2024-11-19 Steering Committee Meeting Notes

Stakeholder group

SHIELD organization

Name of SHIELD member

organization designation

Industry Entity

Labgnostic, Inc.

Steve Box

primary

NEW: Scott Vardy

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

NEW: Christina Gallegos

alternate

Graphite Health

Stan Huff - regrets

primary

alternate

CAP

Raj Dash - regrets

primary

alternate

AMP

Robyn Temple- regrets

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 PM ET - no quorum

Collaborative Community Panel Presentation

Request to participate in Panel on December 17, 2024 3:50 - 4:20 PM ET - these would be the questions; Riki would attend, Andrea would join if she can.

• Question 1: Please briefly refresh the audience regarding the vision, objectives, key participants, and scope of activities in your Collaborative Community, including highlights of recent and ongoing activities and upcoming milestones or events. [3-5 minutes]

• Question 2: What have been the biggest challenges or barriers to achieving standardized methodology and data structures (interoperability) across variety of data-generating devices, lab tests, and organizations?

• Question 3 [back-up, time-permitting]: How has your CC sought to balance the competing needs for both innovation & standardization?

Conferences

ASCLS got submitted - waiting for response

ADLM got submitted - waiting for response

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

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

  • Biomerieux offering to support a proof of concept for LIDR FHIR server

  • maybe could use HL7 Foundry - talk to Diego

  • how much do we need to have to be able to pitch for some funding

• IVD Data Hub

  • last meeting was Oct 31 - ADD LINK

  • meeting with a group (Truveta https://www.truveta.com/truveta-data/regulatory-grade/ ) that has lots of healthcare partners to explore pilot project options, but not having funding is a big issue

• Standards Updates and Vocabulary Working Group

  • No new updates

• Communications and Branding Working Group

  • Present the SHIELD Membership Survey to SHIELD members to better understand what makes folks participate / not attend calls / better understand each stakeholders' perspective

  • Sending to ALL SHIELD call list

  • Propose sending out on Monday, 2 week runtime, send reminders at 1 week and 1 day prior to close

  • Next Steps send email to Steering Committee members to request and vote send out for the first week of December

Lab LOINC Committee question

Question: Should LOINC support IFCC methods (as part of harmonization of tests) or should this be covered by the yet to created harmonization indicator?

only 2 LOINCs with IFCC as method: Hemoglobin A1C, LOINC 91671-8 Transferrin.carbohydrate deficient.disialo/Transferrin.total standardized per IFCC-RMP for CDT in Serum or Plasma

Could have a result with IFCC method and without.

Over 100 tests that are aligend with IFCC method - should more LOINCs be created?

Compinatorial explosion is not good, but we don’t currenlty have HL7 place for the harmonization indicator, but if we can create specific method codes that could cover that and we have had OBX-17 for a long time (some LIS/EHR-s may not support that field yet)

SNOMED CT collaboration on LOINC parts modeling around methods

Sometimes method is in the lab testname, but even then the LOINC chosen may be a methodless code (on the lab side, but also on the EHR-s side)

Method axis in LOINC supports multiple - example would be toxicology testing - SAMSHA drug testing requires different methods based on screening / confirmatory test type / cut-off based / detection limit

Sequoia IG Update - still working on addressing comments - suring a call a newer clinician participating also requested this harmonization indicator to help idetify results that can be merged

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

  • email Andrea and Riki with any nominations

• Steering Committee attendance review:

• Consider changing timeslot - what are some options?

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

maybe add one more sentence or add a reference to the key consideration number for the IVD Datahub (Consideration 4) into these sentences. (change approved in principle.)

Discussion:

• Updated roadmap:

• Also need to remove the duplicate words “for the” in the last sentence

• Anything else needed on this one?

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. Decision making to use Health IT standards are less likely left up to IT analysts as they mainly follow the requirements and then they generally use vendor supplied implementation guidance. However, 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.

Discussion:

• Need to find the exact space for these points, too

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.

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.

ONC Annual Meeting

December 4-5, 2024
Omni Shoreham in
Washington, DC

https://www.astpannualmeeting.com/Agenda

This is in-person only, registration is open now - last year it filed up

no plans so far to have slides / recording available

December 5th 2:15 – 3:15 pm is Enhancing Laboratory Interoperability: Insights and a Path Forward - Sara can give update on January 14th call to SHIELD members

Also the report to congress wil be public one sent off

Antimicrobial result reporting

Placeholder to get back to later

Related work at HL7 Europe:

Next calls

All SHIELD Calls

• November 26^th

• December 17^th

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

Special Topic:

• December 10^th - Clinical Architecture LOINC survey

• January 14th - Update from ONC’s Annual Meeting / Enhancing Laboratory Interoperability: Insights and a Path Forward Panel

Steering Committee:

• December 3^rd

• January 7^th

Adjourned

 11:54 AM ET