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

• Published in: Annales de biologie clinique (Paris) Vol. 78; no. 4; p. 363
• Main Authors: Beauvieux, Marie-Christine, Bost, Erika, Castaing-Mouhica, Gladys, Terral, Catherine, Berthon, Nathalie, Martinel, Isabelle, Chauzit, Emmanuelle
• Format: Journal Article
• Language: French
• Published: France 01.08.2020
• Subjects: Accreditation; Clinical Laboratory Services - standards; Clinical Laboratory Services - statistics & numerical data; Clinical Laboratory Techniques - standards; Clinical Laboratory Techniques - statistics & numerical data; Coronavirus Infections - diagnosis; Coronavirus Infections - epidemiology; COVID-19; COVID-19 Testing; France - epidemiology; Global Health - standards; Global Health - statistics & numerical data; History, 21st Century; Humans; Internationality; Laboratories - standards; Laboratories - statistics & numerical data; Laboratory Proficiency Testing - standards; Pandemics; Pneumonia, Viral - diagnosis; Pneumonia, Viral - epidemiology; Point-of-Care Systems - standards; Point-of-Care Systems - statistics & numerical data; Point-of-Care Testing - organization & administration; Point-of-Care Testing - standards; Point-of-Care Testing - statistics & numerical data; Quality Assurance, Health Care - organization & administration; Surveys and Questionnaires; France; ARS; Comité français d’accréditation; RAQ; test rapide d’orientation diagnostique; Clinical laboratory improvement amendements; pôle de biologie et pathologie; survey in France; Agence régionale de santé; aide-soignant; DM; IDE; ISO 22 870; contrôle de qualité; COVID-19; GHT; SF; EBMD; POCT; dispositifs médicaux; CME; Cofrac; accreditation; responsable assurance qualité; CLIA; polymerase chain reaction; PBP; TDR; test de diagnostic rapide; diagnostic in vitro; infirmier diplômé d’Etat; CQ; DIV; AS; Groupement hospitalier de territoire; TROD; examens de biologie médicale délocalisée; sage-femme; Comité médical d’établissement; PCR
• DOI: 10.1684/abc.2020.1572

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.