血液分析自动审核的周期性验证及其应用适宜性评价

Periodic revalidation of autoverification for blood analysis and its suitability evaluation of application

目的对血液分析15项43条自动审核规则进行应用1年后的周期性验证,分析应用适宜性并进行完善。方法2019年8月1日至2020年1月31日我院528010份血常规检验结果,分析自动审核通过率与拦截率;随机选取其中触及自动审核规则结果拦截标本300份(共触及自动审核规则1012项次)及未触及自动审核规则结果放行标本300份共600份标本进行显微镜镜检,同时关注标本异常性状及不可接受差值(Delta check),计算假阴性率、假阳性率、真阴性率、真阳性率及自动审核通过正确率,并与自动审核规则建立时的二期验证进行率的比较。计算528010份标本中触及Delta check规则的54716份标本的假阴性率、假阳性率、真阴性率、真阳性率,并与自动审核规则建立时的二期验证进行率的比较。率的计算以显微镜镜检结果为金标准,率的比较以P<0.05为结果有显著性差异。对触及的1012项次自动审核规则逐项分析假阳性及真阳性;并对其中触及原始细胞规则的108份标本按拦截条件逐条分析假阳性及真阳性。分别统计528010份标本及其中193750份门诊标本的平均TAT、中位TAT,并统计528010份标本TAT中<30、30~60、>60 min报告的百分比。分析评价规则应用适宜性,判断其是否达到最佳性能,能否满足临床与实验室需求;结合AUTO15优化完善自动审核设计流程、审核规则及应用流程。结果自动审核通过率为63.06%(332971/528010),拦截率为36.94%(195039/528010),假阴性率1.00%(6/600),假阳性率12.67%(76/600),真阴性率49%(294/600),真阳性率37.33%(224/600),通过正确率为98%(294/300)。周期性验证组的自动审核通过率、真阴性率、真阳性率及通过正确率高于二期验证组,假阴性率及假阳性率低于二期验证组;Delta check周期性验证组假阴性率、真阳性率低于二期验证组,假阳性率、真阴性率高于二期验证组,比较结果有显著性差异。528010份血常规标本平均TAT 25 min;193750份门诊血常规标本平均TAT 23 min。528010份血常规标本TAT<30、30~60、>60 min分别为83.30%(439819/528010)、8.00%(42250/528010)、8.70%(45941/528010)。结论自动审核规则应用1年后的周期性验证结果显示,本室在用的15项43条自动审核规则能够保证血液分析检验结果的准确及工作效能,具有较好的应用适宜性。

Objective To conduct periodic revalidation of the 15 items and 43 terms autoverification rules of blood analysis after 1 year of application,analyze the application suitability and make the rules improved.Methods Track the results of 528010 blood analysis samples of our hospital from August 1,2019 to January 31,2020,and analyze the pass rate and interception rate of autoverification;600 specimens in total were selected randomly for microscope examination,including 300 specimens which touched autoverification rules(1012 items of autoverification rules)and were intercepted by autoverification and 300 specimens which untouched autoverification rules and were released by autoverification.The abnormal characteristics and unacceptable Delta check of the specimens also need to be concerned at the same time.The false negative rate and false positive rate,true negative rate,true positive rate and pass correct rate of autoverification were verified and compared with the rate of the second phase verification when the autoverification rule was established.The false negative rate,false positive rate,true negative rate and true positive rate of the Delta check rule which 54716 specimens touched were calculated and compared with the second phase verification rate when the autoverification rule was established.The results of microscopic examination were used as the gold standard for the calculation of the rates,and P<0.05 was considered as a significant difference.The false positive and true positive of 1012 autoverification rules were analyzed item by item.The false positive and true positive of 108 specimens which touched blast cell autoverification rule were analyzed terms by terms.The mean TAT and median TAT of 528010 specimens and 193750 outpatient specimens were calculated respectively,and the report percentages of 528010 samples that TAT<30,30-60 and>60 min were calculated respectively.Analyze and evaluate the application suitability of autoverification rules to juge whether they meet the needs of doctors and laboratory.The design process and the rules and application process of autoverification were optimized and improved.Results The autoverification pass rate was 63.06%(332971/528010),the interception rate was 36.94%(195039/528010).The false negative rate was 1.00%(1/600),the false positive rate was 12.67%(76/600),the true negative rate was 49%(294/600),the true positive rate was 37.33%(224/600),and the correct rate was 98%(294/300).The pass rate,true negative rate,true positive rate and correct rate of the periodic reverification group were higher than the second phase verification group,the false negative rate and false positive rate were lower than that the second phase verification group.The false negative rate and true positive rate of the Delta check of periodic verification group were lower than that the second phase verification group,the false positive rate and true negative rate were higher than the second phase verification group,there were significant differences in the comparition results.The mean TAT of 528010 specimens was25 min,and the median TAT was 22 min.The mean TAT of 193750 outpatient specimens was 23 min,and the median TAT was 20 min.The report percentages of 528010 samples that TAT<30 min,30 min-60 min and>60 min were 83.30%(439819/528010),8.00%(42250/528010)and 8.70%(45941/528010),respectively.Conclusion The results of periodic revalidation of autoverification after 1 years application show that the 15 items and 43 terms autoverification rules of blood analysis could meet requirements about the accuracy and efficiency of the laboratory,and have a good suitability for application.