2023-11-07 SHIELD Steering Committee Meeting Notes

Stakeholder group

SHIELD organization

Name of SHIELD member

organization designation

Industry Entity

Labgnostic, Inc.

Steve Box

primary

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 - regrets

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 - regrets

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

12:04 AM - quorum reached at 12:23 PM ET

Updates

• Welcome Stacy - brief round of introductions

Follow up from LOINC Conference

Open

Patient Generated Health Data cross cutting session two Friday at the LOINC meeting: Listening the LOINC discussion:  2023 LOINC Conference: Committee Updates, Cross-Cutting Issues, and Closing   (near the end ~ 1hr 56 mins through 2 hrs 25 mins) brought up this topic for SHIELD to consider

Discussion:

• Originated from a zulip chat looking for a LOINC for continous Glucose monitors, or wearable insulin pump/measure (ADD LINK); also albumin testing, at home testing for COVID etc, apple watch heart rate (not a lab test, but still relevant for LOINC)

  • suggestion was to use Glucometer LOINC, since that is the only one out there

  • Consider NEW LOINC for these types of tests

  • Request that device manufacturers request LOINCs, if none available

• this is broader than SHIELD

• will continue to be a topic of the lab LOINC Committee - next call Nov 16, feel free to join

• Is it within SHIELD scope to come up with any guidance around this?

  • ONC: providing input in form of a comment on a USCDI data element/class or ISA page would be the most impactful means to get record and can be updated over time

• Have reached out to Pam to see, if this could be a special topic call later - wait for input from the Lab LOINC meeting

Review Working Groups progress

Setting milestones for deliverables should be NEXT / create a milestone page for quarterly reporting?

• Laboratory Interoperability Data Registry (LIDR) Working Group

  • Created a starting google sheet “LIDR” for K+ analyzers

    • collecting from vendors in LIVD format

    • identifying some data elements needed

      • time aspect

      • vendor method

• IVD Data Hub

  • Have finalized the outline

  • divied up outline sections for R&D for white paper

  • provide the requirements for IVD data hub

  • goal is to have handle on R&D part by end of 2023 - draft white paper by end of Q1 2024

• Standards Updates and Vocabulary Working Group

  • Getting order and result messages from Duke, UNMC and other sites, review disparites and differences as a way to start

  • projects around codes for qualitative result codes etc

• Communications and Branding Working Group

  • researching website hosting options (would need to get donations to cover the costs of around $100-200/year)

    • also have researched potential URLs

    • but for the content would need input

  • using confluence for business, is widely open to the public

  • can get a free LinkedIn page - maybe start with this

  • We could maybe ask HL7 to host maybe

    • HL7 is hosting for Affiliates and Accellerators

    • Julia to check with HL7 staff and let us know what she finds out

  • Motion to set up a LinkedIn Page: Julia Skapik, Eric Crugnale - abstain: 0, against: 0, in favor: 14

    • need to decide on the content in the WG and bring back

  • Deliverables discussed:

    • have existing

      • one-pager

      • powerpoint

      • roadmap

    • should we write a SHIELD intro article and publish that somewhere?

      • need to decide on the journal - lab vs informatics vs both

      • time with having the webpage set up so we can link back

      • reference the conferences we have presented at

      • vote on the target publication and content

      • Propublica connection via Stacy - they have articles about patient safety - maybe bring in professional journalist to present their findings to the group to build relationship

      • cooridnate activities between social media / webpage and article

      • patient safety is a good topic and how interoperability issues affect that

      • always good to have stories

      • despite the reporting requriements around COVID results

      • Andrea has patient safety related talking points from ACLS committee

• We have SHIELD Community and FDA SHIELD - Do we need to coordinate content?

  • create the common messages - decide how to brand them

  • all communication materials created by FDA are available for re-branding

  • some topics can only come from the community or FDA respectively

SHIELD#2 call Topic Ideas

• More test naming topics?

  • LOINC naming perspective - aim for Dec 12, 2023

• Update on CAP Cancer summit?

• Netherlands perspective

2024/25 Conferences we might want to submit abstracts to

• Executive War College Apr 30 – May 1, 2024 in New Orleans, LO

European Outreach

• Update on NHS connection effort - Steve Box found a contact

• Others?

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!

Next calls

November 21, 2023

Announcement

Will cancelt he Nov 14th special topic call, since no topic

Adjourned

 12:59 PM ET