2026-06-17 Steering Committee Meeting Notes

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

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

Monica Harry

alternate

Regenstrief Institute

Marjorie Rallins

primary

Eza Hafeza - regrets

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 - regrets

primary

Scott Campbell

alternate

AMP

Robyn Temple

primary

alternate

Governmental - non Voting

CMS

Michael Smalara

primary

Open

alternate

ONC

Sara Armson

primary

 OPEN

alternate

CDC

Hubert Vesper (/DDNID/NCEH/DLS)

primary

Jasmine Chaitram

alternate

NLM

OPEN

primary

OPEN

alternate

FDA

OPEN

primary

alternate

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

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

• Submissions for upcoming conferences:

  • Abstracts for HIMSS 2027 due ​Jun 30, 2026 - we don’t have anything prepared that would be different from the submission form last time, which got rejected

• CLIA in congress: https://www.congress.gov/bill/119th-congress/house-bill/8890/text?s=1&r=1&hl=clia

  • AMP is keeping an eye out

  • affects LDTs, mentions a centralized dB for those, so maybe could expand LIDR to piggy-back off that effort, if there is funding?

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

Updates to Codes for Outbreaks

Hantavirus and Ebola LOINCs: - more Hanta virus updates coming soon along with the new LIVD file; Ebola will be later

• APHL is also researching process to coordinate the communication between the SDOs and outbreak response organizations for the future

• CPT codes needed?

• have been talking with John Snyder about diagnosis codes that might be needed for Andes virus

• Found OraSure Technologies Submits Improved Rapid Ebola Test to FDA for Emergency Use Authorization | 360Dx

  • but we could not find it on FDA website:

  • verified that there is no current EUA out there and the 2014 one for Zaire was rescinded

  • There is however a PREP declaration for Hantavirus

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 is scheduled for Tuesday, ​Jun 23, 2026 10-11 AM EDT

HL7 WGM in Bethesda joint meeting with FDA, ONC and CMS or other participants that are in the area possible?

Sep 19-24th HL7 is at Marriott in Rockville - in person meeting for SHIELD members? Potentially another DC area site.

If we do Q5: 5:30 - 7 PM (1.5 hours), HL7 will not charge participants registration - is that enough time?

From our SC survey these are the counts I have:

APHL’s HQ is in Bethseda and I am checking on availabliity of meeting rooms suggest either afternoon on ​Sep 24, 2026 (maybe overlapping with HL7 Q3 and 4, which starts at 1:45 PM so we have more than 1.5 hours) or we could meet ​Sep 25, 2026 all day, except for many that will be a preferred travel day, so aiming for the morning).

Riki will send a survey to ALL SHIELD list for feedback on how long and what day is preferred and who would attend virtually.

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:

Need to find date to re-invite Serge - consider aiming for ​Aug 11, 2026, so we have some time to polish the text; kight use the Special Topic calls as working sessions

Discussion today:

• the CLIA congress bill for LDT lists a potential for a central database, so could that be a mechanism to support LIDR development for commercial test

• could we ask IVD vendors (in additon to Michael) what data is expected for monitoring, so that we can better understand what data needs to be in real world data to be useful here - Riki to reach out to ALL SHIELD group for input (also include the ask to identify any barrier for creating LIVD files / LOINC mappings for their tests - from ​Apr 29, 2027 call notes!)

• Have better understanding of Serge’s approach - will he just be the conduit for the letter, because he has connections or?

• Do we have a realistic proof of concept with a work product that we could support?

  • like the lab reporting proficiency testing electronically (IHE PaLM is wrting the PMW profile to suppor that - CAP planning to adopt - need to make sure other PT vendors know about it

  • proof of concept LIDR file for PT testing

  • Public health reporting use case as a service/tool for coding - make the content piece easier for labs to implement

ALL: Feel free to make changes directly in the googledoc, so we have more fodder for discussion on our next call

Next calls

All SHIELD Calls

• ​Jun 30, 2026

General Updates: 2024 - WG Chairs please make sure we have material for updates (at least notes we can link to)

Special Topic:

• ​Jul 14, 2026 or ​Aug 11, 2026

Steering Committee:

• ​Jul 1, 2026 and ​Jul 15, 2026

Call adjourned

1:04 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)