Harmonization in laboratory medicine: more than clinical chemistry?

Abstract The goal of harmonizing laboratory information is to contribute to quality in patient care, ultimately improving upon patient outcomes and safety. The main focus of harmonization and standardization initiatives has been on analytical processes within the laboratory walls, clinical chemistry tests in particular. However, two major evidences obtained in recent years show that harmonization should be promoted not only in the analytical phase but also in all steps of the testing process, encompassing the entire field of laboratory medicine, including innovative areas (e.g. “omics”) rather than just conventional clinical chemistry tests. A large body of evidence demonstrates the vulnerability of the extra-analytical phases of the testing cycle. Because only “good biological samples” can assure good analytical quality, a closer interconnection between the different phases of the cycle is needed. In order to provide reliable and accurate laboratory information, harmonization activities should cover all steps of the cycle from the “pre-pre-analytical” phase (right choice of test at right time for right patient) through the analytical steps (right results with right report) to the “post-post-analytical” steps (right and timely acknowledgment of laboratory information, right interpretation and utilization with any necessary advice as to what to do next with the information provided). In addition, modern clinical laboratories are performing a broad menu of hundreds of tests, covering both traditional and innovative subspecialties of the discipline. In addition, according to a centered viewpoint, harmonization initiatives should not be addressed exclusively to clinical chemistry tests but should also include all areas of laboratory medicine.