minimal Common Oncology Data Elements (mCODE) Implementation Guide
2.1.0 - Pre-STU 3 Development United States of America flag

minimal Common Oncology Data Elements (mCODE) Implementation Guide, published by HL7 International Clinical Interoperability Council. This is not an authorized publication; it is the continuous build for version 2.1.0). This version is based on the current content of https://github.com/HL7/fhir-mCODE-ig/ and changes regularly. See the Directory of published versions

Resource Profile: Cancer Disease Status Profile

Official URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-disease-status Version: 2.1.0
Active as of 2023-01-13 Maturity Level: 3 Computable Name: CancerDiseaseStatus

A clinician’s qualitative judgment on the current trend of the cancer, e.g., whether it is stable, worsening (progressing), or improving (responding). The judgment may be based a single type or multiple kinds of evidence, such as imaging data, assessment of symptoms, tumor markers, laboratory data, etc.

Conformance

Observation resources associated with an in-scope patient with Observation.code LOINC 97509-4 MUST conform to this profile. Beyond this requirement, a producer of resources SHOULD ensure that any resource instance associated with an in-scope patient that would reasonably be expected to conform to this profile SHOULD be published in this form.

Usage:

Formal Views of Profile Content

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

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..*ObservationMeasurements and simple assertions
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... evidenceType S0..*CodeableConceptCancer Disease Status Evidence Type Extension
URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-disease-status-evidence-type
Binding: Cancer Disease Status Evidence Type Value Set (required)
... status S1..1coderegistered | preliminary | final | amended +
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... system1..1uriIdentity of the terminology system
Fixed Value: http://loinc.org
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: 97509-4
... subject S1..1Reference(Cancer Patient Profile)Who and/or what the observation is about
... focus S0..*Reference(Primary Cancer Condition Profile | Secondary Cancer Condition Profile | Tumor Profile | Radiotherapy Volume Profile)What the observation is about, when it is not about the subject of record
... effective[x] S0..1dateTimeClinically relevant time/time-period for observation
... performer 0..*Reference(US Core Practitioner Profile)Who is responsible for the observation
... value[x] S0..1CodeableConceptActual result
Binding: Condition Status Trend Value Set (required)
... specimen 0..1Reference(Specimen)Not used in this profile
... device 0..1Reference(Device | DeviceMetric)Not used in this profile
... referenceRange 0..*BackboneElementNot used in this profile
... hasMember 0..*Reference(Observation | QuestionnaireResponse | MolecularSequence)Not used in this profile
... component 0..*BackboneElementNot used in this profile

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
Observation.value[x]requiredConditionStatusTrendVS
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationMeasurements and simple assertions
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... evidenceType S0..*CodeableConceptCancer Disease Status Evidence Type Extension
URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-disease-status-evidence-type
Binding: Cancer Disease Status Evidence Type Value Set (required)
... status ?!SΣ1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... code SΣ1..1CodeableConceptType of observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.


Required Pattern: At least the following
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... system1..1uriIdentity of the terminology system
Fixed Value: http://loinc.org
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: 97509-4
... subject SΣ1..1Reference(Cancer Patient Profile)Who and/or what the observation is about
... focus SΣ0..*Reference(Primary Cancer Condition Profile | Secondary Cancer Condition Profile | Tumor Profile | Radiotherapy Volume Profile)What the observation is about, when it is not about the subject of record
... effective[x] SΣ0..1dateTimeClinically relevant time/time-period for observation
... performer Σ0..*Reference(US Core Practitioner Profile)Who is responsible for the observation
... value[x] SΣC0..1CodeableConceptActual result
Binding: Condition Status Trend Value Set (required)
... specimen 0..1Reference(Specimen)Not used in this profile
... device 0..1Reference(Device | DeviceMetric)Not used in this profile
... referenceRange C0..*BackboneElementNot used in this profile
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
... hasMember Σ0..*Reference(Observation | QuestionnaireResponse | MolecularSequence)Not used in this profile
... component Σ0..*BackboneElementNot used in this profile
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Observation.statusrequiredObservationStatus
Observation.codeexamplePattern: LOINC code 97509-4
Observation.value[x]requiredConditionStatusTrendVS
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationMeasurements and simple assertions
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... evidenceType S0..*CodeableConceptCancer Disease Status Evidence Type Extension
URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-disease-status-evidence-type
Binding: Cancer Disease Status Evidence Type Value Set (required)
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness Identifier for observation
... basedOn Σ0..*Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)Fulfills plan, proposal or order
... partOf Σ0..*Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)Part of referenced event
... status ?!SΣ1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... category 0..*CodeableConceptClassification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


... code SΣ1..1CodeableConceptType of observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.


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://loinc.org
..... version0..1stringVersion of the system - if relevant
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: 97509-4
..... display0..1stringRepresentation defined by the system
..... userSelected0..1booleanIf this coding was chosen directly by the user
.... text0..1stringPlain text representation of the concept
... subject SΣ1..1Reference(Cancer Patient Profile)Who and/or what the observation is about
... focus SΣ0..*Reference(Primary Cancer Condition Profile | Secondary Cancer Condition Profile | Tumor Profile | Radiotherapy Volume Profile)What the observation is about, when it is not about the subject of record
... encounter Σ0..1Reference(Encounter)Healthcare event during which this observation is made
... effective[x] SΣ0..1dateTimeClinically relevant time/time-period for observation
... issued Σ0..1instantDate/Time this version was made available
... performer Σ0..*Reference(US Core Practitioner Profile)Who is responsible for the observation
... value[x] SΣC0..1CodeableConceptActual result
Binding: Condition Status Trend Value Set (required)
... dataAbsentReason C0..1CodeableConceptWhy the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


... note 0..*AnnotationComments about the observation
... bodySite 0..1CodeableConceptObserved body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

... method 0..1CodeableConceptHow it was done
Binding: ObservationMethods (example): Methods for simple observations.

... specimen 0..1Reference(Specimen)Not used in this profile
... device 0..1Reference(Device | DeviceMetric)Not used in this profile
... referenceRange C0..*BackboneElementNot used in this profile
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... low C0..1SimpleQuantityLow Range, if relevant
.... high C0..1SimpleQuantityHigh Range, if relevant
.... type 0..1CodeableConceptReference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.

.... appliesTo 0..*CodeableConceptReference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.


.... age 0..1RangeApplicable age range, if relevant
.... text 0..1stringText based reference range in an observation
... hasMember Σ0..*Reference(Observation | QuestionnaireResponse | MolecularSequence)Not used in this profile
... derivedFrom Σ0..*Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)Related measurements the observation is made from
... component Σ0..*BackboneElementNot used in this profile
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... value[x] Σ0..1Actual component result
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueBooleanboolean
..... valueIntegerinteger
..... valueRangeRange
..... valueRatioRatio
..... valueSampledDataSampledData
..... valueTimetime
..... valueDateTimedateTime
..... valuePeriodPeriod
.... dataAbsentReason C0..1CodeableConceptWhy the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

.... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


.... referenceRange 0..*See referenceRange (Observation)Provides guide for interpretation of component result

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Observation.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
Observation.statusrequiredObservationStatus
Observation.categorypreferredObservationCategoryCodes
Observation.codeexamplePattern: LOINC code 97509-4
Observation.value[x]requiredConditionStatusTrendVS
Observation.dataAbsentReasonextensibleDataAbsentReason
Observation.interpretationextensibleObservationInterpretationCodes
Observation.bodySiteexampleSNOMEDCTBodyStructures
Observation.methodexampleObservationMethods
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
Observation.component.dataAbsentReasonextensibleDataAbsentReason
Observation.component.interpretationextensibleObservationInterpretationCodes

Differential View

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..*ObservationMeasurements and simple assertions
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... evidenceType S0..*CodeableConceptCancer Disease Status Evidence Type Extension
URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-disease-status-evidence-type
Binding: Cancer Disease Status Evidence Type Value Set (required)
... status S1..1coderegistered | preliminary | final | amended +
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... system1..1uriIdentity of the terminology system
Fixed Value: http://loinc.org
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: 97509-4
... subject S1..1Reference(Cancer Patient Profile)Who and/or what the observation is about
... focus S0..*Reference(Primary Cancer Condition Profile | Secondary Cancer Condition Profile | Tumor Profile | Radiotherapy Volume Profile)What the observation is about, when it is not about the subject of record
... effective[x] S0..1dateTimeClinically relevant time/time-period for observation
... performer 0..*Reference(US Core Practitioner Profile)Who is responsible for the observation
... value[x] S0..1CodeableConceptActual result
Binding: Condition Status Trend Value Set (required)
... specimen 0..1Reference(Specimen)Not used in this profile
... device 0..1Reference(Device | DeviceMetric)Not used in this profile
... referenceRange 0..*BackboneElementNot used in this profile
... hasMember 0..*Reference(Observation | QuestionnaireResponse | MolecularSequence)Not used in this profile
... component 0..*BackboneElementNot used in this profile

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
Observation.value[x]requiredConditionStatusTrendVS

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationMeasurements and simple assertions
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... evidenceType S0..*CodeableConceptCancer Disease Status Evidence Type Extension
URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-disease-status-evidence-type
Binding: Cancer Disease Status Evidence Type Value Set (required)
... status ?!SΣ1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... code SΣ1..1CodeableConceptType of observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.


Required Pattern: At least the following
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... system1..1uriIdentity of the terminology system
Fixed Value: http://loinc.org
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: 97509-4
... subject SΣ1..1Reference(Cancer Patient Profile)Who and/or what the observation is about
... focus SΣ0..*Reference(Primary Cancer Condition Profile | Secondary Cancer Condition Profile | Tumor Profile | Radiotherapy Volume Profile)What the observation is about, when it is not about the subject of record
... effective[x] SΣ0..1dateTimeClinically relevant time/time-period for observation
... performer Σ0..*Reference(US Core Practitioner Profile)Who is responsible for the observation
... value[x] SΣC0..1CodeableConceptActual result
Binding: Condition Status Trend Value Set (required)
... specimen 0..1Reference(Specimen)Not used in this profile
... device 0..1Reference(Device | DeviceMetric)Not used in this profile
... referenceRange C0..*BackboneElementNot used in this profile
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
... hasMember Σ0..*Reference(Observation | QuestionnaireResponse | MolecularSequence)Not used in this profile
... component Σ0..*BackboneElementNot used in this profile
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Observation.statusrequiredObservationStatus
Observation.codeexamplePattern: LOINC code 97509-4
Observation.value[x]requiredConditionStatusTrendVS
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationMeasurements and simple assertions
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... evidenceType S0..*CodeableConceptCancer Disease Status Evidence Type Extension
URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-disease-status-evidence-type
Binding: Cancer Disease Status Evidence Type Value Set (required)
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness Identifier for observation
... basedOn Σ0..*Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)Fulfills plan, proposal or order
... partOf Σ0..*Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)Part of referenced event
... status ?!SΣ1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... category 0..*CodeableConceptClassification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


... code SΣ1..1CodeableConceptType of observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.


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://loinc.org
..... version0..1stringVersion of the system - if relevant
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: 97509-4
..... display0..1stringRepresentation defined by the system
..... userSelected0..1booleanIf this coding was chosen directly by the user
.... text0..1stringPlain text representation of the concept
... subject SΣ1..1Reference(Cancer Patient Profile)Who and/or what the observation is about
... focus SΣ0..*Reference(Primary Cancer Condition Profile | Secondary Cancer Condition Profile | Tumor Profile | Radiotherapy Volume Profile)What the observation is about, when it is not about the subject of record
... encounter Σ0..1Reference(Encounter)Healthcare event during which this observation is made
... effective[x] SΣ0..1dateTimeClinically relevant time/time-period for observation
... issued Σ0..1instantDate/Time this version was made available
... performer Σ0..*Reference(US Core Practitioner Profile)Who is responsible for the observation
... value[x] SΣC0..1CodeableConceptActual result
Binding: Condition Status Trend Value Set (required)
... dataAbsentReason C0..1CodeableConceptWhy the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


... note 0..*AnnotationComments about the observation
... bodySite 0..1CodeableConceptObserved body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

... method 0..1CodeableConceptHow it was done
Binding: ObservationMethods (example): Methods for simple observations.

... specimen 0..1Reference(Specimen)Not used in this profile
... device 0..1Reference(Device | DeviceMetric)Not used in this profile
... referenceRange C0..*BackboneElementNot used in this profile
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... low C0..1SimpleQuantityLow Range, if relevant
.... high C0..1SimpleQuantityHigh Range, if relevant
.... type 0..1CodeableConceptReference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.

.... appliesTo 0..*CodeableConceptReference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.


.... age 0..1RangeApplicable age range, if relevant
.... text 0..1stringText based reference range in an observation
... hasMember Σ0..*Reference(Observation | QuestionnaireResponse | MolecularSequence)Not used in this profile
... derivedFrom Σ0..*Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)Related measurements the observation is made from
... component Σ0..*BackboneElementNot used in this profile
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... value[x] Σ0..1Actual component result
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueBooleanboolean
..... valueIntegerinteger
..... valueRangeRange
..... valueRatioRatio
..... valueSampledDataSampledData
..... valueTimetime
..... valueDateTimedateTime
..... valuePeriodPeriod
.... dataAbsentReason C0..1CodeableConceptWhy the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

.... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


.... referenceRange 0..*See referenceRange (Observation)Provides guide for interpretation of component result

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
Observation.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
Observation.statusrequiredObservationStatus
Observation.categorypreferredObservationCategoryCodes
Observation.codeexamplePattern: LOINC code 97509-4
Observation.value[x]requiredConditionStatusTrendVS
Observation.dataAbsentReasonextensibleDataAbsentReason
Observation.interpretationextensibleObservationInterpretationCodes
Observation.bodySiteexampleSNOMEDCTBodyStructures
Observation.methodexampleObservationMethods
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
Observation.component.dataAbsentReasonextensibleDataAbsentReason
Observation.component.interpretationextensibleObservationInterpretationCodes

 

Other representations of profile: CSV, Excel, Schematron