2025-04-16 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 - regrets

primary

alternate

Roche

Nick Decker

primary

Roche

Yue Jin

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 - regrets

primary

UNMC

Scott Campbell - regrets

primary

Longtime Lab Professional

Carmen Pugh

primary

Sonic Healthcare

Eric Crugnale - regrets

primary

Former Quest Diagnostics

Collom, Craig D

primary

Patient Advocate

 OPEN

OPEN

individual

Standards Organization

SNOMED International

Jim Case

primary

Monica Harry - regrets

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

Graphite Health

Stan Huff

primary

alternate

CAP

Raj Dash

primary

alternate

AMP

Robyn Temple

primary

alternate

Governmental - non Voting

CMS

Michael Smalara

primary

Open

alternate

ASTP/ONC

Sara Armson

primary

alternate

CDC

Hubert Vesper (/DDNID/NCEH/DLS)

primary

Jasmine Chaitram

alternate

NLM

 John Snyder

primary

alternate

FDA

 Keith Campbell

primary

Victoria Derbyshire

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 (2 open slots), 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

12:07 PM ET, no quorum

Welcome Carmen!

Introductions

Conferences/Time critical things

AMIA November 15 - 19 in Atlanta, GA AMIA 2025 Annual Symposium Call for Participation submitted proposal

ASCLS presentation is scheduled for June 11, 2025, 8 - 9 AM PT - slides are due to ASCLS by May 16th, so need SC vote for approval before then - assume via email the week of May 12 at the latest, if we can’t get it done on SC call May 6th

USCDI Draft-V6 Feedback

Submission date was extended to May 12th, so we can keep working on this for a bit

Discuss:

The plan is to have each bullet point be voted on separately, and if approved by majority, then it will be included, else it will not be included.

• Overarching Comment:

  • Second bullet:

    • The committees that make recommendations on what to include are looking only at high level points and weighing what can be supported, so not sure we will get much traction on this one

    • they are looking at each element specifically, not sure how much good this will do

    • Prefer to at least state what we want at high level, if we agree that would be the right approach, they will do what they want in the end

• Performance Time (under Procedure):

  • why are these data elements not already in USCDI, they are critical? - because if there is a more general element that can cover the more specific they like that, which is why we are trying to explain here, that these elements don’t fit that modeling, or in the case of the test result date/time might cause more issues, when EHR-s vendors decide to model lab tests as procedures and then using the procedure hierarchy to represent lab orders

  • date/time for results of reference tests:

    • what is actually captured in the LIS when those come back?

      • is it the date/time the performing lab has on their report (that’s what it should be)

      • the date/time result was received into the LIS (have seen this in some places)

      • should we make a note about the workflow steps that labs perform, but not build into the LIS?

        • this would be too detailed and might take away from the point we are trying to make, so leave as is

• Result Unit of Measure: - leave as written

• Updated vocabulary:

  • Question about LOINC panel code: Would it still be ok to use a LOINC code for a panel that has MORE components than those listed in the panel?

    • no, should request the additional component to be added

    • LOINC is seeking feedback on how best to manage panels in LOINC

    • the statement “when an appropriate code is available” ocvers this situation in regards to our feedback

    • Who makes the determination of the right LOINC for send out tests? - this needs to be discussed, but this requirement is about HIT system functionality to allow someone to attach a LOINC code to the order, not about who is doing it

Riki will send email out to SC members to please review all the elements we have currently written up and feel free to add more / add comments etc, we will discuss more and vote on each individual top level bullet on May 7th call

SHIELD Charter Updates as shared via email sent to SC members on

Proposed Charter Updates To Article Three - March 2025 - Review the updated Article Three of the Charter as a whole

Discuss:

Note: Changes to the Charter require unanimous approval by the Steering Committee

LIDR White Paper Review and Vote - Next time

Discuss:

Roadmap section updates in response to ONC comments on the SHIELD roadmap - Next time

Reviewing Updated Roadmap: https://aphlinformatics.atlassian.net/wiki/download/attachments/3214147628/DRAFT_UpdatedSHIELD_Community Roadmap_20250402.docx?api=v2

Changes are highlighted with markup

Addressing these ONC comments:

1. Aligning the roadmap scope to the mission scope

2. Addressing the concern that all standards need training and education

• Still need to review this one:

3. There are several solutions proposed, including repositories and tools, which need to be further evaluated before ONC could fully support the roadmap.  ONC suggests the roadmap be updated to include details around feasibility, scalability and how the proposed changes can be integrated into the current laboratory ecosystem (e.g., regulation and industry).

Identify components that could improve the ecosystem infrastructure, and then highlight the places where these components can be advanced / sustained or made easier to implement. Would SHIELD be willing to consider to provide an example implementation - create the structures and bound terminologies to showcase how each element would be properly represented be working.

For each of the Consideration sections we could certainly add a section on feasibility / requirements (e.g. continued funding for LIDR, better describing the intended use of ANY data element added, overall goal of LIDR, clearly delineate what is commonly used and is minimum, provide best practice and alternatives (non-preferred) - example would be metadata around the value sets in VSAC (curation / usage etc) to be able to ascertain quality) and highlight that other mechanisms are needed to achieve for adoption.

Discussion:

Review Working Groups progress -Next time

THANK YOU to all the WG Chairs for their effort in moving SHIELD work forward!!!

Setting milestones for deliverables should be NEXT for WGs: they will be captured here: SHIELD WG Deliverables and Milestone Grid

• Laboratory Interoperability Data Registry (LIDR) Working Group

  • Waiting for SC review of the LIDR White paper (see below)

  • Working figuring out what a pilot project would entail

• IVD Data Hub

  • Exploring finding funding opportunities - current talks with Truveta (EHR data and analytics | Truveta )

    • Ongoing work with Truveta: they have an IVD hub, which is lacking the IVD test kit and instrument data in their structured data, they are now comparing unstructured data against the Biomerieux LIVD file - next meeting is scheduled

• Standards Updates and Vocabulary Working Group

  • New meeting time (once a month starting week of April 14)?

• Communications and Branding Working Group

  • SHIELD Membership Survey summary results

Placeholder to get back to later - Next time

• Electronic Health Records and Genomics AMP paper - do we need to do something with this as the Steering Committee?

• Antimicrobial result reporting

  • Related work at HL7 Europe:

• Electronic Health Records and Genomics

• Other presentations to folks at FDA?

  • Data Standards Review Committee of the FDA – work with Helena Sviglin

  • FDA Scientific Computing Board (SCB)

  • Compass group lab

Next calls - Next time

All SHIELD Calls

• April 22^nd

• May 27^th

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

Special Topic:

• May 13^th - NEED TOPIC / Overlap with HL7 WGM in Madrid - cancel?

• June 11^th - KOMET demo - the Knowledge Management Envrionment authorign tool

Steering Committee:

• May 7^th - need to vote on ASCSL presentation and also USCDI V6 Feedback

• May 21^th - Riki not available

• June 4^th

• June 18^th

Adjourned

 1:02 PM ET