山东省血站血液检测质量监测指标体系的应用OACSTPCD

Objective To objectively evaluate the quality control level of blood testing process in blood banks through quantitative monitoring and trend analysis,and to promote the homogenization level and standardized management of blood testing laboratories in blood banks.Methods A quality monitoring indicator system covering the whole process of blood col-lection and supply,including blood donation service,blood component preparation,blood testing,blood supply and quality control was established.The questionnaire Quality Monitoring Indicators for Blood Collection and Supply Process with clear definition of indicators and calculation formulas was distributed to 17 blood banks in Shandong province.Quality monitoring indicators of each blood bank from January to December 2022 were collected,and 31 indicators in terms of blood testing were analyzed using SPSS25.0 software.Results The proportion of unqualified serological tests in 17 blood bank laborato-ries was 55.84％for ALT,13.63％for HBsAg,5.08％for anti HCV,5.62％for anti HIV,18.18％for anti TP,and 1.65％for other factors(mainly sample quality).The detection unqualified rate and median were(1.23±0.57)％and 1.11％,re-spectively.The ALT unqualified rate and median were(0.74±0.53)％and 0.60％,respectively.The detection unqualified rate was positively correlated with ALT unqualified rate(r=0.974,P<0.05).The unqualified rate of HBsAg,anti HCV,anti HIV and anti TP was(0.15±0.09)％,(0.05±0.04)％,(0.06±0.03)％and(0.20±0.05)％respectively.The average unqualified rate,average hemolysis rate,average insufficient volume rate and the abnormal hematocrit rate of samples in 17 blood bank laboratories was 0.21‰,0.08‰,0.01‰and 0.02‰respectively.There were differences in the retest concord-ance rates of four HBsAg,anti HCV and anti HIV reagents,and three anti TP reagents among 17 blood bank laboratories(P<0.05).The usage rate of ELISA reagents was(114.56±3.30)％,the outage rate of ELISA was(10.23±7.05)‰,and the out of range rate of ELISA was(0.90±1.17)‰.There was no correlation between the out of range rate,outrage rate and us-age rate(all P>0.05),while the outrage rate was positively correlated with the usage rate(r=0.592,P<0.05).A total of 443 HBV DNA positive samples were detected in all blood banks,with an unqualified rate of 3.78/10 000;15 HCV RNA positive samples were detected,with an unqualified rate of 0.13/10 000;5 HIV RNA positive samples were detected,with an unqualified rate of 0.04/10 000.The unqualified rate of NAT was(0.72±0.04)‰,the single NAT reaction rate[(0.39±0.02)‰]was positively correlated with the single HBV DNA reaction rate[(0.36±0.02)‰](r= 0.886,P<0.05).There was a difference in the discriminated reactive rate by individual NAT among three blood bank laboratories(C,F,H)(P<0.05).The median resolution rate of 17 blood station laboratories by minipool test was 36.36％,the median rate of in-valid batch of NAT was 0.67％,and the median rate of invalid result of NAT was 0.07‰.The consistency rate of ELISA du-al reagent detection results was(99.63±0.24)％,and the median length of equipment failure was 14 days.The error rate of blood type testing in blood collection department was 0.14‰.Conclusion The quality monitoring indicator system for blood testing process in Shandong can monitor potential risks before,during and after the experiment,and has good applicability,feasibility,and effectiveness,and can facilitate the continuous improvement of laboratory quality control level.The applica-tion of blood testing quality monitoring indicators will promote the homogenization and standardization of blood quality man-agement in Shandong,and lay the foundation for future comprehensive evaluations of blood banks.