Quality Control

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.

Clinically relevant lot-to-lot reagent difference in a commercial immunoturbidimetric assay for glycated hemoglobin A1c

Objectives: Hemoglobin A1c (HbA1c) is employed for diagnosis and therapy monitoring of diabetes mellitus. The effect of a change of reagent lot on the measured values of a commercial immunoturbidimetric HbA1c assay (A1C3) was investigated.

Kennen Sie Ihr Labor? Ein Weg zur Selbstbewertung in medizinischen Laboratorien nach dem EFQM-Modell

The association Institut für Qualitätsmanagement in Medizinischen Laboratorien (INQUAM) promotes the principle of excellence and supports medical laboratories
on their way to the first step of the quality management system of the European Foundation for Quality Management “Committed to Excellence” with an adapted
matrix for self-evaluation of medical laboratories.

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