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2016/11/18
The IVD Industry Connectivity Consortium (IICC) presented its proposal for vendors to use when publishing LOINC for their IVD Tests at the November 8 Workshop on Promoting Semantic Interoperability of Laboratory Data at the National Institutes of Health (NIH) in Bethesda, MD.
The workshop was organized by the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH) to receive and discuss input from industry stakeholders regarding proposed approaches to promoting the semantic interoperability of laboratory data between in vitro diagnostic devices and database systems, including laboratory information systems and electronic health records.
LOINC (Logical Observation Identifiers Names and Codes) is currently the main vocabulary for identifying laboratory and clinical observations to electronically report test results. Unfortunately, to use LOINC, laboratories must still map their local codes to terms in the standard, a process that remains unnecessarily complex and error-prone as there is not always a one-to-one relationship between the tests that are run on laboratory instruments and existing LOINC codes. Erroneous mapping can result in the reporting of incorrect patient test results, with potentially detrimental consequences. This also prevents the industry from adopting a true plug-and-play connectivity standard that guarantees 100% correct and effortless test mapping.
The new IICC approach, presented by Ed Heierman, should make it easier for laboratories to find the correct LOINC codes for the tests that they run on their instruments. The format is human readable, assuring that laboratory personnel select the appropriate LOINC codes for vendor IVD test results used by their laboratory. IVD software systems may also be able to automatically map the correct IVD vendor test result to a LOINC code.
The enhanced vendor test format would contain extended data elements, including the manufacturer, the instrument model, an instrument universal identifier (UID), the vendor transmission code, vendor specimen description, vendor result description, the test name, as well as optional data elements (e.g. a reference ID to the package insert, additional instructions or comments related to the test). The proposed data exchange format will use JSON (JavaScript Object Notation), a lightweight, global industry standard format with a simple syntax that is also human readable.
The proposed format will now be formalized in a draft specification that will be presented at the next workshop, scheduled for December. Any parties interested in receiving a copy of the specification should email info@ivdconnectivity.org
For more information on the IVD Industry Connectivity Consortium and the IICC/IHE Laboratory Analytical Workflow (LAW) go to: www.ivdconnectivity.org
Contact: Serge Jonnaert
President, tensei llc
/ President – IVD Industry Connectivity Consortium
/ Board Member, At-Large – IHE International
T: +1(949)259-3807
E: serge.jonnaert@tensei.com