Analysis of clinical specimens to obtain information about the health of a patient.

Data Element

Information from the submission form

Test Result Harmonization Status

Harmonization status indicates equivalency of results across platforms and vendors, ie, a harmonized test for a particular analyte and specimen yield results equivalent to other harmonized tests for that analyte and specimen. Harmonization is required for full clinical interoperability of test results. Results from harmonized tests may be interpreted and trended together, and may use the same calculation and decision support rules. Machine learning models may be trained and applied to data sets from different test platforms and vendors if the tests are harmonized. Tests that are not harmonized do not yield comparable results and should be interpreted and processed separately, not in aggregate with other tests. Incorrect assumption of harmonization status is a serious patient safety risk, and lack of harmonization information impedes public health interpretation of test results.


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