2023-08-15 SHIELD Steering Committee Meeting Notes

Stakeholder group

SHIELD organization

Name of SHIELD member

organization designation

Industry Entity

Labgnostic, Inc.

Aaron Green

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 - regrets

primary

Former Quest Diagnostics

Collom, Craig D

primary

Standards Organization

SNOMED International

James T. Case

primary

Monica Harry

alternate

Regenstrief Institute

Marjorie Rallins - regrets

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

Serafina Brea

primary

alternate

ONC

Sara Armson

primary

alternate

CDC

Hubert Vesper - regrets (/DDNID/NCEH/DLS)

primary

Jasmine Chaitram - regrets

alternate

NLM

 John Snyder

primary

alternate

FDA

primary

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 18 named members, so 2/3 = 12 (excluding chair and government members).

Open Meeting

 12:03 PM ET (got quorum a little later, but we didn’t take votes today)

Updates

• Proposed new members for the SC:

  • Patient Advocate position: Stacy Lange has been in patient advocacy for over 10 years - Synensis sent her our way

  • FDA representative coming soon

  • FDA now has a SHIELD website: https://www.fda.gov/medical-devices/diagnostic-data-program/systemic-harmonization-and-interoperability-enhancement-laboratory-data-shield

• Members leaving the SC

  • Serafina Brea will move to different branch in CMS effective 8/25 - will notify us of replacement member as soon as possible - will go through CDC for now

• New group engagement for SHIELD:

  • Riki met with Pfizer’s evidence creation team

    • they may be joining the ALL SHIELD calls and also let them know about the working groups

    • they are working on feedback on package inserts that are patient facing https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/patient-medication-information#:~:text=Patient%20Medication%20Information%20would%20be,drug%20products%20safely%20and%20effectively. - this might push the FDA towards a more structured data approach in other package inserts, too

• New LOINC release is out: https://loinc.org/news/loinc-version-2-75-adds-almost-2000-new-concepts/

Established SHIELD Calendar

Thanks to Eric for coming up with the idea - we now have calendar of all the calls, including call info for all the open calls (not the SC call)

Goal of the outreach to IVD vendors

• General need is to get more IVD vendors to produce LIVD files

• Differences in testing to better understand how those affect results / data structure / how many UDI needed to cover all of their results / coder more domains

  • hematology

  • micro

  • chemistry

  • blood-bank

Review Working Groups progress

• Laboratory Interoperability Data Repository (LIDR) Working Group

  • finalizing scope by end of August

  • outline of white paper

    • working on use cases - identifying the need and what data elements for each

    • created parking lot

  • Still need input from MDIC on RWE data element starter list

• Real World Evidence Working Group

  • first call mainly around logistics

  • waiting for FDA representative

  • biweekly calls starting end of August

  • first focus will be WG scope

  • identify use cases and data elements for each

  • coordinate which of those go in LIDR

  • ask Standards & Vocabulary WG to identify how to represent each of the elements (in both RWE work and LIDR)

• Standards Updates and Vocabulary Working Group

  • finshed reviewing scope

  • will start with vocab standards in next meeting

LOINC Conference presentation

• Other SHIELD member presentations

  • Christine Spisla, W. Scott Campbell, PhD, MBA, Stephen Powell, DHA, MSc, and Raja Cholan, MS - Deloitte
    Thinking Outside the Box: Using an Integrated Knowledge Management Environment to model LOINC terms

  • John Snyder - National Library of Medicine
    Automating the curation of reference terminologies

  • Pamela Banning - 3M Health Information Systems
    In-roads: Advancing LOINC Adoption in Clinical Trials Data

  • Stanley Huff - Graphite Health
    Semantic Interoperability: The Vision of What Could Be

  • Stephen Powell - Synensys, LLC
    Results from a System Safety Analysis of the U.S. Laboratory Data Ecosystem: How LOINC Impacts System Safety?

  • Christina Gallegos & Ed Heierman, Ph.D - Association of Public Health Laboratories & IICC
    Collaborative Development of LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2

• Andrea Pitkus, Riki Merrick - SHIELD
  SHIELD as a mechanism to support the adoption of LOINC and SNOMED CT standards for laboratory data interoperability:

  • Submitted abstracts bios and headshots

  • Discuss outline (will not be shared here, so we don’t publish before the conference)

SNOMED Conference presentations from SHIELD members

https://issuu.com/snomed/docs/snomed_ct_expo_2023_program?fr=sZTk5OTQ2NTE4OTU

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 next call - sorry - Riki didn’t get the prep done related to the ONC comments

Next call

Sep 5, 2023 - will cancelation

August 29th is our Topic call: Naming Convention

Sep 19, 2023 12 -1 PM EDT

Adjourned

 12:34 PM ET