六西格玛质量管理在某院新引进生化系统性能评估及质量控制中的应用

The Application of Six Sigma Quality Management for the Performance Assessment of the Newly Introduced Biochemical System and Its Quality Control

目的应用六西格玛质量管理方法,对我院新引进的全自动生化分析系统贝克曼AU5800的性能验证数据进行分析,快速了解各生化项目的分析性能,设计质量控制方案,指导质量改进。方法选取21个常规生化项目,分析贝克曼AU5800在2018年10月装机时的性能验证数据,主要包括偏移(BIAS)和不精密度(CV),根据卫生行业标准WS/T403-2012规定的项目允许总误差(TEA),计算西格玛值(σ)并绘制标准化的西格玛性能验证图从而设计质控规则。同时计算所有项目的质量目标指数(quality goal index,QGI),查找σ值小于6的检验项目分析性能不佳的主要原因。结果21个常规生化项目中,分析性能σ值≥6、5、4和3者分别占23.81%、47.62%、66.67%和76.19%,全部检验项目的平均σ值为5.50;在未达六西格玛的16个检验项目中,43.75%的项目需要优先改进精密度;12.50%的项目需要优先改进正确度;有43.75%的项目需要同时改进精密度和正确度。结论新引进生化系统时,基于性能验证数据的六西格玛质量管理可以快速了解检验项目的分析性能,指导质量控制工作。

Objective By applying the Six Sigma Quality Management and analyzing the performance verification data of the newly introduced biochemical system:the fully automatic biochemical instrument AU5800,the analytical performance of the clinical biochemical quantitative testing items was acquired quickly for designing the quality control procedure and then guiding the quality improvement in the Clinical Laboratory of the Third People′s Hospital of Chengdu.Methods By selecting 21 clinical biochemical tests,we collected the performance verification data,including the bias value(BIAS)and imprecision(CV).The sigma metrics were calculated according to the allowable total error(TEA)of WST-2012 and the normalized sigma evaluation chart was graphed in order to develop the quality control rules.The quality goal index(QGI)was also calculated to investigate the main reasons causing the poor performance(withσ<6).Results Of the 21 regular clinical biochemical tests,23.81%,47.62%,66.67%and 76.19%hadσvalues over 6,5,4 and 3,respectively.The average sigma metric of all tests was 5.50.Of all the analyses less than 6σmetric,43.75%needed to be improved due to the imprecision.12.5%needed to be improved due to the accuracy,The rests required the improvment for both.Conclusion Based on the performance verification data of the new biochemical system,the Six Sigma Quality Management can be used for quick acquisition of the quality performance and guiding the quality control procedure.