HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE) Release 1 - US Realm | STU1
1.0.0 - STU1

This page is part of the HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE) Release 1 - US Realm | STU1 (v1.0.0: STU 1) based on FHIR R4. The current version which supercedes this version is 2.0.0. For a full list of available versions, see the Directory of published versions

StructureDefinition: TumorMarker

The result of a tumor marker test. Tumor marker tests are generally used to guide cancer treatment decisions and monitor treatment, as well as to predict the chance of recovery and cancer recurrence. A tumor marker is a substance found in tissue or blood or other body fluids that may be a sign of cancer or certain benign (noncancer) conditions. Most tumor markers are made by both normal cells and cancer cells, but they are made in larger amounts by cancer cells. A tumor marker may help to diagnose cancer, plan treatment, or find out how well treatment is working or if cancer has come back. Examples of tumor markers include CA-125 (in ovarian cancer), CA 15-3 (in breast cancer), CEA (in colon cancer), and PSA (in prostate cancer). Tumor markers differ from genetic markers in that they are measured at the levels of the protein and substance post-RNA protein synthesis. (Definition adapted from: NCI Dictionary of Cancer Terms and Cancer.Net).

Implementation note: The data value for TumorMarker has cardinality is 0..1 (required if known) 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 official URL for this profile is: 

http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-tumor-marker

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation I0..*USCoreLaboratoryResultObservationProfileMeasurements and simple assertions
... id Σ0..1stringLogical id of this artifact
... meta ΣI0..1MetaMetadata about the resource
... implicitRules ?!ΣI0..1uriA set of rules under which this content was created
... language I0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages
... text I0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension I0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!I0..*ExtensionExtensions that cannot be ignored
... identifier ΣI0..*IdentifierBusiness Identifier for observation
... basedOn ΣI0..*Reference(ServiceRequest | MedicationRequest)Fulfills plan, proposal or order
... partOf ΣI0..*Reference(MedicationAdministration | MedicationStatement | Procedure)Part of referenced event
... status ?!SΣI1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required)
... category SI1..*(Slice Definition)Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred)
.... category:Laboratory SI1..1CodeableConceptClassification of type of observation
Binding: ObservationCategoryCodes (preferred)

Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... version0..1stringVersion of the system - if relevant
...... code1..1codeSymbol in syntax defined by the system
Fixed Value: laboratory
...... display0..1stringRepresentation defined by the system
...... userSelected0..1booleanIf this coding was chosen directly by the user
..... text0..1stringPlain text representation of the concept
... code SΣI1..1CodeableConceptLaboratory Test Name
Binding: TumorMarkerTestVS (extensible)
... subject SΣI1..1Reference(Cancer Patient)Who and/or what the observation is about
... focus ΣI0..*Reference(Cancer Condition Parent)What the observation is about, when it is not about the subject of record
... encounter ΣI0..1Reference(Encounter)Healthcare event during which this observation is made
... effective[x] SΣI0..1Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTimedateTime
.... effectivePeriodPeriod
... issued ΣI0..1instantDate/Time this version was made available
... performer ΣI0..*Reference(Practitioner)Who is responsible for the observation
... value[x] SΣI0..1Result Value
.... valueQuantityQuantity
.... valueCodeableConceptCodeableConcept
.... valueRatioRatio
... dataAbsentReason SI0..1CodeableConceptWhy the result is missing
Binding: DataAbsentReason (extensible)
... interpretation I0..1CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible)
... note I0..*AnnotationComments about the observation
... method I0..1CodeableConceptHow it was done
Binding: ObservationMethods (example)
... specimen I0..1Reference(Specimen)Specimen used for this observation
... device I0..1Reference(Device | DeviceMetric)(Measurement) Device
... referenceRange I0..1BackboneElementProvides guide for interpretation
.... id 0..1stringUnique id for inter-element referencing
.... extension I0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!ΣI0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... low I0..1SimpleQuantityLow Range, if relevant
.... high I0..1SimpleQuantityHigh Range, if relevant
.... type I0..1CodeableConceptReference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred)
.... appliesTo I0..*CodeableConceptReference range population
Binding: ObservationReferenceRangeAppliesToCodes (example)
.... age I0..1RangeApplicable age range, if relevant
.... text I0..1stringText based reference range in an observation
... derivedFrom ΣI0..*Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)Related measurements the observation is made from

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation I0..*USCoreLaboratoryResultObservationProfileMeasurements and simple assertions
... id Σ0..1stringLogical id of this artifact
... meta ΣI0..1MetaMetadata about the resource
... implicitRules ?!ΣI0..1uriA set of rules under which this content was created
... language I0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred)
Max Binding: AllLanguages
... text I0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension I0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!I0..*ExtensionExtensions that cannot be ignored
... identifier ΣI0..*IdentifierBusiness Identifier for observation
... basedOn ΣI0..*Reference(ServiceRequest | MedicationRequest)Fulfills plan, proposal or order
... partOf ΣI0..*Reference(MedicationAdministration | MedicationStatement | Procedure)Part of referenced event
... status ?!SΣI1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required)
... category SI1..*(Slice Definition)Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred)
.... category:Laboratory SI1..1CodeableConceptClassification of type of observation
Binding: ObservationCategoryCodes (preferred)

Required Pattern: At least the following
..... id0..1stringUnique id for inter-element referencing
..... extension0..*ExtensionAdditional content defined by implementations
..... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
...... id0..1stringUnique id for inter-element referencing
...... extension0..*ExtensionAdditional content defined by implementations
...... system1..1uriIdentity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... version0..1stringVersion of the system - if relevant
...... code1..1codeSymbol in syntax defined by the system
Fixed Value: laboratory
...... display0..1stringRepresentation defined by the system
...... userSelected0..1booleanIf this coding was chosen directly by the user
..... text0..1stringPlain text representation of the concept
... code SΣI1..1CodeableConceptLaboratory Test Name
Binding: TumorMarkerTestVS (extensible)
... subject SΣI1..1Reference(Cancer Patient)Who and/or what the observation is about
... focus ΣI0..*Reference(Cancer Condition Parent)What the observation is about, when it is not about the subject of record
... encounter ΣI0..1Reference(Encounter)Healthcare event during which this observation is made
... effective[x] SΣI0..1Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTimedateTime
.... effectivePeriodPeriod
... issued ΣI0..1instantDate/Time this version was made available
... performer ΣI0..*Reference(Practitioner)Who is responsible for the observation
... value[x] SΣI0..1Result Value
.... valueQuantityQuantity
.... valueCodeableConceptCodeableConcept
.... valueRatioRatio
... dataAbsentReason SI0..1CodeableConceptWhy the result is missing
Binding: DataAbsentReason (extensible)
... interpretation I0..1CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible)
... note I0..*AnnotationComments about the observation
... method I0..1CodeableConceptHow it was done
Binding: ObservationMethods (example)
... specimen I0..1Reference(Specimen)Specimen used for this observation
... device I0..1Reference(Device | DeviceMetric)(Measurement) Device
... referenceRange I0..1BackboneElementProvides guide for interpretation
.... id 0..1stringUnique id for inter-element referencing
.... extension I0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!ΣI0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... low I0..1SimpleQuantityLow Range, if relevant
.... high I0..1SimpleQuantityHigh Range, if relevant
.... type I0..1CodeableConceptReference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred)
.... appliesTo I0..*CodeableConceptReference range population
Binding: ObservationReferenceRangeAppliesToCodes (example)
.... age I0..1RangeApplicable age range, if relevant
.... text I0..1stringText based reference range in an observation
... derivedFrom ΣI0..*Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)Related measurements the observation is made from

doco Documentation for this format

 

Other representations of profile: Schematron

Terminology Bindings

Terminology Bindings

PathConformanceValueSet / Code
Observation.languagepreferredCommonLanguages
Max Binding: AllLanguages
Observation.statusrequiredObservationStatus
Observation.categorypreferredObservationCategoryCodes
Observation.category:LaboratorypreferredPattern: laboratory
Observation.codeextensibleTumorMarkerTestVS
Observation.dataAbsentReasonextensibleDataAbsentReason
Observation.interpretationextensibleObservationInterpretationCodes
Observation.methodexampleObservationMethods
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
Observation.component.codeexampleLOINCCodes
Observation.component.dataAbsentReasonextensibleDataAbsentReason
Observation.component.interpretationextensibleObservationInterpretationCodes

Constraints

Constraints

IdPathDetailsRequirements
us-core-1Observation.effective[x]Datetime must be at least to day.
: ($this as dateTime).toString().length() >= 8