Scherrer F, Boisson R C, Eynard J C, Chamard D, Poggi B, Grafmeyer D
LABM Buatois et Chamard, 71, Avenue Gabriel Péri (RN7), Roussillon.
Ann Biol Clin (Paris). 2008 Nov-Dec;66(6):721-5. doi: 10.1684/abc.2008.0277.
Current events of clinical laboratories in France argue a lot about quality management. Setting up an assurance quality system can be realized in many approaches listed by increasing requirements: respect of reglementary Guide de bonne exécution des analyses (GBEA), BioQualite qualification, certification and at last accreditation. This last step corresponds to the recognition of the competence of the laboratory to execute specifics tasks. Validation of methods used in the laboratory is a key point when you realize an accreditation package. Fidelity (repetability and reproductibility) is one of the parameters to check in your lab for quantitative methods. These performances are validated in comparison with targets beforehand defined (according to biological variation or state of the art). This article reports fidelity performances obtained in 2000 and 2006 by the participants to ProBioQual internal quality controls. Considering these performances obtained in routine conditions, the different possible approaches to define acceptability limits were discussed.
法国临床实验室的当前事件引发了许多关于质量管理的讨论。建立质量保证体系可以通过增加要求列出的多种方法来实现：遵守规范性的《分析良好执行指南》（GBEA）、生物质量认证、资质认证以及最终的认可。最后这一步对应于对实验室执行特定任务能力的认可。当你准备认可程序包时，实验室所使用方法的验证是一个关键点。准确性（可重复性和可再现性）是定量方法在实验室中需要检查的参数之一。这些性能是与预先定义的目标（根据生物学变异或最新技术水平）进行比较来验证的。本文报告了参与ProBioQual内部质量控制的人员在2000年和2006年获得的准确性性能。考虑到在常规条件下获得的这些性能，讨论了定义可接受限度的不同可能方法。
