6δ质量管理在临床免疫检测项目质量评价中的应用  

An Application of Six Sigma Quality Management in Quality Evaluation of Clinical Immunoassay Projects

作　　者：冉桥生 蒋栋能 项贵明 刘飞 涂奠基 罗小舸 张立群 RAN Qiaosheng;JIANG Dongneng;XIANG Guiming;LIU Fei;TU Dianji;LUO Xiaoge;ZHANG Liqun(Department of Clinical Laboratory, Second Affiliated Hospital of Army Medical University, Chongqing, 400037, China)

机构地区：[1]陆军军医大学第二附属医院检验科,重庆400037

出　　处：《标记免疫分析与临床》2020年第5期892-897,共6页Labeled Immunoassays and Clinical Medicine

基　　金：重庆市技术创新与应用示范项目(编号:cstc2018jscx-msybx0060)。

摘　　要：目的采用6δ质量管理方法对临床免疫检测项目的性能进行验证和评价。方法(1)收集2018年本实验室参加国家卫生健康委临床检验中心室间质评(external quality assessment,EQA)时免疫检测项目的数据,以与靶值的偏离程度作为偏倚(bias)估计的依据,以2018年7月至2018年12月半年的室内质量控制(quality control,QC)累积变异系数(coefficient of variation,CV)作为不精密度的估计值,分别采用我国行业标准和生物学变异导出的“适当”允许总误差(allowable total error,TEa)作为质量规范,计算出δ度量值。(2)根据δ度量值评价分析项目性能并选择合适的质量控制方案;计算质量目标指数(quality goal index,QGI),查找引起项目性能不佳的原因,制定改进计划。(3)运用Origin软件绘制标准化δ性能验证图。结果(1)当选择生物学变异导出的“适当”允许总误差(TEa)计算时,δ≥6的项目有CA125、CRP;5≤δ<6的项目有TSH、总PSA、CEA、AFP、CA19-9;3≤δ<4的项目有CA15-3、IgM。当选择我国行业标准允许总误差(TEa)计算时,δ≥6的项目有FT3、AFP、RF;5≤δ<6的项目有TSH、CEA、IgA、IgG、IgM;4≤δ<5的项目有FT4、T3、T4、总PSA、CA125、C3、C4、CRP;3≤δ<4的项目有CA15-3、CA19-9。以两种质量规范的允许总误差计算,每个项目得到不同的δ度量值,对应6个不同的性能评价等级和不同的质量控制方案。(2)未达到6δ度量水平的项目需要实施改进,通过计算QGI均小于0.8,需优先改进检测精密度。(3)得到了标准化的δ性能验证图,根据性能图可直观的观测免疫检测项目的性能水平。结论选择合适的允许总误差能真实有效地对临床检验项目进行性能验证和评价,运用6δ质量管理方法有助于不断提高临床实验室质量控制水平。Objective To verify and evaluate the performance of clinical immunization projects using six Sigma quality management method.Methods(1)The data of our laboratory participating in the external quality assessment(EQA)immune testing project of the National Health Commission Clinical Laboratory Center in 2018 was collected for the study.The deviation degree from the target value was taken as the basis of the bias estimation.The cumulative coefficient of variation(CV)of indoor quality control(QC)from July,2018 to December,2018 was taken as the estimation value of imprecision.Using the“appropriate”allowable total error(TEa)derived from industry standards and biological variation in China as the quality specification,the Sigma degree value was calculated.(2)According to the Sigma measurement,the project performance was evaluated and analyzed and the appropriate quality control scheme was selected.Furthermore,the quality target index(QGI)was calculated to identify the reasons for the poor performance of the project,and an improvement plan was developed.(3)The standardized Sigma performance verification diagram was drawn by Origin software.Results(1)When choosing the“appropriate”total allowable error(tea)derived from biological variations,the items withδ≥6 were CA125 and CRP;the items with 5≤δ<6 were TSH,PSA,CEA,AFP and CA19-9;the items with 3≤δ<4 were CA15-3 and IgM.When the total allowable error(tea)of China′s industry standard was selected for calculation,the items withδ≥6 were FT3,AFP and RF;the items with 5≤δ<6 were TSH,CEA,IgA,IgG and IgM;the items with 4≤δ<5 were FT4,T3,T4,PSA,CA125,C3,C4 and CRP;the items with 3≤δ<4 were CA15-3 and CA19-9.The Sigma measurements were calculated with the allowable total error of two quality specifications.Each project had different Sigma measurements,corresponding to six different performance evaluation grades and different quality control schemes.(2)Projects that failed to reach the six Sigma measurement level needed to be improved,and by calculating

关 键 词：δ质量管理 允许总误差 变异系数 质量控制 

分 类 号：R-331[医药卫生]