标准化西格玛性能验证图在常规生化项目性能评价中的应用

Application of Standardized Sigma Performance Verification Chart in Performance Evaluation of Routine Biochemical Testing Projects

目的应用标准化西格玛验证图评估实验室常规生化检测项目性能水平。方法选取2021年4月室间质量评价(EQA)回报结果中偏倚绝对值的平均值作为项目的偏倚估计,选取3个月室内质控累积在控变异系数作为不精密度估计,采用卫生行业标准WS/T 403-2012的允许总误差作为项目质量规范,绘制标准化西格玛性能验证图。对σ<6的项目,依据质量目标指数(QGI),确定需要优先改进的方向。结果尿酸、天门冬氨酸氨基转移酶、碱性磷酸酶、α-羟丁酸脱氢酶、胆碱酯酶共5个项目达到世界一流水平(σ≥6),丙氨酸氨基转移酶为优秀(5≤σ<6),甘油三脂、总胆红素为良好(4≤σ<5),钠、胆固醇、肌酸激酶、γ-谷氨酰基转移酶为临界(3≤σ<4),钾、氯、肌酐、钙、磷、葡萄糖、尿素氮、总蛋白、白蛋白、高密度脂蛋白胆固醇、淀粉酶、乳酸脱氢酶、铁共13项检测水平为欠佳或不可接受(σ<3)。根据GQI值提示,5个项目需优先改进精密度,11个项目需优先改进偏倚,4个项目需同时改进精密度和偏倚。结论标准化西格玛性能验证图可显示各检测项目的σ水平情况,方便实验室正确、客观地了解检验项目的性能水平。

Objective To apply the standardized sigma verification chart to evaluate the performance level of laboratory routine biochemical testing items.Methods The average value of the absolute value of bias in the report results of EQA in April 2021 was selected as the bias estimation of the project,and the cumulative in-control coefficient of variation of indoor quality control in 3 months was selected as the imprecision estimation.The allowable total error of health industry standard WS/T 403-2012 was adopted as the project quality standard,and the standardized sigma performance verification chart was drawn.For projects withσ<6,according to the quality goal index(QGI),determine the priority improvement direction.Results UA,AST,ALP,α-HBDH and CHE reached the world-class level(σ≥6),ALT was excellent(5≤σ<6),TG and TBIL were good(4≤σ<5),Na,CHO,CK andγ-GT were critical(3≤σ<4),and the detection levels of K,CL,CREA,CA,P,GLU,UREA,TP,ALB,HDL-C,AMY,LDH and Fe were poor or unacceptable(σ<3).According to GQI value,5 projects need to improve precision first,11 projects need to improve bias first,and 4 projects need to improve precision and bias at the same time.Conclusion Standardized sigma performance verification chart can show theσlevel of each test item,which is convenient for laboratories to know the performance level of test items correctly and objectively.