西格玛性能验证图在血液脂类项目性能评价中的应用

Application of sigma performance verification in performance evaluation of blood lipid test items

目的用西格玛性能验证图评价江苏大学附属医院医学检验科实验室血液脂类项目的检测性能并指导改进方向。方法采用江苏大学附属医院医学检验科实验室2016年室内质量控制数据计算变异系数;采用江苏大学附属医院医学检验科实验室2016年全国血液脂类室间质评结果计算偏倚;采用卫生和计划生育委员会室间质评中的允许总误差和卫生行业标准(WS/T 403-2012)中的允许总误差;通过6西格玛管理软件计算血液脂类项目西格玛值并绘制性能验证图,最后计算质量目标指数以指导检测项目改进方向。结果血液脂类项目中低密度脂蛋白胆固醇(LDL-C)(σ=9.85)和脂蛋白a(LPa)(σ=6.45)2个项目性能达到世界一流水平;载脂蛋白B(APOB)(σ=5.70)的性能优秀;三酰甘油(TG)(σ=4.01)、高密度脂蛋白胆固醇(HDL-C)(σ=4.09)和载脂蛋白A1(APOA1)(σ=4.72)3个项目性能良好;总胆固醇(CHOL)(σ=3.30)性能处于临界;LDL-C和LPa无需改进精密度和准确度,可使用13s(N=2,R=1)质控规则满足性能要求;APOA1、APOB、TG、HDL-C需要优先改进准确度,CHOL性能处于临界需要优先改进精密度,同时选择13s22sR4S41s8x(N=4,R=2或N=2,R=4)方可进一步提升性能。结论西格玛性能验证图可以帮助实验室分析各检测项目性能水平,提供参考的质控规则以及优先改进方向。

Objective To evaluate the detection performance of blood lipids items in our laboratory with sigma performance verification chart and to guide the improvement. Methods The coefficient of variation （ CV ） was calculated using the laboratory internal quality control data in 2016.The bias was calculated using the results of the national blood lipids external quality assessment in 2016.The total error allowable in external quality assessment and in health industry standard （WS/T 403-2012） were adopted as the quality specification;calculate sigma value of blood lipid items with 6 sigma management software and draw a performance verification chart;and finally calculate the quality target index to guide the detection items to improve the direction. Results The performance of the two blood lipids items LDL-C （σ=9.85） and LPa （σ=6.45） reached the first-class performance in the world.The APOB （σ=5.70） reached the excellent performance.The three items of TG （σ=4.01）,HDL-C （σ=4.09） and APOA1 （σ=4.72） performed well.The CHOL （σ=3.30） performance was at a critical state.LDL-C and LPa did not need to improve the precision and accuracy,and 1 3s （ N= 2,R=1） Quality control rules to meet performance requirements;APOA1,APOB,TG,HDL-C needed to improve accuracy,CHOL performance at a critical state needed to improve precision,while selecting 1 3s 2 2s R 4S 4 1s 8 x （N=4,R=2 or N=2,R=4） could further improve performance. Conclusion Sigma performance verification maps can help laboratories analyze the performance levels of each test item,provide quality control rules and prioritize improvements.