西格玛度量及质量目标指数在常规生化质量评价中的应用

Application of sigma measurement and quality goal index in routine chemistry tests

目的:应用西格玛(σ)性能验证图评价常规生化检测项目性能,结合质量目标指数(QGI)查找性能不佳的原因,为提高检验质量提供参考。方法:收集本院2017年全国常规化学室间质量评价(EQA)和室内质控数据,采用卫生行业标准WS/T406-2012的允许总误差(TEa),使用检验医学信息网软件,计算σ值,绘制σ性能验证图,评价检验项目分析性能并选择适当的质量控制规则。计算质量目标指数(QGI),查找性能不佳的主要原因。结果:22个项目中,σ值≥6、5、4、3、2者分别占13.64%、13.64%、9.09%、31.82%、31.82%。在σ值低于6的19个项目中,14个项目(占73.68%)需要优先改进精密度。结论:σ性能验证图和QGI结合能更全面有效地评价常规生化项目的性能指标,有助于实验室发现问题,持续改进检验质量。

Objective To evaluate the performance routine chemistry using sigma verification of performance and find the cause of poor performance through the quality goal index(QGI)so as to provide a rectification direction for improving the quality.Methods The data were collected from the National External Quality Assessment of routine chemical tests and internal quality control in the Hunan Prevention and Treatment Center for Occupational Diseases during 2017.The total allowable errors(TEa)was defined according to the health industry standard WS/T406-2012.The performance of the test items was evaluated by using the software operation provided by the laboratory medical information network.The sigma values were calculated by using these data and the sigma of verification performance chart were drawed to select appropriate quality control rules.For projects withσvalue<6,the QGI values were calculated to find out the main reasons for poor performance.Results The percent was 13.64%,13.64%,9.09%,31.82%and 31.82%for the 22 analysis items withσvalue≥6,5,4,3 and 2 respectively.In the 19 analysis items which theσvalue did not reach 6,14 analysis items need precision improvement.Conclusionσmeasurement and QGI can be used to evaluate the performance indexes of routine biochemical projects more comprehensively and effectively,and is helpful for the laboratory to find problems and take measures to continuously improve the quality of inspection.