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• GS1 proposal for embedded identifiers in containers
  • Always will have tube id – there will still be the placer / or filler system created identifier
  • In v2 we can differentiate between the 2
  • 2D barcode to support labeling – that is not human readable, so still need the label
  • Also have to track when you make aliquots
    • New containers have their own IDs – could link to parents to create that linkage
    • Need multiple identifiers for bloodbank
  • But all labs that get the original container will use the same identifier
  • GS1 is coming from EUN
• IHE is looking for sending identifiers – so need to add
  • GTIN – UDI has 2 versions – the model and the serial number
    • Would have to have this, since we
  • We need to make sure which agency is creating the UDI
  • Knowing if it is a model ID or a serial number
  • https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics
  • and https://www.fda.gov/media/96648/download
  • Every instrument has a serial number, but that may not need to be communicated
  • What if you have device ID and serial number, but not the elements in between?
  • in IHE LAW we use OBX-18 repeating for manufacturer, device and serial number
    • may have to revisit LAW / AUTO-16
  • We will need to pull together all the options for UDI
    • need help from Marti,
    • Ralf to contact Neil Piper to get some input into this in more detail and invite them for a call
    • Then we can draft the UTG proposal

• V2 OO/Specimen
  • Not discussed
• FHIR Specimen JIRAs
  • FHIR-40646
    
    • THO request for Specimen.processing.method value set
    • Relates to UP-408, which Marti created in order to support this
    • Not sure why we need to move the value set to THO – this is example binding
    • Provide input: Not sure we need to, because this is already in R5 and it is an example binding
    • This code system should be on the to-do list to ensure it is complete enough
      • Could be here / in LabMCoP
  • FHIR-40643

    • Extension was added as we could not add it to the Specimen core for R5; Rob was going to pre-apply

    • Create an extension in R5 for specimen.additive as 0..* as codeableReference to Substance

      • Note: example binding to a value set defined as descendants of SNOMED CT 'Substance for the codeable part of the Reference

    • Also see comments on 2023-03-14 OO on FHIR from Andrea, which is where we voted on this change 

    • Review how it was applied: https://build.fhir.org/ig/HL7/fhir-extensions/StructureDefinition-specimen-additive.html
      • All extensions are managed in the FHIR Extensions Pack – will be published in concert with IG – but it also pulls the extension into the CI build now
      • Added it at 2 levels
        • Specimen
        • specimenContainer – that gives us the R4 context back
      • how to address the percentage / amount the additive
        • this may be done with container deviceType
          • in specimen.container.reference to device
            • use ode for the purpletop tube with x% EDTA – include that in the code
            • If we need to pull this out as separate elements, then we will have to model that in R6
          • When we create codeableReference for the device we could to it there
        • We can also handle it through the code for the additive
        • Device type will also handle the glass vs plastic of the container which is import
        • Motion to find persuasive with mod to add the extension at 2 levels as pre-applied - Ralf, Riki, no further discussion, against: 0, abstain: 0, in favor: 7
      • Mark as change applied
      • Vocab: HL70371 vs SNOMED CT
        • Should be on the to do list to review / create mapping - either here or LabMCoP

From Chat

• Andrea Pitkus to  Everyone 2:28 PM
  • Here's some examples of containers, different additive amounts, volumes, colors, etc.
  • https://www.bd.com/en-ca/offerings/capabilities/specimen-collection/blood-specimen-collection/venous-collection/bd-vacutainer-blood-collection-tubes/view-hematology-tubes
• Andrea Pitkus 2:36 PM
  • Actually, trying to search table 371 in additive SCT codes and a number are missing. So what we voted upon may not be usable for common lab use cases
  • http://hl7.org/fhir/R4/v2/0371/index.html
• Andrea Pitkus 2:55 PM
  • Ralf, can you look up each serial # unique PI in GUDID? I was seeing the instrument level not serial # level
  • https://accessgudid.nlm.nih.gov/devices/07613336179505
  • This example from Roche has a serial #, but no expiration to your earlier point, and no manufacturing date

Call Adjourned at 3:02 PM

Next Meeting:  3/27/2023

Next Time: 

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