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.pdf

190现代检验医学杂志第 38 卷第 5 期2023 年 9 月J Mod Lab Med,Vol.38,No.5,Spet.2023基于西格玛规则图法的血细胞分析室内质控 控制限设定新方法童小东1，佘仕金1，刘慧英1，郑春莲1，向尹1，王钱红2（1.乐山市人民医院检验科，四川乐山 614003；2.乐山市妇幼保健院检验科，四川乐山 614001）摘要：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值，再根据CV=（TEa-|Bias|）/（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 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），度量值均 6，选择 13S质控规则的同时，计算出各项目该 度量区间的 CV 临界值（=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（2=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一一对应，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。关键词：血细胞分析；质量控制；西格玛规则；控制限中图分类号：R446文献标识码：A文章编号：1671-7414（2023）05-190-05doi:10.3969/j.issn.1671-7414.2023.05.036A New Method for Setting Quality Control Limits of Blood Cell Analysis Based on Sigma Rule Diagram MethodTONG Xiaodong1，SHE Shijin1，LIU huiying1，ZHENG Chunlian1，XIANG Yin1，WANG Qianhong2（1.Department of Clinical Laboratory，Leshan Peoples Hospital，Sichuan Leshan 614003,China;2.Department of Clinical Laboratory,Leshan Women and Childrens Hospital,Sichuan Leshan 614000,China）Abstract:ObjectiveTo 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.MethodsUsing 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 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|)/(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 theprevious coefficient of variation（weighted CV）,and evaluated the effectiveness and practicability of the control limit of the Sigma interval.ResultsThe 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）measurements were 6,while selecting the 13s quality control rule,the CV critical value(CV at=6)of the 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(2=11.75,P6 的实验室，从而导致各实验室控制限方法设置不一，Westgard 多规则质控法是基于风险管理的实验室质量控制设计，其 6 度量值将实验中可能存在的缺陷分区间量化，质控规则根据西格玛度量区进行选择12，17-18。这种将检测错误区间量化的质控规则的选择方式用于符合正态分布的质控图是产生假失控数据的来源，尤其是室内变异系数控制很好的项目和不合理的质控规则搭配时会出现更多的假失控数据，所以实验室在运行正确的室内质控时必须选择正确的质控规则和与之匹配的控制限设置。本次实验中计算出 值的大小，选择恰当的质控规则及其关键，CNAS-CL02-A00119中对全血细胞计数室内质控要求至少两个浓度水平的质控品，至少选择 13s/22s的质控规则，但实验室在满足管理要求的基础上，并对质控规则进行验证，可合理选择适合本实验室的质控规则20。本实验室血细胞分析各项目可以只选用 13s的质控规则，与程秀丽等4的研究结果保持一致，西格玛区间控制限的设定符合对实验室内部规定必须保证的分析数据精密度的要求可使用目标控制限21。西格玛区间控制限和传统的以前变异系数的方法均未遗漏失控数据，真实的失控数为 1 次系统误差，是仪器部件老化导致，其余 23 次失控可能是由于操作不当、质控品混匀不足或吸样异常等导致的误差，经重新测定质控品后均取得理想结果，西格玛区间控制限在控制假失控方面比采用传统的“以前变异系数控制193现代检验医学杂志第 38 卷第 5 期2023 年 9 月J Mod Lab Med,Vol.38,No.5,Sept.2023限”的方法减少了 19 次（占 80%），更具实用性。文中提出的“西格玛区间控制限”能够解决前文中提出的几个问题：质控规则和控制限均由相同的 度量值区间得到而相互匹配，保证了质控规则控制区间的合理性，为实验室室内质控控制限的设定提供了依据；更符合临床实际需求，减少了假失控数据的产生,尤其是对于室内质量控制结果较好（6）的项目，可减少不必要的浪费。实验室应结合临检中心室间质评结果定期对检验项目进行 度量值的计算（建议半年一次）及时评估更新室内质控设定 CV，每月实际测定 CV 设定CV 时，说明仪器的精密度在该质控规则的控制范围内，可选择对应区间的质控规则，当每月室内质控 CV 设定 CV 时需重新评估室内质控控制限的设定是否合理并及时分析整改。使用西格玛规则图法除了为不同的检验项目选择特征性的质控规则，同时也为西格玛区间控制限的设置提供了依据，让室内质控的管理更加科学和高效，保证了实验室的检测质量。参考文献：1 中华人民共和国国家卫生健康委员会.WS/T641-2018：临床检验定量测定室内质量控制 S.北京：中国标准出版社,2019.National Health Commission of the Peoples Republic of China.WS/T641-2018：Internal quality control for Quantitative measurement in clinical laboratory S.Beijing:Standards Press of China,2019.2 葛雪微,马晓,秦海萍,等.基于临床允许总误差血液分析仪检测结果室内质控体系的建立 J.山东医药,2017,57(35):87-89.GE Xuewei,MA Xiao,QIN Haiping,et al.Establishment of indoor quality control system based on clinical allowable total error hematology analyzer test resultsJ.Shandong Medical Journal,2017,57(35):87-89.3 WESTGARDJ O,WESTGARD S A.Annalsex-press:quality control review,implement ingascientifical-ly based quality control systemJ.Annals of 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