EUROPEAN COMMITTEE (PARTIAL AGREEMENT) ON BLOOD TRANSFUSION (CD-P-TS)...8 Members...8 Observers... 19

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1 FOREWORD...3 EUROPEAN COMMITTEE (PARTIAL AGREEMENT) ON BLOOD TRANSFUSION (CD-P-TS)...8 Members...8 Observers MEMBERS OF THE AD HOC GROUP (GTS)...23 Members...23 Recommendation No. R (95) Guide to the preparation, use and quality assurance of blood components...57 PRINCIPLES...59 Chapter 1 Introduction...60 Chapter 2 Principles of donor selection General remarks Overview Medical assessment of the donor...63 Age of the donor

2 Guide to the preparation, use and quality assurance of blood components Hazardous occupations...63 Donor deferral...64 Conditions requiring permanent deferral...64 Conditions requiring temporary deferral (suspension)...64 Vaccination Conditions requiring individual assessment...64 Post-donation information...66 Infectious diseases History of malignancy Specific considerations for donors of different components...69 Quantity of whole blood donation...69 Frequency of whole blood donation...71 Laboratory examination before donation...71 Apheresis donors...72 Designated donations Directed donations...77 Chapter 3 Principles of blood collection Overview Premises for donor sessions Equipment used at blood donation sessions Pre-donation checks and labelling Venepuncture...79 Preparation of the venepuncture site...79 Successful venepuncture and proper mixing...80 Handling of filled containers and samples Apheresis...82 Pre-medication and apheresis...82 Automated apheresis...82 Manual apheresis Repository of archive samples Management of adverse reactions in donors...83 Prevention of adverse reactions in donors...84 Treatment of adverse reactions in donors...84 Documentation of adverse reactions in donors...85 Information for a donor with adverse reactions

3 9. Donor clinic documentation...86 Chapter 4 Principles of blood component processing Overview Processing procedures Choice of anti-coagulant and bag system Centrifugation of blood components Component separation...94 Separation after the initial centrifugation Separation after initial filtration...94 Other separation principles Leucocyte depletion Freezing and thawing of plasma...99 Rationale...99 Methods of freezing Methods of thawing Cryoprecipitation Open and closed systems and sterile connection Devices Irradiation of blood components Prevention of CMV transmission Pathogen reduction technologies Purity of components Bacterial safety of blood components Overview Quality control for aseptic collection and processing of blood components Release as culture-negative to date after bacteriological testing of all platelets Storage of blood components Equipment Storage at + 2 to + 6 C Storage of frozen plasma components Storage at + 20 to + 24 C Aspects of red cell preservation Additive solutions

4 Guide to the preparation, use and quality assurance of blood components Micro-aggregates in whole blood and red cell components Red cell preparations Platelet preparations Granulocyte preparations Plasma components Transportation of blood components Transport of standard red cell components Transport of platelet components Transport of frozen plasma 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 autologous transfusion Overview Pre-deposit autologous transfusion Patient selection Blood collection Preparation, storage and distribution of pre-deposit autologous components Labelling Storage

5 Records Audit Red cell salvage Collection system Processing system Indications for the use of cell salvage Parameters for quality control Precautions Chapter 8 Principles of immunohaematology Overview Immunohaematological testing Blood group testing Screening and investigation of antibodies Pre-transfusion testing Validation and quality assurance Quality control Quality control of equipment Quality control of reagents Quality control of techniques Internal quality control External quality assurance Quality control of antibody quantitation Chapter 9 Principles of screening for markers of infection Overview (general comments for all mandatory tests) Algorithm for infectious marker screening and confirmatory testing Confirmatory testing Anti-HIV-1/2, anti-hcv and HBsAg Anti-HTLV-I-II Nucleic acid screening Additional serological screening Syphilis screening Anti-HBc screening CMV screening

6 Guide to the preparation, use and quality assurance of blood components Malaria screening Trypanosoma cruzi screening Chapter 10 Principles of haemovigilance Overview Prerequisites for implementation of a haemovigilance network Traceability of blood components Co-operation between blood establishments, hospital blood banks and clinical departments Types of adverse reactions and adverse events collected in a haemovigilance network Adverse reactions in patients Adverse reactions in donors Adverse events Device defects Tracing and recall of potentially infectious donations for HIV, HCV or HBV (look-back) Post-transfusion infection in a recipient reported to the blood establishment Post-donation information Recall of blood components Tracing of recipients of potentially infectious blood donations (look-back/review) Contracts between blood establishments and hospitals for haemovigilance Minimum information to be captured in the initial incident report at hospital level Reporting haemovigilance data Standardisation of reporting Data analysis Information sent to the haemovigilance database Component information Information about severity Information about imputability Information about the type of adverse events and reactions

7 Chapter 11 Principles of clinical use of blood Overview Elements for a quality system in clinical transfusion Indications for blood component transfusion and the role of clinical auditing Informed consent for transfusion The transfusion request Transfusion of blood components Transfusion reporting and management of transfusion reactions Clinical indications for blood components Clinical indications of red cells Clinical indications for platelet transfusion Clinical indications for fresh frozen plasma Clinical use of granulocytes The request form Issuing blood components Administration of blood components Safety measures Handling and storage of blood in the hospital Monitoring Efficacy Transfusion complications Hospital transfusion committees STANDARDS Chapter 1 Introduction Chapter 2 Standards for selection of donors Overview Information to be provided to the donor Medical assessment of the donor Donor eligibility Questionnaire and interview Donor details

8 Guide to the preparation, use and quality assurance of blood components Age of the donor Donor appearance and inspection Donor deferral Infectious diseases Specific standards for donors of different types of components Whole blood donors Quantity of donation Apheresis donors 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 Venepuncture, bleeding and mixing Preparation of the venepuncture site Successful venepuncture and proper mixing Handling of filled containers and samples Special requirements for apheresis Return of red blood cells of donors undergoing manual apheresis Repository of archive samples Chapter 4 Standards for the processing, storage and distribution of blood components Processing Component labelling and information Release of blood components Storage and distribution Irradiation of blood components Leucocyte depletion Bacterial safety Chapter 5 Component monographs

9 Component monographs Part A. Whole Blood components Whole Blood Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Whole Blood, Leucocyte-Depleted Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Component monographs Part B. Red cell components Red Cells Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Red Cells, Buffy Coat Removed Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Red Cells, in Additive Solution Definition and properties Preparation

10 Guide to the preparation, use and quality assurance of blood components Requirements and quality control Storage and transport Labelling Warnings Red Cells, Buffy Coat Removed, in Additive Solution Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Red Cells, Leucocyte-Depleted Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Red Cells, Leucocyte-Depleted in Additive Solution Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Red Cells, Apheresis Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Red Cells, Washed Definition and properties Preparation

11 Requirements and quality control Storage and transport Labelling Warnings Red Cells, Cryopreserved Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Component monographs Part C. Platelet components Platelets, Recovered, Single Unit Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Platelets, Recovered, Pooled Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Platelets, Recovered, Pooled, Leucocyte-Depleted Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Platelets, Recovered, Pooled, in Additive Solution

12 Guide to the preparation, use and quality assurance of blood components Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Platelets, Recovered, Pooled, Leucocyte-Depleted, in Additive Solution Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Platelets, Pooled, Pathogen-reduced Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Platelets, Apheresis Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Platelets, Apheresis, Leucocyte-Depleted Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings

13 9. Platelets, Apheresis, in Additive Solution Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Platelets, Apheresis, Leucocyte-Depleted, in Additive Solution Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Platelets, Apheresis, Pathogen-reduced Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Platelets, Cryopreserved Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Component monographs Part D. Plasma components Plasma, Fresh Frozen Definition and properties Preparation Requirements and quality control

14 Guide to the preparation, use and quality assurance of blood components Storage and transport Labelling Warnings Plasma, Fresh Frozen, Pathogen Reduced Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Cryoprecipitate Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Plasma, Fresh Frozen, Cryoprecipitate-Depleted Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Component monographs Part E. White cell components Granulocytes, Apheresis Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings

15 Chapter 6 Standards for blood components for intra-uterine, neonatal and infant use Standards for blood components for intra-uterine, neonatal and infant use Part A. Components for intra uterine transfusions Red Cells, Leucocyte-Depleted for Intrauterine Transfusion..348 Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Platelets, Leucocyte-Depleted for Intra-uterine Transfusion..350 Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Standards for blood components for intra-uterine, neonatal and infant use Part B. Components for neonatal exchange transfusion Whole Blood, Leucocyte-Depleted for Exchange Transfusion 354 Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Whole Blood, Leucocyte-Depleted, Plasma Reduced for Exchange Transfusion Definition and properties Preparation Requirements and quality control

16 Guide to the preparation, use and quality assurance of blood components Storage and transport Warnings Red Cells, Leucocyte-Depleted, suspended in Fresh Frozen Plasma, for Exchange Transfusion Definition and properties Preparation Requirements and quality control Storage and transport Labelling Warnings Standards of blood components for intra-uterine, neonatal and infant use Part C. Components (small volume) for neonatal and infant transfusion Red Cells for Neonatal and Infant Small Volume Transfusion 362 Definition and properties Preparation Quality control Storage and transport Labelling Warnings Chapter 7 Standards for autologous pre deposit transfusion Overview Selection of patients for PAT and blood collection Role of the physician in charge of collection Information for donors Contraindications or deferral criteria Preparation, storage and distribution of pre-deposit autologous blood components Blood typing and microbiological screening Preparation Labelling Storage and handling Warnings

17 Chapter 8 Standards for immunohaematology Overview Selection and validation of reagents and methods Quality control Blood group testing of blood donors and donations ABO and RhD Additional typing Irregular antibody testing Testing of patient samples Blood grouping and antibody detection Compatibility testing 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 Traceability of blood components Confidentiality of haemovigilance data Device defects Post-transfusion infection reported to the blood establishment GOOD PRACTICE GUIDELINES Introduction Good practice guidelines for blood establishments and hospital blood banks required to comply with EU Directive 2005/62/EC General principles Personnel and organisation

18 Guide to the preparation, use and quality assurance of blood components 3. Premises Equipment and materials Documentation Blood collection, testing and processing Storage and distribution Contract management Non-conformance Self-inspection, audits and improvements Quality monitoring and control APPENDIX 1. KEY CRITERIA FOR DONOR ELIGIBILITY APPENDIX 2. TABLES FOR CALCULATION OF BLOOD VOLUMES APPENDIX 3. DATA PROCESSING SYSTEMS Planning of a system Defining the system Implementation and validation Functional testing of components Data migration Environmental testing Change control Maintenance of the system Quality assurance APPENDIX 4. STATISTICAL PROCESS CONTROL Introduction Implementation of SPC Strategy for statistical sampling Tolerance of failure Confidence level Frequency of control sampling

19 Example 1. Use of control charts Example 2. Method of scan statistics Example 3. Statistical process control for dichotomous outcomes: an approach based upon hypergeometric/binomial distributions DEFINITIONS ABBREVIATIONS REFERENCES

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