2023-06-06 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

primary

alternate

FDA

primary

alternate

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

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.

2. 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.

Feedback from ONC on Roadmap

Was discussed on May 30th call - any follow up?

Logistics of publishing community approved work products

Where do we publish the roadmap - and how to we communicate its publication?

<LINK TO FINAL VERSION OF ROADMAP>

Review Working Group Committee list and establish SC representation

Working Groups

Created Confluence pages for the 4 priority groups - announcements on May 30th call

Leads will find call time and invite interested people

Sequoia Usability Working Group

Does SC want to try to solicit feedback from physicians in time for the proposal deadline?

maybe get painpoints from providers and how this relates to SHIELD initatives?

NPRM feedback

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 - need to reschedule - do later in June

Charter updates: Draft non-participation clause for SC

Any volunteers?

NOT DISCUSSED

Document decision workflow (e.g. WG product - ALL SHIELD review and comment - comment resolution in WG - Steering Committee approval - work product publication)

NOT DISCUSSED

Meetings

https://loinc.org/conference/atlanta-2023/ October 17-20

Submit proposals by May 31

Should SHIELD submit something?

Next call

June 20. 2023 12 -1 PM EDT

Adjourned