QI-Core STU 5 had a general Observation profile which did not conflict with US Core because US Core 5.0.1 only had specific observation profiles. However, now that US Core 6.1.0 has a SimpleObsevation profile, we have built our Observation based on US Core's SimpleObservation. While that sounds straightforward, we have public health use cases creating measures about available resources (SANER is one) rather than subject=patient. While QI-Core STU 5 allowed Observation.subject = patient, location, device, implantable device, QI-Core STU 6.0 cannot include any references other than patient to be consistent with US Core. The ballot includes QICoreSimpleObservation with subject = patient (i.e., we removed the other references).  I specifically asked the best approach - either a variance to allow additional subjects in QI-Core SimpleObservation or creating a new ResourceObservation to address the non-patient subjects.  

Discussion in Cross-Group Projects Workgroup July 27, 2023 indicated the SimpleObservation profile built directly on US Core Simple Observation could not add any references to the existing Patient reference and that FMG would not approve such a variance. However, QI-Core may develop a new specific Observation Profile (e.g., QICoreResourceObservation) with the references required. While that profile would result in QA errors, a variance could be applied. Thus, CGP approved a variance for this to be developed profile and we can reference the variance request and approval FHIR-41475 in the QA to address the error for the anticipated ballot resolution to add a new ResourceObservation profile in QI-Core.

1. Proposal: Create a new profile for ResourceObservation - reference variance approval FHIR-41475