西格玛度量在临床血液学项目分析质量上的应用研究  

The application of sigma metrics in evaluating the analytical quality of clinical hematologyanalytes

作　　者：刘倩[1] 杨伏猛[1] 梁伟 付梅[1] 朱文俊 马丽萍 Liu Qian;Yang Fumeng;Liang Wei;Fu Mei;Zhu Wenjun;Ma Liping(Department of Laboratory, the Second People＇s Hospital of Lianyungang, Lianyungang 222006, Chin)

机构地区：[1]江苏省连云港市第二人民医院检验科,222006

出　　处：《中国实用医刊》2018年第7期28-32,共5页Chinese Journal of Practical Medicine

基　　金：连云港市第二人民医院中青年人才成长基金（TQ201710）

摘　　要：目的探讨不同来源的允许总误差（TEa）导出的西格玛（σ）度量在临床血液学项目分析质量上的应用价值。方法应用四个不同的TEa标准、2017年第一次卫计委临检中心室间质量评价的数据作为偏倚以及室内质控数据累积的变异系数（CV）作为不精密度来计算2个批次的σ值；分析不同标准的σ度量在临床血液学项目分析质量上的差异；并依据σ度量水平选择合适的质量控制规则。结果依据生物学变异标准得出的σ值较低，σ≥6的比例为0～60%；美国CLIA’88标准得出的σ值处于中间，σ≥6的比例为60%～80%；我国卫生行业标准和德国RiliBAK标准得出了较高的σ值，σ≥6的比例均为80%；依据我国卫生行业标准得到的σ值水平，白细胞计数（WBC）、红细胞计数（RBC）、血红蛋白（Hb）和血细胞比容（HCT）项目采用单规则13s，血小板计数（PLT）采用多规则13s/22s/R4s/41s/8x。结论6σ理论能够对临床血液学项目的性能进行合理的评估，对于室内质控规则的选择具有重要的指导价值。Objective To investigate the application value of sigma （or） metrics derived according to different allowalble total errors （TEa） in evaluating the analytical quality of clinical hematology an- alytes. Methods The data of first external quality assessment in 2017 organized by National Center for Clinical Laboratory were considered as bias. The variation coefficient （CV） comulated by internal quality control data was considered as imprecision, a metrics of 2 runs calculated by four different standards of TEa, bias and imprecision were selected to analyze the difference of cr metrics in evaluating the quality of clinical hematology analytes. Evenmore, appropriate quality control rules were selected according to σ metrics. Results The σ metrics were low relatively by the standard of biological variation. The propor- tion of cry〉6 was only between 0 -60%. The σ metrics derived according to the standard of CLIA＇ 88 was moderate, the proportion of σ≥6 was between 60% -80%. According to the standards of the Na- tional Health Industry and RiliBAK, σ metrics were high relatively, and the proportion of σ≥6 were 80%. According to σ metrics by the standard of the National Health Industry, white blood cell count （WBC）, red blood cell count （RBC）, hemoglobin （Hb） and hematocrit （HCT） were applied with the single rule 13s and platelet count （PLT） were applied with multiple rules of 13s/22s/R4s/41s/8x. Conclusions The σ theory can reasonably evaluate the performance of the clinical hematology ana- lytes. It has important guidance for the selection of internal quality control rules.

关 键 词：西格玛度量 允许总误差 质量控制规则 

分 类 号：R446.1[医药卫生—诊断学]