Guidelines for the management of point-of care testing nonconformities according to the EN ISO 22870

Guidelines for the management of point-of care testing nonconformities according to the EN ISO 22870

In this paper, guidelines are proposed to fulfill the requirements of EN ISO 22870 standard regarding the management of point-of-care testing (POCT) nonconformities. In the first part, the main nonconformities that may affect POCT are given, the means for resolution and the control of adverse events...

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Veröffentlicht in:Annales de biologie clinique (Paris) 2012-02, Vol.70 Spec No 1, p.249-260
Hauptverfasser: Houlbert, C, Annaix, V, Szymanowicz, A, Vassault, A, Guimont, M C, Pernet, P
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Sprache:fre
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Zusammenfassung:In this paper, guidelines are proposed to fulfill the requirements of EN ISO 22870 standard regarding the management of point-of-care testing (POCT) nonconformities. In the first part, the main nonconformities that may affect POCT are given, the means for resolution and the control of adverse events are proposed. In the second part, we propose recommendations in case of unavailability of a point-of-care testing device from the occurring of the adverse event, to the restarting of the device.
ISSN:1950-6112