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Master Thesis

Mise en place de la norme NF EN ISO 15189 au laboratoire : application à la gestion des contrôles de qualité et à un changement de méthode de dosage

Abstract : The reform of medical biology in 2010 in France mandates the accreditation of clinical laboratory according to NF EN ISO 15189. This standard establishes requirements but it is up to biologists to determine the most appropriate way to respond. The purpose of this work is to present the various means used to answer to certain standard requirements for initial accreditation visit in our laboratory of Hormonology - Tumor Markers. We describe the application of the quality assurance requirements: internal quality control and external quality assessment. We detail among others the organization, the selection of control samples, the choice of acceptable limits, the interpretation of results, the impact studies, the review of results. Then we present the application of requirements to a change of thyroglobulin assay method: change of a RIA IRMA assay (CisBio Bioassay) to an automated chemiluminescence assay (Beckman analyzer UniCel DXI 800). We describe the methodology and the observed performance. The results between the two methods are not comparable. The impact on laboratory organization and the management of patients was evaluated and we proposed an adapted solution.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-01167478
Contributor : Bu Carreire Université de Bordeaux <>
Submitted on : Wednesday, June 24, 2015 - 3:09:07 PM
Last modification on : Wednesday, August 23, 2017 - 4:40:19 PM
Long-term archiving on: : Tuesday, April 25, 2017 - 6:08:57 PM

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Rémi Seguès. Mise en place de la norme NF EN ISO 15189 au laboratoire : application à la gestion des contrôles de qualité et à un changement de méthode de dosage. Médecine humaine et pathologie. 2015. ⟨dumas-01167478⟩

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