Chin J Blood Transfusion Nov 2013 Vol. 26 No LIMS electronic issue EI and Healthcare Products Regulatory Agency MHRA 2. 1

2013 11 26 11 Chin J Blood Transfusion Nov 2013 Vol. 26 No. 11 郭永建 1161 BCSH 英国血液学标准委员会 2012 年 赵国华赵维齐 100021 BCSH R457. 1 A 1004-549X 2013 11-1161-12 British Committee for Standards in Haematology BCSH 2004 2012 2004 1 2 quality control QC external quality assessment EQA 3 4 laboratory information management system LIMS 1 2. 4 < 3 < 3 d 2. 5 3 d 2004 ABO ABO ABO BCSH 50 2. 7 BCSH 3 2. 8 2. 9 2005 Blood Safety and Quality Regulations 2005 BSQR 2005 2. 10 Serious Hazards of Transfusion SHOT 2 ABO 2 2. 1 indirect 2. 3 2. 6 ABO 1 LIMS 2. 11 2. 12 antiglobulin test IAT 2. 2 2. 13

1162 2013 11 26 11 Chin J Blood Transfusion Nov 2013 Vol. 26 No. 11 2. 14 LIMS electronic issue EI and Healthcare Products Regulatory Agency MHRA 2. 15 SHOT 2. 16 ABO 2. 17 1 ILAC G13 2000 direct antiglobulin test DAT ISO17043 2010 3 3. 1 LIMS 1 LIMS 3. 2 8 3. 3 BCSH 4. 2. 1 4. 2. 2 good manu- 3. 4 facturing practice GMP 2. 5 1 4. 2. 3 4. 2. 4 4. 2. 5 3. 6 3. 7 3. 8 D ABO 4 4. 1 4. 1. 1 4. 3. 2 CE 4. 3. 3 4. 1. 2 2005 4. 3. 4 11 BCSH 2005 /62 /EC 2 4. 3. 5 4. 1. 3 4. 1. 4 4. 3. 7 4. 1. 5 4. 3. 8 4. 1. 6 4. 3. 9 Medicines 4. 1. 8 EQA EQA 4. 1. 9 4. 2 4. 2. 6 4. 3 4. 3. 1 ABO D CE BCSH 4. 3. 6 4. 1. 7 4. 3. 10

2013 11 26 11 Chin J Blood Transfusion Nov 2013 Vol. 26 No. 11 1163 4. 3. 11 IAT 4. 4 4. 4. 1 BCSH 1 4. 4. 2 BCSH 2 IAT 5. 6. 2 BCSH 5 4 5. 7 4. 4. 3 5. 7. 1 4. 5 SH 4. 5. 2 / 5. 7. 2 < 3 4. 5. 3 < 3 4. 5. 4 < 3 d 3 d 1 1 d 2 d / 2 < 3 3 1 5 5. 7. 3 5. 1 ABO SHOT 1996 ~ 2010 3 d < 7 d 5. 5. 2 LIMS 5. 6 5. 6. 1 EDTA 4. 5. 1 BC- 5. 2 5. 2. 1 100 BCSH LIMS 5. 2. 2 BCSH 5. 2. 3 5. 7. 4 / fetomaternal hemorrhage FMH 5. 3 BCSH 5. 3. 1 / 5. 8 5. 8. 1 5. 4 5. 4. 1 IgM 1 The Royal College of Pathologists RCPath 1 2 ~ 8-30 5. 5 < 3 48 h 3 d * NA 5. 5. 1 < 3 48 h 7 d 3 *

1164 2013 11 26 11 Chin J Blood Transfusion Nov 2013 Vol. 26 No. 11 5. 8. 2 6. 2. 3 > 6 < 3 5. 8. 3 1 6. 2. 4 -B B 6. 3 6. 3. 1 ABO 1 ABO -A -B A1 5. 9 B 2 5. 9. 1 ABO 3 5. 9. 2 3 d 1 /2 000 ABO 1 2 3 5. 9. 3 1 1 7 ~ 14 d LIMS 6 ABO D 4 1 1 6. 1 6. 1. 1 ABO ABO ABO 5 ED- 6. 1. 2 TA SHOT ABO 6. 3. 2 D 1 D DⅥ IgM -D 6. 1. 3 2 ABO IgM -D 2 IgM -D D D 6. 1. 4 RhD DAT D 1 D D DⅥ D 3 -CDE -D 1 6. 2 r' r D -CDE 6. 2. 1 4 DⅥ D 6. 2. 2 column agglutination Ⅵ technology CAT 1 DⅥ 5 2 -D D D 2 2 D 1 O D -A -B -D A B 6. 4 - - - - + + 6. 4. 1 AB B A -D -B -A + + - - - - 6. 4. 2

2013 11 26 11 Chin J Blood Transfusion Nov 2013 Vol. 26 No. 11 1165 6. 4. 3 6. 6. 3 O 6. 4. 4 12 h 1 6. 6. 4 4. 1. 4 6. 7 6. 7. 1 1 6. 4. 5 1 / ABO /D 6. 4. 6 A3 B3 2 12 h 1 6. 4. 7 3 3 3 ABO D -A -B -A A B -B B A -D D D 3 A /B A B 6. 4. 8 1 5 6. 4. 9 ABO D IgG -c 6 D D D -D D D -D D 6. 4. 10 ABO D D -D D 6. 5 D 1 6. 5. 1 1 RCPath 6. 8 LIMS 6. 8. 1 6. 8. 2 O 6. 5. 2 6. 8. 3 6. 5. 3 6. 8. 4 -D 1 6. 5. 4 -D 1 1 2 D D 1 2 D D 6. 5. 5 24 /7 6. 5. 6 1 / 7 6. 2. 2 7. 1 6. 6 7. 1. 1 6. 6. 1 1 LIMS 6. 6. 2 ABO D

1166 2013 11 26 11 Chin J Blood Transfusion Nov 2013 Vol. 26 No. 11 1 2 3 1 D -D + + - 7. 1. 2 -c - + + -Fy a + - + 1 7. 4. 7 7. 3. 3 JK a JK b JK a JK a 7. 4. 8 Jk a -JK a 2 3 > 1 + 7. 2 IAT 7. 4. 9 IAT IgG 7. 2. 1 IAT IgG 7. 2. 2 LISS IAT 7. 3 8 7. 3. 1 2 1 1 R2R2 8. 1. 2 1 R1R1 R1W R1 2 K k Fy a Fy b Jk a Jk b S s M N P1 Le a Le b 8. 1. 3 7. 3. 2 7. 3. 3 1 Fy a Fy b Jk a Jk b S 8. 1. 4 s 1 -Kidd 8. 2 7. 3. 4 8. 2. 1 1 IAT 7. 3. 5 8. 2. 2 7. 3. 6 / 7. 3. 7 7. 4 7. 4. 1 6. 4 7. 4. 2 DAT 8. 2. 4 2 7. 4. 3 -D -D < 0. 1 IU /ml 5. 4. 6 7. 4. 4 -Fy a Fy a 7. 4. 5 S -S 7. 4. 6 4 4 IgG 8. 1 8. 1. 1 8. 2. 3 2

2013 11 26 11 Chin J Blood Transfusion Nov 2013 Vol. 26 No. 11 1167 8. 2. 5 1 8. 4. 6 IAT 1 -c R1R1 2 DAT CCDee 8. 2. 6 -Jk a -Jk b -S -s -Fy a -Fy b 1 DAT < 1 8. 2. 7 Rh 8. 4. 8 DAT 7. 2. 8 -HI O AB A B -HI 8. 3 8. 3. 1 1 8 O 8. 4. 9 1 > 2 > 2 8. 5 8. 3. 2 1 R1R1 CCDee R1WR1 CwCDee 2 K k Fy a Fy b Jk a Jk b S s R2R2 ccdee r'r Ccddee r r 1 K k Jk a Jk b S s Fy a Fy b 8. 3. 3 1 2 8. 5. 3 -e 8. 4 8. 4. 1 DAT C3d IgM DAT 37 37 IAT 8. 4. 2 8. 2. 8 8. 5. 5 AIHA 1 IgG 2 DAT 1 / 3 ZZAP 2 DAT 4 < 3 5 8. 4. 3 < 3 3 / 8. 4. 4 Rh C c E e 8. 4. 5 3 ABO 8. 4. 7 DAT 1 8. 5. 1 autoimmune hemolytic anemia AIHA ABO ccddee 1 3 rr ccddee Rh 8. 5. 2 AIHA ABO CcDEe K 8. 5. 4 AIHA IgG DAT 8. 5. 6

1168 2013 11 26 11 Chin J Blood Transfusion Nov 2013 Vol. 26 No. 11 8. 6 37 8. 6. 1 37 5 < 3 IgG -A -B 9. 3. 4 37 IAT 8. 6. 2 < 37 9. 3. 5 -D O R1r R1R1 37 9. 4 9 9. 1 9. 1. 1 1 ABO ABO 9. 4. 3 IAT 9. 1. 2 9. 4. 4 9. 2 9. 2. 1 2 000 1 9. 4. 5 SHOT 1 EDTA C1 9. 4. 6 2 ABO 9. 5 EI 9. 5. 1 EI LIMS 9. 2. 2 LIMS IAT 9. 5. 2 BCSH IAT EI IT EI IT IT 9. 2. 3 ABO 9. 5. 3 EI 9. 2. 4 1 9. 5. 4 EI 3 1 1 2 BCSH IT LIMS EI 3 9. 2. 5 MHRA LIMS 9. 5. 5 EI 1 1 2 2 9. 3 IAT 9. 3. 1 IAT ABO 4 LIMS 5 ABO EI 6 LIMS 9. 3. 2 EI 8 IAT 9. 3. 3 IAT 1 9. 5. 6 EI 1 2 3 4 LIMS 5 2 3 IgG 9. 16. 7 4 9. 4. 1 ABO 9. 4. 2 -A -B IgG 2 1 2% ~ 3% 2 ~ 5 min IT 6 7 3 EI 7 LIMS < 3 6

2013 11 26 11 Chin J Blood Transfusion Nov 2013 Vol. 26 No. 11 1169 9. 3. 3 7 5. K 3. 8 9. 6 9. 6. 1 9. 10. 2 LIMS 9. 6. 2 LIMS D-C-E- K 9. 6. 3 LIMS ABO D 9. 10. 4 Rh C c E e Rh 9. 6. 4 LIMS 5 5 Rh Rh Rh / Rh 9. 6. 5 LIMS -D rr ccddee r'r Ccddee r r ccddee 9. 6. 6 LIMS -E R1R1 CCDee R1r CcDee R0r or R0R0 ccdee 9. 7 ABO -C 9. 7. 1 ABO 9. 7. 2 A B O -c 9. 7. 3 AB AB AB -e A B O 9. 7. 4 O 9. 11 -Wr a 1 ABO 2 ABO 9. 11. 1 IAT 3 ABO ABO 4 9. 12 ABO 8. 12. 1 IAT 1 9. 8 D 37 IAT 9. 8. 1 D D 9. 13 2 D 9. 13. 1 D D D D 1 > 50 2 D D 3 9. 13. 2 IAT > 8 U -D 8. 5. 5 9. 8. 2 D D 9. 13. 3 1 LIMS 9. 8. 3 D 1 D < 51 2 < 18 D 3 - D 4 D 9. 13. 4 IAT 9. 9 9. 9. 1 K K -K K 9. 6. 7 rr ccddee r'r Ccddee 9. 10. 3 -D rr ccddee R2R2 ccdee R2r ccdee R0r or R0R0 ccdee rr ccddee r r ccddee R1R1 CCDee r'r' CCddee R2R2 ccdee r r ccddee D-C-E- rr D-C-E- rr D-C-E- rr c-e- R1R1 E- C-E- R0 or rr D-C-E- rr D-E- rr C-e- R2R2 C- C-E- R0 or rr D-C-E- rr D-C- rr c-e- R1R1 D-c-E r'r' C-e- R2R2 D-C-e- r r ABO 9. 13. 5 / 9. 10 DAT 9. 10. 1

1170 2013 11 26 11 Chin J Blood Transfusion Nov 2013 Vol. 26 No. 11 9. 17. 7 -A -B -AB DAT O 9. 14 9. 14. 1 AIHA 9. 18. 1 -HI 8. 4. 8 9. 14. 2 9. 18. 2 9. 14. 3 C c E e K k Jk a Jk b Fy a Fy b S s 2 S-s- LISS 1 U NISS IAT 9. 15 9. 15. 1 24 h 1 < 3 h 50% 9. 18. 5 HbS 150 ml /h 9. 15. 2 O 10. 4 2 10 d 9. 15. 3 1 < 24 h 8 ~ 10 U 80 ~ 100 ml /kg ABO D 9. 19 9. 15. 4 9. 14. 3 9. 16 9. 16. 1 Rh CcEe K 2012 BCSH 9. 16. 2 Rh K IAT O D K 9. 19. 3 NHS 9. 17 4 9. 17. 1 4 9. 20 2012 BCSH 9. 20. 1 ABO 4 9. 17. 2 O ABO 9. 20. 2 9. 17. 3 O 9. 20. 3 / ABO O 9. 17. 4 IgG DAT O D 9. 20. 4 SHOT 9. 18 1 9. 18. 3 Rh K 9. 18. 4 R0 R0 rr 9. 18. 6 7 d 9. 19. 1 ABO D 70% 9. 19. 2 14 d ABO IAT LIMS ABO 9. 17. 5 IgG ABO D ABO D 9. 17. 6 DAT 9. 20. 5 ABO ABO

2013 11 26 11 Chin J Blood Transfusion Nov 2013 Vol. 26 No. 11 1171 DAT 9. 23. 4 RI ABO D 9. 23. 5 RI EI EI RI 9. 20. 6 1 D 9. 23. 6 D 9. 20. 7 10 ABO D 9. 20. 8 10. 1 9. 21 9. 21. 1 1 ABO 9. 21. 2 ABO 1 2 3 4 5 10. 1. 2 1 6 7 ABO D 8 9 10 ABO D 9. 21. 3 10. 1. 3 O 1 O 9. 21. 4 10. 1. 4 9. 21. 5 9. 21. 6 10. 2 1 9. 21. 7 1 1 3 9. 21. 8 1 1 10. 3 9. 21. 9 O 1 9. 22 9. 22. 1 1 1 10. 3. 2 O 2 3 4 9. 23 remote issue RI 9. 23. 1 RI ABO D ABO 1 10. 4. 2 1 9. 23. 2 ABO D 10. 1. 1 1 / 2 10. 3. 1 1 10. 4 ABO D 10. 4. 1 9. 23. 3 LIMS 10. 4. 3 -A -B -D ABD

1172 2013 11 26 11 Chin J Blood Transfusion Nov 2013 Vol. 26 No. 11 11. 3. 2 -JK a 10. 4. 4 10. 4. 5 2 10. 4. 6 1 1 10. 5 10. 5. 1 11. 3. 4 10. 6 10. 6. 1 ABO D 3 IAT 4 IAT 1 1 5 DAT 2 3 10. 6. 2 ABO O 11. 3. 5 10. 6. 3 > 8 U 2 -D > 50 3 D O D 11. 3. 6 10. 6. 4 1 D D D 2 1 3 AIHA 2 DAT 4 CMV 3 DAT 11 DAT 4 11. 1 11. 1. 1 11. 3. 7 11. 2 11. 2. 1 1 11. 2. 2 1 3 2 11. 2. 3 BCSH. British Committee for Standards in Haema- tology BCSH. Guidelines for compatibility procedures in blood transfusion Laboratories 2004. 2004-03-25 2012-12-11 http / / 11. 3 www. bcshguidelines. com / documents / compatability _ bjh _2004. 11. 3. 1 pdf BCSH. Guidelines for pre-transfusion compatibility procedures in blood transfusion laboratories 2012. 2012-11-06 2012- / 12-11 http / /www. bcshguidelines. com /documents /Compat _ Guideline_for_submission_to_TTF_011012. pdf LDH 1 IgG C3 11. 3. 3 2 1 2 1 IAT 2 2013-04-07 11-11