2024-10-01 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

Jim 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

Michael Smalara

primary

Open

alternate

ONC

Sara Armson

primary

alternate

CDC

Hubert Vesper (/DDNID/NCEH/DLS)

primary

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

 12:09 - no quorum yet

USCDI V6 feedback

Missed deadline of due September 30, 2024 , so no comment from SHIELD

USCDI comments are reviewed in order of these bullets, so best to formulate the comment to address these points. In addition if a data element is considered a sub-element of an existing USCDI data element, the chance for getting it in is deminished, so addressing why it needs to be its own would help also:

Level 2 data elements meet the following criteria:

• Represented by a terminology standard or SDO-balloted technical specification or implementation guide.

• Data element is captured, stored, or accessed in multiple production EHRs or other HIT modules from more than one developer.

• Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.

• Use cases apply to most care settings or specialties.

HTI-2 feedback

due October 4, 2024

Review and vote today! (Since no quorum we will hold e-vote)

Notes:

• In general format should be what needs to be changed and why

• LOINC versions (and other terminologies)

  • ideal use current version at time of certification, but HTI-2 should list minimum version

  • SVAP can be used to update from listed minimum version, but since only once 1 year may still be a little behind terminology releases

  • List of standards is updated every 3? years

• Discussion around loss of content - some content may only be needed for routing / internal business, not part of the clinical context - will add separate bullet to indicate relevant content should not be lost in translation (especially for intermediaries, but this also applies to end systems)

• TEFCA SOP

  • https://www.healthit.gov/sites/default/files/page/2024-07/HTI-2_ProposedRule_TEFCA_factsheet_508.pdf

  • is the payload limited to FHIR artifacts?

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

NOT DISCUSSED

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.

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

NOT DISCUSSED

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

  • Work continues on white paper - review final draft before sending to SC October 14th

• IVD Data Hub

  •  

• Standards Updates and Vocabulary Working Group

  • No new updates

• Communications and Branding Working Group

  •  

Antimicrobial result reporting

NOT DISCUSSED

Placeholder to get back to later

Related work at HL7 Europe:

Next calls

All SHIELD Calls

•October 22^nd

•November 26^th (week of Thanksgiving – or meet November 12^th?)

•December would be 24 or 31 – do we want to meet 17^th?

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

Special Topic:

•October 8^th - European FHIR Lab IG and European Interoperability Developments

•November 12^th – should we move that to October 29^th, if we have a topic?

December 10^th or January 14^th- Clinical Architecture LOINC survey

Steering Committee:

October 15^th – finalize roadmap updates

November 5^th

Adjourned