6σ性能验证图在医学检验质量管理中的应用实践

The Application Verification of the Performance of 6 Sigma in Quality Management of Medical Laboratory

目的探讨6σ性能验证图在医学检验检测系统性能评价及室内质量控制中的应用,合理应用质量目标指数(QGI)提高临床检验质量。方法利用实验室常规化学检测项目的室内质控累积变异系数作为实验室内不精密度的估计值,利用卫生部室间质量评价正确度验证和常规化学室间质量评价数据作为偏倚的估计值。采用卫生行业标准WS/T 403-2012的允许总误差作为质量规范,按公式Sigma=(TEa%-|Bias%|)/CV%计算σ值,用检验医学信息网上的软件绘制常规化学22个项目的σ性能验证图,评价检测系统性能,并以此设计个性化质量控制方案。σ﹤6的项目计算QGI值,指导改进方案。结果常规化学22个项目的平均σ值为5.78,其中碱性磷酸酶、尿酸、三酰甘油、钾、γ-谷氨酰基转移酶、钠、肌酸激酶、淀粉酶、肌酐、白蛋白、乳酸脱氢酶11个项目σ≥6.0性能达到世界一流标准,天门冬氨酸氨基转移酶、钙2个项目4≤σ﹤5性能达到良好标准,总胆固醇、磷、丙氨酸氨基转移酶、总胆红素4个项目3≤σ﹤4性能为临界标准,氯、总蛋白、血糖、镁、尿素5个项目σ﹤3性能为欠佳到不可接受。结论6σ性能验证图是一个非常好的实验室检测系统过程能力评估评价工具,可根据σ值评估其分析性能,采取相应的质量控制规则,提升误差检出概率的同时,降低假失控概率,使其更好的满足临床实验室的质量要求。

Objective To explore the application of 6 Sigma in the performance evaluation and internal quality control of medical laboratory testing system,and to improve the quality of laboratory testing by reasonable application of quality goal index(QGI).Methods The accumulated coefficient of variation(CV)of laboratory routine chemical testing analytes was used as the estimation of the imprecision,and the accuracy of external quality assessment(EQA)and routine chemical data were used as the bias estimation.The total allowable errors of the health industry standard WS/T 403-2012 was used as the quality specification.Theσwas calculated according to the formula:Sigma=(TEa%-Bias%|)/CV%.Sigma verification of performances of 22 analytes of routine chemistry were drawn with the software of the clinet,and the testing system was then evaluated.When the analytes ofσ<6,value the QGI was calculate and to further guide the improvement plan.Results Theσaverage value of 22 analytes was 5.78.There were 11 analytes,including ALP,UA,TG,K,GGT,NA,CK,AMY,CREA,ALB,LDH hadσ≥6,reaching the world-class standard.AST,CA analytes had 4≤σ<5,reaching a good standard.CHO,P,ALT,TBIL analytes had 3≤σ<4,reaching the critical standard.CL,TP,GLU,MG,UREA analytes hadσ<3,which was not acceptable.Conclusion Sigma performance verification is a very good tool for evaluating the process capability of laboratory testing system.It can evaluate the superiority of analytical performance according toσand adopt the recommended quality control rules to improve the detection probability of errors and reduce the probability of false runaway,so to better meet the quality requirement of clinical laboratories.