对某三甲医院临床实验室全血细胞分析质量水平的评价  

Evaluation of the quality level of whole blood cell analysis in clinical laboratories of a tertiary first-class hospital

作　　者：曾张琴[1] Zeng Zhangqin(Clinical laboratory,fourth affiliated hospital of Guangxi Medical University,Liuzhou,Guangxi,545005,China)

机构地区：[1]广西医科大学第四附属医院医学检验科,广西柳州545005

出　　处：《齐齐哈尔医学院学报》2023年第10期957-961,共5页Journal of Qiqihar Medical University

摘　　要：目的采用六西格玛(6σ)质量管理方法对在用的12台血细胞分析模块检测项目的质量水平进行评价,为血细胞分析仪检测项目质量的改进提供依据。方法收集2021年1—12月12台血细胞分析模块室内质控低值和中值浓度的在控数据,利用加权法计算它们的加权平均变异系数(CV),然后将两个浓度的加权平均CV计算合成CV。用配套校准物校准仪器测得的均值与靶值的偏差,计算检测项目的正确度。采用国家卫生行业标准WS/T406-2012推荐的允许总误差(TEa)作为12台血细胞分析模块检测项目的允许总误差计算出西格玛(σ)度量值和质量目标指数(QGI)值。用σ度量值评价血细胞分析仪对白细胞计数(WBC)等5个检测项目的分析性能,用QGI值分析判断仪器的精密性和正确性方面的改进方向。结果根据σ和QGI值评估,12种仪器的WBC计数质量良好,无需改进。在红细胞计数试验中,仪器编号1、2、3、4、5、6、7、9、10、11、12的σ值均较好。仪器8的σ值为3.86,表明检测质量处于临界线,仪器8的精度需要根据QGI值进行提高。在测定血红蛋白(HGB)时,仪器1、3、5、6、7、8、9、12的σ值均较优,仪器2、10、11的σ值在3≤σ<4以内。根据QGI值,仪器11的精度有待提高,仪器2、10的正确度和精密度有待提高。在进行红细胞压积(HCT)测定,所有仪器的检测质量表现优秀,12台仪器的HCT检测质量继续保持。仪器在进行血小板(PLT)计数时,仪器1、2、3、5、6、7、8、9、10、11、12的σ值表现优异,仪器4的σ值为3.96,处于检测质量临界范围。根据QGI值,仪器4需要改进正确度和精密度。结论6σ和QGI是对临床实验室分析仪器整体性能评价的重要手段。他们能客观地判断仪器对各项目检测的质量水平和引出影响检测质量的原因,并为持续质量改进指明方向。Objective Six sigma(6σ)quality management method was used to evaluate the quality level of the test items of the 12 blood cell analysis modules,to provide a basis for the improvement of the quality of the test items of the blood cell analyzer.Methods The in-control data of low and median concentration of internal quality control measured by 12 blood cell analysis modules during January to December 2021 were collected for analysis.The weighting method was adopted to calculate their weighted average coefficient of variation(CV),and then calculate the weighted average CV of the two concentrations to compose CV.Calibrate the deviation between the mean value measured by the instrument and the target value with the matching calibrator,and calculate the accuracy of the test item.The allowable total error(TEa)recommended by the national health industry standard WS/T406-2012 was used as the allowable total error of the detection items of the 12 blood cell analysis modules,and the sigma(σ)measurement value and the quality goal index(QGI)value were calculated.σmetric value was used to evaluate the analytical performance of hematology analyzer in detecting five detection items which including white blood cell count(WBC),etc.The QGI value was used to judge the improvement direction of the precision and correctness of the instrument.Results According to theσand QGI values conclusions,WBC counting quality of the 12 instruments was good and no improvement was needed.In the red blood cell(RBC)count test,theσvalues of instrument numbers 1,2,3,4,5,6,7,9,10,11,and 12 were all above good.σvalue of instrument 8 is 3.86,showing that the detection quality is at the critical line,and the precision of instrument 8 needs to be improved according to the QGI value.For the determination of hemoglobin(HGB),theσvalues of instruments 1,3,5,6,7,8,9,and 12 are all excellent,and theσvalues of instruments 2,10,and 11 are within 3≤σ<4.According to the QGI values,instrument 11 needs improvement in precision,and instruments 2,10 need improve

关 键 词：全血细胞分析 六西格玛 质量目标指数 正确度 性能 

分 类 号：R446[医药卫生—诊断学]