基于σ值的血细胞分析质量控制规则的选择与应用  

The selection and application of quality control rules for blood cell analysis based on the value of sigma value

作　　者：黎海生[1] 田若男 杨悦林[1] 赵晓丽[1] 赵丽芝[1] LI Haisheng;TIAN Ruonan;YANG Yuelin;ZHAO Xiaoli;ZHAO Lizhi(Department of Laboratory Medicine,the Frist People′s Hospital of Kunming,Kunming,Yunnan 650011,China)

机构地区：[1]云南省昆明市第一人民医院检验科,650011

出　　处：《检验医学与临床》2018年第13期1899-1902,共4页Laboratory Medicine and Clinic

摘　　要：目的探讨如何运用σ值为血细胞分析检验项目选择合适的室内质量控制(质控)规则。方法收集该院2016年1-12月的血细胞分析项目室内质控累积变异系数(CV)作为测量不精密度的估计值;收集2015年第2次和2016年两次参加原国家卫生和计划生育委员会临床检验中心全血细胞计数室间质评的百分差值作为偏移的估计值,以生物学变异导出要求的TEa作为标准,依照公式σ=(TEa-|Bias|)/CV,求出各项目的σ值。根据σ值利用Westgard西格玛规则为临床检验室的血细胞分析项目选择适当的室内质控规则。结果采用基于生物学变异TEa的性能规范,WBC的σ值达到6σ质量水平,选用13s规则(N=3,R=1),Hb的σ值达到5σ质量水平,选用1_(3s)/2of 3_(2s)/R_(4s)规则(N=3,R=1);RBC、PLT和HCT的σ值均达到4σ质量水平,选用1_(3s)/2of 3_(2s)/R_(4s)/3_(1s)规则(N=3,R=1)。结论基于σ值利用Westgard西格玛规则,可以快捷地帮助实验室检验项目选择合适的室内质控规则以及每批质控测定值个数。Objective To investigate how to use the sigma value to chose the appropriate quality control rules for the blood cell analysis test project.Methods The cumulative variation coefficient(CV)of quality control conducted in our hospital from January to December 2016 were collected as an estimate value of the inaccuracy of the measurement;The date of Percentage difference of blood cell analysis test of external quality assessment of National Clinical Laboratory center in 2015 second and 2016 was took advantage of estimated value,the TEa of the biological variation derivation is used as the standard,according to the formula of sigma=(TEa-|Bias|)/CV,calculate the sigma value of each item.Use the Westgard sigma rule to select the appropriate quality control rules for the clinical laboratory′s blood cell analysis test.Results Using a performance specification based on TEa of biological variation,the sigma value of WBC was achieved 6σquality level,the 1 3s rule was chosed(N=3,R=1),and the sigma value of the Hb was achieved 5σquality level,1 3s/2 of 3 2s/R 4s was chosed(N=3,R=1).and the sigma value of the RBC,PLT and HCT are all 4σquality level,1 3s/2 of 3 2s/R 4s/3 1s were chosed(N=3,R=1).Conclusion Using the rule based on TEa of the Westgard sigma rule could help to chose the appropriate quality control rules and the number of each batch of quality control measurement value for test items of clinical laboratory quickly.

关 键 词：σ值 Westgard西格玛规则 血细胞分析 室内质量控制 

分 类 号：R446[医药卫生—诊断学]