Chapters

Contents

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