SPECIAL COVID-19 NOTICE
Clinical laboratories that are looking for information on proper handling and coding of COVID-19 tests can find more information here:
- LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Tests
Using LOINC and SNOMED-CT to identify and report SARS-CoV-2 test results in electronic reporting systems will facilitate timely and quality data reporting to state and federal public health agencies.
https://www.cdc.gov/csels/dls/sars-cov-2-livd-codes.html - Weekly CDC Laboratory Outreach
CDC’s Division of Laboratory Systems (DLS) convenes a weekly call every Monday at 3:00 PM EDT with clinical laboratories to discuss the nation’s clinical laboratory response to coronavirus disease (COVID-19). https://www.cdc.gov/safelabs/resources-tools/covid-19-weekly-clinical-calls.html/LOCS0406 - FDA COVID-19 Virtual Town Hall Series
The FDA is holding virtual Town Halls for clinical laboratories and commercial manufacturers related to provide Coronavirus (COVID-19) Diagnostic Tests
https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-town-hall-series-immediately-effect-guidance-coronavirus-covid-19-diagnostic-tests-05132020 - LOINC
https://loinc.org/sars-coronavirus-2/ and https://loinc.org/prerelease/ - SNOMED-CT
https://www.snomed.org/news-and-events/articles/COVID-19-added-to-GPS; https://confluence.ihtsdotools.org/display/snomed/SNOMED%2BCT%2BCoronavirus%2BContent - CDC COVID-19 Information for Laboratories
https://www.cdc.gov/coronavirus/2019-ncov/lab/index.html - CDC Interim Laboratory Biosafety Guidelines
https://www.cdc.gov/coronavirus/2019-nCoV/lab/lab-biosafety-guidelines.html - CDC Laboratory Biosafety Frequently Asked Questions
https://www.cdc.gov/coronavirus/2019-ncov/lab/biosafety-faqs.html - FDA COVID-19 Emergency Use Authorization (EUA) Information
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations - FDA COVID-19 Frequently Asked Questions
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/coronavirus-disease-2019-covid-19-frequently-asked-questions - FDA COVID-19 Updates
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov - WHO
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance/laboratory-guidance
The IVD Industry Connectivity Consortium (IICC) is a global, nonprofit organization dedicated to creating and encouraging adoption of a unified connectivity standard to reduce the cost and variability of data exchange between IVD devices and healthcare informatics in clinical laboratories. This will improve healthcare efficiency and patient care.
In Collaboration With
The IICC has collaborated with several government bodies and industry organizations to develop two standards that together allow for true Plug & Play connectivity of IVD instruments to Middleware and Laboratory Information Systems (LIS):
- LAW – Laboratory Analytical Workflow Profile – The LAW Profile 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. 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 LAW [ click here ]
- 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 [ click here ]
Why are LAW and LIVD important for clinical laboratories?
The LAW Profile and LIVD specifications should have a significant positive impact on laboratory operations. Clinical laboratories are encouraged to ask their instrument, middleware, and LIS vendors about their current or planned support for the IICC/IHE Laboratory Analytical Workflow (LAW) and LIVD. The LAW Profile is currently being implemented by all major IVD companies.
- LAW and LIVD will significantly reduce the time and cost involved with deploying, connecting, and updating instruments in the laboratory by eliminating the need for vendor customized connectivity implementations, favoring vendors that adopt the specifications and pass the savings to their customers.
- Addresses all the shortcomings of outdated laboratory connectivity standards such as CLSI LIS1-A (ASTM 1391) and CLSI LIS2 (ASTM E1394).
- LAW will be a global standard (CLSI AUTO16).
- LAW and LIVD support federal guidelines on Meaningful Use.
- Improves the integrity of patient data.
- The LAW and LIVD specifications are available for download and do not require any licensing or fees for implementation.
Clinical Laboratory Connectivity before and after LAW and LIVD
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IVD Industry Connectivity Consortium Founding Members
