Westgard-西格玛规则在血细胞分析室内质量控制选择上的应用  

Application of Westgard-Sigma Rules to the Selection of Indoor Quality Control for Blood Cell Analysis

作　　者：李伟[1] 李燕[1] 王玉霞 Li Wei;Li Yan;Wang Yuxia(Department of Clinical Laboratory,The Forth Division Hospital of Xinjiang Production and Construction Corps,Yining,Xinjiang,835000,China)

机构地区：[1]新疆生产建设兵团第四师医院检验科,新疆伊宁835000

出　　处：《黑龙江医学》2024年第4期407-409,共3页Heilongjiang Medical Journal

摘　　要：目的:利用Westgard-西格玛规则帮助临床实验室血细胞分析室内质量控制(IQC)选择恰当的质控规则,以确保室内质控结果合格、有效。方法:选择2021年6月—2021年12月新疆生产建设兵团第四师医院检验科临床实验室的5个项目低、中两个浓度质控水平的IQC数据,计算各项目的不精密度(CV)。根据2021年本临床实验室参加新疆维吾尔自治区临床检验中心全血细胞计数2次室间质量评价的结果,计算5个项目的平均偏倚(Bias)值。根据《临床血液学检验常规项目分析质量要求》(WS/T 406-2012)规定的允许总误差(TEa),计算出各个项目的质量水平西格玛指数(σ),公式为σ=(TEa-|Bias|)/CV。根据Westgard-西格玛规则的要求,对血细胞分析中的白细胞(WBC)、红细胞(RBC)、血红蛋白(HGB)、平均红细胞体积(MCV)、血小板(PLT)项目选用相应的质控规则。结果:WBC项目应采用的IQC规则是1_(3S)、2_(2S)、R_(4S)、4_(1S)。RBC项目应采用的IQC规则是1_(3S)、2_(2S)、R_(4S)、4_(1S)、8_(X)。HGB项目应采用的IQC规则是1_(3S)、2_(2S)、R_(4S)、4_(1S)、8_(X)。MCV项目应采用的IQC规则是1_(3S)、2_(2S)。PLT项目应采用的IQC规则是1_(3S)、2_(2S)、R_(4S)、4_(1S)。结论:Westgard-西格玛规则能够帮助临床实验室优化IQC规则和使用质控品浓度水平的个数,甚至每个浓度水平质控品重复测定的次数,使临床实验室IQC规则更实际、实用。Objective:To assist clinical laboratory blood cell analysis indoor quality control(IQC)by utilizing Westgard-Sigma rules to select appropriate QC rules to ensure competent and valid indoor QC results.Methods:The IQC data from June 2021 to December 2021 from the clinical laboratories of the hospital’s laboratory department for five items at low and medium concentra-tion quality control levels were selected and the imprecision(CV)of each item was calculated.The mean bias(Bias)values of the 5 items were calculated based on the results of 2 interlaboratory quality evaluations of complete blood counts in 2021 in which clini-cal laboratory participated in the Xinjiang Uygur Autonomous Region Clinical Laboratory Center.According to the allowable total error(TEa)specified in the health industry standard WS/T 406-2012 of the People’s Republic of China,the quality level sigma in-dex(σ)of each item was calculated according to the formulaσ=(TEa-|bias|)/CV.According to the requirements of Westgard-Sigma rules,the appropriate quality control rules were selected for the items WBC,RBC,HGB,MCV,and PLT in the blood cell analysis.Results:The IQC rules to be used for the WBC program were 1_(3S),2_(2S),R_(4S),4_(1S).The IQC rules to be used for the RBC program were 1_(3S),2_(2S),R_(4S),4_(1S),8_(X).The IQC rules to be used for the HGB program were 1_(3S),2_(2S),R_(4S),4_(1S),8_(X).The IQC rules to be used for the HGB program were 1_(3S),2_(2S),R_(4S),4_(1S),8_(X).The IQC rules to be used for the HGB program were 1_(3S),2_(2S),R_(4S),4_(1S),8_(X).The IQC rules that should be used for MCV projects were 13S,22S.The IQC rules that should be used for PLT projects were 1_(3S),2_(2S),R_(4S),4_(1S).Conclusion:Westgard-Sigma rules can help clinical laboratories optimize IQC rules and the number of concentration levels of QCs used,and even the number of times QCs are repeated at each concentration level,making clinical laboratory IQC rules more practical and pragmatic.

关 键 词：Westgard-西格玛规则 室内质量控制 血细胞分析 

分 类 号：R197.32[医药卫生—卫生事业管理]