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Guidelines for the Blood Transfusion Services

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Guidelines for the Blood Transfusion Services Joint United Kingdom (UK) Blood Transfusion and Tissue PDF Generated JPAC Transplantation Services Professional Advisory Committee 26/09/2021 08:32 Guidelines for the Blood Transfusion Services Index http://www.transfusionguidelines.org/red-book/index Index Names of blood components are in bold type. Page numbers relating to tabulated information are in italics. ABO grouping anomalous 222–3, 224 antisera 188–96 of blood 222–3 of donations 216 fully automated 222 indication on dispatch note 68 indication on labels 316, 317–18 mismatched transplant testing 226 molecular genetics 231 in the presence of autoantibodies 224 quality control 216 acute coronary syndrome 56 additive solutions 135 advanced therapy medicinal product (ATMP) 293 adverse events/reactions EU directives 7, 8, 14 febrile transfusion reactions 249 haemolytic transfusion reactions (HTRs) 218 International Haemovigilance Network categories for 54–6 recording and reporting 21–2, 42, 51–2 serious/severe 14, 21, 56, 281 page 1 of 67 Guidelines for the Blood Transfusion Services / Index suspected bacterial contamination of blood components 176 tissue and organs 281 TRALI 234, 244, 248–9, 253, 254 transfusion reactions 176, 178, 218, 249 air embolism 56 air quality 61, 274 alarm systems 44, 144, 296 alert/action levels, processing facilities 175 allergic reactions 55, 56 alloadsorption techniques 223 alloantibodies in anomalous ABO grouping 222 detection in the presence of autoantibodies 224–5 alternative assay testing, definition 161 ambient temperature 61 amnion donation 266 amotosalen ultraviolet treatment 57 anaphylaxis 56 Anatomy Act 1984 8 anonymity/confidentiality of donors 27, 28, 46, 263, 290 antecubital fossa 48 anti-A 107, 110, 112, 114 high-titre testing 218 performance and evaluation testing 191 reference preparations 182, 204, 360 anti-A,B 183, 191 high-titre testing 218 anti-A+B 183 anti-A1 191 page 2 of 67 Guidelines for the Blood Transfusion Services / Index anti-B 110, 112, 114 high-titre testing 218 performance and evaluation testing 191 reference preparations 182, 204, 360 antibodies clinically important or significant 183 complex mixtures 223 detection 202, 203, 252 extended phenotyping 223, 224 to hepatitis B 157 heterospecific 197 to HFA 224 HLA specific 241–4 HTLA 223–4 identification 182, 218, 223–4 irregular 183, 201–2 to LFA 224 to malaria 164 polyclonal 189 quantification and titration for HDFN 225–6 screening 182, 217 to syphilis 163 titration in ABO mismatched transplant 226 weak 203, 209 see also alloantibodies; autoantibodies Antibody Quantification Quality Assurance Scheme 225 anti-C 191, 192 reference preparation 360 anti-c 192, 225 reference preparation 360 page 3 of 67 Guidelines for the Blood Transfusion Services / Index anti-C3c 196 anti-C3d 211 anti-C4b 210–11 anti-C4d 197, 211 anti-Ch 223, 224 anti-Coa 224 anticoagulant during apheresis procedures 30, 37, 44 labelling 357 weight 60 anticoagulant flow indicator 44, 144 anti-Cob 224 anti-complement 196, 198, 210 anti-Csa 223 anti-Cw 193 anti-D fetal typing 230, 231 partial 188 performance and evaluation testing 191 in potency testing 208–9, 210 quantification and titration for HDFN 225 reference preparations 182, 204, 360, 361 weak 188 anti-E 192 reference preparation 360 anti-e 192 anti-Fy3 224 anti-Fya 193, 210 anti-Fyb 194 page 4 of 67 Guidelines for the Blood Transfusion Services / Index antigen profile 188 anti-HBc 164–5 anti-HBs 165 anti-HCV 163 anti-HIV 1+2 or HIV 1+2 Ag/Ab combination 162 anti-HLA-Bw4 and anti-HLA-Bw6-specific reagents 244, 245 anti-HTLV I/II 163 anti-human globulins batch release testing 197–9, 206–12 manufacturing requirements 196–7 performance evaluation 197, 206–12 polyspecific 210–12 potency testing 197–8 reference preparations 182, 198, 204, 360 anti-IgG chequerboard titration studies 209–10 essential component of anti-human globulin reagents 196 potency testing 197–8, 208–9 reference reagent 209 anti-Inb 224 anti-Jka 194 anti-Jkb 194 anti-K 193, 210 anti-k 224, 193 anti-Kna 223 anti-Kpb 224 anti-Lea 196 anti-Leb 196 anti-light chain activity 196 anti-Lub 224 page 5 of 67 Guidelines for the Blood Transfusion Services / Index anti-M 195 anti-malaria serum, reference preparation 362 anti-McCa 223 anti-measles serum, reference preparation 361 antimicrobial medication, donors 31 antimicrobial processing, terminal 272, 274, 275–6 anti-N 195 anti-P1 195 anti-parvovirus B19 serum (IgG), reference preparation 361, 362 anti-poliovirus serum, reference preparations 361 anti-Rg 223, 224 anti-rubella serum, reference preparation 361, 362 anti-S 194 anti-s 195 anti-S1a 223 anti-T.cruzi 164 anti-Toxoplasma serum, reference preparations 362 anti-U 224 anti-varicella zoster, reference preparation 361, 362 anti-Vel 224 anti-Yka 223 anti-Yta 224 anxiety 52 apheresis adverse events/reactions 54–6, 289–90 anticoagulant 30, 37, 44 blood flow 49 citrate toxicity 37 complications 54–6 page 6 of 67 Guidelines for the Blood Transfusion Services / Index donors 25, 246, 290, 292 equipment 43–4, 144–5, 146 frequency of procedures 29 HPC collection 291, 292 information leaflets 27 labelling of donations 42 mandatory screening tests 156, 156 preparation of pack 48 sample collection 50–1 serious adverse events/reactions 56 venepuncture 48, 49 apheresis continued volume of blood processed per pass 38 volume collected 29 archiving of documents 17 of results 215, 229 of samples 179, 187, 268, 296, 299 arm cleansing 48, 168 arterial puncture 54 aseptic processing facilities 274 aseptic techniques, for collection 43, 49 ASII text files 341 aspirin 25, 32 ‘assumed negative’ procedure, not acceptable 215 audit, Blood and Tissue Establishments 21 autoantibodies alloantibody detection in the presence of 224–5 in anomalous ABO grouping 222 management of patients with 225 page 7 of 67 Guidelines for the Blood Transfusion Services / Index autologous donations status label 339 stem cell 161 autologous serum eye drops 173 automated apheresis machines, specifications 43–4 automated microbial detection system 170 automated test systems 216, 220 avidity determination 206 B cell depleted, definition 294 bacterial see microbial barcodes on blood group labels 316–17 Codabar ABC 311–12 on component labels 323 converting to ISBT 306 decodability grade 315 dimensions 312 ISBT 128 309–11 printing requirements 312–13, 329 quiet zone 315 reading and interpretation 308–9 specifications 307, 312–13 base label 307, 326, 327, 330–1 batch identification number label 307 batch numbers, recording 43, 49 batch of reagent, definition 183 batch of tests, definition 183 batch/pool identification number label 326 beds 53 page 8 of 67 Guidelines for the Blood Transfusion Services / Index biohazards microbiologically reactive 159 quarantine storage 65 safe disposal 66 status label 320, 321–2, 338 status labelling 337 tissue 279 biological variability 71 biotinylated Brad-5 (Bio-Brad-5), reference preparation 361 blood anticoagulation during collection 49 donation procedure 49–50 for neonates, antibody screening 217 rare phenotypes 223, 231 uniform labelling 306–24 blood bags, evaluation and inspection 43 see also blood packs blood collection sets, inspection 43 blood collection teams designated clinical lead 39, 41 evaluation protocol 149, 150, 152 Blood Compliance Report 14 blood components see components blood derivatives, dispatch information (Protocol 000002) 343, 346, 347 blood donations see donations Blood Establishments consultant with responsibility for donors 25 guidelines for the use of DNA/PCR techniques 228–9 message envelope 342 quality management system 12–13 page 9 of 67 Guidelines for the Blood Transfusion Services / Index regulation 6–8, 9 standard operating procedures (SOPs) 57 blood filter 144 blood flow 49, 50 blood flow monitor 44, 144 blood group genotyping 223, 231–2 reference preparations 361 blood group labels 306, 316–22 blood group molecular typing 230–2 blood group polymorphisms 231, 232 blood grouping kit, definition 183 blood grouping reagents definition 183 potency test methods 205–6 potency testing 190, 191–6 reference preparations 203–4 blood grouping system, definition 183 blood grouping tests, components 71 blood groups classifications 318 ISBT 128 label codes 306 blood packs evaluation 145–53 labelling 306, 352–6 positioning 48 preparation 48–9 blood pressure measurement 33 blood products, minimum release criteria 217 Blood Safety and Quality Regulations 2005 7, 13, 46, 154, 221 page 10 of 67 Guidelines for the Blood Transfusion Services / Index blood tests, donors 33–5 blood typing antisera 188–96 blood volume 33 monitoring 50 bone donation 281–2 bone marrow collection facilities 291–2 donors 289, 290–1 HPCs 286 mandatory microbiological testing 173 bovine serum albumin, manufacturing requirements 202 bovine spongiform encephalopathy (BSE) 202 see also Creutzfeldt-Jakob Disease (CJD) British Bone Marrow Registry 290 British Committee for Standards in Haematology (BCSH) 35, 221 British Standards BS 15000 10 BS EN 13612:2002 185, 189, 197 BS EN 13640:2002 185, 189, 197 BS EN 13641:2002 185 BS EN 18113:2011 188 BS EN 375 183 BS EN ISO 14971:2012 185 BS EN ISO 18113:2009 236, 243 see also European Standards buffy coat enriched, definition 294 buffy coat layer 213 C3d 196 cadaver donors see deceased donors Caldicott Report (1997) 10, 226 page 11 of 67 Guidelines for the Blood Transfusion Services / Index calibration 18 capacity, for consent 27–8, 265 cardiac disease, donors 35 cardiovascular tissue, retrieval and processing 282–3 Care Quality Commission 10 cause of death, deceased
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