Chapters

1. Introduction

1.1: The development of the Red Book
1.2: Organisation of the UK Blood and Tissue Services
1.3: Other relevant institutions

2. Quality in blood and tissue establishments and hospital blood banks

2.1: Introduction
2.2: Key initiatives
2.3: Other standards
2.4: Systems
2.5: Application of a quality management system
2.6: Quality management system
2.7: Reporting of incidents to external bodies

3. Care and selection of whole blood and component donors (including donors of pre-deposit autologous blood)

3.1: Introduction
3.2: General principles
3.3: Assessment of fitness to donate
3.4: Informed consent
3.5: Donor age
3.6: Frequency of donation
3.7: Volume of donation
3.8: Medical history of donors
3.9: Genetically determined conditions
3.10: Donors on treatment with medications (drugs)
3.11: Transfusion-transmissible infectious disease
3.12: Travel history
3.13: Prion-associated diseases including sporadic Creutzfeldt-Jakob Disease (CJD) and variant CJD (vCJD)
3.14: Physical examination of donors
3.15: Blood tests
3.16: Autologous donations
3.17: References

4. Premises and quality assurance at blood donor sessions

4.1: Premises
4.2: Staffing and training principles for donation sessions
4.3: Clinical leadership at donor sessions
4.4: Donor identification
4.5: Labelling
4.6: Records
4.7: Equipment and consumables
4.8: Protection and preservation of product quality

5. Collection of a blood or component donation

5.1: Information to be provided to prospective donors of blood or blood components
5.2: Information to be obtained from donors by Blood Establishments at every donation
5.3: Haemoglobin screening
5.4: Preparation of the venepuncture site
5.5: Preparation of the blood pack
5.6: Performance of the venepuncture
5.7: Whole blood donation
5.8: Component donation by apheresis
5.9: Information to be provided to the donor post-donation
5.10: Donor Adverse Events
5.11: Adverse events
5.12: Donor compensation
5.13: References

6. Evaluation and manufacture of blood components

6.1: Scope of the guidelines
6.2: Setting and maintaining specifications
6.3: Component and process monitoring tests
6.4: Component processing
6.5: Component shelf life
6.6: Labelling
6.7: Component storage
6.8: Non-conforming components and biohazards
6.9: Component release
6.10: Release of components which do not conform to specified requirements
6.11: Transportation of blood components
6.12: Component recall and traceability
6.13: References

7. Specifications for blood components

7.1: Introduction
7.2: Whole blood components
7.3: Red cell components
7.4: Platelet components
7.5: Plasma components
7.6: Granulocyte components
7.7: Components suitable for use in intrauterine transfusion, neonates and infants under 1 year

8. Evaluation of novel blood components, production processes and blood packs: generic protocols

8.1: Aims and introduction
8.2: Evaluation of new red cell components for transfusion
8.3: Evaluation of new platelet components for transfusion
8.4: Evaluation of new fresh frozen plasma/cryoprecipitate components for transfusion
8.5: Evaluation of plasma for fractionation for the manufacture of immunoglobulin
8.6: Generic protocol for the evaluation of apheresis equipment
8.7: Generic protocol for the evaluation of blood packs for whole blood donations and apheresis collections
8.8: Further guidance on the evaluation of blood packs and apheresis collection systems containing new plasticisers and additive solutions, where they are combined
8.9: References

9. Microbiology tests for donors and donations: general specifications for laboratory test procedures

9.1: General requirements
9.2: Microbiology screening
9.3: Specific screening targets
9.4: Reinstatement of blood donors
9.5: Recommended standards for the reduction of bacterial contamination of blood components
9.6: Recommended standards for microbiological screening
9.7: Recommended standards for environmental monitoring of processing facilities
9.8: Investigation of suspected bacterial contamination of blood components
9.9: References

10. Investigation of suspected transfusion-transmitted infection

10.1: General considerations
10.2: Assessment of validity of the possible diagnosis of TTI
10.3: Non-bacterial TTI: identification of possible infectious donations
10.4: Investigation of possible bacterial TTI
10.5: Closing TTI investigations
10.6: Look-back investigations

11. Reagent manufacture

11.1: Guidelines for reagent manufacture
11.2: Specifications, performance evaluation and quality control of blood grouping reagents
11.3: Reference preparations
11.4: Recommended serological techniques for reagent testing

12. Donation testing (red cell immunohaematology)

12.1: Scope
12.2: General requirements
12.3: Samples
12.4: Reagents and test kits
12.5: Equipment
12.6: Test procedure
12.7: Reporting of results
12.8: Release of tested components
12.9: Laboratory test categories
12.10: Mandatory testing of blood donations
12.11: Additional testing
12.12: Donations found to have a positive direct antiglobulin test
12.13: Automated testing
12.14: Manual testing

13. Patient testing (red cell immunohaematology)

13.1: Scope
13.2: Sample acceptance and labelling
13.3: Pre-transfusion testing
13.4: Antibody quantification and titration
13.5: Fetomaternal haemorrhage estimation by flow cytometry
13.6: Post-examination
13.7: References

14. Guidelines for the use of DNA/PCR techniques in Blood Establishments

14.1: Safety precautions
14.2: Avoidance of contamination
14.3: Working practices

15. Molecular typing for red cell antigens

15.1: Introduction
15.2: Clinical applications of blood group molecular typing
15.3: ABO typing by molecular genetics
15.4: Methods available for molecular blood grouping
15.5: External quality assurance
15.6: References

16. HLA typing and HLA serology

16.1: Preamble
16.2: Introduction
16.3: Terminology and nomenclature
16.4: Reagents
16.5: Testing of HLA genes and gene products
16.6: Testing for HLA-specific antibodies
16.7: Leucocyte crossmatching in blood transfusion
16.8: Application of HLA testing to patients and donors

17. Granulocyte immunology

17.1: Reagent manufacture, reference preparations and cell panels
17.2: Nomenclature
17.3: HNA typing methods
17.4: HNA antibody detection methods
17.5: Donor testing
17.6: Patient testing

18. Platelet immunology

18.1: Reagent manufacture and reference preparations
18.2: Methods
18.3: Donor testing
18.4: Patient testing

19. Tissue banking: general principles

19.1: Regulatory environment in the UK
19.2: Reference documents for tissue banking
19.3: Data protection and confidentiality
19.4: References

20. Tissue banking: selection of donors

20.1: General considerations
20.2: Consent
20.3: Medical and behavioural history
20.4: Tissue-specific donor considerations
20.5: Donor testing
20.6: Living tissue donor samples
20.7: Deceased donor samples
20.8: Follow-up
20.9: Autologous tissue donation
20.10: Archiving of donor samples
20.11: Release criteria
20.12: References

21. Tissue banking: tissue retrieval and processing

21.1: General considerations
21.2: Retrieval
21.3: Transportation conditions from retrieval site to Tissue Establishment
21.4: Bacteriostasis and disinfection
21.5: General guidelines for tissue processing
21.6: Tissue storage
21.7: Tracking of tissues
21.8: Notification of serious adverse events and reactions
21.9: Additional guidelines for skeletal tissue retrieval and processing
21.10: Cardiovascular tissue retrieval and processing
21.11: Skin retrieval and processing
21.12: Ocular tissue retrieval, processing and storage
21.13: References

22. Haemopoietic progenitor cells

22.1: Introduction
22.2: Terminology
22.3: Policy and procedure requirements and Safety
22.4: Adverse events and reactions
22.5: Donor selection, consent and testing
22.6: Collection, processing and storage
22.7: Testing of haemopoietic progenitor cell donors and components
22.8: Requirements for the timing of testing
22.9: Labelling, packaging, transportation and release
22.10: Disposal of haemopoietic progenitor cells
22.11: Record maintenance

23. Specification for the uniform labelling of blood, blood components and blood donor samples

23.1: Introduction
23.2: The labelling system
23.3: Barcode reading and interpretation
23.4: Donation identification number (DIN)
23.5: Blood group labels
23.6: Component labels

24. Specification for the uniform labelling of human tissue products using ISBT 128

24.1: Introduction
24.2: The labelling system
24.3: General requirements
24.4: Tissue product labels

25. Standards for electronic data interchange within the UK Blood Transfusion Services

25.1: Introduction
25.2: Control of message structures
25.3: General protocol
25.4: Envelope definition
25.5: Message protocols
25.6: Protocol 000001 – blood component dispatch information
25.7: Protocol 000002 – blood derivative dispatch information
25.8: Protocol 000003 – reagent dispatch information
25.9: Protocol 000004 – blood component dispatch acknowledgement
25.10: Protocol 000005 – blood component fate information

26. Specification for blood pack base labels

26.1: Introduction
26.2: Specification
26.3: Manufacturers’ blood pack catalogue and lot numbers

27. Specification for labelling consumables used in therapeutic product production

27.1: Introduction
27.2: Specification
27.3: Manufacturers’ catalogue and lot numbers

Labelling, packaging, transportation and release - Haemopoietic progenitor cells - Chapter 22

The mandatory requirements for these are described in the HTA’s Guide to Quality and Safety Assurance for Human Tissue and Cells for Patient Treatment.

The FACT-JACIE Standards and NetCord-FACT Standards will also apply as appropriate.

The requirement for an EU Single European Code (SEC) still applies in Northern Ireland.

health.ec.europa.eu/blood-tissues-cells-and-organs/implementation/single-european-code-sec-tissues-and-cells_en#:~:text=The%20%22Single%20European%20Code%E2%80%9D%20or,type%20of%20tissue%20or%20cells

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