基于西格玛规则图法的血细胞分析室内质控 控制限设定新方法. (Chinese)

Objective To explore a new method of setting internal quality control(IQC) limits for blood cell analysis using the sigma rule diagram method, in order to make the setting of internal quality control limits more reasonable. Methods Using the results of the inter-chamber quality evaluation of the blood cell count of the Clinical Laboratory Center of National Health Commission, the coefficient of variation of indoor quality control, and the allowable total error (TEa) specified in WS/T 406- 2012, the σ value was calculated by the sigma rule graph method, and then the control limit of the variation coefficient of indoor quality control was set by using the sigma rule calculation CV= (TEa-|Bias|)/(σ interval minimum) as the indoor quality control (hereinafter referred to as the “Sigma interval control limit”). Analyzed the indoor quality control data from November 2021 to September 2022, compared the differences between the control limit of the sigma interval and the traditional control limit setting method of the previous coefficient of variation(weighted CV), and evaluated the effectiveness and practicability of the control limit of the Sigma interval. Results The σ values of the items tested in the blood cell analysis were WBC(7.74)，RBC(6.62)， Hb(9.69)，HCT(8.03), MCV(8.63), MCH(8.61), MCHC(8.38) and PLT(6.31)σ measurements were > 6, while selecting the 1 3s quality control rule, the CV critical value (CV at σ=6) of the σ measurement interval of each project was calculated, and the control limit was calculated as the set coefficient of variation (CV ) of the indoor quality control chart of the project. The Sigma interval control limit setting method did not omit runaway data, and it was more practical than the traditional method of rejecting false runaway of control, and the difference was statistically significant (χ 2 =11.75, P<0.01).Conclusion The Sigma rule chart method can help the laboratory set a reasonable control limit of the indoor quality control chart, and the setting method of the established control limit of the Sigma interval makes the quality control rule correspond to the control limit of the interval one by one, reduces the generation of false runaway data, and makes the application of indoor quality control in the clinic more scientific and practical. [ABSTRACT FROM AUTHOR]

目的 探索西格玛规则图法设定血细胞分析室内质量控制控制限的新方法,使室内质控的控制限设定更加合理.方法 用乐山市人民医院检验科参加2021年国家卫生健康委员会临床检验中心血细胞计数第二次室间质量评价结果、室内质控变异系数和WS/T 406-2012中规定的允许总误差(TEa),采用西格玛规则图法计算σ值,再根据CV=(TEa-|Bias|)/(σ区间最小值)计算出的变异系数设定控制限(以下简称"西格玛区间控制限").采用两种方法分析2021年11月～2022年9月室内质控数据,比较西格玛区间控制限与传统的以前变异系数(加权CV)的控制限两种设定方法之间失控数据的差异,评价西格玛区间控制限的有效性与实用性.结果 血细胞分析中检验项目的σ值:WBC(7.74),RBC(6.62),Hb(9.69),HCT(8.03),MCV(8.63),MCH(8.61),MCHC(8.38)和PLT(6.31),σ度量值均＞6,选择1 3S 质控规则的同时,计算出各项目该σ度量区间的CV临界值(σ=6时的CV)及控制限.控制限设定方法的对比实验中室内质控共297次,传统控制限设置方法失控24次,西格玛区间控制限设定法仅失控5次(减少假失控80%),二者均没有遗漏失控数据,在拒绝假失控方面西格玛区间控制限比传统的以前变异系数的方法更具实用性,差异有统计学意义(χ2=11.75,P＜0.01).结论 西格玛规则图法可以帮助实验室设定合理的室内质控图的控制限,西格玛区间控制限的设定方法使质控规则与该区间的控制限--对应,减少假失控数据的产生,使室内质控在临床中的应用更具科学性和实用性. [ABSTRACT FROM AUTHOR]

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