目的:建立常规出凝血检验项目结果自动审核规则,为临床实验室提高检验结果审核质量和效率提供参考.方法:收集2020年1-3月期间解放军总医院第一医学中心等8家医院检验科的24 510份枸橼酸钠抗凝常规出凝血检测标本,根据随机抽样法将其分为规则建立组和规则验证组,规则建立组血标本6 670份,其中差值检查2 056份;规则验证组血标本17 840份,其中差值检查3 210份.使用Stago STA R Max全自动血凝分析仪及配套试剂检测凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、纤维蛋白原(Fib)、凝血酶时间(TT)、D-二聚体(DD)和(或)抗凝血酶(AT)活性.以人工审核结果为标准,计算两组自动审核与人工假阴性率(无效审核)、假阳性率(无效拦截)、通过率、阳性符合率、阴性符合率、审核一致率和标本周转时间(TAT).结果:建立的自动审核规则及规则应用流程,涉及室内质量控制、报警信息、自动审核范围、危急值和差值检查.规则建立组单个项目通过率为82.6%~92.4%,总体通过率为73.8%,自动审核与人工审核结果一致率为98.2%,阳性符合率和阴性符合率分别为24.4%和73.8%.规则验证组单个项目通过率为86.4%~91.5%,总体审核通过率为71.5%.模拟应用自动审核规则,8家医院中两家医院单位的平均TAT分别缩短1.5 h和2.1 h.结论:应用常规出凝血自动审核规则能够使人工审核工作量减少,明显缩短TAT,提高实验室工作效率.
Objective:To establish auto verification rules for the routine coagulation assays,and to provide reference for clinical laboratories to improve the quality and efficiency of results verification.Methods:A total of 24,510 specimens of sodium citrate anticoagulation routine coagulation test from the laboratory departments of eight hospitals including the First Medical Center,Chinese PLA General Hospital during January to March 2020 were collected and randomly divided into a rule establishment group and a rule verification group,with 6,670 specimens in the rule establishment group,including 2,056 Delta checks,and 17,840 specimens in the rule validation group,including 3,210 Delta checks.The activities of prothrombin time(PT),activated partial thromboplastin time(APTT),fibrinogen(Fib),thrombin time(TT),D-dimer(DD)and/or antithrombin(AT)were detected by Stago STA R Max automatic coagulation analyzer and supporting reagents.Taking the manual verification results as the standard,the auto verification and manual false negative rate(invalid verification),false positive rate(invalid interception),pass rate,positive coincidence rate,negative coincidence rate,verification consistency rate and specimen turnaround time(TAT)of the two groups were calculated.Results:The auto verification rules and the application process were preliminarily established,including internal quality control,alarm information,auto verification scope,critical value and deviation value inspection.In the rule establishment group,the single item pass rate was 82.6%-92.4%,and the overall pass rate was 73.8%.The consistency rate between auto verification and manual verification was 98.2%,and the positive coincidence rate and negative coincidence rate were 24.4%and 73.8%,respectively.In the rule verification group,the single item pass rate was 86.4%-91.5%,and the overall review pass rate was 71.5%.By simulating the application of auto verification rules,the average TAT of two hospitals among the eight hospitals was shortened by 1.5 hours and 2.1 hours,respectively.Conclusion:The application of auto verification rules can reduce workload of manual verification,and significantly shorten the TAT,and improve the report efficiency of the laboratory.