六西格玛质量管理方法在临床生化检测的质量改进中的应用  

Application of 6σquality management method in quality improvement of clinical biochemical tests

作　　者：徐曼[1] Xu Man(Nanyang Central Hospital,Nanyang 473000,Henan,China)

机构地区：[1]南阳市中心医院医学检验科,河南南阳473000

出　　处：《四川生理科学杂志》2024年第3期473-476,680,共5页Sichuan Journal of Physiological Sciences

摘　　要：目的:应用六西格玛度量值计算评估临床生化检验项目的室内指控数据,科学合理的建立个性化质控方案,指导改进.方法:收集本科室的临床生化25个项目两个水平室内质控累积数据,收集每年三次国家卫生健康委室间质评数据,计算每个项目的平均偏倚,以卫生行业标准、国家标准及室间质量评价标准的允许总误差来计算西格玛值.绘制标准化西格玛性能验证图,并计算质量目标指数,设计质控方案,明确下一步改进方向.结果:2019年室内质控评估,25个项目中,σ≥6(世界一流)的有4 项占16%;5≤σ<6(优秀)有1项,为甘油三酯(TG),占4%;4≤σ<5(良好)的项目有4项,占16%;3≤σ<4(临界)的项目有9项,占36%;3≤σ<2(欠佳)的项目有6项,占24%;σ<2(不可接受)的项目有1项为总蛋白(TP),占4%.根据质量目标指数结果显示有20项需要改进精密度,1 个项目需要改进精密度加准确度.改进后,评估 2020 年数据,不可接受项目数为零,7 个项目提高至性能状态良好的水平.结论:西格玛质量管理方法对临床生化项目检测提升有重要的作用,可以科学指导实验室临床生化项目的质量持续改进.Objective:To evaluate the clinical biochemical test items by applying the Sigma quality management method,establish a scientific and reasonable personalized quality control program,and guide the improvement.Methods:The cumulative data of two-level internal quality control of 25 items of clinical biochemistry in Department of Medical Laboratory of Nanyang Central Hospital were collected,and the average bias of each item was calculated from National Health Commission EQA data three times per year,The Sigma value was calculated according to the allowable total errors of health industry standards,national standards,and external quality assessment standards.The standardized Sigma performance verification chart was drawn and the quality objective index was calculated.Results:The results of 2019 showed that,4 items withσ≥6,account for 16%;1 item with 5≤σ<6,account for4%;4 items with 4≤σ<5,account for 16%;9 items with 3≤σ<4,account for 36%;6 items with 3≤σ<2,account for 24%;1 items withσ<2,account for 4%.According to the quality objective index,20 items need to be improved in precision priority,and 1 item needs to be improved in precision plus accuracy priority.After improvement,the number of unacceptable items is zero.7 items had improved in good condition.Conclusion:Sigma’s quality management method can effectively improve the performance of clinical biochemical tests,and can guide continuous quality improvement.

关 键 词：六西格玛 质量控制 质量目标指数 质量改进 

分 类 号：R197.32[医药卫生—卫生事业管理]