医学实验室运用室内质控与能力验证数据程序化评定测量不确定度  

Programmatic evaluation of measurement uncertainty using IQC and PT data in medical laboratory

作　　者：丁海峰 张琪[1] 魏鹏飞 周剑涛 Hai-Feng DING;Qi ZHANG;Peng-Fei WEI;Jian-Tao ZHOU(Wuhan Chain Medical Laboratories,Wuhan 430010,China;Department of Medical Laboratory,School of Medicine,Huanggang Polytechnic College;Zhengzhou Qianmai Beikang Medical Laboratory,Zhengzhou 450066,China)

机构地区：[1]武汉千麦医学检验实验室,武汉430010 [2]黄冈职业技术学院医药学院医学检验教研室,湖北黄冈438021 [3]郑州千麦贝康医学检验实验室,郑州450066

出　　处：《数理医药学杂志》2023年第5期346-351,共6页Journal of Mathematical Medicine

基　　金：湖北省教育厅“百校联百县”专项项目(BXLBX1265)。

摘　　要：目的 在Excel软件上建立测量不确定度的评定程序,促进医学实验室推广应用测量不确定度。方法 采用自上而下(top-down)方法,利用实验室室内质量控制(internal quality control,IQC)数据和能力验证(proficiency testing,PT)数据,在Excel软件上分别计算由实验室室内测量数据的重复性和由误差引入的测量不确定度,再合成为标准测量不确定度,评价实验室测量值是否达到应用要求。结果 实验室运用IQC与PT数据程序化评定检测项目的测量不确定度,满足ISO15189认可标准要求。结论 选择top-down法,运用IQC与PT数据评定分析测量阶段的测量不确定度是可行的,且在Excel软件上能便捷地计算出结果,适合医学检验实验室普及应用测量不确定度。Objective To establish a procedural evaluation method of measurement uncertainty on Excel software,and to promote the popularization and application of measurement uncertainty in medical laboratories.Methods According to the“top-down”approach,using internal quality control(IQC)data and proficiency testing(PT)evaluation data,the measurement uncertainty introduced by the basis of the within-laboratory reproducibility and the uncertainty of laboratory bias was calculated respectively on the Excel software,then synthesized into the standard measurement uncertainty to evaluate whether the laboratory measurement values meet the application requirements.Results Using IQC and PT data,the laboratory quickly assessed the measurement uncertainty of quantitative test items,which met the requirements of ISO15189 accreditation standards.Conclusion It is feasible to select the“top-down”approach to evaluate and analyze the measurement uncertainty in the measurement stage using laboratory IQC and PT data,and the results can be calculated conveniently on Excel software,which is suitable for the universal application of measurement uncertainty in medical laboratory.

关 键 词：测量不确定度 医学实验室 EXCEL软件 室内质量控制 能力验证 

分 类 号：R197.32[医药卫生—卫生事业管理]