Asignment

Indicators Parameters
1 Mortality ICU:Crude , Severity adjusted, Disease based
Hospital mortality
2 Morbidity Incidence Of:
Accidental extubation,Reintubation in planned
extubated patients, pneumothorax,
Unanticipated cardiac arrest, hypotension, renal failure
%Nosocomial infections (VAP , BSI,UTI)
%of patient with VRE, MRSA etc.
% of patients with GI bleed
Pressure sore, dental trauma, nerve & vascular injury.
ICU readmission within 24hours
3 Cost effectivity Patient/ICU day cost to the institution.
Actual expenditure on
Man power cost, capital equipment cost
Equipment maintenance, consumables,
Diagnostics, house keeping, electricity etc.
Overall expenditure in ICU Expense
(post ICU) in hospital Expense (post
hospital) after discharge Long term
survival and quality of life
Per survivor cost in ICU/ hospital / post discharge
4 Safety of patient Error reporting : incidence of different errors
complication rates related to care Number
of complications/ patient Incidence of

mishaps during transportation
% compliance to waste disposal
% compliance to hand hygiene protocol
Blood component therapy
Frequency of Noncompliance to protocol.
Antibiotic free stay ( days) in ICU
Antibiotic resistance & Drug resistant microbial
pattern
Broad spectrum antibiotic use/1000 patient days
Descalation in % of patients receiving antimicrobials- 26 -
Indicators Parameters
5 Safety of ICU personnel Number of needle stick injuries
Number injured while working
6 Man power Per Person training (in hours or days) /Yr
Appraisal of targets given.
Staff satisfaction and turnover rate
7 Resource utilization
Infrastructure
Equipment
ICU:
Number of patient managed, %bed occupancy,
Av. LOS, total occupied bed days,
% ICU patient ideally should be shifted but remaining in ICU
number of readmissions, fraction of patients
for whom ICU care is expected to be futile, number of X

rays done / 1000 patient days.
Average ventilatory days
Utilization in days or hours/ month
Downtime in days or hours/ month
ROI (Return on Investment) of individual equipment
8 Customer external
Internal Customer
% satisfaction level of patient/relatives
Number of negative and positive fee backs
Number of complains/ suggestions & number
addressed.
Satisfaction of others in the hospital with the care and
services supplied by the ICU.
9 Administrative Revenue generation
B ) Selection and action plan for implementation of indicat
The quality indicators applied hospital wide are:

1. Clinical Monitoring includes those aspects of patient assessment selected by the leaders
(Percentage of compliance with Pain assessment P and P)
2. Clinical monitoring includes those aspects of laboratory services selected b y the leaders
(Laboratory-machines and test quality control)
3. Clinical monitoring includes those aspects of radiology and diagnostic imaging services
selected by the leaders (Radiology-TLD check) (Radiology-Quality Control Reporting)
4. Clinical monitoring includes those aspects of surgical care selected by the leaders
(Returned to OR/DR within 24 hours after procedure)
5. Clinical monitoring includes those aspects of antibiotics and other medication use selected
by the leaders (a)Percentage of restricted antibiotic consumption) (b)Adverse drug reaction
(ADR)
6. Clinical monitoring includes of medication and near misses (Medication Error (ME)
7. Clinical monitoring includes the those aspects of anesthesia and sedation use selected by
the leaders (Moderate Sedation/Analgesia documentation in Anesthesia)
8. Clinical monitoring includes the those aspects of the use of blood and blood products
selected by the leaders
(a)Percent of compliance in reporting of blood and blood product transfusion reaction
(b)Percent of compliance with Blood and blood product Transfusion (cross
matched/transfusion Ratio)
(c)Percent of compliance with duration time Blood is transfused after release from blood
Bank)
9. Clinical monitoring includes the those aspects of availability, content and use of the
patient’s record selected by the leaders
(a) Percent of compliance with contents element of Medical record.
(b) Percent of compliance with MR availability in OPD
10. Clinical monitoring includes the those aspects of infection control, surveillance and
reporting selected by the leaders
(a) Nosocomial Infection rate related to patients stay in the ICU’s
(b) Nosocomial Infection rate related to devices
(c)Percent compliance with hand hygiene Policy
11. Clinical monitoring includes those aspects of clinical research selected by the leaders
(Not applicable)
12. Managerial monitoring includes those aspects of procurement of routinely required

supplies and medications essential to meet patient needs selected by the leaders
(Availability of essential medications within 48 hours)
13. Managerial monitoring includes those aspects of reporting of activities as required by

law and regulation selected by the leaders (Percent compliance with reporting time frame of
communicable diseases)
14. Managerial monitoring includes those aspects of risk management selected by the
leaders (Percent of action taken and completion of OVR)
15. Managerial monitoring includes those aspects of utilization management selected by the
leaders
(a)Percent of compliance with Average Length of Stay of most common diagnosis and
procedures)
(b)Percent of average length of stay by department/year
16. Managerial monitoring includes those aspects of patient and family expectation and
satisfaction selected by the leaders (Percent of complaints with patient satisfaction)
17. Managerial monitoring includes those aspects of staff expectation and satisfaction
selected by the leaders (Percent of staff expectation and Satisfaction)
18. Managerial monitoring includes those aspects of patients demographics and clinical
diagnoses selected by the leaders (Demographic Data)
(Percent patient seen in the OPD by specialty)
19. Managerial monitoring includes those aspects of financial management selected by the
leaders (Percent of cost for commissioned bed)
20. Managerial monitoring includes those aspects of the prevention and control of events
that jeopardize the safety of the patients, families and staff selected by the leaders,
including IPSG
(a)Percent of patient’s falls in the inpatients floors
(b)Percent of staff injury/Exposure to BBF)
What is the difference between accreditation, certification and licensure? Give an
example of each.
Accreditation refers to a process whereby a nongovernmental agency grants a recognized

status to an organization that has satisfied specific criteria. Accreditation is usually time specific
and the process is reviewed as defined by the granting agency. An example of accreditation is
when JCAHO (Joint Commission for Accreditation of Healthcare Organizations) visits a hospital
and reviews the facility for compliance to specific JCAHO criteria and if satisfied the hospital
receives JCAHO accreditation for a specific period of time.
Certification refers to an individual who is already licensed and ha s satisfied specific criteria
regarding specialized knowledge and/pr skills that are above the minimum entry level of
practice. An example of certification is when a nurse receives certification from the ANA
(American Nurses Association) for satisfying specific requirements (theory plus clinical practice)
in the area of defined clinical specialties such as medical-surgical nursing, obstetrical nursing or
advanced practice. Once certification is successfully attained, the nurse is required to continue
to meet criteria of specialization either through continuing education, practice or by
examination.
Licensure refers to minimum standards of competency that are set by a government agency
(state level) that are met by an individual that allows the capacity to function as a professional
nurse either through exam or by endorsement. Licensure requirements are initially satisfied and
then maintained via the process of license renewal by meeting specific criteria relative to
continuing education competency.
Role of medical audit
The aim of clinical audit is continuous improvement of the quality of care through systematic and critical review of
current practice against explicit criteria and the implementation of change if necessary. The audit is a regular
multidisciplinary activity by which all participants of care including doctors, nurses and other health professionals
carry out a systematic review of their own practice. Data collected during the process of audit should be handled with
care, and individual data concerning care-givers, patients or health professionals must be treated confidentially.
Clinical audit needs realistic timeframe and necessary resources as well as tolerant culture of learning organisations.
Furthermore the success of clinical audit depends on the commitment and support of the management of the
organisations. Clinical audit could relatively easily be embodied into the current practice of peer-review processes
and other quality improvement initiatives in Hungary. Widespread and systemic application of clinical audit may
improve the quality of patient care and maintain the trust of the population. However, clinical audit should be effective
and cost-effective. The recently published methodological guideline by the Ministry intends to promote good practice
in clinical audit.
What is clinical audit?
Clinical audit is by definition a quality improvement
process that seeks to improve patient care and
outcomes through systematic review of care
against explicit criteria and the implementation of
changes. Aspects of the structure, processes and
outcomes of care are systematically evaluated
against explicit criteria. Changes are implemented
where indicated at an individual, team or service
level and further monitoring is used to confirm
improvement in health care delivery [1,3].
Clinical audit ensures that what should be done is
being done. If it is not being done it provides a
framework to enable changes to be made to
improve the process.
WHY IS CLINICAL AUDIT IMPORTANT?

There are a number of reasons why clinical audit is an important activity. The main reason is that
it helps to improve the quality of the service being offered to users. Without some form of
clinical audit, it is very difficult to know whether you are practising effectively and even more
difficult to demonstrate this to others. The benefits of clinical audit are that it:
• identifies and promotes good practice and can lead to improvements in service delivery
and outcomes for users
• can provide the information you need to show others that your service is effective (and
cost-effective) and thus ensure its development
• provides opportunities for training and education
• helps to ensure better use of resources and, therefore, increased efficiency
• can improve working relationships, communication and liaison between staff, staff and
service users, and between agencies.
The overarching aim of clinical audit is to improve service user
outcomes by improving professional practice and the general
quality of services delivered

NABH-AG (BB)
Issue No. 1 Issue Date: 05/ 08 Page 1 of 81
ASSESSOR GUIDE
FOR
BLOOD BANKS/ BLOOD CENTRES Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Contents
Sl. Title Page No.
Contents 2
1. Introduction 3
2. Role of Assessment Team 3
3. Adequacy of Quality Manual 5
4. Pre-Assessment 5
5. On-Site Assessment 6
BAF 1 – Assessment Schedule 8
BAF 2 – Assessor’s Observation 9
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 Assessor Guide for
Blood Banks/ Blood Centres – NABH-AG (BB)
1 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).
2 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. 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 centre’s 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 bank’s 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. 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. Assessor Guide for Blood Banks/
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. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
5.2 Assessment
The assessment activities include:
- 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.
5.3 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. 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 Opening/Closing Meeting
Date/Time
Daily Debriefing Date
/ Time
(at the end of each day)
Morning: AM to PM
Afternoon: PM to PM
Opening Meeting:
Closing Meeting:
Day 1:
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 wise)
Day 1 Day 2 Day 3
Name and Expertise

of the Assessor
Morning Afternoon Morning Afternoon Morning Afternoon
Principal Assessor
Assessor 1
Assessor 2
Assessor --
Observer/Expert
Signature of Principal AssessorAssessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
ASSESSOR’S OBSERVATIONS - BAF 2
Name of Blood bank/ blood centre:
Date: Area/ Department: Activity Assessed:
Auditee:
Sl. OBSERVATION REMARKS
Signature & Name of AssessorAssessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
ASSESSOR’S 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 AssessorAssessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
CONSOLIDATED NON-CONFORMITIES - BAF 4
Page 1 of 2
Blood Bank: Date(s) of Visit:
NABH Std.
Clause No.
NABH Standard Requirements No. of Non-Conformities raised
during Assessment
MAJOR MINOR
1 Organisation & Management
1.1 Legal identity
1.2 Responsibility
1.3 Ethics in blood bank/ blood center
1.4 Management system
1.5 Policies, processes and procedures
2 Accommodation and environment
2.1 Space allocation

2.2 Environment Control
2.3 Biological, Chemical and Radiation Safety
2.4 Internal Communication System
3 Personnel
3.1 Personnel requirement
3.2 Qualification
3.3 Job description/ responsibilities
3.4 Responsibilities of Medical Director/ In-charge/
Medical Officer, Technical Manager and Quality
Manager
3.5 Training
3.6 Competence
3.7 Personnel health
3.8 Personnel records
3.9 Confidentiality of information
4 Equipment
4.1 Equipment requirement
4.2 Selection and validation of equipment
4.3 Use of equipment
4.4 Equipment detail record, unique identification
4.5 Programme for calibration and maintenance of
equipment
4.6 Equipment for storage of blood and component
4.7 Computer system
4.8 Breakdown of equipment

5 External Services and supplies
5.1 Policies and procedures for supplier’s selection
5.2 Inventory control
5.3 Evaluation of suppliers Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Page 2 of 2
6 Process Control
6.1 Policies and validation of processes and procedures
6.2 Donor laboratory
6.3 Component Laboratory
6.4 Quarantine and Storage
6.5 Labelling
6.6 Testing of Donated Blood
6.7 Compatibility Testing
6.8 Transfusion Reaction and Evaluation
6.9 Documentation in Transfusion Service
6.10 Histocompatibility Testing
6.11 Quality Control
6.12 Proficiency Testing Programme
6.13 Bio-medical waste disposal and laboratory safety in
blood bank/ blood centre
7 Identification of Deviations and Adverse Events
7.1 Polices and procedures when non-conformity is
detected
7.2 Procedures for release of non-conforming blood
component
7.3 Preventing recurrence of non-conformity
8 Performance Improvement
8.1 Addressing complaints
8.2 Corrective action
8.3 Preventive action
9 Document Control
9.1 Procedure for document control and review of
documents
9.2 Document required
9.3 Maintenance of documents in computer software
10 Record
10.1 Record identification
10.2 Quality and technical records
10.3 Record retaining period
11 Internal Audit and Management Review
11.1 Policy for internal audit and management review
11.2 Procedure of internal audit
11.3 Procedure of management review
11.4 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 Sig. & Name of Principal AssessorAssessor 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:
Enclosures BAF 1 BAF 2 BAF 3 BAF 4 BAF 5
Date by which deficiencies are to be discharged by the blood bank:
Acknowledgement by Authorised Signatory of
blood bank & Date
Signature of Principal Assessor & DateAssessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
ASSESSOR CHECKLIST
(To be filled in by the Principal Assessor)
NABH-Checklist
The following pages present a checklist of the criteria from Standards for Blood Bank/ Blood Centre
and Transfusion Services, which is the basis for the NABH requirements for accreditation of Blood
Bank/ Blood Centre. The Blood Bank/ Blood Centre’s policies and procedures must meet full
requirements of NABH requirements.
The Principal Assessor must complete this checklist, put initials on each page. The following symbols
may be used for completing this checklist.
++ = COMPLIANCE
+ = COMPLIANCE WITH REMARK
A = MAJOR NON-CONFORMITY
B = MINOR NON-CONFORMITY
NA = NOT APPLICABLE
BLANK = NOT ASSESSED
The Principal Assessor must review the blood bank’s documented system to verify conformity with
the requirements of NABH standards, assess to verify that the documented quality system is indeed
implemented as described, record conclusion/ comments related to any requirements on the space
provided or use the bottom of the page or use separate sheet(s). All non-conformities must be
identified and reported separately on each sheet of BAF-3. This checklist be submitted as a part of
the assessment report.
BLOOD BANK ASSESSED
CITY/ TOWN
ASSESSMENT DATE (S)
PRINCIPAL ASSESSOR’S
NAME
SIGNATURE
Major Non-Conformity: absence of which may result in total breakdown (commission, failure, not
implemented) of a system to meet NABH requirement. A number of minor
nonconformities against one requirement can represent a total breakdown
of the system and thus be considered a major nonconformity

Minor Non-Conformity: absence of which may not likely to result in the failure of the management
system or reduce its ability to assure controlled processes or products Assessor Guide for Blood Banks/
ASSESSOR CHECKLIST
(NABH Standards for Blood Bank/ Blood Centre and Transfusion Services)
(To be filled in by the Principal Assessor/ Assessor)
Clause Requirements of NABH Standards Documentation
Implementation
Remarks
1 ORGANISATION AND MANAGEMENT
1.1 Legal Identity
The blood bank/ blood centre:
- has valid license from Government authorities
- is legally identifiable.
1.2 Responsibility
The blood bank/ blood centre shall have:
- well defined organogram
- top management - well aware of regulations,
standards and laws
- defined responsibility within the centre.
1.3 Ethics in blood bank/ blood centre
Professional ethics shall prevail in the
organization and shall not engage in unethical

practices that are restricted by law.
1.4 Quality System
1.4.1 Responsibility for design, implementation,
maintenance and improvement of quality
management system, well defined.
1.4.2 The blood bank/ blood centre shall have a
Quality Manual with well defined:
- Quality policy & objective
- Quality management system.
The policy shall include the scope of services,
objective of quality management system with
management commitment to comply with
standards and local regulations. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Implementation
Remarks
1.4.3 The Quality Manual shall:
- describe the quality management system
- describe structure of the documentation used
in the quality management system
- refer to all supporting technical procedures
- be kept up dated under the authority of an
individual responsible for maintaining quality
management system
1.4.4 Personnel shall be instructed to familiarize
themselves with the quality management system
with use and application of quality manual and
referenced documents.
1.4.5 Quality Manual shall be under the authority of the
personnel who is responsible for maintaining
quality management system.
1.4.6 Top management shall:
- identify Quality Manager and Technical
Manager and deputies to implementation and
maintenance of quality management system
- define roles, responsibilities and authorities of
quality manager and technical manager
1.5 Policies, processes and procedures
Quality and operational policies, processes and
procedures shall be developed and implemented
to ensure compliance with the standards.
Director/ In-charge shall approve all policies,
process and procedures. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Implementation
Remarks
2 ACCOMMODATION AND ENVIRONMENT
2.1 Space Allocation
2.1.1 Location and surroundings
The blood bank/ blood centre is:
- located in hygienic place
- have good infrastructure and adequate
workspace for efficient operation
- designed as such to minimize the risk of
injury and occupational illness.
2.1.2 Accommodation of blood bank/ blood centre
The blood bank/ blood centre shall have a
minimum area of 100 sq. meters for operations
and additional 50 sq. meters for preparation of
blood components and a room each for:
- registration & medical examination with
adequate facilities
- donor motivation area/ counselor
- blood collection room
- refreshment-cum-rest room
- lab for blood transmissible disease like
hepatitis, syphilis, malaria, HIV-antibodies
- blood component preparation
- lab for blood group serology

- sterilization-cum-washing
- store-cum-record room.
2.1.3 Processing of blood component from whole blood by a blood bank/ blood centre
The blood components shall be prepared by the
blood bank as a part of the blood bank services
and shall have adequate area and other
specifications for preparing blood components
depending upon the quantum of work load. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG
(BB)
Implementation
Remarks
2.1.4 Plasmapheresis Plateletpheresis and Lucapheresis
Adequate area shall be provided for
plasmapheresis plateletpheresis and
leucapheresis
2.1.5 Blood donation camp
Premises for blood donation camp shall have
sufficient area (permanent or mobile van) and
shall be located in hygienic place so as to allow
proper operation, maintenance and cleaning.

Information regarding the camp shall be
documented regarding:
- personnel working
- equipment used
- facilities available
Following facilities shall be ensured at the camp:
- continuous and uninterrupted electrical
supply for equipment used
- adequate lighting for all the required activities
- hand-washing facilities for staff
- reliable communication system from the
camp to the central office
- furniture and equipment arranged within the
available space
- refreshment facilities for donors and staff
- facilities for medical examination of the
donors
- proper disposal of waste
2.1.6 Effective separation shall be there between
neighboring areas where incompatible activities
are performed to prevent cross-contamination.

2.1.7 Access to these areas is controlled where quality
of examination is being done and where
samples, reagents and equipments are kept.
Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Implementation
Remarks
2.1.8 Adequate storage space to ensure continuing
integrity of samples; documents, files, manuals;
equipments & reagents; centres supplies and
records and results.
2.1.9 Blood bank/ blood centre shall have procedure
for:
- good housekeeping
- storage, transportation and disposal of
dangerous material as per regulation
- training of personnel involved.
2.1.10 Adequate backup facility for maintaining electrical
supply.
2.2 Environment Control
Blood bank/ blood centre shall have processes to
minimize environmentally related risks to health

& safety of employees, donors, volunteers,
patients/ recipients and visitors.
2.3 Biological, Chemical and Radiation Safety
Blood bank/ blood centre shall:
- comply to safety standards and regulation for
adherence to biological, chemical and
radiation safety
- monitor, control and record environmental
conditions where there can be influence of
quality of results
- pay due attention to sterility, dust, electromagnetic radiations interference, radiation,
humidity, electric supply, temperature, sound
and vibration for technical activities.
2.4 Internal Communication System
Effective communication system shall prevail
within the centre for efficient transfer of message.Assessor Guide for Blood Banks/ Blood Centres –
NABH-AG (BB)
Implementation
Remarks
3 PERSONNEL
3.1 Personnel Requirement
Blood bank/ blood centre shall have process for

employment of personnel as per qualification,
training and/ or experience.
3.2 Qualification
Blood bank/ blood centre for their activities shall
have one full time Official with appropriate
qualification. The officials are:
- Director/ In-charge/ Medical Officer
- Technician (s)
- Registered Nurse(s)
- Technical Supervisor
3.3 Job description/ responsibilities
Job description shall be maintained and shall
define appropriate qualification for each job
position.
Personnel performing critical task, shall be
qualified to perform the assigned activities on
basis of appropriate education, training and/ or
experience.
3.4 Responsibilities of Director/ In-charge/ Medical Officer; Quality Manager &

Technical Manager
Blood bank/ blood centre shall define
responsibilities for the following:
- Director/ In-charge/ Medical Officer: in
matters related to professional, scientific,
consultative or advisory, organizational,
administrative and educations which are
relevant to services offered by centre
- Technical Manager: in technical operations
and ensuring of required quality of
procedures followed in the centre
- Quality Manager: in compliance with the
requirements of management system and
reporting to the Director/ In-charge of centre
Implementation
Remarks
3.5 Training
Blood bank/ Blood centre shall have procedure
for training and may include:
- training of all personnel specific to their task
they perform and also for quality assurance

and quality management
- personnel adequately trained initially and
continual in the current good manufacturing
practices/ standard operating procedures for
any latest techniques/ latest equipment in the
centre
- continuing education programme available to
staff at all levels
- training to prevent adverse incidents and
contain the effects of also to report the
adverse incidents.
3.6 Competence
Blood bank/ Blood centre shall have the policy of
assessing competence of each person to perform
assigned task after training. When necessary,
centre shall do retraining for the person.
3.7 Personnel Health
Blood bank/ Blood centre shall have the policy of:
- pre-employment medical examination
- regular health check up
- monitoring occupational health hazards
3.8 Personnel Records
Blood bank/ Blood centre shall have the policy to

maintain record, which may include personal
information such as information related to
education, qualification, training, experience,
competence and may also include:
- certificate/ license
- reference from previous employment, if
possible
- job description
Implementation
Remarks
- records of continuing education and
achievement
- untoward incident/ accident reports
- records of identification of signatures/ initials
- competency evaluation
Records of personal health of personnel shall be
maintained and may include:
- exposure to occupational hazards
- immunization status
3.9 Confidentiality of Information

Blood bank/ Blood centre shall have policy to
maintain confidentiality of information regarding
to donor/ patient/ recipient. Health records of staff
to be kept confidential and in safe place. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG
(BB)
Implementation
Remarks
4 EQUIPMENT
4.1 Equipment requirement
Blood bank/ Blood centre shall have the requisite
equipments as per their scope of activities/
services and should have policies, process and
procedures for:
- calibration
- maintenance
- monitoring
4.2 Selection and validation of equipment
Blood bank/ Blood centre shall have procedure
for selection and validation of equipments to
achieve the required performance that shall
comply with specifications relevant to
examinations concerned.
4.3 Use of equipment
Equipments shall be operated by authorized
personnel. Instructions for use and maintenance
of equipment (including that provided by the
manufacturer) are available to personnel.
The equipment used in collection, processing,
testing, storage and distribution of blood and its
components are maintained in clean place.
4.4 Equipment detail record, unique identification
Blood bank/ Blood centre shall maintain records
for each equipment for life span or for any time
period required by law/ regulation and may
include:
- Identification
- Manufacturer’s name, type, identification and
serial number or other unique identification
- Manufacturer’s contact person and telephone
number
- Date of receiving and date of putting into a
service
- Current location, where appropriate

Implementation
Remarks
- Condition when received (new, used or
reconditioned)
- Manufacturer’s instructions, if available, or
reference of their retention
- Equipment performance records that confirm
the equipment suitability for use
- Maintenance carried out and that planned for
the future
- Damage to or malfunction, modification or
repair of the equipment
4.5 Programme for calibration and maintenance of equipment
Centre shall have established/ implemented
procedure for regularly monitoring the following:
- calibration of equipments
- function of instruments
- reagents
- analytical system
The procedure shall also include programme of
preventive maintenance which may atleast
contain recommendations of manufacturers.

The blood bank/ blood centres shall, as per their
SOP, have policy to:
- observe the equipments
- standardize the equipments
- calibrate the equipments
The blood bank/ blood centre shall operate the
equipment for which it is designed and ensure
compliance with the legal requirement
The frequency of calibration of equipments is as
per the annexure H of the standard.
The calibration of equipment shall be traceable to
international system of SI units.
Implementation
Remarks
4.6 Equipment for storage of blood and component
Blood bank/ blood centre shall have detailed
procedure for storage of blood and blood
components that may include:
- adequate storage facility within the centre
- maintenance of proper temperature

- monitoring and recording of temperature
every 4 hours for the refrigerator, freezers
and platelet incubators.
The temperature of blood/ blood components
stored in open storage area shall be maintained
at 22 ± 2
C.
4.7 Computer system
The blood bank/ blood centre using computers
and automated examination equipment for
collecting, processing, recording, reporting,
storage or retrieval of examination data, has to
ensure that:
- computer software including that built into
equipment is documented and is suitably
validated
- the same is maintained and are provided with
environmental and operating conditions for
proper functioning and for maintaining
integrity of data
- access to these computer programmes are
restricted to authorized personnel

Centre shall have implemented policy and
procedure to protect the integrity of data.
4.8 Breakdown of equipment
The blood bank/ blood centre should have
procedure for replacement/ repairing of defective
equipment. The defective equipment shall be
labelled and taken out of service. It has to be
repaired and then calibrated before put in use. Assessor Guide for Blood Banks/ Blood Centres – NABH-
AG (BB)
Implementation
Remarks
5 EXTERNAL SERVICES AND SUPPLIES
5.1 Policies and procedures for supplier’s selection
The blood bank/ blood centre should have policy
and procedure for selection and use of
purchased external services, equipment and
consumable supplies that affect the quality of
services and should consistently meet the quality
requirements. The procedure may also include:
- keeping of record of all purchased items as
may be required by national/ regional or local
regulations
- method for inspection, acceptance/ rejection
and storage of consumable materials
- verifying for complying with standard
specification for the purchased equipment
and consumables supplies that affect the
quality of services
- storing at proper temperature in a safe and
hygienic place for supplies and reagents
used in collection, processing, compatibility
testing, storage and distribution of blood and
blood components
- supplies coming in contact with blood and
blood component for transfusion shall be
sterile and pyrogen-free (it shall not interact
with the product in a manner as to have
adverse effect upon the safety, purity,
potency or effectiveness of the product)
- usage of those supplies and reagents that
are oldest shall be used first for those which
do not bear expiry date/ no expired supplies
and reagent shall be used
- use of supplies and reagent as per
instructions provided by manufacturer
- final containers and closures of blood and
blood components intended for transfusion

shall be clean and free of contaminants
- blood collecting container and satellite
container(s), shall be examined visually for
damage or evidence of contamination prior to
its use and immediately after filling.
Examination for breakage of seals shall also
be done.
Implementation
Remarks
5.2 Inventory control
5.2.1 The blood bank/ blood centre shall have
procedure for inventory control system for
supplies. Quality records are established and
maintained as per the policy for the following:
- external services
- supplies
- purchased product
5.2.2 The blood bank/ blood centre shall have policy
for recording of the following:
- all relevant reagent

- control materials & calibrators
- date of receipt in the centre
- date, when it was placed in service
5.3 Evaluation of suppliers
The blood bank/ blood centre shall have policy
and procedure to evaluate the suppliers of critical
reagents, supplies and services that affect the
quality of examination and maintain records of
these evaluations and list of those approved. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG
(BB)
Implementation
Remarks
6 PROCESS CONTROL
6.1 Policies and validation of processes and procedures
6.1 The blood bank/ blood centre shall have
implemented policies and validated processes
and procedures that ensure the quality of blood,
component, derivatives and services and the
centre shall ensure that these are carried out
under controlled conditions.
Process or procedure steps
The blood bank/ blood center shall have

mechanism to identify the person/ staff who
performed and at what time the following tasks
were performed:
- collection
- processing
- compatibility testing
- transportation of blood, component and
derivatives
6.1.1 Traceability of blood unit and sample from blood collection to issue blood
The blood bank/ blood center shall ensure that
the following are identified and traceable:
- blood, components, derivatives issued
- critical materials used in the processing
activities of the above
- laboratory sample
- donor and patient/ recipient records
The blood bank/ blood center shall have a
procedure to identify the recipient receiving blood
from a particular donor found to be infected with
transfusion transmission infection.
The blood bank/ blood center in this case, shall
inform the patient/ recipient’s physician and keep

the record. The unused components from this
infected unit shall be discarded.
Implementation
Remarks
6.1.2 Standard procedure
The blood bank/ blood center shall have
procedures including examination procedures
and other services that meet the needs of the
users and that it is in conformance to the
National guidelines/ regulatory directives.
In absence of the above, the preferred procedures
published in established/ authoritative textbook, peerreviewed text and journals or international

guidelines
shall be followed.
The blood bank/ blood centre, in case, in-house
procedures are used, the following are done:
- appropriately validation of the procedure
- documentation
- keeping of records viz. results obtained and
procedure used for validation

a) Written procedure:
All the procedures shall be documented and are
available at workstation to all relevant staff and in
understandable language.
Blood bank/ blood centre shall have Card files/
similar system that summarize key information
for quick reference at the workbench but should
correspond to complete manual. The procedures
shall be a part of document control system.
The procedures can be based on the instructions
by manufacturer. The procedures described are
those performed in the blood bank/ blood centre.
The deviation shall be reviewed and
documented. Additional information required to
perform the examination shall be documented.
New version of examination kits with major
changes in reagents or procedures shall be
checked for performance and suitability for
intended use. Procedural changes shall be dated
and authorized as for other procedures.
Implementation
Remarks
b) New procedures/ changes and validation
The new methods and procedure shall be
evaluated before being put in practice to find if it
gives satisfactory result.
The review of procedures shall be done:
- by Director/ In-charge
- at regular defined interval
The review shall be documented and shall
normally be done annually.
Blood bank/ blood centre, if intends to make any
changes in procedure, for which the results or
their interpretations could be significantly
different, the implications shall be explained to
the users in writing.
6.2 Donor Section
6.2.1 Blood donation: The blood bank/ blood centre
shall have procedure for blood donation
6.2.1.1 Donor recruitment
The policy and procedure on donor recruitment
may include:
- collection of blood from voluntary, nonremunerated, low risk, safe and healthy
donors
- encouraging and retaining adequate number
of repeat donors
- felicitating the donors for their contribution
- educating donors regarding risk of transfusion
transmissible infections prior to collection of
blood
- maintaining a directory of voluntary donor.
Implementation
Remarks
6.2.1.2 Pre-donation counselling
The pre-donation counselling shall be done by
trained staff (required to maintain privacy and
confidentiality), which may include:
- modes of transmission due to risk behaviour
and self exclusion for patient/ recipient’s
safety
- information about alternative testing site
- test carried out on donated blood
- confidentiality of test results
- need for honest answers in view of window
period
6.2.1.3 Donor registration, consent and selection
a) Donor registration
Donor registration may include following
activities:
- getting answer by donor to questionnaire (in
English or local language)
- assistance to illiterate donor by registration
staff
- physical examination for health conditions, by
Medical Officer, with minimum qualification of
MBBS
- getting details such as name & address, date
& time of donor selection and donation
b) Consent
The blood bank/ blood centre shall take consent
of the donor prior of donation and may include
following activities:
- informing the donor for all mandatory tests for
safety of recipients
- taking signature/ thumb impression after
procedure is explained
- giving the donor opportunity to ask questions
and refuse consent
- providing the status of Transfusion
Transmitted Infection (TTI), after donation, to
the donor on demand, with prior consent
Implementation
Remarks
c) Criteria for selection of donors
Criteria for selection of donor may be in
conformance to annexure B of NABH Standards
so that it is not detrimental to the donor/
recipients.
d) Donation interval
Blood donation interval shall be atleast for three
months between two donations.
Atleast 48 hours must elapse after
plasmapheresis or cytapheresis (except
erythropheresis) before whole blood is collected
from a donor.
Apheresis shall be done only after three months
of whole blood collection or in an event when red
cells are not returned at the end of pheresis.
Interval between two plateletpheresis shall be 48
hours and not more than twice a week and not to
exceed 24 times in a year. The donor shall be
tested for detection of thrombocytopenia.
Donor shall have haemoglobin 13.5 g/dl and
weight >65 Kgs for double red cell collection and
the interval between two procedures shall be six
months.
For apheresis, the procedure in clause 6.3.3 f
shall be followed.
6.2.1.4 Phlebotomy procedure
a) The blood bank/ blood centre shall have
procedure for Phlebotomy:
- blood shall be collected by a licensed blood
bank/ blood centre
- blood to be drawn by qualified physician or
under his/ her guidance by nurse/ technician
- physician shall be present in the premises
where blood is collected

Implementation
Remarks
- blood shall be collected by single
venipuncture and flow of blood shall be
continuous
- blood donor area shall be clean, congenial,
comfortable and convenient to approach
- blood donor room shall be air-conditioned to
make the donor comfortable and to minimize
chances of donor reaction
b) Method of preparation of phlebotomy site
Blood bank/ blood centre shall have strict
standardized procedure to achieve surgical
cleanliness and preparing venepuncture site to
provide maximum possible assurance of sterile
product.
c) Equipment and blood bag
For collection of blood, there shall be usage of
proper equipment and blood bag.
The blood bags for collection of blood shall be:
- sterile
- pyrogen-free and disposable with a closed
system of collection as per standards by
national authority.
The blood bank/ blood centre shall have multiple
interconnected plastic bags to be used for blood
component preparation (closed system).
Venting of any container shall be done under
laminar airflow bench and such container shall be
used within 24 hours (if preserved at 4
C for red
cells).
The blood bank/ blood centre shall use multiple
inter-connected closed containers to avoid
venting in case of paediatric use.
Implementation
Remarks
d) Anticoagulant solutions
Anticoagulant solutions shall be:
- sterile and pyrogen-free
- of appropriate strength
- Addition of appropriate additive solution to
packed cells after separation of plasma for
storage
e) Volume
Volume of blood collected shall be proportionate
to volume of anti-coagulant with ± 10% variation
and shall not exceed 10 ml/kg body weight.
Units of blood where volume collected is out of
the permitted limits shall not be used for
transfusion.
Collection of blood from such donor during the
same session shall not be done.
Extracorporeal blood volume shall not exceed
15% of the donor’s estimated blood volume.
6.2.1.5 Post donation care
Post donation care shall have:
- advice regarding post phlebotomy care to
donor and the possible adverse reactions
- proper display of the same at blood
collection/ observation room
6.2.1.6 Adverse donor reaction management

For adverse donor reaction, blood bank/ blood
centre shall have:
- availability of necessary drugs and
equipments for treatment of donor reaction
- officials be trained in identification and
management of various donor reactions
Implementation
Remarks
6.2.1.7 Blood donation camp/ drives
Outdoors blood donation camps
The blood bank/ blood centre shall organize
blood donation camp/ drives only when it is
authorized by SBTC.
To organize blood donation camp/ drives, blood
banks/ blood centres shall:
- have adequate publicity and Information
Education and Communication (IEC) material
available
- collect number of blood units that is
commensurate with the actual requirement of
blood units
- inspect the donation site prior to the day of
blood collection for availability of all facilities
by authorized personnel from the centre
- organize camps in conducive and
comfortable environment and shall be
cleaned before and after the collection
- quality shall be maintained at each step viz.
donor recruitment, selection and collection.
Large Camps
Blood bank/ blood centre shall plan for large
camp as per criteria laid down by Drug and
Cosmetic Acts/ other directive from national/
state authority.
Measures shall be taken so that Quality
measures, pre-donation counselling and
transportation procedures are not compromised.
6.2.1.8 Autologous transfusion procedure
The blood bank/ blood centre shall have process
and procedure for autologous transfusion and
shall contain procedure for:
- predeposit criteria for autologous donation

- testing of units
- labeling required
- pretransfusion testing
- perioperative procedures and
- post operative procures
Implementation
Remarks
6.2.1.9 Donor notification of abnormal findings, test results and counselling
a Information of test results:
The medical officer of the centre shall inform the
donor about any sero-reactive result of TTI with
prior written consent as per existing regulations.
b Counseling and referral
Blood bank/ blood centre, for ensuring blood
safety, shall provide:
- pre and post donation counseling services
- training to their donor organizers/ medical
officers to undertake counselling in the
absence of a donor counsellor

- counselling of donor who are HIV seroreactive to a voluntary counselling and testing
centre (VCTC) for post donation confirmation
and counselling or the same may be provided
at the blood bank/ blood centre
- the donor who are TTI and other HIV,
referred to the speciality for further
management.
6.2.1.10 Records of donor and donor’s blood/ components
process and procedure of keeping Donor
Records which shall contain the following:
- Demographic details
- Identification number
- Selection record (Medical history & Physical
examination)
- Deferral records
Donor deferral records
process and procedure of keeping Donors’ blood
collection records which shall contain the
following:
- date of collection
- batch number and bag manufacturer’s name
Implementation
Remarks
- segment number on the donor tubing
- particulars of donor
- identification number
- amount of blood collected
- time and duration of collection
- signature of phlebotomist and medical officer
The blood bank/ blood centre shall make a
donation reaction statement having following
details:
- time of occurrence with description
- management details
- actions taken for prevention of such reactions
in future
Blood components records

Blood bank/ blood centre shall keep blood
component records, which shall contain the
following:
- name and volume of component prepared
- date, time and mode of preparation
- disposition record
The blood bank/ blood centre shall have record
of processing of donor’s blood with following
details:
- ABO & Rh (D) type
- antibody screening and identification
- Anti-HIV 1 & 2, Anti-HIV 1 & 2, Anti-HCV,
HBsAg, VDRL test and its interpretation
- test for absence for malaria parasites
The blood bank/ blood centre shall have
documentation of details of grouping indicating
the following:
- reaction results
- batch number and manufacturer’s name of
reagents in use
- reagent red cells in use
Implementation
Remarks
documentation of all infectious disease tests
including ELISA printouts showing:
- results and interpretation
- batch number
- expiry date and
- manufacturer’s name of the kit used for
testing
The blood bank/ blood centre shall maintain
records of the following:
- all rapid tests/ spot test, interpreted by two
competent individual
- quality control records indicating testing of
components, reagents and equipment
- apheresis procedures
- blood discarded
6.2.1.11 Therapeutic plasmapheresis and cytapheresis
Therapeutic Plasmapheresis/ Cytapheresis done
only at patient/ recipient’s physician request and
done at the centre or at ward.
Records shall be maintained for the following:
- patient/ recipient’s identification
- diagnosis
- therapeutic procedures
- haemapheresis method
- volume of blood removed and returned
- time taken
- nature and volume of replacement fluids
- adverse reaction if any
- medication administered
Informed consent of patient/ recipient shall be
taken.
Provision for emergency care shall be available.
Implementation
Remarks
Therapeutic phlebotomy
Therapeutic phlebotomy shall be done only on
the request of the patient/recipient’s physician,
where the centre doctor must decide whether to
accept the responsibility of the patient/recipient.
Blood collected in such circumstance shall not be
used for transfusion
6.2.2 Handling of samples and blood units
6.2.2.1 Samples for laboratory tests
The blood samples in the pilot tubes (plain and
with anticoagulant) shall be collected at the time
of collection of blood by the same person and
shall be marked before collection to be identified
with the unit of blood.
Integral donor tubing of plastic bag shall be filled
with anticoagulated blood and sealed in a
manner that it will be available with segment
numbers for traceability for subsequent
compatibility tests.
6.2.2.2 Identification and traceability

processes and procedure for identification and
traceability of blood collected. It shall have a
unique numeric/ alphanumeric number on each
container of blood/ blood components/ pilot tubes
so as to be traced back to donor and also to
recipient. The segment number printed on the
integral donor tubing shall be recorded.
a) Blood unit identification: unique numeric/
alphanumeric number shall make it possible
to trace any unit of blood from its source to
destination.
The numeric/ alphanumeric identification on
label shall be provided by collecting facility
and shall be documented for traceabilty.
Advance technology for identification eg.
Barcode system is preferable.
No identification mark of donor shall be
written on the label and original label with
same identification shall be retained if the unit
of blood is transferred to storage centre.

Implementation
Remarks
b) Traceability: all blood, components prepared
in the centre as well as laboratory, samples
and donor and patient/ recipient records are
identified and traceable to donor and
recipients.
6.2.2.3 Transportation
procedure for transportation of blood/ blood
component which may include placing at
appropriate temperature for:
- storing
- component preparation
The transportation and storage shall be at
appropriate temperature for the following;
- red cell concentrate
- platelet/ granulocyte concentrates
- components stored frozen
Components stored frozen shall be transported in
a manner to maintain them frozen and shall be
thawed prior to issue.

The temperature shall be monitored during
transportation.
6.3 Component Laboratory
6.3.1 Sterility
Blood bank/ blood centre shall maintain sterility
of all components used during processing by the
use of aseptic methods and sterile pyrogen-free
disposable bags and solutions.
6.3.2 Seal
The laboratory shall use blood bags that allows
transfer to component without breakage of seal
(closed system).
If the seal is broken during processing, components
stored between 4
C±2
C must be transfused within
24 hours and component stored between 22
C±2
o
shall be transfused as early as possible within 6
hours.
Implementation
Remarks
Thawed frozen components shall be transfused
within 6 hours.
For preparation of final components the integrally
connected tubing shall be filled with aliquots of
the components and sealed in a manner that it
shall be available for subsequent compatibility
and assay testing, if needed.
6.3.3 Preparation of components
procedure for preparation of components viz.
Red Blood Cells components; Platelets
Concentrate; Plasma; Single Donor
Cryoprecipitate; Donor Apheresis.

a) Red Blood Cells Components: Preparation
of Red blood cells components shall include,
preparation of:
Red blood cells: The red blood cell
concentrate shall be prepared from whole
blood and collected in plastic bags,
preferably in double or multiple plastic bag
system. Plasma is separate from red blood
cells following either centrifugation or
undisturbed sedimentation before expiry
date of blood.
If closed system is in use, the expiry date of red
cells shall be the same as whole blood. The
hematocrit of packed cells shall be adjusted so
that it is not more than 70%.
Washed red cells:
Washing of Red blood cells shall be:
- done by normal saline by automatic cell
washer or manually by centrifugation
- washed 2–3 times with normal saline by
centrifuging at 4
C±2
o
A laminar bench that is validated yearly shall be
used. Closed system of washing is
recommended.
Implementation
Remarks
Leucocyte depleted red blood cells:
Leucocyte depleted red blood cells
concentrate shall be prepared by a method
known to reduce leucocytes in the final
component to less than 5 x 10
when
intended to prevent febrile reactions.
Frozen and deglycerolised red blood cell
concentrate:
Red cells shall be stored frozen continuously
at low temperature of –80

o
C to –196
C in the
presence of cryoprotective agent. The red
cells shall be washed to remove the
cryoprotective agent prior to transfusion.
The method of preparation, storage, thawing and
washing shall ensure a recovery of at least 80% of
original red cells depending on the procedure in use.
Red blood cells shall be ordinarily frozen within 6 days
of collection of blood and can be kept frozen up to 10
years.
b) Platelets Concentrate: Platelets concentrate
shall be prepared by centrifugation of single
unit of whole blood collected with a smooth
venipuncture and a continuous flow of blood.
Platelets concentrate shall be separated
from whole blood within 6 hours of collection
by centrifugation at 22
C+ 2
o
C using either
platelet rich plasma (PRP) or buffy coat (BC)
method, which is validated.
Platelets shall be suspended in
approximately 50 ml of plasma and stored at
22
C+ 2
C under agitation. The pH at
storage temperature shall not be lower than
6.0 at the end of storage period.
Continuous gentle agitation (60–70
oscillations/per min) using horizontal agitator or a
rotator with 5–10 cycles/minute shall be
maintained throughout the storage period varying
from 3 to 5 days depending on the nature of
plastic of the bag in use considering day of blood
collection as day zero.
There shall be no grossly visible platelet
aggregates during the storage. Swirling
phenomenon shall be checked before issue.

Implementation
Remarks
The concentrate prepared shall not be
contaminated with red cells. The degree of
reddish tinge of the concentrate indicates red cell
contamination. The units contaminated with red
cells shall be used as group specific. If the
contamination of RBCs is more than 5 ml the unit
shall be issued after cross match.
c) Granulocyte concentrate: Granulocytes
concentrates shall be prepared by use of cell
separator shall have 1 x 10
10
leucocytes and
shall be kept at 22
C±2
C for a maximum
period of 24 hours.
d) Plasma:
Single donor plasma
Plasma shall be separated from whole blood
at any time up to 5 days after the expiry of
the whole blood.
The plasma separated after 5 days of expiry date
shall be used only for fractionation.
Fresh frozen plasma
Fresh plasma shall be separated from the
whole blood and frozen solid at –80
C or
blast freezer not later than 6 hours of
collection.
Further storage shall be done at –30°C or
lower.
Plasma shall be thawed rapidly at 30 – 37
in a water bath with shaker prior to infusion.
Once thawed it shall be used within 6 hours,
when kept at room/ ambient temperature, or
within 24 hours when kept at 4
C±2
o
C.
Cryo poor plasma or Factor VIII deficient
Plasma
This is plasma from which cryoprecipitate
has been removed. It shall be stored at –
30
C or lower and once thawed shall be
used within 6 hours.
Implementation
Remarks
e) Single Donor Cryoprecipitate
(Cryoprecipitated Anti-hemophilic factor):
For preparation of cryoprecipitate the plasma
shall be separated within 6 hours of
collection and frozen hard at –80
C and then
can be preserved at –30
C or lower and
when needed thawed at 4
C in circulating
water bath or in 4
C Cold Room/ Blood bank
refrigerator.
Thawed plasma shall be immediately
centrifuged and separated from the cold
insoluble material under sterile conditions.
The cryoprecipitate (cold insoluble material)
shall be frozen within 1 hour and shall be
kept at –30
C or lower up to 1 year from the
date of donation. Once thawed, it should be
used within 6 hours.
f) Donor Apheresis:
Donor Apheresis procedure shall be carried
out only in licensed blood bank/ blood centre
for this purpose.
A medical officer shall be trained in
apheresis technique shall be responsible for

the procedure.
The staff working on the cell separator shall
be trained in apheresis procedure and shall
work directly under the supervision of the
medical officer.
There shall be provision for emergency
medical care, in the event of any adverse
reaction to the donor.
6.4 Quarantine and Storage
procedure and process for quarantine and
storage.
6.4.1 Refrigerator and freezers for storage
Designated area shall be used for storage to limit
deterioration and prevent damage to materials in
process and final products and access to such
areas shall be controlled. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Implementation
Remarks
Refrigerator or freezers used for storage of

blood, blood components and blood samples
shall not be used for any other items.
Reagents shall be stored in refrigerators with
thermograph or temperature monitor in the
specific laboratories.
Specific temperature shall be maintained with
refrigerator/ deep freezer.
Adequate alternate storage facility and written
display of instructions to maintain the blood and
components in the event of failure of power or
equipment shall be provided in the area of
prevention.
6.4.2 Quarantine
The quarantine storage area shall be used to
store untested blood.
The whole blood or components shall not be
issued for transfusion, till the mandatory test are
completed and reported as non-reactive.
The units which test reactive in any test shall be
segregated immediately and kept in separate
quarantine area till sent for disposal as per bio
medical waste (BMW) rules.

Refrigerator or freezers in which blood and blood
components are stored for quarantine shall be
appropriately labelled.
The procedure for Storage and Expiration shall
be as per the Annexure A of NABH Standards.
Implementation
Remarks
The blood bank/ blood centre shall have process
and procedure for expiration for:
- Whole blood: It shall be stored at 4
C±2
C in
plastic blood bags.
Whole blood collected in anticoagulant citratephosphate-dextrose solution (CPD) shall have an
expiry date, not exceeding 21 days after
phlebotomy. Whole blood collected in
anticoagulant citrate-phosphate-dextrose with
adenine (CPDA-1) shall have an expiry date not
exceeding 35 days after phlebotomy.
Red Blood Cell Components

- Red blood cells: These are separated in a
closed system shall have the same expiry
date as the whole blood from which they are
prepared.
The time of removal of plasma is not relevant
to the expiry date of red cell concentrates.
However, if an open system is used, the
expiry date shall be 24 hours after separation.
Red cell concentrate shall be stored at 4
C±
C.
- Frozen red cells: The expiry for glycerolized
(low or high) frozen red cells is 10 years and
shall be stored between - 80
C and - 196
C.
- Washed and deglycerolised red cells: These
shall be stored at 4
C±2
o
C and shall be
transfused as soon as possible and within 24
hours after processing.
- Leucocytes depleted red blood cells: These
shall be stored at 4
C±2
C and shall have
same expiry date as whole blood from which
it has been prepared, if closed system is
used. In case of open system, the expiry shall
be within 24 hours.
Implementation
Remarks
- Platelet concentrate: These shall be stored at
at 22
C±2
o
C with continuous gentle flat bed
agitation (60 - 70 strokes/min) or a rotator (5 -
10 cycles/min.) maintained throughout the
storage period. The expiry date of platelet
concentrate prepared in closed system shall
be 3 day after the collection of original blood,
which may be extended to 5 days when
special plastic bags or anticoagulants are in
use.
- Granulocyte concentrate: The storage
temperature for leucocyte concentrate is
22
C±2
C. It shall be transfused as soon as
possible and not later than 24 hours of
phlebotomy.
Plasma
- Single donor plasma: These are separated
during shelf life shall be stored for 1 year at -
30
C, or lower and used as plasma for
transfusion.
- Fresh-frozen plasma and cryoprecipitate:
These components shall be stored at - 30
or below and shall be stored no longer than
12 months.
If fresh frozen plasma (FFP) remains unused
at the end of 1 year at - 30
C, it may be
labelled as ‘plasma’ and shall be used upto 5
years.
Expiry date of any component shall be
calculated by considering the day of
collection as day zero.
Cryo poor plasma (normal human plasma)
shall be stored at - 30
C or below and shall
be stored no longer than 5 years from the
date of collection.

Implementation
Remarks
6.5 Labelling
process for labeling to ensure that final container
is labelled only after all mandatory testing is
completed as per Indian Pharmacopoeal
requirements.
Requirements shall ensure:
- traceability of product
- appropriate storage and handling of units
- appropriate selection of units for transfusion
The label shall be attached firmly to the container
and shall be clean and readable. Any handwritten information shall be legible and in
permanent and moisture proof ink.
6.5.1 Labelling for whole blood/ component
The final label affixed on the bag of processed
blood shall have following information:
- name of product i.e. whole blood or
component or intended component
- unique numeric or alphanumeric identification
- date of collection and expiry
- name and amount of anticoagulant and the

approximate volume of blood collected
- approximate volume of the components shall
be indicated in case of platelet concentrate,
plasma and for component obtained through
apheresis
- Specific colour scheme for different blood
groups
- Storage temperature
- ABO and Rh type
- Interpretation of HBsAg/HCV/HIV1 & 2/VDRL/
malaria test/unexpected antibodies
- Name, address and manufacturing license
number of the collecting facility
Implementation
Remarks
6.5.2 Instructions for transfusion
The final label affixed on the bag of processed
blood shall have additional information printed:
- Do not use if there is any visible evidence of
deterioration
- Store the product at appropriate temperature

(as defined for each of the product) before
use (e.g Keep at 4
C±2
C)
- Shake gently before use
- Do not add any other medication to the
blood/blood component
- Check blood group on label and that of the
recipient before administration
- Use a fresh, clean, sterile and pyrogen-free
disposable transfusion set with filter to
transfuse blood
- Do not dispense without a prescription
6.5.3 Special requirements for component label
The blood bank/ blood centre shall place special
requirements on component label, which shall
contain information to identify the facility that
carries out any part of the preparation.
The label shall specify:
- Storage temperature
- Expiry date/time
- If the plasma is intended for use of
fractionation, suitable documentation and
labelling shall be done
- Label shall indicate whether the component is
prepared by apheresis method
- Label shall indicate the addition of any
adjuvant or cryoprotective agents used
Rh(D) type is not required to be mentioned for
plasma or cryoprecipitate but it is necessary for
platelet and granulocyte concentrate especially in
case of red cell contamination of the product,
Implementation
Remarks
6.6 Testing of Donated Blood
process and procedure for testing of Donated
blood. The procedure shall include determination
of the following:
- Determination of ABO group
- Determination of Rh(D) type
- Determination of Unexpected Antibodies

- Test for Transfusion Transmitted Infection
such as Screening for HIV antibody; Test for
Viral Hepatitis; Test for syphilis; Test for
Malaria
6.7 Compatibility Testing
6.7.1 Request for blood and its components
Request form for whole blood or components
accompanied by the recipient’s blood samples
shall have the following information: :
a) recipient’s name, age, sex, ward and bed
number
b) blood group of recipient (if present)
c) name of head of treating unit
d) amount, date and time of blood/ component
needed/ required
e) routine/ emergency
f) diagnosis
g) reason for transfusion, hemoglobin/ platelet
count
h) history of previous transfusion
i) obstetric history in case of female patient/
recipient
j) name of the hospital/ hospital registration

number
k) signature of the medical officer
l) name and signature of the phlebotomist
collecting patient/ recipient’s sample
Implementation
Remarks
6.7.2 Sample receiving, acceptance and preservation
The centre shall receive, accept and preserve the
samples of the recipients in a stoppered plain
vial/tube or in a vial/tube containing anticoagulant
having labels for:
a) Patient/recipient’s full name and Identification
number
b) Name of hospital
c) Ward/bed number (Optional)
d) Date and time
The recipient’s blood sample is received in the
laboratory. Competent staff in the laboratory
confirms the information on the label and on the
transfusion request form is identical. In case of
any discrepancy or doubt, a new sample shall be

obtained.
Retaining and storing of blood sample
The recipients’ blood sample and a segment from
each donor unit shall be retained at appropriate
temperature for 7 days after each transfusion.
In case of a need for transfusion after 48 hours of
earlier transfusion, a fresh sample shall be asked
for to perform a cross match.
6.7.3 Pre-transfusion testing
6.7.3.1 Testing of recipient blood
Determination of ABO group
ABO grouping shall be determined by testing red
cells with anti-A, anti-B, anti-AB sera (anti-AB is
optional if monoclonal anti-A and anti-B are used)
and testing serum or plasma for expected
antibodies with fresh pooled A,B and O cells
(pool of 3 for each group) using tube/microplate
method/gel technology (manual or automated).
Either monoclonal/or polyclonal antisera may be used.

Implementation
Remarks
Determination of Rh (D) type
The Rh (D) type shall be determined with anti-D
reagents from 2 different sources by tube/
microplate method/ gel technology. If negative it
shall be labelled as Rh-(D) negative.
Test for detection of unexpected antibodies
Serum of the recipient should be tested for:
- unexpected antibodies with pooled O Rh(D)
positive cells
- screening red cell panel at room temperature
by saline technique and at 37
C by
commercially available (use manufacturer’s
instruction) or in house validated
albumin/enzyme as well as indirect
antiglobulin test with proper controls (positive,
negative).
If on screening, antibody(ies) is/ are detected,

this/ these should be identified by red cell panel,
if possible.
A control system using red blood cells sensitised
by IgG anti-D must be used with antiglobulin
tests to detect false negatives.
6.7.3.2 Repeat Testing of Donor Blood
The blood bank/ blood centre performing cross
matching shall confirm ABO and Rh (D) group of
all blood units using a sample obtained from an
attached segment.
Crossmatch
A sample of donor cells from a segment attached
to the bag and recipient serum or plasma shall be
crossmatched. The method used shall
demonstrate ABO incompatibility and clinically
significant unexpected complete and/or
incomplete antibodies and shall include an
antiglobulin test.
If clinically significant antibody(ies) are not detected
during the antibody screening test and if there is no
record of previous alloantibodies and no history of
transfusion or pregnancy within the past three months,
then an antiglobulin cross-match is not required. An

immediate spin must be performed.
Implementation
Remarks
If clinically significant antibody(ies) is/are
detected in recipient, blood lacking
corresponding antigens on cells shall be
crossmatched or by trial method the blood, which
is compatible, shall be issued. In certain clinical
conditions, where autoantibodies are present, the
least incompatible unit shall be issued with
warning to clinicians.
Minor cross matching using donor serum or
plasma and recipient’s cells shall not be
necessary as tests for complete and incomplete
unexpected antibodies in donor sample are
mandatory.
6.7.4 Issue of blood and its component
6.7.4.1 Issue of blood
Blood shall be issued by the blood bank/ blood
centre along with the blood cross matching

report.
A portion of the integral tube with at least one
numbered segment shall remain attached with
the blood bag being issued.
The cross matching report shall have:
- patient/recipient’s first name with surname
- age
- sex
- ward & bed number
- ABO and Rh(D) type
The report shall have donor unit identification
number, ABO and Rh (D) type and expiry date of
the blood.
Interpretation of cross matching report and the
name of the person performing the test and
issuing the blood shall be recorded.
Implementation
Remarks
A label or a tag shall also be attached to the
blood bag container before it is issued from the

blood bank/blood centre with the following
information:
- patient/ recipient’s name
- hospital name
- blood unit number assigned by the
collecting/intermediary facility
- interpretation of the cross matching test
Each unit of blood shall be visually inspected
before issue. It shall not be issued if there is any
evidence of leakage, hemolysis or suspicion of
microbial contamination such as unusual
turbidity, or change of colour.
6.7.4.2 Reissue of blood
Blood once issued shall not be taken back by the
blood bank/ blood centre if the cold chain is
broken.
6.7.4.3 Urgent requirement of blood
Blood bank/ blood centre shall on receipt of
request of treating physician stating that the
clinical condition of the patient/ recipient is
sufficiently urgent and delay in providing blood
may jeopardize the patient’s life, blood or blood

components shall be issued before completion of
routine cross matching tests
Records of such requests shall be retained for 5
years.
Under such circumstances, recipients whose ABO
and Rh(D) type is not known shall receive red cells of
group O Rh(D) negative if available, otherwise O
Rh(D) positive blood shall be used.
Recipient whose ABO and Rh(D) type has been
determined shall receive ABO and Rh(D) specific
blood group whole blood or red cells before the
tests for compatibility have been completed.
Implementation
Remarks
The donor tag or label on the blood container and
the cross match report form shall indicate that
compatibility testing has not been completed at
the time of issue.
However, standard compatibility test shall be
completed promptly. If discrepancy in the result is
noted, the concerned clinician shall be informed
immediately.
6.7.4.4 Selection of blood and components for transfusion
Whole blood, red cell component
Recipient shall receive ABO type specific compatible
whole blood or red blood cell components. In the
absence of ABO type specific blood, group O packed
red cells shall be transfused. Rh(D) negative recipient
shall receive Rh(D) negative whole blood or red blood
cell components except for reasonable qualifying
circumstances when Rh positive may be issued only
when Rh antibodies are absent and with due consent
of treating physician. Rh(D) positive recipient can
receive either Rh(D) positive or negative whole blood
or red blood cell components.
If clinically significant unexpected antibodies are
detected in recipient, whole blood or red blood
cells component, which do not have
corresponding antigens and are compatible shall
be transfused. On reasonable qualifying
circumstance indicated by the clinician, a least
incompatible unit shall be issued with instruction
to clinician to transfuse under constant
observation.
Single donor plasma and fresh frozen plasma
Single donor plasma or fresh frozen plasma shall
be ABO type specific/compatible with recipient’s
red blood cells. For cryoprecipitate ABO/Rh
grouping is not must.
Implementation
Remarks
Platelets concentrate
Platelet concentrates shall be ABO and Rh (D)
type specific or compatible with the recipient
blood. In case of shortage platelets concentrate
of any ABO/Rh group shall be used provided
there is no visual red cell contamination of the
platelet concentrate. In case of apheresis
platelets, plasma shall be reduced when plasma
incompatible concentrate is in use (e.g. use of ‘O’
group to ‘B’ group patient/recipient).
Granulocyte concentrate
Leucocyte concentrate shall be ABO and Rh(D)

type specific or compatible with the recipient
blood.
6.7.4.5 Massive Transfusion
When an amount of blood equal to or greater
than recipient’s total blood volume is transfused
within 24 hours, a fresh blood sample shall be
used after active bleeding is controlled for crossmatch at the time of subsequent transfusion of
blood. Component therapy shall be actively
considered in these cases.
6.7.4.6 Neonates
For ABO grouping of neonates only cell grouping
with anti-A, anti-B and anti-AB sera shall be
required.
Serum of the mother shall be tested for
unexpected antibody(ies).
In the management of haemolytic disease of the
newborn it is preferable to use mother’s serum
for the cross matching. In absence of mother’s
serum, child’s serum shall be used for
compatibility testing.
Neonatal recipient shall not be transfused with

whole blood/plasma/component containing
clinically significant antibodies.
For exchange transfusion or in hypoxic condition,
it is recommended that the blood is screened for
haemoglobin S if possible.
Implementation
Remarks
Paediatric blood collection bags are available
and are preferable for use.
Multiple blood bags shall be used to make one
aliquot for adult and one for paediatric
transfusion.
Blood preferably within 72 hours of collection, but
not exceeding 5 days, shall be used for
exchange transfusion.
6.7.5 Records of recipient
The blood bank/ blood centre shall keep records
of recipient and may include:
• Blood requisition form with full particulars of
recipient and identification number
• Results of ABO and Rh (D) tests and their

interpretation
• Interpretation of compatibility tests
• Compatibility record
• Report of adverse reaction and record of their
investigation
The blood bank/ blood centre shall maintain
Issue Register that may include:
a) Date and time of issue
b) Particulars of patient/recipient and his/her
ABO and Rh (D) type
c) Identification number and segment number of
red cells units issued, ABO and Rh (D) type,
blood/component issued
d) Signature of persons issuing and receiving
components
6.7.6 Transfusion Related Advices (for clinician)
The blood bank/ blood centre has the
responsibility to educate the users regarding
transfusion related advices and other scientific
matters through meeting. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)

Implementation
Remarks
6.7.6.1 Informed Consent
The blood bank/ blood centre shall inform
patient/recipient:
- about his/ her need for blood
- alternatives available
- risks involved in transfusion and nontransfusion
His/ her written consent shall be taken in the
language he/she understands best only after
providing information. For minors and
unconscious patient/recipients the next of kin
shall sign the informed consent.
6.7.6.2 Identification of Recipient and Donor Unit
Immediately before transfusion, the doctor/
transfusionist shall verify the identification of the
patient/recipient, the blood unit, blood group and
cross matching report and associated records.
All identifications attached to the container shall
remain attached at least until the transfusion is over.
The blood compatibility report shall be attached
in the patient/recipient’s file.

6.7.6.3 Supervision
Transfusion shall be prescribed and administered
under medical direction. The doctor/
transfusionist shall observe the patient/recipient
for an appropriate time at the initial stage and
during the transfusion to observe any evidence of
untoward reaction and to regulate the speed of
transfusion.
To ensure good clinical practice (GCP) the user
hospital shall formulate a hospital transfusion
committee.
6.7.6.4 Administration of Blood and Blood Components
Blood and blood components shall be maintained
at the optimum temperature before transfusion.
The transfusion shall be given with sterile,
pyrogen-free and disposable transfusion set with
filter. The transfusion shall be started
immediately on receipt of blood.
Implementation
Remarks
Warming of blood to body temperature shall be
done:
- in case of rapid transfusion
- massive transfusion
- exchange transfusion in infants
- patient/ recipients with cold agglutinins
Warming of blood shall be accomplished using a
blood warming device attached to the transfusion
set. The warming system shall be equipped with
a visible thermometer and ideally with an audible
alarm system.
Medication shall never be added to the whole
blood or components. Similarly no other
intravenous fluid except 0.9% sodium chloride
injection I.P. should be administrated with blood
components.
Red cells shall not be administered with I.V.
solution containing calcium, dextrose or lactated
ringer’s solution.
6.7.6.5 Guidelines for Transfusion Practices
There shall be a written protocol for
administration of blood and blood components

and the use of infusion device and auxiliary
equipment.
For appropriate use of blood, guidelines approved by
the transfusion committee shall be used.
6.7.6.6 Special Considerations for use of components
Red Cell Transfusion
Red cell transfusion shall be ABO and Rh (D)
compatible.
Transfusion of one unit of red cells shall not take
longer than 4 hours and should begin within 30
minutes of taking out of refrigerator.
The viscosity of red cell concentrate can be reduced
by the addition of small volume (50 ml) of sterile
normal saline through one limb of a Y-infusion set.
Implementation
Remarks
Fresh frozen Plasma
Plasma transfusion shall be ABO compatible.
Cross matching tests are usually not performed

on plasma products.
Products that have been thawed shall be infused
without delay to avoid bacterial proliferation. This
is thawed at temperature of 37
C.
If it is used as a source of labile coagulation factors, it
shall be used immediately and in any case within 6
hours after thawing. If used for a purpose other than
labile coagulation factor replacement, it shall be
transfused within 24 hours after it is thawed and
stored at 1 - 6
C.
Cryoprecipitate
The component shall be thawed at temperature
of 37
C and shall be used immediately.
ABO compatibility is not required.
Single donor plasma

It shall be transfused within 24 hours after it is
thawed and stored at 1 - 6
C.
Cryopoor plasma
The plasma left after separation of
cryoprecipitate shall be immediately frozen and
used within five year of collection. The
component shall be thawed at temperature of
37
C and shall be used within 24 hours if stored
at 1- 6
C.
Platelets and leucocytes
Platelets shall be ABO-identical but in absence of
availability of ABO compatible platelets, ABOincompatible platelets can be used, if there is
visible red cell contamination in platelet and
leucocytes concentrate, group specific and cross
matched product shall be used.

Implementation
Remarks
Platelets and leucocytes shall be administered
through a standard filter. Micro aggregate filters
shall not be used for these products.
Platelets and leucocytes shall be infused at the
rate of 1–2 ml/minute or as tolerated by the
patient/recipient.
Irradiation
Irradiation shall be done in the following cases:
• Granulocyte concentrates shall be irradiated
before transfusion
• Cellular components shall be irradiated in
order to reduce the risk of post transfusion
graft verses host disease (GVHD) when a
patient/recipient is identified as being at risk
for GVHD e.g. for all immunosuppressed
patient/recipients including bone marrow
transplant (BMT) patient/recipients
• When blood from a blood relative is used

• In case of intrauterine transfusion
The minimum dose delivered to the center of the
blood bag shall be 25 Gy ± 2 and any other part,
it should be 15 Gy.
Verification of dose delivery system of the
irradiator shall be performed and documented
annually.
The component irradiated shall be labelled
accordingly.
Irradiated components can be issued to
immunologically normal patient/recipient provided
there is compliance with required storage
condition and protocols of issue.
The expiry date shall be the original date.
However, in case of red cell concentrate it will be
28 days from the date of irradiation or original
whichever is earlier. In case of neonate, the
component shall be transfused immediately after
irradiation.
The irradiation facility may be shared and the
user shall be informed about it.

Implementation
Remarks
Leucocyte Depleted Component
Storage shall depend on whether a closed or
open system is in use.
The verification of leucocyte reduction shall be
done in 1% of products prepared of which 75%
should contain less than 5 x 10
leukocytes in the
blood bag.
6.8 Transfusion Reaction and Evaluation
6.8.1 The centre shall develop mechanism for error
prevention in transfusion. The most common
cause of haemolytic transfusion reaction is a
clerical error. Measures shall be developed such
as:
- request form shall have phlebotomist’s name
and initials
- blood group of the blood in the bag shall be
re-confirmed by testing the sample from the
donor tubing attached to the bag
- instructions to be given to transfusionists to

check the identity of patient/recipient on the
bag matches the identity of the patient/
recipient and ensure correctness of unit
number on the bag as well as segment and
the cross match report
- where feasible Bar coding shall be introduced
6.8.2 Immediate complication
For a symptom of haemolytic transfusion
reaction, transfusion shall immediately be
discontinued and the following actions to be
taken and appropriate records maintained:
a) label on the blood container and all other
records be checked if an error is there to
identifying patient/ recipient or blood unit
b) a post transfusion blood sampled properly
labelled shall be obtained from the
patient/recipient from different site and sent to
transfusion services along with blood
container and attached transfusion set
c) patient/recipient’s post-reaction serum or
plasma shall be inspected for evidence of
haemolysis, comparing with pre-transfusion
sample
Implementation
Remarks
d) direct antiglobulin test shall be done on the
post transfusion specimen and on pre
reaction sample for comparison.
On the above clinical findings, review of accuracy
of records and result of laboratory tests,
additional tests shall be done such as:
a) determination of ABO and Rh(D) type on pre
and post reaction blood sample from the
patient/recipient and from the blood bag
b) Repeat tests for unexpected antibodies in
donor and recipients blood and repeat cross
match using pre and post reaction blood
samples of the patient/recipient and donor
blood from the bag
c) Examination of post transfusion urine shall be
carried out for haemoglobin and its
metabolites
d) Determination of bilirubin concentration in

serum shall be obtained preferably 5 to 7
hours after the transfusion
e) Supernatant plasma and remaining blood in
the blood container as well as the post
reaction sample of the patient/recipient shall
be tested for bacteria by smear and culture
If investigations are suggestive of a haemolytic
reaction or bacterial contamination, patient/
recipient’s physician shall be informed
immediately.
6.8.3 Delayed Complications
Appropriate test for antibody screening and test
for TTI shall be done to detect the cause of the
delayed reaction. The record shall be maintained
in patient/ recipient’s medical file.
Reported cases of suspected transfusiontransmitted disease shall be evaluated. If
confirmed, the involved blood unit shall be
identified in the report. Attempt shall be made to
recall the donor for retesting and counselling.
Other recipients who received components from the
suspected blood unit shall also be investigated. The
remaining components shall be discarded.

Implementation
Remarks
6.8.4 Detection, reporting & evaluation of transfusion reaction
The centre shall have a mechanism/ procedure
for detection, reporting and evaluation of
suspected adverse reaction to transfusion. The
procedure may include the following:
a) the personnel attending the patient/recipient
shall notify immediately the responsible
physician and transfusion service with
necessary documentation and appropriate
sample
b) evaluation of all suspected transfusion
reactions but this should not delay proper
clinical management of the patient/recipient
c) details of all cases, with interpretation of
evaluation shall be recorded and reported to
the hospital transfusion committee
d) a written protocol for the investigations of
transfusion reactions.
6.9 Documentation in Transfusion Service

The blood bank/ blood centre shall have records
keeping system that shall serve its needs and
that may make it possible for the centre to trace a
unit of blood/component from source to final
destinations; ensure confidentiality of donor and
patient/recipient records.
The records shall be legible and any
amendments shall be initialized with date only by
authorized person. The records shall have date
of performance of procedures, tests and
interpretation.
The centre shall have a procedure to retaining of
all records for a minimum of 5 years or
accordance to national or state requirements and
regular reports shall be submitted to respective
authority as per the requirement of the state.
Centre shall maintain records:
a) for donor and donor’s blood/ components as
per clause no. 6.2.1.10 (of this standard)
b) of recipient as per clause no 6.7.5
c) for all other record as per Annexure E (of this
standard) Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)

Implementation
Remarks
6.10 Histocompatibility Testing
Histocompatibility testing refers to the determination of
tissue antigens and their immunologic reactions.
Testing includes isolation of cells such as
lymphocytes, platelets, granulocytes and other
tissue cells, HLA typing for A, B, C, DP, DR and
DQ locus antigens, antibody detection crossmatching and mixed lymphocyte culture.
Terminology of HLA antigens shall conform to the
nomenclature adopted by the World Health
Organisation.
Centers having facility of histocompatibility
testing shall have the defined processes,
procedures and equipment for:
- HLA typing reagents
- HLA typing
- compatibility testing
- sample identification
- HLA antibody detection
- lymphocytotoxicity cross match
- pretransfusion transplant and records.
6.11 Quality Control (Also see Annexure D)

Blood bank/ blood centre shall have an
implemented procedure for Quality Control.
6.11.1 ABO and Anti-D Reagents
Quality control for ABO and Anti-D Reagents
shall include:
- checking of every new batch/ lot for its
potency (titre) besides specificity and avidity
on receipt
- checking of all antisera and other reagents
daily for specificity and avidity, using known
positive and negative controls
- discarding of all reagents showing turbidity
and discoloration
Implementation
Remarks
- manufacturer’s package insert shall specify
titre, avidity and for all other relevant
information
- methods for all shall be as per manufacturer’s
instructions
- no reagents to be used after date of expiry
At any given time, there shall be two different batches
of anti-D reagents available either from two different
manufacturers or two different batches from the same
manufacturer.
6.11.2 Reagent Red Blood Cells
Cells shall be prepared by pooling, daily and
shall be free of haemolysis. There shall be a
minimum pool of 3 individuals cells for each
group.
Each batch of reagent cells (A, B and O) for
serum grouping prepared shall be tested to
confirm specificity.
6.11.3 Red Cell Panel
Blood bank shall use either commercially
available or in house prepared panels.
The red cells shall be stored frozen, or at 4
C.
Red cells stored for more than 48 hours at 4
o
C, shall
be checked for reactivity, of at least one weak reactive
antigen by saline and indirect anti-globulin test.
6.11.4 Anti-Human Globulin Reagent
One vial from every new batch/lot shall be
checked for its specificity and reactivity using
(incomplete anti-Rh) IgG coated cells.
Each test shall include positive and negative
controls.
Non-sensitised A, B and O cells shall be checked
to rule out non-specific reactions.
All negative AHG tests shall be confirmed by
addition of IgG coated cells in the test. IgG
coated cells shall give positive agglutination.
Implementation
Remarks
6.11.5 Bovine Serum Albumin
The reagent shall be free of the non-specific
agglutinins and shall not react with saline

suspension of A, B and O cells.
Reagent shall give positive reaction with Rh (D)
positive cells coated with incomplete anti-Rh (D).
6.11.6 Enzyme Reagents
Enzymes such as papain, ficin, trypsin or
bromelin shall be used for detection of
incomplete antibodies.
Using the standard technique employed by
individual laboratory, the reagent shall give
specific result using incomplete anti-Rh(D) with
positive and negative control.
Preparation of working reagent shall be by
standard method.
Enzyme shall be aliquoted and stored in frozen
state. Only required amount for the day shall be
thawed.
The unused enzyme remaining at the end of
each day shall be discarded.
6.11.7 Hepatitis B surface antigen, Anti-HCV and Anti-HIV 1 & 2 Test
Use of enzyme linked immuno sorbent assay
(ELISA)/ Rapid test is recommended, using kits

approved by CDSCO. Any another recent
approved technology with same or increased
sensitivity may be used.
Test shall be performed as per the instructions of
the manufacturer.
Positive and negative control (kit control or inhouse) shall be run with every batch.
Rapid tests approved by CDSCO shall be used
for screening in emergency, in rural areas, any
centre collecting small volumes or where power
and require maintenance is problem.
Implementation
Remarks
6.11.8 Test for Syphilis
VDRL or TPHA or RPR or ELISA method can be
used.
Test shall be performed as per manufacturer’s
instructions.
Positive and negative controls (kit control and inhouse) must be included with every batch.
6.11.9 Normal Saline and Buffered Solutions

These solutions shall be checked daily for pH
between 6.7 - 7.2.
Absence of haemolysis with random A, B and O
cells provide useful indications for its suitability.
6.11.10 Blood Component
Quality of blood components shall be as per
annexure D of the standard.
6.12 Proficiency Testing Programme
The centre shall participate in External Quality
Assurance Scheme (EQAS)/ Proficiency Testing
Programme (PT) and monitor the results of these
programmes and participate in implementation of
corrective action.
Whenever a formal EQAS/ PT programme is not
available, the centre shall develop a mechanism
for determining the acceptability of procedures
not otherwise evaluated.
Centre can participate in a suitable interlaboratory comparison or adopt alternative
methods to validate performance.
The centre shall document, record and act upon
results from this comparison.
Problems and deficiencies identified shall be
acted upon and record of action retained.

Implementation
Remarks
6.13 Bio-medical waste disposal and laboratory safety in blood bank/ blood centre
Blood bank/ blood centre shall have implemented
policy and procedure for bio-medical waste
disposal and laboratory safety programme.
6.13.1 Protection of blood bank/ blood centre personnel against laboratory infection
The centre shall have procedure for protection of
its personnel against laboratory infection and
may include:
a) lab personnel be informed of the hazards
including transmission of viral infection
involved in working in a blood bank/blood
centre laboratory
b) reporting and recording with concerned
authorities about incidental exposure to
infected samples like bag breakage, splash,
needle stick injury
c) usage of post exposure prophylaxis as per
guidelines of regulatory authority

d) Immunization of the blood bank/blood centre
staff against hepatitis-B infection
6.13.2 Safety in the laboratory
Blood bank/ blood centre shall have safety
measures in its laboratory, these may include:
a) staff adequately trained in the safety aspects
of the lab
b) behave of staff in a safe and responsible
manner at all times
c) restriction of authorized personnel only inside
the lab
d) appropriate protective clothing must be worn
all the times
e) eating, drinking, smoking, applying cosmetic
and handling contact lens must be prohibited
in the lab
f) mouth pipetting prohibited in the lab
g) avoid the formation of aerosols or splashing
of materials
Implementation
Remarks
h) work surfaces must be decontaminated after
any spillage and at the end of each working
day
i) contaminated waste or reusable materials
must be appropriately decontaminated before
disposal or reuse
j) in case of needle stick injury, squeezeing out
the blood; washing of hand with soap and
water or anti septic and making out an
incident report
k) disposal of all sharps in puncture proof
containers
6.13.3 Disposal of Blood and Laboratory Material
Method of disposal of Blood Bags
Blood bank/ blood centre shall comply with
requirement of Biomedical Wastes Rules of
Ministry of Environment and Forest and local
Pollution Control Board.
Needles shall be burnt using electric needle
destroyers or soaked in hypochlorite solution and
discarded in puncture proof container or a nonchlorinated plastic. These shall then be sent for
deep burial or incineration.

Disinfection of glassware
All reusable glassware shall be disinfected by
treating with hypochlorite and detergent before
cleaning. Subsequently glassware must be kept
in hot-air oven at 160
C for 1 hour.
Spills on the table tops/ sinks
Spill shall be covered with filter papers or plain
cloth and soaked with 1% hypochlorite solution
for at least 30 minutes and later swabbed.
Hypochlorite/ detergent solution
0.5 - 1.0 percent solution of hypochlorite is the
best general-purpose disinfectant if contact is
maintained for at least 30 minutes (except for
metallic equipment which could be autoclaved or
put in 2% glutaraldehyde).

Implementation
Remarks
Disposal by Sterilisation
Autoclaving for 30 minutes at 121
C and 15 p.s.i
(68.5 cm Hg) is the method of choice. Validation
with use of biological indicator (Bacillus
sterothermophilus) shall be done at least once a
month.
Implementation
Remarks
7 IDENTIFICATION OF DEVIATIONS AND ADVERSE EVENTS
7.1 Policies and procedures when non-conformity is detected
7.1.1 The Blood bank/ blood centre shall have defined
policy and procedure when any aspect of its test
analysis or function does not conform to laid
down procedure.
7.1.2 After the occurrence of deviated function, the
procedure for defined responsibility shall be laid
down for:
- analyzing the nonconformity
- resumption of work after taking corrective
action
7.1.3 The Blood bank/ blood centre shall take
appropriate corrective action.
7.2 Procedure for release of non-conforming blood component
The Blood bank/ blood centre shall have policy
and procedure for release/ discard of nonconforming blood component and may include:
- Director/ In-charge of the blood bank/ blood
centre to be the authorized personnel for the
same
- Event shall be recorded.
7.3 Preventing recurrence of non-conformity
The blood bank/ blood centre shall have a policy
and procedure to identify, document and
eliminate the root cause of non-conformity. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG
(BB)
Implementation
Remarks
8 PERFORMANCE IMPROVEMENT
The blood bank/ blood centre shall have policy
and procedure for performance improvement that
may include the following:
1. addressing complaints
2. corrective action
3. preventive action
8.1 Addressing Complaints
8.1.1 Blood bank/ blood centre shall have policy and
procedure for addressing complaints or other
feed backs received from donors, clinicians,
blood camp organizers or other parties.
8.1.2 Record of complaints, investigations and
corrective actions taken by the blood bank/ blood
centre shall be maintained.
8.2 Corrective action
8.2.1 Root cause analysis
The procedure for corrective action shall include
process of investigation to determine root cause
of the problem.
The corrective action shall be appropriate to the

magnitude of the problem and shall
commensurate with the risk encountered.
8.2.2 Implementation and monitoring changes resulting from corrective action
The blood bank/ blood centre shall document and
implement any changes required after
investigation as a corrective action.
The blood bank/ blood centre shall monitor the
results of any corrective action taken, in order to
ensure that they have been effective in
overcoming the identified problems.
The blood bank/ blood centre shall have an
additional audit for the particular area if the
investigation casts doubt on compliance with
policies and procedures.
Implementation
Remarks
8.2.3 Documentation of corrective action
All corrective actions taken shall be documented
and recorded with root cause analysis. It shall be
submitted in management review meetings.

8.3 Preventive action
Preventive action is a proactive process for
identifying opportunities for improvement.
Procedure for preventive action shall include:
- identifying opportunities for improvement in
technical or management system whenever
they are identified
- action plan shall be developed, implemented
and monitored to reduce the occurrence of
such non-conformities
- initiation of such action and ensure that these
are effective.
Implementation
Remarks
9 DOCUMENT CONTROL
implemented policy and procedure for document
control that may include the following:
1. procedure for document control and review of

documents
2. document requirements
3. maintenance of documents in computer
software (electronic records)
9.1 Procedure for document control and review of documents
9.1.1 The blood bank/ blood centre shall define
document and have procedure for document
control and also control of information (from
internal and external sources).
Note: In this context, ‘document’ is any information or
instructions, including policy statements, text books,
procedures, specifications, calibration tables, biological
reference intervals and their origins, charts, posters, notices,
memoranda, software, drawings, plans, and documents of
external origin such as regulations, standards or
examination procedures.
9.1.2 Blood bank shall adopt a procedure so that all
documents issued to blood bank personnel as
part of the quality management system are
reviewed and approved by authorized personnel
prior to issue.
9.1.3 Blood bank shall maintain a master list of
documents giving details about the documents
viz., issue no., issue date, revision no., revision
date and their distribution details, which helps in
identifying the current valid revisions.
9.1.4 Current authorized version of the documents
shall be available at relevant locations.
9.1.5 Documents shall be periodically reviewed, revise
when necessary, and approved by authorized
personnel.
9.1.6 Invalid or obsolete documents shall be removed
from all points of use. Assessor Guide for Blood Banks/ Blood Centres – NABH-AG (BB)
Implementation
Remarks
9.1.7 Prevention shall be done for inadvertent use of
retained or archived superseded documents.
9.1.8 Procedures shall be defined for amendment of
documents by hand, pending the re-issue of
documents. The amendments are clearly
marked, initialled and dated and a revised

document is formally re-issued as soon as
practicable.
9.1.9 Procedure shall be established to describe the
amendments made in the documents in
computerized systems and for its controlling.
9.2 Document required
The blood bank/ blood centre shall have all the
documents as mentioned in Annexure E of the
standards.
The procedure on document control shall also
include archiving copy of each controlled
documents for future reference and may be
maintained on appropriate medium.
Blood bank/ blood centre shall define the
retention period of these documents.
The centre shall comply with national, regional,
local regulations for retention of documents.
9.3 Maintenance of documents in computer software
Electronic Records
The procedure on document control may also
include documents in computer and electronic
records and may include:
- processes and procedures to support the

management of computer system
- process in place for routine backup of all
critical data
Implementation
Remarks
- an alternative method to be used during
system breakdown must be known and shall
have hard copies of all document even when
documentation is electronically maintained.
- maintenance and continuous operations must
be ensured
- shall ensure that data are retrievable and
usable
- personnel must be trained
- validation of system and integrity and security
of data entry
- records required by Drugs and Cosmetics Act
shall also be maintained as hard copies
Implementation
Remarks
10 RECORDS
implemented policy for keeping and retaining of
records and may include:
1. record identification: all records relevant to
the quality management system shall be
uniquely identified with appropriately labelled.
Records shall be identified, reviewed,
retained and also records are created, stored
and archived in accordance with record
retention policies.
2. quality and technical records: quality records
as well as technical records that may include
original observation, calibration record, staff
record, copy of each test report, and
calibration certificate are to be kept for
defined period.
Records shall be legible and stored in easy
retrievable way. Storage shall be in
compliance to national/ regional requirements
and shall have suitable environment to
prevent damage, deterioration, loss or
unauthorized access.
3. record retaining period: stated policy shall be
there stating the duration of retaining records
pertaining to quality management system or
technical records. National and local
regulation must be kept in mind before
formulation of such policy.
Note: maintaining and retention of records, see
annexure E
Implementation
Remarks
11 INTERNAL AUDIT & MANAGEMENT REVIEW
implemented policy and procedure for conduct of
Internal Audit and Management Review.
11.1 Policy for internal audit and management review
The blood bank/ blood centre shall have a policy
for the conduct of internal audit and management
review to verify the compliance of the
requirements of both management system and

technical requirements.
11.2 Procedure of internal audit
implemented procedure for internal audit and
may include frequency of audit, methodologies
and requirements for documentation.
Audits shall be formally planned and organized
and shall be carried out by Quality Manager or
designated personnel. Audit shall not be done for
their own activities. The Deficiencies of audit are
noted and appropriate action, corrective/
preventive action shall be carried out within
agreed time.
The main elements of the management system
shall be normally be subject to internal audit once
every twelve months.
11.3 Procedure of management review
implemented procedure for conducting
management review. Management shall review
the quality management system and all of its
medical services, including examination and

advisory activities, to ensure their continuing
suitability and effectiveness in support of donor
and/ or patient/ recipient care and to introduce
any necessary changes or improvements. The
results shall be incorporated into a plan including
goals, objectives and action plans. The interval
for management review shall atleast be once a
year.
Implementation
Remarks
The management review, apart from other, shall
also take account of all including:
1. reports from management and supervisory
personnel
2. the outcome of recent internal and external
audit
3. feed back, complaints
4. non-conformities with corrective and
preventive action.
11.4 Documentation of internal audit and management review

The blood bank/ blood centre shall in the
management review meeting review reports of
internal audit and follow up corrective action.
The findings and action arising from
management review shall be recorded and
centre shall be informed of these findings and
decisions made as a result of review. The
management shall ensure that arising action are
discharged with appropriate and agreed-upontime.
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 organisation and am/ am not* related to any
person of the management of the health care organisation.
iii. I got an opportunity to go through various documents of the above hospital 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

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Indicators Parameters

1 Mortality ICU:Crude , Severity adjusted, Disease based

2 Morbidity Incidence Of:

Accidental extubation,Reintubation in planned

extubated patients, pneumothorax,

Unanticipated cardiac arrest, hypotension, renal failure

%Nosocomial infections (VAP , BSI,UTI)

%of patient with VRE, MRSA etc.

% of patients with GI bleed

Pressure sore, dental trauma, nerve & vascular injury.

ICU readmission within 24hours

3 Cost effectivity Patient/ICU day cost to the institution.

Man power cost, capital equipment cost

Equipment maintenance, consumables,

Diagnostics, house keeping, electricity etc.

Overall expenditure in ICU Expense

(post ICU) in hospital Expense (post

hospital) after discharge Long term

survival and quality of life

Per survivor cost in ICU/ hospital / post discharge

4 Safety of patient Error reporting : incidence of different errors

complication rates related to care Number

of complications/ patient Incidence of

% compliance to waste disposal

% compliance to hand hygiene protocol

Blood component therapy

Frequency of Noncompliance to protocol.

Antibiotic free stay ( days) in ICU

Antibiotic resistance & Drug resistant microbial

Broad spectrum antibiotic use/1000 patient days

Descalation in % of patients receiving antimicrobials- 26 -

5 Safety of ICU personnel Number of needle stick injuries

Number injured while working

6 Man power Per Person training (in hours or days) /Yr

Appraisal of targets given.

Staff satisfaction and turnover rate

Number of patient managed, %bed occupancy,

Av. LOS, total occupied bed days,

% ICU patient ideally should be shifted but remaining in ICU

number of readmissions, fraction of patients

for whom ICU care is expected to be futile, number of X

Average ventilatory days

Utilization in days or hours/ month

Downtime in days or hours/ month

ROI (Return on Investment) of individual equipment

% satisfaction level of patient/relatives

Number of negative and positive fee backs

Number of complains/ suggestions & number

Satisfaction of others in the hospital with the care and

services supplied by the ICU.

9 Administrative Revenue generation

B ) Selection and action plan for implementation of indicat

The quality indicators applied hospital wide are:

12. Managerial monitoring includes those aspects of procurement of routinely required

13. Managerial monitoring includes those aspects of reporting of activities as required by

Accreditation refers to a process whereby a nongovernmental agency grants a recognized

What is clinical audit?

Clinical audit is by definition a quality improvement

process that seeks to improve patient care and

outcomes through systematic review of care

against explicit criteria and the implementation of

changes. Aspects of the structure, processes and

outcomes of care are systematically evaluated