Harmonization: the Sample, the Measurement, and

Harmonization of clinical laboratory results means that results are comparable irrespective of the measurement procedure used and where or when a measurement was made. Har-monization of test results includes consideration of pre-analytical, analytical, and post-ana-lytical aspects. Progress has been made in each of these aspects, but there is currently poor coordination of the effort among different professional organizations in different coun-tries. Pre-analytical considerations include terminology for the order, instructions for prepa-ration of the patient, collection of the samples, and handling and transportation of the sam-ples to the laboratory. Key analytical considerations include calibration traceability to a ref-erence system, commutability of reference materials used in a traceability scheme, and specificity of the measurement of the biomolecule of interest. International organizations addressing harmonization include the International Federation for Clinical Chemistry and Laboratory Medicine, the World Health Organization, and the recently formed International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR). The ICHCLR will provide a prioritization process for measurands and a service to coordinate global harmoni-zation activities to avoid duplication of effort. Post-analytical considerations include nomen