六西格玛质量管理规则在罗氏电化学发光免疫分析仪检测项目质量控制中的应用

Six Sigma Quality Management for Choosing Appropriate Quality Control Rules in Roche Electrochemical Luminescence Immunoanalyzer

目的应用六西格玛(6σ)质量管理规则评价罗氏电化学发光免疫分析仪各项目检测性能水平,从而指导质量改进。方法以我国国家标准和生物学变异导出的"最佳"允许总误差(TEa)为质量规范,以2019年在罗氏Cobas e 601上测定的14个检测项目的累计在控室内质控数据计算不精密度(CV),以2019年两次卫生部室间质评偏倚数据均值作为偏倚(Bias)来源,计算σ值,应用标准化西格玛性能验证图选择合适的质量控制规则,并计算各项目的质量目标指数(QGI),分析导致其性能不佳的原因,提出优先改进方法。结果按国家标准,有8个(57%)项目的σ值> 6;按生物学变异标准,只有2个(18%)项目的σ值> 6;加权σ值后,6个(43%)项目的σ值> 6,1个(7%)项目的σ值> 5,6个(43%)项目的σ值> 4,1个(7%)项目的σ值<3。其中,AFP,CA153,CA199,T4,FT3,T3和NT-ProBNP需改进精密度,FT4需改进精密度和正确度。不同项目采用不同质控规则。结论临床实验室可综合应用合适的质量规范计算6σ度量,全面而有效地评价项目的性能指标,优化质量控制规则,保证检测项目质量。

Objective To evaluate the performance of Roche electrochemical luminescence immunoanalyzer by six sigma(6σ)quality management, choose appropriate quality control rules with sigma performance verification charts and ensure determination quality. Methods Sigma(σ)metrics were calculated, according to imprecisions, biases(Bias)and allowable total error(TEa)by Roche electrochemical luminescence immunoanalyzer. Calculate the quality objective index(QGI) of the project, analyze the causes of poor performance, and propose the priority improvement method. Results According to the national standard, values of eight(57%) projects were >6σ. According to the criteria of biological variation, value of two(18%) projects were >6σ. After weighting value of 6(43%) projects were >6σ, with 1(7%) >5σ, 6(43%) >4σ and 1(7%) < 3σ. Among them, AFP, CA153, CA199, T4, FT3, T3 and NT-ProBNP needed to improve the precision, and FT4 needed to improve the precision and accuracy. Different projects adopt different quality control rules. Conclusion The appropriate six sigma measurement can be used to analyze indoor quality control and quality evaluation data in clinical laboratory by the appropriate six sigma measurement.