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  • Device identification data is not included in device/test documentation
    • The latest LIVD guide does not include an ability for the relevant identifier for each test kit. - QUESTION: it does not have a slot for it (I thought that's what the Equipment (to be renamed to Product) UID is for) - or that information is not currently provided in that slot?  HJB: Still TBD in R2 to finalize location, either ObservationDefinition or DeviceDefinition. Riki: I was just talking about the current published spreadsheet version
  • Deployed lab order implementation guides do not include the guidance on how to convey all the relevant ask-at-order-entry questions and answers recognizably and consistently.
    • The latest eDOS guide has the commonly used set of AOEs with standard LOINC codes and where applicable answer sets, but is not complete to cover the latest updates. Riki: but it coudl be - the lan is to do STU update, so we could add these additonal AOEs as STU comments and include, so that part can be remedied as fast as Frieda can edit (wink) (AP:  eDOS supports any AOE as each laboratory may have different AOE needs for their CLIA Specimen Collection Manual/order catalog/lab compendium/eDOS content.  Each lab also determines their own phrasing for their AOEs.  Some refer to culture sources as site or specimen source.) (FH: There is a list of "LOINC terms related to public health case reporting" here:  https://loinc.org/sars-cov-2-and-covid-19/ Planning to add the list or at minimum the hyperlink to the eDOS IG update.)
    • The latest LOI guide addresses the ability to communicate all relevant data, including any AOEs, but is not deployed in active use.
    • Upgrading to the latest LOI guide is a major lift for everybody, so although desired for the mid/long-term, it is not a good short-term recommendation.
  • Deployed lab reporting implementation guides do not include the guidance on how to convey all the relevant ask-at-order-entry questions and answers recognizably and consistently, nor the relevant device information, nor sufficient clarity on minimum desired demographic data (some fields may need to be marked RE rather than O, or X).
    • The latest LRI guide (that now includes ELR in form of the PH_component) accommodates the ability to send any relevant AOEs, but may need more specificity on other patient demographic data already available in PID or PD1, while it does need guidance on how to convey the relevant device/test kit(s) used to perform the test.
    • Upgrading to the latest LRI guide is a major lift for everybody, so although desired for the mid/long-term, it is not a good short-term recommendation.

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