Abstract

In recent years, the field of medicine has considerably changed;an important, widespread trend is the reorganization of medical laboratories. These facilities made an effort to improve their efficiency through a process of consolidation and decentralization. In this context, Point-of-Care Testing (POCT) devices offer numerous advantages, but also pose a clinical risk, particularly in Italy, which is limited by its varied, often inadequate, regional regulations. Some examples are reported, representing scenarios of frequent or bothersome POCT use. This document outlines the SIBioC Working Group recommendations for the safe use of POCT instruments. It defines how these have been updated to the state of technologies and medical requirements. Particular attention has been paid to clinical governance, connectivity, the role of the laboratory director and staff, quality control, education, risk management and the role of the in vitro diagnostic companies. Most of the Italian medical practice is based on hospital experience, but the recent pandemic outbreak of SARS-CoV-2 forces us to re-think about the use of POCT in settings that are outside of the hospital such as local clinics, nursing homes and primary care facilities. These facilities will be the next important field of application for those indispensable tools. Networks of instruments, professionals and competence should be carefully tailored to meet local needs and specific clinical settings.

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