Laboratory Interoperability Data Regristry (LIDR)

Strategy 1

Requirements for LIDR

1

https://aphlinformatics.atlassian.net/wiki/spaces/SLC/pages/915407143

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

https://duke.zoom.us/j/98972839706?pwd=eDdhTUxDOGVDZTJ3K1gyZGRQbkZVQT09

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)

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/

https://mdic.org/resource/ivd-rwe-education-series-module-1/

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

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

https://sonichealthcareusa.zoom.us/j/92902861424

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