2021-06-02
SHIELD Meeting Minutes: Effectiveness Kick-Off Meeting
Held on: | Wednesday, 06/02/2021 |
Attendees: | Prashila Dullabh, Vishal Patel, Andrew Quinn, David Baorto, MariBeth Gagnon, Carolyn Hiller, Michael Berman, Giovanna Giannico, Victor Landim Araujo, Zerina Borhan, Greg R, Marranda Scott, Vaishali Patel, Greg Pappas |
Action Items: |
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Meeting Notes |
Agenda/Discussion Items:
a. Alternate times
a. Some Examples i. How well are we moving coding upstream?
LIVID file comprised of COVID 19 testing ii. Are we improving awareness of standards, coding and interoperability efforts?
iii. Are we seeing downstream improvements in the coding of patient data?
a. How many labs are reporting? How many are reporting correctly?
a. Profiency testing – Link to CLIA b. IVD Data hub iv. Other strategies?
a. Examples i. Measure coding of vendors, coding results, code inclusion in vendor materials. Other thougths? ii. Surveys, Other thoughts? iii. Data access modalities? Large projects? Lab surveys?
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Issues/Resolution:
O We are coming up with ways of measuring and monitoring what other components of SHIELD is producing · How are we getting data / insight from other committees? Contacts from committees, deadlines, etc · Progress so far of LIVID Committee in relation to Effectiveness Committee: o They can’t do all IBD. What we need is a repository that does this work for other data systems and have industry submit to that repository their codes which would turn into public access. o LIVID committee would provide template in beginning on how industry should proceed and some quality assurance activity around this file o Getting labs (LIS system) to adopt this coding scheme in a consistent way o 1) We want to link the effort to current CLIA performance measurements · Progress so far on Implementation Committee in relation to Effectiveness Committee: o 2) IBD data hub that would be used by industry to do studies for safety and efficacy to submit to FDA. Post market data that would be useful to industry to evaluate their products for the FDA § Series of healthcare providers that are all participating in providing the data o 3) Identify healthcare systems for their own purposes that need to sort out their interoperability issues and patient safety issues |
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Risks/Mitigation: · Where are we going to get the data that we need to make assessments regarding all of this? · How are we going to measure our deltas from data discrepancies? · Do we measure the number of labs that are online? · What are the KPIs that are we measuring for the program to be successful? |
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