2023-11-21 SHIELD 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

James T. 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

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

12:05 EST

Follow up Items

• LOINC naming convention confirmed for Dec special topic call on Dec 12th

• Patient Generated Health Data topic - any update?

• Other Topics for the special topics call?

  • CLIAC Update

    • Enough material for update?

    • ALL SHIELD Call to share recommendations

      • Laboratory result data transmitted throughout the ecosystem needs to reflect the CLIA requirements. Anywhere data goes in Health IT. Results going through HIEs missing specimen source or other info.

      • Workgroup revising CLIA looking at required data elements. Looking to include UDI.

      • So hopefully now the US Core FHIR IG will have some of these data elements going forward

      • Hung Luu can speak to these at next All SHIELD call

  • Synensys Final Report (Alana Keller and team) : Jan 2024 Topic call

  • Update on CAP Cancer summit?

  • Netherlands perspective

  • LOINC extension in SNOMED CT (Stan Huff) (Jim Case & Regenstrief)

    • LOINC content available as SNOMED CT extension: Feb 13, 2024 Topic call. Check on scheduling (Stan and Jim ok)

  • How to align SNOMED/LOINC/LIDR in a productive way

• European Outreach: Riki and Andrea have an introductory call set up with Dr. Turnbull and Mr. Nashkar for Nov 30 - we will report back after that

Presentations etc

• FDA Collaborative Community is holding a virtual panel “The Power of Data” on Dec 13th 12:30 - 2 PM ET for CDRH staff - looking for participation / Commitment: ~30-minute panel discussion; some questions provided ahead of time in addition to live audience Q&A / Topics: general updates from SHIELD Collaborative Community, including “The Power of Data”-related efforts.

  • Will it be recorded?

• Children’s Health Laboratory Medicine Conference (Regional Conference 400 people- Virtual on February 16, 2024 intended to provide continuing education to laboratory personnel - suggestion to have Andrea and Riki present SHIELD overview with the specific viewpoint around impact of SHIELD work on laboratorians; will provide PACE credits for attendees

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

  • Met yesterday 20 Nov 2023.

  • Set deliverables.

  • Looked at PH Use Case, where PHAs often prefer to have a single LOINC code for IVD test. PH as user/stakeholder - decided they should have the same LOINC coding the same as clinical lab.

  • LIDR has 2 aspects:

    • technical aspect = distribute content.

    • content

      • How to get content together.

      • Discussed crowdsourcing it via google sheet that folks can contribute information. PH often researches tests with PH reportables.

      • Added NEW elements for Source of content and Reviewed by Whom (IVD vendor or CDC/NLM/ONC/FDA reps)

      • Added date mapping was performed

  • A vendor version would take precedent. Labs would access official version via LIDR, the crowdsourcing is for content collection, not distribution.

• IVD Data Hub

  • Next meeting, 22 Nov 2023

• Standards Updates and Vocabulary Working Group

  • Standards WG is working through a few different tests to document workflows and identify necessary standards. The selected tests are in the minutes.

• Communications and Branding Working Group

  • Discussed milestones and LinkedIn page, and potential Introduction to SHIELD article(s) – had CAP participation, so maybe put it in CAP Today – by end of 2023

2024/25 Conferences we might want to submit abstracts to

• Executive War College Apr 30 – May 1, 2024 in New Orleans, LO - pretty expensive - didn’t see a link to submit abstracts.

  • Discussion: Organizer is Robert Michel.

  • Always looking for Thought Leadership

  • May not be a registration fee if speaker

  • Business Leader focus.

  • A number of informatics vendors.

  • Steve will reach out to Robert.

    • Would be good to introduce SHIELD to him and see what he thinks

    • Would they consider a virtual option?

  • Any SHIELD attendees?

    • Eric may be, Steve for sure

• ADLM (submission deadlines for 2024 presentations passed, but consider 2025)

• API (submission deadlines for 2024 presentations passed, but consider 2025)

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

We will talk about approach to updates in general and these specific comments in particular related to the ONC comments - set a deadline to have these reviewed and addressed!

-Not a specific deadline

Next calls

All SHIELD: November 28, 2023

SC: December 5, 2023

Announcement

-Can we transition to "take 10" meetings for all SHIELD meetings? Start at 5 after, and end a 55 after? Riki updated invitations. Can announce on future SHIELD meetings.

-LOINC and SNOMED CT collaboratation (see above for ALL SHIELD calls)

Adjourned

12:50 EST