山东省血站血液检测质量监测指标体系的应用  

Application of quality monitoring indicators of blood testing in blood banks of Shandong province

作　　者：李雪梅 翟玮玮 杨忠思 赵淑红 吴玉清 刘群 宋哲 戎志全 孙庶丽 范晓娟 张韦 韩金玉 朱琳 安宪武 张惠 任俊霞 李雪晶 杨晨曦[15] 周博 黄海燕[16] 刘广彩 陈平 叶辉[4] 谯铭铭 申华[4] 贡觉顿珠 庄云龙[4] LI Xuemei;ZHAI Weiwei;YANG Zhongsi;ZHAO Shuhong;WU Yuqing;LIU Qun;SONG Zhe;RONG Zhiquan;SUN Shuli;FAN Xiaojuan;ZHANG Wei;HAN Jinyu;ZHU Lin;AN Xianwu;ZHANG Hui;REN Junxia;LI Xuejing;YANG Chenxi;ZHOU Bo;HUANG Haiyan;LIU Guangcai;CHEN Ping;YE Hui;QIAO Mingming;SHEN Hua;GONGJUE Dunzhu;ZHUANG Yunlong(Weifang Central Blood Bank 261043,China;Qingdao Central Blood Bank;Zibo Central Blood Bank;Blood Center of Shandong Province;Yantai Central Blood Bank;Weihai Central Blood Bank;Rizhao Central Blood Bank;Binzhou Central Blood Bank;Heze Central Blood Bank;Dongying Central Blood Bank;Liaocheng Central Blood Bank;Zaozhuang Central Blood Bank;Dezhou Central Blood Bank;Jinan Central Blood Bank;Taian Central Blood Bank;Jining Central Blood Bank;Linyi Central Blood Bank)

机构地区：[1]潍坊市中心血站,山东潍坊261043 [2]青岛市中心血站 [3]淄博市中心血站 [4]山东省血液中心 [5]烟台市中心血站 [6]威海市中心血站 [7]日照市中心血站 [8]滨州市中心血站 [9]菏泽市中心血站 [10]东营市中心血站 [11]聊城市中心血站 [12]枣庄市中心血站 [13]德州市中心血站 [14]济南血液供保中心 [15]泰安市中心血站 [16]济宁市中心血站 [17]临沂市中心血站

出　　处：《中国输血杂志》2024年第3期258-266,共9页Chinese Journal of Blood Transfusion

基　　金：山东省级医疗质量管理工作项目(2018-22)。

摘　　要：目的通过量化监控和趋势分析对血站血液检测过程的质量控制水平做出客观评价,并以此促进血站血液检测实验室同质化水平和标准化管理。方法建立覆盖采供血全过程的献血服务、成分制备、血液检测、血液供应和质量控制的质量监测指标体系,向山东省17家血站发放《采供血过程质量监测指标统计表》,明确指标定义和计算公式,收集各血站2022年1—12月质量监测指标数据,利用SPSS23.0软件对其中血液检测(31个)的质量监测指标数据进行统计分析。结果17家血站实验室血清学检测不合格项目占比为ALT 55.84%、HBsAg 13.63%、抗-HCV 5.08%、抗-HIV 5.62%、抗-TP 18.18%、其他因素(主要标本不合格)1.65%。检测不合格率和中位数分别为(1.23±0.57)%与1.11%,ALT不合格率和中位数分别为(0.74±0.53)%与0.60%,检测不合格率与ALT不合格率呈正相关(r=0.974,P<0.05)。HBsAg不合格率为(0.15±0.09)%,抗-HCV不合格率为(0.05±0.04)%,抗-HIV不合格率为(0.06±0.03)%,抗-TP不合格率为(0.20±0.05)%。17家血站实验室标本不合格率均值为0.21‰,标本溶血率均值为0.08‰,标本容量不足率均值为0.01‰,标本血细胞比容异常率0.02‰。17家血站实验室4种HBsAg、抗-HCV、抗-HIV试剂和3种抗-TP试剂复检符合率均有差异(P<0.05)。ELISA试剂使用率为(114.56±3.30)%,ELISA中断率为(10.23±7.05)‰,ELISA失控率为(0.90±1.17)‰,失控率与中断率、试剂使用率均不存在相关性(均为P>0.05),中断率与试剂使用率呈正相关(r=0.592,P<0.05)。所有血站共检出HBV DNA阳性标本443份,不合格率为3.78/万;检出HCV RNA阳性标本15份,不合格率为0.13/万;检出HIV RNA阳性标本5份,不合格率为0.04/万。NAT不合格率为(0.72±0.04)‰,NAT单反应率为(0.39±0.02)‰,HBV DNA单反应率为(0.36±0.02)‰,NAT单反应率与HBV DNA单反应率呈正相关(r=0.886,P<0.05)。3家血站实验室(C、F、H)使用单检核酸检测系统的鉴别阳性�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 collection 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 laboratories 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%,respectively.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 concordance 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

关 键 词：血站 血液检测 质量监测指标体系 

分 类 号：R457.1[医药卫生—治疗学] R446[医药卫生—临床医学]