Guidelines for the blood transfusion services in the United Kingdom

2005·2.8 MB·English

by  United Kingdom Blood Transfusion Services

Guidelines
for the
Blood
Transfusion
Services in
the United
Kingdom
7th Edition 2005
London: TSO
Published by TSO (The Stationery Office) and available from:
Online
www.tsoshop.co.uk
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© Crown copyright 2005
Published with permission of the National Blood Service on behalf of the
Controller of Her Majesty’s Stationery Office.
Seventh Edition 2005
ISBN 0 11 703371 5
Applications for reproduction should be made in writing to:
The Copyright Unit,Her Majesty’s Stationery Office,St Clements House,
2-16 Colegate,Norwich NR3 1BQ
Web Access
This publication is also available on the Official Documents website at:
http://www.official-documents.co.uk/document/other/0117033715/0117033715.asp
Printed in the United Kingdom for The Stationery Office
179955 C15 9/05
Contents
Preface to seventh edition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x
Figures and tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi
Change notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiv
Chapter 1 The regulatory environment in the United Kingdom in 2005 . . . . . . . . . . . 1
1.1 The key institutions involved in developing guidelines and regulations
relevant to the UK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2 EU legislation relevant to blood transfusion and tissue transplantation . . . 6
1.3 The Blood Safety and Quality Regulations 2005 . . . . . . . . . . . . . . . . . . . 7
Chapter 2 Quality in blood and tissue establishments and hospital blood banks . . . . 9
2.1 Key European initiatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.2 Other standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.3 Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.4 Planned improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.5 Reporting of incidents to external bodies . . . . . . . . . . . . . . . . . . . . . . . . 19
Chapter 3 Care and selection of blood donors (including donors of pre-deposit
autologous blood) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.1 General principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.2 Assessment of fitness to donate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.3 Medical history of donors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.4 Genetically determined conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.5 Donors on treatment with medications (drugs) . . . . . . . . . . . . . . . . . . . . 25
3.6 Transfusion transmissible infectious diseases . . . . . . . . . . . . . . . . . . . . . . 25
3.7 Prion-associated diseases including sporadic Creutzfeldt-Jakob
Disease (CJD) and variant CJD (vCJD) . . . . . . . . . . . . . . . . . . . . . . . . . 26
3.8 Physical examination of donors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
3.9 Donors of pre-deposit autologous donations . . . . . . . . . . . . . . . . . . . . . . 27
3.10 Donors of immune plasma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Chapter 4 Premises and quality assurance at blood donor sessions . . . . . . . . . . . . . 29
4.1 Premises . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.2 Collection of the donation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
4.3 Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
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Guidelines for the Blood Transfusion Services in the UK 2005
Chapter 5 Collection of a blood donation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.1 Information to be provided to prospective donors of blood or blood
components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
5.2 Information to be obtained from donors by blood establishments at
every donation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.3 Haemoglobin or haematocrit screening . . . . . . . . . . . . . . . . . . . . . . . . . . 34
5.4 Preparation of the venepuncture site . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5.5 Preparation of the blood pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
5.6 Performance of the venepuncture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.7 Blood donation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5.8 Information to be provided to the donor post-donation . . . . . . . . . . . . . . 38
5.9 Adverse reactions in donors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
5.10 Adverse events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Chapter 6 Component donation:apheresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6.1 Criteria for acceptance of donors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
6.2 General specifications for apheresis sessions . . . . . . . . . . . . . . . . . . . . . . 42
6.3 Frequency of apheresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
6.4 Volume collected . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
6.5 Staffing and training principles for apheresis sessions . . . . . . . . . . . . . . . . 43
6.6 Collection,testing and storage of apheresis components . . . . . . . . . . . . . . 44
6.7 Adverse events and adverse reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
6.8 Notification of hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
6.9 Donor compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Appendix I Donor consent form:apheresis . . . . . . . . . . . . . . . . . . . . . . . . 48
Appendix II Donor consent form:leucapheresis . . . . . . . . . . . . . . . . . . . . . 49
Appendix III Total blood volume and extra-corporeal volume tables . . . . . . . 50
Appendix IV Citrate anticoagulants and the avoidance of citrate toxicity . . . . 51
Appendix V Volume of blood processed per pass . . . . . . . . . . . . . . . . . . . . . 52
Chapter 7 Evaluation and manufacture of blood components . . . . . . . . . . . . . . . . . 53
7.1 Setting and maintaining specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
7.2 Component and process monitoring tests . . . . . . . . . . . . . . . . . . . . . . . . 53
7.3 Component processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
7.4 Component shelf life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
7.5 Labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
7.6 Component storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
7.7 Non-conforming components and biohazards . . . . . . . . . . . . . . . . . . . . . 59
7.8 Component release . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
7.9 Release of components which do not conform to specified requirements . . 60
7.10 Transportation of blood components . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
7.11 Component recall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Chapter 8 Specifications for blood components . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
8.1 Leucocyte depletion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
8.2 Other component specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
8.3 Production advice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
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Contents
8.4 Whole Blood,Leucocyte Depleted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
8.5 Red Cells,Leucocyte Depleted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
8.6 Red Cells in Additive Solution,Leucocyte Depleted . . . . . . . . . . . . . . . . 69
8.7 Red Cells,Washed,Leucocyte Depleted . . . . . . . . . . . . . . . . . . . . . . . . . 70
8.8 Red Cells,Thawed and Washed,Leucocyte Depleted . . . . . . . . . . . . . . . . 72
8.9 Platelets,Pooled,Buffy Coat Derived,Leucocyte Depleted . . . . . . . . . . . 74
8.10 Platelets,Apheresis,Leucocyte Depleted . . . . . . . . . . . . . . . . . . . . . . . . . 76
8.11 Platelets,Suspended in Additive Solution,Leucocyte Depleted . . . . . . . . . 77
8.12 Granulocytes,Apheresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
8.13 Fresh Frozen Plasma,Leucocyte Depleted . . . . . . . . . . . . . . . . . . . . . . . 80
8.14 Fresh Frozen Plasma,Methylene Blue Treated and Removed,
Leucocyte Depleted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
8.15 Cryoprecipitate,Leucocyte Depleted . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
8.16 Cryoprecipitate,Methylene Blue Treated and Removed,Leucocyte
Depleted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
8.17 Plasma,Cryoprecipitate Depleted,Leucocyte Depleted . . . . . . . . . . . . . . 86
8.18 Components Suitable for Use in Intrauterine Transfusion,Neonates and
Infants Under One Year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
8.19 Red Cells for Intrauterine Transfusion (IUT),Leucocyte Depleted . . . . . . 88
8.20 Whole Blood for Exchange Transfusion,Leucocyte Depleted . . . . . . . . . . 90
8.21 Red Cells for Exchange Transfusion,Leucocyte Depleted . . . . . . . . . . . . . 92
8.22 Red Cells for Neonates and Infants,Leucocyte Depleted . . . . . . . . . . . . . 94
8.23 Red Cells in Additive Solution for Neonates and Infants,Leucocyte
Depleted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
8.24 Fresh Frozen Plasma,Neonatal Use,Methylene Blue Treated and
Removed,Leucocyte Depleted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
8.25 Cryoprecipitate,Methylene Blue Treated and Removed,Leucocyte
Depleted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
8.26 Platelets for IUT,Leucocyte Depleted . . . . . . . . . . . . . . . . . . . . . . . . . . 101
8.27 Platelets for Neonatal Use,Leucocyte Depleted . . . . . . . . . . . . . . . . . . . . 103
8.28 Irradiated components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
8.29 Tabulated information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Chapter 9 Evaluation of blood components:generic protocols . . . . . . . . . . . . . . . . . 116
9.1 Novel blood components,production processes and new whole blood
collection bags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
9.2 Evaluation of new red cell components for transfusion . . . . . . . . . . . . . . . 119
9.3 Evaluation of new platelet components for transfusion . . . . . . . . . . . . . . . 121
9.4 Evaluation of new fresh frozen plasma/cryoprecipitate components for
transfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
9.5 Generic protocol for the evaluation of apheresis equipment . . . . . . . . . . . 126
9.6 Generic protocol for the evaluation of blood packs for whole blood
donations and apheresis collections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Chapter 10 Microbiology tests for donors and donations:general specifications for
laboratory test procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
10.1 General requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136
10.2 Mandatory testing of blood donations . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
10.3 Specific assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
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Guidelines for the Blood Transfusion Services in the UK 2005
10.4 Additional microbiological testing of selected donations . . . . . . . . . . . . . . 141
10.5 Reinstatement of donors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142
10.6 Recommended standards for the reduction of bacterial contamination
of platelets:donor arm cleansing,diversion of donation and testing of
donation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Chapter 11 Investigation of suspected transfusion-transmitted infection . . . . . . . . . . 145
11.1 General considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
11.2 Assessment of validity of the possible diagnosis of TTI . . . . . . . . . . . . . . 145
11.3 Identification of possible infectious donations . . . . . . . . . . . . . . . . . . . . . 146
11.4 Closing TTI enquiries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
11.5 Lookback investigations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Chapter 12 Reagent manufacture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
12.1 Guidelines for reagent manufacture . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148
12.2 Specifications,performance evaluation and quality control of blood
grouping reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
12.3 Reference preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
12.4 Recommended serological techniques for reagent testing . . . . . . . . . . . . . 168
Chapter 13 Donation testing (red cell immunohaematology) . . . . . . . . . . . . . . . . . . . 176
13.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
13.2 General requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
13.3 Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
13.4 Reagents and test kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
13.5 Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
13.6 Test procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
13.7 Reporting of results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
13.8 Release of tested components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
13.9 Laboratory test categories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
13.10 Mandatory testing of blood donations . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
13.11 Additional testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 180
13.12 Donations found to have a positive direct antiglobulin test . . . . . . . . . . . 181
13.13 Automated testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
13.14 Manual testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
Chapter 14 Patient testing (red cell immunohaematology) . . . . . . . . . . . . . . . . . . . . . 183
14.1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
14.2 General requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
14.3 Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184
14.4 Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184
14.5 Test reagents and test systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
14.6 Authorizing and reporting results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186
14.7 ABO and D grouping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
14.8 Antibody screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191
14.9 Antibody identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192
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Chapter 15 HLA typing and HLA serology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195
15.1 Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196
15.2 Testing of HLA genes and gene products . . . . . . . . . . . . . . . . . . . . . . . . 202
15.3 Testing for HLA-specific antibodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
15.4 Leucocyte crossmatching in blood transfusion . . . . . . . . . . . . . . . . . . . . . 205
15.5 Donor and patient testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207
Chapter 16 Granulocyte immunology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212
16.1 Reagent manufacture/reference preparations . . . . . . . . . . . . . . . . . . . . . . 212
16.2 Nomenclature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213
16.3 HNA typing methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213
16.4 HNA antibody detection methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 213
16.5 Donor testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214
16.6 Patient testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 214
Chapter 17 Platelet immunology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216
17.1 Reagent manufacture /reference preparations . . . . . . . . . . . . . . . . . . . . . . 216
17.2 Donor testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218
17.3 Patient testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219
Chapter 18 Guidelines for the use of DNA/PCR techniques in transfusion centres . . . 220
18.1 Safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220
18.2 Avoidance of contamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220
18.3 Working practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221
Chapter 19 Fractionated plasma products/derivatives . . . . . . . . . . . . . . . . . . . . . . . . 222
19.1 Product range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 222
19.2 Manufacturing sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 223
19.3 Summary of regulatory arrangements . . . . . . . . . . . . . . . . . . . . . . . . . . . 223
19.4 The sourcing of plasma for manufacture of fractionated plasma products . 223
19.5 Summary of key steps during the manufacture of plasma products . . . . . . 224
19.6 Release of plasma products by an official medicines control laboratory . . . 225
19.7 Regulatory guidelines and monographs on fractionated plasma
products and plasma fractionation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226
Chapter 20 Hospital Blood Banks:impact of EU Blood Directives and Better Blood
Transfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228
20.1 EU Blood Directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228
20.2 Blood Safety and Quality Regulations 2005:hospital blood bank
requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229
20.3 Better Blood Transfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231
Chapter 21 Tissue banking:general principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232
Chapter 22 Tissue banking:selection of donors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
22.1 General considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235
22.2 Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236
22.3 Medical and behavioural history . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236
22.4 Tissue-specific donor considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237
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Guidelines for the Blood Transfusion Services in the UK 2005
22.5 Donor testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 237
22.6 Testing of living donors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238
22.7 Testing of cadaver donors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239
22.8 Counselling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240
22.9 Autologous tissue donation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240
Chapter 23 Tissue banking:tissue retrieval and processing . . . . . . . . . . . . . . . . . . . . 241
23.1 General considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241
23.2 Retrieval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 241
23.3 Transportation conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242
23.4 Bacteriostasis and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
23.5 General guidelines for tissue processing . . . . . . . . . . . . . . . . . . . . . . . . . 243
23.6 Additional guidelines for skeletal tissue retrieval and processing . . . . . . . . 249
23.7 Cardiovascular tissue retrieval and processing . . . . . . . . . . . . . . . . . . . . . 250
23.8 Skin retrieval and processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
Chapter 24 Haemopoietic progenitor cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 252
24.1 Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253
24.2 Policy and procedure requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253
24.3 Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254
24.4 Transmissible disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254
24.5 Safety requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254
24.6 Donor selection,consent and testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 255
24.7 Haemopoietic progenitor cell collection facilities . . . . . . . . . . . . . . . . . . . 260
24.8 Component definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262
24.9 Haemopoietic progenitor cell processing standards . . . . . . . . . . . . . . . . . 263
24.10 Liquid storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 265
24.11 Cryopreservation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 265
24.12 Testing of haemopoietic progenitor cell donors and components . . . . . . . . 267
24.13 Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270
24.14 Conditions for storage of components . . . . . . . . . . . . . . . . . . . . . . . . . . . 273
24.15 Release . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 273
24.16 Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 274
24.17 Documentation of infusion and adverse incidents . . . . . . . . . . . . . . . . . . 275
24.18 Disposal of haemopoietic progenitor cells . . . . . . . . . . . . . . . . . . . . . . . . 275
24.19 Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 276
Chapter 25 Specification for the uniform labelling of blood and blood components . . 278
25.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278
25.2 General specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279
25.3 Donation numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 284
25.4 Blood group labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 287
25.5 Component labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 294
25.6 Manufacturers’base labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295
25.7 Future developments in labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297
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Contents
Chapter 26 Uniform labelling of human tissue products using ISBT 128 . . . . . . . . . . 300
26.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300
26.2 The labelling system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 301
26.3 General requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 302
26.4 The base label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 304
26.5 Donation and pool identification number labels . . . . . . . . . . . . . . . . . . . . 305
26.6 The product label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 307
26.7 The tissue status label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 308
26.8 Status label definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 310
26.9 The expiry date label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 312
26.10 National ISBT 128 definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 313
Chapter 27 Standards for electronic data interchange within the UK Blood
Transfusion Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 315
27.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 315
27.2 Control of message structures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 316
27.3 General protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 316
27.4 Envelope definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 316
27.5 Message protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 316
27.6 Protocol 000001 – Blood component dispatch information . . . . . . . . . . . 316
27.7 Protocol 000002 – blood derivative dispatch information . . . . . . . . . . . . . 317
27.8 Protocol 000003 – reagent dispatch information . . . . . . . . . . . . . . . . . . . 317
27.9 Protocol 000004 – blood component dispatch acknowledgement . . . . . . . 319
27.10 Protocol 000005 – blood component fate information . . . . . . . . . . . . . . . 319
Chapter 28 Specification for blood pack base labels . . . . . . . . . . . . . . . . . . . . . . . . . . 327
28.1 Specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 327
Annex 1 Standards available at the National Institute for Biological Standards
and Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 329
Annex 2 ISBT 128 check character calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . 333
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 335
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 339
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Preface to seventh edition
This seventh edition takes account of the European Directives on blood and tissues and
the resulting United Kingdom Regulations.We have tried to indicate throughout this
edition which of our guidelines are now legal requirements.The book continues to include
best practice guidelines and detailed technical procedures.
Blood Safety and Quality Regulation definitions and terminology are used throughout.A
list of definitions is included.The four National Blood/Blood Transfusion Services in the
UK are blood establishments in accordance with the EU Directives as are the individual
centres associated with them.Hospital blood banks fulfil different functions but several
Articles in the ‘Blood Directives’and hence the Blood Safety and Quality Regulations
2005 apply to them;these are explained.
The format of the book has changed with the material presented in continuous chapters
rather than in parts.All chapters have been revised and several new chapters added;
therefore changes introduced in this edition are not indicated in the text.
We have included a few blank pages in the front of the publication where changes notified
by the Joint UKBTS/NIBSC Professional Advisory Committee (JPAC) can be attached.
The ‘Red Book’is as up to date as we can make it at the time of printing.Further EU
Directives are in preparation and will in time be transposed into UK Regulations.Changes
in these guidelines will therefore continue to occur.These will be notified on the JPAC
website www.transfusionguidelines.org.uk and through the management of each of the UK
Blood Services.
We hope the users of these guidelines and regulations find this edition clear and helpful.
We wish to thank the members of the Standing Advisory Committees who undertook the
task of revising or writing the relevant chapters.In particular we wish to thank Caroline
Smith for her painstaking preparation of the material for this publication.
Virge James (Editor)
National Blood Service,Sheffield Centre
Longley Lane
SHEFFIELD
S5 7JN
Brian McClelland
Professional Director,Joint UKBTS/NIBSC Professional Advisory Committee
Scottish National Blood Transfusion Service
Protein Fractionation Centre
Ellen’s Glen Road
EDINBURGH
EH17 7QT
[email protected]
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