Working Groups
Working Group Name | Topic or Strategy covered | Project | Priority | Reference documentation | SC Lead Name | Interested people | Meeting Info |
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Strategy 1 | Requirements for LIDR | 1 | Hung Luu Riki Merrick | Andrea Pitkus Xavier Gansel Andrew Quinn Stan Huff Dan Rutz Susan Downer Walter Sujanski Marti Velezis Pam Banning | Mondays 9-10am EST | ||
Additional data elements for LIVD file (e.g. UDI for equipment/ reagents, harmonization methods, UDIs for devices/kits/reagents |
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Clinically relevant test definitions - what makes results “co-minglable” |
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| Andrea Pitkus | ||||
Support dataflow throughout the ecosystem / Strategy 2 | Xavier project around result codes - qualitative (all lab domains) | 1 | 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 Meeting ID: 989 7283 9706 https://duke.zoom.us/j/98972839706?pwd=eDdhTUxDOGVDZTJ3K1gyZGRQbkZVQT09
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Xavier project around result codes - micro-organism |
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Xavier project around result codes - AST |
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Xavier project around result codes - microscopic and culture observations |
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Specimen CMT content / adoption |
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| Xavier Gansel | ||||
surgical synoptic reporting |
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| Mehdi Nassiri Will Humphrey | ||||
Anatomic Pathology Structured Reporting (cancer pathology) |
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| Mehdi Nassiri Will Humphrey | ||||
Structured genomics reporting (WGS, biomarkers, etc.) |
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| Xavier Gansel Nanguneri Nirmala Mehdi Nassiri | ||||
Test naming conventions |
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Tooling / Strategy 3 | Specimen CMT (tooling aspect) |
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| LIDR (Tooling aspect) |
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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
| 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) |
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Overarching Strategy |
| 1 |
| Eric Crugnale | Andrea Pitkus Nanguneri Nirmala Aaron Green Will Humphrey | Every Other Wednesdday 12:05 PM EST - starting 2/28/2024
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Overarching Strategy |
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| Andrew Quinn |
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Overarching Strategy |
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| Andrew Quinn |
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Overarching Strategy | International alignment / awareness |
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| Xavier Gansel Marjorie Rollins Eza Hafeza Andrew Quinn |
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Project Proposals:
LIDR Requirements:
<add the template for each project>