【摘要】 目的应用六西格玛(6σ)质量管理方法定量分析临床实验室常规化学检测项目,评价其检测性能,并结合质量目标指数(QGI)查找检测水平不佳的原因,指导质量改进。方法收集该室2017年京津冀盲样常规化学检测结果,以各项目靶值百分差值的均值作为偏倚估计值,以室内质量控制6个月累积在控变异系数作为不精密度估计值,以国家标准和卫生行业标准中的允许总误差作为质量规范,根据检验医学信息网提供的软件计算σ度量值和绘制σ性能验证图,并计算质量目标指数。结果 23个常规生化检测项目中,采用国家标准时,30.44%(7/23)检验项目性能大于6σ,26.09%(6/23)检验项目的分析性能在σ<3水平,平均σ值为4.78。在未达6σ的16个检验项目中,7个项目需优先改进精密度,5个项目需优先改进正确度,4个项目精密度和正确度可进一步提高。当使用更严格的卫生行业标准时,有10个检验项目σ值低于3,没有达到6σ水平的检验项目,平均σ值为3.03。结论 6σ方法可以有效地应用于临床常规化学的质量管理,指导实验室项目的持续改进,值得推广。更多还原

【Abstract】 Objective Using the six sigma technique to quantitatively analyze the routine clinical chemistry measurements,evaluate the laboratory performance and find the orientation of improvement by the quality goal index(QGI).Methods Data were collected from the results of Beijing-Tianjin-Hebei blind sample testing of clinical chemistry in our laboratory in 2017.The mean percentage difference of target values of each item was calculated as the estimation of bias and the accumulative in-control coefficient of variation(CV)from the past six months of internal quality control was recognized as imprecision.TEa was allowable total error derived from the national standards or the health industry standards.Sigma values and Sigma Quality Assessment Charts were obtained from the software provided in the clinet network.The QGI values were calculated according to a specific function.Results Among the 23 routine clinical chemistry testing items,30.44%(7/23)of items were scoredσ>6 and 26.09%(6/23)were scored under 3 with meanσvalue of 4.78 when using the national standards.Among the 16 items which scores did not reach 6σ,7 and 5 out of 23 needed to improve the precision and trueness of the tests,respectively based on the QGIs.Four items′quality might improve greatly if both the precision and trueness of the test be improved.When using the much stricter health industry standards,no item reached the 6σlevel,there were 10 items scored under 3 and mean value was 3.03.ConclusionSix sigma techniques could be effectively applied into the quality management of routine clinical chemistry measurements,it could facilitate the continuous improvement of laboratory and deserved promotion.更多还原