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Name

Organization

Role

Hung Luu

UT Southwestern Medical Center

Working Group Co-Chair; SC liasion

Riki Merrick

Association of Public Health Laboratories

Working Group Co-Chair; SC liasion

Andrea Pitkus

University of Wisconsin-Madison

Steering Committee member

Xavier Gansel

Biomerieux

Steering Committee member

Rob Rae

CAP

Dan Rutz

Epic

Steering Committee member

Pam Banning

3M Health Information Systems

Laurent LARDIN

Biomerieux

Amy McCormick

Epic

Sandy Jones

CDC Cancer Surveillance

Stan Huff

Graphite

Steering Committee member

Craig Collom

Steering Committee member

Marti Velezis

Sonrisa/FDA

Walter Sujanski

FDA

Observer

Raja Cholan

FDA

Observer

Russ Ott

FDA

Observer

Akila Namasivayam

FDA

Observer

Operational Definitions

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Name (Acronym)

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Definition

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- see SHIELD Glossary

Projects

Project Name

[include link to the filled out project template file, if created]

Brief Description

Priority

LIVD File Repository Requirements

Compile the requirements for LIDR - functional/policy/starting content/sustainability and develop and document the process for adding NEW

1

Additional data elements for LIVD file (e.g. UDI for equipment/ reagents, harmonization methods, UDIs for devices/kits/reagents

this is defining the WHAT elements are needed in LIDR - it will inform the requirements above, where we need to define the process of HOW to add new elements, when those are identified

2

Clinically relevant test definitions - what makes results “co-minglable”

3

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