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Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Test; Guidance for Industry and Food and Drug Administration Staff.

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Silver Spring, Md: Center for Devices and Radiological Health, FDA, 2018.
Abstract: 

The Food and Drug Administration (FDA or Agency) recognizes that with the increasing implementation of electronic health records (EHR), there has been a greater demand to standardize the way that in vitro diagnostic (IVD) tests are coded. Efforts to harmonize and standardize information captured and stored in electronic healthcare systems carry important implications for public health, including expediting access to patient diagnostic information for health care providers, reducing burdens on laboratories for connecting new diagnostic systems to Laboratory Information Systems (LIS), and facilitating the use of healthcare information for decision support tools, in addition to many more potential uses.

Inform ation from IVD tests form a significant proportion of all EHRs. Laboratories commonly associate a LOINC ® (Logical Observation Identifiers Names and Codes; owned , developed , and curated by the Regenstrief Institute) 1 code with each test being performed by a laboratory. For each IVD test, LOINC provides a unique numeric code associated with test attributes that identify the type of IVD test such as the component, property, time, system, scale and method. 2 At present, LOINC is the IVD coding system that is mos t widely used by clinical laboratories and EHRs, and is the IVD coding standard recommended by the Office of the National Coordinator f or Health Information Technology (ONC) in the U.S. Department of Health and Human Services (HHS) as an essential part of meaningful use.

Available at: www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm610636.pdf?utm_campaign=fda%20final%20guidance%20on%20logical%20observation%20identifiers%20names&utm_medium=email&utm_source=eloqua&elqtrackid=5996578efca1565655ba5e374f9b10fe&elq=dba5b1e97c9b4154871ec8293b063b14&elqaid=3935&elqat=1&elqcampaignid=3060.

Accessed June 18, 2018.

McDonald CJ. Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Test; Guidance for Industry and Food and Drug Administration Staff. Silver Spring, Md: Center for Devices and Radiological Health, FDA, 2018.