In the risk assessment of point-of-care services, the aim is to provide a robust service that provides the right result on the right patient every time. Here, Carole Gough looks not only to standards in the laboratory, but also to international risk management standards applicable across, for example, the pharmaceutical, medical device and aviation industries.
Clinical diagnostic testing is traditionally performed in a laboratory environment with medical scientists trained specifically for the task at hand, and a robust quality system in place.
By contrast, point-of-care testing (POCT) devices can be used and operated by multiple users from disparate backgrounds. Each operator’s skill level is different and performing diagnostic testing does not have to be the operator’s core area of expertise.
In addition, as POCT becomes increasingly decentralised into the community and at-home testing, we must remain cognisant of the quality assurance and governance necessary for the implementation and use of such tests in new and decentralised settings.
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