应用6σ质量管理方法评价c16000全自动生化分析系统检测质量水平

Application of 6 sigma metrics in quality evaluation of c16000 automatic biochemical analysis system

目的应用六西格玛(6σ)质量管理方法评价c16000全自动生化分析系统质量水平,以促进质量改进,提高检测质量。方法收集2018年海南省人民医院c16000全自动生化分析系统42项生化检测项目的室内质量控制(IQC)和室间质量评价(EQA)数据,通过IQC数据计算累计合成变异系数(CV),根据EQA数据评估偏移(Bias),依据我国卫生行业标准WS/T403-2012要求的允许总误差(TEa)计算各检测项目的西格玛σ水平及质量目标指数(QGI),分析导致性能不佳的主要原因。通过σ性能验证图评价各项目的分析性能及应采用的质控规则。结果 42项生化检测项目中有13项(31%)检测水平≥6σ,3项(7%)检测水平为5σ~6σ,7项(17%)检测水平为4σ~5σ,8项(19%)检测水平为3σ~4σ,7项(17%)检测水平为2σ~3σ,4项(9%)检测水平<2σ。在<6σ的检测项目中,2项需优先改进正确度,21项需优先改进精密度,6项正确度和精密度均需改进。结论 6σ质量管理方法是临床生化检验项目质量控制的有效管理方法,可提示生化检测项目需要改进的方向,促进临床实验室生化检验水平的提高。

Objective To evaluate the quality of c16000 automatic biochemical analysis system by 6 sigma(σ) metrics. Methods External quality assessment(EQA) and internal quality control(IQC) data of 42 clinical chemistry assay items were collected in 2018. The biases(Bias) were calculated by EQA data,and the coefficients of variation(CV) were got by IQC data. Allowable total errors(TEa) were from Chinese health industry standard WS/T403-2012. σ scale was obtained,and the quality of growth indexes(QGI) were calculated. The clinical chemistry assay items were evaluated by σ performance verification diagram. Results In the 42 clinical chemistry assay items,13(31%) items were ≥6σ,3(7%) items were 5σ-6σ,7(17%) items were 4σ-5σ,8(19%) items were 3σ-4σ,7(17%) items were 2σ-3σ,4(9%) items were <2σ. In the items of <6σ,2 items were needed to improve accuracy firstly,21 items were needed to improve precision firstly,and 6 items were needed to improve both accuracy and precision. Conclusions 6σ quality management is an effective method for the quality control of clinical chemical assay items. It can point out the quality improvement aspect and improve the analysis level.