JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee


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Chapter 1 Introduction
1.1 Development of the Red Book
1.2 Organisation of the UK Blood Services
1.3 Other institutions involved in developing guidelines and regulations relevant to the UK
1.4 References
Chapter 2 Quality in blood and tissue establishments and hospital blood banks
2.1 Introduction
2.2 Key European 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
2.8 References
Chapter 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 diseases
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 Donors of pre-deposit autologous donations
3.17 Donors of immune plasma
3.18 References
Appendix l
Appendix ll
Appendix lll
Chapter 4 Premises and quality assurance at blood donor sessions
4.1 Premises
4.2 Staffing and training principles for donation sessions
4.3 Collection of the donation
4.4 Donor identification
4.5 Labelling
4.6 Records
4.7 Control of purchased material and services
4.8 Protection and preservation of product quality
4.9 References
Chapter 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 Adverse reactions in donors
5.11 Adverse events
5.12 Donor compensation
5.13 References
Appendix l
Appendix ll
Appendix lll
Chapter 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
Chapter 7 Specifications for blood components
7.1 Leucocyte depletion
7.2 Other component specifications
7.3 Production advice
7.4 Whole Blood, Leucocyte Depleted
7.5 Red Cells, Leucocyte Depleted
7.6 Red Cells in Additive Solution, Leucocyte Depleted
7.7 Red Cells, Washed, Leucocyte Depleted
7.8 Red Cells, Thawed and Washed, Leucocyte Depleted
7.9 Platelets, Pooled, Buffy Coat Derived, Leucocyte Depleted
7.10 Platelets, Apheresis, Leucocyte Depleted
7.11 Platelets, Pooled, Buffy Coat Derived, in Additive Solution and Plasma, Leucocyte Depleted
7.12 Platelets in Additive Solution, Leucocyte Depleted
7.13 Granulocytes, Apheresis
7.14 Granulocytes, Pooled, Buffy Coat Derived, in Platelet Additive Solution and Plasma
7.15 Fresh Frozen Plasma, Leucocyte Depleted
7.16 Fresh Frozen Plasma, Methylene Blue Treated and Removed, Leucocyte Depleted
7.17 Cryoprecipitate, Leucocyte Depleted
7.18 Cryoprecipitate Pooled, Leucocyte Depleted
7.19 Cryoprecipitate, Methylene Blue Treated and Removed, Leucocyte Depleted
7.20 Plasma, Cryoprecipitate Depleted, Leucocyte Depleted
7.21 Components suitable for use in intrauterine transfusion, neonates and infants under 1 year
7.22 Red Cells for Intrauterine Transfusion (IUT), Leucocyte Depleted
7.23 Whole Blood for Exchange Transfusion, Leucocyte Depleted
7.24 Red Cells for Exchange Transfusion, Leucocyte Depleted
7.25 Red Cells for Neonates and Infants, Leucocyte Depleted
7.26 Red Cells in Additive Solution for Neonates and Infants, Leucocyte Depleted
7.27 Fresh Frozen Plasma, Neonatal Use, Methylene Blue Treated and Removed, Leucocyte Depleted
7.28 Cryoprecipitate, Methylene Blue Treated and Removed, Leucocyte Depleted
7.29 Platelets for Intrauterine Transfusion, Leucocyte Depleted
7.30 Platelets for Neonatal Use, Leucocyte Depleted
7.31 Irradiated components
7.32 References
7.33: Cryoprecipitate, Pooled, Methylene Blue Treated and Removed, Leucocyte Depleted
Chapter 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 Generic protocol for the evaluation of apheresis equipment
8.6 Generic protocol for the evaluation of blood packs for whole blood donations and apheresis collections
8.7 References
Chapter 9 Microbiology tests for donors and donations: general specifications for laboratory test procedures
9.1 General requirements
9.2 Microbiology screening
9.3 Specific assays
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
Chapter 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
Chapter 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
11.5 References
Chapter 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
Chapter 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 Post-examination
13.6 References
Chapter 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
Chapter 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
Chapter 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/HPA testing to patients and donors
16.9 References
Chapter 17 Granulocyte immunology
17.1 Reagent manufacture/reference preparations/cell panels
17.2 Nomenclature
17.3 HNA typing methods
17.4 HNA antibody detection methods
17.5 Donor testing
17.6 Patient testing
17.7 References
Chapter 18 Platelet immunology
18.1 Reagent manufacture/reference preparations
18.2 Methods
18.3 Donor testing
18.4 Patient testing
18.5 References
Chapter 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
Chapter 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 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
Chapter 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
Chapter 22 Haemopoietic progenitor cells
22.1 Introduction
22.2 Terminology
22.3 Policy and procedure requirements
22.4 Safety requirements
22.5 Adverse events and reactions
22.6 Donor selection, consent and testing
22.7 Collection facilities for HPC-A, HPC-M, HPC-C and TC
22.8 Component definitions
22.9 Haemopoietic progenitor cell processing standards
22.10 Storage of cellular therapy products
22.11 Testing of haemopoietic progenitor cell donors and components including therapeutic cells
22.12 Labelling, packaging, transportation and temperature controls
22.13 Release
22.14 Transportation
22.15 Thawing and infusion
22.16 Disposal of haemopoietic progenitor cells
22.17 Records
Chapter 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 numbers (DIN)
23.5 Blood group labels
23.6 Component labels
Chapter 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
Chapter 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
Chapter 26 Specification for blood pack base labels
26.1 Introduction
26.2 Specification
26.3 Manufacturers’ blood pack catalogue and lot numbers
Chapter 27 Specification for labelling consumables used in therapeutic product production
27.1 Introduction
27.2 Specification
27.3 Manufacturers’ catalogue and lot numbers
27.4 References
Annex 1 Standards available from the National Institute for Biological Standards and Control
Annex 2 ISBT 128 check character calculation
Annex 3 -Trial Components