The roadmap for harmonization: status of the International Consortium for Harmonization of Clinical Laboratory Results

Abstract

Abstract The International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR) was established to fulfill recommendations identified by an international conference convened to review the available infrastructure and challenges in achieving harmonization of results among different measurement procedures. The specific objectives of the ICHCLR are to: prioritize measurands by medical importance, coordinate the work of different organizations, and stimulate development of technical and regulatory processes to achieve harmonization. Central to these objectives is the website “www.harmonization.net” developed by the ICHCLR as an information portal designed to provide a resource center for global activities to harmonize and standardize results from clinical laboratory measurement procedures. Priorities based on medical impact are provided for measurands for which harmonization is needed or work to implement harmonization is incomplete or inactive. By making information available regarding harmonization activities in progress or planned, coordination of work to harmonize laboratory measurement procedures will minimize duplication of effort and optimize the use of limited resources. A toolbox of technical procedures developed by ICHCLR to be considered when developing a process to achieve harmonization for a measurand is presented. The ICHCLR initiated a proposal to ISO Technical Committee 212 for a harmonization protocol as the basis for calibration traceability when there are no other higher order reference system components available. The ICHCLR offers a unique service to prioritize measurands in need of harmonization and to provide a centralized approach to organize global efforts to achieve harmonization of clinical laboratory test results.