2026-03-04 Steering Committee Meeting Notes
Date
Mar 4, 2026
Attendees
(bolded names indicate attendance)
Stakeholder group | SHIELD organization | Name of SHIELD member | organization designation |
Industry Entity | Labgnostic, Inc. | Steve Box | primary |
|
| alternate | |
Epic | Dan Rutz | primary | |
|
| alternate | |
Biomerieux | Xavier Gansel | primary | |
|
| alternate | |
Roche | Nick Decker | primary | |
Roche | Open | alternate | |
Healthcare Provider | Indiana University/Indiana University Health/Association for Molecular Pathology | Mehdi Nassiri, MD | primary |
University of Wisconsin-Madison | Andrea Pitkus, PhD, MLS(ASCP)CM, FAMIA | primary | |
UT Southwestern Medical Center | Hung Luu | primary | |
UNMC | Scott Campbell | primary | |
Longtime Lab Professional | Carmen Pugh | primary | |
Sonic Healthcare / ACLA | Eric Crugnale | primary | |
Former Quest Diagnostics | Collom, Craig D | primary | |
Patient Advocate | OPEN | OPEN | individual |
Standards Organization | SNOMED International
| Jim Case | primary |
Monica Harry | alternate | ||
Regenstrief Institute
| Marjorie Rallins | primary | |
Eza Hafeza | alternate | ||
HL7
| Julia Skapik | primary | |
| alternate | ||
Professional Organization | Association of Public Health Laboratories
| Riki Merrick | primary |
Christina Gallegos | alternate | ||
Logica
| Stan Huff | primary | |
| alternate | ||
CAP
| Raj Dash | primary | |
| alternate | ||
AMP
| Robyn Temple - regrets | primary | |
| alternate | ||
Governmental - non Voting | CMS | Michael Smalara | primary |
Open | alternate | ||
ASTP/ONC | Sara Armson | primary | |
OPEN | alternate | ||
CDC | Hubert Vesper (/DDNID/NCEH/DLS) | primary | |
Jasmine Chaitram | alternate | ||
NLM | OPEN | primary | |
OPEN | alternate | ||
FDA | Keith Campbell | primary | |
alternate | |||
IICC | Serge Jonnaert | guest |
Agenda and Notes
Item | Notes |
|---|---|
Quorum evaluation (two-thirds (2/3) of the Voting Representatives shall be necessary to constitute a quorum for the transaction of business) | Currently we have 17 named members (1 open slot, future 3 openings), so 2/3 = 11 is quorum (excluding chair and government members). # of voting member per charter: 13 - 21 # of non-voting members per charter: 7 |
Open Meeting | 12:06 PM ET - quorum at 12:08 |
Vision 2030 work | Discussion today: #1 We seem to have been in this endless loop / holding pattern around lab data standardization - we have standards, but no adoption The ASTP/ONC report to congress is a well put together document, but it feels like the final version got “watered down” and it fails to address interoperabilty between the IVD and the middleware / LIS. FDA has been disengaged recently, which begs the question if we still have the goal of a clinical datahub #2 we need legislation to get adoption - this legislation should be sponsored by all of us: professional organizations, vendors, providers, academic centers and spell out a full proposal with final goal and the actions to get there We should find the different levers of the federal agencies SHIELD can collect the vision of what we want (final goal) Currently working on feedback on USCDI V7 (is some progress, but slow) Could you legislate production of LIVD file (or LIVD file content)? This will need funding to support adoption = we will fail without incentives as we saw during the COVID pandemic, these things take time and cannot be implemented in 30 days need planning for handling of PHI and security concerns on the lab side (not waiting till we have to deal with it) Intent of the ASTP report was to inform congress, so that they could do something about it, but with HTI-5 looseing certification requirements and removing references to standards it isn’t clear what the direction for the next rule will be - just relying on market forces is not going to do it Next Steps: Define the goal, identify the low hanging fruit and timelines in which adoption of the existing building blocks can be achieved and provide a phased approach to slowly raise the bar (example 20% of tests with correclty coded LOINCs the first year 50% the next) LIS is the weakest link - incentives for vendors and labs are important to move the needle - no certification requirements so far IVD instruments also have no certification requirement currently IHE connectathon testing and the capability statement venders get afterwards is similar to certification and it is already a mechanism that exists for IHE profiles We could socialize the more technical aspects with customers and help them organize to get some market pressure, but that is likely not enough - there were several surveys showing that development will only happen if mandated We could look at EDHS space as a correlary, where they are setting the rules and if vendors don’t implement them, they cannot “play” in that space / be allowed to work on government projects - this would need more research to understand how that is designed to work It would be good to understand the HTI-5 rule reasoning. Greg Pappas mentioned that the we need to get legislators involved if we want to move something - we saw that that is working with the delayed start of the funding changes described in PAMA, becasue the professional organizations pushed for that The next threat is not a new infectious disease - the next threat will be AI use - AI models learn one way, but if that is NOT the standard and other institutions don’t use the same standard, then AI will not work - example is the CIRCLE | ARPA-H proposal (due date is end of March, so we are a little too late for that one, but it is an example that we can use to raise awareness would be good to pull in the same direction with AI Will have Serge back on the call for more discussion Also have open industry slot, please send nominations |
Call adjourend | 1:02 PM ET - below not discussed |
For awareness |
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Steering Committee Membership |
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Next calls
| All SHIELD Calls
General Updates: 2024 - WG Chairs please make sure we have material for updates (at least notes we can link to) Special Topic:
Steering Committee:
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THANK YOU to all the WG Chairs for their effort in moving SHIELD work forward!!! Vocab And Standards WG next calls and call information - Julia to set up prior to next week’s All SHIELD call, so we can announce | |
https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/4171104264 | |
Placeholder to get back to later |
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From Chat:
Missed the last set - here are a few things I remember:
Carmen: I have to drop off for a work call, i hate to miss this conversation.
Andrea: Is there someone who can shed light on the HTI-5 rationale?
Agree that with the current interest of this administration in use of AI providing the means to make AI successful could help us moving the needle forward - maybe invite AI vendors . implementers to SHIELD calls to educate them on the need for standardized lab data. Similar to how SHIELD has worked with Sequoia and where Sequioa members are pledging to implement the Sequoia Interoperability guide. Maybe get professional organizations / members to pledge to implement the steps we lay out in the action plan
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