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Consortium Releases New Interoperability Standard for Lab IT Systems

With the release of a new information technology (IT) standard, the dream of true interoperability of electronic health care information has gotten one step closer to reality. The new standard, called LIVD maps in vitro diagnostic (IVD) test results directly to the Logical Observation Identifiers Names and Codes (LOINC) code set for identifying lab procedures and results.

In other words, LIVD enables the automated transfer of test results directly to laboratory information systems and electronic health records, without transmitting plain text or non-machine-readable PDF reports. Previously there was not a unique relationship between LOINC codes and each individual test.

The standard was released by the IVD Industry Connectivity Consortium in collaboration with Integrating the Healthcare Enterprise’s (IHE’s) Pathology and Laboratory Medicine domain, Regenstrief Center for Biomedical Informatics, the U.S. Centers for Disease Control and Prevention, and the U.S. Food and Drug Administration and was based on efforts resulting from the National Institutes of Health’s (NIH’s) 2016 workshops on Promoting Semantic Interoperability of Laboratory Data. The LIVD specification adopts interoperability, as defined by the Office of the National Coordinator for Health IT’s Interoperability Roadmap.

The LIVD specification outlines an IVD industry-defined format to facilitate the publication and exchange of LOINC codes for vendor IVD test results.

“This effort will accelerate the inclusion of universal LOINC codes in laboratory reports to clinicians and health care systems because it will eliminate the additional laboratory effort now needed to figure out the right LOINC code for each laboratory test,” said Clem J. McDonald, M.D., director of the Lister Hill National Center for Biomedical Communications at the NIH, in a statement. “The increasing use of universal LOINC codes in laboratory reports will unleash the same wave of efficiency and quality improvements as bar codes did for grocers and retailers.”

LIVD complements IHE’s Laboratory Analytical Workflow (LAW) profile, which contains rules for exchanging orders and results between IVD devices and health IT systems. Together, LIVD and LAW offer a “plug-and-play” solution.

While some vendor systems began documenting PDF instructions on how to associate LOINC codes with laboratory information systems, it was a manual process and a potential source of errors. The new standard allows automatic sending of lab values to the electronic health records and enables units of measure standardization to normalize laboratory result values.

“The LIVD specification addresses a major pain point for today’s clinical laboratory,” said Serge Jonnaert, president of the IVD Industry Connectivity Consortium, in a statement. “We finally have a true plug-and-play solution to interface IVD instruments to middleware and LIS systems. Clinical laboratories will no longer be subjected to outrageously high fees for custom connectivity implementations.”

It has been reported that Abbott Laboratories, Roche, and BioMérieux are among the companies that committed LIVD will available on product websites for labs to download. It is hoped that in the future there may be a central web-based portal to act as a repository of files, but for now downloadable versions of the LIVD specifications are available voluntarily by manufacturers.

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