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Date

Attendees (bolded = present)

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

Agenda and Notes

Agenda Item

Notes

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.

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 - move to July 11th or just cancel?

Meetings

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

Plan to submit

Feedback from ONC on Roadmap (FINAL VERSION)

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

Review Working Group Committee list and establish SC representation

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

For recording access (SC members only) reach out to Riki

Future Agenda Items:

  • Document decision workflow

  • Logistics of publishing community approved work products

  • Charter updates: Draft non-participation clause for SC

  • Prioritization of projects to ensure external milestones are met

    • qualitative result value set - Standards WG item

Action items

  •  

Quick decisions not requiring context or tracking

For quick, smaller decisions that do not require extra context or formal tracking, use the “Add a decision…” function here.

    Decisions requiring context or tracking

    For decisions that require more context (e.g., documentation of discussion, options considered) and/or tracking, use the decision template to capture more information.

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