HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE) Release 1 - US Realm | STU Ballot 1

HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE) Release 1 - US Realm | STU Ballot 1 - Local Development build (v0.9.1). See the Directory of published versions

mCODE Release Notes / Change Log

mCODE 0.9.1 Release

The following are changes relative to mCODE 0.9.0.


  • Updated to FHIR Release 4 from DSTU 2.
  • Changed base class of mCODE laboratory panels (CBC and CMP) from Observation to DiagnosticReport.
  • Documented mCODE compliance criteria.
  • Documented preferred value sets for extensible binding and affect on US Core compliance.
  • Changed HistologyMorphologyBehaviorVS value set to descendants of SCT#367651003 (Malignant neoplasm of primary, secondary, or uncertain origin (morphologic abnormality)), from descendants of SCT#108369006 (Neoplasm (morphologic abnormality)), because the latter brought in some concepts that do not represent malignant neoplasms.

Corrections and Modifications to Existing Content

  • Updated code systems to new FHIR R4 base URL, http://terminology.hl7.org (previously was http://hl7.org/fhir)
  • Changed profile name from GeneticMutationTested to GeneticVariantTested.
  • Corrected mapping so the reference to PrimaryCancerCondition in all staging-related observations uses the existing 'focus' attribute.
  • Renamed extension Orientation to AnatomicalOrientation. The associated value set was also renamed to AnatomicalOrientationVS and its enumerated content was replaced by a logical definition.
  • Eliminated ClockDirection as a separate value set because values are incorporated in logically-defined SNOMED-CT AnatomicalOrientationVS.
  • Re-wrote the introductory narratives to consolidate multiple pages.
  • Changed clinicalStatus on PrimaryCancerCondition and SecondaryCancerCondition from 1..1 to 0..1.
  • Typographical fixes to multiple documentation pages.
  • Eliminated reference range from GeneticVariantTested and components of GeneticVariantFound.
  • Improved the definition of "curative" and "palliative" in TreatmentIntentVS.
  • Corrected the definition of TreatmentIntent.
  • Improved the explanation of the relationships between the genomics-related profiles.
  • Updated examples to validate against FHIR R4 and other changes to the profiles.
  • Changed blood pressure test code to LNC#85354-9 "Blood pressure panel with all children optional" to align with FHIR
  • Restored device attribute on TumorMarkerTest since laboratories do report it on occasion.
  • Added string as an allowable datatype for TumorMarkerTest.value[x], since it is a valid datatype for some of the tests included in TumorMarkerTestVS.
  • Changed cardinality of ECOGPerformanceStatus.value and KarnofskyPerformanceStatus.value to 1..1 and ECOGPerformanceStatus.dataAbsentReason and ECOGPerformanceStatus.dataAbsentReason to 0..0
  • Changed cardinality of GeneticVariantTested.referenceRange to 0..0.
  • Changed cardinality of referenceRange for GeneticVariantFound.component[VariantFoundIdentifier], GeneticVariantFound.component[VariantFoundHGVSName] and GeneticVariantFound.component[VariantFoundDescription] and to 0..0.
  • Clarified description of HistologyMorphologyBehaviorVS regarding the use of ICD-O-3 behavior codes.
  • Corrected descriptions for multiple codes in the ComorbidConditionVS.
  • Updated Data Dictionary to reflect FHIR R4 and other changes to the Implementation Guide.
  • Renamed PrimaryCancerConditionVS to PrimaryOrUncertainBehaviorCancerDisorderVS, for greater alignement with value set content.
  • Renamed extension prefixes from `shr-core` to `obf-datatype`.
  • Replaced onco-core-GeneStudied-extension with observation-geneticsGene standard extension in GeneticVariantTested.
  • Corrected the definition of obf-RadiationDosePerFraction-extension.
  • Renamed vital-precondition-extension to vital-preconditionCode-extension to distinguish from precondition whose datatype is Reference().
  • Improved the definition for obf-RadiationFractionsDelivered-extension.
  • Replaced locally defined LateralityVS with FHIR-defined laterality value set in obf-datatype-Laterality-extension.
  • Improved definition of onco-core-EvidenceType-extension.
  • Replaced obf-dateOfDiagnosis-extension with condition-assertedDate standard extension in PrimaryCancerCondition and SecondaryCancerCondition.
  • Added logical definition to TNM-related value sets to include all codes from AJCC staging systems.
  • Removed references to MedicationRequest on basedOn attribute for TNMClinicalPrimaryTumorCategory, TNMClinicalRegionalNodesCategory, TNMClinicalDistantMetastasesCategory, KarnofskyPerformanceStatus and ECOGPerformanceStatus.

Approved for Public Release. Distribution Unlimited. Case Number 16-1988