临床化学自动审核规则的建立及应用

Establishment and application of automatic audit rules in clinical chemistry

目的建立一套临床化学检测结果的自动审核规则,运用计算机系统实现检测结果的自动审核确认。方法按照美国临床实验室标准化委员会颁布的AUTO10-A临床实验室检验结果的自动审核指南,结合患者的基本信息、各检测项目的医学决定水平、检测项目在本实验室的方法学性能、检验项目之间的关系以及实验室的质量控制水平,设定临床化学审核规则,运用Data Manager 2中间件系统对临床化学检测结果进行审核。结果我们为53项生化检测项目建立了540条自动审核规则,对16 593份常规化学样本进行285 415项测试,结果显示,自动审核通过的样本为14 289份,其中门诊样本自动审核通过率为97%,住院样本自动审核通过率为80%,总的自动审核通过率为86%。报告周转时间,从183 min降至131 min,缩短28.4%。结论制定合理有效的临床化学审核规则,利用DM2软件的自动审核功能,能够充分发挥全自动流水线的使用效率,缩短TAT,提高临床检验分析后的质量控制水平。

Objective To establish a set of automatic audit rules for clinical chemistry test results,and use computer system to realize automatic audit and confirmation of test results.Methods The study followed the requirements of the Clinical and Laboratory Standards Institute(CLSI)AUTO10-A and combined the basic data of patients,medical decision levels,methodological performance,relationship between the test items,and quality control level of the laboratory.The autoverification rules of clinical chemistry was formulated and the test results were automatically auditted by the middleware system of DM2(Data Manager 2).Results We have established 540 autoverification rules for 53 biochemical test items.285415 tests have been conducted on 16593 routine chemical samples.The results showed that 14289 samples have passed the automatically audit,accounting for 97%of outpatient samples,80%of inpatient samples,and 86%of the total.The reported turnaround time(TAT)decreased from 183 minutes to 131 minutes,which was 28.4%less.Conclusion Formulating reasonable and effective clinical chemical autoverification rules and using the automatic audit function of DM2 can fully utilize the efficiency of automated assembly line,shorten TAT and improve the post-analytical quality control.