Harmonization of Clinical Laboratory Information - Current and Future Strategies.
According to a patient-centered viewpoint, the meaning of harmonization in the context of laboratory medicine is that the information should be comparable irrespective of the measurement procedure used and where and/or when a measurement is made. Harmonization represents a fundamental aspect of quality in laboratory medicine as its ultimate goal is to improve patient outcomes through the provision of an accurate and actionable laboratory information. Although the initial focus has to a large extent been to harmonize and standardize analytical processes and methods, the scope of harmonization goes beyond to include all other aspects of the total testing process (TTP), such as terminology and units, report formats, reference intervals and decision limits, as well as tests and test profiles request and criteria for interpretation. Two major progresses have been made in the area of harmonization in laboratory medicine: first, the awareness that harmonization should take into consideration not only the analytical phase but all steps of the TTP, thus dealing with the request, the sample, the measurement, and the report. Second, as the processes required to achieve harmonization are complicated, a systematic approach is needed. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has played a fundamental and successful role in the development of standardized and harmonized assays, and now it should continue to work in the field through the collaboration and cooperation with many other stakeholders.
Department of Laboratory Medicine, University Hospital of Padova , Padova, Italy.
Mario
M
Plebani
harmonization; interchangeability; patient safety; quality; quality indicators; standardization; total testing process; traceability
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