[How to accredit bedside total hemoglobin measurement with the HemoCue® point-of-care device?] / Accréditer la mesure de l'hémoglobine totale au lit du malade sur équipement de biologie délocalisée de type HemoCue®.

HemoCue® point-of care devices are widely used in Bordeaux university hospital center to assess hemoglobin in critical situations, with 45 devices in 13 health units. Based on our experience, we here propose essential steps in order to prepare the accreditation file. We develop risks analysis, mandatory validation method check points, and caregiver professional training. Among the tasks, precise reference quality instructions i.e. instruction for use, maintenance and troubleshooting should be available. We also share reflections to offer solutions to encountered difficulties. The implemented quality management must rely on a solid and involved laboratory organization. A strong caregiver membership also appears to be the key to move forward.

[Point-of-care testing: place of France in the world National survey in healthcare establisments in 2019]. / Examens de biologie médicale délocalisée : place de la France dans le monde Enquête nationale en 2019 dans les établissements de santé.

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.