[Guidelines for selection and implementation of a point-of-care testing device according to the EN ISO 22870 and French regulation]. / Recommandations pour le choix et la mise en place d'un dispositif de biologie médicale délocalisé.

ABSTRACT

Implementation is the main step of the point-of-care testing (POCT) device installation process to comply with EN ISO 22870. The multidisciplinary POCT management group is in charge to align that process with the standards but also with the French regulation (ordinance 2010-49 of 13 January 2010) which authorizes POCT only in case of urgent therapeutic decisions. This article defines two reports to be prepared during the deployment of a POCT device a report that justifies the use of a POCT device, taking into account a risk-benefit analysis and a report that justifies the choice of the device including proofs of conformity of its installation.