The role of EQA in harmonization in laboratory medicine – A global effort

Abstract

There are many activities currently being undertaken in the field of laboratory medicine under the broad heading of “harmonization”. These include traceability of results to international reference standards, processes to align results from assays where traceability has not been achieved (analytical harmonization) and international or national clinical guidelines based on studies from many parts of the world. Many of these issues are global in nature, with clinical evidence derived from studies performed in all parts of the world and multinational diagnostic companies providing assays worldwide. As with all aspects of medicine, progress can only be assured where these is evidence of effectiveness of the activities. External Quality Assurance (EQA) programs are designed to meet this need. Currently EQA processes have significant limitations in meeting the global needs of the laboratory medicine community. This paper aims to identify the steps that can be taken to allow current and future EQA programs to provide information on global variation in results. It is only by being aware of result differences that steps can be taken to improve performance.