Working Groups

Working Group Name	Topic or Strategy covered	Project	Priority	Reference documentation	SC Lead Name	Interested people	Meeting Info

Working Group Name	Topic or Strategy covered	Project	Priority	Reference documentation	SC Lead Name	Interested people	Meeting Info
Laboratory Interoperability Data Regristry (LIDR)	Strategy 1	Requirements for LIDR	1	LIVD File Repository Requirements	Hung Luu Riki Merrick	Andrea Pitkus Xavier Gansel Andrew Quinn Stan Huff Dan Rutz Susan Downer Walter Sujanski Marti Velezis Pam Banning	Join Zoom Meeting Mondays 9-10am EST
		Additional data elements for LIVD file (e.g. UDI for equipment/ reagents, harmonization methods, UDIs for devices/kits/reagents
		Clinically relevant test definitions - what makes results “co-minglable”				Andrea Pitkus
Standards Updates and Vocabulary Working Group	Support dataflow throughout the ecosystem / Strategy 2	Xavier project around result codes - qualitative (all lab domains)	1	https://aphlinformatics.atlassian.net/wiki/download/attachments/1887437089/Shield Project Report Biomerieux 28Mar23.docx?api=v2	Raj Dash LOOKING FOR VOLUNTEER!	Andrea Pitkus Xavier Gansel Jim Case Marjorie Rollins Eza Hafeza Andrew Quinn Dan Rutz Mary Kennedy Pam Banning	Every other Monday starting July 24 1:30 PM - 2:30 PM EST Join Zoom Meeting Join our Cloud HD Video Meeting Meeting ID: 989 7283 9706 Passcode: shield Join our Cloud HD Video Meeting
		Xavier project around result codes - micro-organism
		Xavier project around result codes - AST
		Xavier project around result codes - microscopic and culture observations
		Specimen CMT content / adoption				Xavier Gansel
		surgical synoptic reporting				Mehdi Nassiri Will Humphrey
		Anatomic Pathology Structured Reporting (cancer pathology)				Mehdi Nassiri Will Humphrey
		Structured genomics reporting (WGS, biomarkers, etc.)				Xavier Gansel Nanguneri Nirmala Mehdi Nassiri
		Test naming conventions
Toolsmith Working Group	Tooling / Strategy 3	Specimen CMT (tooling aspect)
Toolsmith Working Group		LIDR (Tooling aspect)
Real World Evidence Working Group	IVD Data Hub / Strategy 4	RWE data element requirements		https://mdic.org/resource/framework-for-developing-clinical-evidence-for-regulatory-and-coverage-assessments-in-in-vitro-diagnostics-ivds/ Hung Luu 12:45 PM https://mdic.org/resource/framework-for-developing-clinical-evidence-for-regulatory-and-coverage-assessments-in-in-vitro-diagnostics-ivds/ IVD RWE Education Series Module 1: Application of the MDIC IVD RWE Framework - Medical Device Innovation Consortium https://mdic.org/resource/mdic-fda-workshop-advancing-eua-ivd-products-toward-full-marketing-status/	Nick Decker	Xavier Gansel Gyan Penrose-Kafka Andrew Quinn Walter Sujanski Marti Velezis	Every Other Thursday starting 2/8/2024 from 11 AM to 12 PM ET Meeting link: https://meet.google.com/hac-xhar-hvw
Real World Evidence Working Group	IVD Data Hub / Strategy 4	Coordination with other domains / projects (research, PH, RWE)
Communications and Branding Working Group	Overarching Strategy		1		Eric Crugnale	Andrea Pitkus Nanguneri Nirmala Aaron Green Will Humphrey	Every Other Wednesdday 12:05 PM EST - starting 2/28/2024 Join our Cloud HD Video Meeting
Evaluation and Feedback Loops Working Group	Overarching Strategy					Andrew Quinn
Implementation and Quality Working Group	Overarching Strategy					Andrew Quinn
International Alignment Working Group	Overarching Strategy	International alignment / awareness		https://aphlinformatics.atlassian.net/wiki/download/attachments/1887437089/Shield Project Report Int. effort _ 2023-04-27.docx?api=v2		Xavier Gansel Marjorie Rollins Eza Hafeza Andrew Quinn

Project Proposals:

LIDR Requirements: LIVD File Repository Requirements
<add the template for each project>