A Guide Book to NABH Standards on Hospital Accreditation

First Edition Issued on August 2006

National Accreditation Board for Hospitals and Healthcare Providers

Amendments

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

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

A guide book to NABH standards on hospital accreditation August 2006

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

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

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

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

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

INDEX Page Sr, No. Particular

01

Introduction

02

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

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 : Fax : Email : Website: +91 11 23379321/23379621 +91 11 23379321 nabh@qcin.org 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 a) The services being provided are clearly defined. b) The defined services are prominently displayed. Action/ Documentation A Policy to be framed clearly stating the services the hospital can provide The services so defined should be displayed prominently in an area visible to all patients entering the organization. The display could be in the form of boards, citizens charter, scrolling messages, etc. Care should be taken to ensure that these are displayed in the language (s) the patient understands. All that staff is the hospital mainly in the reception/registration, OPD, IPD are oriented to these facts through training program regularly or through manuals. Remarks/ Audit Points See Policy document

Display in the form of brochures only is NOT acceptable

c) The staff is oriented to these services

Interview the staff in these locations

AAC.2 The Organization has well defined registration and admission process. Objective Element a) Standardized policies and procedures are used for registering and admitting patients Interpretation Health care Organization (HCO) has prepared document (s) detailing the policies and procedures for registration and admission of patients which should also include unidentified patients. Self explanatory Remarks/ Audit Points See Policy for the same

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

Interview staff at these areas

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

The staff handling admission and registration needs to be aware of the services that the organization can provide. It also advisable to have a system wherein the staff is aware as to whom to contact if they need any clarification on the services provided. The HCO is aware of the availability HCOs where the patients may be directed in case of non-availability of beds Also refer to AAC 3. All the staff handling these activities should be oriented to

Interview staff

Interview staff

See evidence of training programs

these policies and procedures. Orientation can be provided by documentation/training AAC.3 There is an appropriate mechanism for transfer or referral of patients who do not match the organizational resources Objective Element a. Policies guide the transfer of unstable patients to another facility in an appropriate manner. Interpretation The documented policy and procedure should address the methodology of safe transfer of the patient in a life threatening situation (like whose who are on ventilator) to another HC-O. Availability of an appropriate ambulance fitted with life support facilities and accompanied by trained personnel. Remarks/ Audit Points The organization shall at the outset define as to who is an unstable patient. These patients include those who have come to the casualty but need to be transferred to another organization or those already admitted but who now require care in another. Organization. It also includes patients being shifted for diagnostic tests. See the process and policy

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

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

Patient not in life-threatening situation (stable) should also be transported in a safe manner during transfer. The staff shall at least be trained trauma or emergency technician/ nurse. He/she shall have undergone training in BCLS and/or ACLS. The HCO gives a case summary mentioning the significant findings and treatment given in case of patients who are being transferred from emergency. For admitted patients a discharge summary has to be given (refer AAC15). The same shall also be given to patients going against medical advice.

It is preferable that a doctor accompanies an unstable patient.

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

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

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

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

Interview the patients

See evidence of the estimate.

AAC.5. Patients cared for by the organization undergo an established initial assessment Objective Element a. The organization defines the content of the assessments for the out-patients, in-patients and emergency patients. Interpretation The hospital shall have protocol/policy by which a standardized initial assessment of patient is done in the OPD, Emergency and IPD. The initial could be standardized across the hospital or it could be modified depending on the need of the department. However, it shall be the same in that particular area. E.g. in a pediatric OPD the weight and height may be a must whereas it may not be so for orthopedics OPD. The organization can have different assessment criteria for the first visit and for subsequent visits. In emergency department this shall include recording the vital parameters. The assessment can be done by the treating doctor, junior doctor or a nurse. The organization shall determine who can do that assessment and it should be the same across the hospital The HCO has defined and documented the time frame within which the initial assessment is to be completed with respect to emergency/indoor patients The HCOs documented protocol mentions that the initial assessment is to be completed within 24 hours or earlier depending upon the patients condition. This should also cover history, progress notes, investigation ordered and Remarks/ Audit Points See the evidence of such practices.

b. The organization determines who can perform the assessments

Interview the staff and observe the practice.

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

See the evidence of such a documents

See the evidence of such practices in the medical records.

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

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

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

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

b. Staff involved in direct clinical care documents reassessments

Evidence of such documentation to be seen.

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

See evidence of progress notes.

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

For adequacy of qualification refer to NABL 112 (Annexure)

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

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

e. Critical results are intimated immediately to the concerned personnel

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

supervise the staff 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 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 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. 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

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).

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

If it is not practical to establish the biological reference interval for a particular analyte the laboratory should carefully evaluate the published data for its own reference intervals.

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

AAC.8. There is an established laboratory quality assurance program Objective Elements a. The laboratory quality assurance program is documented Interpretation The HCO has documented quality assurance program (preferably as per ISO 15189: Medical laboratories Particular requirements for quality and Remark/Audit Points Evidence of such program to be seen.

b. The program addresses verification and validation of test methods c. The program addresses surveillance of tests results d. The program includes periodic calibration and maintenance of all equipment. e. The program includes the documentation of corrective and preventive actions

competence) This holds true for any laboratory developed methods

Examine the same

The laboratory director shall periodically assess the test results. Refer to ISO 15189

Examine the same

Examine the same

Self explanatory

Examine the same

AAC.9. There is an established laboratory safety program Objective Elements a. The laboratory safety program is documented. Interpretation 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. Lab safety program is incorporated in the safety program of the hospital. The lab staff should follow standard precautions The disposal of waste is according to biomedical handling and management rules, 1998. All the lab staff undergo training regarding safe practices in the lab. Remark/Audit Points This could be as per occupational health and safety management system OHSAS 18001:1999 Cross examine both the documents.

b. This program is integrated with the organizations safety program c. Written Policies and procedures guide the handling and disposal of infections and hazardous materials. d. Laboratory personnel are appropriately trained in safe practices. e. Laboratory personnel are provided with appropriate safety equipment/devices.

Examine the same.

See evidence of training program.

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 a. Imaging services comply with legal and other requirements Interpretation The HCO is aware of the legal and other requirements of imaging services and the same are documented for information and compliance by all concerned in the HCO. The HCO maintains and updates its compliance status of legal and other requirements in a Remark/Audit Points All the statutory requirements are met with like BARC clearance, dosimeters, lead sheets, lead aprons, signages, display as per PNDT act, reports to competent authority, etc.

b. Scope of the imaging services are commensurate to the services provided by the organization. c. Adequately qualified and trained personnel performed/or supervise the investigations. d. Policies and procedures guide identification and safe transportation of patients to imaging services.

regular manner Self Explanatory

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

As per AERB guidelines

Interview the HOD.

e. Imaging results are available within a defined time frame f. Critical results are intimated immediately to the concerned personnel. g. Imaging tests not available in the organization are outsourced to organization(s) based on their quality assurance system.

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. The organization shall document turnaround time of imaging results. Critical results shall be intimated to the treating clinician at the earliest on phone, followed by written report. 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

Interview the patients.

The defined timeframe could be different for different type of tests. The HCO shall define critical results which require immediate attention of clinician e.g. ectopic pregnancy. See evidence of MOU and terms and conditions.

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

Objective Elements
a. The quality assurance program for imaging services is documented b. The program addresses verification and validation of imaging methods

Interpretation
Refer to AERB guidelines

Remark/Audit Points
See evidence of AERB guidelines in facility. Verify the same

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

c. The program addresses surveillance of imaging results d. The program includes periodic calibration and maintenance of all equipment. e. The program includes the documentation of corrective and preventive actions

HOD shall periodically assess the imaging results. Calibration and maintenance of all equipment shall be carried out by competent persons. Self explanatory

Verify the same

Verify the same

Verify the same

AAC.12. There is an established radiation safety program Objective Elements a. The radiation safety program is documented. b. This program is integrated with the organizations safety program c. Written policies and procedures guide the handling and disposal of radioactive and hazardous materials. d. Imaging personnel are provided with appropriate radiation safety devices e. Radiation safety devices are periodically tested and documented f. Imaging personnel are trained in radiation safety measures. g. Imaging signage are prominently displayed in all appropriate locations h. Policies and procedures guide the safe use of radioactive isotopes for imaging services. Interpretation Refer to AERB guidelines Remark/Audit Points See evidence

The safety program of the imaging department has reference in the hospital safety manual. Radioactive and hazardous materials shall be disposal off and per bio-medical waste management and handling rules, 1998. Self explanatory.

See evidence

See evidence

See evidence

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

See evidence

See evidence

Self explanatory

See evidence

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

See evidence

AAC.13. Patient care is continuous and multidisciplinary in nature Objective Elements a. During all phases of care there is a qualified individual identified as response Interpretation The HCO to ensure that the care of patients is always given by appropriately qualified medical personnel (resident doctor, consultant and/or nurse). Remark/Audit Points Examine records

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

c. Information about the patients care and response to treatment is shared among medical, nursing and other care providers. d. Information is exchanged and documented during each staffing shift, between shifts, and during transfers between units/departments. e. The patients record (s) is are available to the authorized care providers to facilitate the exchange of information. f. Policies and procedures guide the referral of patients to other department / specialities.

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. 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. Self explanatory

Interview Staff

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

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

Self explanatory

Interview staff

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

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 a. The patients discharge process is planned Interpretation The patients treating doctor determines the readiness for discharge during regular reassessments The discharge policies and procedures are documented to ensure coordination amongst various departments including account so that the discharge papers are organization shall ensure that the police is informed. The HCO has documented policy for the LAMA cases. The treating doctor should explain the consequences of this action to the patient/attendant. Remark/Audit Points Interview nurses

b. Policies and procedures exist for coordination of various departments and agencies involved in the discharge process (including medico-legal cases) c. Policies and procedures are in place for patients leaving against medical advice

Interview nurses

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

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 a. Discharge summary is provided to the patients at the time of discharge b. Discharge summary contains the reasons for findings and diagnosis and the patients condition at the time of discharge. c. Discharge summary contains information regarding investigation results, any procedure performed, medication and other treatment given d. Discharge summary contains follow up advice, medication and other instructions in an understandable manner. e. Discharge summary incorporates instructions about when and how to obtain urgent care f. In case of death the summary of the case also includes the cause of death g. Patient records also contain a copy of the discharge/case summary Interpretation Self explanatory Remark/Audit Points See evidence

Self explanatory

Examine the document

Self explanatory

Examine the document

Self explanatory

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

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. Examine the document

Self explanatory

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 a. Patient and family rights are documented Interpretation Hospital should respect patients rights. All the rights of the patients should be displayed in the form of a citizens charter which should also give information of the charges and grievance redressal mechanism. Self Explanatory Remark/Audit Points See evidence

b. Patients and families are informed of their rights in a format and language that they can understand c. The organizations leaders protect patients rights d. Staff is aware of their responsibility in protecting patients rights e. Violation of patient rights is reviewed and corrective/preventive measures taken

See evidence

Protection also includes addressing patients grievances w.r.t rights Training and sensitization programs shall be conducted to create awareness among the staff. 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.

Verify the same

Examine evidence of training programs

Examine the same

PRE.2. Patient rights support individual beliefs, values and involve the patient and family in decision making process Objective Elements a. Patient rights include respect for personnel dignity and privacy during examination, procedures and treatment Interpretation 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 patients identity is not revealed. Self explanatory. Special Remark/Audit Points In addition the HCO could also define patient responsibilities. Refer to glossary for details.

b. Patient rights include

Examples of the include falling

protection from physical abuse or neglect

c. Patient rights include treating patient information as confidential d. Patient rights include refusal of treatment

e. Patient rights include informed consent before anesthesia, blood and blood product transfusions and any invasive/high risk procedures/treatment f. Patient rights include information and consent before any research protocol is initiated

precautions shall be taken especially w.r.t vulnerable patients e.g. elderly, neonates, etc. Self explanatory. Statutory requirements w.r.t privileged communication shall be followed at all times. 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. Self Explanatory

from the bed/trolley due to negligence, assault, repeated internal examinations, manhandling, etc. Examples of this include MTP, patients of tuberculosis or any other infectious diseases. In case of refusal the treating doctor shall explain the consequences of refusal of treatment and document the same.

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

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

h. Patient rights include information on the expected cost of the treatment i. Patient has right to have an access to hi/her clinical records

The organization shall ensure that International conference on harmonization (ICH) of good clinical practice (GCP) and declaration of Helsinki Somerset (1996) and ICMR requirements are followed. Grievance redressal mechanism must be accessible and transparent. Displayed information must be clearly available on how to voice a complaint. Refer AAc4d

See evidence

Examine the process

Examine the process

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 a. General consent for treatment is obtained when the patient enters the organization b. Patient and/or his family Interpretation Self explanatory Remark/Audit Points See evidence

The organization shall define as

Interview the patient

members are informed of the scope of such general consent c. The organization has listed those procedures and treatment where informed consent is required 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

to what is the scope of this consent and the same shall be communicated to the patient and/or his family members. A list of procedures should be made for which informed consent should be taken

See the list

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 a. When appropriate, patient and families are educated about eh safe and effective use of medication and the potential side effects of the medication b. Patient and families are educated about diet and nutrition c. Patient and families are educated about diet and nutrition Interpretation Self explanatory Remark/Audit Points Interview the patient and the family

Self explanatory

Interview the patient and the family. Interview the patient and the family

d. Patient and families are educated about their specific disease process, complications and preventions strategies e. Patient and families are educated preventing infections f. Patients are taught in a language and format that they can understand

Self explanatory more applicable for pediatric population, In adults it could be for influenza, streptococcus pneumonia, typhoid, hepatitis B and neisseria meningitides, etc. Self Explanatory. This could also be done through patient education booklets/videos/leaflets, etc. Self Explanatory

Interview the patient and the family

Self explanatory

For example, hand washing and avoiding overcrowding near the patient Interview the patient and the family

PRE.5. Patient and families have a right to information on expected costs Objective Elements a. There is uniform pricing policy in a given setting (out-patient and ward Interpretation There should be a billing policy which defines the charges to be levied for various activities Remark/Audit Points See the Policy

category) b. The tariff list is available to patients

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

The organization shall ensure that there is an updated tariff list and that this list is organization shall charge as per the tariff list. 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 Refer to AAC4d

Interview the patients

See the estimate paper randomly. See evidence

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

CHAPTER 3 : Care of Patient COP.1. Uniform care of patients is guided by the applicable laws and regulations Objective Elements a. Care delivery is uniform when similar care is provided in more than one setting Interpretation The organization shall ensure that patients with the same health problems and care needs receive the same quality of healthcare throughout the organization irrespective of the category of ward. Self explanatory Remark/Audit Points Interview nurses and examine the records

b. Uniform care is guided by policies and procedures which reflect applicable laws and regulations c. The care and treatment orders are signed, named, timed and dated by the concerned doctor d. The care plan is countersigned by the clinician in-charge of the patient within 24 hours e. Evidence based medicine and clinical practice guidelines are adopted to guide patient care whenever possible

Self explanatory

For example consent before surgery, providing first-aid to emergency patients and police intimation in cases of medicolegal cases. For electronic records the organization shall ensure that the same is captured in the system Cross check the evidence of signature

The treatment of the patient could be initiated by a junior doctor but the same should be countersigned and authorized by the treating doctor within 24hrs. 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 a. Policies and procedure for emergency care are documented Interpretation These could include SOPs/protocols to provide either general emergency care or management of specific conditions e.g. poisoning. Also refer to AAC5a. 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). Self explanatory Remark/Audit Points See evidence of SOPs

b. Policies also address handling of medicolegal cases

See the policy

c. The patients receive care in consonance with the policies

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

Self explanatory

For triage refer to glossary

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

All the staff working in the casualty should be oriented to the policies and practices through training/documents. Staff should preferably be trained/well versed in ACLS and BCLS. Self explanatory. Also refer to AAC 14 and 15.

See evidence of training programs

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 a. There is adequate access and space for the ambulance(s) Interpretation 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. This shall be done based on the organizations scope Remark/Audit Points Examine the same

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

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

d. There is a checklist of all equipment and emergency medications e. Equipment is checked on a daily basis f. Emergency medications are checked daily and prior to dispatch

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. The organization shall develop a checklist and ensure that the ambulance is equipped as the checklist. This shall include both the ambulance and the equipment within it. Self explanatory. This also includes checking the expiry date of drugs.

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

See the checklist

See evidence

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

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

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. See evidence

COP.4. Policies and procedures guide the care of patients requiring cardio-pulmonary resuscitation Objective Elements a. Documented policies and procedures guide the uniform use of resuscitation throughout the organization b. Staff providing direct patient care is trained and periodically updated in cardiopulmonary resuscitation c. The events during a cardio-pulmonary resuscitation are recorded d. A post-event analysis of all cardiac arrests is done by a multidisciplinary committee e. Corrective and preventive measures are taken based on the post-event analysis Interpretation The organization shall document the procedure for the same. This shall be in consonance with accepted practices. Remark/Audit Points The document could be displayed prominently in critical areas such as emergency, ICU, OT, etc.

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. In the actual event of COR or a mock drill of the same, all the activities along with the personnel attended should be recorded. The analysis shall include the cause, steps taken to resuscitate and the outcome. Multidisciplinary committee shall include physicians, anaesthetists and nurses Self explanatory.

Verify training schedule

See the records

See evidence

Check the record

COP.5. Policies and procedures define rational use of blood and blood products Objective Elements a. Documented policies and procedures are used to guide rational use of blood and blood products b. The transfusion services are governed by the applicable laws and regulations c. Informed consent is obtained for donation and transfusion of blood and blood products d. Informed consent is also includes patient and family education about donation e. Staff is trained to implement the policies Interpretation This shall address the conditions where blood and conditions where blood products can be used. Remark/Audit Points See the Policy

Refer to drugs and cosmetics act.

Evidence of availability of the Act in the facility

Self explanatory. Also refer to PRE3 d and e

Check the instrument

Self explanatory

This could be in the form of booklet/leaflet.

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 g. Transfusion reactions are analyzed for preventive and corrective actions

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

See the SOPs

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 a. The organization has documented admission and discharge criteria for its intensive care and high dependency units b. Staff is trained to apply these criteria c. Adequate staff and equipment are available Interpretation The organizations shall develop these criteria and adhere to it. Remark/Audit Points See the policy

d. Defined procedures for situation of bed shortages are followed

e. Infection control practices are followed

f. The unique needs of end of life patients are identified and cared for g. A quality assurance program is implemented

This shall be done by training and/or by displaying the criteria. 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 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. 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. These are identified in consultation with patient/patients relatives and wherever possible the same are provided These could be developed individually or it could be a part of the hospital quality assurance program. The organization shall

Evidence of training and staff interview Examine the facility

See the policy and interview staff.

See the SOPs

See the SOPs and interview the nurses

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 a. Policies and procedures are documented and are in accordance with the prevailing laws and the national and international guidelines b. Care is organized and delivered in accordance with the policies and procedures c. The organization provides for a safe and secure environment for this vulnerable group d. A documented procedure exists for obtaining informed consent from the appropriate legal representative e. Staff is trained to care for this vulnerable group Interpretation Self explanatory Remark/Audit Points Refer to disability

HCO develops SOPs for delivery of care.

Examine SOPs

The organization shall provide proper environment taking into account the requirements of the vulnerable group The informed consent for their group people should be obtained from their family or legal representative.

For example, play room for children, anti-skid titles for elderly, ramps with railings for disabled, etc. Refer to PRE 3e

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

Evidence of such training and staff interview

COP.8. Policies and procedures guide the care of high risks obstetrical patients Objective Elements a. The organization defines and displays whether high risk obstetric cases can be cared for or not b. Persons caring for high risk obstetric cases are competent Interpretation The organization shall define as to what constitutes high risk obstetric case in consonance with best clinical practices These shall not just be doctors but shall include nursing staff also. The competency shall be based on qualifications, experience and training. Self explanatory Remark/Audit Points See the display

Interview the HOD

c. High risk obstetric patients assessment also includes maternal nutrition d. The organization has the facilities to take care of neonates of high risk pregnancies

Examine the patients records

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

Examine the facility

COP.9. Policies and procedures guide the care of Pediatrics Patients Objective Elements a. The organization defines and displays the scope of its pediatric services b. The policy for care of neonatal patients is in consonance with the national/international guidelines c. Those who care for children have age-specific competency Interpretation The scope also include neonatal services, it any. Self explanatory Remark/Audit Points See the policy and the display

d. Provisions are made for special care of children e. Patient assessment includes detailed nutritional, growth, psychological and immunization assessment f. Policies and procedures prevent child/neonate abduction and abuse g. The childrens family members are educated about nutrition, immunization and safe parenting and this is documented in the medical record

These shall not just be for doctors but shall include nursing staff also. The competency shall be based on qualification, experience and training. Adequate amenities for the care of infants and children to be available in the hospital Self explanatory

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

For example, playroom and breast feeding room Examine records

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

Examples could include identification tag, unsupervised phototherapy leading to burns, etc. For example, growth chart, immunization chart, etc.

COP.10. Policies and procedures guide the care of Patients undergoing moderate sedation Objective Elements a. Competent and trained persons perform sedation b. The person administering and monitoring sedation is different from the person performing the procedure c. Intra-procedure monitoring includes at minimum the heart rate, cardiac rhythm, respiratory rate, blood pressure, oxygen Interpretation Whenever parenteral route is used this shall be carried out by a doctor/nurse. Self explanatory Remark/Audit Points Technician shall not administer sedation. Observe the practice and interview staff

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

e. Criteria are used to determine appropriateness of discharge from the recovery area f. Equipment and manpower are available to rescue patients from a deeper level of sedation than that intended

The patients vitals shall be monitored at regular intervals (as decided by the organization) till he/she recovers completely from the sedation These shall be developed by the organization in consonance with good clinical practices.

Interview staff and verify the records

See the SOPs

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 There is a documented policy and procedure for the administration of anesthesia a. All the patients for anesthesia have preanesthesia assessment by a qualified individual Interpretation HCO shall document on the indications, the type of anesthesia and procedure for the same. 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 Self explanatory Remark/Audit Points For definition of anesthesia refer to glossary. The standard is not applicable for local anesthesia See the evidence

b. The pre-anesthesia assessment results in formulation of an anesthesia plan which is documented. c. An immediate preoperative reevaluation is documented. d. Informed consent for administration of anesthesia is obtained by the anesthetist 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

See the evidence

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

Check the records

This shall apply to local anesthesia also. (Refer to PRE 3d) Check the records

Self Explanatory

f. Each patients postanesthesia status is monitored and documented

g. A qualified individual applies defined criteria to transfer the patient from the recovery area h. All adverse anesthesia events are recorded and monitored

This shall be done in the recovery area OT and at least include monitoring of vitals till the patient recovers completely from anaesthesia and shall be done by an anaesthesiologist. If the patients condition is unstable and he/she requires ICU are the same Shall be monitored there. This shall be done by a designated individual as decided by the HCO and shall be in consonance with best clinical practices. Self explanatory

Check the records

See the SOPs

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 a. The policies and procedures are documented b. Surgical patients have a preoperative assessment and a provisional diagnosis documented prior to surgery c. An informed consent is obtained by a surgeon prior to the procedure d. Documented policies and procedures exist to prevent adverse events like wrong site, wrong patient and wrong surgery e. Persons qualified by law are permitted to perform the procedures that they are entitled to perform f. A brief operative note is documented prior to transfer out of patient from recovery area Interpretation This shall include the list of surgical procedures as well as competency level for performing these procedures. 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 Self explanatory Remark/Audit Points See the SOPs

This shall be done by the operating surgeon.

See the evidence

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. See the document and interview the HOD.

g. The operating surgeon documents the postoperative plan of care

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

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

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 HCOs overall quality assurance program, it shall focus on post operative complications e.g. bleeding , rational use of antibiotics, etc. Surveillance activities include monitoring the quality of air provided, rate of air exchange, cleaning and disinfection processes, etc. Self explanatory See the manual

i. A quality assurance program includes surveillance of the operation theatre environment j. The plan also includes monitoring of surgical site infection rates

See the manual

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 a. Documented policies and procedures guide the care of patients under restraints b. These includes both physical and chemical restraint measures c. These includes documentation of reasons for restraints d. These patients are more frequently monitored Interpretation 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. Physical restraints include boxers bandage, use of cuffs, etc. Chemical restraints include sedatives. Self explanatory Remark/Audit Points See the policy

See the policy

See the Policy

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

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

See the records

See the training schedule

COP.14. Policies and procedures appropriate pain management Objective Elements a. Documented policies and procedures guide the management of pain Interpretation 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. Self explanatory` Remark/Audit Points For example, cancer pain, neuralgias, and arthralgia

b. The organization respects and supports the appropriate assessment and

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 a. Documented policies and procedures guide the provision of rehabilitative services b. These services are commensurate with the organizational requirements c. Rehabilitative services are provided by a multidisciplinary team Interpretation Self explanatory Remark/Audit Points See the policy

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

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

For example, provision of antenatal and postnatal and postnatal exercise could form a part of obstetric rehabilitation program. Observe the process and interview the HOD

COP.16. Policies and procedures guide all research activities Objective Elements a. Documented polices and procedures guide all research activities in compliance with national and international guidelelines b. The organization has an ethics committee to oversee all research activities Interpretation Self explanatory Remark/Audit Points 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) Refer to ICMR guidelines

c. The committee has the powers to discontinue a research trail when risks outweigh the potential benefits d. Patients informed consent is obtained before entering them in research protocols e. Patients are informed of their right to withdraw from the research at any stage and also of

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

See evidence

Self explanatory

See evidence

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 organizations services

Self explanatory

See evidence

COP.17. Policies and procedures guide nutritional therapy Objective Elements a. Documented polices and procedures guide nutritional assessment and reassessment b. Patients receive food according to their clinical needs c. There is a written order the diet Interpretation Self explanatory Remark/Audit Points See policy

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

e. When families provide food, they are educated about the patients diet limitations f. Food is prepared, handled, stored and distributed in a safe manner

A dietitian shall do the assessment of the patient in consulation with the clinician and advice regarding food. The dietitian shall prepare this in the form of a diet sheet and patient shall receive food accordingly The dietician shall ensure that this is planned in consultation with the treating doctor and the patient/patients food habits (vegnon-veg) and likes and dislikes. The dietician/nurse shall ensure this during planning.

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

Interview the dietician and treating doctor

Interview the patients

The dietary services to be designed in a manner that there is no criss cross of traffic. 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 a. Documented policies and procedures guide the end of life care Interpretation The HCO has a documented policy for providing care to terminally ill admitted patients. This shall include providing appropriate pain and palliative care according to the wishes of the family and patient. Self explanatory Remark/Audit Points Refer to glossary for definition of end of life.

b. These polices and

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

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

The religious and sociocultural beliefs of patient/family shall be addresses and respected. 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. Self explanatory

Interview the nurse

Interview the head of the organization

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 a. There is a documented policy and procedure for pharmacy services and medication usage Interpretation The policies and procedure shall address the issues related to procurement, storage, formularly,prescription, dispensing, administration, monitoring and use of medications Self explanatory Remark/Audit Points See the policy

b. These comply with the applicable laws and regulations

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.

Relevant legislations include drugs and cosmetics act, food and drugs Act, narcotic drugs and psychotropic drugs and magical remedies (objectionable advertisement)Act, etc For example, pharmacotherapeutic committee

MOM.2. There is a hospital formulatory Objective Elements a. A list of medication appropriate for the patients and organizations resources is developed b. The list is developed collaboratively by the multidisciplinary committee c. There is defined process for acquisition of these medications Interpretation The hospital formulary shall be prepared and be preferably updated at regular intervals Remark/Audit Points See the formulatory

Refer to MON 1c

See evidence

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

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

Examine the purchase procedure

For example, local purchase

MOM.3. Policies and procedures guide the storage of medication Objective Elements a. Documented policies and procedures exist for storage of medication Interpretation These should address pertaining to temperature (refrigeration), light, ventilation, preventing entry Remark/Audit Points 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 manufacturers recommendation. This shall be applicable to all areas where medications are stored including wards. Self explanatory Examine the facility

c. Sound inventory control practices guide storage of the medications d. Medications are protected from loss or theft

e. Sound-alike and lookalike medications are stored separately f. There is a method to obtain medication when the pharmacy is closed g. Emergency medications are available all the time h. Emergency medications are replenished in timely manner when used.

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 Many drugs in ampules, vials or tablets may look-alike or soundalike. They should be segregated and stored separately. When pharmacy is closed, there should be a SOP to procure the drugs Adequate amount of emergency medicines should be stocked at all times. Re-order level at define quality should be done. Self explanatory

The organization shall follow inventory control practices like first in first out, ABC, etc. Interview the HOD

The organization can follow a method of storing drugs by generic name in an alphabetical order to address this issue. It is preferable that the HCO has a 24 hours pharmacy Verify the same

Examine the same

MOM.4. Policies and procedures guide the prescription of medications Objective Elements a. Documented policies and procedures exist for prescription of medications b. The organization determines who can write orders c. Orders are written in a uniform location in the medical records Interpretation Self explanatory Remark/Audit Points Refer to MOM 1a

This shall be done by the treating doctor Al the orders for medicines are recorded on a uniform location of the case sheet. Electronic orders when typed shall again follow the same principles Self explanatory

Examine the same

Examine the same

d. Medication orders are clear, legible

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

dated, named and signed

e. Policy on verbal orders is documented and implemented f. The organization defines a list of high risk medication g. High risk medication orders or verified prior to dispensing

The organization shall ensure that it has a policy to address this issue and it shall address as to who can give verbal orders and how these orders will be validated The organization shall develop the risk taking into consideration statutory requirements e.g.NDPS Act These medications shall preferably be given only after written orders and it should be verified by the staff before dispensing

legibility is addressed. A good practice would also include mentioning the time of prescribing. Verbal orders should be followed by written orders

See the list

Interview the nurse

MOM.5. Policies and procedures guide the prescription of medications Objective Elements a. Documented policies and procedures guide the safe dispensing of medications b. The policies include a procedure for medication recall c. Expiry dates are checked prior to dispensing d. Labeling requirements are documented and implemented by the organization Interpretation Clear polices to be laid down for dispensing of medication e.g. route of administration, dosage, rate of administration, expiry date, etc. Recall may result based on letters from regulatory authorities or internal feedback (e.g. visible contaminant in IV fluid bottle). Self explanatory Remark/Audit Points See the policy

See the policy

This shall be done at all levels e.g. pharmacy, ward, etc. Examine the practice

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

MOM.6. There are defined procedures for medication administration Objective Elements a. Medications are administrated by those who are permitted by law to do so b. Prepared medication are labeled prior to Interpretation Self explanatory Remark/Audit Points Refer to statutory requirements, in addition to doctors, nursing staff may also administer.

Self explanatory

Applicable for parenteral drugs

preparation of a second drug c. Patient is identified prior to administration d. Medication is verified from the order prior to administration

Self explanatory

e. Dosage is verified from the order prior to administration f. Route is verified form the order prior to administration g. Timing is verified from the order prior to administration h. Medication administration is documented

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 Self explanatory

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

Interview the nurse

Self Explanatory

Interview the nurse

Self explanatory

Interview the nurse

i.

Policies and procedures govern patients self administration of ,medications

j.

Policies and procedures govern patients medications brought from outside the organization

The organization shall ensure that this is done in a uniform location and it shall include the name of the medication, dosage, route of administration, timing and the name and signature of the person who has administered the medication At the outset the HCO could define if it would permit self administration of medications. In case the HCO permits then the policy shall include the medications which the patient can self administer. It is preferable that the organization also incorporates a method to ensure that the patient is reminded to take the medication (before every dose) and documentation of self administration. These shall address as to what are the pre-requisites for such a medication (e.g. Invoice; clear label with mention of name, dose, expiry date, etc.)

Interview the nurse

For example, self administration of insulin

See the policy

MOM.7. Patients and family members are educated about safe medication and food-drug Interactions Objective Elements a. Patient and family are educated about safe and effective use of mediation b. Patient and family are educated about food-drug interactions Interpretation The organization shall make a list of such drugs and accordingly educate. E.g. digoxin. This could also include education regarding the importance of taking a drug at a specific time e.g. sustained release medications Patient and family should be counseled about their diet during medication e.g. no alcohol when taking metronidazale. Remark/Audit Points Interview the patients

Interview the patients

MOM.8. Patients are monitored after medication administration Objective Elements a. Patients are monitored after medication administration and this is documented Interpretation 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. The organization shall define as to what constitutes an adverse drug event. This shall be in consonance with best practices. Self explanatory. The organization shall define the timeframe for reporting once the adverse drug event has occurred. All the adverse drug reactions are analyzed regularly by the multidisciplinary committee (refer to MOM1C). Self explanatory Remark/Audit Points Interview the nurse

b. Adverse drug events are defined

See the document

c. Adverse drug events are reported within a specified time frame d. Adverse drug events are collected and analyzed e. Policies are modified to reduce adverse drug events when unacceptable trends occurs

Examine adherence to the SOPs

See evidence

See the policy

MOM.9. Policies and procedures guide the use of narcotic drugs and psychotropic substances Objective Elements a. Documented polices and procedures guide the use of narcotic drugs and psychotropic Interpretation Self explanatory. Refer to MOM 1a Remark/Audit Points See the policy

substances b. These policies are in consonance with local and rational regulations c. A proper record is kept of the usage, administration and disposal of these drugs d. These drugs are handled by appropriate personnel in accordance with polices This is in the context of Narcotic Drugs and Psychotropic substances act These shall be kept in accordance with statutory requirements See evidence of the presence of the Act. Examine the records

Self explanatory

See the Policy

MOM.10. Policies and procedures guide the usage of chemotherapeutic agents Objective Elements a. Documented policies and procedures guide the usage of chemotherapeutic agents b. Chemotherapy is prescribed by those who have the knowledge to monitor and treat the adverse effect of chemotherapy c. Chemotherapy is prepared and administrated by qualified personnel d. Chemotherapy drugs are disposed off in accordance with legal requirements Interpretation Self explanatory Remark/Audit Points See the Policy

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

Interview the medical oncologist

This shall preferably be staff who have received special training in preparing and administration These shall be disposed off according to BMW management and handling rules, 1998 or manufacturers recommendation.

Interview the nurse

Examine the practice

MOM.11. Policies and procedures govern usage of radioactive or investigational drugs Objective Elements a. Documented polices and procedures govern usage of radioactive or investigational drugs b. These policies and procedures are in consonance with laws and regulations c. The policies and procedures include the safe storage, preparation, handling, distribution and disposal of radioactive and investigational drugs Interpretation Self explanatory Remark/Audit Points See the policy

Refer to AERB guidelines

See the evidence of the guidelines in the facility

Self explanatory. This shall however be in accordance with AERB guidelines. For investigational drugs these shall be as per the manufacturers 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 a. Documented policies and procedures govern procurement and usage of implantable prosthesis b. Selection of implantable prosthesis is based on scientific criteria and internationally recognized approvals Interpretation Self Explanatory Remark/Audit Points See policy

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

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 Self explanatory

Examine purchase procedures for the same

See evidence

MOM.13. Policies and procedures guide the use of medical gases Objective Elements a. Documented policies and procedures govern procurement, handling, storage, distribution, usage and replenishment of medical gases. b. The policies and procedures address the safety issues at all levels Interpretation 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 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. This is the context of the India explosives act of 1884, Gas cylinder rules 1981 and static and mobile pressure vessel (unfired) 1981 Remark/Audit Points See policy

See policy

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

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 a. The hospital has a multi-disciplinary infection control committee b. The hospital has an infection control team. Interpretation Self explanatory. This shall preferably have administrator, microbiologist, physician, surgeon and the hospital infection control nurse. The team is responsible for dayto-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. The qualification shall be either a graduate nurse qualified nurse with competence gained by experience Self explanatory Remark/Audit Points See evidence of the committee and document of meetings held.

See evidence of the team

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

Interview the infection control nurse

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 a. The manual identifies the various high-risk areas. b. It outlines methods of surveillance in the identified high-risk areas. c. It focuses on adherence to standard precautions at all times. d. Equipment cleaning and sterilization practices are included Interpretation The manual should clearly identify the high risk areas of the hospital e.g. ICU, HDU, OT, post-operative ward, blood bank, CSSD, etc. It shall define the frequency and mode of surveillance. Remark/Audit Points See the list of high risk areas

See the document

Self explanatory

Refer to glossary for standard precautions Examine the practice

e. An appropriate antibiotic policy is established and implemented.

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. 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

f. Laundry and linen management processes are also included. g. Kitchen sanitation and food handling issues are included in the manual

h. Engineering controls to prevent infections or included i. Mortuary practices and procedure are included as appropriate to the organization

policy, which shall be reviewed at periodic intervals (may be once in 3 months) for it continuing applicability. Self explanatory. If outsourced the organization shall ensure that it establishes adequate controls to ensure infection control. 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 Engineering control shall address air changes, air conditioning replacement of filters, c page leading to fungal colonization , etc Mortuary practices of preserving body, or body parts should be in accordance to the policy.

Examine the practice

Check in the manual

Interview the maintenance staff

Refer to standard precautions

HIC.3. The infection control team is responsible for surveillance activities in identified areas of the hospital Objective Elements a. Surveillance activities are appropriately directed towards the identified high-risk areas. b. Collection of surveillance data is an ongoing process. Interpretation Self explanatory Remark/Audit Points Interview the infection control nurse

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

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

The organization shall ensure that it has a process in place to collect surveillance data and also to ensure that it is able to capture all such data The data so collected shall be authenticated by the team by going through every data or by using random sampling so that the process can be validated. The team shall preferably verify every serious infection (as defined by the organization) report. 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

See evidence

See evidence

Refer to glossary for notifiable diseases

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

the format as required by statutory authorities. 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 a. The organization monitors urinary tract infections b. The organization monitors respiratory tract infections. Interpretation This can be done either by sending urine or catheter tip for culture. The organization shall do this for all symptomatic catheterized patients This can be done by sending sputum or ET/ tracheotomy secretions (obtained using a suction catheter) or ET/tracheostomy tip or protected specimen brushing (PSB) or mini bronchoalveolar lavage (BAL) for culture. The organization shall do this for all patients on the ventilator having clinical features suggestive of infection. 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 This shall be done by sending pus/swab for culture Remark/Audit Points The HCO may extend this activity to asymptomatic catheterized patients also

See evidence

c. The organization monitors intravascular device infections

See evidence

d. The organization monitors surgical site infections. e. Appropriate feedback regarding HAI rates are provided on

See evidence

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

See evidence

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

b. This procedure is implemented during outbreaks c. After the outbreak is over

Interview the infection control nurse

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

limits in a secure manner. d. Bio-medical waste treatment facility is managed as per statutory provisions (if- in-house) or outsourced to authorized contractors(s) e. Requisite fees, documents and reports are submitted to competent authorities on stipulated dates.

authorized contractor. 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. 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. Self explanatory Examine the facility and MOU with the contact

See evidence

Appropriate For example, gloves and masks, personnel protective glosses, gowns, etc. protective measures are used by all categories of staff handling biomedical waste. HIC 9 The infection control program is supported by hospital management and includes training of staff and employee health. Objective Interpretation Remark/Audit Points Elements a. Hospital The HCO shall ensure that Examine the stock management the resources required by makes available the personnel should be resources required available in sustained for the infection manner. This includes both control program men and materials. b. The hospital There shall be separate Examine the budget regularly earmarks budget demarcated for adequate funds HIC activity. This shall be from its annual prepared taking into budget in this consideration the scope of regard. the activity and previous years experience. c. It conducts regular Self explanatory See evidence of training schedule pre-induction training for appropriate categories of staff before joining concerned departments(s) d. It also conducts Self explanatory See evidence of training schedule regular in-service training sessions for all concerned categories of staff

f.

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

program is a for updation could be based continuous process on the review carried out by and updated at least the quality assurance once in a year. 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. As stated 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 c. Monitoring includes all invasive procedures. d. Monitoring includes adverse drug events. e. Monitoring includes use of anesthesia

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

As stated in the remarks column

Complications following such procedures and reexploration surgery Hypersensitivity reactions following antibiotic administration and GI bleed following NSAIDs Parathesia following spinal anaesthesia, need of ventilation following anaesthesia and adherence to pre-anaesthesia assessment Checking for transfusion transmissible infections ( TTIs) as per statutory requirements, severe hazards of transfusion and blood hemolysed during transportation

As stated in the remarks column

As stated in the remarks column

f.

Monitoring includes use of blood and blood products.

As stated in the remarks column

C. Patient and clinician anonymity is maintained. D. All Audit are documented.

Self explanatory.

Self explanatory

Remedial Self explanatory measures are implemented CQI 6. Sentimental events are intensively analyzed Objective Interpretation element a. The organization has defined sentinel events. b. The organization has established processes for intense analysis of such events. c. Sentinel events are intensively analysed when they occur d. Actions are taken upon findings of such analysis. Self explanatory

E.

The HCO could use a checklist with the predefined parameters and the audit findings could be recorded on this sheet. This should preferably be done based on root cause analysis. Remarks/Audit Points

Self explanatory

Refer to glossary for definition of Sentinel events See records

Self explanatory. This shall be done as per the process established by the HCO. This should be done based on root cause analysis so as to prevent recurrences.

See records

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

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 The HCO shall have For definition of mission refer to public the a mission glossary mission statement and the statement of the same shall be organization displayed prominently. b. The leaders The HCO shall A good reference guide is code of establish the function in an medical ethics-2002 published by organizations ethical manner. MCI. ethical management c. The organization The ownership of The disclosure could be in the discloses it the hospital e.g. registration certificate/quality ownership trust, private, manual, etc public has to be disclosed d. The organization Self explanatory Here portrays implied that the HCO honestly portrays conveys to the patients clearly what the services it can and cannot provide. The which it can and services that it cannot provide could cannot provide also be conveyed verbally. Refer to AAC 1 also. e. The organization Self explanatory Also refer to PRE 5. The tariff could accurately bills be devised by a tariff committee. for its services based upon a standard billing tariff. ROM 4 A suitably qualified and experienced individual heads the organization Objective elements Interpretation Remarks/Audit points a. The designated Self explanatory This implies to the individual individual has looking after the day to day requisite and operations and not to the chairman appropriate of board of governors. Appropriate administrative implies qualification in hospital qualification management/administration b. The designated Self explanatory Appropriate implies administrative individual has experience in a HCO. requisite and appropriate

c. Administrative policies and procedures for each department is maintained d. Department leaders are involved in quality improvements

have a brochure detailing the scope of each department. This shall include administrative procedures like attendance, leave, conduct, etc. Self explanatory

It could be common for the entire 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 Self explanatory This group could have a mix of has an administrators, engineers, doctors, interdisciplinary and nurses. Refer to glossary for group assigned to definition of safety program oversee the hospital wide safety program b. The scope of the Self explanatory Refer to glossary for definition of program is defined adverse events and sentinel to include adverse events events ranging from no harm to sentinel events. c. Management The HCO has For example, review meeting and ensures system in place accident reporting for bio-medical implementation of for internal and waste. systems for external internal and reporting of external reporting system and of system and process failures process failures. in the context of adverse events as defined above. d. Management Self explanatory. Refer to glossary for definition of provides resources The end result of risk assessment and risk for proactive risk these shall result reduction. assessment and in preventive risk reduction actions activities.

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 A designated For example, fire conversant with the laws and management functionary protection guidelines regulations and knows their has been given the given in national applicability to the responsibility to enlist the building code of organization. laws and regulation as India, relevant state applicable to the HCO. and local body This functionary has regulations (Kerala identified the appropriate state building rules) personnel in the HCO who are supposed to implement the respective laws and regulations b. Management regularly Self explanatory See evidence updates any amendments in the prevailing laws of the land. c. The management ensures Self explanatory See evidence implementation of these requirements d. There is a mechanism to Self explanatory For Example, regularly update licenses for lifts, DG licenses/registration/certificat sets,etc ions FMS.2. The organizations 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 Self explanatory Refer glossary for operational and definition of maintenance (preventive preventive and and breakdown) plan. breakdown maintenance. b. Up-to-date drawings are A designated personnel Examine the maintained which detail maintains the drawings. drawings the site layout, floor plans and fire escape routes. c. The provision of space Self explanatory For example, India shall be in accordance standards (IS with the available 12433) formulated literature on good by bureau of Indian practices (Indian or Standards ( for 30 international standards) and 100 bedded and directives from hospitals and other government agencies standards), IS 10905 for basic requirements for hospital buildings d. There are designated A person in the HCO Interview the head individuals responsible for management is of the maintenance the maintenance of all the designated to be indepartment facilities. charge of maintenance of facilities. The HCO has

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

e. Maintenance staff is contactable round the clock for emergency repairs. f. Response times are monitored from reporting to inspection and implementation of corrective actions

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

See the roster

b. Alternate sources are provided for in case of failure. c. The organization regularly tests the alternate sources. d. There is a maintenance plan for piped medical gas and vacuum installation FMS.5 The organization has plans facilities Objective element a. The organization has plans and provisions for early detection, abatement and containment of fire and non-fire emergencies

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

See evidence

Check records

Self explanatory

Check records

for fire and non-fire emergencies within the Objective element The HCO has a fire and non-fire emergency committee (FNEC) to review the HCOs 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 Objective element 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

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

c. Staff is trained for their role in case of such emergencies d. Mock drills are held at least twice a year FMS.6 Sentinel events are intensively analyzed Objective element Objective element a. The organization has Self explanatory defined sentinel events. b. The organization has Self explanatory established processes for intense analysis of such events. c. Sentinel events are Self explanation. This intensively analyzed shall be done as per the when they occur. process established by the HCO. d. Actions are taken This should be done upon findings and based on root cause such analysis analysis so as to prevent recurrences

supply of electricity, 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. Fire exit plan shall be displayed on each floor particularly close to the lists. Exist doors should remain open on the time. In case of fire designated person are assigned particular work. Self explanatory

Examine the fire exit route

Interview the staff

See evidence

Objective element Refer to glossary for definition of sentinel events See evidence

See evidence

See evidence

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 Self explanatory A good reference could be adequate number and mix of the MCI and NCI staff to meet the care, guidelines treatment and service needs of the patient. b. The required job specifications Self explanatory Refer to glossary for and job description are well definitions of job defined for each category of description and job staff. specification c. The organization verifies the Self explanatory This report could be got antecedents of the potential form the district employee with regards to magistrate (s) of the criminal/negligence district (s) where the background. 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 Self explanatory This could be done as a student and voluntary worker part of the induction is appropriately oriented to the training. organizations mission and goals. b. Each staff member is made Self explanatory This could be done as part aware of hospital wide policies of the induction training and procedures as well as and the same could be relevant provided in the form of department/unit/service/progr booklet. ams policies and procedures. c. Each staff member is made The HCO shall define the This could be done as a aware of his/her rights and same in consonance with part of the induction responsibilities statutory requirements training and the same and the same shall be could be provided in the communicated to the form of a booklet. employees. d. All employees are educated For patient rights to PRE For patient responsibilities with regard to patients rights 2. refer to glossary and responsibilities e. All employees are oriented to The HCO shall develop Interview of the staff the service standards of the benchmarks for different organization. services being provided. This shall be based on the HCOs value and focus on development of soft skills: behavior, attitude, communication skills, etc. 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 Self explanatory For, example, training development policy exists for manual which includes the staff. identification of training needs, training

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 The HCO shall define such For example, fire and non within the hospital risks which shall include fire emergency, needle environment. both patient and stick injury, etc. employee related. b. Staff members can Self explanatory Interview the staff. demonstrate and take actions to report, eliminate/minimize risks. c. Staff member are made aware Self explanatory Interview the call of procedures to follow in the event of an incident. d. Reporting processes for The HCO has defined Interview the staff common problems, failures and procedure for reporting of user errors exist. these events. 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 Self explanatory For definition of performance appraisal performance appraisal system exists in the refer to glossary organization. b. The employees are made Self explanatory Interview the staff aware of the system of appraisal at the time of induction c. Performance is evaluated Self explanatory For definition of job based on the performance description refer to expectations described in glossary job description. d. The appraisal system is Self explanatory. This can Interview the HR head used as a tool for further be done by identifying development. training requirements and accordingly providing for the same (wherever possible) e. Performance appraisal is Self explanatory This shall be done at least carried out at pre defined once a year. intervals and is documented. HRM. 6 The organization has well-documented disciplinary procedure.

b. Training also occurs when job responsibilities change/new equipment is introduced. c. Feedback mechanisms for assessment of training and development program exist

Self explanatory

methodology, documentation of training, training assessment, etc. See evidence

Self explanatory

Objective element a. A written statement of the policy of the organization with regard to discipline is in place. b. The disciplinary policy and procedure is based on the principles of natural justice.

Interpretation Self explanatory

Remarks/Audit Points For definition of disciplinary procedure refer to glossary Interview for HR head and see policy

The HCO shall designated Appellate authority should an appellate authority to be higher than the consider appeals in disciplinary authority disciplinary cases. HRM. 7 A grievance handling mechanism exists in the organization Objective element Interpretation Remarks/Audit Points a. The employees are For definition for The HCO could address all aware of the procedure grievance handing refer points in HRM 2, HRM 4, to be followed in case to glossary. The HCO has HRM 5, HRM 6 and HRM7 they feel aggrieved. a written procedure for by providing every handling grievances of employee with a manual employees. incorporating the various policies and procedures. b. The redress procedure Self explanatory See SOPs addresses the grievance. c. Actions are taken to Self explanatory See records redress the grievance. HRM. 8 The organization addresses the health needs of the employees Objective element Interpretation Remarks/Audit Points a. A pre-employment medical Self explanatory. This For example, performing examination is conducted on all shall in consonance with pre employment HIV the employees the law of the land testing is illegal b. Health problems of the Self explanatory. This For example, employee employees are taken care of in shall be in consonance health and safety policy accordance with the with the law of the land organizations policy. and good clinical practices. c. Regular health checks of staff Self explanatory. The The HCO could define the dealing with direct patient care results should be parameters and it could are done at-least once a year documented in the be different for different and the findings/ results are personnel file. categories of personnel. documented. The HCO could also identity competent individuals to perform the same. d. Occupational health hazards Self explanatory For definition of are adequately addressed. occupational health hazard refer to glossary.

c. The policy and procedure is known to all categories of employees of the organization.` d. The disciplinary procedure is in consonance with the prevailing laws. e. There is provision for appeals in all disciplinary cases

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

This could be in the form of services rules

Self explanatory

Refer to relevant labour laws and CCS (CCA) rules

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

medical professionals brochure itself. are known to them as well as the various departments/units of the hospital. 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, The HCO identifies the Refer to Indian Nursing training and experience of individuals who have the Council, Act 1947 nursing staff is documented required qualification (s), and updated periodically. 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 b. All such information pertaining The HCO shall do the See evidence to the nursing staff is same by verifying the appropriately verified when credentials from the possible. organization whish has awarded the qualification/training 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 The HCO shall identity as See job responsibilities nursing staff is in consonance to what each nurse is with their qualification, training authorized to do. and registration. b. The services provided by Self explanatory Interview the nursing nursing staff are in accordance head with the prevailing laws and regulations c. The requisite services to be Self explanatory Interview the nursing provided by the nursing staff head are known to them as well as the various departments/units of the hospital.

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 HCO has manual For example, daily the organization are and/or electronic census report, identified and are Hospital information utilization rates, etc. appropriate to the scope system and/or Also refer to CQI 2 and of the services being management CQI 3 provide by the information system organization and the which provides relevant complexity of the information to all organization. concerned stakeholders. b. Policies and procedures A Policy document is See the Policy to meet the information available where the needs are documented. HIS/MIS is described. c. These policies and Self explanatory Some of these include: procedures are in - IT act 2000 for compliance with the computer based prevailing laws and records, PNDT Act for regulations 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 Self explanatory See the policy management and technology acquisitions are in accordance with the policies and procedures e. The organization Self explanatory For example, sending contributes to external birth and death databases in accordance statistics, notifiable with the law and diseases (refer to regulations 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 MIS/HIS data is Examine the formats collection are collected in standardized standardized. format from all areas/services in the HCO. b. Necessary resources are This could be men, Interview the available for analyzing material space and accreditation data. budget. coordinator c. Documented procedures Self explanatory The organization could

are laid down for timely and accurate dissemination

d. Documented procedures exist for storing and retrieving data.

Self explanatory

There is multidisciplinary committee which is responsible for the appropriate selection of indicators, measurement of trends and initiating action wherever required. 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 This shall also apply to For example, CR a unique identifier records on digital media number, hospital number, etc. b. Organization policy HCO has a written policy There could be different identifies those stating who all can category of personnel authorized to make makes entries. for different entries, entries in medical record 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 Self explanatory For records in entry is dated and electronic media it is timed. preferable that the date and time is automatically generated by the system. d. The author of the entry This could be by writing Examine the same can be identified. 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.

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

decide which data needs to be shared with whom and also the modalities (e.g. memos, circulars, etc.) for dissemination for such data. Storage could be physical or electronic. Wherever electronic storage is done, the HCO shall ensure that there are adequate safeguards for protection of data. Interview the accreditation coordinator

The HCO identifies which documents form part of the medical records, documents and implements the same f. The record provides an The HCO decides the up-to-date and format chronological account of (POMR/SOMR/IMR) for patient care. maintaining medical records. IMS.4. The medical record reflects continuity of care. Objective element Interpretation a. The medical record contains information regarding reasons for admission, diagnosis and plan of care. Self explanatory

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

For example, IP sheet, doctors order sheet etc

Examine the same

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

Remarks/Audit Points 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. Also refer to COP 12f

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

d. The medical record contains a copy duly signed by appropriate and qualified personnel. e. In case of death, the medical record contains, a copy of the death certificate indicating the cause, date and time of death. f. Whenever a clinical autopsy is carried out, the medical record contains a

Self explanatory. Discharge note is the same as discharge summary. Self explanatory. The HCO provides the death certificate as per the international certification of cause of death

If the patient has been transferred at his/her request a note may be added to that effect. 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. Also refer to AAC 15.

Also refer to AAC 15 g.

Self explanatory

For definitions of autopsy refer to glossary

The HCO provides See evidence access to medical records to designed health care providers (those who are involved in the care of that patient) IMS.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 Self explanatory. This is See the policy procedures exist for applicable for both maintaining manual and electronic confidentiality, security, and integrity of information b. Policies and procedures This is in the context of For example, privileged are in consonance with Indian evidence act, communication the applicable laws. Indian Penal Code and Code of medical Ethics. c. The policies and For physical records the It is preferable that procedures incorporate HCO shall ensure that softwares when used, safeguarding of there is adequate pest shall be validated and data/record against loss, and rodent control duly authenticated. destruction and measures. For electronic tampering. 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. d. The hospital has an The HCO carries out Refer to IMS 2 effective process of regular audits/rounds to monitoring compliance of check compliance with the laid down policy. policies. e. The hospital uses Self explanatory For example, moving developments in from physical to appropriate technology electronic format, for improving remote backup of data, confidentiality, integrity etc. and security. f. Privileged health Self explanatory Special car should be information is used for taken in medico-legal the purposes identified cases or as required by law and not disclosed without the patents

copy of the report of the same. g. Care providers have access to current and past medical record.

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

deficiencies in records. g. Appropriate corrective and preventive measures undertaken are documented Self explanatory

of OT notes in an operated patient, etc. 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 nongovernmental organization. 2. It also represents the outcome of the review and the decision that an eligible organization meets an applicable set of standards. 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 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)

Accreditation assessment

Advance life support

Ambulance

Anaesthesia

Assessment

Autopsy

Barrier nursing

Basic life support

Tension pneumothorax (tear in the lung leading to collapsed lung and twisting of the large blood vessels) Tamonade (fluid or blood in the pericardium, 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) 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. 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. All activities including history taking, physical examination, laboratory investigations that contributes towards determining the prevailing clinical status of the patient. 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 Type of nursing for immunocompromised patients with a view to prevent any secondary infections e.g. use of gloves, masks and relatively disinfected environment. 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 ABCs 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. 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 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.

Bylaws

Clinical audit

Clinical practice guidelines

Competence

Consent

Credentialing Data Discharge summary

Disciplinary proceedings Employees

End of life Ethics

Guidelines that assist practitioners to provide appropriate clinical car for specific clinical conditions, 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. 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. 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. The process of obtaining, verifying and assessing the qualification of a health care provider. Raw facts, clinical observations, or measurements collected during an assessment activity. A part of a patient record that summarizes the reasons for admission, significant clinical finding, procedures performed, treatment rendered, patients condition on discharge and any specific instructions given to the patient or family (for example follow-up medications). 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. 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. Period of time marked by disability or disease that is progressively worse until death 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) 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 physicians clinical

Evidence based medicine

Family

expertise and the patients desires. The person(s) with a significant role in the patients 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. 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

Formulatory

Grievance handling procedures Hazardous materials

Sequence of activities carried out to address the grievance of patients, visitors, relatives and staff Substance dangerous to human and other living organisms. They include radioactive or chemical materials. 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. Generic term is used to describe the various types of organizations that provide health care services. This includes ambulatory care centres, hospitals, laboratories, etc. A high dependency unit (HDU) is an area for patients 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. 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. A statistical measure of the performance of functions, systems or processes overtime. For example, hospital

Hazardous waste

Health care organization

High dependency unit

In service education/training

Indicator

acquired infections rate, mortality rate, ceasearian section rate, absence rate, etc. Information Intent Processed data which lends meaning to the raw data. A brief explanation of the rational, meaning and significance of the standards laid down in a particular chapter. 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. 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. 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. 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.

Inventory control

Isolation

Job description

Job specification

Laws

Medical audit Medical equipment Mission

Monitoring

Legal document setting forth the rules governaning a particular kind of activity e.g. organ transplantation act which governs the rules for undertaking organ transplantation. A peer review carried out by analysis of medical records with a view to improve the quality of the patient care Any fixed or portable non drug item or appartus used for diagnosis, treatment, monitoring and direct care of patient. A written expression that sets forth the purpose of the organization. It usually precedes the formation of goals and objectives The performance and analysis of routine measurements aimed at identifying and detecting changes in the health status or the environment, e.g. monitoring of growth and nutritional status, air quality in operation theatre. It requires careful planning

Multi-disciplinary Nosocomial/hospital acquired/hospital associated infection (s)

Notifiable disease

Objective element

Occupational health hazard Organ gram Outsourcing

Patient care setting Patient record/medical record/clinical

and use of standardized procedures and methods of data collection. A generic term which include representatives from various disciplines, profession or service areas. 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: hospitalacquired-infection).(www.hardydignostics.com/glossary N.html) 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 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. 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. A graphic representation of reporting relationship in an organization. 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. The location where a patient is provided health care as per his needs e.g. ICU, specialty ward, private ward and general ward. 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 Performance appraisal

Plan of care

Policies Privileging

Procedure

Process Program Protocol Quality

Quality assurance

Re-assessment Resources

Restraints

Risk management Safety

notes and discharge summary. (Death certificate where required) It is the process of evaluating the performance of employees during a defined period of time with the aim of ascertaining their suitability for the job, potential for growth as well determining training needs. 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 individuals 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. They are the guidelines for decision making, e.g. admission, discharge policies, antibiotic policy, etc. It is the process for authorizing all medical professional to admit and treat patients and provide other clinical services commensurate with their qualifications and skills 1. 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. A Set of interrelated or interacting activities which transforms inputs into outputs (Para 3.4.1 of ISO 9000:2000) A sequence of activities designed to implement policies and accomplish objectives A plan or a set of steps to be followed in a study, an investigation to an intervention. 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. Part of quality management focused on providing confidence that quality requirements will be fulfilled. (Para 3.2.11 of ISO 9000:2000) It implies continuous and on-going assessment of the patient which are recorded in the medical records as progress notes. 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 Devices used to ensure safety by restricting and controlling a persons 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. Clinical and administrative activities to identity evaluate and reduce the risk of injury. 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 Security Sedation

Range of clinical and supportive activities that are provided by an healthcare organizations. Protection from loss, destruction, tampering, and unauthorized access or use 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. 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. 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. All personnel working in the organization either as full paid employees or as consultants on honorarium basis 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 Dont touch or use anything that has the victims 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 A statement of expectation that defines the structures and

Sentinel events*

Social responsibility

Staff Standard Precautions

Standards

Sterilization

Surveillance

Unstable patient Validation

process that must be substantially in place in an organization to enhance the qualify of care. It is the process of killing or removing microorganisms including their spores by thermal, chemical or irradiation means. 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 Patient whose vital parameters need external assistance for their maintenance. 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 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.

Vulnerable Patient

*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