IVD Industry Connectivity Consortium

11/17/2020

The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) launch the "COVID-19 At-Anywhere Diagnostics Design-A-Thon", an initiative to help develop technical innovations to help fight COVID-19.

To support a data-driven response to the coronavirus pandemic, America is looking for better ways to capture COVID-19 diagnostic data

10/06/2020

https://www.gofundme.com/f/in-memory-of-dr-michael-waters

Dear family and friends: For months, Dr. Michael Waters worked tirelessly, weekdays and week… Duy Ngo needs your support for In memory of Dr. Michael Waters

08/20/2020

U.S. Department of Health & Human Services (HHS) mandates use of IICC’s Laboratory In Vitro Diagnostics (LIVD) standard for COVID-19 laboratory testing data reporting
On June 4, 2020 the U.S. Department of Health & Human Services (HHS) issued a guideline requiring that all COVID-19 (SARS-CoV-2) related laboratory testing data be reported using the appropriate LOINC and SNOMED codes, as defined by the IICC’s Laboratory In Vitro Diagnostics (LIVD) test code mapping.

https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf

LIVD (digital format for publication of LOINC to vendor IVD test results) defines the digital publication of LOINC using vendor defined IVD tests associated with a set of predefined LOINC codes. LIVD assures that laboratory personnel select the appropriate LOINC codes for IVD test used by their laboratory. It also allows LIS systems to automatically map the correct IVD vendor test result to a LOINC code.

03/19/2020

For looking for links to information on proper handling and of tests, click here https://ivdconnectivity.org

10/15/2019

The Office of the National Coordinator for Health Information Technology (ONC) recently adopted the IIVD Industry Connectivity Consortium’s Laboratory Analytical Workflow (LAW) and LOINC for IVD (LIVD) specifications in its Interoperability Standards Advisory (ISA).

05/19/2019

The IVD Industry Connectivity Consortium (IICC) celebrates its 10th Anniversary with the Publication of CLSI AUTO16 for Clinical Laboratories

This April, the IVD Industry Connectivity Consortium (IICC) celebrated its 10th Anniversary. The event coincided with the official publication of the Clinical and Laboratory Standards Institute’s AUTO16 (Next-Generation In Vitro Diagnostic Instrument Interface, 1st Edition), the standard for which...

05/03/2019

The IVD Industry Connectivity Consortium (IICC) celebrates its 10th Anniversary with the Publication of CLSI AUTO16 for Clinical Laboratories

This April, the IVD Industry Connectivity Consortium (IICC) celebrated its 10th Anniversary. The event coincided with the official publication of the Clinical and Laboratory Standards Institute’s AUTO16 (Next-Generation In Vitro Diagnostic Instrument Interface, 1st Edition), the standard for which...

01/26/2019

Our latest article on clinical laboratory connectivity in the January 2019 issue of Clinical Lab Products.

Adoption of the new standards for laboratory connectivity has broad benefits for all stakeholders in the healthcare ecosystem.

09/18/2018

FHIR Connectathon 19 in Baltimore to feature testing opportunity for IICC LIVD (LOINC to In Vitro Diagnostic)

The FHIR Connectathon will be held Saturday Sept 29 and Sunday Sept 30 at the Hyatt Regency Baltimore Inner Harbor, Baltimore, MD prior to the Sept. HL7 Working Group Meeting. It will feature several tracks, including testing of LIVD (LOINC to In Vitro Diagnostic) on FHIR, the standard for health care data exchange published by HL7®.

LIVD defines the digital publication of LOINC using vendor defined IVD tests associated with a set of predefined LOINC codes. It assures that laboratory personnel select the appropriate LOINC codes for IVD test used by their laboratory. It also allows LIS systems to automatically map the correct IVD vendor test result to a LOINC code. The objective of LIVD on FHIR is for IVD vendors to make their publication available at least as a file (e-mail, downloadable, CD, website link) or on a FHIR server.
The Connectathon is a great format where participants can get together and test their software implementation of updates to FHIR using real-world scenarios in an informal and live way. Onsite access to FHIR test servers is provided. Sufficient time is provided for break-out sessions for demonstrations and in-depth discussions.

If you or your company are interested in participating in the FHIR Connectathon 19

http://www.hl7.org/events/working_group_meeting/2018/09/

HL7 International Working Group Meetings (WGMs) are held three times per year at varying locations and serve two important purposes:

09/06/2018

IVD Industry Connectivity Consortium launches initiative to verify the applicability of its LAW Profile to microbiology

The IVD Industry Connectivity Consortium™ (IICC) today announced a new initiative to verify the applicability of its LAW Profile to microbiology. The Laboratory Analytical Workflow Profile (LAW) defines the physical connection, message definitions (based on the HL7 Messaging Standard v2.5.1), and workflow definitions between instruments, middleware, and LIS systems in the laboratory.

The IVD Industry Connectivity Consortium will start a new working group open to its members to establish that the existing IHE LAW profile (CLSI AUTO16) can be used by microbiology middleware. The expected outcome will be a guidance document describing how to implement the IHE LAW profile between microbiology instruments and LISs and middleware. If warranted, the working group will submit a change proposal to the IHE PaLM (Pathology and Laboratory Medicine) domain in order to update the LAW profile to accommodate specific microbiology requirements.

IICC collaborated with the IHE Pathology and Laboratory Medicine (PaLM) domain to develop the LAW Profile. LAW is currently being implemented by all major IVD companies.

For more information on the IVD Industry Connectivity Consortium and the IICC/IHE Laboratory Analytical Workflow (LAW) go to:

The IVD Industry Connectivity Consortium (IICC) is dedicated to creating and encouraging the adoption of a unified connectivity standard for data exchange between IVD devices and healthcare informatics.

09/06/2018

FDA encourages the adoption of the IVD Industry Connectivity Consortium’s LIVD format for distribution of LOINC codes for IVD tests

The US Food and Drug Administration published a Guidance for Industry and Food and Drug Administration Staff, titled ”Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests” in which it encourages the adoption of the IVD Industry Connectivity Consortium’s LIVD format for distribution of LOINC codes for IVD tests. The FDA recognizes LIVD as a consensus standard that contributes to greater semantic interoperability within and across laboratories.

LIVD (Digital Format for Publication of LOINC to Vendor IVD Test Results) defines the digital publication of LOINC using vendor defined IVD tests associated with a set of predefined LOINC codes. LIVD assures that laboratory personnel select the appropriate LOINC codes for IVD test used by their laboratory. It also allows LIS systems to automatically map the correct IVD vendor test result to a LOINC code.

For more information on LIVD go to http://ivdconnectivity.org/livd/

For a copy of the June 15, 2018 FDA Guidance for Industry and Food and Drug Administration Staff, titled ”Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests” go to
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM610636.pdf