Clinical Chemistry

Learning Health Systems and Laboratory Medicine

Health systems worldwide struggle to provide the optimal treatment amid the rapid pace of scientific progress and frequent structural changes. Learning health systems (LHS) that continuously analyze their data to generate evidence and to enable informed decisions have been proposed as a possible solution. This paper investigates the involvement of laboratory medicine in LHS and evaluates relevant systems according to their scope, enabling technologies, architecture for evidence generation, data-action latency, and social aspects. While laboratory medicine provides a central source of information in many large-scale LHS, there are also systems with a particular focus on laboratories. For example, external quality assessments are performed by sending samples with known quantities to laboratories worldwide to verify their analytical methods. This data are also analyzed for other purposes, such as post-market surveillance of devices. These schemes have operated successfully over several decades. Newer, innovative tools harvest the possibilities of wearable devices and increased connectivity. LHS in laboratory medicine need to be recognized and incorporated into systems of systems to generate better evidence. Further research on the roles of other stakeholders will identify opportunities and obstacles for building and maintaining successful LHS.

Fremdes POCT in sicheren Händen?

In der neue Medizinprodukte-Betreiberverordnung (MPBetreibV) wird klarer definiert, wer für die Anwendung eines Point-of-Care Tests (POCT) verantwortlich ist. Ausschlaggebend ist nicht, wem das Gerät gehört, sondern wer es tatsächlich benutzt. Dadurch können sich für eine Gesundheitseinrichtung weitreichende Konsequenzen ergeben.

Sicheres POCT durch kompetente Anwender

In den letzten Jahren wurde die analytische Qualität vieler Point-of-Care Tests kontinuierlich verbessert. Mittlerweile sind diese patientennahen Tests aus dem diagnostischen Leistungsspektrum vieler Labore nicht mehr wegzudenken. Aber eine gute Analytik alleine reicht nicht aus. Während in einem Zentrallabor eine geringe Anzahl gut ausgebildetes Fachpersonal sich mit der Durchführung klinisch-chemischer Analysen beschäftigt, werden Point-of-Care Tests von vielen, sehr heterogenen Anwendern durchgeführt.

Central Laboratory Service and Point-of-Care Testing in Germany - From Conflicting Notions to Complementary Understandings

Point-of-care testing (POCT) enables health care personnel to perform laboratory medicine tests near the patient. The underlying technology and the range of test parameters available are evolving rapidly. Thus, a series of clinical applications are possible that can shorten the time for clinical decision-making about additional testing or therapy, as delays are no longer caused by preparation of clinical samples, transport, and central laboratory analysis.

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