六西格玛和质量目标指数在血细胞分析仪质量管理中的应用  

Application of six sigma and quality target index in quality management of blood cell analyzer

作　　者：李薇[1] 赵启波 李建英[1] 张时民[1] 吴卫[1] LI Wei;ZHAO Qibo;LI Jianying;ZHANG Shimin;WU Wei(Department of Clinical Laboratory,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences,Beijing 100730,China;Department of Clinical Laboratory,the First People′s Hospital of Zhaotong,Zhaotong,Yunnan 657000,China)

机构地区：[1]中国医学科学院北京协和医院检验科,北京100730 [2]云南省昭通市第一人民医院检验科,云南昭通657000

出　　处：《国际检验医学杂志》2020年第18期2223-2227,共5页International Journal of Laboratory Medicine

基　　金：中国医学科学院医学与健康科技创新工程资助项目(2018-12M-AI-002)。

摘　　要：目的应用六西格玛(6σ)和质量目标指数(QGI)对11台血细胞分析仪相关检测项目进行质量管理,对仪器性能做出正确评价,指导质量改进。方法收集2017年实验室室内质控在控数据,计算变异系数;用配套校准物校准仪器与靶值的偏差,计算不准确度。依据国家卫生行业标准WS/T 406-2012,评价11台血细胞分析仪对白细胞计数(WBC)、红细胞计数(RBC)、血红蛋白(Hb)、平均红细胞体积(MCV)、血细胞比容、血小板计数(PLT)的分析性能,并计算σ和QGI,查找导致性能不佳的主要原因,对仪器进行整体评价。结果仪器9检测各项目的性能均能达到世界一流水平;仪器11在评价中出现检测RBC的σ<2,属于不可接受状态,检测MCV处于欠佳状态,检测Hb处于临界状态;仪器4、5、7、8、9检测各项目的性能表现为世界一流、优秀或良好;仪器1、2、3中,除了仪器2在评价中出现Hb的检测性能处于临界外,其余各项目的检测性能均表现为世界一流、优秀或良好;仪器10总体性能一般,检测WBC、PLT、MCV的性能为良好,检测RBC、Hb的性能为临界。结论6σ和QGI是对血细胞分析仪整体性能评价的重要指标,能判断仪器对各项目的检测质量水平,适用于临床实验室。Objective Apply six sigma(6σ)and quality target index(QGI)to carry out quality management on the related detection items of 11 blood cell analyzers,make correct evaluations of instrument performance,and guide quality improvement.Methods Collected the in control data of laboratory indoor quality control in 2017 and calculated the coefficient of variation.Calibrated the deviation between the instrument and the target value with the matching calibrator,and calculated the inaccuracy.According to the national health industry standard WS/T 406-2012,the analytical performance of 11 blood cell analyzers on white blood cell count(WBC),red blood cell count(RBC),hemoglobin(Hb),mean red blood cell volume(MCV),hematocrit and platelet count(PLT)was evaluated,and calculatedσand QGI,found out the main reason of poor performance,and evaluated the instrument as a whole.Results The performance of each item detected by instrument 9 could reach the world first-class level.In the evaluation of the instrument 11,the detection of RBC(σ<2)was unacceptable,the detection of MCV was in a poor state,and the detection of Hb was in a critical state.The performance of the instrument 4,5,7,8,9 detected each item was world first-class,excellent or good.Among the instrument 1,2 and 3,except for the Hb detection performance of the instrument 2 was critical in the evaluation,the detection performance of other items were world first-class,excellent or good.The overall performance of the instrument 10 was average,the detection performance of WBC,PLT and MCV were good,and the detection performance of RBC and Hb were critical.Conclusion 6σand QGI are important indicators for evaluating the overall performance of blood cell analyzer,which could judge the detection quality of each item of the instrument,and which is suitable for clinical laboratories.

关 键 词：六西格玛 质量目标指数 血细胞分析仪 

分 类 号：R446.113[医药卫生—诊断学]