Hung Luu

Children’s

Riki Merrick

Vernetzt, APHL

Andrea Pitkus

UW

Pam Banning

3M

Xavier Gansel

Biomerieux

Amy McCormick

Epic

Dan Rutz

Epic

Rob Rae

CAP

Sandy Jones

CDC

Stan Huff

Graphite

Ed Heierman

Abbott / IICC

Andrew Quinn

Laurent Lardin

Biomerieux

Anthony Killeen

UMN

Craig Collom

UDI representation

Ed Heierman

• IICC introduction on how to communicate equipment information (manufacturer, model, serial number) – is covered s part of LAW supports UDI essentially (in OBX-18)-  IICC revisited this as part of the LIVD work related to COVID-19 – establishing the test kit and

• Connie reached out about understanding how to share instrument UDIs from instruments

• We know we want to get UDI form test kit and equipment into the IVD datahub – also there is the need to have this information available to folks in LIDR and what is the flow of data from IVD instrument to IVD datahub and all systems in between, so establish the requirements on how the data needs to be represented, need to better understand

• UDI has different formats across international regions, so need to make sure on how to represent that

• Are we looking at human readable format, or barcode, how would it be stored in datahub

• There may be more than on UDI for the system and the test kit

• UDI has several parts

  • Device Identifier

  • Production identifier

  • For comparability the device identifier may be enough, but for real world evidence the production identifier may also be needed

• Before trying to push FDA we need to examine what we can do with what we have today

• US and Europe should address this similarly

• Reagan Udall or MDIC – whoever developed the Real World evidence requirements – so we can better understand what is needed

• Affects both us and IVD data hub group – Hung to reach out to Carolyn to give us a starting point

• Share the potential proposals with this group, with the understanding that this is the starting point, not the final solution - Xavier wil pull this together and send out

• UDI is not in USCDI

  • Test kit is level 2, instrument is level 1 – we will keep pushing for it

  • May just need to be stored / pass through with the result, anytime it is shared (treat it similar to the LOINC – maintained with the result) – UDI of instrument and maybe reagent – this needs more research

  • Understand the data model around this, then figure out how to properly express in V2, FHIR and CDA

  • Expect that for LIDR capture the device identifier, but leave out the serial number

  • LIVD can capture the device ID now

  • In LAW we require serial number of the instruments

  • The combination of both of these may give you what is needed

  • Have a clear understanding on what is in LIDR, what is the responsibility of the instrument to share

• Plan on August 21 for the next discussion

What product are we producing?

Hung Luu

• Need to have something citable - white paper or article?

  • white paper is most reasonable approach

  • Information model that includes the access needs

Reviewing scope

Riki Merrick

• Requirements:

  • Free access to LIDR

    • Are some IVD manufacturers still wanting to limit access to customers

    • IVD manufacturer likes to know who is accessing the data for analytics

    • IICC can get some feedback on that

    • Who needs to have the data available – provide reasons why each group needs to have access

      • Customers only

      • Folks working on code harmonization

      • Researchers

      • Anyone in the world

  • Biomerieux already has created some disclaimer language on their shared code mappings.

    • Their link is posted on the CDC webpage: https://www.cdc.gov/csels/dls/livd-codes.html

      • Has 2 ways to get to the LOINCs

        • Product specific mappings: https://www.biofiredx.com/support/documents/#toggle-id-4

        • Generic resource center with access to LIVD files – free account needed: https://resourcecenter.biomerieux.com/

Timeline for work products

Hung Luu / Riki Merrick

• scope for this working group by end of August

• outline of white paper by end of October

• Deadline for requirements for LIDR MVP – end of October