Contents 7th Edition

Update notice: Chapters 3, 4, 5, 6 have been redrafted. Please refer to Change Notification 12 - 2010.


	Preface to seventh edition
	Figures and tables
	Change notification
Chapter 1	The regulatory environment in the United Kingdom in 2005
	1.1	The key institutions involved in developing guidelines and regulations relevant to the UK
	1.2	EU legislation relevant to blood transfusion and tissue transplantation
	1.3	The Blood Safety and Quality Regulations 2005
Chapter 2	Quality in blood and tissue establishments and hospital blood banks
	2.1	Key European initiatives
	2.2	Other standards
	2.3	Systems
	2.4	Planned improvement
	2.5	Reporting of incidents to external bodies
Chapter 3	Care and selection of blood 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
		References
		Appendix I
		Appendix II
		Appendix III
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
		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
		References
		Appendix I
		Appendix II
		Appendix III
Chapter 6	Component donation: apheresis
Chapter 7	Evaluation and manufacture of blood components
	7.1	Setting and maintaining specifications
	7.2	Component and process monitoring tests
	7.3	Component processing
	7.4	Component shelf life
	7.5	Labelling
	7.6	Component storage
	7.7	Non-conforming components and biohazards
	7.8	Component release
	7.9	Release of components which do not conform to specified requirements
	7.10	Transportation of blood components
	7.11	Component recall
Chapter 8	Specifications for blood components
	8.1	Leucocyte depletion
	8.2	Other component specifications
	8.3	Production advice
	8.4	Whole Blood, Leucocyte Depleted
	8.5	Red Cells, Leucocyte Depleted
	8.6	Red Cells in Additive Solution, Leucocyte Depleted
	8.7	Red Cells, Washed, Leucocyte Depleted
	8.8	Red Cells, Thawed and Washed, Leucocyte Depleted
	8.9	Platelets, Pooled, Buffy Coat Derived, Leucocyte Depleted
	8.10	Platelets, Apheresis, Leucocyte Depleted
	8.11	Platelets, Suspended in Additive Solution, Leucocyte Depleted
	8.12	Granulocytes, Apheresis
	8.13	Fresh Frozen Plasma, Leucocyte Depleted
	8.14	Fresh Frozen Plasma, Methylene Blue Treated and Removed, Leucocyte Depleted
	8.15	Cryoprecipitate, Leucocyte Depleted
	8.16	Cryoprecipitate, Methylene Blue Treated and Removed, Leucocyte Depleted
	8.17	Plasma, Cryoprecipitate Depleted, Leucocyte Depleted
	8.18	Components Suitable for Use in Intrauterine Transfusion, Neonates and Infants Under One Year
	8.19	Red Cells for Intrauterine Transfusion (IUT), Leucocyte Depleted
	8.20	Whole Blood for Exchange Transfusion, Leucocyte Depleted
	8.21	Red Cells for Exchange Transfusion, Leucocyte Depleted
	8.22	Red Cells for Neonates and Infants, Leucocyte Depleted
	8.23	Red Cells in Additive Solution for Neonates and Infants, Leucocyte Depleted
	8.24	Fresh Frozen Plasma, Neonatal Use, Methylene Blue Treated and Removed, Leucocyte Depleted
	8.25	Cryoprecipitate, Methylene Blue Treated and Removed, Leucocyte Depleted
	8.26	Platelets for IUT, Leucocyte Depleted
	8.27	Platelets for Neonatal Use, Leucocyte Depleted
	8.28	Irradiated components
	8.29	Tabulated information
	8.30	Cryoprecipitate Pooled, Leucocyte Depleted
	8.31	Platelets in Additive Solution and Plasma
Chapter 9	Evaluation of blood components: generic protocols
	9.1	Novel blood components, production processes and new whole blood collection bags
	9.2	Evaluation of new red cell components for transfusion
	9.3	Evaluation of new platelet components for transfusion
	9.4	Evaluation of new fresh frozen plasma/cryoprecipitate components for transfusion
	9.5	Generic protocol for the evaluation of apheresis equipment
	9.6	Generic protocol for the evaluation of blood packs for whole blood donations and apheresis collections
Chapter 10	Microbiology tests for donors and donations: general specifications for laboratory test procedures
	10.1	General requirements
	10.2	Mandatory testing of blood donations
	10.3	Specific assays
	10.4	Additional microbiological testing of selected donations
	10.5	Reinstatement of donors
	10.6	Recommended standards for the reduction of bacterial contamination of platelets: donor arm cleansing, diversion of donation and testing of donation
Chapter 11	Investigation of suspected transfusion-transmitted infection
	11.1	General considerations
	11.2	Assessment of validity of the possible diagnosis of TTI
	11.3	Identification of possible infectious donations
	11.4	Closing TTI enquiries
	11.5	Lookback investigations
Chapter 12	Reagent manufacture
	12.1	Guidelines for reagent manufacture
	12.2	Specifications, performance evaluation and quality control of blood grouping reagents
	12.3	Reference preparations
	12.4	Recommended serological techniques for reagent testing
Chapter 13	Donation testing (red cell immunohaematology)
	13.1	Scope
	13.2	General requirements
	13.3	Samples
	13.4	Reagents and test kits
	13.5	Equipment
	13.6	Test procedure
	13.7	Reporting of results
	13.8	Release of tested components
	13.9	Laboratory test categories
	13.10	Mandatory testing of blood donations
	13.11	Additional testing
	13.12	Donations found to have a positive direct antiglobulin test
	13.13	Automated testing
	13.14	Manual testing
Chapter 14	Patient testing (red cell immunohaematology)
	14.1	Scope
	14.2	General requirements
	14.3	Requests
	14.4	Samples
	14.5	Test reagents and test systems
	14.6	Authorizing and reporting results
	14.7	ABO and D grouping
	14.8	Antibody screening
	14.9	Antibody identification
Chapter 15	HLA typing and HLA serology
	15.1	Reagents
	15.2	Testing of HLA genes and gene products
	15.3	Testing for HLA-specific antibodies
	15.4	Leucocyte crossmatching in blood transfusion
	15.5	Donor and patient testing
Chapter 16	Granulocyte immunology
	16.1	Reagent manufacture/reference preparations
	16.2	Nomenclature
	16.3	HNA typing methods
	16.4	HNA antibody detection methods
	16.5	Donor testing
	16.6	Patient testing
Chapter 17	Platelet immunology
	17.1	Reagent manufacture /reference preparations
	17.2	Donor testing
	17.3	Patient testing
Chapter 18	Guidelines for the use of DNA/PCR techniques in transfusion centres
	18.1	Safety precautions
	18.2	Avoidance of contamination
	18.3	Working practices
Chapter 19	Fractionated plasma products/derivatives
	19.1	Product range
	19.2	Manufacturing sites
	19.3	Summary of regulatory arrangements
	19.4	The sourcing of plasma for manufacture of fractionated plasma products
	19.5	Summary of key steps during the manufacture of plasma products
	19.6	Release of plasma products by an official medicines control laboratory
	19.7	Regulatory guidelines and monographs on fractionated plasma products and plasma fractionation
Chapter 20	Hospital Blood Banks: impact of EU Blood Directives and Better Blood Transfusion
	20.1	EU Blood Directives
	20.2	Blood Safety and Quality Regulations 2005: hospital blood bank requirements
	20.3	Better Blood Transfusion
Chapter 21	Tissue banking: general principles
Chapter 22	Tissue banking: selection of donors
	22.1	General considerations
	22.2	Consent
	22.3	Medical and behavioural history
	22.4	Tissue-specific donor considerations
	22.5	Donor testing
	22.6	Testing of living donors
	22.7	Testing of deceased donors
	22.8	Follow up
	22.9	Autologous tissue donation
Chapter 23	Tissue banking: tissue retrieval and processing
	23.1	General considerations
	23.2	Retrieval
	23.3	Transportation conditions
	23.4	Bacteriostasis and disinfection
	23.5	General guidelines for tissue processing
	23.6	Tissue storage
	23.7	Tracking of tissues
	23.8	Notification of serious adverse events and reactions
	23.9	Additional guidelines for skeletal tissue retrieval and processing
	23.10	Cardiovascular tissue retrieval and processing
	23.11	Skin retrieval and processing
Chapter 24	Haemopoietic progenitor cells
	24.1	Terminology
	24.2	Policy and procedure requirements
	24.3	Safety requirements
	24.4	Adverse events and reactions
	24.5	Donor selection, consent and testing
	24.6	Collection facilities for HPC-A, HPC-M, HPC-C and TC
	24.7	Component definitions
	24.8	Haemopoietic progenitor cell processing standards
	24.9	Storage of cellular therapy products
	24.10	Testing of haemopoietic progenitor cell donors and components including therapeutic cells
	24.11	Labelling, packaging, transportation and temperature controls
	24.12	Release
	24.13	Transportation
	24.14	Thawing and infusion
	24.15	Disposal of haemopoietic progenitor cells
	24.16	Records
Chapter 25	Specification for the uniform labelling of blood and blood components
	25.1	Introduction
	25.2	General specification
	25.3	Donation numbers
	25.4	Blood group labels
	25.5	Component labels
	25.6	Manufacturers' base labels
	25.7	Future developments in labelling
Chapter 26	Uniform labelling of human tissue products using ISBT 128
	26.1	Introduction
	26.2	The labelling system
	26.3	General requirements
	26.4	The base label
	26.5	Donation and pool identification number labels
	26.6	The product label
	26.7	The tissue status label
	26.8	Status label definitions
	26.9	The expiry date label
	26.10	National ISBT 128 definitions
Chapter 27	Standards for electronic data interchange within the UK Blood Transfusion Services
	27.1	Introduction
	27.2	Control of message structures
	27.3	General protocol
	27.4	Envelope definition
	27.5	Message protocols
	27.6	Protocol 000001 – Blood component dispatch information
	27.7	Protocol 000002 – blood derivative dispatch information
	27.8	Protocol 000003 – reagent dispatch information
	27.9	Protocol 000004 – blood component dispatch acknowledgement
	27.10	Protocol 000005 – blood component fate information
Chapter 28	Specification for blood pack base labels
	28.1	Specification
Annex 1	Standards available at the National Institute for Biological Standards and Control
Annex 2	ISBT 128 check character calculation
Definitions