guide book nabh standards

82
A Guide Book to NABH Standards on Hospital Accreditation First Edition Issued on August 2006 National Accreditation Board for Hospitals and Healthcare Providers

Upload: naravichandran3662

Post on 26-Oct-2015

769 views

Category:

Documents


16 download

DESCRIPTION

NABH standards

TRANSCRIPT

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 Interpretation Remarks

a. The organization defines it policies to reduce or eliminate smoking

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.

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

Smoking and non-smoking zones are properly displayed as documented.

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 identifies potential emergencies

The HCO has a documented plans and procedure for handling the situations like 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 has documented disaster management plan.

as above

A guide book to NABH standards on hospital accreditation – August 2006 Page 1 of 3

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

as above

d. Hospital staff is trained in the hospital’s disaster management plan.

as above

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

Self explanatory

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.

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

The HCO has conducted an exercise of hazard identification and risk analysis (HIRA) associated with handling of hazardous 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

A guide book to NABH standards on hospitals accreditation – August 2006 Page 2of 3

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

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

d. There is plan for managing spills of hazardous materials

Self explanatory

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

Self explanatory

FMS.9 The organization has systems in place to provide a safe and secure environment.

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

The HCO has duly contributed safety committee which has identified the potential safety and security risks to staff, patients and visitors. 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 coordinates development, implementations, and monitoring of the safety plan and policies.

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

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

See FMS 5 and FMS 8 above

d. Inspection reports are documented and corrective and preventive measures are undertaken.

See FMS 5 and FMS 8 above

e. There is a safety education programme for all staff.

See FMS 5 and FMS 8 above

A guide book to NABH standards on hospitals accreditation – August 2006 Page 3of 3

INDEX

Sr, No.

Particular

Page

01

Introduction

2

02

CHAPTER 1: Access, 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

Foreword

NABH standard for hospital accreditation were released in February 2005. India health industry has long waiting for this initiative. It facilitates hospitals in demonstrating commitment to patient safety and quality of care. It raises community confidence in the services provided by the hospital. Medical tourism comes as welcome by-product. Indian health industry has taken the accreditation program in right earnest. There has been demand to have some kind of guidance, which can facilitate in speedy compliance of accreditation standards. The present edition of guide book is expected to fulfill this very need. The book is result of collaborative effort put in by members of NABH technical committee, empanelled assessors of NABH, and experts from health industry and NABH secretariat. This guide book is to be read in conjunction with the NABH Hospital Standards, First edition, 2005. The comments from all stake holders are welcome. CEO National Accreditation Board for Hospitals

& Healthcare Providers (NABH) 2nd floor, Institution of Engineers Building Bahadur Shah Zafar Marg New Delhi – 110002 India Tel : +91 11 23379321/23379621 Fax : +91 11 23379321 Email : [email protected] Website: www.qcin.org

Introduction

The NABH standards have been laid down keeping the Indian ethos and working environment

in mind. The main focus of the standards is on patient, employee, visitor and environment safety. These standards are applicable to multidisciplinary hospitals and single especially hospitals providing secondary, tertiary and quaternary levels of health/medical care. They are not applicable to primary health care institutions and rural hospitals. All the standards are core standards would not be applicable to them while assessment. The compliance with these standards will indicate that the hospital is patient, staff and environment friendly. The standards deceptively simple. 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. It may also be observed, at the time of implementation, that there may be some duplication at few places. Duplication is necessity since it will ensure compliance with the said standards and also emphasize the importance of the standards and the objective elements. We are aware that apart from extra resources needed from implementation, a few guidelines, chapter-wise in tabulated form, have been laid down for easy comprehension, better understanding of the standards and the objective elements, removing and clarifying ambiguities uniform application of standards across the organization, and smoother and more efficient implementation. 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, the initial implementation of the standards and the subsequent monitoring of the same. 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. Finally it must also be understood that accreditation is an ongoing process. Each time one has to raise the bar and hence the importance of continual quality improvement. Accreditation is thus journey and not a destination.

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

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

Objective Element Action/ Documentation

Remarks/ Audit Points

a) The services being provided are clearly defined.

A Policy to be framed clearly stating the services the hospital can provide

See Policy document

b) The defined services are prominently displayed.

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

Display in the form of brochures only is NOT acceptable

c) The staff is oriented to these services

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.

Interview the staff in these locations

AAC.2 The Organization has well defined registration and admission process.

Objective Element Interpretation

Remarks/ Audit Points

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

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

See Policy for the same

b) The policies and procedures address outpatients, inpatients and emergency patients

Self explanatory Interview staff at these areas

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

The staff handling admission and registration needs to be aware of the services that the organization can provide. It 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.

Interview staff

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

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.

Interview staff

e) Staff is aware of these processes

All the staff handling these activities should be oriented to

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 Interpretation

Remarks/ Audit Points

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

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.

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.

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

Patient not in life-threatening situation (stable) should also be transported in a safe manner during transfer.

See the process and policy

c. Procedures identify staff responsible 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.

It is preferable that a doctor accompanies an unstable patient.

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

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

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 Interpretation

Remarks/ Audit Points

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

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

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. and conditions and also the exceptions, if any.

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

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

Interview the patients

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

Possible complications of the treatment, if any, are clearly communicated to the patient and their signature taken.

Interview the patients

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

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

See evidence of the estimate.

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

Objective Element Interpretation

Remarks/ Audit Points

a. The organization

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

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.

See the evidence of such practices.

b. The organization determines who can perform the assessments

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

Interview the staff and observe the practice.

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

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

See the evidence of such a documents

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

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

See the evidence of such practices in the medical records.

treatment ordered and all these are to be authenticated by treating doctor.

e. Initial assessment includes screening for nutritional needs.

The protocol for patients initial assessment should cover his/her nutritional needs

This could be done by the treating doctor and/or dietitian

f. The initial assessment results in a documented plan of care.

This shall be documented by the treating doctor or by a member of his team in the case sheet.

For definition of “plan of care” refer to glossary.

g. The plan of care also includes preventive aspects

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

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 Interpretation Remark/Audit Points

a. All the patients are reassessed at appropriate intervals

After the initial assessment, the patient is reassessed periodically and this is documented in the case sheet. The frequency 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.

Every patient shall be reassessed at least once every day.

b. Staff involved in direct clinical care documents reassessments

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.

Evidence of such documentation to be seen.

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

Self explanatory See evidence of progress notes.

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

Objective Elements Interpretation Remark/Audit Points

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

The HCO should ensure availability of laboratory services commensurate with the health care services offered by it. See also (f) below for outsourced lab facilities.

For example a cardiac care HCO must necessarily have facilities for cardiac enzyme

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

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

For adequacy of qualification refer to NABL 112 (Annexure)

supervise the staff c. Policies and procedures

guide collection, identification, handling, safe transportation and disposal of specimens.

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

The policy should be in lined with standard precautions. The disposal of waste shall be as per the statutory requirements (biomedical waste management and handling rules, 1998 act).

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

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

The turnaround time could be different for different tests and could be decided based on the nature of test and criticality of test.

e. Critical results are intimated immediately to the concerned personnel

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

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.

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

The HCO has documented procedure for outsourcing tests for which it has no facilities. This should include: a) list of tests for 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. A methodology to check the performance of service rendered by the outsourced laboratory as per the requirements of the HCO

See documentation in the form of MOU, and terms and condition of the same with an accredited lab.

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

Objective Elements Interpretation Remark/Audit Points

a. The laboratory quality assurance program is documented

The HCO has documented quality assurance program (preferably as per ISO 15189: Medical laboratories – Particular requirements for quality and

Evidence of such program to be seen.

competence) b. The program addresses

verification and validation of test methods

This holds true for any laboratory – developed methods

Examine the same

c. The program addresses surveillance of tests results

The laboratory director shall periodically assess the test results.

Examine the same

d. The program includes periodic calibration and maintenance of all equipment.

Refer to ISO 15189 Examine the same

e. The program includes the documentation of corrective and preventive actions

Self explanatory Examine the same

AAC.9. There is an established laboratory safety program

Objective Elements

Interpretation Remark/Audit Points

a. The laboratory safety program is documented.

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

This could be as per occupational health and safety management system – OHSAS 18001:1999

b. This program is integrated with the organization’s safety program

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

Cross examine both the documents.

c. Written – Policies and procedures guide the handling and disposal of infections and hazardous materials.

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

Examine the same.

d. Laboratory personnel are appropriately trained in safe practices.

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

See evidence of training program.

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

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

See evidence of the same.

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

Objective Elements Interpretation Remark/Audit Points

a. Imaging services comply with legal and other requirements

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

All the statutory requirements are met with like BARC clearance, dosimeters, lead sheets, lead aprons, signage’s, display as per PNDT act, reports to competent authority, etc.

regular manner b. Scope of the imaging

services are commensurate to the services provided by the organization.

Self Explanatory For example, a neoro-science centre shall have CT and MRI.

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

As per AERB guidelines Interview the HOD.

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

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

Interview the patients.

e. Imaging results are available within a defined time frame

The organization shall document turnaround time of imaging results.

The defined timeframe could be different for different type of tests.

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

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

The HCO shall define critical results which require immediate attention of clinician e.g. ectopic pregnancy.

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

The HCO has documented procedure for outsourcing tests for which it has no facilities. This should include: a) list of tests for outsourcing b) identity of personnel in the outsourced facilities to ensure safe transportation of specimens and completing of imaging tests, 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

See evidence of MOU and terms and conditions.

AAC.11. There is an established quality assurance program for imaging services

Objective Elements Interpretation Remark/Audit Points

a. The quality assurance program for imaging services is documented

Refer to AERB guidelines See evidence of AERB guidelines in facility.

b. The program addresses verification and validation of imaging methods

A documents for verification and validation of imaging methods shall be available

Verify the same

c. The program addresses surveillance of imaging results

HOD shall periodically assess the imaging results.

Verify the same

d. The program includes periodic calibration and maintenance of all equipment.

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

Verify the same

e. The program includes the documentation of corrective and preventive actions

Self explanatory Verify the same

AAC.12. There is an established radiation safety program

Objective Elements Interpretation Remark/Audit Points

a. The radiation safety program is documented.

Refer to AERB guidelines See evidence

b. This program is integrated with the organization’s safety program

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

See evidence

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

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

See evidence

d. Imaging personnel are provided with appropriate radiation safety devices

Self explanatory. See evidence

e. Radiation safety devices are periodically tested and documented

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

See evidence

f. Imaging personnel are trained in radiation safety measures.

Self explanatory See evidence

g. Imaging signage are prominently displayed in all appropriate locations

Self explanatory See evidence

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

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

See evidence

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

Objective Elements Interpretation Remark/Audit Points

a. During all phases of care there is a qualified individual identified as response

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

Examine records

b. Care of patients is coordinated in all care settings within the organization.

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

Interview Staff

c. Information about the patient’s care and response to treatment is shared among medical, nursing and other care providers.

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

This could be done on the basis of entries on case sheet or electronic patient records (EPR)

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

Self explanatory For example 1) nurses’ handling-taking over notes 2) transfer summary

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

Self explanatory Interview staff

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

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

Referral could be for opinion, co-management, take over. It could be graded into immediate, urgent, priority or routine categories.

AAC.14. The organization has a documented discharge process

Objective Elements Interpretation Remark/Audit Points

a. The patients discharge process is planned

The patient’s treating doctor determines the readiness for discharge during regular reassessments

Interview nurses

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

The discharge policies and procedures are documented to ensure coordination amongst various departments including account so that the discharge papers are organization shall ensure that the police is informed.

Interview nurses

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

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

This policy could address the reasons of LAMA for any possible corrective and/or preventive action by the HCO.

d. A discharge summary is given to all the patients leaving against medical advice.

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

See the evidence

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

Objective Elements Interpretation Remark/Audit Points

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

Self explanatory See evidence

b. Discharge summary contains the reasons for findings and diagnosis and the patient’s condition at the time of discharge.

Self explanatory Examine the document

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

Self explanatory Examine the document

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

Self explanatory The instructions shall be in manner that the patient can easily understand and avoid use of medical terms e.g. BID, TID, etc.

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

Self explanatory. This could be in the form of what medicines to take, when to consult a doctor or how to seek medical help and contact number of the hospital/doctor.

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

Self explanatory Examine the document

g. Patient records also contain a copy of the discharge/case summary

Self explanatory Examine the record

CHAPTER 2: Patient Rights and Education (PRE)

PRE.1. The organization protects patient and family rights during care

Objective Elements Interpretation Remark/Audit Points

a. Patient and family rights are documented

Hospital should respect patient’s rights. 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.

See evidence

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

Self Explanatory See evidence

c. The organization’s leaders protect patient’s rights

Protection also includes addressing patient’s grievances w.r.t rights

Verify the same

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

Training and sensitization programs shall be conducted to create awareness among the staff.

Examine evidence of training programs

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

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

Examine the same

PRE.2. Patient rights support individual beliefs, values and involve the patient and

family in decision making process

Objective Elements Interpretation Remark/Audit Points

a. Patient rights include respect for personnel dignity and privacy during examination, procedures and treatment

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

In addition the HCO could also define patient responsibilities. Refer to glossary for details.

b. Patient rights include Self explanatory. Special Examples of the include falling

protection from physical abuse or neglect

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

from the bed/trolley due to negligence, assault, repeated internal examinations, manhandling, etc.

c. Patient rights include treating patient information as confidential

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

Examples of this include MTP, patients of tuberculosis or any other infectious diseases.

d. Patient rights include refusal of treatment

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

In case of refusal the treating doctor shall explain the consequences of refusal of treatment and document the same.

e. Patient rights include informed consent before anesthesia, blood and blood product transfusions and any invasive/high risk procedures/treatment

Self Explanatory Informed consent of the patient is mandatory for doing HIV test.

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

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

See evidence

g. Patient rights include information on how to voice a complaint

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

Examine the process

h. Patient rights include information on the expected cost of the treatment

Refer AAc4d Examine the process

i. Patient has right to have an access to hi/her clinical records

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

Interview the patients

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

Objective Elements Interpretation Remark/Audit Points

a. General consent for treatment is obtained when the patient enters the organization

Self explanatory See evidence

b. Patient and/or his family The organization shall define as Interview the patient

members are informed of the scope of such general consent

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

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

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

See the list

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

Self explanatory. The organization shall take into consideration the statutory norms.

This would include next of kin/legal guardian. However, in case of unconscious/unacco mpanied ;patients the treating doctor can take a decision in life saving circumstances

PRE.4. The policy describes who can give consent when patient is incapable of independent decision making.

Objective Elements Interpretation Remark/Audit Points

a. When appropriate, patient and families are educated about eh safe and effective use of medication and the potential side effects of the medication

Self explanatory Interview the patient and the family

b. Patient and families are educated about diet and nutrition

Self explanatory Interview the patient and the family.

c. Patient and families are educated about diet and nutrition

Self explanatory more applicable for pediatric population, In adults it could be for influenza, streptococcus pneumonia, typhoid, hepatitis B and neisseria meningitides, etc.

Interview the patient and the family

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

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

Interview the patient and the family

e. Patient and families are educated preventing infections

Self Explanatory For example, hand washing and avoiding overcrowding near the patient

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

Self explanatory Interview the patient and the family

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

Objective Elements Interpretation Remark/Audit Points

a. There is uniform pricing policy in a given setting (out-patient and ward

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

See the Policy

category) b. The tariff list is available

to patients The organization shall ensure that there is an updated tariff list and that this list is organization shall charge as per the tariff list. Any additional charge should also be enumerated in the tariff and the same communicated to the patients. The tariff rates should be uniform and transparent

Interview the patients

c. Patients are educated about the estimated costs of treatment

Refer to AAC4d See the estimate paper randomly.

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

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

See evidence

CHAPTER 3 : Care of Patient

COP.1. Uniform care of patients is guided by the applicable laws and regulations

Objective Elements Interpretation Remark/Audit Points

a. Care delivery is uniform when similar care is provided in more than one setting

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

Interview nurses and examine the records

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

Self explanatory For example consent before surgery, providing first-aid to emergency patients and police intimation in cases of medico-legal cases.

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

Self explanatory For electronic records the organization shall ensure that the same is captured in the system

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

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

Cross check the evidence of signature

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

The organization could develop clinical protocols based on these and the same could be followed in management of patients

For definitions of evidence based medicine and clinical practice guidelines, refer to glossary

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

regulations

Objective Elements Interpretation Remark/Audit Points

a. Policies and procedure for emergency care are documented

These could include SOPs/protocols to provide either general emergency care or management of specific conditions e.g. poisoning. Also refer to AAC5a.

See evidence of SOPs

b. Policies also address handling of medico-legal cases

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

See the policy

c. The patients receive care in consonance with the policies

Self explanatory Poisoning cases, road traffic accidents, patients with coronary disease, etc. shall be dealt as per hospital.

d. Policies and procedures guide the triage of patient s for initiation of appropriate care

Self explanatory For triage refer to glossary

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

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

See evidence of training programs

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

Self explanatory. Also refer to AAC 14 and 15.

See the registers or any other document

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

provided by the organization

Objective Elements Interpretation Remark/Audit Points

a. There is adequate access and space for the ambulance(s)

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

Examine the same

b. Ambulance(s) is (are) appropriately equipped

This shall be done based on the organization’s scope

This shall be in consonance with ALS or BLS guidelines. It is expected that any ambulance shall be equipped with life support.

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

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

Verify the same

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

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

See the checklist

e. Equipment is checked on a daily basis

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

See evidence

f. Emergency medications are checked daily and prior to dispatch

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

In case a rapid turn around of the ambulance is required (where checking may not be possible prior to dispatch), only the medications used could be topped up or the HCO could keep an additional set of drugs as standby.

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

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

See evidence

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

Objective Elements Interpretation Remark/Audit Points

a. Documented policies and procedures guide the uniform use of resuscitation throughout the organization

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

The document could be displayed prominently in critical areas such as emergency, ICU, OT, etc.

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

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

Verify training schedule

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

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

See the records

d. A post-event analysis of all cardiac arrests is done by a multidisciplinary committee

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

See evidence

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

Self explanatory. Check the record

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

Objective Elements Interpretation Remark/Audit Points

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

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

See the Policy

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

Refer to drugs and cosmetics act. Evidence of availability of the Act in the facility

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

Self explanatory. Also refer to PRE3 d and e

Check the instrument

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

Self explanatory This could be in the form of booklet/leaflet.

e. Staff is trained to implement the policies

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

See the evidence of training schedule.

f. The organization defines the time frame within which blood must be available for emergency use

The organization shall define as to what constitutes emergency use and accordingly develop timeframes.

See the SOPs

g. Transfusion reactions are analyzed for preventive and corrective actions

The organization shall ensure that any transfusion reaction is reported. These are then analyzed (by individual/committee as decided by the organization) and appropriate corrective/preventive action is taken, The organization shall maintain a record of transfusion reactions

For transfusion reactions refer to glossary.

COP.6. Policies and procedures guide the care of patient in the intensive care and high dependency units

Objective Elements Interpretation Remark/Audit Points

a. The organization has documented admission and discharge criteria for its intensive care and high dependency units

The organizations shall develop these criteria and adhere to it.

See the policy

b. Staff is trained to apply these criteria

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

Evidence of training and staff interview

c. Adequate staff and equipment are available

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

Examine the facility

d. Defined procedures for situation of bed shortages are followed

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

See the policy and interview staff.

e. Infection control practices are followed

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

See the SOPs

f. The unique needs of end of life patients are identified and cared for

These are identified in consultation with patient/patient’s relatives and wherever possible the same are provided

See the SOPs and interview the nurses

g. A quality assurance program is implemented

These could be developed individually or it could be a part of the hospital quality assurance program. The organization shall

Examine the manual

ensure that the program is in consonance with good clinical practices.

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

Objective Elements Interpretation Remark/Audit Points

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

Self explanatory Refer to disability

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

HCO develops SOP’s for delivery of care.

Examine SOPs

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

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

For example, play room for children, anti-skid titles for elderly, ramps with railings for disabled, etc.

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

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

Refer to PRE 3e

e. Staff is trained to care for this vulnerable group

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

Evidence of such training and staff interview

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

Objective Elements Interpretation Remark/Audit Points

a. The organization defines and displays whether high risk obstetric cases can be cared for or not

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

See the display

b. Persons caring for high risk obstetric cases are competent

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

Interview the HOD

c. High risk obstetric patient’s assessment also includes maternal nutrition

Self explanatory Examine the patients records

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

The organization shall have NICU/PICU with proper equipment and staff

Examine the facility

COP.9. Policies and procedures guide the care of Pediatrics Patients

Objective Elements Interpretation Remark/Audit Points

a. The organization defines and displays the scope of its pediatric services

The scope also include neonatal services, it any.

See the policy and the display

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

Self explanatory There are national and international guidelines available for the case of neonates by WHO, etc. The hospital should take them into account.

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

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

Interview the HOD and staff

d. Provisions are made for special care of children

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

For example, playroom and breast feeding room

e. Patient assessment includes detailed nutritional, growth, psychological and immunization assessment

Self explanatory Examine records

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

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

Examples could include identification tag, unsupervised phototherapy leading to burns, etc.

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

Self explanatory For example, growth chart, immunization chart, etc.

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

sedation

Objective Elements Interpretation Remark/Audit Points

a. Competent and trained persons perform sedation

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

Technician shall not administer sedation.

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

Self explanatory Observe the practice and interview staff

c. Intra-procedure monitoring includes at minimum the heart rate, cardiac rhythm, respiratory rate, blood pressure, oxygen

Self explanatory In addition, certain other parameters may be monitored on a case to case basis.

saturation and level of sedation

d. Patients are monitored after sedation

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

Interview staff and verify the records

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

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

See the SOPs

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

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

Examine facility

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

Objective Elements Interpretation Remark/Audit Points

There is a documented policy and procedure for the administration of anesthesia

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

For definition of anesthesia refer to glossary. The standard is not applicable for local anesthesia

a. All the patients for anesthesia have pre-anesthesia assessment by a qualified individual

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

See the evidence

b. The pre-anesthesia assessment results in formulation of an anesthesia plan which is documented.

Self explanatory See the evidence

c. An immediate preoperative reevaluation is documented.

This shall be done by an anesthesiologist just before the patient is wheeled into the respective OT.

Check the records

d. Informed consent for administration of anesthesia is obtained by the anesthetist

Self explanatory This shall apply to local anesthesia also. (Refer to PRE 3d)

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

Self Explanatory Check the records

f. Each patient’s post-anesthesia status is monitored and documented

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

Check the records

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

This shall be done by a designated individual as decided by the HCO and shall be in consonance with best clinical practices.

See the SOPs

h. All adverse anesthesia events are recorded and monitored

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

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

Objective Elements Interpretation Remark/Audit Points

a. The policies and procedures are documented

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

See the SOPs

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

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

This shall be done by the operating surgeon.

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

Self explanatory See the evidence

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

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

The HCO should be able to demonstrate methods to prevent these events. E.g. identification tags, badges, cross checks, etc.

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

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

See the document and interview the HOD.

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

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

If it is documented by a person other then the chief operating surgeon the same shall be countersigned by the chief surgeon.

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

Self explanatory The plan shall include advice on IV fluids, medication, care of wound, nursing care, observing

for any complications, etc.

h. A quality assurance program is followed for the surgical services

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

See the manual

i. A quality assurance program includes surveillance of the operation theatre environment

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

See the manual

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

Self explanatory All the post operative patients shall be screened for the same.

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

Objective Elements

Interpretation Remark/Audit Points

a. Documented policies and procedures guide the care of patients under restraints

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

See the policy

b. These includes both physical and chemical restraint measures

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

See the policy

c. These includes documentation of reasons for restraints

Self explanatory See the Policy

d. These patients are more frequently monitored

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

See the records

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

Self explanatory See the training schedule

COP.14. Policies and procedures appropriate pain management

Objective Elements Interpretation Remark/Audit Points

a. Documented policies and procedures guide the management of pain

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

For example, cancer pain, neuralgias, and arthralgia

b. The organization respects and supports the appropriate assessment and

Self explanatory` Pain assessment and management carried out using a pain rating scale.

management of pain for all patients

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

Self explanatory Interview the patients

COP.15. Policies and procedures appropriate rehabilitative services

Objective Elements Interpretation Remark/Audit Points

a. Documented policies and procedures guide the provision of rehabilitative services

Self explanatory See the policy

b. These services are commensurate with the organizational requirements

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

For example, provision of antenatal and postnatal and postnatal exercise could form a part of obstetric rehabilitation program.

c. Rehabilitative services are provided by a multidisciplinary team

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

Observe the process and interview the HOD

COP.16. Policies and procedures guide all research activities

Objective Elements Interpretation Remark/Audit Points

a. Documented polices and procedures guide all research activities in compliance with national and international guidelelines

Self explanatory For example, 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)

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

An ethics committee should be framed in the hospital to monitor activities undertaken by various providers. Any research undertaken in the hospital falls under it ambit.

Refer to ICMR guidelines

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

Self explanatory See evidence

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

Self explanatory See evidence

e. Patients are informed of their right to withdraw from the research at any stage and also of

Self explanatory See evidence

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.17. Policies and procedures guide nutritional therapy

Objective Elements Interpretation Remark/Audit Points

a. Documented polices and procedures guide nutritional assessment and reassessment

Self explanatory See policy

b. Patients receive food according to their clinical needs

A dietitian shall do the assessment of the patient in consulation with the clinician and advice regarding food.

For example, diabetic diet, high protein diet, total parental nutrition, etc.

c. There is a written order the diet

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

See the instrument

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

The dietician shall ensure that this is planned in consultation with the treating doctor and the patient/patient’s food habits (veg-non-veg) and likes and dislikes.

Interview the dietician and treating doctor

e. When families provide food, they are educated about the patients diet limitations

The dietician/nurse shall ensure this during planning.

Interview the patients

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

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

Visit the facility

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

Objective Elements Interpretation Remark/Audit Points

a. Documented policies and procedures guide the end of life care

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

Refer to glossary for definition of end of life.

b. These polices and Self explanatory See the SOPs

procedures are in consonance with the legal requirements

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

The religious and socio-cultural beliefs of patient/family shall be addresses and respected.

Interview the nurse

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

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

Interview the head of the organization

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

Self explanatory Evidence of training schedule

CHAPTER 4 : Management of Medication (MOM)

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

Objective Elements Interpretation Remark/Audit Points

a. There is a documented policy and procedure for pharmacy services and medication usage

The policies and procedure shall address the issues related to procurement, storage, formularly,prescription, dispensing, administration, monitoring and use of medications

See the policy

b. These comply with the applicable laws and regulations

Self explanatory Relevant legislations include drugs and cosmetics act, food and drugs Act, narcotic drugs and psychotropic drugs and magical remedies (objectionable advertisement)Act, etc

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

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

For example, pharmaco-therapeutic committee

MOM.2. There is a hospital formulatory

Objective Elements Interpretation Remark/Audit Points

a. A list of medication appropriate for the patients and organizations resources is developed

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

See the formulatory

b. The list is developed collaboratively by the multidisciplinary committee

Refer to MON 1c See evidence

c. There is defined process for acquisition of these medications

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

Examine the purchase procedure

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

Self explanatory For example, local purchase

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

Objective Elements Interpretation Remark/Audit Points

a. Documented policies and procedures exist for storage of medication

These should address pertaining to temperature (refrigeration), light, ventilation, preventing entry

Verify the practice

of pests/rodents and worms

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

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

Examine the facility

c. Sound inventory control practices guide storage of the medications

Self explanatory The organization shall follow inventory control practices like first in first out, ABC, etc.

d. Medications are protected from loss or theft

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

Interview the HOD

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

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

The organization can follow a method of storing drugs by generic name in an alphabetical order to address this issue.

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

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

It is preferable that the HCO has a 24 hours pharmacy

g. Emergency medications are available all the time

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

Verify the same

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

Self explanatory Examine the same

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

Objective Elements Interpretation Remark/Audit Points

a. Documented policies and procedures exist for prescription of medications

Self explanatory Refer to MOM 1a

b. The organization determines who can write orders

This shall be done by the treating doctor

Examine the same

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

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

Examine the same

d. Medication orders are clear, legible

Self explanatory The organization can explore the possibly of writing orders in block letters so that the issue of

dated, named and signed

legibility is addressed. A good practice would also include mentioning the time of prescribing.

e. Policy on verbal orders is documented and implemented

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

Verbal orders should be followed by written orders

f. The organization defines a list of high risk medication

The organization shall develop the risk taking into consideration statutory requirements e.g.NDPS Act

See the list

g. High risk medication orders or verified prior to dispensing

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

Interview the nurse

MOM.5. Policies and procedures guide the prescription of medications

Objective Elements Interpretation Remark/Audit Points

a. Documented policies and procedures guide the safe dispensing of medications

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

See the policy

b. The policies include a procedure for medication recall

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

See the policy

c. Expiry dates are checked prior to dispensing

Self explanatory This shall be done at all levels e.g. pharmacy, ward, etc.

d. Labeling requirements are documented and implemented by the organization

At a minimum, labels must include the drug name, strength and frequency of administration.

Examine the practice

MOM.6. There are defined procedures for medication administration

Objective Elements Interpretation Remark/Audit Points

a. Medications are administrated by those who are permitted by law to do so

Self explanatory Refer to statutory requirements, in addition to doctors, nursing staff may also administer.

b. Prepared medication are labeled prior to

Self explanatory Applicable for parenteral drugs

preparation of a second drug

c. Patient is identified prior to administration

Self explanatory Identification shall be done by unique identification number (e.g. hospital number/IP number, etc.) and/or name

d. Medication is verified from the order prior to administration

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

Examine the practice

e. Dosage is verified from the order prior to administration

Self explanatory Interview the nurse

f. Route is verified form the order prior to administration

Self Explanatory Interview the nurse

g. Timing is verified from the order prior to administration

Self explanatory Interview the nurse

h. Medication administration is documented

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

Interview the nurse

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

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

For example, self administration of insulin

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

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

See the policy

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

Objective Elements

Interpretation Remark/Audit Points

a. Patient and family are educated about safe and effective use of mediation

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

Interview the patients

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

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

Interview the patients

MOM.8. Patients are monitored after medication administration

Objective Elements

Interpretation Remark/Audit Points

a. Patients are monitored after medication administration and this is documented

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

Interview the nurse

b. Adverse drug events are defined

The organization shall define as to what constitutes an adverse drug event. This shall be in consonance with best practices.

See the document

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

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

Examine adherence to the SOPs

d. Adverse drug events are collected and analyzed

All the adverse drug reactions are analyzed regularly by the multi-disciplinary committee (refer to MOM1C).

See evidence

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

Self explanatory See the policy

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

Objective Elements

Interpretation Remark/Audit Points

a. Documented polices and procedures guide the use of narcotic drugs and psychotropic

Self explanatory. Refer to MOM 1a See the policy

substances

b. These policies are in consonance with local and rational regulations

This is in the context of Narcotic Drugs and Psychotropic substances act

See evidence of the presence of the Act.

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

These shall be kept in accordance with statutory requirements

Examine the records

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

Self explanatory See the Policy

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

Objective Elements

Interpretation Remark/Audit Points

a. Documented policies and procedures guide the usage of chemotherapeutic agents

Self explanatory See the Policy

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

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

Interview the medical oncologist

c. Chemotherapy is prepared and administrated by qualified personnel

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

Interview the nurse

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

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

Examine the practice

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

Objective Elements

Interpretation Remark/Audit Points

a. Documented polices and procedures govern usage of radioactive or investigational drugs

Self explanatory See the policy

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

Refer to AERB guidelines See the evidence of the guidelines in the facility

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

Self explanatory. This shall however be in accordance with AERB guidelines. For investigational drugs these shall be as per the manufacturer’s recommendation.

Examine the practice

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

Self explanatory This refers to the layout/location of radiation waste pipes, delay tanks, etc.

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

Objective Elements

Interpretation Remark/Audit Points

a. Documented policies and procedures govern procurement and usage of implantable prosthesis

Self Explanatory See policy

b. Selection of implantable prosthesis is based on scientific criteria and internationally recognized approvals

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

Examine purchase procedures for the same

c. The batch and serial number of the implantable prosthesis are recorded in the patient’s medical record and the master logbook

Self explanatory See evidence

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

Objective Elements

Interpretation Remark/Audit Points

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

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

See policy

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

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

See policy

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

This is the context of the India explosives act of 1884, Gas cylinder rules 1981 and static and mobile pressure vessel (unfired) 1981

Examine the records

CHAPTER 5: Hospital Infection Control (HIC)

HIC.1. The organization has well-designed, comprehensive and coordinated Hospital Infection Control (HIC) Programme aimed at reducing/eliminating risks to patient,

visitors an providers of care.

Objective Elements Interpretation Remark/Audit Points

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

Self explanatory. This shall preferably have administrator, microbiologist, physician, surgeon and the hospital infection control nurse.

See evidence of the committee and document of meetings held.

b. The hospital has an infection control team.

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

See evidence of the team

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

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

Interview the infection control nurse

d. The hospital infection control programme is documented.

Self explanatory See the manual

HIC.2. The hospital has an infection control manual, which is periodically updated. ( The HCO defines the periodicity of updation)

Objective Elements

Interpretation Remark/Audit Points

a. The manual identifies the various high-risk areas.

The manual should clearly identify the high risk areas of the hospital e.g. ICU, HDU, OT, post-operative ward, blood bank, CSSD, etc.

See the list of high risk areas

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

It shall define the frequency and mode of surveillance.

See the document

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

Self explanatory Refer to glossary for standard precautions

d. Equipment cleaning and sterilization practices are included

It shall address this at all levels e.g. ward, OT and CSSD. It is preferable that the organization follow a uniform policy across different departments within the organization.

Examine the practice

e. An appropriate antibiotic policy is established and implemented.

The HCO shall develop a system of monitoring drug susceptibility (based on culture sensitivity) and accordingly develop its antibiotic

The HCO could also refer to international guidelines while framing the policy

policy, which shall be reviewed at periodic intervals (may be once in 3 months) for it continuing applicability.

f. Laundry and linen management processes are also included.

Self explanatory. If outsourced the organization shall ensure that it establishes adequate controls to ensure infection control.

Examine the practice

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

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

Check in the manual

h. Engineering controls to prevent infections or included

Engineering control shall address air changes, air conditioning replacement of filters, c page leading to fungal colonization , etc

Interview the maintenance staff

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

Mortuary practices of preserving body, or body parts should be in accordance to the policy.

Refer to standard precautions

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

Objective Elements

Interpretation Remark/Audit Points

a. Surveillance activities are appropriately directed towards the identified high-risk areas.

Self explanatory Interview the infection control nurse

b. Collection of surveillance data is an ongoing process.

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

See evidence

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

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

See evidence

d. In case of notifiable diseases, information (in

relevant format) is sent to appropriate authorities.

The organization shall identify all notifiable diseases after taking into consideration the local laws and rules. The organization shall ensure that this is sent at the specified frequency and in

Refer to glossary for notifiable diseases

the format as required by statutory authorities.

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

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.4. The hospital takes actions to prevent or reduce the risks of hospital associated infections (HAI) in patients and employees.

Objective Elements

Interpretation Remark/Audit Points

a. The organization monitors urinary tract infections

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

The HCO may extend this activity to asymptomatic catheterized patients also

b. The organization monitors respiratory tract infections.

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. The organization shall do this for all patients on the ventilator having clinical features suggestive of infection.

See evidence

c. The organization monitors intra-vascular device infections

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

See evidence

d. The organization monitors surgical site infections.

This shall be done by sending pus/swab for culture

See evidence

e. Appropriate feedback regarding HAI rates are provided on

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

See evidence

regular basis to medical and nursing staff.

reduce the HAI rate.

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

control program

Objective

Elements

Interpretation Remark/Audit Points

a. Hand washing facilities in all patient care areas are accessible to health care providers.

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

Examine the facility

b. Compliance with proper hand washing is monitored regularly

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

Observe the procedure

c. Isolation/barrier nursing facilities are available

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

Refer to glossary for isolation/barrier nursing

d. Adequate gloves mask, soaps, disinfections are available and used correctly.

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

Examine the same

HIC.6. The hospital takes appropriate action to control outbreaks of infections

Objective

Elements

Interpretation Remark/Audit Points

a. Hospital has a documented procedure for handling such outbreaks.

This shall incorporate definitions as to what constitutes and outbreak; identification and investigation of such outbreaks and the procedure for management. This shall be in accordance with good clinical practices

See the SOPs

b. This procedure is implemented during outbreaks

Self explanatory Interview the infection control nurse

c. After the outbreak is over

Self explanatory See the record

appropriate corrective actions are taken to prevent recurrence

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

Objective

Elements

Interpretation Remark/Audit Points

a. There is adequate space available for sterilization

Self explanatory The HCO shall provide for the same in all areas where sterilization activities are carried out.

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

This shall be done by accepted methods e.g. bacteriologic, strips, etc.

Check record

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

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

The HCO could have a batch processing system with date and machine number for effective recall.

HIC 8 Statutory provisions with regard to bio-medical waste (BMW) management and

handling, 1998 are complied with

Objective

Elements

Interpretation Remark/Audit Points

a. The hospital is authorized by prescribed authority for the management and handling of bio-medical waste.

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

See the license

b. Proper segregation and collection of bio-medical waste from all patient care areas of the hospital is implanted and monitored

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

Observe the practices

c. The organization ensures that bio-medical waste is stored and transported to the site of treatment and disposal in proper covered vehicles within stipulated time

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

Observe the process

limits in a secure manner.

authorized contractor.

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

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.

Examine the facility and MOU with the contact

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

The HCO shall ensure that the fees are deposited in a timely manner. In addition, the annual reports have to be submitted by the 31st

January of every year and accident reporting has to be carried out in the prescribed form.

See evidence

f. Appropriate personnel protective measures are used by all categories of staff handling bio-medical waste.

Self explanatory For example, gloves and masks, protective glosses, gowns, etc.

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

Objective

Elements

Interpretation Remark/Audit Points

a. Hospital management makes available resources required for the infection control program

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

Examine the stock

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

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

Examine the budget

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

Self explanatory See evidence of training schedule

d. It also conducts regular “in-service” training sessions for all concerned categories of staff

Self explanatory See evidence of training schedule

at least once in a year.

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

Chapter 6: Continuous Quality Improvement (CQI)

CQI1. There is a structured quality assurance and continuous monitoring program in the organization.

Objective Element Interpretation Remarks/Audit Points

a. The quality assurance program is developed, implemented and maintained by a multi-disciplinary committee.

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

For example, core committee, quality, assurance committee, etc.

b. The quality assurance programme is documented.

This could be documented as manual. This shall incorporate the mission, vision, quality policy, quality objectives, service standards etc. the manual could be stand alone or it could have cross linkages with other manuals

Refer to AAC 8, AAC 11, COP 6, COP 12 and HIC 2 also

c. There is a designated individual for coordinating and implementing the quality assurance program

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

For example, accreditation co-ordinator, quality management representative, quality manager

d. The quality assurance program is comprehensive and covers all the major elements related to quality assurance and risk management.

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

Refer to glossary for definition of “risk management” and “quality assurance program”

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

Self explanatory This could be done through regular training program or printed or printed materials.

f. The quality assurance program is reviewed at predefined intervals and opportunities for improvement are identified.

As quality improvement is a dynamic process, it needs to be reviewed at regular pre-defined intervals (as defined by the HCO in the quality assurance manual) by the multi-disciplinary committee. The review shall also include analysis of key indicators as defined by the standards. Refer to CQI 2 and CQI3.

For example, management review meeting, quality review meeting, etc.

g. The quality assurance Self explanatory. The inputs See evidence of the same.

program is a continuous process and updated at least once in a year.

for updation could be based on the review carried out by the quality assurance committee.

CQI 2. The organization identifies key indicators to monitor the clinical structures, processes and outcomes.

Objective element Interpretation Remark/Audit Points

a. Monitoring includes appropriate patient assessment.

Self explanatory. The HCO shall develop appropriate key performance indicators suitable to it. The data pertaining to the identified indicators shall be captured from all patients; however, monitoring could be done using suitable samples. Certain illustrative examples are given in the remarks column.

Time for initial assessment of indoor patients and time taken for initial assessment in emergency

b. Monitoring includes diagnostic services’ safety and quality control programs

As stated in the remarks column

Reporting time for critical lab results, adherence to standard precautions and adherence to quality checks

c. Monitoring includes all invasive procedures.

As stated in the remarks column

Complications following such procedures and re-exploration surgery

d. Monitoring includes adverse drug events.

As stated in the remarks column

Hypersensitivity reactions following antibiotic administration and GI bleed following NSAIDs

e. Monitoring includes use of anesthesia

As stated in the remarks column

Parathesia following spinal anaesthesia, need of ventilation following anaesthesia and adherence to pre-anaesthesia assessment

f. Monitoring includes use of blood and blood products.

As stated in the remarks column

Checking for transfusion transmissible infections ( TTIs) as per statutory requirements, severe hazards of transfusion and blood hemolysed during transportation

C. Patient and clinician anonymity is maintained.

Self explanatory.

D. All Audit are documented.

Self explanatory The HCO could use a checklist with the predefined parameters and the audit findings could be recorded on this sheet.

E. Remedial measures are implemented

Self explanatory This should preferably be done based on root cause analysis.

CQI 6. Sentimental events are intensively analyzed

Objective

element

Interpretation Remarks/Audit Points

a. The organization has defined sentinel events.

Self explanatory Refer to glossary for definition of “Sentinel events”

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

Self explanatory See records

c. Sentinel events are intensively analysed when they occur

Self explanatory. This shall be done as per the process established by the HCO.

See records

d. Actions are taken upon findings of such analysis.

This should be done based on root cause analysis so as to prevent recurrences.

See records

CHAPTER 7: Responsibility of Management (ROM)

ROM 1 The responsibilities of the management are defined

Objective elements Interpretation Remarks/Audit points

a. The organization has a documented oraganogram

The HCO shall have an organization structure/chart and this shall clearly documented the hierarchy, line of control and function

See the organization structure

b. Those responsible for governance appoint the senior leaders in the organization

Self explanatory “Responsible for governance “implies the governing board/body or the head of the HCO. Senior leaders include the first two rungs of the organogram.

c. Those responsible for governance support the quality improvement plan

Self explanatory It is not only the head of the HCO but the members of the board of governance(where applicable) who need to support this

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

Self explanatory This shall include central legislations (e.g Drugs and Cosmetics act and MTP act), respective state legislations (e.g. Travancore Cochin Nurses and Midwaves act 1953, Maharashtra Maintenance of clinical Records act) and local regulations (e.g. building byelaws)

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

The HCO shall develop social responsibility policy and accordingly address it.

For example, free camps, outreach programs, adoption of villages and PHCs, etc.

ROM 2 The services provided by each department are documented Objective elements Interpretation Remarks/Audit points a. Each

organizational program, service, site or department has effective leadership

The organizational of hospital is usually a matrix one. There needs to be an effective leadership style by which it is governed

Interview the head of organization

b. Scope of services of each department is defined

Each departments activity it to be predefined. This could be documented either at individual department level or the HCO could

For example, nephrology department could do all activities like biopsy, shunts, fistulas, dialysis (haemo, CAPD), etc.

have a brochure detailing the scope of each department.

c. Administrative policies and procedures for each department is maintained

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

It could be common for the entire HCO

d. Department leaders are involved in quality improvements

Self explanatory To effectively implement this, 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. The leaders make public the mission statement of the organization

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

For definition of “mission” refer to glossary

b. The leaders establish the organization’s ethical management

The HCO shall function in an ethical manner.

A good reference guide is “code of medical ethics-2002” published by MCI.

c. The organization discloses it ownership

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

The disclosure could be in the registration certificate/quality manual, etc

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

Self explanatory Here portrays implied that the HCO conveys to the patients clearly what it can and cannot provide. The services that it cannot provide could also be conveyed verbally. Refer to AAC 1 also.

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

Self explanatory Also refer to PRE 5. The tariff could be devised by a tariff committee.

ROM 4 A suitably qualified and experienced individual heads the organization

Objective elements Interpretation Remarks/Audit points

a. The designated individual has requisite and appropriate administrative qualification

Self explanatory This implies to the individual looking after the day to day operations and not to the chairman of board of governors. Appropriate implies qualification in hospital management/administration

b. The designated individual has requisite and appropriate

Self explanatory Appropriate implies administrative experience in a HCO.

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. The organization has an interdisciplinary group assigned to oversee the hospital wide safety program

Self explanatory This group could have a mix of administrators, engineers, doctors, and nurses. Refer to glossary for definition of “safety program”

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

Self explanatory Refer to glossary for definition of “adverse events” and sentinel events”

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

The HCO has system in place for internal and external reporting of system and process failures in the context of adverse events as defined above.

For example, review meeting and accident reporting for bio-medical waste.

d. Management provides resources for proactive risk assessment and risk reduction activities.

Self explanatory. The end result of these shall result in preventive actions

Refer to glossary for definition of “risk assessment and risk reduction”.

CHAPTER 8: Facility of Management and Safety

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

Objective element Interpretation Remarks/Audit

Points

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

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

For example, fire protection guidelines given in national building code of India, relevant state and local body regulations (Kerala state building rules)

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

Self explanatory See evidence

c. The management ensures implementation of these requirements

Self explanatory See evidence

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

Self explanatory For Example, licenses for lifts, DG sets,etc

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

Objective element Interpretation Remarks/Audit

Points

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

Self explanatory Refer glossary for definition of “preventive and breakdown maintenance”.

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

A designated personnel maintains the drawings.

Examine the drawings

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

Self explanatory For example, India standards (IS 12433) formulated by bureau of Indian Standards ( for 30 and 100 bedded hospitals and other standards), IS 10905 for basic requirements for hospital buildings

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

A person in the HCO management is designated to be in-charge of maintenance of facilities. The HCO has

Interview the head of the maintenance department

the required number of supervision and tradesmen to manage the facilities.

e. Maintenance staff is contactable round the clock for emergency repairs.

Self explanatory See the roster

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

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

Verify from the complaint book

FMS.3 The organization has a program for clinical and support service

equipment management.

a. The organization plan for equipment in accordance with it services and strategic plan

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

Interview the bio-medical engineer

b. Equipment is selected by a collaborative process

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

Interview the bio-medical engineer

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

Self explanatory Interview the bio-medical engineer

d. Qualified and trained personnel operate and maintain the equipment

Self explanatory Interview the bio-medical engineer

e. Equipment is periodically inspected and calibrated for their proper functioning

The HCO has week/monthly/ annual schedules of inspection and calibration of equipment which involve measurement, in an appropriate manner. The HCO either calibrates the equipment in-house or out sources; maintaining traceability.

Check the records

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

Self explanatory See the plan

FMS.4 the organization has provisions for safe water, electricity, medical gases

and vacuum system

Objective element Interpretation Remarks/Audit Points

a. Potable water and electricity are available round the clock

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

For water quality refer to IS 10500

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

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

See evidence

c. The organization regularly tests the alternate sources.

Self explanatory Check records

d. There is a maintenance plan for piped medical gas and vacuum installation

Self explanatory Check records

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

Objective element Objective element Objective element

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

The HCO has a fire and non-fire emergency committee (FNEC) to review the HCO’s preparedness. 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. The HCO has:

A. Fire plan covering fire arising out of burning of inflammable items, explosion, and electric short circuiting or act o negligence or due to incompetence of the staff on duty.

B. Deployed adequate and qualified personnel for this

C. Acquired fire fighting equipment for this which records are kept up-to-date.

D. Adequate training plans

E. Scheduled for conduct of mock fire drills

F. Mock drill records G. Exit plans well

displayed The HCO has a dedicated emergency illumination system which comes into

See evidence

effect in case of a fire. The HCO takes care of non-fire emergency situations by identifying them and by deciding appropriate course of action. These may include: a. Terrorist attack b. Invasion for

swarms of insects and pests

c. Earthquake d. Invasion of stray

animals e. Hysteric fits of

patients and/or relatives

f. Civil disorders effecting the HCO

g. Anti-social behavior by patients/ relatives

h. Temperamental disorders of staff causing deterioration in patient care

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

j. Building or structural collapse

k. Fall or slips (from height or on floor) or collision of personnel in passage way

l. Fall of patient from bed

m. Bursting of pipe lines

n. Sudden flooding of areas like basements due to clogging in pipe lines

o. Sudden failure of

supply of electricity, gas, vacuum, etc.

p. Bursting of boilers and/or autoclaves the HCO has established liaison with civil and police authorities and fire brigade as required by law for enlisting their help and support in case of an emergency.

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

Fire exit plan shall be displayed on each floor particularly close to the lists. Exist doors should remain open on the time.

Examine the fire exit route

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

In case of fire designated person are assigned particular work.

Interview the staff

d. Mock drills are held at least twice a year

Self explanatory See evidence

FMS.6 Sentinel events are intensively analyzed

Objective element Objective element Objective element

a. The organization has defined sentinel events.

Self explanatory Refer to glossary for definition of “sentinel events”

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

Self explanatory See evidence

c. Sentinel events are intensively analyzed when they occur.

Self explanation. This shall be done as per the process established by the HCO.

See evidence

d. Actions are taken upon findings and such analysis

This should be done based on root cause analysis so as to prevent recurrences

See evidence

CHAPTER 9: Human Resources Management (HRM)

HRM. 1 The organization has a documented system of human resources planning.

Objective element Interpretation Remarks/Audit Points

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

Self explanatory A good reference could be the MCI and NCI guidelines

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

Self explanatory Refer to glossary for definitions of “job description and job specification”

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

Self explanatory This report could be got form the district magistrate (s) of the district (s) where the employee has served earlier and/or from the previous employer.

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

Objective element Interpretation Remarks/Audit Points

a. Each staff member, employee student and voluntary worker is appropriately oriented to the organization’s mission and goals.

Self explanatory This could be done as a part of the induction training.

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

Self explanatory This could be done as part of the induction training and the same could be provided in the form of booklet.

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

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

This could be done as a part of the induction training and the same could be provided in the form of a booklet.

d. All employees are educated with regard to patient’s rights and responsibilities

For patient rights to PRE 2.

For patient responsibilities refer to glossary

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

The HCO shall develop benchmarks for different services being provided. This shall be based on the HCOs value and focus on development of soft skills: behavior, attitude, communication skills, etc.

Interview of the staff

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

staff.

Objective element Interpretation Remarks/Audit Points

a. A documented training and development policy exists for the staff.

Self explanatory For, example, training manual which includes identification of training needs, training

methodology, documentation of training, training assessment, etc.

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

Self explanatory See evidence

c. Feedback mechanisms for assessment of training and development program exist

Self explanatory This shall include both internal and external training, For external training it could be done either by the HCO itself or by the external agency which imparted the training.

HRM. 4 The staff members, students and volunteers or adequately trained on specific

job duties or responsibility related to safety

Objective element Interpretation Remarks/Audit Points

a. All staff is trained on the risks within the hospital environment.

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

For example, fire and non fire emergency, needle stick injury, etc.

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

Self explanatory Interview the staff.

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

Self explanatory Interview the call

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

The HCO has defined procedure for reporting of these events.

Interview the staff

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

Objective element Interpretation Remarks/Audit Points

a. A well – documented performance appraisal system exists in the organization.

Self explanatory For definition of “performance appraisal” refer to glossary

b. The employees are made aware of the system of appraisal at the time of induction

Self explanatory Interview the staff

c. Performance is evaluated based on the performance expectations described in job description.

Self explanatory For definition of “job description “refer to glossary

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

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

Interview the HR head

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

Self explanatory This shall be done at least once a year.

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

Objective element Interpretation Remarks/Audit Points

a. A written statement of the policy of the organization with regard to discipline is in place.

Self explanatory For definition of disciplinary procedure” refer to glossary

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

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

Interview for HR head and see policy

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

Self explanatory This could be in the form of services rules

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

Self explanatory Refer to relevant labour laws and CCS (CCA) rules

e. There is provision for appeals in all disciplinary cases

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

Appellate authority should be higher than the disciplinary authority

HRM. 7 A grievance handling mechanism exists in the organization

Objective element Interpretation Remarks/Audit Points

a. The employees are aware of the procedure to be followed in case they feel aggrieved.

For definition for “grievance handing” refer to glossary. The HCO has a written procedure for handling grievances of employees.

The HCO could address all points in HRM 2, HRM 4, HRM 5, HRM 6 and HRM7 by providing every employee with a manual incorporating the various policies and procedures.

b. The redress procedure addresses the grievance.

Self explanatory See SOPs

c. Actions are taken to redress the grievance.

Self explanatory See records

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

Objective element Interpretation Remarks/Audit Points

a. A pre-employment medical examination is conducted on all the employees

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

For example, performing pre employment HIV testing is illegal

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

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

For example, employee health and safety policy

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

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

The HCO could define the parameters and it could be different for different categories of personnel. The HCO could also identity competent individuals to perform the same.

d. Occupational health hazards are adequately addressed.

Self explanatory For definition of “occupational health hazard” refer to glossary.

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

Objective element Interpretation Remarks/Audit Points

a. Personnel files are maintained in respect of all employees.

Self explanatory See random files

b. The personnel files contain personnel information regarding the employee’s qualification, disciplinary background and health status.

Self explanatory See random files

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

Self explanatory See random files

d. Personnel files contain results of all evaluations

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

See random files

HRM. 10 There is a process for collecting, verifying and evaluating the credentials

(education, registration, training and experience) of medical professionals permitted

to provide patient care without supervision.

Objective element Objective element Objective element

a. Medical professionals permitted by law, regulation and the hospital to provide patient care without supervision or identified.

The HCO identifies the individuals who have the required qualification (s), training. And experience to provide patient care in consonance with the law

For definition of “credentialing” refer to glossary

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

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

Examine the process

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

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

A good reference could be MCI’s website.

HRM. 11 There is a process for authorizing all medical professionals to admit and

treat patients and provide other clinical services commensurate with their

qualifications

Objective element Interpretation Remarks/Audit Points

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

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

For example, radiotherapy can only be given by a radiation oncologist

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

Self explanatory Where authorization is provided on the basis of training the HCO shall maintain a copy of the training record and verify it.

c. The requisite services to be provided by the

Self explanatory The HCO could incorporate this in the

medical professionals are known to them as well as the various departments/units of the hospital.

brochure itself.

HRM. 12 There is a process for collecting, verifying and evaluating the credentials

(education, registration, training, and experience) of nursing staff.

Objective element Interpretation Remarks/Audit Points

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

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

Refer to Indian Nursing Council, Act 1947

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

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

See evidence

HRM. 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. The clinical work assigned to nursing staff is in consonance with their qualification, training and registration.

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

See job responsibilities

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

Self explanatory Interview the nursing head

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

Self explanatory Interview the nursing head

CHAPTER 10: Information Management System (IMS)

IMS.1. Polices and procedure exist to meet the information needs of the care providers, management of the organization as well as other agencies

that require date and information from the organizations

Objective element Interpretation Remarks/Audit Points

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

The HCO has manual and/or electronic Hospital information system and/or management information system which provides relevant information to all concerned stakeholders.

For example, daily census report, utilization rates, etc. Also refer to CQI 2 and CQI 3

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

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

See the Policy

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

Self explanatory Some of these include: - IT act 2000 for computer based records, PNDT Act for relevant details of all patients undergoing ultrasound, Code of medical ethics, 2002, RTI Act 2005 etc. Relevant state legislation e.g. maintenance of clinical records Act (MOCRA) in Maharashtra

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

Self explanatory See the policy

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

Self explanatory For example, sending birth and death statistics, notifiable diseases (refer to glossary) and pulse polio program

IMS.2. The organizations has process in place for effective management of data.

Objective element Interpretation Remarks/Audit

Points

a. Formats for data collection are standardized.

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

Examine the formats

b. Necessary resources are available for analyzing data.

This could be men, material space and budget.

Interview the accreditation coordinator

c. Documented procedures Self explanatory The organization could

are laid down for timely and accurate dissemination

decide which data needs to be shared with whom and also the modalities (e.g. memos, circulars, etc.) for dissemination for such data.

d. Documented procedures exist for storing and retrieving data.

Self explanatory Storage could be physical or electronic. Wherever electronic storage is done, the HCO shall ensure that there are adequate safeguards for protection of data.

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

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

Interview the accreditation coordinator

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

every patient.

Objective element Interpretation Remarks/Audit

Points

a. Every medical record has a unique identifier

This shall also apply to records on digital media

For example, CR number, hospital number, etc.

b. Organization policy identifies those authorized to make entries in medical record

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

There could be different category of personnel for different entries, but it shall be uniform across all the HCO. E.g. progress record by doctor and medication administration chart by nurse

c. Every medical record entry is dated and timed.

Self explanatory For records in electronic media it is preferable that the date and time is automatically generated by the system.

d. The author of the entry can be identified.

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

Examine the same

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

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

For example, IP sheet, doctors order sheet etc

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

The HCO decides the format (POMR/SOMR/IMR) for maintaining medical records.

Examine the same

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

Objective element Interpretation Remarks/Audit

Points

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

Self explanatory For definition of “plan of care” refer to glossary. After The initial visit it shall at least have a provisional diagnosis. It is preferable that the final diagnosis (IP) is as per ICD 10.

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

Self explanatory Also refer to COP 12f

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

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

If the patient has been transferred at his/her request a note may be added to that effect. In such instance the name the receiving hospital could be the name the patient desires to go to. However, if the patient has been transferred by the HCO it shall have an acknowledgment from the receiving hospital.

d. The medical record contains a copy duly signed by appropriate and qualified personnel.

Self explanatory. Discharge note is the same as discharge summary.

Also refer to AAC 15.

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

Self explanatory. The HCO provides the death certificate as per the international certification of cause of death

Also refer to AAC 15 g.

f. Whenever a clinical autopsy is carried out, the medical record contains a

Self explanatory For definitions of “autopsy” refer to glossary

copy of the report of the same.

g. Care providers have access to current and past medical record.

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

See evidence

IMS.5. Policies and procedures are in place for maintaining confidentiality,

integrity and security of information

Objective element Interpretation Remarks/Audit

Points

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

Self explanatory. This is applicable for both manual and electronic

See the policy

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

This is in the context of Indian evidence act, Indian Penal Code and Code of medical Ethics.

For example, privileged communication

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

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

It is preferable that software’s when used, shall be validated and duly authenticated.

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

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

Refer to IMS 2

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

Self explanatory For example, moving from physical to electronic format, remote backup of data, etc.

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

Self explanatory Special car should be taken in medico-legal cases

authorization. g. A documented procedure

exists on how to respond to patient/physicians and other public agencies requests for access to information in the medical record in accordance with the local and national law.

Self explanatory. In this context, the release of information in accordance with the code of medical ethics 2002 should be kept in mind.

See the SOPs

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

Objective element Interpretation Remarks/Audit

Points

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

Self explanatory See policy

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

Some of the related laws in this context are code of medical ethics 2002, consumer protection act 1987 and relevant state legislation, If any.

See policy

c. The retention process provides expected confidentiality and security.

This is applicable for both manual and electronic system

Examine the process

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

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

See policy

IMS.7. The organization regularly carries our medical audits.

Objective element Interpretation Remarks/Audit

Points

a. The medical records are reviewed periodically.

Self explanatory The HCO could define the periodicity.

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

Self explanatory. The review could be based on conditions of clinical and/or community importance

It could be based on total discharges including deaths, total indoor patients, etc.

c. The review is conducted by identified care providers.

Self explanatory The HCO shall identify and authorize such individuals.

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

Self explanatory Examine the records randomly

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

Self explanatory An adequate mix of both active and discharged patients should be use.

f. The review points out and documents any

Self explanatory For example, missing final diagnosis, absence

deficiencies in records. of OT notes in an operated patient, etc.

g. Appropriate corrective and preventive measures undertaken are documented

Self explanatory See evidence

Glossary

The commonly used terminologies in the NABH standards are briefly described and explained herein to remove any ambiguity regarding their comprehension. The definitions narrated have been taken from various authentic sources as stated where ever possible. Notwithstanding the accuracy of the explanations given, in the event of any discrepancy with a legal requirement enshrined in the law of the land, the provisions of the later shall apply. Accreditation 1. The process of external review of the quality of the

health care being provided by a health care organization. This is generally carried out by a non-governmental organization.

2. It also represents the outcome of the review and the

decision that an eligible organization meets an applicable set of standards.

Accreditation assessment

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. b) Facility tour c) Interview of staff, patients and visitors d) On-site observations by assessors e) Education about standards compliance

Advance life support

Emergency medical care of sustaining life, including defibrillation, airway management, and drugs and medications. The main algorithm of ALS, which is invoked when actual cardiac arrest has been established, relies on the monitoring of the electrical activity of the heart on a cardiac monitor. Depending on the type of Cardiac arrhythmia, defibrillation is applies, and medication is administrated. Oxygen is administrated and enedotracheal intubation may be attempted to secure the airway. At regular intervals, the effect of the treatment on the heart rhythm, a as well as the presence of cardiac output, is assessed. Medication that may be administrated may include adrenaline (epinephrine), amiodarone, atropine, bicarbonate, calcium, potassium and magnesium. Saline or colloids may be administrated to increase the circulating volume. While CPR is given (either manually, or though automated equipment such as Auto Pulse), members of the team consider eight forms of potentially reversible causes for cardiac arrest, commonly abbreviated as “4H4T”:

• Hypoxia (low oxygen levels in the blood) • Hypovolemia (low amount of circulating blood, 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)

• Tension pneumothorax (tear in the lung leading to collapsed lung and twisting of the large blood vessels)

• Tamonade (fluid or blood in the pericardium, compressing the heart)

• Toxic and/or therapeutic (chemicals, 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)

Ambulance A patient carrying vehicle having facilities to provide unless otherwise indicated atleast basic life support during the process of transportation of patient. There are various types of ambulance, air ambulance that provide special services viz. coronary care ambulance, trauma ambulance, air ambulance etc.

Anaesthesia It consists of general anaesthesia and spinal or major regional anaesthesia and does not include local anaestheisa. General anaesthesia. General anaesthesia is a drug-inducted loss of consciousness during which patient cannot be aroused even by painful stimulation. The ability to independently maintain ventilator function is often impaired.

Assessment All activities including history taking, physical examination, laboratory investigations that contributes towards determining the prevailing clinical status of the patient.

Autopsy 1. An examination of a cadaver in order to determine the cause of death or to study pathologic changes.

2. A surgical procedure performed after death to examine body tissues and determine the cause of death

Barrier nursing Type of nursing for immunocompromised patients with a view to prevent any secondary infections e.g. use of gloves, masks and relatively disinfected environment.

Basic life support Emergency procedures to sustain life that include cardiopulmonary resuscitation, control of bleeding, treatment of shock, stabilization of injuries and wounds and first, aid. Basic life support consists of a number of life-saving techniques which are focused on the “ABC”s of prehospital. 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, natural or artificial respiration, 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.

Bylaws A rule governing the internal management of an organization. It can supplement or complement the government law but cannot countermand it. E.g. municipal bylaws for construction of hospital/nursing homes, for disposal of hazardous and/or infections waste

Clinical audit Analysis of clinical aspects of patient car for improving the quality of health care services e.g. tissue audit, x-ray audit, lab investigation audit, etc.

Clinical practice guidelines

Guidelines that assist practitioners to provide appropriate clinical car for specific clinical conditions, for example recommendation on management of cerebral malaria. The guideline include relevant history taking, physical signs to look for, lab investigations to carried out and treatment to prescribed.

Competence Demonstrated ability to apply knowledge and skills. (para 3.9.2 of ISO 9000:2000) Knowledge is the understanding of facts and procedures. Skills is the ability to perform specific action. For example, a competent gynecologist knows about the path physiology of the female genitalia and can conduct both normal as well as abnormal deliveries.

Consent 1. Willingness of party to undergo examination/procedure/treatment by a health care provider. It may be implied (e.g. patient registering in OPD), expressed which may be written or verbal. Informed consent is a type of consent in which the health care provider has duty to inform his/her patient about eh procedure, its potential risk and benefits, alternative procedure with their risk and benefits so as to enable the patient to take an informed decision of his/her healthcare .

2. In law, it means active acquiescence or silence compliance by a person legally capable of consenting. In India legal age consent is 18 years. It may be evidenced by words or acts or by silence when silence implies concurrence. Actual or implied consent is necessarily an element in every contract and every agreement.

Credentialing The process of obtaining, verifying and assessing the qualification of a health care provider.

Data Raw facts, clinical observations, or measurements collected during an assessment activity.

Discharge summary A part of a patient record that summarizes the reasons for admission, significant clinical finding, procedures performed, treatment rendered, patient’s condition on discharge and any specific instructions given to the patient or family (for example follow-up medications).

Disciplinary proceedings

Sequence of activities to be carried out when staff does not conform to the laid down norms, rules and regulations of the health care organization.

Employees 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.

End of life Period of time marked by disability or disease that is progressively worse until death

Ethics Medical ethics is the discipline of evaluating the merits, risk, and social concerns of activities in the field of medicine.( en.wikpedia.org/wiki/medical ethics)

Evidence based medicine

1. It is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patient

2. It also implies making medical decisions and applying the same to patients based on the best external evidence combined with the physician’s clinical

expertise and the patient’s desires. Family The person(s) with a significant role in the patient’s life.

It mainly includes spouse, children, and parents. 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.

Formulatory An approved list of prescription drugs that a health care

facility may provide to their clientele. Some plans

restrict prescriptions to those contained on the

formulatory and others also provide nonformulatory

prescriptions. Drugs contained on the formulatory are

generally those that are determined to be cost effective

and medically effective.

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

Grievance handling procedures

Sequence of activities carried out to address the

grievance of patients, visitors, relatives and staff

Hazardous materials

Substance dangerous to human and other living

organisms. They include radioactive or chemical

materials.

Hazardous waste Waste materials dangerous to living organisms. Such

materials require special precautions for disposals. They

include biologic waste that can transmit disease (for

example, blood, tissues) radioactive materials, and

toxic chemicals. Other examples are infectious waste

such as used needles, used bandages and fluid soaked

items.

Health care organization

Generic term is used to describe the various types of

organizations that provide health care services. This

includes ambulatory care centre’s, hospitals,

laboratories, etc.

High dependency unit

A high dependency unit (HDU) is an area for patient’s

who requires more intensive observation, treatment

and nursing care than are usually provided for in a

general ward. It is a standard of care between the

general ward and full intensive care.

In service education/training

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.

Indicator A statistical measure of the performance of functions,

systems or processes overtime. For example, hospital

acquired infections rate, mortality rate, ceasearian

section rate, absence rate, etc.

Information Processed data which lends meaning to the raw data.

Intent A brief explanation of the rational, meaning and

significance of the standards laid down in a particular

chapter.

Inventory control The method of supervising the intake, use and disposal

of various goods in hands. It relates to supervision of

the supply, storage and accessibility of items in order to

ensure adequate supply without stock outs/excessive

storage. It is also the process of balancing ordering

costs against carrying costs of the inventory so as to

minimize total costs.

Isolation Separation of an ill person who has communicable disease (e.g., measles, chicken ox, mumps, SARS) form those who are healthy, isolation prevents transmission of infection to others also allows the focused delivery of specialized health care to ill patients. The periods of isolation caries from disease to disease. Isolation facilities can also be extended to patients for fulfilling their individual, unique needs.

Job description 1. It entails an explanation pertaining to duties, responsibilities and conditions required to perform a job.

2. A summary of the most important features of a job, including the level (ie, skill, effort, responsibility and working conditions) of the work performed. It typically includes job job specifications that include employee characteristics required for competent performance of the job. A job description should describe and focus on the job itself and not on any specific individual who might fill the job.

Job specification 1. The qualifications/physical requirements, experience and skills required to perform particular job/tasks.

2. A statement of the minimum acceptable qualifications that an incumbent must possess to perform a given job successfully.

Laws Legal document setting forth the rules governaning a particular kind of activity e.g. organ transplantation act which governs the rules for undertaking organ transplantation.

Medical audit A peer review carried out by analysis of medical records with a view to improve the quality of the patient care

Medical equipment Any fixed or portable non drug item or appartus used for diagnosis, treatment, monitoring and direct care of patient.

Mission A written expression that sets forth the purpose of the organization. It usually precedes the formation of goals and objectives

Monitoring The performance and analysis of routine measurements aimed at identifying and detecting changes in the health status or the environment, e.g. monitoring of growth and nutritional status, air quality in operation theatre. It requires careful planning

and use of standardized procedures and methods of data collection.

Multi-disciplinary A generic term which include representatives from various disciplines, profession or service areas.

Nosocomial/hospital acquired/hospital associated infection (s)

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; or the residual of an infection acquired during a previous admission. Includes infections acquired in the hospital but appearing after discharge, and also such infection among the staff of the facility (Synonym: hospital-acquired-infection).(www.hardydignostics.com/glossary N.html)

Notifiable disease Certain specified diseases which are required by law to be notified to the public health authorities. Under the international health regulation the following diseases are notifable to WHO;-

a. Cholera b. Plague c. Yellow fever In India the following diseases are also notifable and may vary from state to state: a. Polio b. Influenza c. Malaria d. Rabies e. HIV/AIDS f. Louse-borne typhus g. Tuberculosis h. Leprosy i. Leptospirosis j. Viral hepatitis k. Dengue fever

The various diseases notifiable under he factories act are lead poisoning, bysinnosis, anthrax, asbestosis and silicosis

Objective element It is that component of standard which can be measures objectively on a rating scale. The acceptable compliance with the measurable elements will determine the overall compliance with the standard.

Occupational health hazard

The hazards to which an individual is exposed during the course of performance of his job. These include physical, chemical, biological, mechanical and psychosocial hazards.

Organ gram A graphic representation of reporting relationship in an organization.

Outsourcing 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. e.g. outsourcing of house keeping, security, laboratory/certain special diagnostic facilities with other institutions after drawing a memorandum of understanding that clearly lays down the obligations of both the organizations, the one which is outsourcing and the one which is providing the outsourced facility. It also addresses the quality related aspects.

Patient care setting The location where a patient is provided health care as per his needs e.g. ICU, specialty ward, private ward and general ward.

Patient record/medical record/clinical

A document which contains the chronological sequence of events that a patient undergoes during his stay in the health care organization. It includes procedures undergone, progress

record notes and discharge summary. (Death certificate where required)

Performance appraisal

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, potential for growth as well determining training needs.

Plan of care A plan that identifies patient care needs, lists the strategy to meet those needs, documents treatment goals and objective, outline the criteria for ending interventions, and documents the individual’s progress in meeting specified goals and objectives. The format of the ma be guided specific polices and procedures, protocols, practices guidelines or combination for these. It includes preventive, promotive, curative and rehabilitative aspects of care.

Policies They are the guidelines for decision making, e.g. admission, discharge policies, antibiotic policy, etc.

Privileging 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

Procedure 1. A specified way to carryout and activity or a process. (Para 3.4.5 of ISO 9000:2000) 2. 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.

Process A Set of interrelated or interacting activities which transforms inputs into outputs (Para 3.4.1 of ISO 9000:2000)

Program A sequence of activities designed to implement policies and accomplish objectives

Protocol A plan or a set of steps to be followed in a study, an investigation to an intervention.

Quality 1. Degree to which a set of inherent characteristics fulfil requirements (Para 3.1.1 of ISO 9000:2000)

Characteristics imply distinguishing feature (Para 3.5.1 of ISO 9000:2000) Requirements are need or expectation that is stated, generally implied or obligatory 9para 3.1.2 of ISO 9000:2000)

2. Degree of adherence to pre-established criteria or standards.

Quality assurance Part of quality management focused on providing confidence that quality requirements will be fulfilled. (Para 3.2.11 of ISO 9000:2000)

Re-assessment It implies continuous and on-going assessment of the patient which are recorded in the medical records as progress notes.

Resources It implies all inputs in terms of men, material, money, machines, minutes (time), methods, meters (space), skills, knowledge and information that are needed for efficient and effective functioning of an organization

Restraints Devices used to ensure safety by restricting and controlling a person’s movement. May facilities are “restraint free” or use alternative methods to help modify behavior. www.alz.org/resources/glosssary.asp. Restraint may be physical or chemical (by use of sedatives.

Risk management Clinical and administrative activities to identity evaluate and reduce the risk of injury.

Safety The degree to which the risk of an intervention/procedure, in the care environment are reduced for a patient, visitors and health care providers

Scope of services Range of clinical and supportive activities that are provided by an healthcare organizations.

Security Protection from loss, destruction, tampering, and unauthorized access or use

Sedation The administration to an individual, in any setting for any purpose, by any route, moderate or deep sedation. There are three levels of sedation:- Minimal sedation (anxiolysis) – A drug induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, vertilatory and cardiovascular functions are not affected. Moderate sedation/analgesia (conscious sedation) A drug induced deression. Of consciousness during which patient respond purposefully to verbal commands either alone or accompanied by light tactile stimulation. No interventions are needed to maintain a patient airway. Deep sedation/Analgesia – A drug induced deression of consciousness during which patients cannot be easily aroused but respond purposefully after repeated or painful stimulation. Patients may need help in maintaining a patent airway.

Sentinel events* A relatively infrequent, unexpected incident, related to system or process deficiencies, which leads to death or major and enduring loss of function for recipient of health care services. Major and enduring loss of function refers to sensory, motor, physiological, or psychological impairment not present at the time services were sought or begun. The impairment last for a minimum period of tow weeks and is not related to an underlying conditions.

Social responsibility A balanced approach for organization to address economic, social and environmental issues is an way that aims to benefit people, communities and society, e.g. adoption of villages for providing health care, holding of medical camps and proper disposal of hospital wastes.

Staff All personnel working in the organization either as full paid employees or as consultants on honorarium basis

Standard Precautions

1. A method of infection control in which all human blood and other bodily fluids are considered infectious for HIV, HBV and other bloodborne pathogens, regardless of patient history. It encompasses a variety of practices to prevent occupational exposure, such as the use of personnel protective equipment (PPE), disposal of sharps and safe housekeeping.

2. A set on guidelines protecting first aiders or healthcare professionals from pathogens. The main message is “Don’t touch or use anything that has the victim’s body fluid on it without a barrier. “It also assumes that all body fluid of patient is infectious, and must be treated accordingly.

Standard Precautions apply to blood, all body fluids, secreations, and excretions (expect sweat) regargless of whether or not they contain visible blood, non-intact skin and mucous membranes

Standards A statement of expectation that defines the structures and

process that must be substantially in place in an organization to enhance the qualify of care.

Sterilization It is the process of killing or removing microorganisms including their spores by thermal, chemical or irradiation means.

Surveillance The continuous scrutiny of factors that determines the occurrence and distribution of disease and other conditions of ill health. It implies watching over with great attention, authority and often with suspicion. It requires professional analysis and sophisticated inpretertation of data leading to recommendations for control activities

Unstable patient Patient whose vital parameters need external assistance for their maintenance.

Validation 1. Confirmation through the provision of objective evidence that the requirements for a specific intended use or application have been fulfilled (Para 3.8.5 of ISO 9000:2000)

Objective Evidence – Data supporting the existence or variety of something (Para 3.8.1 of ISO 9000:2000) 2. The checking of data for correction or for compliance

with applicable standards, rules or conversation. These are the tests to determine whether an implemented system fulfills its requirements. It also refers to what extent does a test accurately measures what it purports to measure

Vulnerable Patient Those patients who are prone to injury and disease by virtue of their age, sex, physical, mental and immunological status, e.g. infants, elderly, physically and mentally challenged, those on immunosuppressive and/or chemotherapeutic agents.

*REFERANCE GUIDE ON SENTINEL EVENTS

Definition:

An unexpected incident, related to system or process deficiencies, which leads to death or major and enduring loss of function* for a recipient of health care services. Major and enduring loss of function refers to sensory, motor, physiological, or psychological impairment not present at the time services were sought or begun. The impairment lasts for a minimum period of two weeks and is not related to an underlying condition. Section 1.01 Event type description

1. Surgical events

• Surgery performed on the wrong body part

• Surgery performed on the wrong patient

• Wrong surgical procedure performed on the wrong patient.

• Retained instruments in patient discovered after surgery/procedure

• Patient death during or immediately post surgical procedure

• Anesthesia related event

2. Device or product events

Patient death or serious disability associated with: • The use of contaminated drugs, devices, 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.

• Intravascular air embolism

3. Patient protection events

Article II. • Discharge of an infant to the wrong person

• Patient death or serious disability associated with elopement from the health care facility

• Patient suicide, attempted suicide, or deliberate self-harm resulting in serious disability

• Intentional injury to a patient by a staff member, another patient, visitor, 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. Environmental events

Patient death or serious disability while being cared for in healthcare facility associated with: • A burn incurred from any source

• A slip, trip, or fall

• An electric shock

• The use of restraints or bedrails

5. 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

• Medication error leading to the death or serious disability of patient due to incorrect

administration of drugs, 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.

6. 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

List of Licenses and statutory Obligations

All of them might not be applicable to all the Hospitals.

1. Building Permit ( From the Municipality) 2. No Objection certificate from the Chief Fire Officer. 3. License under Io-medical Management and handling Rules, 1998. 4. No objection certificate under Pollution Control Act. 5. Radiation Protection Certificate in respect of all X-ray and CT Scanners from BARC. 6. Excise permit to store Sprit. 7. Income tax PAN. 8. Permit to operate lifts under the lifts and escalators Act. 9. Narcotics and Psychotropic substances Act. 10. Sales Tax Registration certificate. 11. Vehicle registration certificates. 12. Retail drug license. 13. Wireless operation certificate from Indian post and telegraphs. 14. Air (prevention and control of pollution) Act, 1981. 15. Arms Act, 1950. 16. Atomic energy regulatory body approvals. 17. Biomedical waste management handling rules 1998. 18. Boilers Act 1923. 19. Cable television networks Act 1995. 20. Central exercise Act. 1944. 21. Central sales tax act, 1956. 22. Charitable and religious trusts Act, 1920. 23. Child Labor Act 1986. 24. Citizenship Act, 1955. 25. Consumer protection Act, 1986. 26. Contract Act, 1982. 27. Copyright Act, 1982. 28. Customs Act, 1962. 29. Dentist regulations, 1976. 30. Drugs & Cosmetics Act, 1940. 31. Electricity Act, 1998 32. Electricity rules, 1956. 33. Employees provident fund Act, 1952. 34. ESI Act, 1948. 35. Employment exchange Act, 1969. 36. Environment protection Act, 1986. 37. Equal remuneration Act, 1976. 38. Explosives Act 1884. 39. Fatal accidents Act 1855. 40. Gift tax Act, 1958. 41. Guardians and wards Act, 1980. 42. Hire purchase Act, 1972. 43. Income tax Act, 1961. 44. Indian lunacy Act, 1912 45. Indian medical council Act and code of medical ethics, 1956. 46. Indian nursing council Act 1947. 47. India penal code, 1860. 48. Indian trade unions Act, 1926. 49. Industrial disputes Act, 1947. 50. Insecticides Act, 1968. 51. Lepers Act. 52. Maternity benefit Act, 1961. 53. MTP Act, 1971.

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