Contents Foreword...3 Members of the European Committee (Partial Agreement) on Blood Transfusion... 8 Members of the GTS working group... 22 Members of the TS066 working group... 30 Recommendation No. R (95) 15 of the Committee of Ministers...40 The Guide to the preparation, use and quality assurance of blood components, Appendix to Recommendation No. R (95) 15 PRINCIPLES... 45 Chapter 1. Principles of a quality system for blood establishments... 47 1. Introduction... 47 2. General Principles... 47 3. Elements of the quality system... 48 4. Premises... 49 5. Qualification and validation... 50 6. Process validation...54 7. Control of equipment and materials...58 8. Documentation... 64 9. Contract management... 67 10. Non-conformance... 69 11. Self-inspection, audits and improvements...72 12. Quality monitoring and control...72 34
Chapter 2. Principles of donor selection...75 1. Overview...75 2. Donor screening...77 3. Specific considerations for donors of different components... 86 4. Example of a donor screening questionnaire...95 Chapter 3. Principles of blood collection... 97 1. Overview... 97 2. Premises for donor sessions... 97 3. Equipment used at blood donation sessions... 98 4. Pre-donation checks and labelling... 98 5. Venepuncture... 98 6. Apheresis... 101 7. Repository of archive samples... 101 8. Management of adverse reactions in donors...102 9. Donor clinic documentation...105 Chapter 4. Principles of blood component processing storage and distribution...107 1. Overview...107 2. Processing procedures...108 3. Choice of anti-coagulant and bag system...109 4. Centrifugation of blood components...111 5. Component separation... 114 6. Leucocyte depletion... 118 7. Freezing and thawing of plasma... 119 8. Open and closed systems and sterile connection devices...121 9. Irradiation of blood components...121 10. Prevention of CMV transmission... 122 11. Pathogen reduction... 123 12. Purity of components... 125 13. Bacterial safety of blood components... 125 35
14. Storage of blood components...129 15. Transportation of blood components... 134 16. Component information and principles of labelling... 136 Chapter 5. Principles of blood component monographs...139 1. Definition and properties...139 2. Preparation... 140 3. Requirements and quality control... 140 4. Storage and transport... 140 5. Labelling... 141 6. Warnings... 141 Chapter 6. Principles of blood components for foetal, neonatal and infant use...143 1. Overview... 143 2. Components for intra-uterine transfusions...144 3. Components for neonatal exchange transfusion...144 4. Red cells for neonatal and infant small volume transfusion... 145 5. Fresh frozen plasma for neonatal and infant use...146 6. Platelets for neonatal and infant use...146 Chapter 7. Principles of pre-deposit autologous transfusion... 149 1. Overview...149 2. Selection of patients for pre-deposit autologous transfusion and blood collection...151 3. Preparation, storage and distribution of pre-deposit autologous components... 153 Chapter 8. Principles of immuno-haematology... 155 1. Overview...155 2. Blood group serological investigations... 156 3. Validation and quality assurance... 157 Chapter 9. Principles of screening for markers of infection...167 1. Overview (general comments for all mandatory tests)...167 2. Algorithm for infectious marker screening and confirmatory testing...168 36
3. Confirmatory testing...170 4. Nucleic acid screening... 171 5. Additional serological testing... 172 Chapter 10. Principles of haemovigilance... 175 1. Overview... 175 2. Prerequisites for implementation of a haemovigilance network...176 3. Types of adverse reactions and adverse events collected in a haemovigilance network... 179 4. Tracing and recall of potentially infectious donations for HIV, HCV or HBV (look-back)... 183 5. Contracts between blood establishments and hospitals for haemovigilance... 185 6. Reporting of haemovigilance data...186 Chapter 11. Principles of clinical use of blood...189 1. Overview...189 2. Elements for a quality system in clinical transfusion...189 3. Clinical indications of blood components...192 4. The request form...201 5. Issuing blood components... 202 6. Administration of blood components... 202 7. Monitoring... 204 8. Transfusion complications... 205 9. Hospital transfusion committees...206 STANDARDS...209 Chapter 1. Standards for a quality system for blood establishments and hospital blood banks... 211 1. Introduction and general principles...211 2. Elements of the quality system...214 Chapter 2. Standards for selection of donors...225 1. Overview...225 2. Information to be provided to the donor...225 37
3. Medical assessment of the donor...227 4. Donor deferral... 229 5. Specific standards for donors of different types of components... 235 6. Post-donation information...241 Chapter 3. Standards for collection of blood and blood components...241 1. Premises for donor sessions...241 2. Procedures and equipment used at blood donation sessions...241 3. Pre-donation checks... 242 4. Labelling... 242 5. Venepucture, bleeding and mixing...243 6. Handling of filled containers and samples...245 7. Special requirement for apheresis...245 8. Repository of archive samples... 246 Chapter 4. Standards for blood component processing, storage and distribution...247 1. Processing... 247 2. Component labelling and information... 248 3. Release of blood components... 249 4. Storage and distribution... 251 5. Irradiation of blood components...252 6. Leucocyte depletion...253 7. Bacterial safety...253 Chapter 5. Component monographs...255 Part A. Whole blood components...257 Part B. Red cell components...265 Part C. Platelet components... 299 Part D. Plasma components... 351 Part E. White cell components... 369 Chapter 6. Standards for blood components for intra-uterine, neonatal and infant use...375 Part A. Components for intra-uterine transfusions...377 38
Part B. Components for neonatal exchange transfusion...383 Part C. Components (small volume) for neonatal and infant transfusion...391 Chapter 7. Standards for autologous pre-deposit transfusion...395 1. Overview...395 2. Selection of patients for PAT and blood collection... 396 3. Preparation, storage and distribution of pre-deposit autologous blood components...397 Chapter 8. Standards for immuno-haematology... 399 1. Overview... 399 2. Selection and validation of reagents and methods... 399 3. Quality control...400 4. Blood group testing of blood donations/donors...400 5. Blood group testing of patients...401 Chapter 9. Standards for screening for infectious markers... 405 1. Selection and validation of infectious marker tests... 405 2. Mandatory serological screening tests...406 3. Additional serological screening tests... 407 4. Management of reactive results in serological screening tests... 407 5. Nucleic acid screening (NAT)...409 6. Selective screening of donations...409 Chapter 10. Standards for haemovigilance... 411 1. Overview... 411 2. Pre-requisites for implementation of a haemovigilance network... 411 3. Device defects...412 4. Post-transfusion reported to the blood establishment...412 Appendices...415 List of definitions...496 Abbreviations... 504 Recommendations and resolutions of the Council of Europe in the field of blood transfusion... 507 List of publications... 509 39