Guide to the preparation, use and quality assurance of blood components

Transcription

1 Contents Foreword...3 Members of the European Committee (Partial Agreement) on Blood Transfusion... 8 Members of the GTS working group Members of the TS066 working group 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 Chapter 1. Principles of a quality system for blood establishments Introduction General Principles Elements of the quality system Premises Qualification and validation Process validation Control of equipment and materials Documentation Contract management Non-conformance Self-inspection, audits and improvements Quality monitoring and control

2 Chapter 2. Principles of donor selection Overview Donor screening Specific considerations for donors of different components Example of a donor screening questionnaire...95 Chapter 3. Principles of blood collection Overview Premises for donor sessions Equipment used at blood donation sessions Pre-donation checks and labelling Venepuncture Apheresis Repository of archive samples Management of adverse reactions in donors Donor clinic documentation Chapter 4. Principles of blood component processing storage and distribution Overview Processing procedures Choice of anti-coagulant and bag system Centrifugation of blood components Component separation Leucocyte depletion Freezing and thawing of plasma Open and closed systems and sterile connection devices Irradiation of blood components Prevention of CMV transmission Pathogen reduction Purity of components Bacterial safety of blood components

3 14. Storage of blood components Transportation of blood components Component information and principles of labelling Chapter 5. Principles of blood component monographs Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Chapter 6. Principles of blood components for foetal, neonatal and infant use Overview Components for intra-uterine transfusions Components for neonatal exchange transfusion Red cells for neonatal and infant small volume transfusion Fresh frozen plasma for neonatal and infant use Platelets for neonatal and infant use Chapter 7. Principles of pre-deposit autologous transfusion Overview Selection of patients for pre-deposit autologous transfusion and blood collection Preparation, storage and distribution of pre-deposit autologous components Chapter 8. Principles of immuno-haematology Overview Blood group serological investigations Validation and quality assurance Chapter 9. Principles of screening for markers of infection Overview (general comments for all mandatory tests) Algorithm for infectious marker screening and confirmatory testing

4 3. Confirmatory testing Nucleic acid screening Additional serological testing Chapter 10. Principles of haemovigilance Overview Prerequisites for implementation of a haemovigilance network Types of adverse reactions and adverse events collected in a haemovigilance network Tracing and recall of potentially infectious donations for HIV, HCV or HBV (look-back) Contracts between blood establishments and hospitals for haemovigilance Reporting of haemovigilance data Chapter 11. Principles of clinical use of blood Overview Elements for a quality system in clinical transfusion Clinical indications of blood components The request form Issuing blood components Administration of blood components Monitoring Transfusion complications Hospital transfusion committees STANDARDS Chapter 1. Standards for a quality system for blood establishments and hospital blood banks Introduction and general principles Elements of the quality system Chapter 2. Standards for selection of donors Overview Information to be provided to the donor

5 3. Medical assessment of the donor Donor deferral Specific standards for donors of different types of components Post-donation information Chapter 3. Standards for collection of blood and blood components Premises for donor sessions Procedures and equipment used at blood donation sessions Pre-donation checks Labelling Venepucture, bleeding and mixing Handling of filled containers and samples Special requirement for apheresis Repository of archive samples Chapter 4. Standards for blood component processing, storage and distribution Processing Component labelling and information Release of blood components Storage and distribution Irradiation of blood components Leucocyte depletion Bacterial safety Chapter 5. Component monographs Part A. Whole blood components Part B. Red cell components Part C. Platelet components Part D. Plasma components Part E. White cell components Chapter 6. Standards for blood components for intra-uterine, neonatal and infant use Part A. Components for intra-uterine transfusions

6 Part B. Components for neonatal exchange transfusion Part C. Components (small volume) for neonatal and infant transfusion Chapter 7. Standards for autologous pre-deposit transfusion Overview Selection of patients for PAT and blood collection Preparation, storage and distribution of pre-deposit autologous blood components Chapter 8. Standards for immuno-haematology Overview Selection and validation of reagents and methods Quality control Blood group testing of blood donations/donors Blood group testing of patients Chapter 9. Standards for screening for infectious markers Selection and validation of infectious marker tests Mandatory serological screening tests Additional serological screening tests Management of reactive results in serological screening tests Nucleic acid screening (NAT) Selective screening of donations Chapter 10. Standards for haemovigilance Overview Pre-requisites for implementation of a haemovigilance network Device defects Post-transfusion reported to the blood establishment Appendices List of definitions Abbreviations Recommendations and resolutions of the Council of Europe in the field of blood transfusion List of publications