High level notes and action items:
Action Item: Riki said the goal is to go to the Implementation Plan Brainstorming Page and find out which section the LIVD File Expansion Committee is responsible for.
Sections that LIVD File Expansion Committee should be responsible are:
Riki said to leverage the User Guide to assign LOINC code to your test
IVD Vendor Engagement will be addressed by the proposal that Serge Jonnaert pull together
Action Item: Riki said the Committee needs to identify what data elements are needed for each of the use cases and then from a LIVID File perspective, what does the IVD, vendor and instrument know what they can share and find those data elements right and then ensure that they are made available for the laboratories.
Action Item: Greg Pappas said the first piece to to ask CAP what are their perspective on the LOINC User Guide and then the status of SNOMED.
Action Item: Greg Pappas said a preliminary step is the creation of IVD’s subset to focus on the issue of volume and sensitivity to clinical outcome.
Another step is an evaluation of the Implementation Guide
Develop a Workgroup for UDI assignment
Creation of an Committee to develop a strategy and how to work with FDA to move that forward.
Riki said SNOMED released educational material on how to properly use the code.
Riki thinks that working with ICC to pull a resource page together would be the best approach.
MariBeth said that since we are an international effort, we do need to have an agreement that we can use a group of codes for that purpose.
Action Item: Greg Pappas to send Matt Rahn the document that he put together with Julia after Micky provides his comments/feedback
Action Item: Ana Szarfman said she will work with the Use Case scenario
Action Item: Samuel McCash will work on Data Elements Needed
Ed Heierman will assist Samuel.
Action Item: Matt Rahn said he will work with others to improve the submission
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