A Metrology-Based Quality Assurance System for Clinical Laboratories in Europe

Bernd Güttler, Chemical Physicsand Explosion Protection, Physikalisch-technische Bundesanstalt, Braunschweig, Germany (bernd.guettler@ptb.de)

The assessment of the quality of measurement results is increasingly demanded in European legislation. A central concern is to ensure the international comparability of measurement results which is achieved by traceability to common standards – typically to the SI. In laboratory medicine, the goal is to produce equivalent results for the most important measurands irrespective of the measurement procedure used or the laboratory performing the measurement.

The metrological traceability of in-vitro diagnostica (IVDs) is of central importance to achieve this goal. IVD manufacturers need to comply with legal requirements for traceability to gain and maintain market access. These requirements are defined in the regulation on in vitro diagnostic medical devices EU 2017/746 (IVDR) and include metrological traceability of calibrator and control material values by EU reference laboratories.

The European Metrology Network on Traceability in Laboratory Medicine (EMN-TraceLabMed) was established to build a coordinated metrology­ based quality infrastructure in this area. The European Association of Metrology Institutes EURAMET is, by forming EMNs, aiming to create sustainable, stakeholder­-oriented structures in areas of strategic importance for the future of European metrology.

The EMN in laboratory Medicine enhances metrological traceability of in-vitro diagnostica (IVDs), to meet regulatory requirements, and align European activities with global challenges.

The results in clinical routine laboratories are integrated in the international reference framework. This is achieved by establishing and maintaining a metrology infrastructure that helps to disseminate metrological traceability via accredited reference institutions.

In some European countries, collaborations and interactions with the involved stakeholders are already implemented on a national level and are proved to be successful. In a Europe-wide infrastructure these approaches such as the dissemination from the NMI via calibration laboratories to routine laboratories in Germany shall be integrated in a European Network.

In this presentation examples and options for a concerted activity in Europe are described.

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Short Biography of Presenting Author

Bernd Güttler studied mineralogy and crystal physics at Leibniz University Hannover (Germany) and received his Ph.D. in 1988. He joined the  University of Cambridge, (UK) in 1987 in the Department of Earth Sciences  and later moved to the Cavendish Laboratories where he was working in the Interdisciplinary Research Centre for Superconductivity. He joined PTB in 1990 starting as a senior researcher in solid-state chemistry. He became first head of the Department for Metrology in Chemistry in 2002 and then head of the Division for Chemical Physics and Explosion Protection in 2015. He represents Germany at the Consultative Committee for Chemistry and Biology of the Meter Convention (CCQM) since 2002, where he is head of the Working Group on the mole. In this capacity he framed the revised definition of the SI unit mole. He was also chair of the EURAMET Technical Committee for Chemistry (TC-MC) and is the current chair of CITAC.