西格玛度量值联合质量目标指数在不同型号血液分析仪性能评价中的应用  

The Application of the Sigma Measurement Value Combined with theQuality Target Index in Evaluating the Performance ofVarious Blood Analyser Models

作　　者：林澜 何恩萍 刘柳 全晖 LIN Lan;HE Enping;LIU Liu;QUAN Hui(Department of Clinical Laboratory,the Second Affiliated Hospital of Chengdu Medical College,Nuclear Industry 416 Hospital,Chengdu 610051,China)

机构地区：[1]成都医学院第二附属医院·核工业四一六医院检验科,四川成都610051

出　　处：《标记免疫分析与临床》2024年第11期2120-2126,共7页Labeled Immunoassays and Clinical Medicine

摘　　要：目的运用σ度量值联合质量目标指数的方法对临床实验室不同型号全自动血液分析仪定量检测项目进行性能评价,为本实验室4台不同型号血细胞分析模块定量检测项目的分析质量的评价及质量改进方向提供依据。方法通过中国合格评定国家认可委员会CNAS-TRL-001:2012技术报告中“自上而下”的方法,收集2023年1月至12月本实验室4台不同型号全自动血液分析仪的室内质控在控数据,利用加权法计算加权平均变异系数(CV),再将水平1、水平2的两个浓度全血质控物的加权CV计算合成CV。用国家卫生健康委临床检验中心下发的室间质评物检测数据与公布的相应分组靶值计算偏移(Bias)。采用国家卫生行业标准文件WS/T 406-2012推荐的允许总误差作为4台不同型号全自动血液分析仪的允许总误差(TEa)计算西格玛(σ)度量值和质量目标指数(QGI)。以σ度量值评价实验室各型号全自动血液分析仪性能,并用QGI值判断质量改进的项目及方向。结果通过σ度量值及QGI的联合评价,其中模块1、模块2的8个检测项目σ值均≥4,检测质量判定为“良好”及以上,根据相关报道无需改进。模块3的HCTσ值在2≤σ<3之间,检测质量判定为“欠佳”,QGI值>1.2提示正确度需改进。模块4的WBC、HCTσ值在3≤σ<4之间,检测质量判定为“临界”,RBC、MCHCσ值在2≤σ<3之内,检测质量判定为“欠佳”,MCVσ值<2检测质量判定为“不可接受”,其中WBC、HCT的QGI值<0.8提示精密度需改进,RBC的QGI值在0.8≤QGI≤1.2之间,提示精密度和正确度均需改进,MCV、MCHC的QGI值>1.2提示正确度需改进。结论σ度量值能客观地判断临床实验室不同型号血细胞分析模块定量检测项目分析质量水平,同时联合运用QGI值的判断规则可更好地为临床实验室各项目质量改进提供方向。Objective This study aims to evaluate the performance of quantitative testing items in different types of automatic hematology analyzers in a clinical laboratory using theσmeasure combined with the quality goal index(QGI).This approach can provide a foundation for assessing and improving the analytical quality of these testing items across four different types of hematology analysis modules in the laboratory.Methods Following the“top-down”approach specified in the CNAS-TRL-001:2012 technical report by the China National Accreditation Service for Conformity Assessment,the indoor datasets were collected from January to December,2023 for four different types of automatic hematology analysers.The weighted average coefficient of variation(CV)was calculated using a weighting method,and combined CVs were determined for two concentrations of whole blood quality control substances at levels 1 and 2.The Bias(Bias%)was calculated using IQA data and the target values for the respective groups,which provided by the National Center for Clinical Laboratories.Allowable total error(TEa)was determined according to the National Health Industry Standard WS/T 406-2012,which was then used to calculate the sigma(σ)measure and QGI for the four different types of automatic hematology analysers.Performance of studied analyser was evaluated using theσmeasure,while QGI was employed to identify specific areas and directions for quality improvement.Results The combined evaluation ofσmeasure and QGI revealed that eight testing items in modules 1 and 2 achievedσmeasures of 4 or higher,indicating a good or superior analytical quality,with no recommended improvements according to relevant literature.In module 3,the HCTσmeasure ranged from 2 to less than 3,indicating a poor analytical quality,with a QGI greater than 1.2 suggesting a need for accuracy improvement.For module 4,the WBC and HCTσmeasures ranged from 3 to less than 4,indicating a critical analytical quality.The RBC and MCHCσmeasures ranged from 2 to less than 3,indicating a

关 键 词：六西格玛 全自动血液分析仪 质量评定 质量改进 

分 类 号：R-331[医药卫生]