2026-08-11 Steering Committee Meeting Notes

Date

Aug 11, 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
	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 - regrets	primary
	OPEN	OPEN	primary
	Longtime Lab Professional	Carmen Pugh	primary
	Sonic Healthcare / ACLA	Eric Crugnale - regrets	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)	primary
	CDC	Jasmine Chaitram	alternate
	NLM	OPEN	primary
	NLM	OPEN	alternate
	FDA	OPEN	primary
	FDA		alternate
Guest	IICC	Serge Jonnaert

Agenda and Notes

Item	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:?? PM ET
Vision 2030 work	https://docs.google.com/document/d/11A9VyhtSGm9dCjJNOi7_eJzz3gPDMYhkmNCoQNVbxuo/edit?tab=t.0#heading=h.yp9lsvo5yvsf Discussion: we have mature standards avaliable that are implementable we should make an inventory of available standards describe the carrot and stick strategy we can get endorsed and then funded by all members of the federal government we are working with (ONC, CDC, CMS, FDA) ONC’s Report to Congress was missing the connection between IVD instruments / middleware to LIS ONC’s Report to Congress was missing call to action Do we need to look at mandate for public tenders like Europe is doing? We should reach out to the various committees in congress like HELP and others that oversee the funding to HHS Labs seem to be asking for mandates - we won’t implement until we have to (federal mandate or financial reasons) Vision statement is more granular than the elements in the ONC Report to Congress inventory of standards would be very helpful At the SHIELD F2F we aim to come up with activites to focus on and prioritize those and intergate into a strategy How do we get more IVD vendors to embrace adoption of the LIVD Standard (thank you IICC for that work)? HELP Committee has proposed to build a database of LDTs - could we work with FDA to get the same for 510k tests? Have been missing FDA participation for the last 2 years - still the case Reviewing 2 RFI’s - should submit responses to: CLIA (due Sep 14, 2026) - AI use in lab, specimen preparation, suboptimal specimen (e.g. acceptability, specimen condition, rejection), blood culture contamination information, data only facilities, cybersecurity, preparedness, competencies etc: CMS (due Sep 16, 2026) - Duplicate lab testing, software as a service, genetic sequencing, redefining :applicable labroatory”, lab interoperabililty barriers, stnadards and incentives, use of FHIR etc: Proposal to focus on common lab tests' (based on PT, Common LOINCs, CMS reimbursement, Sequoia physician list) coding and get those implemented over time In RFI’s FACA findings were cited, but those FACA, like CLIAC have been removed, so could comment on that RFIs are helpful, one way to publicize public comment, but how can we be more proactive, rather than responding? Wishlist: implementable interoperability framework national repository of clinical data (we should have that now, since COVID) Create inventory list of standards and actions and present to congress; attach costs and impact to each (the ONC report to Congress did that at a high level, maybe we need more granular?) Rather than just technincal input would be great if we coudl get formal endoresment of actions / strategy from all SHIELD members Certification of systems only goes so far, we need certification of production systems Support by LIS vendors for LOINC, SCT, HL7 V2.5.1 messages Support by IVD vendors for LIVD (with LOINC, SCT etc) Incrementally increase the certification requirements on implemeners (EHR-s have had 10+ years of that, but LIS still has nothing) Make more folks in congress aware of the RFI responses Competing priorities for CDC, but we support this effort as much as we can technical merrit does not move the market - need to have financial advantage for implementers to do that certifying systems is less valuable than certifying implementations / production use Is ONC report to Congress distributes to all members of congress? Next Steps (last 15 minutes!): Share Serge’s email with the SC members Respond to RFIs and include linkage for each possible action to one or more of the 4 main points he calls out that should be important to congress: National Security and Pandemic Readiness / Patient Safety / Economic Competitiveness / Neutrality factor (innovation barriers) - if we can provide costs for each propsed action (T-shirt size) might also be helpful along with the impact of each (highlight the ‘what’ and the ‘why’) Reach out to congress committees to make them aware of ONC report to congress and SHIELD’s vision statement and highlight the fact that while interoperability has been going on for decades, we are only incrementally closer to a working interoperabilty framework - might not be possible for SHIELD as a whole, but might be doable for some SHIELD members Review and potentially re-order the action items in the Vision Statement Get SHIELD members to approve the Vision Statement and maybe even endorse it
Call adjourned	12:54 PM EDT

From Chat:

Action items

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

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

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

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

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)

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

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

Quick decisions not requiring context or tracking

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Decisions requiring context or tracking

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