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JUNE 1, 2017
By: IVD Industry Connectivity Consortium
Chicago, IL – June 1, 2017 – The IVD Industry Connectivity Consortium (IICC) today announced the LIVD specification for digital publication of LOINC to vendor IVD test results in clinical laboratories. Along with the IICC/IHE LAW Profile -soon to be recast as CLSI AUTO16- LIVD allows IVD instruments and IVD software systems to efficiently and unambiguously exchange test results, with vendor defined IVD tests associated with a set of predefined LOINC codes that identify the distinct observations produced by the test.
According to Ed Heierman, the IICC’s CTO “LIVD assures that laboratory personnel select the appropriate LOINC codes for vendor IVD test results used by their laboratory. It also allows LIS systems to automatically map the correct IVD vendor test result to a LOINC code.”
The LIVD specification outlines an IVD industry-defined format to facilitate the publication and exchange of LOINC codes for vendor IVD test results, based on either vendor IVD test transmission codes or manual test identification, for use by laboratory personnel or laboratory applications. The format can be used as-is by IVD software systems to automate the mapping between vendor IVD test transmission codes and LOINC codes, significantly reducing the risk of erroneously mapped test results and units of measure (UCUM).
“The LIVD Specification addresses a major pain point for today’s clinical laboratory” stated Serge Jonnaert, President of the IVD Industry Connectivity Consortium “Complementing the IICC/IHE LAW Profile, 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. With more vendors announcing products that will support both the IICC/IHE LAW Profile and LIVD Specification, Laboratory Managers and hospital CIOs should demand compliance to the standards in future tenders” he continued.
The LIVD specification was a collaborative effort between the IVD Industry Connectivity Consortium, IHE Pathology and Laboratory Medicine (PaLM), Regenstrief Center for Biomedical Informatics, the U.S. Centers for Disease Control and Prevention (CDC), and the U.S. Food and Drug Administration (FDA) as a result of the Workshops on Promoting Semantic Interoperability of Laboratory Data at the National Institutes of Health (NIH) in 2016. The LIVD specification adopts the same definition of interoperability laid out by the Office of the National Coordinator for Health IT (ONC) in its Interoperability Roadmap.
The LIVD initiative has already received numerous accolades:
“Development of this new common format for publishing mappings from IVD vendor test results to LOINC codes is major advance for interoperability of laboratory data. As IVD vendors make such mappings available, it will greatly improve the efficiency and consistency with which laboratories can deploy standard terminology in their information systems.”
Daniel J. Vreeman, PT, DPT, MS
Director, LOINC and Health Data Standards Regenstrief Center for Biomedical Informatics
“The standard LIVD digital format produced by IICC and major IVD manufactures will enable IVD manufactures to distribute electronic mappings between their internal test codes and universal test identifiers (LOINC codes). 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. 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. The effort by IVD manufacturers to produce the LIVD format is a spectacular example of good corporate citizenship that will yield many benefits to the health of the nation.”
Clem J. McDonald, MD
Director, Lister Hill National Center for Biomedical Communications, National Institutes of Health
“Innovation can only occur once standardization has taken place. Much of the innovative laboratory result analytics being done in research at Geisinger Health System would be difficult, if not impossible, without first applying LOINC to our 350+ million laboratory results for accurate identification. LOINC also provides a platform from which to normalize laboratory result values for a given LOINC code to a single unit of measure, which further streamlines the analytics process. IICC’s LIVD digital format for vendor publication of LOINC content is a significant step forward that will support a laboratory’s ability to not only adopt LOINC but to also maintain LOINC information over time.”
John Snyder, DTR, RDN
Henry Hood Center for Health Research, Geisinger Health Systems
“As one of the participants in this initiative, MDIC strongly believes that the work will greatly enhance information interoperability with accuracy and consistency between IVD vendors and clinical laboratories. Adoption and implementation of this new common format will facilitate efficiency in IVD evidence generation including clinical studies and real-world evidence”
Jing Xie, PhD
Vice President, Clinical Affairs, Medical Device Innovation Consortium (MDIC)
“This specification lays an indispensable step towards unambiguous representation of test results in lab and further downstream. Availability of these LOINC mappings to vendor IVD test results will be an additional facilitator for lab system configuration in countries like France, where LOINC is part of the national interoperability framework and required to communicate lab results to EHR systems.”
François Macary
Semantic Interoperability Manager at Phast, IHE PaLM Technical Committee Cochair
The enhanced vendor test format contains 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 uses JSON (JavaScript Object Notation), a lightweight, global industry standard format with a simple syntax that is also human readable.
The LIVD specification and related samples can be downloaded from:
http://ivdconnectivity.org/livd/
The LIVD specification and IICC/IHE LAW Profile will be demonstrated at the 69th AACC Annual Scientific Meeting & Clinical Lab Expo in San Diego, CA (July 30–August 3) at the IICC booth #1955.
Contact:
Serge Jonnaert
President – IVD Industry Connectivity Consortium
/ President, tensei llc
/ Board Member, At-Large – IHE International
T: +1(949)259-3807
E: serge.jonnaert@tensei.com
Logical Observation Identifiers Names and Codes (LOINC) is a database and universal standard for identifying medical laboratory observations. First developed in 1994, it was created and is maintained by the Regenstrief Institute, a US nonprofit medical research organization. LOINC was created in response to the demand for an electronic database for clinical care and management and is publicly available at no cost. Reference labs, healthcare organizations, U.S. federal agencies, insurance companies, software vendors, in vitro diagnostic testing companies, and more than 45,300 registered users from 165 countries use LOINC to move data seamlessly between systems.
LOINC® is a registered United States trademark of Regenstrief Institute, Inc. All other trademarks cited herein are the property of their respective owners.