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Implementing HHS reporting requirements of COVID-19 test results and future epidemics: a call to IVD companies for immediate action

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Mid 2020, the FDA contracted Deloitte to conduct a pilot with several key laboratory groups in the US, which included an investigation on their adoption and use of LIVD, as stated in the HHS requirement. It became quickly apparent that very few IVD vendors had LIVD catalogs or pre-assigned LOINC codes for tests running on their instruments, let alone where aware of the stated requirement. The IVD Industry Connectivity Consortium tried to assist but many calls to IVD companies remain unanswered to date.

Why IVD Companies Should Act First

The last ten years we have seen an unprecedented collaboration between industry, government, and standards organizations towards the development of well-defined, practical, modularized, and easier to implement interoperability standards; and yet, adoption is still significantly lagging, partially due to the absence of laboratory informatics stakeholder representatives. Most laboratories installing new instruments are forced to revert to specifications that are now more than fifteen years old and no longer meet a laboratory’s contemporary data interoperability and security needs.

The IVD instruments is the ultimate source of the clinical test results, so IVD manufacturers must assure that their instruments can capture and properly present the required data in a harmonized semantic format downstream to EHRs, and research and public organizations. This equally extends to middleware and LIS vendors. To assist clinical laboratories to meet the above-mentioned HHS requirement, all systems upstream and downstream must adopt support for the same standardized data elements.

IVD companies should:

  • Create LIVD catalogs for their instruments. The LIVD mapping catalogue requires coding for these data elements: LOINC test order, LOINC test result, and Device Identifier and provides fields to describe all allowable specimen as well as detail about expected results and comments that may be helpful to understand the coding. This goes beyond just COVID-19 tests. IVD manufacturers are encouraged to adopt LIVD for all tests running on their instruments, preferably made available to customers electronically using the HL7® FHIR® LIVD definition. LIVD V2.0 may be implemented under a royalty-free public license. Ideally a consensus could be reached to have a central repository hosted by the FDA, IICC, Regenstrief, or other. The LIVD specification can be downloaded here http://ivdconnectivity.org/livd/
  • Implement CLSI AUTO16 (analog of IICC/IHE Laboratory Analytical Workflow Profile). It defines plug-n-play connectivity between instruments, middleware, and laboratory information systems in the clinical laboratory, improving interoperability, reducing connectivity installation cost and time, and improving integrity of patient and QC data. It essentially assures that the required RWD elements for IVD Test Results necessary to support RWE are captured and transmitted downstream, no a vital component in the national response to COVID-19. The specification can be downloaded here https://clsi.org/standards/products/automation-and-informatics/documents/auto16/
  • Explore implementing SNOMED-CT where appropriate. The specification* can be viewed here https://www.hl7.org/fhir/snomedct.html
  • Actively contribute and participate in standards development and promotion initiatives. Never has the need for industry to collaborate on unified standards been higher. Many areas of the broader healthcare ecosystem (including IVD) still shun the adoption of interoperability standards for fear that it may expose them to competitive pressures. Other industries have proven that standards lead to lowering research and development costs, improve speed to market, and quality and safety of products and services. It also serves the greater good, in this case, allowing the rapid aggregation and analysis of data for epidemiology data and treatment discovery.

COVID-19 exposed our healthcare system’s current inability to collect and aggregate quality epidemiology data in a timely manner without significant pains and inefficiencies. Adoption of the called for interoperability standards represent an opportunity that should not be missed. Laboratories should evaluate the tangible benefits that these standards offer their operations, and mandate compliance in all future procurement tenders for any and all health systems. We owe it to the common good to assure that we get better prepared to respond to future pandemics. Industry working closer together on open interoperability can be a big contributor thereto. Stay safe. Stay healthy.

Serge Jonnaert is President of the IVD Industry Connectivity Consortium, Senior Vice President for technology mergers and acquisitions at the Corum Group Ltd, former board member at large of Integrating the Healthcare Enterprise International, and a member of the FDA-sponsored systemic harmonization and interoperability enhancement for lab data (SHIELD) workgroup.

Ed Heierman, PhD, is Chief Technology Officer of the IVD Industry Connectivity Consortium, a product software architect at Abbott Laboratories, chair of the CLSI automation and informatics expert panel, and a member of the SHIELD workgroup.

References

(*) Standard currently in trial use

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