摘要:
目的 用6σ质量标准和实际总误差评估Sysmex CS-5100全自动血凝仪的性能,进而进行质量改进.方法 收集2016年血凝仪的PT、INR、APTT、Fbg、TT5个项目的室内质量控制数据和全年室间质量评价回报的偏倚,以CLIA'88允许总误差为标准,计算σ和QGI值,通过公式TE=1.96s+| Bias |计算实际总误差,从而综合评估血凝仪的检测性能.结果 5个检测项目中,TT的σ值大于6.0,属于世界级性能,PT、INR、APTT的σ值都大于5.0,属优秀性能,Fbg的σ值为4.0,属良好性能,优秀以上性能占80%,良好以上性能占100%,除了TT不需要改进质量外,其他项目的QGI都小于0.8,需要改进精密度,所有检测项目的实际总误差均小于允许总误差要求.结论 用6σ质量标准和总误差的方法能对血凝仪的性能进行综合分析和评估,进而督促实验室对性能不佳的项目查找原因并制定改进措施,从而保障日常检测结果的精密度和准确度,以便更好地服务于临床.%Objective To improve the performance of coagulation analyzer Sysmex CS-5100with 6σ quality standard and total error management.Methods In 2016,internal quality control data and estimation bias of 5 items (PT、INR、APTT、Fbg、TT)were collected using coagulation analyzer.Based on Clinical Laboratory Improvement Amendments (CLIA'88)standards,their σ values and QGI and total errors were calculated according to the formula(TE =1.96s + | Bias |).Results All σ values of five items showed more than 80% excellence(TT >6.0;PT,INR,APTT > 5.0;Fbg =4.0) and their total error was within allowable range.Only few items with QGI < 0.8 requiredmore imprecision.Conclusion It is necessary to comprehensively evaluate coagulation analyzer using 6σ quality standard and total error management.These methods will make improvement of precision and accuracy in routine laboratory assays and provide better clinical services.