六西格玛规则在全血细胞分析中的应用(1)
[摘要] 目的 采用六西格玛规则为临床实验室选择合适的全血细胞计数项目质控规则。方法 收集该实验室参加室间质评结果和室内质控数据，评估该实验室红细胞计数(RBC)、血红蛋白(HGB)、血细胞比容(Hct)、血细胞计数(PLT)和白细胞计数(WBC)的偏倚(Bias)和不精密度(CV)，以国家卫生行业标准《临床血液学检验常规项目分析质量要求》(WS/T406-2012)的允许总误差(TEa)为标准计算各项目σ值。根据σ值和六西格玛规则选择合适的质控规则。结果 RBC、HGB和WBC 3个项目σ值均大于6，选择13S质控规则;Hct项目σ值为5.3，应选择13S/22S/R4S质控规则;PLT项目σ值为4.2，应选择13S/22S/R4S/41S质控规则。结论 利用六西格玛规则可为临床实验室选择更加科学、合理的室内质控规则。
[关键词] 全血细胞计数;六西格玛规则;室内质控
[中图分类号] R446.1 [文献标识码] A [文章编号] 1674-0742(2020)08(b)-0180-03
Application of Six Sigma Rule in Whole Blood Cell Analysis
LIU Hui-rong
Department of Laboratory， Zibo Municipal Government Hospital， Zibo， Shandong Province， 255000 China
[Abstract] Objective To adopt Six Sigma rules to select appropriate quality control rules for complete blood count in clinical laboratories. Methods Collect the results of the laboratory's inter-room quality assessment and indoor quality control data to evaluate the laboratory's red blood cell count (RBC)， hemoglobin (HGB)， hematocrit (Hct)， blood cell count (PLT) and white blood cell count (WBC) The bias (Bias) and imprecision (CV) are calculated according to the allowable total error (TEa) of the national health industry standard “Analysis Quality Requirements for Routine Items of Clinical Hematology Tests” (WS/T406-2012) as the standard. Choose the appropriate quality control rules based on the σ value and Six Sigma rules. Results The σ values of the three RBC， HGB and WBC projects were all greater than 6， and the 13S quality control rule was selected; the Hct project σ value was 5.3， and the 13S/22S/R4S quality control rule should be selected; the PLT project σ value was 4.2， and the 13S/ 22S/R4S/41S quality control rules. Conclusion Using Six Sigma rules can choose more scientific and reasonable indoor quality control rules for clinical laboratories.
[Key words] Complete blood count; Six Sigma rule; Indoor quality control
隨着临床检验技术和管理水平的提升，临床实验室对如何正确、科学地选择室内质控规则有越来越高的要求[1]。做好血细胞计数的室内质控是保证检测结果可靠性的重要环节，对患者健康和疾病诊断非常重要。Westgard多规则质控是临床实验室血细胞计数项目最常使用的质控方法，但全血细胞分析与临床实验室其他检测项目相比具有其独特性。单纯使用Westgard多规则质控方法具有较大的局限性，如何正确、科学地选择室内质控规则对血细胞分析项目实施有效监控是困扰临床实验工作人员的问题之一。近来有报道[2]将Westgard多规则质控与西格玛质量管理相结合使室内质控更加科学、合理。该文探讨六西格玛规则在临床实验室全血细胞计数中的应用，为临床实验室制定更加科学、合理的质控规则提供参考，现报道如下。
1 材料与方法
1.1 实验材料
血细胞计数室间质评标本(国家卫生健康委员会临床检验中心)，血细胞分析仪中、低浓度配套室内质控品(希森美康，日本)。
1.2 试剂与仪器
Sysmex 500i全血细胞分析仪及原装配套试剂校准品(希森美康，日本)。, 百拇医药(刘惠荣)
[关键词] 全血细胞计数;六西格玛规则;室内质控
[中图分类号] R446.1 [文献标识码] A [文章编号] 1674-0742(2020)08(b)-0180-03
Application of Six Sigma Rule in Whole Blood Cell Analysis
LIU Hui-rong
Department of Laboratory， Zibo Municipal Government Hospital， Zibo， Shandong Province， 255000 China
[Abstract] Objective To adopt Six Sigma rules to select appropriate quality control rules for complete blood count in clinical laboratories. Methods Collect the results of the laboratory's inter-room quality assessment and indoor quality control data to evaluate the laboratory's red blood cell count (RBC)， hemoglobin (HGB)， hematocrit (Hct)， blood cell count (PLT) and white blood cell count (WBC) The bias (Bias) and imprecision (CV) are calculated according to the allowable total error (TEa) of the national health industry standard “Analysis Quality Requirements for Routine Items of Clinical Hematology Tests” (WS/T406-2012) as the standard. Choose the appropriate quality control rules based on the σ value and Six Sigma rules. Results The σ values of the three RBC， HGB and WBC projects were all greater than 6， and the 13S quality control rule was selected; the Hct project σ value was 5.3， and the 13S/22S/R4S quality control rule should be selected; the PLT project σ value was 4.2， and the 13S/ 22S/R4S/41S quality control rules. Conclusion Using Six Sigma rules can choose more scientific and reasonable indoor quality control rules for clinical laboratories.
[Key words] Complete blood count; Six Sigma rule; Indoor quality control
隨着临床检验技术和管理水平的提升，临床实验室对如何正确、科学地选择室内质控规则有越来越高的要求[1]。做好血细胞计数的室内质控是保证检测结果可靠性的重要环节，对患者健康和疾病诊断非常重要。Westgard多规则质控是临床实验室血细胞计数项目最常使用的质控方法，但全血细胞分析与临床实验室其他检测项目相比具有其独特性。单纯使用Westgard多规则质控方法具有较大的局限性，如何正确、科学地选择室内质控规则对血细胞分析项目实施有效监控是困扰临床实验工作人员的问题之一。近来有报道[2]将Westgard多规则质控与西格玛质量管理相结合使室内质控更加科学、合理。该文探讨六西格玛规则在临床实验室全血细胞计数中的应用，为临床实验室制定更加科学、合理的质控规则提供参考，现报道如下。
1 材料与方法
1.1 实验材料
血细胞计数室间质评标本(国家卫生健康委员会临床检验中心)，血细胞分析仪中、低浓度配套室内质控品(希森美康，日本)。
1.2 试剂与仪器
Sysmex 500i全血细胞分析仪及原装配套试剂校准品(希森美康，日本)。, 百拇医药(刘惠荣)