NABH-AG ASSESSOR GUIDE FOR PANCHAKARMA CLINIC. Issue No. 04 Issue Date: 05/15 Page 1 of 13

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1 NABH-AG ASSESSOR GUIDE FOR PANCHAKARMA CLINIC Issue No. 04 Issue Date: 05/15 Page 1 of 13

2 CONTENTS Sl. Title Page Nos. Content 2 1. Introduction 3 2. Role of Assessment team Pre-Assessment 5 4. On-site Assessment Feedback 8 HAF 1 to HAF Declaration of Impartiality, Confidentiality and Integrity (NABH I&C 01) 13 Issue No. 04 Issue Date: 05/15 Page 2 of 13

3 1 INTRODUCTION Accreditation is an incentive to improve capacity of Heath Care Organisations to provide quality of care. The National Accreditation Board for Hospitals and Healthcare Providers (NABH) provides third-party accreditation to Health Care Organizations in India. It ensures that Panchakarma Clinic, whether public or private, national or expatriate, play their expected role in national heath system. Country and culture specific accreditation system safeguard the country health care system and also involve fewer cost and better accepted as compare to external international accreditation systems. The assessment is carried out by a team of NABH empanelled Assessors. The assessment is carried out systematically for comprehensive review of Panchakarma Clinic services, functions and Panchakarma Clinic s quality management system. The objective evidence so collected forms the basis: for arriving at a judgment for recommendation of the team, to the Accreditation Committee for formulating the advice to assist the Panchakarma Clinic in its development. The objective of the assessment, however, is not to compile non-conformances/ deficiencies as an evidence to justify denial of accreditation. This guide has been prepared based on the general practices followed by international bodies and the experience of experts of the country. This document accordingly aims to: a. Provide the guidance to the Assessors during the assessment of Panchakarma Clinic b. Ensure uniformity of assessment and reporting, and c. Eliminate ambiguities or doubts about the interpretation of requirements(s). 2 ROLE OF ASSESSMENT TEAM The role of NABH Assessment team is to conduct on-site assessment of applicant Panchakarma Clinic and provide the report to NABH. The objective of the on-site assessment is to obtain evidence on compliance with respect to NABH standards and other policy documents. Since Panchakarma Clinic accreditation requires compliance with NABH Panchakarma Clinic Standards the assessment team should consider conformances against these standards in the assessment. Thus, the members of the assessment team would be required to exercise their scientific judgmental skill and form their opinion regarding extent of conformance with respect to accreditation criteria. Notwithstanding the strength of the NABH system, the success of the accreditation scheme depends on the assessment team who perform on-site assessment and, thus, play a vital role in determining the credibility and value of the accreditation. Issue No. 04 Issue Date: 05/15 Page 3 of 13

4 The assessment team consists primarily of Assessor. However, in some cases a technical expert may join the team to support on specific area. Team members are required to maintain the confidentiality on the matters/ subjects related to health care organizations. Role of Assessor Before the start of Assessment the Assessor should prepare an Assessment schedule in HAF 1 which should include the departments/ sections/ areas/ activities to be assessed and assignment to various Assessors based on their expertise. The schedule shall be presented to the Panchakarma Clinic representative. The Panchakarma Clinic will be requested to assign guide/ co-coordinator to accompany each assessor during the assessment. The Assessor must review the Panchakarma Clinic s documented Management System to verify compliance with the requirements of NABH standards. He should assess that the documented Management System is indeed implemented & effective, as described and record observations in HAF 2. All Non-Conformance(s) must be identified and reported, separately on each sheet in HAF 3. Assessor would finally summarise the conduct of Assessment and record the recommendations in HAF 4. If, during Surveillance or Re-assessment, a case of critical system failure and gross negligence in technical aspects is noticed, the Assessor will at the earliest inform NABH and elaborately bring it out in the Assessment summary (HAF-4) of assessment report. The Assessor must sign all pages of the assessment report. He must get an endorsement from the Panchakarma Clinic on HAF 4 and hand over a photocopy of the forms HAF 3 & 4 to the Panchakarma Clinic to enable them to take corrective actions. The Assessor is also required to monitor the performance of the Trainee Assessor. He shall recommend whether the Trainee Assessor is capable to perform the role of an Assessor in his next visit. His comments/ rating for each Assessor shall be enclosed with the report. The Assessor should clearly understand the areas/ activities to be assessed by him. He must review the Panchakarma Clinic documented system to verify compliance with the requirements of NABH standards. He should assess to verify that the documented SOPs, records are indeed implemented & effective, as described and record observations in HAF 2. Issue No. 04 Issue Date: 05/15 Page 4 of 13

5 Role of Technical Expert The role of Technical Expert is same as of an Assessor. He will provide technical assistance to the team and he will seek guidance of Assessor in filling the relevant forms. Role of Trainee Assessor The Trainee Assessor (Potential Assessor) will be assigned to accompany the Assessor as per the schedule provided to him. The Assessor shall guide him. He is not involved in assessment directly but supports the assessment as assigned by the Assessor. He is not entitled for payment of any honorarium. 3. PRE-ASSESSMENT NABH Secretariat on intimation from the organization about the preparedness to take up pre-assessment, appoints a Assessor from the pool of empanelled Assessors from assessor database. Scope and type of the Panchakarma Clinic is kept in mind while selecting the Assessor. For carrying out the pre-assessment, Assessor may also be accompanied with other assessors. The number of assessors depends on the size of the Panchakarma Clinic. The name of assessor(s) and the names of their organizations from which they belong are intimated to the organization for seeking their consent. Following documents are provided to the assessment team for carrying out the assessment: - Copy of application form of the organization - Copy of self assessment toolkit submitted - Quality Manual (however named) and other NABH related documents (department manuals, SOPs) - Pre-Assessment Guidelines and Forms - Confidentiality form (NABH I&C 01) - Travel expenditure form Pre-assessment is carried out to check the preparedness of the organization to undergo assessment and to review the scope of accreditation. The Assessor s major role is to explain the purpose of the assessment. He/ She explains to the organisation the methodology adopted by his/ her team during the assessment. Things are discussed in detail with the management of the organization during the opening meeting of the pre-assessment. The detailed guidelines for the assessors for carrying out Pre-Assessment is described in NABH document Pre-Assessment Guidelines and forms. Issue No. 04 Issue Date: 05/15 Page 5 of 13

6 4 ON-SITE ASSESSMENT A similar methodology as used in the Pre-Assessment is followed in comprising the team for final assessment of the organization. The number of assessors depends on the size of the Panchakarma Clinic. The assessor(s) and the names of their organizations from which they belong are intimated to the organization for seeking their consent. NABH also assures that the team does not have any competitive position with the applicant organization. NABH also ensures that assessors do not have any direct/ in-direct relationship with the organization or they/ or their organization. Consent is obtained for the date(s) of the assessment of the organization from the Assessor and other assessors accompanying for the assessment. A written communication is sent to all the team members with the following documents: - Application form of the organization - Pre-Assessment report - Corrective action report - Self assessment submitted by the organization - Panchakarma Clinic manuals/ documents submitted by the organization - Confidentiality form (NABH I&C 01) - Travel expenditure form Assessment Team shall meet and plan assessment programme. This shall include the distribution of work amongst the Assessors. The format of the assessment schedule to be finalised is given at HAF Opening Meeting (a) (b) (c) (d) Assessor and the team shall have an opening meeting with Panchakarma Clinic representatives where they get acquainted with the Panchakarma Clinic, departments/ sections and their locations. The Assessors shall explain the objective and scope of assessment and what is expected from the Panchakarma Clinic during the assessment. The Assessor shall present the assessment schedule (HAF 1) to Panchakarma Clinic representatives. The Panchakarma Clinic will be requested to assign guide/ co-coordinator to accompany each Assessor. The Assessor shall inform the Panchakarma Clinic that the assessment team shall not be approached by the Panchakarma Clinic for closure of nonconformances while the assessment is in progress. Non-conformances may be closed while the assessment report is being compiled. Issue No. 04 Issue Date: 05/15 Page 6 of 13

7 4.2 Assessment The assessment activities include: - Orientation of assessors to the organization s services The assessment procedure will start with an opening meeting. The assessors will introduce themselves and explain the assessment process. Any changes to assessment agenda will also be discussed. - Document review Document review includes review of polices, evidence of compliance with policies, evidence of committees and evidence of statements. - Functional interview Leadership interview. Infection control interview. Management of information/ patient records interview. Staff qualification and education interview. - Visit to patient care areas and selected department The surveyor will evaluate the process for patient care in different setting across the organization. - Facility tour - Special interview/ issue resolution 4.3 Compilation of assessment report The Assessment Report should consist of various documents in the order as indicated in HAF 4. Each form or checklist should be carefully filled in. The pages should be serially numbered. Assessor shall compile the observations from the assessors (HAF 2) and summary on non-compliance (HAF 3) from all the assessors. The Assessor shall give the summary of the assessment in his final report (HAF 4). The reports shall be signed by the authorized signatory of the Panchakarma Clinic. In addition to the above, Assessor in consultation with the team members shall fill up the score sheet and send it to NABH along with report. This remains a confidential document and copy should not be given to the Panchakarma Clinic. Issue No. 04 Issue Date: 05/15 Page 7 of 13

8 Guidelines for evaluation are as follows: Assessment is based on the scoring on a scale of 0, 5 and 10 as per the following details. Compliance to the requirement : 10 Partial compliance to the requirement : 5 (if any of the sample is found to be non co out of total samples selected) Non-compliance to the requirement : 0 Not Applicable : NA Assessor has to provide details of deficiency both in the case of non-compliance as well as partial compliance. Evaluation criteria: No individual standard should have more than one zero to qualify. However, no zero is accepted in the regulatory/legal requirements. The average score for individual standard must not be less than 5. The average score for individual chapter must not be less than 7. The overall average score for all standards must exceed Closing Meeting The Assessor and other assessors shall have a meeting with the Panchakarma Clinic representatives. A copy of the report summary of non-conformances (HAF 3) shall be handed over to the Panchakarma Clinic. The closing meeting is to end with thanks giving for the co-operation and assistance provided by the Panchakarma Clinic. 4.5 Post Assessment Assessor shall send the report to NABH at the earliest. NABH secretariat reviews the assessment report and seeks clarification and documentation from the Assessor and Panchakarma Clinic, if required. NABH, on receipt of evidence of corrective action, if any, shall place the report before the Accreditation Committee for its consideration for accreditation. The assessment report is reviewed by the Accreditation Committee and recommendations made. 5 FEEDBACK Following feedbacks are obtained by NABH through the evaluation forms in the NABH document Feedback Forms. - feedback on performance of the assessment team is obtained from the Panchakarma Clinic. - feedback on performance of other assessors by the Assessor. Issue No. 04 Issue Date: 05/15 Page 8 of 13

9 Name & address of Panchakarma Clinic: ASSESSMENT SCHEDULE- HAF 1 Accreditation Coordinator: Date(s) of Visit: Type of Visit: Assessment / Surveillance / Re-Assessment / Verification Assessment Standard: NABH Standards for Panchakarma Clinic Assessment Timings Opening/Closing Meeting Daily Debriefing Date/Time Date / Time (at the end of each day) Morning: AM to PM Opening Meeting: Day 1: Afternoon: PM to PM Closing Meeting: Day 2: Day 3: Assessment schedule: Assessor to provide details of activities taken up by individual assessors/ technical expert in the following format and obtained their signature. (Separate sheets may be used for individual assessors) Name and Expertise of the Assessor Assessor 1 Schedule of Department/ Section/ Activity to be Assessed (date wise) Day 1 Day 2 Day 3 Morning Afternoon Morning Afternoon Morning Afternoon Assessor 2 Assessor 3 Assessor -- Trainee Assessor/Expert Signature of Assessor Issue No. 04 Issue Date: 05/15 Page 9 of 13

10 ASSESSOR S OBSERVATIONS- HAF 2 Name of Panchakarma Clinic: Date: Area/ Department: Activity Assessed: Auditee: Sl. OBSERVATION REMARKS Signature & Name of Assessor Issue No. 04 Issue Date: 05/15 Page 10 of 13

11 ASSESSOR S SUMMARY ON NON-COMPLIANCE- HAF 3 (For each non-compliance, refer observation no. from HAF 2 and NABH std. no. against which non-compliance is being raised) Panchakarma Clinic: Date: Type of Assessment: Assessment / Surveillance / Re-Assessment / Verification Non-compliance observed: 1. Signature & Name of Panchakarma Clinic Representative Signature & Name of Assessor Issue No. 04 Issue Date: 05/15 Page 11 of 13

12 SUMMARY OF THE ASSESSMENT- HAF 4 Panchakarma Clinic name & address: Accreditation Coordinator: Date(s) of Visit: Type of Visit: Assessment / Surveillance / Re-Assessment / Verification Assessor1: Assessor 2: Other/TE: Trainee Assessor : Date of earlier visit and Purpose: ASSESSMENT SUMMARY: Enclosures HAF 1 HAF 2 HAF 3 HAF 4 Acknowledgement by Authorised Signatory of Panchakarma Clinic & Date Signature of Assessor & Date Issue No. 04 Issue Date: 05/15 Page 12 of 13

13 NABH I&C-01 DECLARATION OF IMPARTIALITY, CONFIDENTIALITY & INTEGRITY (to be filled in by each Assessor and enclosed with the Assessment report) Name Assessor ID : (To be filled in by NABH Sect.) Designation Organisation Address Capacity Assessor / Technical Expert / Trainee Assessor Health care organisation Assessed Date of visit(s) Type of visit Pre-assessment/ Assessment / Surveillance / Re-Assessment / Verification I, hereby declare that i. I have not offered any consultancy, guidance, supervision or other services to the Panchakarma Clinic in any way. ii. iii. iv. I am/ am not* an ex-employee of the health care organization and am/ am not* related to any person of the management of the health care organization. I will declare to the Board my and/ or my immediate family s association with any of the organization that can affect the impartiality of the assessment process. I shall also keep the Board informed about changes in the status of my association with the organization before every assignment. I got an opportunity to go through various documents of the above Panchakarma Clinic and other related information that might have been given by NABH. I undertake to maintain strict confidentiality of the information acquired in course of discharge of my responsibility and shall not disclose to any person other than that required by NABH. * strike out which is not applicable Date: Place : Signature Issue No. 04 Issue Date: 05/15 Page 13 of 13