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
3.14: Physical examination of donors
3.15: Blood tests
3.16: Autologous donation

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

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

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

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

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

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

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 patient and donor investigations

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

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 tissue donor samples
20.8: Follow-up
20.9: Autologous tissue donation
20.10: Archiving of donor samples
20.11: Release criteria

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

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

22.7 Testing of haemopoietic progenitor cell donors and components - Haemopoietic progenitor cells

Infectious disease marker testing, ABO and RhD typing and clonogenic assays must be done in accordance with the Human Tissue Authority (HTA) Guide to Quality and Safety Assurance for Tissues and Cells for Patient Treatment (updated on January 2021), and SaBTO guidance.

Additional information and guidance available with FACT-JACIE, WMDA and NetCord-FACT standards.

The minimum current requirements for mandatory and additional microbiology testing (serology and/or NAT) are described in chapter 9.

Annex 7 indicates the requirements for the timing of testing for each type of HPC.

Last updated on 4 September 2023

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