2024-08-06 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 - 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

primary

Tufts Medical Center

Nanguneri Nirmala - regrets

primary

Sonic Healthcare

Eric Crugnale

primary

Former Quest Diagnostics

Collom, Craig D

primary

Patient Advocate

Stacy Lange

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- regrets

primary

Dari Shirazi

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

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 - regrets last 30 min

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

12:09 PM ET

Follow up Items -

• Special Topic calls:

  • Next dates:

    • August 13 - SNOMED model in AP

    • September 10 - Specimen CrossMapping Table

• Update on HIMSS proposal (Aug)

  • No word yet

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. Oct 4, 2024 Comments are Due

Starting HTI-2 Feedback Collection

USCDI / USCDI+ feedback

Discussion about differences between Lab Orders, Procedure, Clinical Test Orders in USCDI. Sara indicated HL7 Cross Group Projects (CGP) WG call is best place for feedback - Every Thursday 1-2 PM ET - https://www.hl7.org/concalls/CallDetails.cfm?concall=73923 - check the main calendar https://www.hl7.org/concalls/ , if happening for the week, or better sign up for the listserve https://www.hl7.org/myhl7/managelistservs.cfm?ref=nav , so you get call notifications.

Robyn mentioned the definitions for the items are broad. Andrea mentioned CPT and SCT use of terms.

Administrative things

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

• Representative first 3 year terms expire 12/20/2025

• Chair and Vice Chair 2 year terms expire 3/14/2025

  • 90 days would be 12/14/2024 for call for nominations for Chair and Vice-Chair, so folks, start thinking about who might want to take the reins

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

  • Been reviewing Stan’s comments on white paper

• IVD Data Hub

  • Meeting with Dr. Crawford later this week to discuss CWRI.

• Standards Updates and Vocabulary Working Group

  • Last meeting in July. Completed discussion of LRI specification. Recommendations. A number of open issues. Draft nearly complete for Vocab group for review via email. Notes in Confluence.

• Communications and Branding Working Group

  • Member survey to get stakeholder perspectives.

  • Support HTI-2

  • HIMSS No word yet. Look at 2025 conferences. Add to confluence page or email Eric, Riki or Andrea.

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.

Updated language draft: Roadmap update: ONC Feedback

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 - from their March 18^th call (notes here, recording here)

1. Concepts around Healthcare IT (HIT) standards needs to be conveyed earlier in training for healthcare providers as use and application of standards in vended applications is the major gap.

2. IT folks are less susceptible because they have a script that is more rigidly followed through implementation guidance. A vendor may not support functionality for standards or only partially support.

3. Regulatory requirements (such as CLIA) may pose a hurdle to implementation of data standards.

4. Implementation guidance is often not well read. Training resources may not be well publicized or readily available. Perhaps conformance testing tools need to be made more widely available?

5. What might be helpful is to look at standards implementation from a data lifecycle standpoint across all users (end to end across ecosystem), rather than just training on a single standard for a single use case.

6. Last paragraph on page 4 of the road map final version could be augmented with these points.

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.

HTI-2 feedback

Will look at LRI first.

Antimicrobial result reporting

Placeholder to get back to later

Related work at HL7 Europe:

Next calls

All SHIELD:

General Updates: August, 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

August 20 - ALL SHIELD HTI-2

August 27 - ALL SHIELD

Steering Committee:

Sept 3 - SC (please re- send invite)

Sept 17- Cancel due to LOINC

Adjourned