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:

  • Laboratory Interoperability Data Resources (LIDR) - LIVD expansion file management

  • Creation of LIVD data elements and population of LIDR database

  • Sustainability Plan

  • Implementation Approach

• Riki said to leverage the LOINC user guide as well as the as well as the domain specific guides to assign LOINC code to the IVD test

• IVD Vendor Engagement will be addressed by the proposal that Serge Jonnaert pulled together - information about the availablity of these user guides and other education material to promote correct coding should be included in there = maybe create a one stop shop for IVD vendor education on LOINC, SNOMED and UDI

• Action Item: Riki said the Committee needs to identify what data elements are needed for each of the use cases and then from a LIVD 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 Guides and then the status of SNOMED.

• Action Item: Greg Pappas said a preliminary step is the creation of identifying a subset of IVD’s to focus on - based on volume and sensitivity to clinical outcome (the implementation committee has input from Hung Luu, Scott Campbell and Stan Huff so far)

  • Develop a Workgroup for UDI assignment

  • Creation of an Committee to develop a strategy and how to work with FDA to move that forward.

• 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 - we may be able to leverage the value set created for the international Patient Summary

• 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

• Step 1 - Data Element

• Step 2 - Ensure all data elements in LIVD format definition

• Step 3 - Create process for hub submission which includes code review for accuracy

• Step 4 - Create process for hub repository maintanence