John Libbey Eurotext




Guidelines for validation of the results in laboratory medicine
Annales de Biologie Clinique. Volume 70, Number 1, 23-46, Hors série n°1, Février 2012 - Recommandations pour l’Accréditation des laboratoires de biologie médicale - Volume 2, Qualité et accréditation en biologie médicale. Phase post-analytique
Résumé PDF
Author(s) : A. Perrin, M. Vaubourdolle, A. Vassault, A. Szymanowicz, JM. Giannoli, A. Suiro, F. Doucet-Populaire, JP. Lionne, A. Boutten
Summary : The validation of the results is defined as the review and verification of the coherency and likelihood of the whole results of the examination for a patient, taking into account needed clinical data, uncertainty of measurement and anteriority's as well. The signature of the authorized person certifies this validation according to the requirements of the French regulation and ISO standard as well. Recommendations are given for the organization of this step specially for duty periods and in case of utilization of an expert system software. Requirements about the content, the release and the signature of the reports are given. A quality indicator applied to the control of the validation process is proposed.
Keywords : accreditation, ISO 15189, results validation, expert system, results report, electronic signature

Guidelines for validation of the results in laboratory medicine