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IVD Industry Connectivity Consortium
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IICC develops and promotes a unified IVD connectivity standard.
IICC develops and promotes a unified IVD connectivity standard.

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IVD Industry Connectivity Consortium announces LIVD specification for digital publication of LOINC to vendor IVD test results in clinical laboratories
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)

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.












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VITEK® 2 System connectivity enhanced with support for the ICC/IHE LAW Profile and LOINC®

bioMérieux has updated its VITEK® 2 system for automated identification and antimicrobial susceptibility testing with software version 8.01 that is fully compliant with the IICC/IHE Laboratory Analytical Workflow (LAW) profile. The IICC/IHE LAW profile defines plug-n-play connectivity between instruments, middleware, and LIS systems in the laboratory. An IICC founding member, bioMérieux successfully tested its LAW Profile implementation at three IHE Connectathons in the USA and Europe. With this new interface, VITEK® 2 system software version 8.01 also supports LOINC® codification. Implementation of this connectivity standard in the VITEK® 2 system will help improve healthcare lab efficiency and contribute to better patient care through increased reliability of test order data and patient test results.

http://ivdconnectivity.org/vitek-2-system-connectivity-enhanced-support-iccihe-law-profile-loinc/

+biomerieuxdiagnostic #LOINC @IHE #connectivity #clinicaldiagnostics #ivd

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IVD Industry Connectivity Consortium tackles vendor specific LOINC codes

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


#digitalhealth #healthIT #interoperability #ivd #diagnostics #connectivity #LOINC #HL7 #FDA #CDC @IVDConnectivity

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IVD Industry Connectivity Consortium (IICC) to present at Public Workshop on Promoting IVD Semantic Interoperability of Laboratory Data

The IVD Industry Connectivity Consortium (IICC) will present a JSON based vendor defined format for IVD Tests Documents using LOINC at the November 8 Public Workshop on Promoting IVD Semantic Interoperability of Laboratory Data. This should make it easier for laboratories to find the correct LOINC codes for the tests that they run on their instruments.


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A recent interview in @captodayonline about the future of clinical laboratory connectivity. @serge_jonnaert @tensei_llc
http://www.captodayonline.com/beyond-connectivity-middlewares-shifting-shape/

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Clinical Laboratory Connectivity - IICC/IHE Laboratory Analytical Workflow (LAW) Final Text Published

The IHE Pathology and Laboratory Medicine (PaLM) Technical Committee has published the final text of the IICC/IHE Laboratory Analytical Workflow (LAW). The LAW standard provides plug-n-play connectivity between instruments, middleware, and LIS systems in the laboratory and is currently being implemented by all major IVD companies. Clinical laboratories are encouraged to ask their instrument, middleware, and LIS vendors about their planned support for the IICC/IHE Laboratory Analytical Workflow (LAW).

http://www.ihe.net/uploadedFiles/Documents/PaLM/IHE_PaLM_Suppl_LAW.pdf

Details on online conformity testing through the IHE Gazelle platform and the IHE Conformity Assessment program will be announced in the coming weeks.

Serge Jonnaert
President
IVD Industry Connectivity Consortium 
serge.jonnaert@ivdconnectivity.org
https://www.linkedin.com/in/sjonnaert
www.ivdconnectivity.org


The IVD Industry Connectivity Consortium – IICC (www.ivdconnectivity.org) is a global, nonprofit organization that has worked with several standards organizations to develop a new interoperability framework that provides plug-n-play connectivity between instruments, middleware, and LIS systems in the laboratory.

The resulting IICC standard is documented in the IHE Laboratory Analytical Workflow (LAW) profile. It was recently selected by the European Union to be part of the eHealth European Interoperability Framework (eEIF) and will be the basis for the upcoming Clinical and Laboratory Standards Institute (CLSI) AUTO16 standard for next generation In Vitro Diagnostic (IVD) instrument interfaces.

IICC members include Abbott Diagnostics, Beckman Coulter, Becton Dickinson, bioMérieux, Data Innovations, Orchard Software, Ortho Clinical Diagnostics, Roche Diagnostics, Siemens Healthcare Diagnostics, and Systelab Technologies, S.A.


@OpenQAP, @interopshowcase, @MedInterop, @ehrandhit, @eHealthDC, @HealthStandards, @HIMSS, @ONC_HealthIT, @HITNewsTweet,@CLN_AACC, @FierceMedDev, @MedscapePath, @ivdtechnology, @mnt_medicaldev, @med_diagnostics, @ldtimmerman, @TheDeviceGuy, @ivdt, @ClinicalDx, @Dark_Daily, @CLPmag, @LabMedica @LabManager @ADVANCEforLab @Clin_Chem_AACC @LabTestsOnline @CLN_AACC, @Pathologists @_AACC @labsoftnews, @CLSI_LabNews, @AdvaMedUpdate, @IBFmedtech, @meddevicegroup, @MedDeviceGurus, @FDAcdrhIndustry, @medtecheurope, @medicaldevices, @QmedNews, @MedTechWorld, @Rock_Health
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We need your insights & opinions regarding clinical laboratory connectivity

The IVD Industry Connectivity Consortium (IICC) is sponsoring a quick survey to gather feedback about the state of #connectivity in the #clinical #laboratory. It should take no more than a few minutes to complete. Can we count on you to participate? Please do share this survey invitation with professional colleagues through email and social media. If you would like to receive a copy of the results, also provide your contact information upon completing the survey.

http://survey.tensei.com/s_tensei/2015-middleware-survey.htm

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IICC Conducts Live Plug and Play Instrument Demonstration of ASTM/LIS01/LIS02 replacement standard at AACC 2015

+AACC +ASTM International  #diagnostics  +HIMSS @IHE_USA

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EU selects IICC/IHE Laboratory Analytical Workflow (LAW) for eHealth European Interoperability Framework (eEIF)

#europeanunion   #ehealth  #InteropRoadmap
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