An overview of EFLM harmonization activities in Europe

Abstract

The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has initiated many harmonization activities in all phases of the examination process. The EFLM is dealing with both the scientific and the educational aspects of harmonization, with the intention of disseminating best practice in laboratory medicine throughout Europe. Priorities have been given (1) to establish a standard for conducting and assessing biological variation studies and to construct an evidence based EFLM webpage on biological variation data, (2) to harmonize preanalytical procedures by producing European guidelines, (3) to improve test ordering and interpretation, (4) to produce other common European guidelines for laboratory medicine and play an active part in development of clinical guidelines, (5) to establish a common basis for communicating laboratory results to patients, (6) to harmonize units of measurement throughout Europe, (7) to harmonize preanalytical procedures in molecular diagnostics and (8) to harmonize and optimize test evaluation procedures. The EFLM is also now launching the 5th version of the European Syllabus to help the education of European Specialists in Laboratory Medicine (EuSpLM), which is being supported by the development of e-learning courses. A register of EuSpLM is already established for members of National Societies in EU countries, and a similar register will be established for specialists in non-EU countries.

Alanine Aminotransferase Results Differ by Analyzer Manufacturer in a National Integrated Health Setting, 2012–2017

“…To address ALT measurement differences by analyzer, manufacturers could standardize their analyzers against an objective reference population, as has been attempted in Europe. 18,19 In the United States, the Food and Drug Administration has recently started the Food and Drug Administration-Systemic Harmonization and Interoperability for Enhancement of Laboratory Data (SHIELD) program, a pilot for inclusion of the unique device identifier for each lab result as metadata. 20 This would allow health care organizations to implement decision support and reference ranges based on the type of device used.…”