Harmonization Initiatives in Europe.

INTRODUCTION: Modern medicine is more and more based on protocols and guidelines; clinical laboratory data play very often a relevant role in these documents and for this reason the need for their harmonization is increasing. To achieve harmonized results the harmonization process must not be limited to only the analytical part, but has to include the pre- and the post-analytical phases.

RESULTS: To fulfill this need the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) has started several initiatives. A Working Group on harmonization of the total testing process (WG-H) has been created with the aims of: 1) surveying and summarizing national European and pan European harmonization initiatives; 2) promoting and coordinating the dissemination of especially promising harmonization initiatives among the EFLM member societies; and 3) taking initiatives to harmonize nomenclature, units and reference intervals at a European level. The activity of the WG started this year with a questionnaire targeted at surveying the status of various harmonization activities, especially those in the pre- and post-analytical phase categories, among the European laboratory medicine societies.

CONCLUSIONS: Based on the results of the questionnaire, some activities promoting the dissemination of best practice in blood sampling, sample storage and transportation, in collaboration with WG on the pre-analytical phase, will be promoted, and initiatives to spread to all the European countries the use of SI units in reporting, will be undertaken. Moreover, EFLM has created a Task and Finish Group on standardization of the color coding for blood collection tube closures that is actively working to accomplish this difficult task through collaboration with manufacturers.