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 organization’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 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 organization’s 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 CLINIC’s 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 CLINIC’s 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 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’.
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 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.

Principal Assessor shall compile the observations from the assessors (HAF 2) and
summary on non-compliance (HAF 3) from all the assessors.
The Principal 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 CLINIC.

In addition to the above, Principal 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 CLINIC.
 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 7

4.4 Closing Meeting

The Principal Assessor and other assessors shall have a meeting with the CLINIC
representatives. A copy of the report – summary of non-conformances (HAF 3) shall
be handed over to the Clinic.

The closing meeting is to end with thanks giving for the co-operation and assistance
provided by the organization.

4.5 Post Assessment

Principal Assessor shall send the report to NABH at the earliest.

NABH secretariat reviews the assessment report and seeks clarification and
documentation from the Principal Assessor and 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 CLINIC.
- feedback on performance of other assessors by the Principal Assessor.
 ASSESSMENT SCHEDULE- HAF 1

Name & address of CLINIC:

Accreditation Coordinator: Date(s) of Visit:

Type of Visit: Assessment / Surveillance / Re-Assessment / Verification

Assessment Standard: NABH Standards for Clinic (strike off which is not applicable)

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: Principal 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)

Schedule of Department/ Section/ Activity to be Assessed (date

Name and Expertise wise)
of the Assessor Day 1 Day 2 Day 3
Morning Afternoon Morning Afternoon Morning Afternoon
Principal Assessor

Assessor 1

Assessor 2

Signature of Principal Assessor

 ASSESSOR’S OBSERVATIONS- HAF 2

Name of CLINIC:
Date: Area/ Department: Activity Assessed:
Auditee:

Sl. OBSERVATION REMARKS

Signature & Name of Assessor

 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)

CLINIC:

Date: Type of Assessment: Assessment / Surveillance / Re-Assessment / Verification

Non-compliance observed:
1.

Signature & Name of CLINIC Representative Signature & Name of Assessor

 SUMMARY OF THE ASSESSMENT- HAF 4

Clinic (Centre)name & address:

Accreditation Coordinator: Date(s) of Visit:
Type of Visit: Assessment / Surveillance / Re-Assessment / Verification
Principal Assessor: Assessor 1: Assessor 2:
Assessor 3: Assessor 4: Assessor 5:
Assessor 6: Other/TE Observer:
Date of earlier visit and
Purpose:
ASSESSMENT SUMMARY:

Enclosures HAF 1 HAF 2 HAF 3 HAF 4

Date by which deficiencies are to be discharged by the organization

Acknowledgement by Authorised Signatory of Signature of Principal Assessor & Date

Organization & Date
 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 Principal Assessor / Assessor / Technical Expert / Observer

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
Clinic in any way.

ii. 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.

iii. 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.

iv. I got an opportunity to go through various documents of the above 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