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ASSESSOR GUIDE
FOR
BLOOD BANKS/ BLOOD CENTRES
Issue No. 3
Page 1 of 14
Contents
Sl.
Title
Page No.
Contents
1.
Introduction
2.
3.
4.
Pre-Assessment
5.
On-Site Assessment
10
11
13
6.
Assessor Checklist
14
7.
81
Issue No. 3
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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 formulating the advice to assist the blood bank in its development.
a.
Provide the guidance to the Assessors during the assessment of blood banks/ blood
centres.
b.
c.
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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 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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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.
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 review the scope of accreditation and ascertain the requirement of the number of
assessors and duration for the 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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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:
-
Quality Manual
Pre-Assessment report
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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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.
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Accreditation Coordinator:
Date(s) of Visit:
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
Day 1
Morning
Afternoon
Day 2
Morning
Day 3
Afternoon
Morning
Afternoon
Principal Assessor
Assessor 1
Assessor 2
Assessor -Observer/Expert
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Area/ Department:
Activity Assessed:
Auditee:
Sl.
OBSERVATION
REMARKS
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Date:
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Blood Bank:
NABH Std.
Clause No.
Date(s) of Visit:
NABH Standard Requirements
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
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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.
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Date(s) of Visit:
Assessor 1:
Assessor 2:
Assessor 3:
Other/TE
Observer:
Enclosures
BAF
BAF 2
BAF
BAF 4
BAF 5
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NABH I&C_BB 01
Name
Assessor ID
Designation
Organisation
Address
Capacity
Health care
organisation Assessed
Date of visit(s)
Type of visit
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.
Date:
Place :
Issue No. 3
Signature
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