- Base FHIR Resource: Observation
- Derived from: USCoreLaboratoryResultObservationProfile
- Description: A result of a tumor marker test.
- mCODE-specific Attribute Constraints:
- basedOn reference restricted to (ServiceRequest | MedicationRequest)
- partOf reference restricted to (MedicationAdministration | MedicationStatement | Procedure)
- subject reference restricted to (Cancer Patient)
- focus reference restricted to (Cancer Condition Parent)
- performer reference restricted to (Practitioner)
- Interpretation and referenceRange are 0..1
- bodySite, hasMember, and component are zeroed out
- Value[x] restricted to valueQuantity, valueCoedableConcept, or valueRatio
- mCODE-specific Extensions: none
- mCODE-specific Slices:
- mCODE-specific ValueSets:
- Code is bound to TumorMarkerTestVS (extensible)
Other Notes of Interest:
- Biomarker status can be determined using TumorMarker or the Genomics profiles
- The primary decision to separate both TumorMarker and Genomics was pragmatically driven based on how some prognostic molecular marker results are sent by reference labs today.
- TumorMarker represents tests for substances found in tissue, blood, or other bodily fluids
- The Genomics profiles represent tests that measure DNA, RNA, or chromosomal changes
- Due to the wide variability in the results of tumor marker tests, value[x] can be a Quantity, CodeableConcept, or Ratio.
- Value[x] for TumorMarker has a cardinality of 0..1 because when the test result is indeterminate, no quantitative data value will be reported. Instead, the reason for the null value will be reported in the DataAbsentReason field.
- The basedOn, partOf, subject, focus, and performer attributes are restricted so references that would not be logical for this profile are not allowed.
- referenceRange and interpretation are restricted so only one data element can be used.