Transfusion Medicine | GUIDELINES
Guidelines for pre-transfusion compatibility procedures
in blood transfusion laboratories*
British Committee for Standards in Haematology
C. Milkins,1 J. Berryman,2 C. Cantwell,3 C. Elliott,4 R. Haggas,5 J. Jones,6 M. Rowley,3,7 M. Williams8 & N. Win9
1
UK NEQAS (BTLP), West Herts Hospitals NHS Trust, Watford, UK, 2 Department of Blood Transfusion, University College London
Hospitals, NHS Foundation Trust, London, UK, 3 Department of Blood Transfusion, Imperial College Healthcare NHS Trust, London,
UK, 4 Department of Blood Transfusion, South Tees Healthcare Trust, Middlesborough, UK, 5 Department of Blood Transfusion, Leeds
teaching Hospital NHS Trust, Leeds, UK, 6 Welsh Blood Service, Cardiff, UK, 7 Colindale Centre, NHSBT, London, UK, 8 Leeds Centre,
NHSBT, Leeds, UK, and 9 Tooting Centre, NHSBT, Tooting, UK
Received 18 July 2012; accepted for publication 27 September 2012
Contents Appendix 7 REQUIREMENT FOR TWO SAMPLES FOR
ABO/D GROUPING PRIOR TO ISSUE OF
INTRODUCTION RED CELLS
SUMMARY OF KEY RECOMMENDATIONS Appendix 8 THE NEED FOR AN IAT CROSSMATCH
Section 1 ORGANISATION OF THE GUIDELINES RATHER THAN ELECTRONIC ISSUE (EI)
Section 2 QUALITY MANAGEMENT IN PRE-TRANS WHERE THE ANTIBODY SCREEN IS
FUSION TESTING POSITIVE
Section 3 SAMPLES AND DOCUMENTATION Appendix 9 EXAMPLE OF A CONCESSIONARY RE-
Section 4 ABO AND D GROUPING LEASE FORM
Section 5 ANTIBODY SCREENING Appendix 10 GLOSSARY
Section 6 ANTIBODY IDENTIFICATION Appendix 11 ACRONYMS AND ABBREVIATIONS
Section 7 SELECTION AND ISSUE OF RED CELLS CONFLICT OF INTEREST
Section 8 TESTING AND RED CELL ISSUE IN NON- DISCLAIMER
ROUTINE SITUATIONS
Section 9 POST ISSUE OF BLOOD COMPONENTS INTRODUCTION
Appendix 1 EXAMPLES OF CRITICAL CONTROL
The effective development and maintenance of satisfactory
POINTS
standards in pre-transfusion testing requires a structured
Appendix 2 TIMING OF SAMPLE COLLECTION IN
approach in the adoption of a quality management system.
RELATION TO PREVIOUS TRANSFUSIONS
Technical errors, clerical errors, the use of non-validated
AND STORAGE OF SAMPLES POST-
techniques or equipment and non-compliance with established
TRANSFUSION
procedures may result in missed incompatibilities and
Appendix 3 RESOLUTION OF GROUPING ANOMALIES
immediate or delayed haemolytic transfusion reactions (SHOT,
Appendix 4 WORKED EXAMPLES OF ANTIBODY IDE-
1996–2010; Stainsby et al., 2006). The purpose of these
NTIFICATION
guidelines, which replace those published in 2004 (Chapman et
Appendix 5 ADDITIONAL TECHNIQUES FOR ANTI-
al., 2004), is to define the laboratory processes and procedures
BODY IDENTIFICATION
that should be adopted to undertake pre-transfusion testing.
Appendix 6 CLINICAL SIGNIFICANCE OF RED CELL
The guideline group was selected to be representative of UK-
ANTIBODIES based medical, scientific and technical experts. The writing group
produced the draft guideline which was subsequently revised
by consensus by members of the Transfusion Task Force of the
Correspondence: BCSH Secretary, British Society for Haematology, British Committee for Standards in Haematology. The guideline
100 White Lion Street, London N1 9PF, UK. was then reviewed by a sounding board of approximately 50 UK
e-mail: haematologists, the BCSH (British Committee for Standards
∗
‘Guidance and Recommendations’ as per the BCSH website (date for in Haematology) and the Transfusion Laboratory Managers
guideline review July 2014). Working Group of the National Blood Transfusion Committee
Writing group members: C. Milkins, J. Berryman, C. Cantwell, and its equivalent in the other three countries, and comments
C. Elliott, R. Haggas, J. Jones, M. Rowley, M. Williams and N. Win. incorporated where appropriate.
© 2012 The Authors First published online 6 December 2012
Transfusion Medicine © 2012 British Blood Transfusion Society doi: 10.1111/j.1365-3148.2012.01199.x
, 13653148, 2013, 1, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1365-3148.2012.01199.x by INASP/HINARI - PAKISTAN, Wiley Online Library on [22/08/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
4 Guidelines
These guidelines are formulated from expert opinion and of functioning, validated IT or when electronic issue is
based on the requirements of the Blood Safety and Quality contra-indicated.
Regulations (BSQR, 2005), and the recommendations of Clin- 14. An IAT crossmatch must be used if the patient’s
ical Pathology Accreditation (CPA, 2010), Guidelines for Blood plasma contains or has been known to contain, red cell
Transfusion Services in the UK (UK Blood Transfusion Services, alloantibodies of likely clinical significance.
2012), the UK Transfusion Laboratory Collaborative (Chaffe 15. The overall process for determining eligibility for electronic
et al., 2009), and data from UK NEQAS (BTLP) (Knowles et issue (EI) must be controlled by the LIMS and not rely on
al., 2002; UK NEQAS ANNUAL REPORTS) and the Serious manual intervention or decision making.
Hazards of Transfusion (SHOT) haemovigilance scheme annual 16. Laboratories should have written protocols in place which
reports (SHOT, 1996–2010). Where evidence exists to support define the responsibilities of all staff in dealing with urgent
new and potentially contentious recommendations, this is requests.
referenced in the text. 17. For genuinely unknown patients, the minimum identifiers
are gender and a unique number.
SUMMARY OF KEY RECOMMENDATIONS 18. Following an emergency rapid group, a second test to
detect ABO incompatibility should be undertaken prior to
1. The laboratory must identify all critical control points in release of group specific red cells.
pre-transfusion testing and build in security at these points. 19. If the direct antiglobulin test (DAT) is positive in a patient
See Appendix 1 for examples. transfused within the previous month, an eluate made
2. Laboratories must have contingency plans for action to be from the patient’s red cells should be prepared and tested
taken when normal systems are not available. for the presence of specific alloantibodies.
3. The laboratory should have a policy with respect to the
manual editing and authorisation of test results.
4. Serological studies should be performed using blood 1. ORGANISATION OF THE GUIDELINES
collected no more than 3 days in advance of the actual
The quality section includes all of the quality recommendations
transfusion when the patient has been transfused or
from the whole guideline, so those using this guideline should
pregnant within the preceding 3 months.
refer back to the quality section for advice relating to individual
5. A pre-transfusion sample should be retained for at
sections.
least 3 days post-transfusion, to ensure that repeat ABO
All aspects of testing relating to emergency situations have
grouping of the pre-transfusion sample can be performed
been put into a separate section – Section 8. Other sections now
in the event of an acute transfusion reaction.
6. ABO grouping is the single most important serological test relate solely to routine testing.
performed on pre-transfusion samples and the sensitivity Efforts have been made to avoid duplication and overlap with
and security of testing systems must not be compromised. other guidelines. This guidance is complementary to the BCSH
7. Fully automated systems should be used where possible to guidelines that cover transfusion of paediatric patients, antenatal
reduce the risks of interpretation and transcription errors. serology, information technology (IT) systems, administration
8. Any abbreviation of the ABO group must be fully risk of blood components and validation in the transfusion
assessed. laboratory (BCSH, 2004, 2006a,2006b, 2009, 2010a), and these
9. The patient demographics on the sample should be checked should be available for reference. The referenced versions of
against the computer record prior to validation of results these guidelines were current at the time of publication of this
(preferably prior to testing) to ensure that they match and document but it is recognised that they may be updated during
that no errors have been made during data entry onto the the lifetime of this guideline, and reference should always be
Laboratory Information Management System (LIMS). made to the current version.
10. If the patient is known to have formed a red cell Where expansion on the decision making on the recommen-
alloantibody, each new sample should be fully tested to dations is required, this is covered in a series of appendices.
exclude the presence of further alloantibodies. Recommendations are based on overriding principles, but it is
11. When one antibody specificity has been identified, it is recognised that a safe outcome may be achieved using a different
essential that the presence or absence of additional clinically approach, whilst still complying with minimum standards. In
significant antibodies is established. these circumstances, a fully documented risk assessment is
12. Unless secure electronic patient identification systems required.
are in place, a second sample should be requested for Exceptions to policy relating to individual patients are now
confirmation of the ABO group of a first time patient prior covered by a statement relating to concessionary release and an
to transfusion, where this does not impede the delivery of example is given in Appendix 9.
urgent red cells or other components. There is an additional section relating to what happens after
13. The indirect antiglobulin test (IAT) crossmatch is the components have been issued, and the serological investigation
default technique which should be used in the absence of a suspected transfusion reaction.
Transfusion Medicine, 2013, 23, 3–35 © 2012 The Authors
Transfusion Medicine © 2012 British Blood Transfusion Society
, 13653148, 2013, 1, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1365-3148.2012.01199.x by INASP/HINARI - PAKISTAN, Wiley Online Library on [22/08/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
Guidelines 5
There are new flow charts for anomalous D typing and Approved EQA schemes are those that have been
selection of blood in this circumstance, and for anomalous ABO accredited to standards based on ILAC G13:2000
typing (Appendix 3). Guidelines for the Requirements for the Competence
There are worked examples of antibody identification in of Providers of Proficiency Testing Schemes, or to
Appendix 4. ISO 17043:2010: General Requirements for Proficiency
Testing.
2. QUALITY MANAGEMENT IN 2.1.9. Laboratories must have contingency plans for actions
PRE-TRANSFUSION TESTING to be taken when routine systems are not available.
These plans should include manual systems to deal
2.1. Quality management system with loss of automation and LIMSs. Examples include:
2.1.1. In keeping with all other clinical laboratories, the suspending testing that is not absolutely necessary;
transfusion laboratory must have an operational and recording information for uploading later to ensure
documented Quality Management System, clearly the audit trail; consideration given to sending routine
defining the organisational structure, procedures, samples to another site with same LIMS; suspending
processes and resources necessary to meet the the use of electronic issue.
requirements of its users, to accepted standards of
good practice. KEY RECOMMENDATION: Laboratories must have
2.1.2. From November 2005, all Hospital Blood Banks and contingency plans for actions to be taken when normal
Blood Establishments have been subject to the Blood systems are not available.
Safety and Quality Regulations (BSQR, 2005). Article
2 of European Commission directive 2005/62/EC
gives details of the Quality System standards and 2.2. Staff training and competency
specifications required.
2.2.1. There must be a documented programme for training
2.1.3. Transfusion laboratories must use equipment, infor-
laboratory staff, including on-call staff not routinely
mation systems and test systems that have been
working in the laboratory, which covers all tasks and
validated against the documented requirements of
testing performed appropriate to the grade of staff
the laboratory.
and which fulfils the documented requirements of the
2.1.4. The systems must enable a full audit trail of laboratory (Chaffe et al., 2009). It must also include
laboratory steps, including the original results, handling major incidents and emergency situations
cross-referenced to associated internal controls, including contingency plans for major system failures.
interpretations, amendments, authorisations, and the
2.2.2. Staff must receive regular update training on the
staff responsible for conducting each critical step.
principles of Good Manufacturing Practice (GMP).
2.1.5. The laboratory must identify all critical control points
2.2.3. Laboratory tasks must only be undertaken by
in pre-transfusion testing, and build in security at
appropriately trained staff.
these points. See Appendix 1 for examples.
2.2.4. There must be a documented programme for assessing
staff competency in all laboratory tasks.
KEY RECOMMENDATION: The laboratory must identify
2.2.5. Where decisions are required about interpretation
all critical control points in pre-transfusion testing and
of results, component selection and/or specialist
build in security at these points.
requirements, the staff involved must have the required
knowledge (supported by relevant qualification) to do
2.1.6. A programme of regular independent internal audits this safely.
must be instituted to assess compliance with laboratory 2.2.6. Specialist clinical and technical advice should be
processes. available at all times from staff who have demonstrated
2.1.7. The laboratory management must conduct regu- sufficient knowledge, training and competency to do
lar reviews of quality incidents including: untoward so (Chaffe et al., 2009). This could be from within a
laboratory incidents [including those reported to network or Blood Service reference laboratory if not
the Medicines and Healthcare products Regulatory available from within a single centre.
Agency (MHRA) and SHOT via the SABRE system],
complaints, external quality assessment reports, inter-
nal audits of the laboratory procedures, concessionary 2.3. Reagents and test systems
release, recalls and process deviations. 2.3.1. Reagents used for ABO and D grouping must be CE
2.1.8. The laboratory should participate in relevant accred- marked, and be stored and used in accordance with
ited External Quality Assessment (EQA) Schemes. the manufacturers’ instructions.
© 2012 The Authors Transfusion Medicine, 2013, 23, 3–35
Transfusion Medicine © 2012 British Blood Transfusion Society
, 13653148, 2013, 1, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1365-3148.2012.01199.x by INASP/HINARI - PAKISTAN, Wiley Online Library on [22/08/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
6 Guidelines
2.3.2. Reagents used for all other tests should be, where Laboratories (BCSH, 2010a), Guidelines for validation
available, CE marked, and be stored and used in of automated systems in blood establishments
accordance with the manufacturers’ instructions. (ISBT, 2010), GAMP®5: A Risk-based Approach to
2.3.3. All critical processes, equipment, facilities or systems Compliant GxP Computerised Systems (ISPE, 2008),
in the transfusion laboratory must be validated in and Eudralex Vol 4 GMP guidelines (EUDRALEX,
accordance with the BCSH Guidelines for Validation & 2011).
Qualification, including Change Control, for Hospital 2.4.3. The system must be revalidated following the
Transfusion Laboratories (BCSH, 2010a). installation of any upgrades or changes in interface.
2.3.4. All changes to critical process, equipment, facilities The level of revalidation required will depend on the
or systems in the transfusion laboratory must be magnitude of the changes in the upgrade or interface
validated in accordance with the BCSH Guidelines for alteration.
Validation & Qualification, including Change Control,
for Hospital Transfusion Laboratories (BCSH, 2010a). 2.5. Automated blood grouping and antibody screening
2.3.5. Laboratories should ensure that they have a way systems
of identifying and documenting changes made by 2.5.1. Prior to introduction and use, the system must be
manufacturers to the raw material used for reagents validated in accordance with the BCSH Guidelines for
or test systems; if this occurs, the performance of the Validation & Qualification, including Change Control,
system should be reviewed and revalidated. for Hospital Transfusion Laboratories (BCSH, 2010a).
2.3.6. There should be a record of all batch numbers and 2.5.2. Planned preventative maintenance/emergency repair
expiry dates of all reagents used in the laboratory. The will require a documented ‘return to service’ procedure
record should either include the time periods during to be undertaken.
which they are in use or should link directly to the test 2.5.3. The laboratory should have a policy with respect to
result. the manual editing and authorisation of test results;
2.3.7. All laboratory equipment must be regularly main- this should include the designation of staff allowed
tained in accordance with the manufacturer’s instruc- to edit results, with password controlled access where
tions. Where appropriate, calibration of equipment possible (SHOT, 1996–2010).
must include details of the reference standard used.
2.3.8. There should be a record of instrument failure, subse-
KEY RECOMMENDATION: The laboratory should have a
quent corrective action and ‘downtime’. There should
policy with respect to the manual editing and authorisation
be a process for trending instrument failures and for
of test results.
returning equipment to use after corrective action.
2.3.9. Appropriate quality control (QC) must be used for
all parts of the test system. The type and frequency of 2.5.4. Automated grouping and antibody screening systems
any controls used should be based upon appropriate should have, wherever possible, safeguards built into
risk assessments. the systems to detect possible failures; these could
include but are not limited to:
2.3.10. There must be a documented procedure for dealing
i. notification of failure to dispense and/or aspirate
with QC failure with all actions documented. The
samples, reagents or wash solutions;
process should include action to be taken with regard
ii. presence of a level check on final test mixture.
to results already released since the previous QC
testing. Result acceptance should only continue once
the QC failure has been satisfactorily resolved. 3. SAMPLES AND DOCUMENTATION
2.3.11. There should be a documented programme to ensure 3.1. Introduction
the efficacy of the IAT, including efficacy of the cell
washers, where used (Voak et al., 1988). Errors in patient identification and sample labelling may lead
to ABO-incompatible transfusions. Evidence for this is well
2.4. Information systems documented in the annual reports of the SHOT steering group
(SHOT, 1996–2010) and by others (Stainsby et al., 2006;
2.4.1. The LIMS should comply with the requirements Sazama, 1990).
described in the BCSH guidelines for the specification
and use of information technology systems in blood
transfusion practice (BCSH, 2006b). 3.2. Written/electronic requests
2.4.2. The system must be validated in accordance with 3.2.1. There should be written policies for generating blood
the BCSH Guidelines for Validation & Qualification, transfusion requests and for the collection of blood
including Change Control, for Hospital Transfusion samples for pre-transfusion compatibility testing. This
Transfusion Medicine, 2013, 23, 3–35 © 2012 The Authors
Transfusion Medicine © 2012 British Blood Transfusion Society
Guidelines for pre-transfusion compatibility procedures
in blood transfusion laboratories*
British Committee for Standards in Haematology
C. Milkins,1 J. Berryman,2 C. Cantwell,3 C. Elliott,4 R. Haggas,5 J. Jones,6 M. Rowley,3,7 M. Williams8 & N. Win9
1
UK NEQAS (BTLP), West Herts Hospitals NHS Trust, Watford, UK, 2 Department of Blood Transfusion, University College London
Hospitals, NHS Foundation Trust, London, UK, 3 Department of Blood Transfusion, Imperial College Healthcare NHS Trust, London,
UK, 4 Department of Blood Transfusion, South Tees Healthcare Trust, Middlesborough, UK, 5 Department of Blood Transfusion, Leeds
teaching Hospital NHS Trust, Leeds, UK, 6 Welsh Blood Service, Cardiff, UK, 7 Colindale Centre, NHSBT, London, UK, 8 Leeds Centre,
NHSBT, Leeds, UK, and 9 Tooting Centre, NHSBT, Tooting, UK
Received 18 July 2012; accepted for publication 27 September 2012
Contents Appendix 7 REQUIREMENT FOR TWO SAMPLES FOR
ABO/D GROUPING PRIOR TO ISSUE OF
INTRODUCTION RED CELLS
SUMMARY OF KEY RECOMMENDATIONS Appendix 8 THE NEED FOR AN IAT CROSSMATCH
Section 1 ORGANISATION OF THE GUIDELINES RATHER THAN ELECTRONIC ISSUE (EI)
Section 2 QUALITY MANAGEMENT IN PRE-TRANS WHERE THE ANTIBODY SCREEN IS
FUSION TESTING POSITIVE
Section 3 SAMPLES AND DOCUMENTATION Appendix 9 EXAMPLE OF A CONCESSIONARY RE-
Section 4 ABO AND D GROUPING LEASE FORM
Section 5 ANTIBODY SCREENING Appendix 10 GLOSSARY
Section 6 ANTIBODY IDENTIFICATION Appendix 11 ACRONYMS AND ABBREVIATIONS
Section 7 SELECTION AND ISSUE OF RED CELLS CONFLICT OF INTEREST
Section 8 TESTING AND RED CELL ISSUE IN NON- DISCLAIMER
ROUTINE SITUATIONS
Section 9 POST ISSUE OF BLOOD COMPONENTS INTRODUCTION
Appendix 1 EXAMPLES OF CRITICAL CONTROL
The effective development and maintenance of satisfactory
POINTS
standards in pre-transfusion testing requires a structured
Appendix 2 TIMING OF SAMPLE COLLECTION IN
approach in the adoption of a quality management system.
RELATION TO PREVIOUS TRANSFUSIONS
Technical errors, clerical errors, the use of non-validated
AND STORAGE OF SAMPLES POST-
techniques or equipment and non-compliance with established
TRANSFUSION
procedures may result in missed incompatibilities and
Appendix 3 RESOLUTION OF GROUPING ANOMALIES
immediate or delayed haemolytic transfusion reactions (SHOT,
Appendix 4 WORKED EXAMPLES OF ANTIBODY IDE-
1996–2010; Stainsby et al., 2006). The purpose of these
NTIFICATION
guidelines, which replace those published in 2004 (Chapman et
Appendix 5 ADDITIONAL TECHNIQUES FOR ANTI-
al., 2004), is to define the laboratory processes and procedures
BODY IDENTIFICATION
that should be adopted to undertake pre-transfusion testing.
Appendix 6 CLINICAL SIGNIFICANCE OF RED CELL
The guideline group was selected to be representative of UK-
ANTIBODIES based medical, scientific and technical experts. The writing group
produced the draft guideline which was subsequently revised
by consensus by members of the Transfusion Task Force of the
Correspondence: BCSH Secretary, British Society for Haematology, British Committee for Standards in Haematology. The guideline
100 White Lion Street, London N1 9PF, UK. was then reviewed by a sounding board of approximately 50 UK
e-mail: haematologists, the BCSH (British Committee for Standards
∗
‘Guidance and Recommendations’ as per the BCSH website (date for in Haematology) and the Transfusion Laboratory Managers
guideline review July 2014). Working Group of the National Blood Transfusion Committee
Writing group members: C. Milkins, J. Berryman, C. Cantwell, and its equivalent in the other three countries, and comments
C. Elliott, R. Haggas, J. Jones, M. Rowley, M. Williams and N. Win. incorporated where appropriate.
© 2012 The Authors First published online 6 December 2012
Transfusion Medicine © 2012 British Blood Transfusion Society doi: 10.1111/j.1365-3148.2012.01199.x
, 13653148, 2013, 1, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1365-3148.2012.01199.x by INASP/HINARI - PAKISTAN, Wiley Online Library on [22/08/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
4 Guidelines
These guidelines are formulated from expert opinion and of functioning, validated IT or when electronic issue is
based on the requirements of the Blood Safety and Quality contra-indicated.
Regulations (BSQR, 2005), and the recommendations of Clin- 14. An IAT crossmatch must be used if the patient’s
ical Pathology Accreditation (CPA, 2010), Guidelines for Blood plasma contains or has been known to contain, red cell
Transfusion Services in the UK (UK Blood Transfusion Services, alloantibodies of likely clinical significance.
2012), the UK Transfusion Laboratory Collaborative (Chaffe 15. The overall process for determining eligibility for electronic
et al., 2009), and data from UK NEQAS (BTLP) (Knowles et issue (EI) must be controlled by the LIMS and not rely on
al., 2002; UK NEQAS ANNUAL REPORTS) and the Serious manual intervention or decision making.
Hazards of Transfusion (SHOT) haemovigilance scheme annual 16. Laboratories should have written protocols in place which
reports (SHOT, 1996–2010). Where evidence exists to support define the responsibilities of all staff in dealing with urgent
new and potentially contentious recommendations, this is requests.
referenced in the text. 17. For genuinely unknown patients, the minimum identifiers
are gender and a unique number.
SUMMARY OF KEY RECOMMENDATIONS 18. Following an emergency rapid group, a second test to
detect ABO incompatibility should be undertaken prior to
1. The laboratory must identify all critical control points in release of group specific red cells.
pre-transfusion testing and build in security at these points. 19. If the direct antiglobulin test (DAT) is positive in a patient
See Appendix 1 for examples. transfused within the previous month, an eluate made
2. Laboratories must have contingency plans for action to be from the patient’s red cells should be prepared and tested
taken when normal systems are not available. for the presence of specific alloantibodies.
3. The laboratory should have a policy with respect to the
manual editing and authorisation of test results.
4. Serological studies should be performed using blood 1. ORGANISATION OF THE GUIDELINES
collected no more than 3 days in advance of the actual
The quality section includes all of the quality recommendations
transfusion when the patient has been transfused or
from the whole guideline, so those using this guideline should
pregnant within the preceding 3 months.
refer back to the quality section for advice relating to individual
5. A pre-transfusion sample should be retained for at
sections.
least 3 days post-transfusion, to ensure that repeat ABO
All aspects of testing relating to emergency situations have
grouping of the pre-transfusion sample can be performed
been put into a separate section – Section 8. Other sections now
in the event of an acute transfusion reaction.
6. ABO grouping is the single most important serological test relate solely to routine testing.
performed on pre-transfusion samples and the sensitivity Efforts have been made to avoid duplication and overlap with
and security of testing systems must not be compromised. other guidelines. This guidance is complementary to the BCSH
7. Fully automated systems should be used where possible to guidelines that cover transfusion of paediatric patients, antenatal
reduce the risks of interpretation and transcription errors. serology, information technology (IT) systems, administration
8. Any abbreviation of the ABO group must be fully risk of blood components and validation in the transfusion
assessed. laboratory (BCSH, 2004, 2006a,2006b, 2009, 2010a), and these
9. The patient demographics on the sample should be checked should be available for reference. The referenced versions of
against the computer record prior to validation of results these guidelines were current at the time of publication of this
(preferably prior to testing) to ensure that they match and document but it is recognised that they may be updated during
that no errors have been made during data entry onto the the lifetime of this guideline, and reference should always be
Laboratory Information Management System (LIMS). made to the current version.
10. If the patient is known to have formed a red cell Where expansion on the decision making on the recommen-
alloantibody, each new sample should be fully tested to dations is required, this is covered in a series of appendices.
exclude the presence of further alloantibodies. Recommendations are based on overriding principles, but it is
11. When one antibody specificity has been identified, it is recognised that a safe outcome may be achieved using a different
essential that the presence or absence of additional clinically approach, whilst still complying with minimum standards. In
significant antibodies is established. these circumstances, a fully documented risk assessment is
12. Unless secure electronic patient identification systems required.
are in place, a second sample should be requested for Exceptions to policy relating to individual patients are now
confirmation of the ABO group of a first time patient prior covered by a statement relating to concessionary release and an
to transfusion, where this does not impede the delivery of example is given in Appendix 9.
urgent red cells or other components. There is an additional section relating to what happens after
13. The indirect antiglobulin test (IAT) crossmatch is the components have been issued, and the serological investigation
default technique which should be used in the absence of a suspected transfusion reaction.
Transfusion Medicine, 2013, 23, 3–35 © 2012 The Authors
Transfusion Medicine © 2012 British Blood Transfusion Society
, 13653148, 2013, 1, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/j.1365-3148.2012.01199.x by INASP/HINARI - PAKISTAN, Wiley Online Library on [22/08/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
Guidelines 5
There are new flow charts for anomalous D typing and Approved EQA schemes are those that have been
selection of blood in this circumstance, and for anomalous ABO accredited to standards based on ILAC G13:2000
typing (Appendix 3). Guidelines for the Requirements for the Competence
There are worked examples of antibody identification in of Providers of Proficiency Testing Schemes, or to
Appendix 4. ISO 17043:2010: General Requirements for Proficiency
Testing.
2. QUALITY MANAGEMENT IN 2.1.9. Laboratories must have contingency plans for actions
PRE-TRANSFUSION TESTING to be taken when routine systems are not available.
These plans should include manual systems to deal
2.1. Quality management system with loss of automation and LIMSs. Examples include:
2.1.1. In keeping with all other clinical laboratories, the suspending testing that is not absolutely necessary;
transfusion laboratory must have an operational and recording information for uploading later to ensure
documented Quality Management System, clearly the audit trail; consideration given to sending routine
defining the organisational structure, procedures, samples to another site with same LIMS; suspending
processes and resources necessary to meet the the use of electronic issue.
requirements of its users, to accepted standards of
good practice. KEY RECOMMENDATION: Laboratories must have
2.1.2. From November 2005, all Hospital Blood Banks and contingency plans for actions to be taken when normal
Blood Establishments have been subject to the Blood systems are not available.
Safety and Quality Regulations (BSQR, 2005). Article
2 of European Commission directive 2005/62/EC
gives details of the Quality System standards and 2.2. Staff training and competency
specifications required.
2.2.1. There must be a documented programme for training
2.1.3. Transfusion laboratories must use equipment, infor-
laboratory staff, including on-call staff not routinely
mation systems and test systems that have been
working in the laboratory, which covers all tasks and
validated against the documented requirements of
testing performed appropriate to the grade of staff
the laboratory.
and which fulfils the documented requirements of the
2.1.4. The systems must enable a full audit trail of laboratory (Chaffe et al., 2009). It must also include
laboratory steps, including the original results, handling major incidents and emergency situations
cross-referenced to associated internal controls, including contingency plans for major system failures.
interpretations, amendments, authorisations, and the
2.2.2. Staff must receive regular update training on the
staff responsible for conducting each critical step.
principles of Good Manufacturing Practice (GMP).
2.1.5. The laboratory must identify all critical control points
2.2.3. Laboratory tasks must only be undertaken by
in pre-transfusion testing, and build in security at
appropriately trained staff.
these points. See Appendix 1 for examples.
2.2.4. There must be a documented programme for assessing
staff competency in all laboratory tasks.
KEY RECOMMENDATION: The laboratory must identify
2.2.5. Where decisions are required about interpretation
all critical control points in pre-transfusion testing and
of results, component selection and/or specialist
build in security at these points.
requirements, the staff involved must have the required
knowledge (supported by relevant qualification) to do
2.1.6. A programme of regular independent internal audits this safely.
must be instituted to assess compliance with laboratory 2.2.6. Specialist clinical and technical advice should be
processes. available at all times from staff who have demonstrated
2.1.7. The laboratory management must conduct regu- sufficient knowledge, training and competency to do
lar reviews of quality incidents including: untoward so (Chaffe et al., 2009). This could be from within a
laboratory incidents [including those reported to network or Blood Service reference laboratory if not
the Medicines and Healthcare products Regulatory available from within a single centre.
Agency (MHRA) and SHOT via the SABRE system],
complaints, external quality assessment reports, inter-
nal audits of the laboratory procedures, concessionary 2.3. Reagents and test systems
release, recalls and process deviations. 2.3.1. Reagents used for ABO and D grouping must be CE
2.1.8. The laboratory should participate in relevant accred- marked, and be stored and used in accordance with
ited External Quality Assessment (EQA) Schemes. the manufacturers’ instructions.
© 2012 The Authors Transfusion Medicine, 2013, 23, 3–35
Transfusion Medicine © 2012 British Blood Transfusion Society
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6 Guidelines
2.3.2. Reagents used for all other tests should be, where Laboratories (BCSH, 2010a), Guidelines for validation
available, CE marked, and be stored and used in of automated systems in blood establishments
accordance with the manufacturers’ instructions. (ISBT, 2010), GAMP®5: A Risk-based Approach to
2.3.3. All critical processes, equipment, facilities or systems Compliant GxP Computerised Systems (ISPE, 2008),
in the transfusion laboratory must be validated in and Eudralex Vol 4 GMP guidelines (EUDRALEX,
accordance with the BCSH Guidelines for Validation & 2011).
Qualification, including Change Control, for Hospital 2.4.3. The system must be revalidated following the
Transfusion Laboratories (BCSH, 2010a). installation of any upgrades or changes in interface.
2.3.4. All changes to critical process, equipment, facilities The level of revalidation required will depend on the
or systems in the transfusion laboratory must be magnitude of the changes in the upgrade or interface
validated in accordance with the BCSH Guidelines for alteration.
Validation & Qualification, including Change Control,
for Hospital Transfusion Laboratories (BCSH, 2010a). 2.5. Automated blood grouping and antibody screening
2.3.5. Laboratories should ensure that they have a way systems
of identifying and documenting changes made by 2.5.1. Prior to introduction and use, the system must be
manufacturers to the raw material used for reagents validated in accordance with the BCSH Guidelines for
or test systems; if this occurs, the performance of the Validation & Qualification, including Change Control,
system should be reviewed and revalidated. for Hospital Transfusion Laboratories (BCSH, 2010a).
2.3.6. There should be a record of all batch numbers and 2.5.2. Planned preventative maintenance/emergency repair
expiry dates of all reagents used in the laboratory. The will require a documented ‘return to service’ procedure
record should either include the time periods during to be undertaken.
which they are in use or should link directly to the test 2.5.3. The laboratory should have a policy with respect to
result. the manual editing and authorisation of test results;
2.3.7. All laboratory equipment must be regularly main- this should include the designation of staff allowed
tained in accordance with the manufacturer’s instruc- to edit results, with password controlled access where
tions. Where appropriate, calibration of equipment possible (SHOT, 1996–2010).
must include details of the reference standard used.
2.3.8. There should be a record of instrument failure, subse-
KEY RECOMMENDATION: The laboratory should have a
quent corrective action and ‘downtime’. There should
policy with respect to the manual editing and authorisation
be a process for trending instrument failures and for
of test results.
returning equipment to use after corrective action.
2.3.9. Appropriate quality control (QC) must be used for
all parts of the test system. The type and frequency of 2.5.4. Automated grouping and antibody screening systems
any controls used should be based upon appropriate should have, wherever possible, safeguards built into
risk assessments. the systems to detect possible failures; these could
include but are not limited to:
2.3.10. There must be a documented procedure for dealing
i. notification of failure to dispense and/or aspirate
with QC failure with all actions documented. The
samples, reagents or wash solutions;
process should include action to be taken with regard
ii. presence of a level check on final test mixture.
to results already released since the previous QC
testing. Result acceptance should only continue once
the QC failure has been satisfactorily resolved. 3. SAMPLES AND DOCUMENTATION
2.3.11. There should be a documented programme to ensure 3.1. Introduction
the efficacy of the IAT, including efficacy of the cell
washers, where used (Voak et al., 1988). Errors in patient identification and sample labelling may lead
to ABO-incompatible transfusions. Evidence for this is well
2.4. Information systems documented in the annual reports of the SHOT steering group
(SHOT, 1996–2010) and by others (Stainsby et al., 2006;
2.4.1. The LIMS should comply with the requirements Sazama, 1990).
described in the BCSH guidelines for the specification
and use of information technology systems in blood
transfusion practice (BCSH, 2006b). 3.2. Written/electronic requests
2.4.2. The system must be validated in accordance with 3.2.1. There should be written policies for generating blood
the BCSH Guidelines for Validation & Qualification, transfusion requests and for the collection of blood
including Change Control, for Hospital Transfusion samples for pre-transfusion compatibility testing. This
Transfusion Medicine, 2013, 23, 3–35 © 2012 The Authors
Transfusion Medicine © 2012 British Blood Transfusion Society
