2026-07-15 Steering Committee Meeting Notes

Date

Jul 15, 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 - regrets	primary
			alternate
	Biomerieux	Xavier Gansel	primary
			alternate
	OPEN	OPEN	primary
	OPEN	OPEN	alternate
Healthcare Provider	Quest Diagnostics, Seattle, WA	Mehdi Nassiri, MD - regrets	primary
	University of Wisconsin-Madison	Andrea Pitkus, PhD, MLS(ASCP)CM, FAMIA	primary
	UT Southwestern Medical Center	Hung Luu	primary
	OPEN	OPEN	primary
	Longtime Lab Professional	Carmen Pugh	primary
	Sonic Healthcare / ACLA	Eric Crugnale	primary
	Harvard	Li Zha	primary
Patient Advocate	OPEN	OPEN	individual
Standards Organization	SNOMED International	Jim Case	primary
	SNOMED International	Monica Harry	alternate
	Regenstrief Institute	Marjorie Rallins	primary
	Regenstrief Institute	Eza Hafeza	alternate
	HL7	Julia Skapik	primary
	HL7		alternate
Professional Organization	Association of Public Health Laboratories	Riki Merrick	primary
	Association of Public Health Laboratories	Christina Gallegos	alternate
	Logica	Stan Huff	primary
	Logica		alternate
	CAP	Raj Dash - regrets	primary
	CAP	Scott Campbell	alternate
	AMP	Robyn Temple	primary
	AMP		alternate
Governmental - non Voting	CMS	Michael Smalara	primary
	CMS	Open	alternate
	ONC	Sara Armson	primary
	ONC	OPEN	alternate
	CDC	Hubert Vesper (DDNID/NCEH/DLS) - regrets	primary
	CDC	Jasmine Chaitram	alternate
	NLM	OPEN	primary
	NLM	OPEN	alternate
	FDA	OPEN	primary
	FDA		alternate

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	12:09 PM ET - no quorum
Follow up items	NLM and FDA participation: John Snyder is asking about decision for NLM Reached out to contacts for FDA Collaborative Community and lead in OHT7 - they are working on finding a resource HTI-5 expected in August HTI-6 expected in November FDA statement: Genomic results are “not” the same as lab test results - re-analyzing the sample genomics result against a NEW VERSION of the library CMS rule: CMS RFI: Federal Register :: Request for Information; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations - comments due by Sep 14, 2026 repeat testing differentiating re-interpretation of existing result values on specimen from the initial result creation Upcoming rules listing:
SC Members	Scott Campbell now at CAP and will replace Raj as primary CAP representative, Kevin will be alternate - Riki requested email to that effect for records - still open
Updates to Codes for Outbreaks	Hantavirus LIVD file should come out soon Will work on Ebola LIVD later APHL is also researching process to coordinate the communication between the SDOs and outbreak response organizations for the future
Review SHIELD WG Deliverables and Milestone Grid	THANK YOU to all the WG Chairs for their effort in moving SHIELD work forward!!! The Standards and Vocab WG first call was held on Tuesday, Jun 23, 2026 10-11 AM EDT - start out with once a month on the third Tuesday - need call invite JULIA!!!
HL7 WGM in Bethesda joint meeting with FDA, ONC and CMS or other participants that are in the area possible?	Updated spreadsheet: realized that Monday is Yom Kippur, so we shoud not plan a meeting then. APHL time options are 8:00 AM - 5:30 PM, for Friday would have to be at APHL; for Thursday afternoon, I’d have to double-check with MaryAnn. Stan prefers Wed at HL7 - he was the only one with a preference, so Riki will confirm with MaryAnn and then we will send out the calendar hold Review Potential Agenda Items next copule of calls: 1.Short term interoperability goals/recommendations (aligned with Vision) 2.Top lab tests for national adoption 3.Blockers and what's needed to overcome 4.ONC presentation on their lab interoperability goals. (What they can share. areas of focus so SHIELD can align) 5.Presentation about SHIELD, interop challenges, needs to any congressional reps (education, conversation) 6.Conversation with FDA on need for discrete, searchable test details (510 K). Do they have details? Website issue? What would address? Emphasize need for PH among others (COVID, Hanta, Ebola, etc.) 7.Conversation with other agencies/entities on lab topics in their area? (e.g. CLIA, SDOs, NLM, Rachel Dunscombe from HL7?) 8.Conversation on IVD vendors on how to get LIVD maps from them (those not yet providing). Ideas, how to execute and by which entities/people, by when? Longer term needs (Vision) discussion - specific semantic concept modeling 10.Next Steps Need to develop time blocks for agenda, Goals, Questions. Next Steps. Maybe 15 min presentation, 15 min Q&A, 15 min discussion 10 min Next Steps w point person and by when. Invite congressional folks related to the CLIA LDT database?
Vision 2030 work	https://docs.google.com/document/d/11A9VyhtSGm9dCjJNOi7_eJzz3gPDMYhkmNCoQNVbxuo/edit?tab=t.0#heading=h.yp9lsvo5yvsf Follow up from last call when discussed see minutes: Serge is available Aug 11, 2026, Discussion today: wordsmithed in document directly, added the clinical burden back in, making sure we state that SHIELD is unfunded and cannot do the LIDR development work without funds Next steps: Add a section on who SHIELD is Add a section that explains the LIVD / LIDR relationship and that both are a means to the same goal, jsut require different funding approaches Might be good to list the steps to achieve our goals by feasibility / timing (short, middle, long-term) -
Next calls	All SHIELD Calls Jul 28, 2026 General Updates: 2024 - WG Chairs please make sure we have material for updates (at least notes we can link to) Special Topic: Aug 11, 2026 meet with Serge Steering Committee: Aug 5, 2026
Call adjourned	1:58 PM ET
	not discussed
Placeholder to get back to later	Antimicrobial result reporting - CAP Informatics Commitee will request feedback from Standards and Vocab WG Any updates from CAP? Other presentations to folks at FDA? Data Standards Review Committee of the FDA FDA Scientific Computing Board (SCB) Compass group lab Next HTI rule (whenever it comes out)

From Chat:

Action items

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For Vison 2030 identify the low hanging fruit and pick timelines and phased adoption goals

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All review the ASTP/ONC Lab Data Interop report and pull out items that SHIELD can support / identify the order of steps needed to improve adoption and provide a feasible timeline and phased milestone list

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LIS vendor certification incentives (or IHE Connectathons and capability statements)

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CAP proficiency testing pilot to include UDI in the interface and gather LOINCs for the tested platforms and review and update, where needed, then import that into LIDR and make public - LIDR WG addressing this one

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Find high return PH/emergency preparedness use cases for PH pilot and LIDR population (we already have the crowdsourced LIVD file, maybe see, if we can’t get more active participation in filling it out)

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Robyn and Scott will brainstorm on next steps for creating guidance document around when to use free text vs discrete data vs coded discrete data and other implementation guidance around coding

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Gather lists of qualitative results from LabCorp (Carmen) ARUP (Jenna), SonicHealth (Eric)

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