【摘要】 目的探讨六西格玛(6σ)质量管理在临床定量检测中的应用及相关问题。方法 (1)收集该实验室室间质量评价(EQA)及常规检测质控标本检测结果。(2)以EQA各项目靶值百分差值的均值作为偏倚估计值;去掉离群值后计算常规检测质控标本CV%作为不精密度估计值;计算各项目σ值和质量目标指数(QGI)。(3)根据各项目的σ水平及QGI指数情况评价检测性能、判断误差类型及给出恰当的Westgard质控方法。(4)采用Excel绘制标准化σ性能验证图。结果 (1)全部项目中σ>6的项目有1项,占7.69%;σ为5~<6的项目有2项,占15.38%;σ为4~<5的项目有3项,占23.08%;σ为3~<4的项目有1项,占7.69%;σ<3的有6项,占46.15%。全部项目σ平均值为3.63。(2)分析性能未达到6σ的12个项目中,11项(91.7%)QGI指数<0.8,需优先改进检测精密度;有1项(8.33%)在0.8~1.2,需同时改善准确度和精密度。(3)除天门冬氨酸氨基转移酶外,其他项目均应使用多个质控规则组合的方法以提高误差检出率。结论 6σ质量管理用于临床定量检测简便而实用,值得推广。更多还原

【Abstract】 Objective To investigate the application of six sigma(6σ)quality management in clinical quantitative detection and its related problems.Methods(1)The laboratory external quality assessment(EQA)detection results and quality control samples routine detection results were collected.(2)The percentage difference mean of target value in each EQA item was calculated and served as the bias estimation value;after excluding the outlier values,CV% of routine quality control sample was calculated and served as the imprecision estimated value,then theσvalue in each item and quality goal index(QGI)were calculated.(3)The detection performance and judgment error type were evaluated and the proper Westgard quality control method was given according to theσlevel in each item and QGI index.(4)The standardizedσperformance validation chart was drawn by adopting Excel.Results(1)Among all items,only 1 item(7.69%)was σ>6,2 items(15.38%)were 5≤σ<6,3 items(23.08%)were 4≤σ<5,1 item(7.69%)was 3≤σ<4 and 6 items(46.15%)were σ<3.The averageσvalue of all items was 3.63.(2)Among 12 items which analytical performance did not reach 6σ,11 items had the QGI<0.8,which needed to improve the detection precision;QGI of 1 item(8.33%)was 0.8-1.2,which needed to simultaneously improve the accuracy and precision.Conclusion The 6σ quality management used in clinical quantitative detection is simple,practical and worthy of being promoted.更多还原