2023-06-06 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

primary

Former Quest Diagnostics

Collom, Craig D

primary

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

Serafina Brea

primary

alternate

ONC

Sara Armson

primary

alternate

CDC

Hubert Vesper (/DDNID/NCEH/DLS)

primary

Jasmine Chaitram

alternate

NLM

 John Snyder

primary

alternate

FDA

primary

alternate

Guest FDA

Brittany Caldwell

Quorum evalution (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

Quorum met at 12:06

FDA process for offcially participating in the SHIELD community

Process for selecting FAD representation on community efforts:

• The proposed representative will make a presentation about th community to the Collaborative Community Steerring Committee and if they approve then a similar presentation will be given to FDA leadership

  • Keith is scheduled for his presentation on June 22

  • The SC is looking for sustainable projects, so need to be able to point to those elements of SHIELD that are long-term commitments and how what impacts participation by FDA would have on its success/outcome

• Once approved SHIELD will be recognized as an offical FDA Collaborative Community with a mention on their website
  Questions:

Question:

Does FDA Collaborative community come with suport - particularly for web presence, collab facilitation like zoom etc?

Open

FDA Collabortive Community presentation from June last year for background

Feedback from FDA, specifically Collaborative Community leadership in CDRH on our Charter

1. They recommended that the percentages of various groups be more “fungible”… In that what happens if you are not able get the exact percent representation from particular groups? So anticipate that somehow by saying that is a goal, and that leadership can approve deviations from those numbers, or have the documents say that they are guidelines, not absolute.

   1. Suggested change since current SC numbers are close, but not exact – so probably change: “according to” to “approximately”:

Motion to make this adjustment -Hung, Aaron - no further discussion, against: 0, abstain: 0, in favor: 12

This Change was applied after the call today.

1. For the SHIELD projects, they want to see some goals that are long-term sustaining projects. Not projects that look like they will wrap up in 1-2 years… The question being is this a temporary type group that we might support in the short term more as an focus group, or is this a longer term group that is worth FDA planning to be in partnership with for a long time.

   1. We will need to write a statement of intent with quotes from the roadmap, that make clear that SHIELD is a long-term community, with projects that will become permanent fixtures in the healthcare ecosystem - any volunteers to pull this together? Hung will draft a slide

Call schedule in the summer

June 13th - Andrea will lead - topics:

• final comments on NRPM and maybe vote / or do by email

June 20 - Andrea will lead

June 27 - ALL SHIELD call

July 4 - move to July 11th (Xavier and Eza/Marjorie not available) - let’s cancel July 4th

Meetings

2023 LOINC Conference - Atlanta/Online – LOINC October 17-20

Andrea submitted abstract

HTI-1 NPRM Comment Collection

Took notes directly on the confluence page - focused on question 4

Riki will send reminder email to ALL SHIELD list to either tell us SHIELD should not be submitting comments, or add their thoughts, so that we can wokr on June 13 on craftign the comments and vote on SC call on June 20 (must be near finished then, as that is the deadline for submission).

Feedback from ONC on Roadmap (FINAL VERSION)

NOT DISCUSSED:

Was mentioned on May 30 call - here are the comments:

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.

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.

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).

- any volunteers to draft a response / suggested updates in the roadmap?

Review Working Group Committee list and establish SC representation

NOT DISCUSSED:

Working Groups

Created Confluence pages for the 4 priority groups

Leads will find call time and invite interested people

Next call

June 20. 2023 12 -1 PM EDT

Adjourned

1:02 PM EDT