临床实验室室间质量评价结果解释及不合格结果原因调查的建议性方法

Interpretation of External Quality Assessment Results in Clinical Laboratories and Suggested Approach on Investigating Unacceptable Results

室间质量评价(external quality assessment,EQA)的重要作用是发现分析错误并督促实验室采取相应的纠正措施。该文阐述了EQA结果解释需要的知识并呈现了一种EQA结果不合格时处理的框架性方法。EQA结果的解释取决于5个重要的要素:质控品、靶值、重复测量次数、可接受范围、试剂的批间变异。当出现不合格的EQA结果时,这些因素可能是误差的来源。理想的EQA样品有两个重要的特点:无基质效应,拥有由参考方法建立的靶值。如果这两种标准中任何一个标准不完全满足,将可能导致与实验室性能无关的结果。为了帮助和指导实验室处理不合格的EQA结果,卫生部临床检验中心对EQA计划中的15个专业的不合格项目的原因及其纠正措施进行了初步的调查。该文结合此次调查以及文件QMS24绘制了一种附有注释的流程图,以期帮助实验室利用EQA结果改进质量。

Important objectives of external quality assessment （EQA） is to detect analytical errors and urge laboratories to take corresponding corrective actions. The paper described knowledge required to interpret EQA results and present a structured approach on how to handle unacceptable EQA results. The interpretation of EQA results depends on five key points： the control material, the target value, the number of replicates, the acceptance limits and between lot variations in reagents. When there are unacceptable EQA results,these factors may be the sources of errors. The ideal EQA sample has two important properties：having no matrix effects;having a target value established with a reference method. If either of these two criteria is not entirely fulfilled, results not related to the performance of the laboratory may arise. To help and guide the labora tories in handling an unacceptable EQA result, National Center for Clinical Laboratories has developed a preliminary investigation on the sources of errors and corrective actions for nonconforming EQA results in fifteen EQA schemes. Then a flowchart with additional comments was developed based on the investigation and the document of QMS24 to help laboratories improve quality by use of EQA results