临床实验室传染病八项报告自动审核系统的建立和优化

Establishment and optimization of automatic review system for eight report items of infectious diseases in clinical laboratory

目的建立和优化传染病八项报告的自动审核系统。方法依据美国临床和实验室标准协会(CLSI)发布的AUTO-15及国家卫健委发布的WS/T 616-2018,基于中间件(infinity)及实验室信息系统(LIS)建立传染病八项结果的自动审核规则体系。采用质量控制、标本状态、仪器报警、灰区范围、常规模式以及历史数据对比(Delta check)六大规则对传染病八项检测结果进行自动审核判断。通过人工审核与自动审核相互比对,验证自动审核系统的有效性,并对该系统进行再次优化和验证,以实现该项目的自动审核。结果建立包括质量控制、标本状态、仪器报警、灰区范围、常规模式以及历史数据对比共六部分的自动审核规则体系。自动审核的敏感性和特异性分别为87%和95%,阳性预测值和阴性预测值分别为88%和95%。调整审核规则后,2022年传染病八项报告审核通过率从39%上升至85%,周转时间(TAT)从原来的209(52,215)min缩短到141(83,149)min,审核人员由2名减至1名,将因仪器异常导致的两对半结果、HIV和TP阳性被误发等错误率降低至0.04%。结论传染病八项检测结果自动审核系统可减轻审核人员的工作强度,缩短TAT,降低报告差错风险。

Objective To establish and optimize an automatic review system for eight report items of infectious disease in clinical labo-ratory.Methods According to AUTO-15 issued by the Clinical and Laboratory Standards Institute(CLSI)and WS/T 616-2018 is-sued by the National Health Commission of China,an automatic review rule system for eight test results of infectious disease was estab-lished based on middleware(infinity)and laboratory information management system(LIS).The automatic review and judgment for the eight test results of infectious disease were carried out by using six rules:quality control,specimen status,instrument alarm,gray area range,conventional mode,and historical data comparison(Delta check).The effectiveness of the automatic review system was verified by comparing the manual results with the automatic reviews,and the test system was further optimized for validating to achieve the automatic review for the eight test items.Results An automatic review rule system consisting of six function parts(quality control,specimen status,instrument alarm,gray area range,conventional mode,and historical data comparison)was established.The sensitiv-ity and specificity of the automatic review rule system were 87%and 95%,respectively,and the positive and negative predictive values were 88%and 95%,respectively.After the manual results was adjusted with the established automatic review rules system,the approv-al rate of the eight report items of infectious disease increased from 39%to 85%in 2022,the turnaround time(TAT)time was short-ened from 209(52,215)min to 141(83,149)min,and the number of reviewers was reduced from 2 to 1.The error rate of abnormal test reports of positive results,including hepatitis B five indexes,HIV,and TP issued by the instruments was reduced to 0.04%.Con-clusion The automatic review system for eight report items of infectious disease could greatly reduce the workload of reviewers,short-en TAT,and decrease the risk of reporting errors.