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EURAMET’s European Metrology Network ‘TraceLabMed’ successfully engages with internationally recognised stakeholders in laboratory medicine
Laboratory medicine results affect medical decisions that are made throughout a patient’s lifetime; from blood spot screening for new-borns, to the monitoring of albumin protein levels for senior citizens. Usually, laboratory testing is carried out through in vitro diagnostics (IVDs) – industrially manufactured test kits that are applied to blood or tissue samples to detect diseases and monitor overall patient health. Ideally, laboratories should be able to produce the same reliable result for any given analyte that is measured, in order for the measurement in question to be claimed as traceable. In fact, measurement traceability is so important to medical laboratories that European policymakers continue to enforce stringent traceability requirements for values assigned to calibrators and control materials – through legislation like the IVD Regulation (IVDR).
Despite this, a high percentage of laboratory tests currently used in medicine are neither harmonised (traceable to certain agreed references), nor standardised (traceable to the International SI System of Units that underpins measurements all around the world). EURAMET’s European Metrology Network for Traceability in Laboratory Medicine (EMN TraceLabMed) is working to integrate measurement science with laboratory research, and to strengthen healthcare services with the provision of more reliable medical testing. To achieve this objective, the EMN is focused on developing open and active communication with stakeholders, ensuring that their needs are incorporated into EURAMET’s research initiatives to improve the metrological traceability of in vitro diagnostics. This focus on well-defined stakeholder needs and experiences will form a key pillar of the EMN’s work to support more positive outcomes for patients across Europe.
At the kick-off launch event of the EMN, manufacturers, external quality assessment (EQA) providers and international organisations had the opportunity to present their thoughts and opinions about the measurement reliability of these key diagnostic tools. The German Diagnostics Industry Association provided an industry perspective of the impact on in vitro diagnostic regulation on manufacturers – explaining the significance of the newly-implemented requirement for product portfolios to be certified by Notified Bodies.
The launch event also included keynote talks from external quality assessment providers, given by representatives from the Reference Institute for Bioanalytics (RfB), the Society for Promoting Quality Assurance in Medical Laboratories (INSTAND) and the Wales External Quality Assurance Scheme (WEQAS). Contributions from these stakeholders offered invaluable insight into how traceability in laboratory medicine can be achieved and also highlighted the role of external quality assessment providers. Despite the indirect effects of EU regulation felt by this particular stakeholder group, they still make a decisive contribution to the traceability chain by conducting ring trials for external quality control - with medical laboratories as their customers. A representative from INSTAND, Michael Spannagl, emphasised the importance of embracing both standardisation and harmonisation for the successful advancement of laboratory medicine.
From the RfB, Anja Kessler shed further light on the impact of regulation on external quality assessment providers. She comments:
“Reference measurement procedures and reference materials allow us to determine target values of EQA samples with the highest level of accuracy and precision. Commutable and value assigned EQA schemes can help to identify analytes that need improved standardisation / harmonisation. Developing new RMPs and RMs is an enormous workload that requires scientific work of interdisciplinary networks - the RfB therefore welcomes EURAMET’s initiative.”
As well as these critical stakeholder perspectives, Ian Young, chair of the Joint Committee for Traceability in Laboratory Medicine (JCTLM), also stressed the need for evidence of the economic benefits of standardisation. The JCTLM is a leading international consortium that promotes the global standardisation of clinical laboratory test results and provides information on reference materials, measurement methods and worldwide services. As such, input from this group is considered to be particularly crucial for developing the strategic agenda of the EMN. In his talk, Ian Young also touched on the topic of prioritisation, stemming from the belief that standardisation at present is often triggered by individuals and is not based on clinical priorities. Here, a change for the better requires better communication between lab professionals, clinicians, external quality assessment providers and the metrology community – a view that is shared by Philippe Gillery, chair of the Scientific Division of the IFCC, and Robert Wielgosz, director of the Chemistry Department at the BIPM and executive secretary of the JCTLM.
The TraceLabMed network has continued to strengthen its relationships with standardisation and laboratory medicine groups through other activities as well, including its participation in the biennial JCTLM members’ and stakeholders’ meeting of December 2019. At this particular meeting, the EMN chair, Rainer Stosch, informed event attendees about the network’s aims and current activities, and network members were able to take part in a workshop to promote ‘working together towards standardization in laboratory medicine’. Rainer Stosch, comments on the JCTLM event:
“The consensus opinion of the event was that co-ordination among actors in the field must be effectively promoted and maintained. This is entirely consistent with what we’ve learned during the kick-off and I’m confident that this is the right time for the metrology community to step up their efforts in connecting with stakeholders.”
Importantly, the EMN has taken concrete steps to communicate its message to the wider metrology and measurement science community. In the autumn of 2019, David Auerbach from the network delivered a presentation at the widely-publicised 19th international metrology congress (CIM) – a bi-annual conference to explore measurement challenges, R&D and best practices for metrology in industry. This was a crucial opportunity for the EMN to introduce itself to the numerous metrologists who attended the conference, which was successfully utilised with a presentation outlining its strategies and planned activities.
From its very beginnings, the EMN’s unfailing efforts to form new relationships with key stakeholders and to strengthen existing contacts have shaped its service-oriented approach to promoting the concept of metrological traceability. TraceLabMed continues to ensure their planned activities are aligned to their stakeholders’ foremost need; improving communication within the laboratory medicine community to support better healthcare.
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