Onconova Implementation Guide - Local Development build (v0.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Resource Profile: Tumor Marker Profile
| Official URL: http://onconova.github.io/fhir/StructureDefinition/onconova-tumor-marker | Version: 0.2.0 | |||
| Active as of 2025-10-17 | Computable Name: OnconovaTumorMarker | |||
A profile representing a tumor marker observation for a cancer patient, including the type of tumor marker and its value.
This profile extends the base mCODE TumorMarkerTest profile to include specific constraints and requirements for Onconova.
If relied on the same use context as mCODE, namely for substances found in tissue or blood or other body fluids that may be a sign of cancer or certain benign (non-cancer) conditions measured at the levels of the protein and substance post-RNA protein synthesis (not at genomic level).
Usages:
- Refer to this Profile: Molecular Tumor Board Therapeutic Recommendation
- CapabilityStatements using this Profile: Onconova FHIR REST Capability Statement
You can also check for usages in the FHIR IG Statistics
Formal Views of Profile Content
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints Filter:   |
|---|---|---|---|---|
  Observation |
C | 0..* | TumorMarkerTest(4.0.0) | Measurements and simple assertions Constraints: obs-6, obs-7, us-core-2, o-tma-req-1, o-tma-req-2, o-tma-req-3 |
  implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
  Slices for extension |
1..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |
   extension:relatedCondition |
S | 0..* | CodeableConcept, Reference(Condition) | Condition associated with this test. URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition Constraints: ext-1 |
 extension:tumorMarkerAnalyte |
1..1 | CodeableConcept | Tumor Marker Analyte URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte Binding: TumorMarkerAnalytes (0.2.0) (required) Constraints: ext-1 | |
 modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored Constraints: ext-1 |
| status |
?!SΣ | 1..1 | code | (USCDI) registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. |
 Slices for category |
S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. |
 category:us-core |
S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: USCoreClinicalResultObservationCategory (6.1.0) (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets Required Pattern: At least the following |
  id |
0..1 | string | Unique id for inter-element referencing | |
 extension |
0..* | Extension | Additional content defined by implementations | |
  coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |
 id |
0..1 | string | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category | |
| version |
0..1 | string | Version of the system - if relevant | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory | |
| display |
0..1 | string | Representation defined by the system | |
 userSelected |
0..1 | boolean | If this coding was chosen directly by the user | |
 text |
0..1 | string | Plain text representation of the concept | |
| code |
SΣ | 1..1 | CodeableConcept | (USCDI) Laboratory Test Name Binding: TumorMarkerTestVS (4.0.0) (extensible) |
 subject |
SΣ | 1..1 | Reference(Cancer Patient Profile(0.2.0)) | (USCDI) Who and/or what the observation is about |
| effective[x] |
SΣC | 0..1 | dateTime S | (USCDI) Clinically relevant time/time-period for observation Constraints: us-core-1 |
 value[x] |
SΣC | 1..1 | (USCDI) Result Value Constraints: us-core-3, us-core-4 | |
| valueQuantity |
Quantity S | |||
| valueCodeableConcept |
CodeableConcept S | |||
| valueString |
string S | |||
| valueRatio |
Ratio | |||
| dataAbsentReason |
SC | 0..1 | CodeableConcept | (USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. |
| specimen |
S | 0..1 | Reference(Human Specimen Profile(4.0.0)) | (USCDI) Specimen used for this observation |
| Documentation for this format | ||||
Terminology Bindings
| Path | Status | Usage | ValueSet | Version | Source |
| Observation.status | Base | required | ObservationStatus | 📍4.0.1 | FHIR Std. |
| Observation.category | Base | preferred | Observation Category Codes | 📍4.0.1 | FHIR Std. |
| Observation.category:us-core | Base | required | US Core Clinical Result Observation Category | 📍6.1.0 | US Core v6.1 |
| Observation.code | Base | extensible | Tumor Marker Test Value Set | 📍4.0.0 | minimal Common Oncology Data Elements v4.0 |
| Observation.dataAbsentReason | Base | extensible | DataAbsentReason | 📍4.0.1 | FHIR Std. |
Constraints
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource |
contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | Observation | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | Observation.implicitRules, Observation.extension, Observation.extension:relatedCondition, Observation.extension:tumorMarkerAnalyte, Observation.modifierExtension, Observation.status, Observation.category, Observation.category:us-core, Observation.code, Observation.subject, Observation.effective[x], Observation.value[x], Observation.dataAbsentReason, Observation.specimen | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | Observation.extension, Observation.extension:relatedCondition, Observation.extension:tumorMarkerAnalyte, Observation.modifierExtension | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
| o-tma-req-1 | error | Observation | The subject element is required and must be provided. |
subject.exists() and subject.resolve().is(Patient)
|
| o-tma-req-2 | error | Observation | The effectiveDateTime element is required and must be provided. |
effectiveDateTime.exists() and effectiveDateTime.hasValue()
|
| o-tma-req-3 | error | Observation | The tumorMarkerAnalyte element is required and must be provided. |
extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte').exists()
|
| obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present |
dataAbsentReason.empty() or value.empty()
|
| obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present |
value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
|
| us-core-1 | error | Observation.effective[x] | Datetime must be at least to day. |
$this is DateTime implies $this.toString().length() >= 10
|
| us-core-2 | error | Observation | If there is no component or hasMember element then either a value[x] or a data absent reason must be present |
(component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())
|
| us-core-3 | error | Observation.value[x] | SHALL use UCUM for coded quantity units. |
value.ofType(Quantity).system.empty() or value.ofType(Quantity).system = 'http://unitsofmeasure.org'
|
| us-core-4 | best practice | Observation.value[x] | SHOULD use Snomed CT for coded Results |
value.ofType(CodeableConcept).coding.system.empty() or value.ofType(CodeableConcept).coding.system = 'http://snomed.info/sct'
|
This structure is derived from TumorMarkerTest
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Observation |
C | 0..* | TumorMarkerTest(4.0.0) | Measurements and simple assertions |
| extension |
1..* | Extension | Extension | |
| Slices for extension |
Content/Rules for all slices | |||
| extension:tumorMarkerAnalyte |
1..1 | CodeableConcept | Tumor Marker Analyte URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte Binding: TumorMarkerAnalytes (0.2.0) (required) | |
| subject |
1..1 | Reference(Cancer Patient Profile(0.2.0)) | (USCDI) Who and/or what the observation is about | |
| effective[x] |
0..1 | dateTime | (USCDI) Clinically relevant time/time-period for observation | |
| Documentation for this format | ||||
Constraints
| Id | Grade | Path(s) | Description | Expression |
| o-tma-req-1 | error | Observation | The subject element is required and must be provided. |
subject.exists() and subject.resolve().is(Patient)
|
| o-tma-req-2 | error | Observation | The effectiveDateTime element is required and must be provided. |
effectiveDateTime.exists() and effectiveDateTime.hasValue()
|
| o-tma-req-3 | error | Observation | The tumorMarkerAnalyte element is required and must be provided. |
extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte').exists()
|
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| Observation |
C | 0..* | TumorMarkerTest(4.0.0) | Measurements and simple assertions Constraints: obs-6, obs-7, us-core-2, o-tma-req-1, o-tma-req-2, o-tma-req-3 | ||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
| Slices for extension |
1..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |||||
| extension:relatedCondition |
S | 0..* | CodeableConcept, Reference(Condition) | Condition associated with this test. URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition Constraints: ext-1 | ||||
| extension:tumorMarkerAnalyte |
1..1 | CodeableConcept | Tumor Marker Analyte URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte Binding: TumorMarkerAnalytes (0.2.0) (required) Constraints: ext-1 | |||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored Constraints: ext-1 | ||||
| identifier |
Σ | 0..* | Identifier | Business Identifier for observation | ||||
| basedOn |
Σ | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order | ||||
| partOf |
Σ | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Part of referenced event | ||||
| status |
?!SΣ | 1..1 | code | (USCDI) registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. | ||||
| Slices for category |
S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | ||||
| category:us-core |
S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: USCoreClinicalResultObservationCategory (6.1.0) (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets Required Pattern: At least the following | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory | |||||
| display |
0..1 | string | Representation defined by the system | |||||
| userSelected |
0..1 | boolean | If this coding was chosen directly by the user | |||||
| text |
0..1 | string | Plain text representation of the concept | |||||
| code |
SΣ | 1..1 | CodeableConcept | (USCDI) Laboratory Test Name Binding: TumorMarkerTestVS (4.0.0) (extensible) | ||||
| subject |
SΣ | 1..1 | Reference(Cancer Patient Profile(0.2.0)) | (USCDI) Who and/or what the observation is about | ||||
| focus |
Σ | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | ||||
| encounter |
Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made | ||||
| effective[x] |
SΣC | 0..1 | dateTime S | (USCDI) Clinically relevant time/time-period for observation Constraints: us-core-1 | ||||
| issued |
Σ | 0..1 | instant | Date/Time this version was made available | ||||
| performer |
Σ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Who is responsible for the observation | ||||
| value[x] |
SΣC | 1..1 | (USCDI) Result Value Constraints: us-core-3, us-core-4 | |||||
| valueQuantity |
Quantity S | |||||||
| valueCodeableConcept |
CodeableConcept S | |||||||
| valueString |
string S | |||||||
| valueRatio |
Ratio | |||||||
| dataAbsentReason |
SC | 0..1 | CodeableConcept | (USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||
| interpretation |
0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||
| note |
0..* | Annotation | Comments about the observation | |||||
| bodySite |
0..1 | CodeableConcept | Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality. | |||||
| method |
0..1 | CodeableConcept | How it was done Binding: ObservationMethods (example): Methods for simple observations. | |||||
| specimen |
S | 0..1 | Reference(Human Specimen Profile(4.0.0)) | (USCDI) Specimen used for this observation | ||||
| device |
0..1 | Reference(Device | DeviceMetric) | (Measurement) Device | |||||
| referenceRange |
C | 0..* | BackboneElement | Provides guide for interpretation Constraints: obs-3 | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
| low |
C | 0..1 | SimpleQuantity(4.0.1) | Low Range, if relevant | ||||
| high |
C | 0..1 | SimpleQuantity(4.0.1) | High Range, if relevant | ||||
| type |
0..1 | CodeableConcept | Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range. | |||||
| appliesTo |
0..* | CodeableConcept | Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to. | |||||
| age |
0..1 | Range | Applicable age range, if relevant | |||||
| text |
0..1 | string | Text based reference range in an observation | |||||
| hasMember |
Σ | 0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | Related resource that belongs to the Observation group | ||||
| derivedFrom |
Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from | ||||
 component |
Σ | 0..* | BackboneElement | Component results | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
| code |
Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. | ||||
| value[x] |
Σ | 0..1 | Actual component result | |||||
| valueQuantity |
Quantity | |||||||
| valueCodeableConcept |
CodeableConcept | |||||||
| valueString |
string | |||||||
| valueBoolean |
boolean | |||||||
| valueInteger |
integer | |||||||
| valueRange |
Range | |||||||
| valueRatio |
Ratio | |||||||
| valueSampledData |
SampledData | |||||||
| valueTime |
time | |||||||
| valueDateTime |
dateTime | |||||||
| valuePeriod |
Period | |||||||
| dataAbsentReason |
C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||
| interpretation |
0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||
 referenceRange |
0..* | See referenceRange (Observation) | Provides guide for interpretation of component result | |||||
| Documentation for this format | ||||||||
Terminology Bindings
Constraints
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource |
contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | Observation | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | Observation.meta, Observation.implicitRules, Observation.language, Observation.text, Observation.extension, Observation.extension:relatedCondition, Observation.extension:tumorMarkerAnalyte, Observation.modifierExtension, Observation.identifier, Observation.basedOn, Observation.partOf, Observation.status, Observation.category, Observation.category:us-core, Observation.code, Observation.subject, Observation.focus, Observation.encounter, Observation.effective[x], Observation.issued, Observation.performer, Observation.value[x], Observation.dataAbsentReason, Observation.interpretation, Observation.note, Observation.bodySite, Observation.method, Observation.specimen, Observation.device, Observation.referenceRange, Observation.referenceRange.extension, Observation.referenceRange.modifierExtension, Observation.referenceRange.low, Observation.referenceRange.high, Observation.referenceRange.type, Observation.referenceRange.appliesTo, Observation.referenceRange.age, Observation.referenceRange.text, Observation.hasMember, Observation.derivedFrom, Observation.component, Observation.component.extension, Observation.component.modifierExtension, Observation.component.code, Observation.component.value[x], Observation.component.dataAbsentReason, Observation.component.interpretation, Observation.component.referenceRange | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | Observation.extension, Observation.extension:relatedCondition, Observation.extension:tumorMarkerAnalyte, Observation.modifierExtension, Observation.referenceRange.extension, Observation.referenceRange.modifierExtension, Observation.component.extension, Observation.component.modifierExtension | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
| o-tma-req-1 | error | Observation | The subject element is required and must be provided. |
subject.exists() and subject.resolve().is(Patient)
|
| o-tma-req-2 | error | Observation | The effectiveDateTime element is required and must be provided. |
effectiveDateTime.exists() and effectiveDateTime.hasValue()
|
| o-tma-req-3 | error | Observation | The tumorMarkerAnalyte element is required and must be provided. |
extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte').exists()
|
| obs-3 | error | Observation.referenceRange | Must have at least a low or a high or text |
low.exists() or high.exists() or text.exists()
|
| obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present |
dataAbsentReason.empty() or value.empty()
|
| obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present |
value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
|
| us-core-1 | error | Observation.effective[x] | Datetime must be at least to day. |
$this is DateTime implies $this.toString().length() >= 10
|
| us-core-2 | error | Observation | If there is no component or hasMember element then either a value[x] or a data absent reason must be present |
(component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())
|
| us-core-3 | error | Observation.value[x] | SHALL use UCUM for coded quantity units. |
value.ofType(Quantity).system.empty() or value.ofType(Quantity).system = 'http://unitsofmeasure.org'
|
| us-core-4 | best practice | Observation.value[x] | SHOULD use Snomed CT for coded Results |
value.ofType(CodeableConcept).coding.system.empty() or value.ofType(CodeableConcept).coding.system = 'http://snomed.info/sct'
|
This structure is derived from TumorMarkerTest
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Observation |
C | 0..* | TumorMarkerTest(4.0.0) | Measurements and simple assertions Constraints: obs-6, obs-7, us-core-2, o-tma-req-1, o-tma-req-2, o-tma-req-3 |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| Slices for extension |
1..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |
| extension:relatedCondition |
S | 0..* | CodeableConcept, Reference(Condition) | Condition associated with this test. URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition Constraints: ext-1 |
| extension:tumorMarkerAnalyte |
1..1 | CodeableConcept | Tumor Marker Analyte URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte Binding: TumorMarkerAnalytes (0.2.0) (required) Constraints: ext-1 | |
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored Constraints: ext-1 |
| status |
?!SΣ | 1..1 | code | (USCDI) registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. |
| Slices for category |
S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. |
| category:us-core |
S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: USCoreClinicalResultObservationCategory (6.1.0) (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets Required Pattern: At least the following |
| id |
0..1 | string | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations | |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |
| id |
0..1 | string | Unique id for inter-element referencing | |
| extension |
0..* | Extension | Additional content defined by implementations | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category | |
| version |
0..1 | string | Version of the system - if relevant | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory | |
| display |
0..1 | string | Representation defined by the system | |
| userSelected |
0..1 | boolean | If this coding was chosen directly by the user | |
| text |
0..1 | string | Plain text representation of the concept | |
| code |
SΣ | 1..1 | CodeableConcept | (USCDI) Laboratory Test Name Binding: TumorMarkerTestVS (4.0.0) (extensible) |
| subject |
SΣ | 1..1 | Reference(Cancer Patient Profile(0.2.0)) | (USCDI) Who and/or what the observation is about |
| effective[x] |
SΣC | 0..1 | dateTime S | (USCDI) Clinically relevant time/time-period for observation Constraints: us-core-1 |
| value[x] |
SΣC | 1..1 | (USCDI) Result Value Constraints: us-core-3, us-core-4 | |
| valueQuantity |
Quantity S | |||
| valueCodeableConcept |
CodeableConcept S | |||
| valueString |
string S | |||
| valueRatio |
Ratio | |||
| dataAbsentReason |
SC | 0..1 | CodeableConcept | (USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. |
| specimen |
S | 0..1 | Reference(Human Specimen Profile(4.0.0)) | (USCDI) Specimen used for this observation |
| Documentation for this format | ||||
Terminology Bindings
| Path | Status | Usage | ValueSet | Version | Source |
| Observation.status | Base | required | ObservationStatus | 📍4.0.1 | FHIR Std. |
| Observation.category | Base | preferred | Observation Category Codes | 📍4.0.1 | FHIR Std. |
| Observation.category:us-core | Base | required | US Core Clinical Result Observation Category | 📍6.1.0 | US Core v6.1 |
| Observation.code | Base | extensible | Tumor Marker Test Value Set | 📍4.0.0 | minimal Common Oncology Data Elements v4.0 |
| Observation.dataAbsentReason | Base | extensible | DataAbsentReason | 📍4.0.1 | FHIR Std. |
Constraints
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource |
contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | Observation | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | Observation.implicitRules, Observation.extension, Observation.extension:relatedCondition, Observation.extension:tumorMarkerAnalyte, Observation.modifierExtension, Observation.status, Observation.category, Observation.category:us-core, Observation.code, Observation.subject, Observation.effective[x], Observation.value[x], Observation.dataAbsentReason, Observation.specimen | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | Observation.extension, Observation.extension:relatedCondition, Observation.extension:tumorMarkerAnalyte, Observation.modifierExtension | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
| o-tma-req-1 | error | Observation | The subject element is required and must be provided. |
subject.exists() and subject.resolve().is(Patient)
|
| o-tma-req-2 | error | Observation | The effectiveDateTime element is required and must be provided. |
effectiveDateTime.exists() and effectiveDateTime.hasValue()
|
| o-tma-req-3 | error | Observation | The tumorMarkerAnalyte element is required and must be provided. |
extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte').exists()
|
| obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present |
dataAbsentReason.empty() or value.empty()
|
| obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present |
value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
|
| us-core-1 | error | Observation.effective[x] | Datetime must be at least to day. |
$this is DateTime implies $this.toString().length() >= 10
|
| us-core-2 | error | Observation | If there is no component or hasMember element then either a value[x] or a data absent reason must be present |
(component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())
|
| us-core-3 | error | Observation.value[x] | SHALL use UCUM for coded quantity units. |
value.ofType(Quantity).system.empty() or value.ofType(Quantity).system = 'http://unitsofmeasure.org'
|
| us-core-4 | best practice | Observation.value[x] | SHOULD use Snomed CT for coded Results |
value.ofType(CodeableConcept).coding.system.empty() or value.ofType(CodeableConcept).coding.system = 'http://snomed.info/sct'
|
Differential View
This structure is derived from TumorMarkerTest
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Observation |
C | 0..* | TumorMarkerTest(4.0.0) | Measurements and simple assertions |
| extension |
1..* | Extension | Extension | |
| Slices for extension |
Content/Rules for all slices | |||
| extension:tumorMarkerAnalyte |
1..1 | CodeableConcept | Tumor Marker Analyte URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte Binding: TumorMarkerAnalytes (0.2.0) (required) | |
| subject |
1..1 | Reference(Cancer Patient Profile(0.2.0)) | (USCDI) Who and/or what the observation is about | |
| effective[x] |
0..1 | dateTime | (USCDI) Clinically relevant time/time-period for observation | |
| Documentation for this format | ||||
Constraints
| Id | Grade | Path(s) | Description | Expression |
| o-tma-req-1 | error | Observation | The subject element is required and must be provided. |
subject.exists() and subject.resolve().is(Patient)
|
| o-tma-req-2 | error | Observation | The effectiveDateTime element is required and must be provided. |
effectiveDateTime.exists() and effectiveDateTime.hasValue()
|
| o-tma-req-3 | error | Observation | The tumorMarkerAnalyte element is required and must be provided. |
extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte').exists()
|
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| Observation |
C | 0..* | TumorMarkerTest(4.0.0) | Measurements and simple assertions Constraints: obs-6, obs-7, us-core-2, o-tma-req-1, o-tma-req-2, o-tma-req-3 | ||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
| Slices for extension |
1..* | Extension | Extension Slice: Unordered, Open by value:url Constraints: ext-1 | |||||
| extension:relatedCondition |
S | 0..* | CodeableConcept, Reference(Condition) | Condition associated with this test. URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition Constraints: ext-1 | ||||
| extension:tumorMarkerAnalyte |
1..1 | CodeableConcept | Tumor Marker Analyte URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte Binding: TumorMarkerAnalytes (0.2.0) (required) Constraints: ext-1 | |||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored Constraints: ext-1 | ||||
| identifier |
Σ | 0..* | Identifier | Business Identifier for observation | ||||
| basedOn |
Σ | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order | ||||
| partOf |
Σ | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Part of referenced event | ||||
| status |
?!SΣ | 1..1 | code | (USCDI) registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. | ||||
| Slices for category |
S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | ||||
| category:us-core |
S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: USCoreClinicalResultObservationCategory (6.1.0) (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets Required Pattern: At least the following | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory | |||||
| display |
0..1 | string | Representation defined by the system | |||||
| userSelected |
0..1 | boolean | If this coding was chosen directly by the user | |||||
| text |
0..1 | string | Plain text representation of the concept | |||||
| code |
SΣ | 1..1 | CodeableConcept | (USCDI) Laboratory Test Name Binding: TumorMarkerTestVS (4.0.0) (extensible) | ||||
| subject |
SΣ | 1..1 | Reference(Cancer Patient Profile(0.2.0)) | (USCDI) Who and/or what the observation is about | ||||
| focus |
Σ | 0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | ||||
| encounter |
Σ | 0..1 | Reference(Encounter) | Healthcare event during which this observation is made | ||||
| effective[x] |
SΣC | 0..1 | dateTime S | (USCDI) Clinically relevant time/time-period for observation Constraints: us-core-1 | ||||
| issued |
Σ | 0..1 | instant | Date/Time this version was made available | ||||
| performer |
Σ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Who is responsible for the observation | ||||
| value[x] |
SΣC | 1..1 | (USCDI) Result Value Constraints: us-core-3, us-core-4 | |||||
| valueQuantity |
Quantity S | |||||||
| valueCodeableConcept |
CodeableConcept S | |||||||
| valueString |
string S | |||||||
| valueRatio |
Ratio | |||||||
| dataAbsentReason |
SC | 0..1 | CodeableConcept | (USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||
| interpretation |
0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||
| note |
0..* | Annotation | Comments about the observation | |||||
| bodySite |
0..1 | CodeableConcept | Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality. | |||||
| method |
0..1 | CodeableConcept | How it was done Binding: ObservationMethods (example): Methods for simple observations. | |||||
| specimen |
S | 0..1 | Reference(Human Specimen Profile(4.0.0)) | (USCDI) Specimen used for this observation | ||||
| device |
0..1 | Reference(Device | DeviceMetric) | (Measurement) Device | |||||
| referenceRange |
C | 0..* | BackboneElement | Provides guide for interpretation Constraints: obs-3 | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
| low |
C | 0..1 | SimpleQuantity(4.0.1) | Low Range, if relevant | ||||
| high |
C | 0..1 | SimpleQuantity(4.0.1) | High Range, if relevant | ||||
| type |
0..1 | CodeableConcept | Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range. | |||||
| appliesTo |
0..* | CodeableConcept | Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to. | |||||
| age |
0..1 | Range | Applicable age range, if relevant | |||||
| text |
0..1 | string | Text based reference range in an observation | |||||
| hasMember |
Σ | 0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | Related resource that belongs to the Observation group | ||||
| derivedFrom |
Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from | ||||
| component |
Σ | 0..* | BackboneElement | Component results | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Constraints: ext-1 | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized Constraints: ext-1 | ||||
| code |
Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. | ||||
| value[x] |
Σ | 0..1 | Actual component result | |||||
| valueQuantity |
Quantity | |||||||
| valueCodeableConcept |
CodeableConcept | |||||||
| valueString |
string | |||||||
| valueBoolean |
boolean | |||||||
| valueInteger |
integer | |||||||
| valueRange |
Range | |||||||
| valueRatio |
Ratio | |||||||
| valueSampledData |
SampledData | |||||||
| valueTime |
time | |||||||
| valueDateTime |
dateTime | |||||||
| valuePeriod |
Period | |||||||
| dataAbsentReason |
C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||
| interpretation |
0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||
| referenceRange |
0..* | See referenceRange (Observation) | Provides guide for interpretation of component result | |||||
| Documentation for this format | ||||||||
Terminology Bindings
Constraints
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | Observation | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | Observation | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource |
contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | Observation | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | Observation | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | Observation.meta, Observation.implicitRules, Observation.language, Observation.text, Observation.extension, Observation.extension:relatedCondition, Observation.extension:tumorMarkerAnalyte, Observation.modifierExtension, Observation.identifier, Observation.basedOn, Observation.partOf, Observation.status, Observation.category, Observation.category:us-core, Observation.code, Observation.subject, Observation.focus, Observation.encounter, Observation.effective[x], Observation.issued, Observation.performer, Observation.value[x], Observation.dataAbsentReason, Observation.interpretation, Observation.note, Observation.bodySite, Observation.method, Observation.specimen, Observation.device, Observation.referenceRange, Observation.referenceRange.extension, Observation.referenceRange.modifierExtension, Observation.referenceRange.low, Observation.referenceRange.high, Observation.referenceRange.type, Observation.referenceRange.appliesTo, Observation.referenceRange.age, Observation.referenceRange.text, Observation.hasMember, Observation.derivedFrom, Observation.component, Observation.component.extension, Observation.component.modifierExtension, Observation.component.code, Observation.component.value[x], Observation.component.dataAbsentReason, Observation.component.interpretation, Observation.component.referenceRange | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | Observation.extension, Observation.extension:relatedCondition, Observation.extension:tumorMarkerAnalyte, Observation.modifierExtension, Observation.referenceRange.extension, Observation.referenceRange.modifierExtension, Observation.component.extension, Observation.component.modifierExtension | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
| o-tma-req-1 | error | Observation | The subject element is required and must be provided. |
subject.exists() and subject.resolve().is(Patient)
|
| o-tma-req-2 | error | Observation | The effectiveDateTime element is required and must be provided. |
effectiveDateTime.exists() and effectiveDateTime.hasValue()
|
| o-tma-req-3 | error | Observation | The tumorMarkerAnalyte element is required and must be provided. |
extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte').exists()
|
| obs-3 | error | Observation.referenceRange | Must have at least a low or a high or text |
low.exists() or high.exists() or text.exists()
|
| obs-6 | error | Observation | dataAbsentReason SHALL only be present if Observation.value[x] is not present |
dataAbsentReason.empty() or value.empty()
|
| obs-7 | error | Observation | If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present |
value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
|
| us-core-1 | error | Observation.effective[x] | Datetime must be at least to day. |
$this is DateTime implies $this.toString().length() >= 10
|
| us-core-2 | error | Observation | If there is no component or hasMember element then either a value[x] or a data absent reason must be present |
(component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())
|
| us-core-3 | error | Observation.value[x] | SHALL use UCUM for coded quantity units. |
value.ofType(Quantity).system.empty() or value.ofType(Quantity).system = 'http://unitsofmeasure.org'
|
| us-core-4 | best practice | Observation.value[x] | SHOULD use Snomed CT for coded Results |
value.ofType(CodeableConcept).coding.system.empty() or value.ofType(CodeableConcept).coding.system = 'http://snomed.info/sct'
|
This structure is derived from TumorMarkerTest
Other representations of profile: CSV, Excel, Schematron