NABH-AG (BB)

ASSESSOR GUIDE
FOR
BLOOD BANKS/ BLOOD CENTRES

Issue No. 3

Issue Date: 06/ 12

Page 1 of 14

Assessor Guide for Blood Banks/ Blood Centres NABH-AG (BB)

Contents
Sl.

Title

Page No.

Contents

1.

Introduction

2.

Role of Assessment Team

3.

Adequacy of Quality Manual

4.

Pre-Assessment

5.

On-Site Assessment

BAF 1 Assessment Schedule

BAF 2 Assessors Observation

BAF 3 Summary on Non-Conformities

10

BAF 4 Consolidated Non-Conformities

11

BAF 5 Summary of Assessment

13

6.

Assessor Checklist

14

7.

Declaration of Impartiality, Confidentiality and Integrity (NABH I&C_BB 01)

81

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Assessor Guide for Blood Banks/ Blood Centres NABH-AG (BB)

INTRODUCTION
Accreditation is an incentive to improve quality and safety of collecting, processing, testing,
transfusion and distribution of blood and blood products. The National Accreditation Board for
Hospitals and Healthcare Providers (NABH) provides third-party accreditation to Blood banks/
blood centres and transfusion services.
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 the
quality and operational systems within the facility. 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 blood bank in its development.

The objective of the assessment, however, is not to compile non-conformities/ 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 blood banks/ blood
centres.

b.

Ensure uniformity of assessment and reporting, and

c.

Eliminate ambiguities or doubts about the interpretation of requirements(s).

ROLE OF ASSESSMENT TEAM

The role of NABH Assessment team is to conduct on-site assessment of applicant blood
bank/ blood centre and provide the report to NABH.
The objective of the on-site assessment is to obtain evidence on compliance with respect to
NABH standards, applicable laws and regulations and guidelines.
Since blood bank accreditation requires compliance with NABH 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 performs on-site assessment and, thus, play a vital
role in determining the credibility and value of the accreditation.

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Assessor Guide for Blood Banks/ Blood Centres NABH-AG (BB)

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, Principal Assessor shall prepare an Assessment schedule in
BAF 1 which should include the departments/ sections/ areas/ activities to be assessed and
assignment to various Assessors based on their expertise. The Observer (Potential Assessor)
should also be guided about the conduct of assessment.
The Principal Assessor must review the blood bank/ blood centres documented Quality
System to verify compliance with the requirements of NABH Standards for Blood Bank/ Blood
Centre and Transfusion Services. He should assess that the documented Quality System is
indeed implemented & effective, as described and record observations in BAF 2. He should
also complete Checklist and record conclusion/ comments related to the requirements of
respective clause number. All Non-Conformity (ies) must be identified and reported,
separately on each sheet in BAF 3.
As a leader of the Assessment team, he would collect the reports and documents from all
Technical Assessors including his own report and compile it. Any Non-Conformity, which can
be closed, must be done at this stage. A consolidated statement of Non-Conformities raised
during the Assessment shall be listed in BAF 4. If, during Surveillance or Re-assessment, a
case of total 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 (BAF 5) of assessment report. He would finally summarise the conduct of
Assessment and record the recommendations in BAF 5. The Principal Assessor must sign all
pages of the assessment report.
He must get an endorsement from the blood bank on BAF 6 and hand over a photocopy of the
forms BAF 3, 4, and 5 to the blood bank 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 a
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 Blood banks documented system to verify compliance with the requirements of
NABH standards. He should assess to verify that the documented SOPs, test methods and
records are indeed implemented & effective, as described and record observations in BAF 2.
He should assist Principal Assessor in completing the Checklist. The report should be handed
over to the Principal Assessor along with expenditure claim form.

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Assessor Guide for Blood Banks/ Blood Centres NABH-AG (BB)

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.

ADEQUACY OF QUALITY MANUAL

NABH appoints Principal Assessor from the pool of empanelled assessors from assessor
database. Scope of the blood bank is kept in mind which selecting the Principal Assessor. The
name of Principal Assessor and assessor(s) and the names of their organisations from which
they belong are intimated to the organization for seeking their consent.
Principal Assessor appointed shall be responsible for adequacy of the quality manual and the
application form. The Principal Assessor shall inform NABH regarding inadequacies in the
quality manual, if any. The blood bank shall address to the inadequacies pointed out by the
Principal Assessor in their quality manual and implement the corrective actions in their
management system.

4.

PRE-ASSESSMENT
Earlier appointed Principal Assessor is responsible for conducting pre-assessment of blood
bank. NABH shall organize the pre-assessment of the blood bank in case there are no
inadequacies in the quality manual or when the blood bank has taken satisfactory the
corrective action. The blood bank shall ensure their preparedness by carrying out internal
audit and management review before the pre-assessment.
Objective of Pre-assessment:

to check the preparedness of the blood bank for final assessment

to review the scope of accreditation and ascertain the requirement of the number of
assessors and duration for the assessment

to review the documentation system

to explain the methodology to be adopted for assessment

The Principal assessor shall submit a pre-assessment report in the format specified in the
document Pre-Assessment Guidelines & Forms. Copy of the report is handed over to the
blood bank after the assessment and original sent to NABH Secretariat.

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Assessor Guide for Blood Banks/ Blood Centres NABH-AG (BB)

5.

ON-SITE ASSESSMENT
A similar methodology as used in the Pre-Assessment is followed in comprising the team for
final assessment of the blood bank/ blood centre. The number of assessors depends on the
size and activities of the blood bank.
The assessor(s) and the names of their organizations from which they belong are intimated to
the blood bank 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

Quality Manual

Pre-Assessment report

Corrective action report

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
finalized is given at BAF-1.

5.1

Opening Meeting
(a)

Principal Assessor and the team shall have an opening meeting with blood bank
representatives where they get acquainted with the blood bank, departments/ sections
and their locations.

(b)

The Principal Assessors shall explain in his opening remarks that the object of the
assessment is to assess the work of the blood bank according to the NABH standards.
He shall make it clear as to what is expected from the blood bank during the
assessment.

(c)

The Principal Assessor shall present the assessment schedule (BAF 1) to blood bank
representatives. The blood bank will be requested to assign guide/ co-coordinator to
accompany each Assessor.

(d)

The Principal Assessor shall inform the blood bank that the assessment team shall not
be approached by the blood bank for closure of non-conformities while the
assessment is in progress. Non-conformities may be closed while the assessment
report is being compiled.

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Assessor Guide for Blood Banks/ Blood Centres NABH-AG (BB)

5.2

Assessment
The assessment activities include:

5.3

The Assessment Team shall proceed to various sections/ department of the blood bank as
planned earlier.

The Assessor(s) should verify the effectiveness of Quality System and related documents
using audit techniques and shall raise non-conformities. The Principal Assessor shall use
BAF 2 to record the findings.

The Assessor(s) should also thoroughly examine the technical competence of the blood
bank in terms of manpower, qualification, experience, upto date knowledge, equipment
and other related elements.

The object of assessment is to ascertain by observations of the activities whether the work
of the blood bank is being carried out in accordance with the NABH Standards on Blood
Banks/ Blood Centres and Transfusion Services. Assessor shall record detailed nonconformities as they occur on BAF 3. Each non-conformity shall be countersigned by the
accompanying blood bank representative.

During assessment, Assessors would discuss with the management representative of the
blood bank whether the blood bank is participating in the External Quality Assurance
Scheme (EQAS)/ Proficiency Testing Programme/ Inter-Laboratory Comparison
Programme. They would look for their performance and action taken if the performance
was unsatisfactory.

The Checklist provided should be verified and completed during the course of the
assessment of the blood bank. Checklist are like aid memoir to Assessors so that all
aspect of the blood bank Quality System and technical criteria are taken care of.

Compilation of assessment report

The Assessment Report should consist of various documents in the order as indicated in
BAF 5. Each form or checklist should be carefully filled in. The pages should be serially
numbered.
Principal Assessor shall compile the observations from the assessors (BAF 2) and summary
on non-compliance (BAF 3) from all the assessors.
The Principal Assessor shall give the summary of the assessment in his final report
(BAF 5). The reports shall be signed by the authorized signatory of the blood bank.
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 blood bank.

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Assessor Guide for Blood Banks/ Blood Centres NABH-AG (BB)

ASSESSMENT SCHEDULE - BAF 1

Name & address of Blood bank/ blood centre:

Accreditation Coordinator:

Date(s) of Visit:

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

Assessment Standard: NABH standards on Blood Banks/ Blood Centres and Transfusion
Services
Assessment Timings

Morning:
Afternoon:

AM to
PM to

Daily Debriefing
/ Time
(at the end of each day)
Day 1:
Day 2:
Day 3:

Opening/Closing Meeting
Date/Time
PM
PM

Opening Meeting:
Closing Meeting:

Date

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 wise)
Name and Expertise
of the Assessor

Day 1
Morning

Afternoon

Day 2
Morning

Day 3

Afternoon

Morning

Afternoon

Principal Assessor

Assessor 1
Assessor 2
Assessor -Observer/Expert

Signature of Principal Assessor

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Assessor Guide for Blood Banks/ Blood Centres NABH-AG (BB)

ASSESSORS OBSERVATIONS - BAF 2

Name of Blood bank/ blood centre:
Date:

Area/ Department:

Activity Assessed:

Auditee:
Sl.

OBSERVATION

REMARKS

Signature & Name of Assessor

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Assessor Guide for Blood Banks/ Blood Centres NABH-AG (BB)

ASSESSORS SUMMARY ON NON-CONFORMITY - BAF 3

(Please use separate sheet for raising each Non-Conformity)

Blood bank/ blood centre:

Date:

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

NON-CONFORMITY (NC) RAISED:

Ref to NABH Std. on Blood Bank Clause No.

Classification of NC: MAJOR / MINOR

Signature & Name of Blood bank/ blood centre

Representative

Signature & Name of Assessor

CORRECTIVE ACTION TAKEN/ PROPOSED BY THE BLOOD BANK:

Signature & Name of Blood bank/ blood centre Representative

REMARKS BY ASSESSOR, IF ANY:

Signature & Name of Assessor

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Assessor Guide for Blood Banks/ Blood Centres NABH-AG (BB)

CONSOLIDATED NON-CONFORMITIES - BAF 4

Page 1 of 2

Blood Bank:
NABH Std.
Clause No.

Date(s) of Visit:
NABH Standard Requirements

No. of Non-Conformities raised

during Assessment
MAJOR

1
1.1
1.2
1.3
1.4
1.5
2
2.1
2.2
2.3
2.4
3
3.1
3.2
3.3
3.4

3.5
3.6
3.7
3.8
3.9
4
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
5
5.1
5.2
5.3
Issue No. 3

MINOR

Organisation & Management

Legal identity
Responsibility
Ethics in blood bank/ blood center
Management system
Policies, processes and procedures
Accommodation and environment
Space allocation
Environment Control
Biological, Chemical and Radiation Safety
Internal Communication System
Personnel
Personnel requirement
Qualification
Job description/ responsibilities
Responsibilities of Medical Director/ In-charge/
Medical Officer, Technical Manager and Quality
Manager
Training
Competence
Personnel health
Personnel records
Confidentiality of information
Equipment
Equipment requirement
Selection and validation of equipment
Use of equipment
Equipment detail record, unique identification
Programme for calibration and maintenance of
equipment
Equipment for storage of blood and component
Computer system
Breakdown of equipment
External Services and supplies
Policies and procedures for suppliers selection
Inventory control
Evaluation of suppliers
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Assessor Guide for Blood Banks/ Blood Centres NABH-AG (BB)

Page 2 of 2

6
6.1
6.2
6.3
6.4
6.5
6.6
6.7
6.8
6.9
6.10
6.11
6.12
6.13
7
7.1
7.2
7.3
8
8.1
8.2
8.3
9
9.1
9.2
9.3
10
10.1
10.2
10.3
11
11.1
11.2
11.3
11.4

Process Control
Policies and validation of processes and procedures
Donor laboratory
Component Laboratory
Quarantine and Storage
Labelling
Testing of Donated Blood
Compatibility Testing
Transfusion Reaction and Evaluation
Documentation in Transfusion Service
Histocompatibility Testing
Quality Control
Proficiency Testing Programme
Bio-medical waste disposal and laboratory safety in
blood bank/ blood centre
Identification of Deviations and Adverse Events
Polices and procedures when non-conformity is
detected
Procedures for release of non-conforming blood
component
Preventing recurrence of non-conformity
Performance Improvement
Addressing complaints
Corrective action
Preventive action
Document Control
Procedure for document control and review of
documents
Document required
Maintenance of documents in computer software
Record
Record identification
Quality and technical records
Record retaining period
Internal Audit and Management Review
Policy for internal audit and management review
Procedure of internal audit
Procedure of management review
Documentation of internal audit and management
review

The non-conformities raised during the assessment are as a result of limited sampling and therefore it shall
not be assumed that other non-conformities do not exist.

Sig. & Name of Authorised Signatory of Blood bank

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Sig. & Name of Principal Assessor

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Assessor Guide for Blood Banks/ Blood Centres NABH-AG (BB)

SUMMARY OF THE ASSESSMENT - BAF 5

Blood Bank name & address:
Accreditation Coordinator:

Date(s) of Visit:

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

Principal Assessor:

Assessor 1:

Assessor 2:

Assessor 3:

Other/TE

Observer:

Date of earlier visit and

Purpose:
ASSESSMENT SUMMARY:

Recommendation by the team:

Enclosures

BAF

BAF 2

BAF

BAF 4

BAF 5

Date by which deficiencies are to be discharged by the blood bank:

Acknowledgement by Authorised Signatory of

blood bank & Date

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Signature of Principal Assessor & Date

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Assessor Guide for Blood Banks/ Blood Centres NABH-AG (BB)

NABH I&C_BB 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 Blood Bank 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 familys 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 Blood Bank 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 :

Issue No. 3

Signature

Issue Date: 06/ 12

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