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Management of pre-analytical nonconformities |
Annales de Biologie Clinique. Volume 68, Number 1, 131-45, Hors série n°1, Décembre 2010, Recommandations pour l’accréditation des laboratoires de biologie médicale , Qualité et accréditation en biologie médicale. Phase pré-analytique
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Author(s) : Z. Berkane, J.L. Dhondt, I. Drouillard, F. Flourié, J.M. Giannoli, C. Houlbert, P. Surgat, A. Szymanowicz |
Summary : The main nonconformities enumerated to facilitate consensual codification. In each case, an action is defined: refusal to realize the examination with request of a new sample, request of information or correction, results cancellation, nurse or physician information. A traceability of the curative, corrective and preventive actions is needed. Then, methodology and indicators are proposed to assess nonconformity and to follow the quality improvements. The laboratory information system can be used instead of dedicated software. Tools for the follow-up of nonconformities scores are proposed. Finally, we propose an organization and some tools allowing the management and control of the nonconformities occurring during the pre-examination phase. |
Keywords : accreditation, ISO 15189, pre-examination phase, nonconformity, quality improvement |
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