2025-05-07 Steering Commitee 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

Roche

Nick Decker - regrets

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

primary

UNMC

Scott Campbell

primary

Longtime Lab Professional

Carmen Pugh

primary

Sonic Healthcare

Eric Crugnale

primary

Former Quest Diagnostics

Collom, Craig D

primary

Patient Advocate

 OPEN

OPEN

individual

Standards Organization

SNOMED International

Jim Case - regrets

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

Graphite Health

Stan Huff

primary

alternate

CAP

Raj Dash - regrets

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

1:12 PM ET no quorum

Conferences/Time critical things

AMIA November 15 - 19 in Atlanta, GA https://amia.org/education-events/amia-2025-annual-symposium/call-participation submitted proposal - no update

ASCLS presentation is scheduled for June 11, 2025, 8 - 9 AM PT - slides are due to ASCLS by May 16th - was emailed to list - any feedback - will ask for eVote and feedback (make sure to rename file to refelct ASCLS!)

ADLM reached out to request a webinar about SHIELD later this year

Andrea gave presentation at ASCLS WI conference and mentioned SHIELD - was presentation about LOINC and SNOMED CT adoption

https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/3052175362

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.

Discuss:

Laboratory Order Bullet:

• need to be sure we differentiate between the requested test vs the entire request = https://www.ecfr.gov/current/title-42/section-493.1241 - make that more clear

• also is the requested test the documentation of order or the initiation of the order to the specific lab?

  • in HL7 artifacts this would be both - the initiate depends on where it is found - in V2 the Order control code is NW when it is the initiation of the order, but the LOINC is always in the same place (OBR-4); in FHIR the LOINC is in ServiceRequest.code, but to initiate you would include a task

• LOINC ontology work brought up the need for observables = order codes that are mwthodless, as you may not alwyas know (or care) what method the lab will use - LOINC committee agreed to make methodless order codes

• on LOINC committee call were notified that some PHAs will require LOINC for orders starting Jan 2026

Unique Device Identifier

• work on lab to implement will be huge, so need ot get support for implementation form IVD vendors - making their devices smart enough to know their own UDI and be able to exchange that - the HL7 products all suport exchange ofUDI / UDI parts

• LIS also need a place to put this and for test kits (no instrument interfaces) would still need an easy way to add (barcode scanner?)

• Several folks indicates a large implementation burden on the labs

• just because a data element is in USCDI, it desn’t mean it is required from the labs, which are still outside of HIT certification, but it will give us a place to put the UDI, when we figure out how best to manage it - currently we have no place to put it in any of the HIT systems consistently

• there will still be commercial / marketplace push to implement

• it takes about 10 years to get an element into USCDI to be effective for HIT certification, so we have time to figure out how to implement

SHIELD Charter Updates - Next time

https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/3071279178 - Review the updated Article Three of the Charter as a whole

Discuss:

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

https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/2020966449 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 on a pilot project with KOMET and Biomerieux

• IVD Data Hub

  • Exploring finding funding opportunities - current talks with Truveta (https://www.truveta.com/ )

    • No update since last time

• Standards Updates and Vocabulary Working Group

  •  

• Communications and Branding Working Group

  • SHIELD Membership Survey summary results

Placeholder to get back to later - Next time

• https://www.jmdjournal.org/article/S1525-1578(21)00327-5/fulltext AMP paper - do we need to do something with this as the Steering Committee?

• Antimicrobial result reporting

  • Related work at HL7 Europe:

    EU coded value sets.xlsx

     

• https://www.jmdjournal.org/article/S1525-1578(21)00327-5/fulltext

• 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

• 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:

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

Steering Committee:

• May 21^th - Riki not available

• June 4^th

• June 18^th

Adjourned

 12:55 PM ET