Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests.

On June 15^th, 2018 the FDA released a guidance attempt to standardize the way that in vitro diagnostic (IVD) tests are coded. This standardization was mainly created to assist the implementation of electronic health records (EHR) for the IVD tests. Laboratories commonly use a LOINC® (Logical Observation Identifiers Names and Codes; created by the Regenstrief Institute) code with every test that is being performed. A unique LOINC is assigned to each IVD test to identify the characteristics of the test.  Characteristics of the tests that factor into the LOINC are: components, properties, time, systems, scales, and methods. The LOINC standard is partially recognized by the FDA, where the recognition is limited to IVD tests. The guidance that was released focuses on addressing questions regarding the distribution of LOINC codes by IVD manufacturers to primarily clinical laboratories and software vendors. For more information about LOINC codes please visit https://loinc.org/.

The LOINC coding is not mandated by the FDA for IVD tests, however, a standard of coding IVD tests is encouraged and the FDA recognizes the utility of the LOINC for this purpose. The FDA supports voluntary inclusions of a LOINC code for labeling IVD tests if the information is accurate and consistent with the device’s intended use. This guidance will most likely be beneficial to those manufacturing and using IVD tests as it will help spread information about the tests and how they will be used.

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