2024-02-06 Steering Committee Meeting Notes

Stakeholder group

SHIELD organization

Name of SHIELD member

organization designation

Industry Entity

Labgnostic, Inc.

Steve Box

primary

Andy Harris

alternate

Epic

Dan Rutz

primary

alternate

Biomerieux

Xavier Gansel

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

primary

UNMC

Scott Campbell

primary

Tufts Medical Center

Nanguneri Nirmala

primary

Sonic Healthcare

Eric Crugnale

primary

Former Quest Diagnostics

Collom, Craig D

primary

Patient Advocate

Stacy Lange

individual

Standards Organization

SNOMED International

James T. Case

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

Dari Shirazi

alternate

Graphite Health

Stan Huff

primary

alternate

CAP

Raj Dash

primary

alternate

AMP

Robyn Temple

primary

alternate

Governmental - non Voting

CMS

OPEN

primary

alternate

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 19 named members, so 2/3 = 12 (excluding chair and government members).

Open Meeting

 12:07, quorum reached 12:22

Follow up Items

• Special Topic calls:

  • Confirmed:

    • LOINC Naming Call - Feb 13th

    • State of Interoperability in the UK - March 12th

    • Netherlands perspective/ interoperability solution - May 14th

  • Proposed:

    • Use of standards and reporting across the different systems used in Cancer and Pathology

Presentations etc

• Children’s Health Laboratory Medicine Conference Feb 16 - slides are not quite ready - the slide content will be pretty close to what was presented at LOINC - the changes will be mostly in the spoken part - SC members seemed ok to go ahead, since mostly the same

• API submitted SHIELD abstract for Hung Luu to present, if accepted

• CAP article update

  • see Communications & Branding

Review Working Groups progress

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

  • White paper draft is coming together

  •  

  • LIVD on FHIR frm existing vendor LIVD files as starting point

  • still working on Potassium LIDR example

• IVD Data Hub

  • changed meeting time to Thursdays 11 AM - next is this week, then bi-weekly

  • have high-level requirements and working on details to populate the white paper

  • also have connection with NEST

• Standards Updates and Vocabulary Working Group

  • Looking for another co-chair!

  • Next meeting will be next week

  • Review LRI spec for the example tests referenced in interface examples, catalogs and package inserts to review where those elements would land in there - specifically for some additional elements needed for D-dimer

• Communications and Branding Working Group

  • CAP article - there was an article in 2021 about SHIELD, reviewing that, but still think an update is still good, potential interviewees shared with WG and Kevin will move those names to CAP writer

  • Moving meeting time to Wednesday afternoon - will update the calendar when finalized

  • reviewed conference submission schedules

Feedback on ONC published artifact - do we want to compile as SHIELD, or just as members?

• https://uscdiplus.healthit.gov/uscdi due to ONC by March 4, 2024

• https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi(including USCDI v5) due to ONC by April 15, 2024

• ONC January 2024 Health IT Standards Bulletin due to ONC by July 2024

  Information about the SVAP 2024 can be found at: = https://www.healthit.gov/isa/standards-version-advancement-process

Discussion: Since most will make comments via their own orgs, not sure we have bandwidth to consolidate to SHIELD comments, too

The Standards Bulletin on page 8 has specific questions to answer - in particular the TestKit Unique Identifier - might be good to have a SHIELD reponse on this - will set up a confluence page to collect thoughts for us to review on the next SC call

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

1. The roadmap mission section describes a broad vision of lab interoperability. However, the roadmap proposed solution is limited to the FDA use cases around In-vitro diagnostics (IVD) data, specifically populating the IVD data hub.  ONC suggests clearly describing the roadmap scope so the proposed solutions can be discussed within that context.

Nick will connect with Sara to get more context and then bring this to the IVD datahub group - then Nick will bring back here

Looking for volunteer to tackle this re-write: Reordering the Considerations and moving the IVD Data hub last and renaming the section to “Making Well Standardized Data Available for Secondary Use” - we could then list as a first use case the IVD data hub, but we could expand this section with other uses we described under the business drivers and expand more on what each individual stakeholder can do to improve interoperability in the section on moving data through the systems

2. The roadmap identifies training and education needs around using LOINC as a barrier to interoperability. ONC suggests clarifying how the roadmap addresses this barrier. ONC recognizes that terminologies require training and education, and replacing LOINC with another standard will not address the barrier.

Update from Standards and Vocab WG about re-write of this section - will put on agenda for a future call

Goal: Pulling out how the proposed solutions will address the challenges listed in the roadmap to a less technical level. - linking the solutions to the specific challenge listed above

Should we include actual links for resources in the roadmap, or more a general statement around training for any of the standards - and maybe include the foundational skills needed to apply standards appropriately - pull together some references on this topic?

Maybe suggest a cross-disciplinary team to address the complexities - it is not trivial and don’t want to underestimate the complexity

Maybe we could crosswalk it to action item at SDOs (like accelerator work at HL7)

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 exampel implementation - create the structures and bound terminologies to showcase how each element would be properly represented be working.

Looking for volunteer to tackle this re-write: 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

Next calls

All SHIELD:

General Updates: February 27, 2024

Special Topic: February 13, 2024 - LOINC Naming Conventions

SC: February 20, 2024

Adjourned

 1:02 PM ET