example. The team shall have treating doctor.16. Any research undertaken in the hospital falls under it ambit. Patient and family are educated on various pain management techniques Self explanatory Interview the patients COP. Rehabilitative services are provided by a multidisciplinary team Interpretation Self explanatory Remark/Audit Points See the policy The scope of the departments is in consonance with the scope of the hospital.15. Patients informed consent is obtained before entering them in research protocols e. These services are commensurate with the organizational requirements c.management of pain for all patients c. The committee has the powers to discontinue a research trail when risks outweigh the potential benefits d. Documented polices and procedures guide all research activities in compliance with national and international guidelelines b. rehabilitation therapiest. For example. rehabilitation nurses and other professional experts. Patients are informed of their right to withdraw from the research at any stage and also of An ethics committee should be framed in the hospital to monitor activities undertaken by various providers. Policies and procedures guide all research activities Objective Elements a. Observe the process and interview the HOD COP. Self explanatory See evidence Self explanatory See evidence Self explanatory See evidence . Policies and procedures appropriate rehabilitative services Objective Elements a. Documented policies and procedures guide the provision of rehabilitative services b.

stored and distributed in a safe manner A dietitian shall do the assessment of the patient in consulation with the clinician and advice regarding food. All the activities fall in sequence.17. The dietician/nurse shall ensure this during planning. The dietitian shall prepare this in the form of a diet sheet and patient shall receive food accordingly The dietician shall ensure that this is planned in consultation with the treating doctor and the patient/patient’s food habits (vegnon-veg) and likes and dislikes. Self explanatory Remark/Audit Points Refer to glossary for definition of end of life. Nutritional therapy is planned and provided in a collaborative manner e. Food is prepared. diabetic diet. Policies and procedures guide nutritional therapy Objective Elements a.18. Documented policies and procedures guide the end of life care Interpretation The HCO has a documented policy for providing care to terminally ill admitted patients. Policies and procedures guide the end of life care Objective Elements a. total parental nutrition. When families provide food. This shall include providing appropriate pain and palliative care according to the wishes of the family and patient. they are educated about the patients diet limitations f. Documented polices and procedures guide nutritional assessment and reassessment b. For example. See the instrument Interview the dietician and treating doctor Interview the patients The dietary services to be designed in a manner that there is no criss cross of traffic. The organization shall ensure that hygienic conditions are followed all throughout. handled. Visit the facility COP. Patients receive food according to their clinical needs c.the consequences (if any) of such withdrawal f. patients are assured that their refusal to participate or withdrawal from participation will not compromise their access to the organization’s services Self explanatory See evidence COP. b. etc. There is a written order the diet Interpretation Self explanatory Remark/Audit Points See policy d. These polices and See the SOPs . high protein diet.

It should be discussed with the family in very courteous manner.procedures are in consonance with the legal requirements c. If the body of the deceased is subjected to an autopsy or for organ donation. These also address the identification of the unique needs of such patient and family d. Staff is educated and trained in end of life care The religious and sociocultural beliefs of patient/family shall be addresses and respected. Self explanatory Interview the nurse Interview the head of the organization Evidence of training schedule . These also include sensitively addressing issues such as autopsy and organ donation e.

preventing entry Remark/Audit Points Verify the practice .3. generation of purchase order and receipt of goods as per rules. dispensing. vendor evaluation. administration. There is a process to obtain medications not listed in the formulatory The process should preferably address the issues of vendor selection. etc For example. The list is developed collaboratively by the multidisciplinary committee c. Documented policies and procedures exist for storage of medication Interpretation These should address pertaining to temperature (refrigeration). Self explanatory Examine the purchase procedure For example.prescription. A multidisciplinary committee guides the formulation and implementation of these policies and procedures This shall be representative of major clinical departments. light. There is a hospital formulatory Objective Elements a. administration and shall include a pharmacist/clinical pharmacologist.1. pharmacotherapeutic committee MOM. Policies and procedures guide the organization of pharmacy services and usage of medication Objective Elements a. These comply with the applicable laws and regulations c. Relevant legislations include drugs and cosmetics act. local purchase MOM. storage. food and drugs Act. Policies and procedures guide the storage of medication Objective Elements a. narcotic drugs and psychotropic drugs and magical remedies (objectionable advertisement)Act. There is a documented policy and procedure for pharmacy services and medication usage Interpretation The policies and procedure shall address the issues related to procurement. monitoring and use of medications Self explanatory Remark/Audit Points See the policy b. A list of medication appropriate for the patients and organizations resources is developed b.CHAPTER 4 : Management of Medication (MOM) MOM.2. ventilation. formularly. There is defined process for acquisition of these medications Interpretation The hospital formulary shall be prepared and be preferably updated at regular intervals Remark/Audit Points See the formulatory Refer to MON 1c See evidence d.

The organization could conduct audits at regular intervals (as defined by the organization) to detect such instance Many drugs in ampules. Re-order level at define quality should be done. If the recommendation are conflicting in nature. Emergency medications are replenished in timely manner when used. Policies and procedures guide the prescription of medications Objective Elements a.of pests/rodents and worms b. ABC. The organization shall ensure that it develop proper mechanisms to prevent pilferage. It is preferable that the HCO has a 24 hours pharmacy Verify the same Examine the same MOM. vials or tablets may look-alike or soundalike. Electronic orders when typed shall again follow the same principles Self explanatory Examine the same Examine the same d. The organization determines who can write orders c. There is a method to obtain medication when the pharmacy is closed g. legible The organization can explore the possibly of writing orders in block letters so that the issue of . Self explanatory Examine the facility c. Orders are written in a uniform location in the medical records Interpretation Self explanatory Remark/Audit Points Refer to MOM 1a This shall be done by the treating doctor Al the orders for medicines are recorded on a uniform location of the case sheet. well-lit and ventilated environment The organization shall also ensure that the storage requirements of the drug as specified by the manufacturer are adhered to. Self explanatory The organization shall follow inventory control practices like first in first out. there should be a SOP to procure the drugs Adequate amount of emergency medicines should be stocked at all times. When pharmacy is closed. Documented policies and procedures exist for prescription of medications b. Medications are protected from loss or theft e. Medication orders are clear. Sound inventory control practices guide storage of the medications d. Interview the HOD The organization can follow a method of storing drugs by generic name in an alphabetical order to address this issue. Medications are stored in a clean. etc.4. the organization shall follow the manufacturer’s recommendation. Emergency medications are available all the time h. They should be segregated and stored separately. This shall be applicable to all areas where medications are stored including wards. Sound-alike and lookalike medications are stored separately f.

Verbal orders should be followed by written orders See the list Interview the nurse MOM.g. strength and frequency of administration.6. Labeling requirements are documented and implemented by the organization Interpretation Clear polices to be laid down for dispensing of medication e.5. expiry date. Recall may result based on letters from regulatory authorities or internal feedback (e. named and signed e. Prepared medication are labeled prior to Interpretation Self explanatory Remark/Audit Points Refer to statutory requirements.g. Examine the practice At a minimum. etc. ward. Self explanatory Applicable for parenteral drugs .g. Policy on verbal orders is documented and implemented f. in addition to doctors. dosage. rate of administration. High risk medication orders or verified prior to dispensing 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 The organization shall develop the risk taking into consideration statutory requirements e. Expiry dates are checked prior to dispensing d. Medications are administrated by those who are permitted by law to do so b. There are defined procedures for medication administration Objective Elements a. nursing staff may also administer. A good practice would also include mentioning the time of prescribing. The organization defines a list of high risk medication g. etc. Policies and procedures guide the prescription of medications Objective Elements a.g. The policies include a procedure for medication recall c. MOM.NDPS Act These medications shall preferably be given only after written orders and it should be verified by the staff before dispensing legibility is addressed. Documented policies and procedures guide the safe dispensing of medications b. pharmacy. Self explanatory Remark/Audit Points See the policy See the policy This shall be done at all levels e. route of administration. labels must include the drug name. visible contaminant in IV fluid bottle).dated.

route of administration. Medication is verified from the order prior to administration Self explanatory e. dose. Medication administration is documented Staff administering medications should go through the treatment orders before administration of the medication and then only administer them. Patient is identified prior to administration d. dosage. These shall address as to what are the pre-requisites for such a medication (e. Policies and procedures govern patient’s self administration of . 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. Route is verified form the order prior to administration g. Timing is verified from the order prior to administration h. melting. clear label with mention of name.g. clumping etc) before dispensing Self explanatory Identification shall be done by unique identification number (e.) Interview the nurse For example.g.) and/or name Examine the practice Interview the nurse Self Explanatory Interview the nurse Self explanatory Interview the nurse i. It is preferable that they also check the general appearance of the medication ( e. etc. In case the HCO permits then the policy shall include the medications which the patient can self administer. self administration of insulin See the policy . etc. Dosage is verified from the order prior to administration f. expiry date. Invoice.g. 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.preparation of a second drug c.medications j. hospital number/IP number. Policies and procedures govern patients medications brought from outside the organization The organization shall ensure that this is done in a uniform location and it shall include the name of the medication.

Policies and procedures guide the use of narcotic drugs and psychotropic substances Objective Elements a. The organization could follow either a passive (documenting only if the patient tells) or active (enquiring with every patient) monitoring mechanism. This could also include education regarding the importance of taking a drug at a specific time e.g. This shall be in consonance with best practices. no alcohol when taking metronidazale. Adverse drug events are reported within a specified time frame d. Patients are monitored after medication administration Objective Elements a.MOM. Adverse drug events are defined See the document c. Patients are monitored after medication administration and this is documented Interpretation This shall be done by anyone involved in direct patient care. The organization shall define as to what constitutes an adverse drug event. Policies are modified to reduce adverse drug events when unacceptable trends occurs Examine adherence to the SOPs See evidence See the policy MOM. Patient and family are educated about safe and effective use of mediation b. Documented polices and procedures guide the use of narcotic drugs and psychotropic Interpretation Self explanatory. Adverse drug events are collected and analyzed e. Refer to MOM 1a Remark/Audit Points See the policy . Patient and family are educated about food-drug interactions Interpretation The organization shall make a list of such drugs and accordingly educate. digoxin. E. The organization shall define the timeframe for reporting once the adverse drug event has occurred.g.8. Self explanatory. sustained release medications Patient and family should be counseled about their diet during medication e.g. Remark/Audit Points Interview the patients Interview the patients MOM. Patients and family members are educated about safe medication and food-drug Interactions Objective Elements a.9. Self explanatory Remark/Audit Points Interview the nurse b.7. All the adverse drug reactions are analyzed regularly by the multidisciplinary committee (refer to MOM1C).

Documented polices and procedures govern usage of radioactive or investigational drugs b. Interview the nurse Examine the practice MOM. preparation. Policies and procedures guide the usage of chemotherapeutic agents Objective Elements a.substances b. administration and disposal of these drugs d. A proper record is kept of the usage. These drugs are handled by appropriate personnel in accordance with polices This is in the context of Narcotic Drugs and Psychotropic substances act These shall be kept in accordance with statutory requirements See evidence of the presence of the Act. Examine the records Self explanatory See the Policy MOM.10. 1998 or manufacturer’s recommendation. Examine the practice . handling. distribution and disposal of radioactive and investigational drugs Interpretation Self explanatory Remark/Audit Points See the policy Refer to AERB guidelines See the evidence of the guidelines in the facility Self explanatory. Chemotherapy is prepared and administrated by qualified personnel d. This shall however be in accordance with AERB guidelines.11. For investigational drugs these shall be as per the manufacturer’s recommendation. Chemotherapy drugs are disposed off in accordance with legal requirements Interpretation Self explanatory Remark/Audit Points See the Policy This shall preferably be a medical oncologist or a person who has been trained and has achieved competency in the same Interview the medical oncologist This shall preferably be staff who have received special training in preparing and administration These shall be disposed off according to BMW management and handling rules. Policies and procedures govern usage of radioactive or investigational drugs Objective Elements a. These policies and procedures are in consonance with laws and regulations c. These policies are in consonance with local and rational regulations c. Chemotherapy is prescribed by those who have the knowledge to monitor and treat the adverse effect of chemotherapy c. The policies and procedures include the safe storage. Documented policies and procedures guide the usage of chemotherapeutic agents b.

gas supply lines and the end user area. The policies and procedures address the safety issues at all levels Interpretation This shall be applicable to all gases used in the organization. The batch and serial number of the implantable prosthesis are recorded in the patient’s medical record and the master logbook The organization shall ensure that relevant and sufficient scientific data are available before selection. distribution. Policies and procedures guide the use of medical gases Objective Elements a. It shall follow the international colour coding system This shall include from the point of storage/source area. patients and visitors are educated on safety precautions Self explanatory This refers to the layout/location of radiation waste pipes. Gas cylinder rules 1981 and static and mobile pressure vessel (unfired) 1981 Remark/Audit Points See policy See policy c. MOM. US-FDA) or national notification (Drugs and Cosmetics Act notification October 2005) for approval of the particular product Self explanatory Examine purchase procedures for the same See evidence MOM. b. delay tanks. procedures and legal requirements Examine the records . Documented policies and procedures govern procurement. Documented policies and procedures govern procurement and usage of implantable prosthesis b.12. Appropriate safety measures shall be developed and implemented for all levels. etc. Policies and procedures guide the use of implantable prosthesis Objective Elements a. It shall also look for international (e. It shall also address the issue of statutory requirements and approvals where ever applicable. usage and replenishment of medical gases. storage.13.g. handling.d. Selection of implantable prosthesis is based on scientific criteria and internationally recognized approvals Interpretation Self Explanatory Remark/Audit Points See policy c. This is the context of the India explosives act of 1884. Staff. Appropriate records are maintained in accordance with the policies.

g. Objective Elements a. The hospital has designated and qualified infection control nurse(s) for this activity d. etc. post-operative ward. They shall also participate in audit activity and in infection prevention and control on a day-to-day basis.CHAPTER 5: Hospital Infection Control (HIC) HIC. The manual identifies the various high-risk areas. This shall preferably have administrator. physician. The HCO shall develop a system of monitoring drug susceptibility (based on culture sensitivity) and accordingly develop its antibiotic The HCO could also refer to international guidelines while framing the policy . An appropriate antibiotic policy is established and implemented. ward.g. Remark/Audit Points See the list of high risk areas See the document Self explanatory Refer to glossary for standard precautions Examine the practice e. surgeon and the hospital infection control nurse. It is preferable that the organization follow a uniform policy across different departments within the organization. It shall address this at all levels e. blood bank. The organization has well-designed. The hospital has a multi-disciplinary infection control committee b. The hospital infection control programme is documented. which is periodically updated. visitors an providers of care. CSSD. OT. HDU. The hospital has an infection control manual. OT and CSSD. ICU. Interview the infection control nurse See the manual HIC. b. d. Equipment cleaning and sterilization practices are included Interpretation The manual should clearly identify the high risk areas of the hospital e. They shall support surveillance process and detect outbreaks. It outlines methods of surveillance in the identified high-risk areas. ( The HCO defines the periodicity of updation) Objective Elements a.2. comprehensive and coordinated Hospital Infection Control (HIC) Programme aimed at reducing/eliminating risks to patient. The qualification shall be either a graduate nurse qualified nurse with competence gained by experience Self explanatory Remark/Audit Points See evidence of the committee and document of meetings held. See evidence of the team c. c. It shall define the frequency and mode of surveillance. It focuses on adherence to standard precautions at all times. microbiologist. Interpretation Self explanatory.1. The team is responsible for dayto-day functioning of infection control program. The hospital has an infection control team.

Engineering controls to prevent infections or included i.3. The organization shall ensure that this is sent at the specified frequency and in See evidence See evidence Refer to glossary for notifiable diseases . The same shall be applicable even if this activity is out sourced. g. Verification of data is done on regular basis by the infection control team d. The organization could refer to ISO 22000 : 2005 (food safety) while addressing this issue Engineering control shall address air changes. b. Self explanatory. Interpretation Self explanatory Remark/Audit Points Interview the infection control nurse c. The team shall preferably verify every serious infection (as defined by the organization) report. Mortuary practices and procedure are included as appropriate to the organization policy. air conditioning replacement of filters. The organization shall identify all notifiable diseases after taking into consideration the local laws and rules. Kitchen sanitation and food handling issues are included in the manual h. c page leading to fungal colonization . Laundry and linen management processes are also included. Examine the practice Check in the manual Interview the maintenance staff Refer to standard precautions HIC.f. Surveillance activities are appropriately directed towards the identified high-risk areas. etc Mortuary practices of preserving body. If outsourced the organization shall ensure that it establishes adequate controls to ensure infection control. which shall be reviewed at periodic intervals (may be once in 3 months) for it continuing applicability. or body parts should be in accordance to the policy. 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 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. In case of notifiable diseases. The infection control team is responsible for surveillance activities in identified areas of the hospital Objective Elements a. information (in relevant format) is sent to appropriate authorities. Collection of surveillance data is an ongoing process.

Scope of surveillance activities incorporates tracking and analyzing of infection risks. e. For all peripheral lines clinical evidence or thrombophlebitis would suffice This shall be done by sending pus/swab for culture Remark/Audit Points The HCO may extend this activity to asymptomatic catheterized patients also See evidence c. rates and trends the format as required by statutory authorities. It could also provide specific inputs to See evidence . Interpretation This can be done either by sending urine or catheter tip for culture.4. Appropriate feedback regarding HAI rates are provided on See evidence The feedback shall include the rates. The hospital takes actions to prevent or reduce the risks of hospital associated infections (HAI) in patients and employees. The organization shall do this for all symptomatic catheterized patients This can be done by sending sputum or ET/ tracheotomy secretions (obtained using a suction catheter) or ET/tracheostomy tip or protected specimen brushing (PSB) or mini bronchoalveolar lavage (BAL) for culture.e. The organization monitors surgical site infections. The organization monitors urinary tract infections b. The organization monitors intravascular device infections See evidence d. 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. trends and opportunities for improvement. The organization monitors respiratory tract infections. This shall be done at regular intervals (may be monthly and consolidated into an annual report) and the organization shall take suitable steps based on the analysis See evidence HIC. The organization shall do this for all patients on the ventilator having clinical features suggestive of infection. Objective Elements a.

etc. Interpretation This shall incorporate definitions as to what constitutes and outbreak. gloves.) d. Hand washing The organization shall Examine the facility facilities in all ensure that it provides patient care necessary infrastructure to areas are carry out the same. Adequate Self explanatory. identification and investigation of such outbreaks and the procedure for management. point of use and the disinfections are organization shall ensure available and that it maintains an used correctly. b. This shall be in accordance with good clinical practices Self explanatory Remark/Audit Points See the SOPs b.5. Proper facilities and adequate resources are provided to support the infection control program Objective Interpretation Remark/Audit Points Elements a. observation. The hospital takes appropriate action to control outbreaks of infections Objective Elements a.regular basis to reduce the HAI rate. HIC. masks.g. After the outbreak is over Interview the infection control nurse Self explanatory See the record . Clothing. This procedure is implemented during outbreaks c. Compliance with The organization shall be Observe the procedure proper hand preferably display the washing is necessary instructions monitored near every hand washing regularly and area.6. adequate inventory HIC. Isolation/barrier The organization shall Refer to glossary for isolation/barrier nursing facilities define the conditions nursing are available where the same shall be carried out and ensure that it provides the necessary resources to carry out the activity (E. should be available at the soaps. medical and nursing staff. c. etc. Compliance could be verified by random checking. Hospital has a documented procedure for handling such outbreaks. They Examine the same gloves mask. accessible to health care providers.

The organization The waste is transported Observe the process ensures that bioto be the pre-defined site medical waste is at definite time intervals stored and (maximum within 48 transported to the hours) through proper site of treatment transport vehicles in a safe and disposal in manner. are carried out and documented c. for sterilization bacteriologic. There is Self explanatory The HCO shall provide for the same in adequate space all areas where sterilization activities available for are carried out. Proper segregation Wastes to be segregated Observe the practices and collection of and collected in different bio-medical waste color coded bags and from all patient containers as per statutory care areas of the provisions. There is an The organization shall The HCO could have a batch processing established ensure that the system with date and machine number recall. sterilization procedure is for effective recall.g. strips. Regular This shall be done by Check record validation tests accepted methods e. b. There are documented procedures for sterilization activities in the hospital Objective Interpretation Remark/Audit Points Elements a. Monitoring hospital is shall be done by members implanted and of the committee monitored c.7. sterilization b.g. The hospital is The occupier shall apply in See the license authorized by the prescribed form and prescribed get approval from the authority for the prescribed authority e. If this activity is proper covered outsourced the vehicles within organization shall ensure stipulated time that it is done to an . 1998 are complied with Objective Interpretation Remark/Audit Points Elements a. management and pollution control handling of bioboard/committee medical waste. etc.appropriate corrective actions are taken to prevent recurrence HIC. procedure when regularly monitored and in breakdown in the eventually of a the sterilization breakdown it has a system is procedure for withdrawal identified of such items HIC 8 Statutory provisions with regard to bio-medical waste (BMW) management and handling.

Objective Interpretation Remark/Audit Points Elements a. This includes both control program men and materials.limits in a secure manner. Hospital The HCO shall ensure that Examine the stock management the resources required by makes available the personnel should be resources required available in sustained for the infection manner. the annual reports have to be submitted by the 31st January of every year and accident reporting has to be carried out in the prescribed form. In addition. Requisite fees. etc. This shall be from its annual prepared taking into budget in this consideration the scope of regard. The hospital There shall be separate Examine the budget regularly earmarks budget demarcated for adequate funds HIC activity. authorized contractor. gowns. . It also conducts Self explanatory See evidence of training schedule regular “in-service” training sessions for all concerned categories of staff f. documents and reports are submitted to competent authorities on stipulated dates. d. gloves and masks. It conducts regular Self explanatory See evidence of training schedule pre-induction training for appropriate categories of staff before joining concerned departments(s) d. If the hospital has waste treatment facility within it premises then they have to be in accordance with statutory provisions or they can outsource it to a central facility. protective measures are used by all categories of staff handling biomedical waste. c. the activity and previous years’ experience.in-house) or outsourced to authorized contractors(s) e. Self explanatory Examine the facility and MOU with the contact See evidence Appropriate For example. b. HIC 9 The infection control program is supported by hospital management and includes training of staff and employee health. personnel protective glosses. Bio-medical waste treatment facility is managed as per statutory provisions (if. The HCO shall ensure that the fees are deposited in a timely manner.

e. Appropriate pre and post exposure prophylaxis is provided to all concerned staff members. Self explanatory For example. hepatitis B vaccination and PEP for needlestick injury .at least once in a year.

quality at predefined be reviewed at regular prereview meeting. Refer to CQI 2 and CQI3. quality. quality objectives. implemented and maintained in a structural manner. data assurance program” elements related to collection. . multi-disciplinary committee.Chapter 6: Continuous Quality Improvement (CQI) CQI1. be developed. intervals and defined intervals (as defined opportunities for by the HCO in the quality improvement are assurance manual) by the identified. implementing the standards. the manual could be stand alone or it could have cross linkages with other manuals c. This program shall committee. COP 12 and HIC 2 also documented. quality policy. etc. Also risk management. vision. it needs to review meeting. hospital functioning and operations. There is a structured quality assurance and continuous monitoring program in the organization. review of policy quality assurance and and corrective action. various clinical assurance committee. b. hospital program quality assurance principle and evaluation methodologies. AAC 11. The inputs See evidence of the same. The quality assurance Self explanatory. f. d. incorporate the mission. e. The designated Self explanatory This could be done through program is regular training program or communicated and printed or printed materials. refer to CQI 1b. management program is reviewed dynamic process. representation from committee. The review shall also include analysis of key indicators as defined by the standards. The quality assurance This could be documented as Refer to AAC 8. maintained by a and support departments of multi-disciplinary the HCO. g. core program is developed. statutory quality manager quality assurance requirements. etc. Objective Element Interpretation Remarks/Audit Points a. The quality assurance As quality improvement is a For example. There is a designated This should preferably be a For example. coordinated amongst all the employees of the organization through proper training mechanism. service standards etc. implemented and management. The quality assurance The committee shall have For example. This shall 6. monitoring it. COP programme is manual. The quality assurance This shall preferably cover all Refer to glossary for program is aspects including definition of “risk comprehensive and documentation of the management” and “quality covers all the major program. quality coordinating and knowledge of accreditation management representative. accreditation individual for person having a good co-ordinator.

d. Monitoring includes adverse drug events. The organization identifies key indicators to monitor the clinical structures. however. Objective element Interpretation Remark/Audit Points a. Monitoring includes use of blood and blood products. Monitoring includes diagnostic services’ safety and quality control programs c. committee. CQI 2. As stated in the remarks column . adherence to standard precautions and adherence to quality checks As stated in the remarks column Complications following such procedures and reexploration surgery Hypersensitivity reactions following antibiotic administration and GI bleed following NSAIDs Parathesia following spinal anaesthesia. The HCO shall develop appropriate key performance indicators suitable to it. Monitoring includes appropriate patient assessment. The data pertaining to the identified indicators shall be captured from all patients. As stated in the remarks column Time for initial assessment of indoor patients and time taken for initial assessment in emergency b. monitoring could be done using suitable samples. severe hazards of transfusion and blood hemolysed during transportation As stated in the remarks column As stated in the remarks column f. Self explanatory. Monitoring includes use of anesthesia Reporting time for critical lab results. Monitoring includes all invasive procedures. need of ventilation following anaesthesia and adherence to pre-anaesthesia assessment Checking for transfusion transmissible infections ( TTIs) as per statutory requirements. Certain illustrative examples are given in the remarks column. processes and outcomes.program is a for updation could be based continuous process on the review carried out by and updated at least the quality assurance once in a year. e.

Actions are taken upon findings of such analysis. The organization has established processes for intense analysis of such events. D. b. All Audit are documented. This should preferably be done based on root cause analysis. Self explanatory Remedial Self explanatory measures are implemented CQI 6. Sentimental events are intensively analyzed Objective Interpretation element a. Remarks/Audit Points Self explanatory Refer to glossary for definition of “Sentinel events” See records Self explanatory. Sentinel events are intensively analysed when they occur d. Self explanatory.C. The organization has defined sentinel events. Patient and clinician anonymity is maintained. See records See records . The HCO could use a checklist with the predefined parameters and the audit findings could be recorded on this sheet. This shall be done as per the process established by the HCO. Self explanatory E. This should be done based on root cause analysis so as to prevent recurrences. c.

service. There needs department has to be an effective effective leadership style by leadership which it is governed b. outreach for governance develop social programs. Maharashtra regulations Maintenance of clinical Records act) and local regulations (e. responsibility ROM 2 The services provided by each department are documented Objective elements Interpretation Remarks/Audit points a. etc. defined could be CAPD). respective state legislations applicable (e. The organization Self explanatory This shall include central legislations complies with the (e.CHAPTER 7: Responsibility of Management (ROM) ROM 1 The responsibilities of the management are defined Objective elements Interpretation Remarks/Audit points a. c. The organization The HCO shall have See the organization structure has a an organization documented structure/chart and oraganogram this shall clearly documented the hierarchy. Senior leaders senior leaders in include the first two rungs of the the organization organogram. department is predefined. documented either at individual department level or the HCO could . usually a matrix site or one. This shunts. nephrology department of each activity it to be could do all activities like biopsy. fistulas. Scope of services Each departments For example. etc. Those responsible Self explanatory “Responsible for governance “implies for governance the governing board/body or the appoint the head of the HCO. building byelaws) e. dialysis (haemo. line of control and function b.g Drugs and Cosmetics act and laid down and MTP act). free camps. adoption of villages and address the responsibility policy PHCs.g.g. Travancore Cochin Nurses and legislations and Midwaves act 1953. Those responsible The HCO shall For example. Those responsible Self explanatory It is not only the head of the HCO but for governance the members of the board of support the governance(where applicable) who quality need to support this improvement plan d. Each The organizational Interview the head of organization organizational of hospital is program. organization’s and accordingly social address it.

each department could have its department objectives/key performance indicators and the responsibility of achieving them could be that of the leader ROM 3 The organization is managed by the leaders in an ethical manner Objective elements Interpretation Remarks/Audit points a. Self explanatory It could be common for the entire HCO . for its services based upon a standard billing tariff. The which it can and services that it cannot provide could cannot provide also be conveyed verbally. requisite and appropriate c. The designated Self explanatory Appropriate implies administrative individual has experience in a HCO. The leaders make The HCO shall have For definition of “mission” refer to public the a mission glossary mission statement and the statement of the same shall be organization displayed prominently. etc public has to be disclosed d. e. b.To effectively implement this. Refer to AAC 1 also. MCI. Administrative policies and procedures for each department is maintained d. Appropriate administrative implies qualification in hospital qualification management/administration b. etc. Department leaders are involved in quality improvements have a brochure detailing the scope of each department. manual. private. leave. The organization Self explanatory Also refer to PRE 5. The tariff could accurately bills be devised by a tariff committee. The leaders The HCO shall A good reference guide is “code of establish the function in an medical ethics-2002” published by organization’s ethical manner. The organization Self explanatory Here portrays implied that the HCO honestly portrays conveys to the patients clearly what the services it can and cannot provide. This shall include administrative procedures like attendance. ROM 4 A suitably qualified and experienced individual heads the organization Objective elements Interpretation Remarks/Audit points a. registration certificate/quality ownership trust. The designated Self explanatory This implies to the individual individual has looking after the day to day requisite and operations and not to the chairman appropriate of board of governors. The organization The ownership of The disclosure could be in the discloses it the hospital e. conduct. ethical management c.g.

assessment and in preventive risk reduction actions activities.administrative experience ROM 5 Leaders ensure that patient safety aspects and risk management issues are an integral part of patient care and hospital management Objective elements Interpretation Remarks/Audit points a. engineers. Management Self explanatory. in the context of adverse events as defined above. Refer to glossary for group assigned to definition of “safety program” oversee the hospital wide safety program b. The scope of the Self explanatory Refer to glossary for definition of program is defined “adverse events” and sentinel to include adverse events” events ranging from “no harm” to “sentinel events”. The organization Self explanatory This group could have a mix of has an administrators. doctors. Refer to glossary for definition of provides resources The end result of “risk assessment and risk for proactive risk these shall result reduction”. systems for external internal and reporting of external reporting system and of system and process failures process failures. interdisciplinary and nurses. d. c. review meeting and ensures system in place accident reporting for bio-medical implementation of for internal and waste. . Management The HCO has For example.

The HCO has . staff and visitors. The management ensures Self explanatory See evidence implementation of these requirements d. There is a documented Self explanatory Refer glossary for operational and definition of maintenance (preventive “preventive and and breakdown) plan.CHAPTER 8: Facility of Management and Safety FMS. c. DG licenses/registration/certificat sets. Objective element Interpretation Remarks/Audit Points a. floor plans and fire escape routes. c. IS 10905 for basic requirements for hospital buildings d. laws and byelaws and requisite facility inspection requirements.etc ions FMS.1.2. India shall be in accordance standards (IS with the available 12433) formulated literature on good by bureau of Indian practices (Indian or Standards ( for 30 international standards) and 100 bedded and directives from hospitals and other government agencies standards). The organization’s environment and facilities operate to ensure safety of patients. Objective element Interpretation Remarks/Audit Points a. and local body This functionary has regulations (Kerala identified the appropriate state building rules) personnel in the HCO who are supposed to implement the respective laws and regulations b. The organization is ware of and complies with the relevant rules and regulations. their families. laws and regulation as India. Up-to-date drawings are A designated personnel Examine the maintained which detail maintains the drawings. There is a mechanism to Self explanatory For Example. relevant state applicable to the HCO. The management is A designated For example. The provision of space Self explanatory For example. regularly update licenses for lifts. breakdown maintenance”. b. There are designated A person in the HCO Interview the head individuals responsible for management is of the maintenance the maintenance of all the designated to be indepartment facilities. Management regularly Self explanatory See evidence updates any amendments in the prevailing laws of the land. drawings the site layout. fire conversant with the laws and management functionary protection guidelines regulations and knows their has been given the given in national applicability to the responsibility to enlist the building code of organization. charge of maintenance of facilities.

This Interview the bioequipment in accordance shall also take into medical engineer with it services and consideration future strategic plan requirements. management finance. a. Potable water and The HCO shall make For water quality electricity are available arrangements for supply refer to IS 10500 round the clock of adequate potable water and electricity. b.A complaint attendance Verify from the register is to be complaint book maintained to indicate the date and time of receipt of compliant. The organization plan for Self explanatory. engineering and bio-medical departments c. Equipment is selected by Collaborative process Interview the bioa collaborative process implies that during medical engineer equipment selection there is involvement of end user. Maintenance staff is contactable round the clock for emergency repairs.3 The organization has a program for clinical and support service equipment management. Response times are monitored from reporting to inspection and implementation of corrective actions the required number of supervision and tradesmen to manage the facilities. Qualified and trained Self explanatory Interview the biopersonnel operate and medical engineer maintain the equipment e. Equipment is periodically The HCO has Check the records inspected and calibrated week/monthly/ annual for their proper schedules of inspection functioning and calibration of equipment which involve measurement. in an appropriate manner. d. There is documented Self explanatory See the plan operational and maintenance (preventive and breakdown) plan FMS. f. e. The HCO either calibrates the equipment in-house or out sources. All equipment is Self explanatory Interview the bioinventoried and proper medical engineer logs are maintained as required. maintaining traceability. f. Self explanatory See the roster . medical gases and vacuum system Objective element Interpretation Remarks/Audit Points a. allotment of job and completion of job FMS.4 the organization has provisions for safe water. electricity.

Deployed adequate and qualified personnel for this C. The HCO has conducted and exercise of hazard identification and risk analysis (HIRA) and accordingly taken all necessary steps to eliminate or reduce such hazards and associated risks.5 The organization has plans facilities Objective element a. There is a maintenance plan for piped medical gas and vacuum installation FMS. Mock drill records G. and electric short circuiting or act o negligence or due to incompetence of the staff on duty. solar. abatement and containment of fire and non-fire emergencies Alternate electric supply could be from DG sets. Self explanatory See evidence Check records Self explanatory Check records for fire and non-fire emergencies within the Objective element The HCO has a fire and non-fire emergency committee (FNEC) to review the HCO’s preparedness. Adequate training plans E. UPS. The HCO has: A. Exit plans well displayed The HCO has a dedicated emergency illumination system which comes into Objective element See evidence . Fire plan covering fire arising out of burning of inflammable items. Alternate sources are provided for in case of failure. Acquired fire fighting equipment for this which records are kept up-to-date.b. D. Scheduled for conduct of mock fire drills F. explosion. d. B. and any other suitable source. The organization has plans and provisions for early detection. energy. The organization regularly tests the alternate sources. c.

Hysteric fits of patients and/or relatives f. Building or structural collapse k. etc) medical wastes (Blood. vomits. pus. syringes. Terrorist attack b. Invasion for swarms of insects and pests c. etc. mercury. Sudden flooding of areas like basements due to clogging in pipe lines o. Bursting of pipe lines n. Anti-social behavior by patients/ relatives h. Fall or slips (from height or on floor) or collision of personnel in passage way l.effect in case of a fire. tubing. Spillage of hazardous (acids. The HCO takes care of non-fire emergency situations by identifying them and by deciding appropriate course of action. amniotic fluid. Temperamental disorders of staff causing deterioration in patient care i. Invasion of stray animals e. sharps. Earthquake d. etc) j. Fall of patient from bed m. Sudden failure of . Civil disorders effecting the HCO g. infected materials (used gloves. These may include: a.

d. c. Mock drills are held at least twice a year FMS. process established by the HCO. Staff is trained for their role in case of such emergencies d. gas. c. p. Self explanatory Examine the fire exit route Interview the staff See evidence Objective element Refer to glossary for definition of “sentinel events” See evidence See evidence See evidence .b.6 Sentinel events are intensively analyzed Objective element Objective element a. Sentinel events are Self explanation. Exist doors should remain open on the time. etc. The organization has Self explanatory defined sentinel events. The organization has Self explanatory established processes for intense analysis of such events. Fire exit plan shall be displayed on each floor particularly close to the lists. In case of fire designated person are assigned particular work. vacuum. The organization has a documented safe exit plan in case of fire and non-fire emergencies. This intensively analyzed shall be done as per the when they occur. Actions are taken This should be done upon findings and based on root cause such analysis analysis so as to prevent recurrences supply of electricity. b. Bursting of boilers and/or autoclaves the HCO has established liaison with civil and police authorities and fire brigade as required by law for enlisting their help and support in case of an emergency.

Objective element Interpretation Remarks/Audit Points a. am’s policies and procedures. The organization verifies the Self explanatory This report could be got antecedents of the potential form the district employee with regards to magistrate (s) of the criminal/negligence district (s) where the background. The organization maintains an Self explanatory A good reference could be adequate number and mix of the MCI and NCI staff to meet the care. HRM. b. The required job specifications Self explanatory Refer to glossary for and job description are well definitions of “job defined for each category of description and job staff. employee Self explanatory This could be done as a student and voluntary worker part of the induction is appropriately oriented to the training. All employees are oriented to The HCO shall develop Interview of the staff the service standards of the benchmarks for different organization. employees. All employees are educated For patient rights to PRE For patient responsibilities with regard to patient’s rights 2.CHAPTER 9: Human Resources Management (HRM) HRM. specification” c. etc. refer to glossary and responsibilities e. Each staff member. training development policy exists for manual which includes the staff. 2 The staff joining the organization is socialized and oriented to the hospital environment. example. organization’s mission and goals. c. attitude. employee has served earlier and/or from the previous employer. 3 There is an ongoing program for professional training and development of the staff. communication skills. 1 The organization has a documented system of human resources planning. d. Objective element Interpretation Remarks/Audit Points a. This shall be based on the HCOs value and focus on development of soft skills: behavior. guidelines treatment and service needs of the patient. A documented training and Self explanatory For. Each staff member is made Self explanatory This could be done as part aware of hospital wide policies of the induction training and procedures as well as and the same could be relevant provided in the form of department/unit/service/progr booklet. b. services being provided. HRM. Each staff member is made The HCO shall define the This could be done as a aware of his/her rights and same in consonance with part of the induction responsibilities statutory requirements training and the same and the same shall be could be provided in the communicated to the form of a booklet. training . identification of training needs. Objective element Interpretation Remarks/Audit Points a.

employee related. Staff member are made aware Self explanatory Interview the call of procedures to follow in the event of an incident. Objective element Interpretation Remarks/Audit Points a. The appraisal system is Self explanatory. HRM. HRM. demonstrate and take actions to report. Performance is evaluated Self explanatory For definition of “job based on the performance description “refer to expectations described in glossary job description. needle environment. 6 The organization has well-documented disciplinary procedure. Training also occurs when job responsibilities change/new equipment is introduced. b. Performance appraisal is Self explanatory This shall be done at least carried out at pre defined once a year. c. documentation of training. The employees are made Self explanatory Interview the staff aware of the system of appraisal at the time of induction c. Staff members can Self explanatory Interview the staff. intervals and is documented. d. b. See evidence Self explanatory . eliminate/minimize risks. students and volunteers or adequately trained on specific job duties or responsibility related to safety Objective element Interpretation Remarks/Audit Points a. both patient and stick injury. 4 The staff members. Reporting processes for The HCO has defined Interview the staff common problems. All staff is trained on the risks The HCO shall define such For example. these events. 5 An appraisal system for evaluating the performance of an employee exists as an integral part of the human resource management process. For external training it could be done either by the HCO itself or by the external agency which imparted the training. d.This shall include both internal and external training. training requirements and accordingly providing for the same (wherever possible) e. b. fire and non within the hospital risks which shall include fire emergency. A well – documented Self explanatory For definition of performance appraisal “performance appraisal” system exists in the refer to glossary organization. etc. c. failures and procedure for reporting of user errors exist. HRM. training assessment. This can Interview the HR head used as a tool for further be done by identifying development. Feedback mechanisms for assessment of training and development program exist Self explanatory methodology. etc.

b. The HCO could also identity competent individuals to perform the same. Occupational health hazards Self explanatory For definition of are adequately addressed. e. There is provision for appeals in all disciplinary cases This implies that both parties (employee and employer) are given an opportunity to present their case and decision is taken accordingly Self explanatory This could be in the form of services rules Self explanatory Refer to relevant labour laws and CCS (CCA) rules . HRM 6 and HRM7 they feel aggrieved. The disciplinary policy and procedure is based on the principles of natural justice. a written procedure for by providing every handling grievances of employee with a manual employees. Health problems of the Self explanatory. d. c. HRM. The redress procedure Self explanatory See SOPs addresses the grievance. c. incorporating the various policies and procedures. The policy and procedure is known to all categories of employees of the organization.` d. The The HCO could define the dealing with direct patient care results should be parameters and it could are done at-least once a year documented in the be different for different and the findings/ results are personnel file. categories of personnel. c. b. documented. Interpretation Self explanatory Remarks/Audit Points For definition of disciplinary procedure” refer to glossary Interview for HR head and see policy The HCO shall designated Appellate authority should an appellate authority to be higher than the consider appeals in disciplinary authority disciplinary cases. HRM 4. The HCO has HRM 5. The disciplinary procedure is in consonance with the prevailing laws. This For example. This For example. A written statement of the policy of the organization with regard to discipline is in place. Regular health checks of staff Self explanatory. and good clinical practices. 7 A grievance handling mechanism exists in the organization Objective element Interpretation Remarks/Audit Points a.Objective element a. “occupational health hazard” refer to glossary. Actions are taken to Self explanatory See records redress the grievance. 8 The organization addresses the health needs of the employees Objective element Interpretation Remarks/Audit Points a. to be followed in case to glossary. HRM. The employees are For definition for The HCO could address all aware of the procedure “grievance handing” refer points in HRM 2. A pre-employment medical Self explanatory. performing examination is conducted on all shall in consonance with pre employment HIV the employees the law of the land testing is illegal b. employee employees are taken care of in shall be in consonance health and safety policy accordance with the with the law of the land organization’s policy.

training assessment and outcome of health checks. individuals who have the “credentialing” refer to regulation and the hospital required qualification (s). Medical professionals The HCO identifies the For definition of permitted by law. consonance with the law b. Medical professional The HCO shall identify as For example. b. c. and experience of Updation is done after the identified medical acquisition of new skills professional is documented and/or qualification and updated periodically. training and experience) of medical professionals permitted to provide patient care without supervision. training training record and verify and registration. The education. professionals is credentials from the appropriately verified when organization which has possible. registration. The requisite services to Self explanatory The HCO could be provided by the incorporate this in the . registration. c.HRM. All records of in-service Self explanatory See random files training and education are contained in the personnel files. 10 There is a process for collecting. 11 There is a process for authorizing all medical professionals to admit and treat patients and provide other clinical services commensurate with their qualifications Objective element Interpretation Remarks/Audit Points a. awarded the qualification/training HRM. 9 There is a documented personnel record for each staff member Objective element Interpretation Remarks/Audit Points a. HRM. Examine the process training. radiotherapy admit and care for to what each medical can only be given by a patients as per the laid professional is authorized radiation oncologist down policies and to do. And experience without supervision or to provide patient care in identified. disciplinary background and health status. All such information The HCO shall do the A good reference could be pertaining to the medical same by verifying the MCI’s website. b. Objective element Objective element Objective element a. Personnel files contain results Evaluations would include See random files of all evaluations performance appraisals. glossary to provide patient care training. The services provided Self explanatory Where authorization is by the medical provided on the basis of professionals are in training the HCO shall consonance with their maintain a copy of the qualification. d. Self explanatory. The personnel files contain Self explanatory See random files personnel information regarding the employee’s qualification. verifying and evaluating the credentials (education. c. authorization procedures of the organization. it. Personnel files are maintained Self explanatory See random files in respect of all employees.

b. Updation is done after acquisition of new skills and/or qualification b. All such information pertaining The HCO shall do the See evidence to the nursing staff is same by verifying the appropriately verified when credentials from the possible. and experience) of nursing staff. training and experience to provide nursing care to patients in consonance with the law. The services provided by Self explanatory Interview the nursing nursing staff are in accordance head with the prevailing laws and regulations c. The requisite services to be Self explanatory Interview the nursing provided by the nursing staff head are known to them as well as the various departments/units of the hospital. registration.medical professionals brochure itself. and registration. . verifying and evaluating the credentials (education. training authorized to do. The HCO identifies the Refer to Indian Nursing training and experience of individuals who have the Council. The education. 13 There is a process to identity job responsibilities and make clinical work assignments to all nursing staff members commensurate with their qualifications and any other regulatory requirements Objective element Interpretation Remarks/Audit Points a. Act 1947 nursing staff is documented required qualification (s). organization whish has awarded the qualification/training HRM. are known to them as well as the various departments/units of the hospital. and updated periodically. Objective element Interpretation Remarks/Audit Points a. registration. The clinical work assigned to The HCO shall identity as See job responsibilities nursing staff is in consonance to what each nurse is with their qualification. training. HRM. 12 There is a process for collecting.

1. HIS/MIS is described. Documented procedures Self explanatory The organization could . Relevant state legislation e. appropriate to the scope system and/or Also refer to CQI 2 and of the services being management CQI 3 provide by the information system organization and the which provides relevant complexity of the information to all organization. The organization Self explanatory For example. management of the organization as well as other agencies that require date and information from the organizations Objective element Interpretation Remarks/Audit Points a.g. sending contributes to external birth and death databases in accordance statistics. Code of medical ethics. Objective element Interpretation Remarks/Audit Points a. daily the organization are and/or electronic census report. b. PNDT Act for regulations relevant details of all patients undergoing ultrasound. All Information Self explanatory See the policy management and technology acquisitions are in accordance with the policies and procedures e. maintenance of clinical records Act (MOCRA) in Maharashtra d. Formats for data MIS/HIS data is Examine the formats collection are collected in standardized standardized. coordinator c. concerned stakeholders. format from all areas/services in the HCO. notifiable with the law and diseases (refer to regulations glossary) and pulse polio program IMS. c. RTI Act 2005 etc. Policies and procedures A Policy document is See the Policy to meet the information available where the needs are documented. Necessary resources are This could be men. Interview the available for analyzing material space and accreditation data.CHAPTER 10: Information Management System (IMS) IMS. etc. The organizations has process in place for effective management of data. 2002. budget. identified and are Hospital information utilization rates.IT act 2000 for compliance with the computer based prevailing laws and records. b. The information needs of The HCO has manual For example. Polices and procedure exist to meet the information needs of the care providers. These policies and Self explanatory Some of these include: procedures are in .2.

Every medical record Self explanatory For records in entry is dated and electronic media it is timed. Appropriate clinical and managerial staff participates in selecting. Storage could be physical or electronic. Self explanatory There is multidisciplinary committee which is responsible for the appropriate selection of indicators.3. The author of the entry This could be by writing Examine the same can be identified. etc. The organization has a complete and accurate medical record for every patient. memos.g. In case of electronic based records. integrating and using data. b. etc. Objective element Interpretation Remarks/Audit Points a. preferable that the date and time is automatically generated by the system. Documented procedures exist for storing and retrieving data. entries in medical record but it shall be uniform across all the HCO. with the help of stamp. authorized e-signature provision as per statutory requirements must be kept.g. Every medical record has This shall also apply to For example. etc. Wherever electronic storage is done. progress record by doctor and medication administration chart by nurse c. d. decide which data needs to be shared with whom and also the modalities (e.are laid down for timely and accurate dissemination d. IMS. E. Organization policy HCO has a written policy There could be different identifies those stating who all can category of personnel authorized to make makes entries. Interview the accreditation coordinator . circulars. the full name or mentioning the employee code number. for different entries. e. CR a unique identifier records on digital media number. the HCO shall ensure that there are adequate safeguards for protection of data. measurement of trends and initiating action wherever required.) for dissemination for such data. hospital number.

The record provides an The HCO decides the up-to-date and format chronological account of (POMR/SOMR/IMR) for patient care. It is preferable that the final diagnosis (IP) is as per ICD 10. Objective element Interpretation a. The medical record contains information regarding reasons for admission. the reason for the transfer and the name of the receiving hospital Self explanatory Remarks/Audit Points For definition of “plan of care” refer to glossary. Self explanatory e. It is mandatory to mention the clinical condition of the patient before transfer is effected. Also refer to AAC 15 g. doctors order sheet etc Examine the same b.The HCO identifies which documents form part of the medical records. Operative and other procedures performed are incorporated in the medical record c. IMS. When patient is transferred to another hospital. the medical record contains a Self explanatory. maintaining medical records. The HCO provides the death certificate as per the international certification of cause of death If the patient has been transferred at his/her request a note may be added to that effect. e. However. the medical record contains the date of transfer. In such instance the name the receiving hospital could be the name the patient desires to go to. Discharge note is the same as discharge summary. For example. Whenever a clinical autopsy is carried out. The medical record reflects continuity of care. if the patient has been transferred by the HCO it shall have an acknowledgment from the receiving hospital. IP sheet. In case of death. The medical record contains a copy duly signed by appropriate and qualified personnel. Also refer to COP 12f Self explanatory. d. diagnosis and plan of care. Also refer to AAC 15. the medical record contains. documents and implements the same f. After The initial visit it shall at least have a provisional diagnosis. a copy of the death certificate indicating the cause. date and time of death. f. Self explanatory For definitions of “autopsy” refer to glossary . Self explanatory. The contents of medical record are identified and documented.4.

communication the applicable laws. The hospital has an The HCO carries out Refer to IMS 2 effective process of regular audits/rounds to monitoring compliance of check compliance with the laid down policy. and rodent control duly authenticated. Policies and procedures This is in the context of For example. c. The hospital uses Self explanatory For example. policies. confidentiality. The policies and For physical records the It is preferable that procedures incorporate HCO shall ensure that software’s when used. Policies and procedures are in place for maintaining confidentiality. g. privileged are in consonance with Indian evidence act. For electronic tampering.The HCO provides See evidence access to medical records to designed health care providers (those who are involved in the care of that patient) IMS. Privileged health Self explanatory Special car should be information is used for taken in medico-legal the purposes identified cases or as required by law and not disclosed without the patent’s copy of the report of the same. security. Indian Penal Code and Code of medical Ethics. for improving remote backup of data. Documented policies and Self explanatory. integrity etc. safeguarding of there is adequate pest shall be validated and data/record against loss. In electronic format this could be done by adequate passwords. moving developments in from physical to appropriate technology electronic format. data there should be protection against virus/Trojans and also a proper backup procedure. integrity and security of information Objective element Interpretation Remarks/Audit Points a. Care providers have access to current and past medical record.5. and security. f. d. for physical records access shall be limited only to concerned health care provider. e. . This is See the policy procedures exist for applicable for both maintaining manual and electronic confidentiality. To prevent tampering. destruction and measures. and integrity of information b.

Documented policies and Self explanatory See policy procedures are in place on retaining the patient’s clinical records.7. absence . data and information. data after the retention and information is in period is over and after accordance with the laid taking approval of the down policy. The review is conducted Self explanatory The HCO shall identify by identified care and authorize such providers. The It could be based on representative sample review could be based total discharges based on statistical on conditions of clinical including deaths. A documented procedure Self explanatory. d. IMS. b. 1987 and relevant state legislation. Objective element Interpretation Remarks/Audit Points a. The organization regularly carries our medical audits. local and national laws consumer protection act and regulations. legibility randomly and completeness of the medical records. total principles. b. e. d.6. The review focuses on Self explanatory Examine the records the timeliness. etc. competent authority. should be use. The destruction of Destruction can be done See policy medical records. individuals. the periodicity. The retention process This is applicable for Examine the process provides expected both manual and confidentiality and electronic system security. the release of to patient/physicians and information in other public agencies accordance with the requests for access to code of medical ethics information in the 2002 should be kept in medical record in mind. missing and documents any final diagnosis. accordance with the local and national law. Objective element Interpretation Remarks/Audit Points a. and/or community indoor patients. In this See the SOPs exists on how to respond context. There review process Self explanatory An adequate mix of includes records of both both active and active and discharged discharged patients patients. f. The medical records are Self explanatory The HCO could define reviewed periodically. IMS. c.authorization. Policies and procedures exist for retention time of records. The review points out Self explanatory For example. g. If any. data and information. The review uses a Self explanatory. importance c. The policies and Some of the related laws See policy procedures are in in this context are code consonance with the of medical ethics 2002.

Appropriate corrective and preventive measures undertaken are documented Self explanatory of OT notes in an operated patient.deficiencies in records. etc. See evidence . g.

a as well as the presence of cardiac output. Saline or colloids may be administrated to increase the circulating volume. This is generally carried out by a nongovernmental organization. Depending on the type of Cardiac arrhythmia. calcium. the provisions of the later shall apply. and drugs and medications. commonly abbreviated as “4H4T”: • • Hypoxia (low oxygen levels in the blood) Hypovolemia (low amount of circulating blood. which is invoked when actual cardiac arrest has been established. potassium and magnesium. 2. members of the team consider eight forms of potentially reversible causes for cardiac arrest. The evaluation process for assessing the compliance of an organization with the applicable standards for determining its accreditation status. NABH assessment includes the following:a) Documentation review. defibrillation is applies. including defibrillation. The process of external review of the quality of the health care being provided by a health care organization. patients and visitors d) On-site observations by assessors e) Education about standards compliance Emergency medical care of sustaining life. or though automated equipment such as Auto Pulse). either absolutely due to blood loss or relatively due to vasodilation) Hyperkalemia or hypokalemia (disturbance in the level of potassium in the blood) and related disturbance of calcium or magnesium levels and hypoglycemia (low glucose level) hypothermia (undercooling) Accreditation assessment Advance life support • • . amiodarone. Oxygen is administrated and enedotracheal intubation may be attempted to secure the airway. in the event of any discrepancy with a legal requirement enshrined in the law of the land. the effect of the treatment on the heart rhythm. Accreditation 1. It also represents the outcome of the review and the decision that an eligible organization meets an applicable set of standards. Notwithstanding the accuracy of the explanations given. and medication is administrated. The definitions narrated have been taken from various authentic sources as stated where ever possible. atropine. While CPR is given (either manually. The main algorithm of ALS. At regular intervals. Medication that may be administrated may include adrenaline (epinephrine). bicarbonate. b) Facility tour c) Interview of staff. relies on the monitoring of the electrical activity of the heart on a cardiac monitor.Glossary The commonly used terminologies in the NABH standards are briefly described and explained herein to remove any ambiguity regarding their comprehension. is assessed. airway management.

natural or artificial respiration. E. 1. municipal bylaws for construction of hospital/nursing homes. General anaesthesia. air ambulance that provide special services viz. An examination of a cadaver in order to determine the cause of death or to study pathologic changes. The ability to independently maintain ventilator function is often impaired. All activities including history taking. A rule governing the internal management of an organization. compressing the heart) • Toxic and/or therapeutic (chemicals. physical examination. laboratory investigations that contributes towards determining the prevailing clinical status of the patient. use of gloves. lab investigation audit. emergency care: • Airway: the protection and maintenance of patient airway including the use of airway adjuncts such as an oral or nasal airway • Breathing: the actual flow of air through respirations. x-ray audit. General anaesthesia is a drug-inducted loss of consciousness during which patient cannot be aroused even by painful stimulation. aid. trauma ambulance. coronary care ambulance. • Basic life support consists of a number of life-saving techniques which are focused on the “ABC”s of prehospital. etc. treatment of shock. Bylaws Clinical audit . There are various types of ambulance. air ambulance etc. masks and relatively disinfected environment. control of bleeding.g.Ambulance Anaesthesia Assessment Autopsy Barrier nursing Basic life support Tension pneumothorax (tear in the lung leading to collapsed lung and twisting of the large blood vessels) • Tamonade (fluid or blood in the pericardium. A surgical procedure performed after death to examine body tissues and determine the cause of death Type of nursing for immunocompromised patients with a view to prevent any secondary infections e. Emergency procedures to sustain life that include cardiopulmonary resuscitation. 2. It can supplement or complement the government law but cannot countermand it. often assisted by emergency oxygen • Circulation: the movement of blood through the beating of the heart or the emergency measure of CPR BLS may also include considerations of patient transport such as the protection of the cervical spine and avoiding additional injuries through splinting and immobilization. whether medication or poisoning) • Thromboembolism and related mechanical obstruction (blockage of the blood vessels to the lungs or the heart by a blood clot or other material) A patient carrying vehicle having facilities to provide unless otherwise indicated atleast basic life support during the process of transportation of patient.g. stabilization of injuries and wounds and first. for disposal of hazardous and/or infections waste Analysis of clinical aspects of patient car for improving the quality of health care services e. tissue audit. It consists of general anaesthesia and spinal or major regional anaesthesia and does not include local anaestheisa.g.

wikpedia. expressed which may be written or verbal. In India legal age consent is 18 years. Actual or implied consent is necessarily an element in every contract and every agreement.9. rules and regulations of the health care organization. clinical observations. It is the conscientious. patient registering in OPD). Skills is the ability to perform specific action. lab investigations to carried out and treatment to prescribed. and social concerns of activities in the field of medicine.2 of ISO 9000:2000) Knowledge is the understanding of facts and procedures.org/wiki/medical ethics) 1. risk. Informed consent is a type of consent in which the health care provider has duty to inform his/her patient about eh procedure.( en.g. Period of time marked by disability or disease that is progressively worse until death Medical ethics is the discipline of evaluating the merits. Willingness of party to undergo examination/procedure/treatment by a health care provider. alternative procedure with their risk and benefits so as to enable the patient to take an informed decision of his/her healthcare . explicit and judicious use of current best evidence in making decisions about the care of individual patient 2. for example recommendation on management of cerebral malaria. 2. Raw facts. It may be evidenced by words or acts or by silence when silence implies concurrence. or measurements collected during an assessment activity. All members of the healthcare organization who are employed full time and are paid suitable remuneration of their services as per the laid down policy. it means active acquiescence or silence compliance by a person legally capable of consenting. The guideline include relevant history taking. It may be implied (e. It also implies making medical decisions and applying the same to patients based on the best external evidence combined with the physician’s clinical Evidence based medicine . procedures performed. treatment rendered. Demonstrated ability to apply knowledge and skills. patient’s condition on discharge and any specific instructions given to the patient or family (for example follow-up medications).Clinical practice guidelines Competence Consent Credentialing Data Discharge summary Disciplinary proceedings Employees End of life Ethics Guidelines that assist practitioners to provide appropriate clinical car for specific clinical conditions. a competent gynecologist knows about the path physiology of the female genitalia and can conduct both normal as well as abnormal deliveries. A part of a patient record that summarizes the reasons for admission. Sequence of activities to be carried out when staff does not conform to the laid down norms. 1. physical signs to look for. The process of obtaining. its potential risk and benefits. In law. For example. (para 3. verifying and assessing the qualification of a health care provider. significant clinical finding.

Organised education/training usually provided in the workplace for enhancing the skills of staff members or for teaching them new skills relevant to their jobs/tasks. It may also include a person(s) not legally related to the patient but can make health care decisions for a patient if the patient loses decision making ability. Waste materials dangerous to living organisms. The list is complied by professionals and physicians in the field and is updated preferably each year changes may be made depending on availability or market Formulatory Grievance handling procedures Hazardous materials Sequence of activities carried out to address the grievance of patients. children. The person(s) with a significant role in the patient’s life. Drugs contained on the formulatory are generally those that are determined to be cost effective and medically effective. They include biologic waste that can transmit disease (for example. Other examples are infectious waste such as used needles. treatment and nursing care than are usually provided for in a general ward. They include radioactive or chemical materials. relatives and staff Substance dangerous to human and other living organisms. hospital Hazardous waste Health care organization High dependency unit In service education/training Indicator . It mainly includes spouse. A high dependency unit (HDU) is an area for patient’s who requires more intensive observation. laboratories.Family expertise and the patient’s desires. tissues) radioactive materials. used bandages and fluid soaked items. Generic term is used to describe the various types of organizations that provide health care services. hospitals. Some plans restrict prescriptions to those contained on the formulatory and others also provide nonformulatory prescriptions. visitors. An approved list of prescription drugs that a health care facility may provide to their clientele. A statistical measure of the performance of functions. etc. and parents. blood. systems or processes overtime. Such materials require special precautions for disposals. This includes ambulatory care centre’s. and toxic chemicals. For example. It is a standard of care between the general ward and full intensive care.

experience and skills required to perform particular job/tasks. SARS) form those who are healthy. A statement of the minimum acceptable qualifications that an incumbent must possess to perform a given job successfully. etc. e. meaning and significance of the standards laid down in a particular chapter. effort. monitoring of growth and nutritional status. Separation of an ill person who has communicable disease (e. 1. organ transplantation act which governs the rules for undertaking organ transplantation. The qualifications/physical requirements. responsibilities and conditions required to perform a job. A summary of the most important features of a job. Inventory control Isolation Job description Job specification Laws Medical audit Medical equipment Mission Monitoring Legal document setting forth the rules governaning a particular kind of activity e.. It entails an explanation pertaining to duties. ceasearian section rate. measles. It usually precedes the formation of goals and objectives The performance and analysis of routine measurements aimed at identifying and detecting changes in the health status or the environment.acquired infections rate. skill. The periods of isolation caries from disease to disease.g. Isolation facilities can also be extended to patients for fulfilling their individual. A brief explanation of the rational. It requires careful planning . isolation prevents transmission of infection to others also allows the focused delivery of specialized health care to ill patients. responsibility and working conditions) of the work performed.g. storage and accessibility of items in order to ensure adequate supply without stock outs/excessive storage. 1. monitoring and direct care of patient. A job description should describe and focus on the job itself and not on any specific individual who might fill the job. Information Intent Processed data which lends meaning to the raw data. unique needs. It typically includes job job specifications that include employee characteristics required for competent performance of the job. mumps. 2. It is also the process of balancing ordering costs against carrying costs of the inventory so as to minimize total costs. absence rate. 2. It relates to supervision of the supply. air quality in operation theatre. including the level (ie. mortality rate. A peer review carried out by analysis of medical records with a view to improve the quality of the patient care Any fixed or portable non drug item or appartus used for diagnosis. use and disposal of various goods in hands. A written expression that sets forth the purpose of the organization. chicken ox. treatment.g. The method of supervising the intake.

ICU. anthrax. HIV/AIDS f. biological. and also such infection among the staff of the facility (Synonym: hospitalacquired-infection). security. The hazards to which an individual is exposed during the course of performance of his job. Malaria d. private ward and general ward. mechanical and psychosocial hazards. The acceptable compliance with the measurable elements will determine the overall compliance with the standard. e. Leptospirosis j.hardydignostics. It includes procedures undergone. Polio b. Under the international health regulation the following diseases are notifable to WHO. or the residual of an infection acquired during a previous admission. specialty ward.html) Certain specified diseases which are required by law to be notified to the public health authorities. Influenza c. These include physical. bysinnosis. Tuberculosis h. Includes infections acquired in the hospital but appearing after discharge. the one which is outsourcing and the one which is providing the outsourced facility. An infection occurring in patient in a hospital or other healthcare facility in whom it was not present or incubating at the time of admission. outsourcing of house keeping. progress . profession or service areas.(www. Rabies e. A document which contains the chronological sequence of events that a patient undergoes during his stay in the health care organization. Leprosy i.com/glossary N. chemical. The location where a patient is provided health care as per his needs e.a. Cholera b. A generic term which include representatives from various disciplines.g. asbestosis and silicosis It is that component of standard which can be measures objectively on a rating scale. Dengue fever The various diseases notifiable under he factories act are lead poisoning.g. Plague c. A graphic representation of reporting relationship in an organization. Yellow fever In India the following diseases are also notifable and may vary from state to state: a. Louse-borne typhus g. Viral hepatitis k.Multi-disciplinary Nosocomial/hospital acquired/hospital associated infection (s) Notifiable disease Objective element Occupational health hazard Organ gram Outsourcing Patient care setting Patient record/medical record/clinical and use of standardized procedures and methods of data collection. laboratory/certain special diagnostic facilities with other institutions after drawing a memorandum of understanding that clearly lays down the obligations of both the organizations. Hiring of services and facilities from other organization based upon ones own requirement in areas where such facilities are either not available or else are not cost-effective. It also addresses the quality related aspects.

It implies all inputs in terms of men. Restraint may be physical or chemical (by use of sedatives. documents treatment goals and objective. potential for growth as well determining training needs. in the care environment are reduced for a patient. A series of activities for carrying out work which when observed by all help to ensure the maximum use of resources and efforts to achieve the desired output.11 of ISO 9000:2000) It implies continuous and on-going assessment of the patient which are recorded in the medical records as progress notes. outline the criteria for ending interventions.2.1. e. May facilities are “restraint free” or use alternative methods to help modify behavior. A specified way to carryout and activity or a process. It is the process for authorizing all medical professional to admit and treat patients and provide other clinical services commensurate with their qualifications and skills 1. The format of the ma be guided specific polices and procedures. A Set of interrelated or interacting activities which transforms inputs into outputs (Para 3. methods.alz. It includes preventive. antibiotic policy. Degree of adherence to pre-established criteria or standards. skills. generally implied or obligatory 9para 3. machines. Clinical and administrative activities to identity evaluate and reduce the risk of injury. curative and rehabilitative aspects of care.4.g.5 of ISO 9000:2000) 2. protocols. A plan that identifies patient care needs. an investigation to an intervention. minutes (time). (Death certificate where required) It is the process of evaluating the performance of employees during a defined period of time with the aim of ascertaining their suitability for the job.record Performance appraisal Plan of care Policies Privileging Procedure Process Program Protocol Quality Quality assurance Re-assessment Resources Restraints Risk management Safety notes and discharge summary. discharge policies.5. and documents the individual’s progress in meeting specified goals and objectives. money. meters (space). practices guidelines or combination for these. promotive. admission. material.1 of ISO 9000:2000) Characteristics imply distinguishing feature (Para 3.asp. lists the strategy to meet those needs. etc.4.1 of ISO 9000:2000) Requirements are need or expectation that is stated. visitors and health care providers . knowledge and information that are needed for efficient and effective functioning of an organization Devices used to ensure safety by restricting and controlling a person’s movement.1. 1. The degree to which the risk of an intervention/procedure.2 of ISO 9000:2000) 2. Degree to which a set of inherent characteristics fulfil requirements (Para 3.org/resources/glosssary. (Para 3.1 of ISO 9000:2000) A sequence of activities designed to implement policies and accomplish objectives A plan or a set of steps to be followed in a study. Part of quality management focused on providing confidence that quality requirements will be fulfilled. (Para 3. They are the guidelines for decision making. www.

social and environmental issues is an way that aims to benefit people. A balanced approach for organization to address economic. There are three levels of sedation:Minimal sedation (anxiolysis) – A drug induced state during which patients respond normally to verbal commands. all body fluids. disposal of sharps and safe housekeeping. The impairment last for a minimum period of tow weeks and is not related to an underlying conditions. HBV and other bloodborne pathogens. non-intact skin and mucous membranes A statement of expectation that defines the structures and Sentinel events* Social responsibility Staff Standard Precautions Standards . It encompasses a variety of practices to prevent occupational exposure. related to system or process deficiencies. All personnel working in the organization either as full paid employees or as consultants on honorarium basis 1. regardless of patient history. adoption of villages for providing health care. communities and society. motor. unexpected incident. A set on guidelines protecting first aiders or healthcare professionals from pathogens. A method of infection control in which all human blood and other bodily fluids are considered infectious for HIV. which leads to death or major and enduring loss of function for recipient of health care services. such as the use of personnel protective equipment (PPE). and excretions (expect sweat) regargless of whether or not they contain visible blood. “It also assumes that all body fluid of patient is infectious. Although cognitive function and coordination may be impaired.Scope of services Security Sedation Range of clinical and supportive activities that are provided by an healthcare organizations. Deep sedation/Analgesia – A drug induced deression of consciousness during which patients cannot be easily aroused but respond purposefully after repeated or painful stimulation. in any setting for any purpose. Moderate sedation/analgesia (conscious sedation) A drug induced deression.g. Protection from loss. and must be treated accordingly. tampering. vertilatory and cardiovascular functions are not affected. secreations. and unauthorized access or use The administration to an individual. The main message is “Don’t touch or use anything that has the victim’s body fluid on it without a barrier. e. No interventions are needed to maintain a patient airway. 2. moderate or deep sedation. or psychological impairment not present at the time services were sought or begun. Of consciousness during which patient respond purposefully to verbal commands either alone or accompanied by light tactile stimulation. by any route. Patients may need help in maintaining a patent airway. Standard Precautions apply to blood. Major and enduring loss of function refers to sensory. holding of medical camps and proper disposal of hospital wastes. A relatively infrequent. physiological. destruction.

elderly. It is the process of killing or removing microorganisms including their spores by thermal. It also refers to what extent does a test accurately measures what it purports to measure Those patients who are prone to injury and disease by virtue of their age. It requires professional analysis and sophisticated inpretertation of data leading to recommendations for control activities Patient whose vital parameters need external assistance for their maintenance. Confirmation through the provision of objective evidence that the requirements for a specific intended use or application have been fulfilled (Para 3. e. physically and mentally challenged. mental and immunological status. chemical or irradiation means.5 of ISO 9000:2000) Objective Evidence – Data supporting the existence or variety of something (Para 3. physical.1 of ISO 9000:2000) 2. These are the tests to determine whether an implemented system fulfills its requirements. Vulnerable Patient . It implies watching over with great attention. infants. those on immunosuppressive and/or chemotherapeutic agents. sex.8.8. 1. The continuous scrutiny of factors that determines the occurrence and distribution of disease and other conditions of ill health.Sterilization Surveillance Unstable patient Validation process that must be substantially in place in an organization to enhance the qualify of care. rules or conversation.g. authority and often with suspicion. The checking of data for correction or for compliance with applicable standards.

Device or product events Patient death or serious disability associated with: • The use of contaminated drugs. related to system or process deficiencies. which leads to death or major and enduring loss of function* for a recipient of health care services. or deliberate self-harm resulting in serious disability Intentional injury to a patient by a staff member. visitor. motor. Major and enduring loss of function refers to sensory. or fall An electric shock The use of restraints or bedrails • • • • 5.*REFERANCE GUIDE ON SENTINEL EVENTS Definition: An unexpected incident. or psychological impairment not present at the time services were sought or begun. Patient protection events Article • • • • • • II. Section 1. physiological. Care management events • Patient death or serious disability associated with a hemolytic reaction due to the admistration of ABO-incompatible blood or blood products • Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy . Discharge of an infant to the wrong person Patient death or serious disability associated with elopement from the health care facility Patient suicide. • • • • • • Surgical events Surgery performed on the wrong body part Surgery performed on the wrong patient Wrong surgical procedure performed on the wrong patient. • Intravascular air embolism 3. or other Any incident in which line designated for oxygen or other came to be delivered to a patient and contains the wrong gas or is contaminated by toxic substances Nosocomial infection or disease causing patient death or serious disability 4. Retained instruments in patient discovered after surgery/procedure Patient death during or immediately post surgical procedure Anesthesia related event 2.01 Event type description 1. products supplied by the organization • The use or function of a device in a manner other than the device intended use • The failure or breakdown of a device or medical equipment. Environmental events Patient death or serious disability while being cared for in healthcare facility associated with: A burn incurred from any source A slip. attempted suicide. The impairment lasts for a minimum period of two weeks and is not related to an underlying condition. another patient. trip. devices.

• Medication error leading to the death or serious disability of patient due to incorrect administration of drugs. Criminal events • Any instance of care ordered by or provided by an associated individual impersonating a clinical member of staff • Abduction of a patient • Sexual assault on patient within or on the grounds of the heath care facility Death or significant injury of a patient or staff member resulting from a physical assault or other crime that occurs within or on the grounds of the health care facility . 6. for example: o Omission error o Dosage error o Dose preparation error o Wrong time error o Wrong rate of administration error o Wrong administrative technique error o Wrong patient error Patient death or serious disability associated with an avoidable delay in treatment or response to abnormal test results.

29. No Objection certificate from the Chief Fire Officer. 33. Industrial disputes Act. 9. 1950. 11. 30. Wireless operation certificate from Indian post and telegraphs. Indian nursing council Act 1947. Copyright Act. 15. Guardians and wards Act. Retail drug license. License under Io-medical Management and handling Rules. 1980. Contract Act. Gift tax Act. 36. 1944. 1956. 1986. Arms Act. 8. Charitable and religious trusts Act. 1969. 51. Insecticides Act. Vehicle registration certificates. 24. 1948. 19. 1982. Electricity rules. Central sales tax act. 39. 10. 1986. 23. 4. 1961. Income tax Act. 1968. 28. Drugs & Cosmetics Act. 1956. Lepers Act. 53. 1926. 48.List of Licenses and statutory Obligations All of them might not be applicable to all the Hospitals. Maternity benefit Act. 16. Employment exchange Act. 1982. 1972. Atomic energy regulatory body approvals. 1955. Permit to operate lifts under the lifts and escalators Act. Sales Tax Registration certificate. 1952. 1998. 25. 5. 6. Boilers Act 1923. Child Labor Act 1986. Narcotics and Psychotropic substances Act. 1981. Environment protection Act. 1. 47. Equal remuneration Act. 1976. 1860. 31. 1956. 50. 22. 17. 1947. Income tax PAN. 1958. Indian medical council Act and code of medical ethics. 20. Customs Act. 49. 1940. 3. 35. ESI Act. No objection certificate under Pollution Control Act. Indian lunacy Act. 13. Cable television networks Act 1995. 46. MTP Act. Hire purchase Act. 14. 26. 1962. Indian trade unions Act. 1998 32. Citizenship Act. 7. 21. 1976. . 12. 1912 45. 1920. Fatal accidents Act 1855. Air (prevention and control of pollution) Act. India penal code. 42. Electricity Act. Employees provident fund Act. 44. 1961. 38. Central exercise Act. 40. 43. 18. 41. Consumer protection Act. 27. Radiation Protection Certificate in respect of all X-ray and CT Scanners from BARC. 37. Explosives Act 1884. 52. Biomedical waste management handling rules 1998. Building Permit ( From the Municipality) 2. 1971. Excise permit to store Sprit. Dentist regulations. 34.

Persons with disability Act. 1972. 1989. 1965. 71. Workers compensation Act. 1993. 1948. 1938 78. Urban land Act. 59. Payment of gratuity Act. Negotiable instruments Act. 69. Protection of human right Act. PPF Act. BARC. 68. 1936. 74. 1881. Registration of births and deaths Act. 63. 61. 57. Tax deducted at source Act. 72. 66. 65. 58. National holidays under shops Act. Sale of goods Acts. Companies Act. Society registration Act. Act. 55. Constitution of India 77. 1923 80. 1996. 1948. Minimum wages Act. 67. Payment of wages Act. Insurance Act.54. 1956 76. 64. Payment of bonus Act. License for the blood bank 75. Transplantation of human organs Act 1994 79. National buildings code. 56. 1968. 1995. Sales tax act. Prevention of food adulteration Act. 62. 73. Pharmacy Act. 1993. 60. 1954. 70. 1976 . SC and ST Act. PNDT Act. 1930.