目的

建立能满足临床数据审核需求的安全有效的临床化学实验室自动审核系统。

方法

复旦大学附属中山医院检验科以罗氏中间体软件IT3000为核心，整合本院自行开发与维护的实验室信息系统(laboratory information system, LIS)，并运用分析仪器搭建临床化学实验室自动审核系统，以评价2012年至2015年期间自动化审核系统使用前后周转时间(turn around time，TAT)合格率变化趋势；同时，分析自动审核系统使用前后降低检测报告的差错率（以报告解除确认率表示）的效果。

结果

在2012年1至3月搭建起由LIS、中间体软件、检测仪器和数据审核人员四大部分组成的本院自动审核系统；同时，建立项目匹配、仪器报警、多次结果比较、限值管理、质控规则、逻辑规则六层数据审核策略及审核报警警示系统。用于分析自动审核系统使用前2012年第一季度TAT超时率为0.281% (238/84729)，2013年、2014年、2015年第一季度超时率分别为0.058% (73/126605)、0.051%(86/169403)、0.056% (96/171821)，较2012年第一季度分别下降42%、82%、80%。未使用自动化审核系统的2012年第一季度报告解除确认率为0.16% (135/84729)，2013年、2014年、2015年第一季度解除确认率分别为0.07% (87/126605)、0.03% (51/169403)、0.08% (142/171821)，较2012年第一季度分别下降57%、81%、48%。

结论

临床化学实验室自动审核系统有效的增强工作效率，提高了TAT合格率，降低了报告差错率。

Objective

To establish a safe and effective Auto-validation system for meeting the requirements of clinical data validation in clinical chemistry laboratories.

Methods

The Clinical Laboratory of Zhongshan Hospital, affiliated to Fudan University used Roche′s middleware IT3000 and integrated a series of other software and hardware [such as Laboratory information system(LIS), analyzers, Data flow, quality control and sample flow monitoring] to create an auto-validation system. The trend in turnaround time(TAT) pass rate from 2012 to 2015, before and after the adoption of the auto-validation system, and the reduction of error rates were evaluated.

Results

An auto-validation system had been adopted since Jan. 2012, which comprises of LIS(developed and maintained by Zhongshan Hospital in 3 months), middleware, clinical analyzers and data validation staff members. The auto-validation and alert strategies includes six elements: test matching, instrument alarm,multiple results comparison, limit value management, quality control rules, and logical rules. Before using the autovalidation system, the TAT overtime rate in the first quarter of 2012 was 0.281% (238/84729), while that in the same quarter of 2013, 2014, and 2015 was 0.058% (73/126605), 0.051% (86/169403), and 0.056% (96/171821)respectively, which represented a decrease of 42%, 82%, and 80%. The confirmation rate of report cancellation in the first quarter of 2012 was 0.16% (135/84729), and dropped 57%, 81%, and 48% in 2013, 2014, and 2015 to 0.07% (87/126605)，0.03% (51/169403)，0.08% (142/171821).

Conclusion

The auto-validation system has highly sped up the result validation process and effectively reduced report error rate.