6σ理论在血液分析仪质量控制中的应用探索  

An assessment of six sigma for hematology analyzer using quality control data from Shanghai local internal quality control surveys

作　　者：胡晓波[1] 季慧峰[1] 姚文瑛[1] 熊立凡[2] 金大鸣 

机构地区：[1]上海交通大学医学院附属第三人民医院检验科,上海201900 [2]上海交通大学医学院附属仁济医院检验科,上海200001 [3]上海市临床检验中心,上海200126

出　　处：《检验医学》2007年第6期707-710,共4页Laboratory Medicine

摘　　要：目的通过对血液分析仪质量控制(QC)数据的σ值研究,探讨如何应用σ值来判断方法性能和选择QC规则。方法从我院2005至2006年Sysmex K-4500和Sysmex KX-21参加上海地区血液分析仪室内QC的数据中抽取12次,采用公式σ值=[允许总误差(TEa)-偏倚(bias)]/变异系数(CV),按照美国临床实验室改进修正法案(CLIA′88)允许误差标准,得出各项的σ值。同时与仪器厂商、血液分析仪组和Sysmex组σ值比较。结果Sysmex K-4500白细胞(WBC)计数、红细胞(RBC)计数、血红蛋白(Hb)量、红细胞压积(Hct)和血小板(PLT)计数等项目σ均值分别为11.09、7.35、11.68、6.01和9.35,Sysmex KX-21分别为8.51、7.55、10.40、6.39和8.55,Sysmex组分别为4.37、3.81、5.63、2.18、5.33,与我院2台仪器比较σ值差异有统计学意义(P<0.01)。结论本实验室Sysmex K-4500和Sysmex KX-21血液分析仪的σ值已达6.0以上,采用13.0s(n=2)QC规则就能满足质量要求,但应注意仪器校准和分析前、后质量问题。Objective To evaluate the six sigma（6σ） quality management of hematology analyzer through quality control data, and to explore how to choose quality control rules and performance ways of judgment by 6σ mettle. Methods The 6σ mettle values of each parameter were obtained out of the 12 batches of internal quality control data from Sysmex K-4500 and KX-21 hematology analyzers in our hospital participating the Shanghai local hematology analyzers quality control during the years of 2005 -2006, based on the formula of σ = （TEa- bias）/eoeffieient of variation（CV） and in accordance with the Clinical Laboratory Improvement Amendments （CLIA） 88＇s allowable errors. And these σ metric values were compared with those from manufacturers and the same types of Sysmex＇s analyzer groups. Results The 6σ mettle values of white blood cell count, red blood cell count, hemoglobin, hematocit and platelet count were 11.09,7.35,11.68,6.01,9.35 and 8.51,7.55,10.40,6.39,8.55 from our K-4500 and KX-21 instruments, respectively, while 4.37,3.81,5.63,2.18,5.33 from Sysmex＇s groups. There were significant differences （ P 〈 0.01 ） in σ metric values between the instruments in ours and Sysmex＇s groups. Conclusions The σ metric values from Sysmex K- 4500 and KX-21 in our hospital have been over 6, 0 and hence the single quality control rule of 13.0. （ n = 2 ） could satisfy the quality requirements. But the instrument calibration and any problems occurring in preanalysis and postanalysis should be noted closely.

关 键 词：6σ 质量管理 质量控制 血液分析仪 

分 类 号：R195.1[医药卫生—卫生统计学]