[1]李婷婷,王 薇,赵海建,等.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李婷婷,王 薇,赵海建,等[J].现代检验医学杂志,2017,32(05):152-156.[doi:10.3969/j.issn.1671-7414.2017.05.017]
　LI Ting-ting,WANG Wei,ZHAO Hai-jian,et al.Interpretation of External Quality Assessment Results in Clinical Laboratories and Suggested Approach on Investigating Unacceptable Results[J].Journal of Modern Laboratory Medicine,2017,32(05):152-156.[doi:10.3969/j.issn.1671-7414.2017.05.017]
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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李婷婷,王 薇,赵海建,等()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第32卷
期数:
2017年05期
页码:
152-156
栏目:
质量控制·实验室管理
出版日期:
2017-11-02

文章信息/Info

Title:
Interpretation of External Quality Assessment Results in Clinical Laboratories and Suggested Approach on Investigating Unacceptable Results
文章编号:
1671-7414(2017)05-152-05
作者:
李婷婷1; 2; 王 薇1; 赵海建1; 何法霖1; 钟堃1; 袁 帅1; 王治国1; 2
1.北京医院 国家老年医学中心 卫生部临床检验中心/北京市临床检验工程技术研究中心, 北京 100730; 2.北京协和医学院研究生院,北京 100730
Author(s):
LI Ting-ting1; 2; WANG Wei1; ZHAO Hai-jian1; HE Fa-lin1; ZHONG Kun1;  YUAN Shuai1; WANG Zhi-guo1; 2
1.National Center forClinical Laboratories/Beijing Engineering Research Center of Laboratory Medicine,Beijing Hospital,National Center of Gerontology,Beijing 100730,China; 2.Graduate School,Peking Union Medical College, Chinese Academy of Medical Sciences,Beijing 100730,China
关键词:
室间质量评价;  质量改进;  互通性; 参考方法;  批间变异;  误差
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2017.05.017
文献标志码:
A
摘要:
摘 要: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。
Abstract:
Abstract: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 EQAresults and present a structured approach on how to handle unacceptable EQA results.The interpretation of EQA results depends on five key points:the controlmaterial,the target value,the number of replicates,the acceptance limits andbetween lot variations in reagents.When there are unacceptable EQA results,these factors may be the sources of errors.The ideal EQA sample has two importantproperties: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 laboratories in handling an unacceptable EQA result,National Center for Clinical Laboratories has developed a preliminary investigation on the sources oferrors 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.

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备注/Memo

备注/Memo:
作者简介:李婷婷(1990-),女,硕士研究生,研究方向:实验室质量管理,E-mail:tingting_li151154@163.com。 通讯作者:王治国,E-mail:zgwang@nccl.org.cn。
更新日期/Last Update: 1900-01-01