NABH ASSESSOR GUIDE FOR ACCREDITATION PROGRAMME FOR CLINIC-ALLOPATHY

Issue 02 June 2012

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 Clinic (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, lead by a Principal Assessor. The assessment is carried out systematically for comprehensive review of Clinic, functions and organizations 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 organization 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 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 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 for Clinic and other policy documents.

Since Clinic accreditation requires compliance with NABH Standards for Clinic, 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.

The assessment team consists primarily of Principal Assessor and 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 Principal Assessor

Before the start of Assessment the Principal 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 organizations accreditation coordinator/ representative. The organization will be requested to assign guide/ co-coordinator to accompany each assessor during the assessment. The Principal Assessor must review the CLINICs documented Management System to verify compliance with the requirements of NABH standards for Clinic. 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.

Principal 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 Principal Assessor will at the earliest inform NABH and elaborately bring it out in the Assessment summary (HAF-4) of assessment report. The Principal Assessor must sign all pages of the assessment report. He must get an endorsement from the organization on HAF 4 and hand over a photocopy of the forms HAF 3 & 4 to the organization to enable them to take corrective actions. The Principal Assessor is also required to monitor the performance of Assessor(s) and the Observer. He shall recommend whether the Observer 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.

Role of Assessor

The Assessor should clearly understand the areas/ activities to be assessed by him. He must review the CLINICs documented system to verify compliance with the requirements of NABH standards for Clinic. He should assess to verify that the documented SOPs, records are indeed implemented & effective, as described and record observations in HAF 2. The report should be handed over to the Principal Assessor along with expenditure claim form.

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 Principal Assessor in filling the relevant forms. Role of Observer The Observer (Potential Assessor) will be assigned to accompany the Principal Assessor as per the schedule provided to him. The Principal Assessor shall guide him. He is not involved in assessment directly but supports the assessment as assigned by the Principal 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 Principal Assessor from the pool of empanelled Assessors from assessor database. Scope and type of the Clinic is kept in mind while selecting the Principal Assessor. For carrying out the pre-assessment, Principal Assessor may also be accompanied with assessors. The number of assessors depends on the size of the size and type of modality of the CLINIC. The name of Principal Assessor and 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 Principal Assessors 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.

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 organization. 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 Principal 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

- 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-1.

4.1 Opening Meeting

(a) Principal Assessor and the team shall have an opening meeting with CLINIC representatives where they get acquainted with the CLINIC, departments/ sections and their locations.

(b) The Principal Assessors shall explain the objective and scope of assessment

and what is expected from the CLINIC during the assessment. (c) The Principal Assessor shall present the assessment schedule (HAF 1) to

CLINIC. The CLINIC will be requested to assign guide/ co-coordinator to accompany each Assessor.

(d) The Principal Assessor shall inform the CLINIC that the assessment team

shall not be approached by the organization for closure of non-conformances while the assessment is in progress. Non-conformances may be closed while the assessment report is being compiled.

4.2 Assessment The assessment activities include:

- Orientation of assessors to the organizations services

The assessment procedure will start with an opening meeting. The assessors will introduce themselves