[Point-of-care testing: place of France in the world National survey in healthcare establisments in 2019]

Abstract

The point-of-care tests (POCT) are subject to accreditation. A national inventory survey provides a synthesis of knowledge. The survey distributed 31 questions in 2019. 147 responses were received (75% biologists, 49% CHU, 42% CHG). Only 20.41% are accredited ISO22870, the majority for <50% of the medical departments; 70% say they are going there at the end of 2019 or in 2020. The maps are unknown for 32% (EBMD) and 82% (TROD). Visibility is poor with: medical establishment committee (40%), IT department (31%). Connection is necessary for 87-95% depending on the criterion (QC, authorizations, etc.) and 66% of answers highlight that less than 50% of connexion is effective. The major advantage is the delay of the result (62.5%), then the relationship with the health teams (33.3%). The disadvantages: difficulty of the quality approach (45%), cost of tests (34.3%). Human resource requirements are identified for technicians (82%) and biologists (76%). The multiplicity of sites, devices and operators means that it is difficult to set up and maintain. Biology outside the laboratories, under biological responsibility, must meet a rigorous imperative quality approach.

Keywords: ARS; AS; Agence régionale de santé; CLIA; CME; COVID-19; CQ; Clinical laboratory improvement amendements; Cofrac; Comité français d’accréditation; Comité médical d’établissement; DIV; DM; EBMD; GHT; Groupement hospitalier de territoire; IDE; ISO 22 870; PBP; PCR; POCT; RAQ; SF; TDR; TROD; accreditation; aide-soignant; contrôle de qualité; diagnostic in vitro; dispositifs médicaux; examens de biologie médicale délocalisée; infirmier diplômé d’Etat; polymerase chain reaction; pôle de biologie et pathologie; responsable assurance qualité; sage-femme; survey in France; test de diagnostic rapide; test rapide d’orientation diagnostique.