Attendees: Kathy Walsh (Labcorp), Yanick Gaudet (Star Global), Riki Merrick (Vernetzt, LLC / APHL), Rob Hausam (Hausam Consulting), Elliot SIlver (ResMed), Andrea Pitkus (UW), Ralf Herzog (Roche), JD Nolen (Mercy CHildren's Hospital)

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Chair: Ralf Herzog

Scribe: Riki Merrick

Quorum met (Co-Chair+2): Yes


  • From Lab call 2/10:
    •  - Proposed draft language to implement the disposition:
      • Review draft language:
        • Update and replace text for observation and DiagnosticReport
        • DiagnosticReport examples will be updated and adding in the attributes that need to be considered
        • Do we need to include changes in observation – do we need additional text to clarify some of those
        • Specifically do we need to make the changes around Follow up and Add-0n here or in ServiceRequest (or observation)?
        • Should not take too long to add – Rob will do, Hans has the original jpgs to use
        • This is for diagnosticReport or observation?
        • This jira has been resolved, we are just checking on the final language
        • May need to add some pointers on observation, where people may want to look for grouping – we want to only have the text in one place
        • We have already discussed the mechanisms for grouping on the prior calls and created different diagrams to show what resources are needed
        • Where to put the main text – in DiagnosticReport or observation
          • the grouping mechanism is in observation and many IVD vendors look only at observations
          • the grouping resource for results is the DiagnosticReport
          • Hans suggested in the draft language to break it into 2 parts, for those elements that are more logically associated with DiagnosticReport should go there – then we should crosslink to observation for the other resource
          • Put the diagrams for use cases in DiagnosticReport and have the explanatory text about how to do the grouping in observation, because that is how it is technically done
          • We want to make sure people strongly consider use of diagnosticReport for reporting
          • IVD instruments sometimes perform reflex testing with different dilutions automatically executed on the instrument, but the instrument reports by intention only the final overall interpretation
            • Roche’s IVD instruments do not produce a diagnosticReport, they send overall observation with the additional results as components
            • LIS may not report all the results it gets from an instrument
          • OO recommend ed to use DiagnosticReport when trying to convey ORC/OBR/OBX groupings
        • Can this be its own page and link to that from both places?
          • What about putting it here?
          • Rob prefers to keep it in DiagnosticReport and link to it from observation
          • Put on module page with proper links from observation and DiagnosticReport JD, Andrea, no further discussion, against: 0, abstain: 1, in favor: 6
      • Comingling 2 issues:
        • Specimen in lab and get add-on test request – evaluate, if enough specimen is available
          • Can reference the existing specimen in the ServiceRequest, but need a mechanism to flag to check for specimen availability and NOT draw a new sample (task to create new sample)
        • Specific order to draw a NEW specimen for the add-on test
        • need to support both of those - there are comments in the Jira for considerations
  • From PC discussion


  • Rob Hausam 2:03 PM
  • Andrea Pitkus 2:06 PM
    • Are you referring only for parent child specimens
  • Andrea Pitkus 2:24 PM
    • So if moved to observation, it should be referenced in DR via the link as described
    • Separate observations should be used to communicate each generated
    • and not placing multiple observations in a single observation
  • Ralf 2:25 PM
    • this depends...
  • Andrea Pitkus 2:25 PM
    • on?
  • Ralf 2:26 PM
    • there exists the example of HIV Tests - where you measure two or three or more different Virusvariantes (HIV-1, HIV-2, …) and have one overall result: HIV: positive/negative
  • Andrea Pitkus 2:27 PM
    • are you talking about an assay with a single result value with 3 markers that may be detected, but you don't know which one(s) or separate observations (HIV 1 pos, HIV pos, etc.)
    • They would be structured differently
  • Andrea Pitkus 2:38 PM
    • does CG also reference this page? If so, would cover genomics too
  • Andrea Pitkus 2:44 PM
    • Hopefully some of the issues will be addressed in other future calls