方法评价决定图表工具在血液分析仪幽翻耕的应用

目的：利用方法评价决定图表工具（six sigma MEDx cllart）评估某血液分析仪的性能。方法：利用该工具结合近年来该仪器室内质控（IQC）的不精密度、以及参加卫生部临床检验中心组织的室间质评（EQA）活动得出的偏倚（Bias）等性能指标,按照美国临床实验室改进修正案（CLIA’88）的总误差（TEa）要求,对每个项目做出性能评价。结果：血液分析仪除PLT项目的检测能力外,其他均有良好的性能。结论：该工具能快速、客观地给出各项目的性能指标。并给出初步的设计质控规则。

The application of the method evaluation decision chart tools in assessing the performance of laboratory hematology analyzer

Objective：To assess the performance of our laboratory hematology analyzer. Methods：According to the total error（TEa ） requirements of Clinical Laboratory Improvement Amendments 88（CLIA＇88）, we use the MEDx Chart- tools and the imprecision data from the internal quality control （IQC） of laboratory hematology analyzer in recent years, as well as the bias（Bias） from the National Center for Clinical Lboratory external quality assessment （EQA） ac- tivities, to make the performance evaluation of each project.Results：The good peribrmance evaluation had been achieved in all projects except PLT detection capabilities. Conclusion：The tools can rapidly and objectively give the performance indicators, and provide quality control rules in preliminarv design.