Onconova Implementation Guide
0.2.0 - ci-build
Onconova Implementation Guide - Local Development build (v0.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Official URL: http://onconova.github.io/fhir/StructureDefinition/onconova-tumor-marker | Version: 0.2.0 | |||
| Active as of 2026-03-18 | 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).
Conformance:
Observation resources representing a tumor marker in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.
Usages:
You can also check for usages in the FHIR IG Statistics
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
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C | 0..* | TumorMarkerTest | Measurements and simple assertions Constraints: obs-6, obs-7, us-core-2, o-tma-req-1, o-tma-req-2, o-tma-req-3 | ||||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||||
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1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||||
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SO | 1..* | CodeableConcept, Reference(Condition) | Related Condition Extension URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition
| ||||||
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?! | 0..* | Extension | Extensions that cannot be ignored | ||||||
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?!SΣ | 1..1 | code | Not used in this profile Binding: ObservationStatus (required): Codes providing the status of an observation. | ||||||
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S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | ||||||
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S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets Required Pattern: At least the following | ||||||
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0..1 | string | Unique id for inter-element referencing | |||||||
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0..* | Extension | Additional content defined by implementations | |||||||
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1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |||||||
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0..1 | string | Unique id for inter-element referencing | |||||||
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0..* | Extension | Additional content defined by implementations | |||||||
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1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category | |||||||
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0..1 | string | Version of the system - if relevant | |||||||
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1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory | |||||||
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0..1 | string | Representation defined by the system | |||||||
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0..1 | boolean | If this coding was chosen directly by the user | |||||||
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0..1 | string | Plain text representation of the concept | |||||||
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SOΣ | 1..1 | CodeableConcept | (USCDI) Laboratory Test Name Binding: Tumor Marker Tests (required)
| ||||||
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1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||||
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SO | 1..1 | CodeableConcept | Tumor Marker Analyte URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte Binding: Tumor Marker Analytes Value Set (required)
| ||||||
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SOΣ | 1..1 | Reference(Cancer Patient Profile) | (USCDI) Who and/or what the observation is about
| ||||||
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Σ | 0..* | Reference(Resource) | Not used in this profile | ||||||
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Σ | 0..1 | Reference(Encounter) | Not used in this profile | ||||||
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SOΣC | 1..1 | dateTime S | (USCDI) Clinically relevant time/time-period for observation Constraints: us-core-1
| ||||||
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Σ | 0..1 | instant | Not used in this profile | ||||||
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Σ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Not used in this profile | ||||||
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SOΣC | 1..1 | (USCDI) Result Value Constraints: us-core-3, us-core-4
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Quantity S | |||||||||
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CodeableConcept S | |||||||||
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string S | |||||||||
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Ratio | |||||||||
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SC | 0..1 | CodeableConcept | (USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||||
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0..* | CodeableConcept | Not used in this profile Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||||
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0..1 | CodeableConcept | Not used in this profile Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality. | |||||||
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S | 0..1 | Reference(Human Specimen Profile) | Not used in this profile | ||||||
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0..1 | Reference(Device | DeviceMetric) | Not used in this profile | |||||||
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C | 0..* | BackboneElement | Not used in this profile Constraints: obs-3 | ||||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||||
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Σ | 0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | Not used in this profile | ||||||
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Σ | 0..* | BackboneElement | Not used in this profile | ||||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||||
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Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. | ||||||
Documentation for this format | ||||||||||
| 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 | required | Tumor Marker Tests | 📦0.2.0 | This IG |
| Observation.dataAbsentReason | Base | extensible | DataAbsentReason | 📦4.0.1 | FHIR Std. |
| Observation.interpretation | Base | extensible | Observation Interpretation Codes | 📦4.0.1 | FHIR Std. |
| Observation.bodySite | Base | example | SNOMED CT Body Structures | 📦4.0.1 | FHIR Std. |
| Observation.component.code | Base | example | LOINC Codes | 📦4.0.1 | FHIR Std. |
| 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 | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | 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()
|
| 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. |
code.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
| Path | Status | Usage | ValueSet | Version | Source |
| Observation.code | Base | required | Tumor Marker Tests | 📦0.2.0 | This IG |
| Id | Grade | Path(s) | Description | Expression |
| o-tma-req-1 | error | Observation | The subject element is required and must be provided. |
subject.exists()
|
| 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. |
code.extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte').exists()
|
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
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C | 0..* | TumorMarkerTest | Measurements and simple assertions Constraints: obs-6, obs-7, us-core-2, o-tma-req-1, o-tma-req-2, o-tma-req-3 | ||||||
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Σ | 0..1 | id | Logical id of this artifact | ||||||
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Σ | 0..1 | Meta | Metadata about the resource | ||||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||||
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0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
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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 | |||||||
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0..* | Resource | Contained, inline Resources | |||||||
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1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||||
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SO | 1..* | CodeableConcept, Reference(Condition) | Related Condition Extension URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition
| ||||||
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?! | 0..* | Extension | Extensions that cannot be ignored | ||||||
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Σ | 0..* | Identifier | Business Identifier for observation | ||||||
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Σ | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order | ||||||
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Σ | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Part of referenced event | ||||||
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?!SΣ | 1..1 | code | Not used in this profile Binding: ObservationStatus (required): Codes providing the status of an observation. | ||||||
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S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | ||||||
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S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets Required Pattern: At least the following | ||||||
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0..1 | string | Unique id for inter-element referencing | |||||||
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0..* | Extension | Additional content defined by implementations | |||||||
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1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |||||||
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0..1 | string | Unique id for inter-element referencing | |||||||
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0..* | Extension | Additional content defined by implementations | |||||||
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1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category | |||||||
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0..1 | string | Version of the system - if relevant | |||||||
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1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory | |||||||
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0..1 | string | Representation defined by the system | |||||||
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0..1 | boolean | If this coding was chosen directly by the user | |||||||
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0..1 | string | Plain text representation of the concept | |||||||
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SOΣ | 1..1 | CodeableConcept | (USCDI) Laboratory Test Name Binding: Tumor Marker Tests (required)
| ||||||
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0..1 | string | Unique id for inter-element referencing | |||||||
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1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||||
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SO | 1..1 | CodeableConcept | Tumor Marker Analyte URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte Binding: Tumor Marker Analytes Value Set (required)
| ||||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||||
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SOΣ | 1..1 | Reference(Cancer Patient Profile) | (USCDI) Who and/or what the observation is about
| ||||||
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Σ | 0..* | Reference(Resource) | Not used in this profile | ||||||
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Σ | 0..1 | Reference(Encounter) | Not used in this profile | ||||||
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SOΣC | 1..1 | dateTime S | (USCDI) Clinically relevant time/time-period for observation Constraints: us-core-1
| ||||||
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Σ | 0..1 | instant | Not used in this profile | ||||||
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Σ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Not used in this profile | ||||||
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SOΣC | 1..1 | (USCDI) Result Value Constraints: us-core-3, us-core-4
| |||||||
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Quantity S | |||||||||
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CodeableConcept S | |||||||||
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string S | |||||||||
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Ratio | |||||||||
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SC | 0..1 | CodeableConcept | (USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||||
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0..* | CodeableConcept | Not used in this profile Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||||
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0..* | Annotation | Comments about the observation | |||||||
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0..1 | CodeableConcept | Not used in this profile Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality. | |||||||
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0..1 | CodeableConcept | How it was done Binding: ObservationMethods (example): Methods for simple observations. | |||||||
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S | 0..1 | Reference(Human Specimen Profile) | Not used in this profile | ||||||
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0..1 | Reference(Device | DeviceMetric) | Not used in this profile | |||||||
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C | 0..* | BackboneElement | Not used in this profile Constraints: obs-3 | ||||||
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0..1 | string | Unique id for inter-element referencing | |||||||
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0..* | Extension | Additional content defined by implementations | |||||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||||
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C | 0..1 | SimpleQuantity | Low Range, if relevant | ||||||
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C | 0..1 | SimpleQuantity | High Range, if relevant | ||||||
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0..1 | CodeableConcept | Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range. | |||||||
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0..* | CodeableConcept | Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to. | |||||||
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0..1 | Range | Applicable age range, if relevant | |||||||
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0..1 | string | Text based reference range in an observation | |||||||
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Σ | 0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | Not used in this profile | ||||||
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Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from | ||||||
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Σ | 0..* | BackboneElement | Not used in this profile | ||||||
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0..1 | string | Unique id for inter-element referencing | |||||||
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0..* | Extension | Additional content defined by implementations | |||||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||||
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Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. | ||||||
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Σ | 0..1 | Actual component result | |||||||
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Quantity | |||||||||
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CodeableConcept | |||||||||
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string | |||||||||
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boolean | |||||||||
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integer | |||||||||
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Range | |||||||||
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Ratio | |||||||||
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SampledData | |||||||||
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time | |||||||||
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dateTime | |||||||||
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Period | |||||||||
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C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||||
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0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||||
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0..* | See referenceRange (Observation) | Provides guide for interpretation of component result | |||||||
Documentation for this format | ||||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| Observation.language | Base | preferred | Common Languages | 📦4.0.1 | FHIR Std. |
| 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 | required | Tumor Marker Tests | 📦0.2.0 | This IG |
| Observation.dataAbsentReason | Base | extensible | DataAbsentReason | 📦4.0.1 | FHIR Std. |
| Observation.interpretation | Base | extensible | Observation Interpretation Codes | 📦4.0.1 | FHIR Std. |
| Observation.bodySite | Base | example | SNOMED CT Body Structures | 📦4.0.1 | FHIR Std. |
| Observation.method | Base | example | Observation Methods | 📦4.0.1 | FHIR Std. |
| Observation.referenceRange.type | Base | preferred | Observation Reference Range Meaning Codes | 📦4.0.1 | FHIR Std. |
| Observation.referenceRange.appliesTo | Base | example | Observation Reference Range Applies To Codes | 📦4.0.1 | FHIR Std. |
| Observation.component.code | Base | example | LOINC Codes | 📦4.0.1 | FHIR Std. |
| Observation.component.dataAbsentReason | Base | extensible | DataAbsentReason | 📦4.0.1 | FHIR Std. |
| Observation.component.interpretation | Base | extensible | Observation Interpretation Codes | 📦4.0.1 | FHIR Std. |
| 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 | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | 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()
|
| 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. |
code.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: ![]() ![]() | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
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C | 0..* | TumorMarkerTest | Measurements and simple assertions Constraints: obs-6, obs-7, us-core-2, o-tma-req-1, o-tma-req-2, o-tma-req-3 | ||||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||||
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1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||||
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SO | 1..* | CodeableConcept, Reference(Condition) | Related Condition Extension URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition
| ||||||
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?! | 0..* | Extension | Extensions that cannot be ignored | ||||||
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?!SΣ | 1..1 | code | Not used in this profile Binding: ObservationStatus (required): Codes providing the status of an observation. | ||||||
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S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | ||||||
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S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets Required Pattern: At least the following | ||||||
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0..1 | string | Unique id for inter-element referencing | |||||||
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0..* | Extension | Additional content defined by implementations | |||||||
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1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |||||||
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0..1 | string | Unique id for inter-element referencing | |||||||
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0..* | Extension | Additional content defined by implementations | |||||||
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1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category | |||||||
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0..1 | string | Version of the system - if relevant | |||||||
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1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory | |||||||
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0..1 | string | Representation defined by the system | |||||||
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0..1 | boolean | If this coding was chosen directly by the user | |||||||
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0..1 | string | Plain text representation of the concept | |||||||
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SOΣ | 1..1 | CodeableConcept | (USCDI) Laboratory Test Name Binding: Tumor Marker Tests (required)
| ||||||
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1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||||
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SO | 1..1 | CodeableConcept | Tumor Marker Analyte URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte Binding: Tumor Marker Analytes Value Set (required)
| ||||||
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SOΣ | 1..1 | Reference(Cancer Patient Profile) | (USCDI) Who and/or what the observation is about
| ||||||
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Σ | 0..* | Reference(Resource) | Not used in this profile | ||||||
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Σ | 0..1 | Reference(Encounter) | Not used in this profile | ||||||
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SOΣC | 1..1 | dateTime S | (USCDI) Clinically relevant time/time-period for observation Constraints: us-core-1
| ||||||
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Σ | 0..1 | instant | Not used in this profile | ||||||
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Σ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Not used in this profile | ||||||
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SOΣC | 1..1 | (USCDI) Result Value Constraints: us-core-3, us-core-4
| |||||||
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Quantity S | |||||||||
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CodeableConcept S | |||||||||
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string S | |||||||||
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Ratio | |||||||||
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SC | 0..1 | CodeableConcept | (USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||||
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0..* | CodeableConcept | Not used in this profile Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||||
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0..1 | CodeableConcept | Not used in this profile Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality. | |||||||
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S | 0..1 | Reference(Human Specimen Profile) | Not used in this profile | ||||||
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0..1 | Reference(Device | DeviceMetric) | Not used in this profile | |||||||
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C | 0..* | BackboneElement | Not used in this profile Constraints: obs-3 | ||||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||||
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Σ | 0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | Not used in this profile | ||||||
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Σ | 0..* | BackboneElement | Not used in this profile | ||||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||||
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Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. | ||||||
Documentation for this format | ||||||||||
| 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 | required | Tumor Marker Tests | 📦0.2.0 | This IG |
| Observation.dataAbsentReason | Base | extensible | DataAbsentReason | 📦4.0.1 | FHIR Std. |
| Observation.interpretation | Base | extensible | Observation Interpretation Codes | 📦4.0.1 | FHIR Std. |
| Observation.bodySite | Base | example | SNOMED CT Body Structures | 📦4.0.1 | FHIR Std. |
| Observation.component.code | Base | example | LOINC Codes | 📦4.0.1 | FHIR Std. |
| 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 | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | 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()
|
| 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. |
code.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'
|
Differential View
This structure is derived from TumorMarkerTest
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
![]() |
C | 0..* | TumorMarkerTest | Measurements and simple assertions Constraints: o-tma-req-1, o-tma-req-2, o-tma-req-3 | ||||||
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1..* | Extension | Extension | |||||||
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Content/Rules for all slices | |||||||||
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O | 1..* | RelatedCondition | Related Condition Extension
| ||||||
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1..1 | code | Not used in this profile | |||||||
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O | 1..1 | CodeableConcept | (USCDI) Laboratory Test Name Binding: Tumor Marker Tests (required)
| ||||||
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1..* | Extension | Extension | |||||||
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Content/Rules for all slices | |||||||||
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SO | 1..1 | CodeableConcept | Tumor Marker Analyte URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte Binding: Tumor Marker Analytes Value Set (required)
| ||||||
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O | 1..1 | Reference(Cancer Patient Profile) | (USCDI) Who and/or what the observation is about
| ||||||
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0..* | Reference(Resource) | Not used in this profile | |||||||
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0..1 | Reference(Encounter) | Not used in this profile | |||||||
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O | 1..1 | dateTime | (USCDI) Clinically relevant time/time-period for observation
| ||||||
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0..1 | instant | Not used in this profile | |||||||
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0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Not used in this profile | |||||||
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O | 1..1 | Quantity, CodeableConcept, string, Ratio | (USCDI) Result Value
| ||||||
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0..* | CodeableConcept | Not used in this profile | |||||||
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0..1 | CodeableConcept | Not used in this profile | |||||||
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0..1 | Reference(Human Specimen Profile) | Not used in this profile | |||||||
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0..1 | Reference(Device | DeviceMetric) | Not used in this profile | |||||||
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0..* | BackboneElement | Not used in this profile | |||||||
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0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | Not used in this profile | |||||||
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0..* | BackboneElement | Not used in this profile | |||||||
Documentation for this format | ||||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| Observation.code | Base | required | Tumor Marker Tests | 📦0.2.0 | This IG |
| Id | Grade | Path(s) | Description | Expression |
| o-tma-req-1 | error | Observation | The subject element is required and must be provided. |
subject.exists()
|
| 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. |
code.extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte').exists()
|
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
![]() |
C | 0..* | TumorMarkerTest | Measurements and simple assertions Constraints: obs-6, obs-7, us-core-2, o-tma-req-1, o-tma-req-2, o-tma-req-3 | ||||||
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Σ | 0..1 | id | Logical id of this artifact | ||||||
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Σ | 0..1 | Meta | Metadata about the resource | ||||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||||
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0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||||
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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 | |||||||
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0..* | Resource | Contained, inline Resources | |||||||
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1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||||
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SO | 1..* | CodeableConcept, Reference(Condition) | Related Condition Extension URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition
| ||||||
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?! | 0..* | Extension | Extensions that cannot be ignored | ||||||
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Σ | 0..* | Identifier | Business Identifier for observation | ||||||
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Σ | 0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order | ||||||
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Σ | 0..* | Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy) | Part of referenced event | ||||||
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?!SΣ | 1..1 | code | Not used in this profile Binding: ObservationStatus (required): Codes providing the status of an observation. | ||||||
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S | 1..* | CodeableConcept | (USCDI) Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | ||||||
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S | 1..1 | CodeableConcept | (USCDI) Classification of type of observation Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets Required Pattern: At least the following | ||||||
![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||||
![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||||
![]() ![]() ![]() ![]() |
1..* | Coding | Code defined by a terminology system Fixed Value: (Complex) | |||||||
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||||
![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||||
![]() ![]() ![]() ![]() ![]() |
1..1 | uri | Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category | |||||||
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Version of the system - if relevant | |||||||
![]() ![]() ![]() ![]() ![]() |
1..1 | code | Symbol in syntax defined by the system Fixed Value: laboratory | |||||||
![]() ![]() ![]() ![]() ![]() |
0..1 | string | Representation defined by the system | |||||||
![]() ![]() ![]() ![]() ![]() |
0..1 | boolean | If this coding was chosen directly by the user | |||||||
![]() ![]() ![]() ![]() |
0..1 | string | Plain text representation of the concept | |||||||
![]() ![]() |
SOΣ | 1..1 | CodeableConcept | (USCDI) Laboratory Test Name Binding: Tumor Marker Tests (required)
| ||||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||||
![]() ![]() ![]() |
1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||||
![]() ![]() ![]() ![]() |
SO | 1..1 | CodeableConcept | Tumor Marker Analyte URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-tumor-marker-analyte Binding: Tumor Marker Analytes Value Set (required)
| ||||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||||
![]() ![]() ![]() |
Σ | 0..1 | string | Plain text representation of the concept | ||||||
![]() ![]() |
SOΣ | 1..1 | Reference(Cancer Patient Profile) | (USCDI) Who and/or what the observation is about
| ||||||
![]() ![]() |
Σ | 0..* | Reference(Resource) | Not used in this profile | ||||||
![]() ![]() |
Σ | 0..1 | Reference(Encounter) | Not used in this profile | ||||||
![]() ![]() |
SOΣC | 1..1 | dateTime S | (USCDI) Clinically relevant time/time-period for observation Constraints: us-core-1
| ||||||
![]() ![]() |
Σ | 0..1 | instant | Not used in this profile | ||||||
![]() ![]() |
Σ | 0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Not used in this profile | ||||||
![]() ![]() |
SOΣC | 1..1 | (USCDI) Result Value Constraints: us-core-3, us-core-4
| |||||||
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Quantity S | |||||||||
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CodeableConcept S | |||||||||
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string S | |||||||||
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Ratio | |||||||||
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SC | 0..1 | CodeableConcept | (USCDI) Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||||
![]() ![]() |
0..* | CodeableConcept | Not used in this profile Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||||
![]() ![]() |
0..* | Annotation | Comments about the observation | |||||||
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0..1 | CodeableConcept | Not used in this profile Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality. | |||||||
![]() ![]() |
0..1 | CodeableConcept | How it was done Binding: ObservationMethods (example): Methods for simple observations. | |||||||
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S | 0..1 | Reference(Human Specimen Profile) | Not used in this profile | ||||||
![]() ![]() |
0..1 | Reference(Device | DeviceMetric) | Not used in this profile | |||||||
![]() ![]() |
C | 0..* | BackboneElement | Not used in this profile Constraints: obs-3 | ||||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||||
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C | 0..1 | SimpleQuantity | Low Range, if relevant | ||||||
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C | 0..1 | SimpleQuantity | High Range, if relevant | ||||||
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0..1 | CodeableConcept | Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range. | |||||||
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0..* | CodeableConcept | Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to. | |||||||
![]() ![]() ![]() |
0..1 | Range | Applicable age range, if relevant | |||||||
![]() ![]() ![]() |
0..1 | string | Text based reference range in an observation | |||||||
![]() ![]() |
Σ | 0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | Not used in this profile | ||||||
![]() ![]() |
Σ | 0..* | Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) | Related measurements the observation is made from | ||||||
![]() ![]() |
Σ | 0..* | BackboneElement | Not used in this profile | ||||||
![]() ![]() ![]() |
0..1 | string | Unique id for inter-element referencing | |||||||
![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations | |||||||
![]() ![]() ![]() |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||||
![]() ![]() ![]() |
Σ | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. | ||||||
![]() ![]() ![]() |
Σ | 0..1 | Actual component result | |||||||
![]() ![]() ![]() ![]() |
Quantity | |||||||||
![]() ![]() ![]() ![]() |
CodeableConcept | |||||||||
![]() ![]() ![]() ![]() |
string | |||||||||
![]() ![]() ![]() ![]() |
boolean | |||||||||
![]() ![]() ![]() ![]() |
integer | |||||||||
![]() ![]() ![]() ![]() |
Range | |||||||||
![]() ![]() ![]() ![]() |
Ratio | |||||||||
![]() ![]() ![]() ![]() |
SampledData | |||||||||
![]() ![]() ![]() ![]() |
time | |||||||||
![]() ![]() ![]() ![]() |
dateTime | |||||||||
![]() ![]() ![]() ![]() |
Period | |||||||||
![]() ![]() ![]() |
C | 0..1 | CodeableConcept | Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing. | ||||||
![]() ![]() ![]() |
0..* | CodeableConcept | High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations. | |||||||
![]() ![]() ![]() |
0..* | See referenceRange (Observation) | Provides guide for interpretation of component result | |||||||
Documentation for this format | ||||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| Observation.language | Base | preferred | Common Languages | 📦4.0.1 | FHIR Std. |
| 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 | required | Tumor Marker Tests | 📦0.2.0 | This IG |
| Observation.dataAbsentReason | Base | extensible | DataAbsentReason | 📦4.0.1 | FHIR Std. |
| Observation.interpretation | Base | extensible | Observation Interpretation Codes | 📦4.0.1 | FHIR Std. |
| Observation.bodySite | Base | example | SNOMED CT Body Structures | 📦4.0.1 | FHIR Std. |
| Observation.method | Base | example | Observation Methods | 📦4.0.1 | FHIR Std. |
| Observation.referenceRange.type | Base | preferred | Observation Reference Range Meaning Codes | 📦4.0.1 | FHIR Std. |
| Observation.referenceRange.appliesTo | Base | example | Observation Reference Range Applies To Codes | 📦4.0.1 | FHIR Std. |
| Observation.component.code | Base | example | LOINC Codes | 📦4.0.1 | FHIR Std. |
| Observation.component.dataAbsentReason | Base | extensible | DataAbsentReason | 📦4.0.1 | FHIR Std. |
| Observation.component.interpretation | Base | extensible | Observation Interpretation Codes | 📦4.0.1 | FHIR Std. |
| 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 | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | 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()
|
| 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. |
code.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