2024-03-05 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 - 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

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 - regrets

primary

Monica Harry - regrets

alternate

Regenstrief Institute

Marjorie Rallins - regrets

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 - regrets

primary

alternate

AMP

Robyn Temple - regrets

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

Started 12:07 PM, no quorum reached

Follow up Items

• Special Topic calls:

  • Next dates:

    • March 12 - UK Experience

    • April 9th - open

    • May 14th - Netherlands

    • June 11th

  • Proposed:

    • Use of standards and reporting across the different systems used in Cancer and Pathology - ask CAP folks if interested / someone available (Scott offered)

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

  • working though examples

  • Questions:

    • Are there current requirements for IVD vendors to provide DIs/UDIs for instruments and test kits/reagents?

      • Check with Marti

    • What are the use cases for use of DI for instruments and test kits/reagents? How are they planned to be used in/by each area below.

      • FDA: Post market 510(k), others?

      • Other federal agencies/PH: still being researched by FDA SHIELD group

      • EHRs/patient care:

      • RWD/RWE/research:

  • Decisions. Device identifiers should be provided for both instrument and test kit/reagent for each lab result

• IVD Data Hub

  • still working on White paper

  • present on March ALL SHIELD call

  • call for additional members - looking for more input for real world data use - Vicky to see, if she can find someone or more

  • maybe also reach out to NIH / NCI for research

• Standards Updates and Vocabulary Working Group

  • Still looking for another Co-Chair!

  • no update

• Communications and Branding Working Group

  • no update

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

• United States Core Data for 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: = Standards Version Advancement Process

Discussion:

Provided some feedback on boundaries between data elements and showed how access to the original submission changes once adopted into USCDI draft.

Do we want to submit for USCDI V5 as SHIELD?

Will send email to the SC to see, if folks want to submit comments as SHIELD

Skip FHIR R5 and go to base US Core on FHIR core R6

US Realm SC voted to skip use of FHIR R5 for US Core and will go straight to R6, when it is ready - statement: “Given regulatory dates, industry implementation schedules, and the upcoming publication of FHIR Release 6 in the not-too-distant future, the US Realm voted at the January WGM to never publish a US Core implementation guide built on FHIR Release 5.”
https://blog.hl7.org/dispatch-from-the-us-realm-january-wgm-recap-important-news-about-the-future-of-us-core-hl7-fhir-release-5

Not related too much to USCDI v5 - may affect a few elements, but not in the laboratory class

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.

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

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?

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: March 26, 2024

Special Topic: March 12, 2024 - State of Interoperability in the UK

SC: March 19, 2024

Adjourned

 12:47 PM ET