六西格玛在临床化学项目分析质量上的应用

摘要

目的 探讨不同来源的允许总误差(TEa)导出的西格玛(σ)度量在评价临床化学分析项目质量上的重要性.方法 应用5种不同的TEa作为质量目标,2017年卫生部临检中心室间质评的结果作为偏倚及2017年室内质控数据累积的变异系数(CV)作为不精密度来计算2个批次的σ值,评估不同质量标准的σ度量在临床化学项目分析质量上的差异;并计算项目的质量目标指数(QGI),为实验室检测能力的改进提供方案.结果 由澳大利亚室间质评标准和生物学变异导出的“适当的”质量规范得出的σ值相对较低,σ≥6的比例为10％～35％;德国RiliBAK标准和美国CLIA'88标准得出了较高的σ值,σ≥6的比例为50％～80％;国家卫生行业标准得出的σ值相对适中,σ≥6的比例为35％;ALB、UREA、CREA、Ca、PHOS、TG及LDH需要在精密度方面实施改进措施,TP和GLU则需同时对精密度和正确度进行质量改进.结论 6σ理论能够对检验项目的性能进行合理评估,对实验室检测能力的持续改进具有重要指导价值.%Objective To investigate the importance of allowalble total error (TEa) source in sigma metrics in evaluating the analytical quality of clinical chemical analytes.Methods Five different allowable total errors (TEa) were used as quality goals.The data of external quality assessment in 2017 were used as bias.The cumulative variation coefficient (CV) of internal quality control data was used as imprecision.Sigma metrics of 2 runs were calculated by the application of five different standards of TEa,bias,and imprecision.And the differences of sigma metrics in clinical chemistry analytes were evaluated according to different quality standards.Even more,the quality goal index (QGI) was calculated to improve the quality of laboratory detectability.Results The sigma metrics was relatively low by the standards of Australian external quality assessment and biological variation.The proportion of more than six sigma was only between 10％-35％.The sigma metrics were relatively high by the standards of RiliBAK and CLIA'88.The proportion of more than six sigma was between 50％-80％.The sigma metrics was moderate by the National Health Industry Standard.The proportion of more than six sigma was 35％.ALB,UREA,CREA,Ca,PHOS,TG,and LDH required quality improvement in precision,while TP and GLU needed to improve precision and accuracy at the same time.Conclusion Six sigma can reasonably evaluate the performance of the analytes and has important guidance for the continuous improvement of laboratory detection ability.