2025-08-13 Topic #2 Call

Attendees:

Agenda and Notes:

USCDI V7 Feedback discussion

Presentation on UDI content in IHE LAW (HL7 V2 message specification for IVD to LIS):

Made some changes on this page (under UDI): https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/3453616246

• Brief discussion on SpecimenAcceptability - highlighting the difference between reject reason and condition and why this should be renamed, but did not further discuss in detail

• Focus on UDI element:

  • reviewed the presentation:

    • is there a difference between UID and UDI (post-call note from Riki: UID is broader than UDI; UDI is one format a UID can have)

    • clarifying that UDI has multiple parts, the format is dependent on the assigning authority; the device identifier (DI) in the UDI is the same as the Global Trade Item Number, when assigned by GS1

    • different assigning authorities and the FDA approved formats = https://www.fda.gov/media/96648/download?attachment

      • GS1

      • Health Industry Business Communications Council® (HIBCC)

      • International Council for Commonality in Blood Banking Automation (ICCBBA)

  • discussed that there are many different patterns for lab results, which we would have to examine:

    • example ratios calculated from different reagent-based results (if produced by the instrument, then use that UDI, if by algorithm/software, use that UDI, if manual, no UDI all are possible)

    • single Sensitivity card with 1 UDI, but mulitple ABx elements (different LOINCs) - not an issue, can have 1-to-many for that

    • including collection devices?

    • including POCT

    • including at home test kit (self-contained devices)

  • should focus on the instrument for IVD-instrument produced results first - provide guidance to IVD manufacturers on how to send this data (currently can send manufacturer + model (wich can be translated to DI - in MSH in older messages, in OBX-18 in addition to the MSH in IHE LAW) and serial number (in OBX-18 in IHE LAW), so an LIS could concatenate this after receipt, but might be better to send full UDI from IVD instrument

  • when we expand beyond instrument, then need to consider where to send the kit/reagent information (INV segment, or a second repeat of OBX-18?)

  • need to provide mapping between elements in LIVD (LIDR) = DI level information and where in the patient level result messages this information would be (which should have the PI level information also (LIS has to set this up at least for each instrument interface) => this is where the LIS and then subsequently the certification for EHR-s comes into play.

• For writing the comment:

  • highlight the specific changes needed in USCDI first

  • do include the relationships and indicate any adjustments that need to be made to underlying stnadards and within communicating systems to make this data flow from IVD instrument to the IVD datahub to help ASTP/ONC better understand the impact on certified Health IT as well as other implementation points / incentives / levers to be considered

Recording:

From Chat:

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