2024-07-16 Steering Committee 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 -regrets

primary

Former Quest Diagnostics

Collom, Craig D

primary

Patient Advocate

Stacy Lange

individual

Standards Organization

SNOMED International

James T. 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- regrets

primary

Dari Shirazi

alternate

Graphite Health

Stan Huff- regrets

primary

alternate

CAP

Raj Dash -

primary

alternate

AMP

Robyn Temple

primary

alternate

Governmental - non Voting

CMS

Michael Smalara

primary

Open

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

12:10 EST

Follow up Items -

• Special Topic calls:

  • Next dates:

    • August 13 - SNOMED model in AP

    • September 10 - Specimen CrossMapping Table

• Update on HIMSS proposal (Aug)

  • ?

HTI-2 Proposed Rule released

HHS Proposes HTI-2 Rule to Improve Patient Engagement, Information Sharing, and Public Health Interoperability

Once posted in Federal Register will have 60 days for public comment.

Starting HTI-2 Feedback Collection

Administrative things

Review SC Composition, terms and requirements for re-voting etc

Review Working Groups progress

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

• Laboratory Interoperability Data Registry (LIDR) Working Group

• IVD Data Hub (Meeting this week. Discussion with Dr. Crawford in Aug.)

• Standards Updates and Vocabulary Working Group (LRI review)

• Communications and Branding Working Group

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 previous 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

Nick: Updated language drafted. Can add to minutes for review at next SC.

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 example 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.

Antimicrobial result reporting

Placeholder to get back to later

Related work at HL7 Europe:

Next calls

All SHIELD:

General Updates: July 23, 2024 - WG Chairs please make sure we have material for updates (at least notes we can link to)

Special Topic:

August 13 - Scott’s SNOMED talk

Steering Committee:

August 6 - do we want to also meet July 30 - maybe make it an open call for anyone with interest in HTI-2 comments.

SC thumbs up

Adjourned

12:46 EST