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.
Highlights
There are many activities currently being undertaken under the broad heading of “harmonization” in laboratory medicine [1]
These can be divided into two main components, the first being activities aimed at improving the metrological comparability of laboratory results and the second being actions based on reducing unnecessary between-laboratory variation in test requesting and reporting
That while External Quality Assurance (EQA) traditionally addresses analytical quality, the EQA process can be applied to other aspects of laboratory activities and can be used to assess both differences in other factors e.g. units, reference intervals and test names, as well as changes in response to interventions [2,3,4]
Summary
There are many activities currently being undertaken under the broad heading of “harmonization” in laboratory medicine [1] These can be divided into two main components, the first being activities aimed at improving the metrological comparability of laboratory results and the second being actions based on reducing unnecessary between-laboratory variation in test requesting and reporting. Examples of the latter include the use of common test names, units and reference intervals as well as the development of clinical guidelines to allow application of evidence-based decision making across countries, regions or the world. The development of clinical guidelines, which include the use of laboratory results, requires an understanding of result variability to ensure recommendations including specific decision points can be validly used in different locations
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