常规凝血试验检验项目测量不确定度和西格玛水平的评定研究  

Conventional coagulation test measurement uncertainty and the sigma levels of all items evaluation research

作　　者：曾露云 王巍 冯紫嫣 ZENG Lu-yun;WANG Wei;FENG Zi-yan(Department of Clinical Laboratory,Beijing Xicheng District Maternal and Child Health Hospital;Beijing Jinfeng Yitong Technology Co.,Ltd,Beijing 100102,China)

机构地区：[1]北京市西城区妇幼保健院检验科,北京100054 [2]北京金风易通科技有限公司,北京100102

出　　处：《川北医学院学报》2022年第9期1110-1114,共5页Journal of North Sichuan Medical College

摘　　要：目的:根据测量不确定度和西格玛水平评定常规凝血试验的检验质量。方法:根据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,收集北京市西城区妇幼保健院检验科2021年的室内质控数据和2018~2020年3次北京市临床检验中心室间质评结果,以评定凝血酶原时间(PT)、国际标准化比值(INR)、活化部分凝血活酶时间(APTT)、纤维蛋白原浓度(Fbg)的测量不确定度。同时根据2021年北京市临床检验中心质量评价计划的室间质评结果计算偏倚(Bias%),以国家标准GB/T20470-2006中的允许总误差(TEa)计算西格玛水平,结合质量目标指数(QGI)确定实验室需要优先改进的方向。结果:PT在11.99 s和38.77 s时的相对扩展不确定度分别为6.98%和12.40%;APTT在27.43 s和48.96 s时的相对扩展不确定度分别为13.39%和15.13%;Fbg在2.67 g/L和2.27 g/L时的相对扩展不确定度分别为12.90%和14.92%;INR在1.08和3.74时的相对扩展不确定度分别为13.60%和23.55%。以国家标准的允许总误差评估实验室凝血试验各项目的性能水平后显示,APTT和Fbg处于临界水平,σ值分别为3.22和3.87;PT和INR处于欠佳水平,σ值分别为2.94和2.79。计算各项目的质量目标指数得出PT、Fbg和INR的QGI<0.8;APTT的QGI为0.8~1.2。结论:利用室内质控数据和室间质评回报结果,对常规凝血试验项目测量不确定度进行评定,运用Westgard西格玛质控规则进行性能评价,根据质量目标指数考虑实验室优先改进的方向,均有助于临床实验室的质量管理工作。Objective:According to the uncertainty of measurement and the sigma level evaluate the quality of conventional coagulation test.Methods:According to China national approval committee CNAS conformity assessment-TRL-001:2012“top-down”approach in the technical report,collect the Beijing xicheng district maternal and child health hospital clinical laboratory data of internal quality control results in 2021 and 2018~2020,three times Beijing external qualiy control results as a result,the evaluation of prothrombin time(PT)live part,INR,activated clotting time(APTT),fibrinogen concentration(Fbg),the uncertainty of measurement.And clinical inspection center quality evaluation according to the 2021 Beijing chamber of qualitative evaluation of the results between computing Bias(Bias%),allowed in the national standard GB/T20470-2006 total error(TEa)computing sigma level,to meet the needs of quality target index(QGI)determine the laboratory preferred direction for improvement.Results:PT in 11.99 s and 38.77 s,the relative expanded uncertainty were 6.98%&12.40%,APTT in 27.43 s and 48.96 s,the relative expanded uncertainty were 13.39%&15.13%,Fbg in 2.67 g/L and 2.27 g/L,the relative expanded uncertainty were 12.90%&14.92%,INR in 1.08 and 3.74,the relative expanded uncertainty were 13.60%&23.55%.After evaluating the performance level of each item of the laboratory coagulation test with the allowable total error of the national standard,to national standards to allow total error evaluation laboratory coagulation tests after the project’s performance level shows a critical level,APTT and Fbg sigma value were at critical levels,σvalues was 3.22 and 3.87,respectively.PT and INR in poor level,σvalue was 2.94 and 2.79,respectively.Purpose of calculating various kinds of quality target index of PT,Fbg and INR QGI<0.8,APTT QGI between 0.8~1.2.Conclusion:Using the internal quality control data and internal quality control results,each test project of routine coagulation tests in laboratory measurement uncertainty evaluation,comb

关 键 词：评定 测量不确定度 西格玛性能水平 自上而下 凝血项目 

分 类 号：R320.99[医药卫生—人体解剖和组织胚胎学]