EU Imaging Report R5
1.0.0-ballot - ci-build
150
EU Imaging Report R5
1.0.0-ballot - ci-build
150
EU Imaging Report R5, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/imaging-r5/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.eu/fhir/imaging-r5/StructureDefinition/ObservationRadiationDoseEuImaging | Version: 1.0.0-ballot | ||||
| Standards status: Draft | Maturity Level: 1 | Computable Name: ObservationRadiationDoseEuImaging | |||
Copyright/Legal: Copyright HL7 Europe. Licensed under Creative Commons public domain (CC0 1.0). |
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A record for the radiation dose the subject has been exposed to during an imaging procedure. E.g. based on information from DICOM part 16
This profile is defined based on the work published in the FHIR Radiation Dose Summary IG.
Observation.valueThe field valueString SHALL contain a human‑readable radiation dose summary for the imaging study or series, intended for display in clinical reports or patient records. The string:
The string MAY include modality‑appropriate summary metrics (for example CTDIvol, DLP, DAP, AGD), but only as part of explanatory narrative text.
The string SHALL NOT:
The content of this observation is typically derived from radiation dose information stored in DICOM or provided directly from dose analysis software.
Technologists / radiographers may also directly document radiation exposure. In addition, DICOM Modality Performed Procedure Step (MPPS) was used to file radiation dose information until very recently.
DICOM templates (from https://build.fhir.org/ig/HL7/fhir-radiation-dose-summary-ig/background.html#minimal-radiation-information):
The content of valueString is typically generated by dose analysis software that processes DICOM Radiation Dose Structure Report objects, as defined in DICOM PS3.3 Structured Reports and the IHE Radiation Exposure Monitoring (REM) Profile, and exports a text summary via FHIR as described in the FHIR Radiation Dose Summary IG.
CT examination of the abdomen and pelvis. CTDIvol 9.8 mGy; DLP 520 mGy·cm. Dose values represent scanner output metrics and not patient absorbed dose.
Fluoroscopic coronary angiography. Dose area product (DAP) 45 Gy·cm²; fluoroscopy time 6.2 minutes.
Chest radiography (PA and lateral). Estimated dose indicators within typical range for this examination. Normative references (for the specification text) DICOM PS3.3 – Structured Reports: Radiation Dose Structured Report (Radiation Dose Structure Report) IHE Radiation Exposure Monitoring (REM) Profile FHIR Radiation Dose Summary Implementation Guide IHE Image Data Repository (IDR) Phase 2 (linking Procedure and dose summary Observation)
Usages:
You can also check for usages in the FHIR IG Statistics
Description Differentials, Snapshots, and other representations.
| Name | Flags | Card. | Type | Description & Constraints Filter:  |
|---|---|---|---|---|
  Observation |
C | 0..* | Observation | Measurements and simple assertions Constraints: obs-6, obs-7, obs-8 |
  implicitRules |
0..1 | uri | A set of rules under which this content was created | |
| contained |
0..* | Resource | Contained, inline Resources | |
 modifierExtension |
0..* | Extension | Extensions that cannot be ignored | |
  Slices for basedOn |
0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order Slice: Unordered, Open by type:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them | |
   basedOn:ServiceRequestOrderEuImagingaccession |
0..1 | Reference(ServiceRequest: Imaging Order) | Fulfills plan, proposal or order | |
  reference |
C | 0..1 | string | Literal reference, Relative, internal or absolute URL |
  identifier |
C | 0..1 | AccessionNumberIdentifierEuImaging | Logical reference, when literal reference is not known |
 partOf |
0..* | Reference(Procedure: Imaging Acquisition) | Part of referenced event | |
| status |
1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. | |
| code |
C | 1..1 | CodeableConcept | Type of observation (code / type) Binding: ValueSet: All SNOMED CT and LOINC Codes (preferred) |
 Slices for coding |
1..* | Coding | Code defined by a terminology system Slice: Unordered, Open by value:code, value:system Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them | |
| coding:radiation-dose |
1..1 | Coding | Code defined by a terminology system | |
| system |
0..1 | uri | Identity of the terminology system Fixed Value: http://loinc.org | |
| code |
C | 0..1 | code | Symbol in syntax defined by the system Fixed Value: 73569-6 |
| subject |
1..1 | Reference(Patient (EU core)) | Who and/or what the observation is about | |
| value[x] |
C | 1..1 | string | Dose Summary text. |
| device |
0..1 | Reference(Device: Imaging Device) | Irradiating modality | |
| Slices for derivedFrom |
1..* | Reference(DocumentReference | ImagingStudy | ImagingSelection | QuestionnaireResponse | Observation | MolecularSequence | GenomicStudy) | Related resource from which the observation is made Slice: Unordered, Open by profile:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them | |
 derivedFrom:study |
1..1 | Reference(ImagingStudy: Reported Study) | The study the radiation information relates to. | |
 derivedFrom:dicomSrInstance |
0..* | Reference(ImagingSelection: DICOM SR Instance) | The DICOM SR Structured Report that is the source of the information in this Observation. | |
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Observation.status | Base | required | Observation Status | 📍5.0.0 | FHIR Std. |
| Observation.code | Base | preferred | ValueSet: All SNOMED CT and LOINC Codes | 📦1.0.0-ballot | This IG |
| 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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()
|
| 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.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value). |
value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
|
| obs-8 | error | Observation | bodyStructure SHALL only be present if Observation.bodySite is not present |
bodySite.exists() implies bodyStructure.empty()
|
This structure is derived from Observation
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Observation |
0..* | Observation | Measurements and simple assertions | |
| Slices for basedOn |
0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order Slice: Unordered, Open by type:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them | |
| basedOn:ServiceRequestOrderEuImagingaccession |
0..1 | Reference(ServiceRequest: Imaging Order) | Fulfills plan, proposal or order | |
| identifier |
0..1 | AccessionNumberIdentifierEuImaging | Logical reference, when literal reference is not known | |
| partOf |
0..* | Reference(Procedure: Imaging Acquisition) | Part of referenced event | |
 code |
1..1 | CodeableConcept | Type of observation (code / type) Binding: ValueSet: All SNOMED CT and LOINC Codes (preferred) | |
| Slices for coding |
1..* | Coding | Code defined by a terminology system Slice: Unordered, Open by value:code, value:system Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them | |
| coding:radiation-dose |
1..1 | Coding | Code defined by a terminology system | |
| system |
0..1 | uri | Identity of the terminology system Fixed Value: http://loinc.org | |
| code |
0..1 | code | Symbol in syntax defined by the system Fixed Value: 73569-6 | |
| subject |
1..1 | Reference(Patient (EU core)) | Who and/or what the observation is about | |
| value[x] |
1..1 | string | Dose Summary text. | |
| device |
0..1 | Reference(Device: Imaging Device) | Irradiating modality | |
| Slices for derivedFrom |
1..* | Reference(DocumentReference | ImagingStudy | ImagingSelection | QuestionnaireResponse | Observation | MolecularSequence | GenomicStudy) | Related resource from which the observation is made Slice: Unordered, Open by profile:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them | |
| derivedFrom:study |
1..1 | Reference(ImagingStudy: Reported Study) | The study the radiation information relates to. | |
| derivedFrom:dicomSrInstance |
0..* | Reference(ImagingSelection: DICOM SR Instance) | The DICOM SR Structured Report that is the source of the information in this Observation. | |
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Observation.code | Base | preferred | ValueSet: All SNOMED CT and LOINC Codes | 📦1.0.0-ballot | This IG |
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| Observation |
C | 0..* | Observation | Measurements and simple assertions Constraints: obs-6, obs-7, obs-8 | ||||
| id |
0..1 | id | Logical id of this artifact | |||||
| meta |
0..1 | Meta | Metadata about the resource | |||||
| implicitRules |
0..1 | uri | A set of rules under which this content was created | |||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for 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 | |||||
 extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored | |||||
| identifier |
0..* | Identifier | Business Identifier for observation | |||||
| instantiates[x] |
0..1 | canonical(ObservationDefinition), Reference(ObservationDefinition) | Instantiates FHIR ObservationDefinition | |||||
| Slices for basedOn |
0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order Slice: Unordered, Open by type:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them | |||||
| basedOn:ServiceRequestOrderEuImagingaccession |
0..1 | Reference(ServiceRequest: Imaging Order) | Fulfills plan, proposal or order | |||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| reference |
C | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
| type |
0..1 | uri | Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). | |||||
| identifier |
C | 0..1 | AccessionNumberIdentifierEuImaging | Logical reference, when literal reference is not known | ||||
| display |
C | 0..1 | string | Text alternative for the resource | ||||
| triggeredBy |
0..* | BackboneElement | Triggering observation(s) | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| observation |
1..1 | Reference(Observation) | Triggering observation | |||||
| type |
1..1 | code | reflex | repeat | re-run Binding: TriggeredBytype (required): The type of TriggeredBy Observation. | |||||
 reason |
0..1 | string | Reason that the observation was triggered | |||||
| partOf |
0..* | Reference(Procedure: Imaging Acquisition) | Part of referenced event | |||||
| status |
1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. | |||||
| category |
0..* | CodeableConcept | Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | |||||
| code |
C | 1..1 | CodeableConcept | Type of observation (code / type) Binding: ValueSet: All SNOMED CT and LOINC Codes (preferred) | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| Slices for coding |
1..* | Coding | Code defined by a terminology system Slice: Unordered, Open by value:code, value:system Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them | |||||
| coding:radiation-dose |
1..1 | Coding | Code defined by a terminology system | |||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| system |
0..1 | uri | Identity of the terminology system Fixed Value: http://loinc.org | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
C | 0..1 | code | Symbol in syntax defined by the system Fixed Value: 73569-6 | ||||
| display |
C | 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 | |||||
| subject |
1..1 | Reference(Patient (EU core)) | Who and/or what the observation is about | |||||
| focus |
0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | |||||
| encounter |
0..1 | Reference(Encounter) | Healthcare event during which this observation is made | |||||
 effective[x] |
0..1 | Clinically relevant time/time-period for observation | ||||||
| effectiveDateTime |
dateTime | |||||||
| effectivePeriod |
Period | |||||||
| effectiveTiming |
Timing | |||||||
| effectiveInstant |
instant | |||||||
| issued |
0..1 | instant | Date/Time this version was made available | |||||
| performer |
0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Who is responsible for the observation | |||||
| value[x] |
C | 1..1 | string | Dose Summary text. | ||||
| dataAbsentReason |
C | 0..1 | CodeableConcept | 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 |
C | 0..1 | CodeableConcept | Observed body part Binding: SNOMEDCTBodyStructures (example): SNOMED CT Body site concepts | ||||
| bodyStructure |
C | 0..1 | Reference(BodyStructure) | Observed body structure | ||||
| method |
0..1 | CodeableConcept | How it was done Binding: ObservationMethods (example): Methods for simple observations. | |||||
| specimen |
C | 0..1 | Reference(Specimen | Group) | Specimen used for this observation Constraints: obs-9 | ||||
| device |
0..1 | Reference(Device: Imaging Device) | Irradiating modality | |||||
| 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 | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| low |
C | 0..1 | SimpleQuantity(5.0.0) | Low Range, if relevant Constraints: sqty-1 | ||||
| high |
C | 0..1 | SimpleQuantity(5.0.0) | High Range, if relevant Constraints: sqty-1 | ||||
| normalValue |
0..1 | CodeableConcept | Normal value, if relevant Binding: ObservationReferenceRangeNormalValueCodes (extensible): Codes identifying the normal value of the observation. | |||||
| 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 |
C | 0..1 | markdown | Text based reference range in an observation | ||||
| hasMember |
0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | Related resource that belongs to the Observation group | |||||
| Slices for derivedFrom |
1..* | Reference(DocumentReference | ImagingStudy | ImagingSelection | QuestionnaireResponse | Observation | MolecularSequence | GenomicStudy) | Related resource from which the observation is made Slice: Unordered, Open by profile:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them | |||||
| derivedFrom:study |
1..1 | Reference(ImagingStudy: Reported Study) | The study the radiation information relates to. | |||||
| derivedFrom:dicomSrInstance |
0..* | Reference(ImagingSelection: DICOM SR Instance) | The DICOM SR Structured Report that is the source of the information in this Observation. | |||||
| component |
C | 0..* | BackboneElement | Component results | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| code |
C | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. | ||||
| value[x] |
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 | |||||||
| valueAttachment |
Attachment | |||||||
| valueReference |
Reference(MolecularSequence) | |||||||
| dataAbsentReason |
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 | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| Observation.language | Base | required | All Languages | 📍5.0.0 | FHIR Std. |
| Observation.basedOn:ServiceRequestOrderEuImagingaccession.type | Base | extensible | Resource Types | 📍5.0.0 | FHIR Std. |
| Observation.triggeredBy.type | Base | required | triggered Bytype | 📍5.0.0 | FHIR Std. |
| Observation.status | Base | required | Observation Status | 📍5.0.0 | FHIR Std. |
| Observation.category | Base | preferred | Observation Category Codes | 📍5.0.0 | FHIR Std. |
| Observation.code | Base | preferred | ValueSet: All SNOMED CT and LOINC Codes | 📦1.0.0-ballot | This IG |
| Observation.dataAbsentReason | Base | extensible | Data Absent Reason | 📍5.0.0 | FHIR Std. |
| Observation.interpretation | Base | extensible | Observation Interpretation Codes | 📍5.0.0 | FHIR Std. |
| Observation.bodySite | Base | example | SNOMED CT Body Structures | 📍5.0.0 | FHIR Std. |
| Observation.method | Base | example | Observation Methods | 📍5.0.0 | FHIR Std. |
| Observation.referenceRange.normalValue | Base | extensible | Observation Reference Range Normal Value Codes | 📍5.0.0 | FHIR Std. |
| Observation.referenceRange.type | Base | preferred | Observation Reference Range Meaning Codes | 📍5.0.0 | FHIR Std. |
| Observation.referenceRange.appliesTo | Base | example | Observation Reference Range Applies To Codes | 📍5.0.0 | FHIR Std. |
| Observation.component.code | Base | example | LOINC Codes | 📍5.0.0 | FHIR Std. |
| Observation.component.dataAbsentReason | Base | extensible | Data Absent Reason | 📍5.0.0 | FHIR Std. |
| Observation.component.interpretation | Base | extensible | Observation Interpretation Codes | 📍5.0.0 | 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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()
|
| 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.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value). |
value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
|
| obs-8 | error | Observation | bodyStructure SHALL only be present if Observation.bodySite is not present |
bodySite.exists() implies bodyStructure.empty()
|
| obs-9 | error | Observation.specimen | If Observation.specimen is a reference to Group, the group can only have specimens |
(reference.resolve().exists() and reference.resolve() is Group) implies reference.resolve().member.entity.resolve().all($this is Specimen)
|
| sqty-1 | error | Observation.referenceRange.low, Observation.referenceRange.high | The comparator is not used on a SimpleQuantity |
comparator.empty()
|
This structure is derived from Observation
Summary
Mandatory: 6 elements
Fixed: 2 elements
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Maturity: 1
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Observation |
C | 0..* | Observation | Measurements and simple assertions Constraints: obs-6, obs-7, obs-8 |
| implicitRules |
0..1 | uri | A set of rules under which this content was created | |
| contained |
0..* | Resource | Contained, inline Resources | |
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored | |
| Slices for basedOn |
0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order Slice: Unordered, Open by type:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them | |
| basedOn:ServiceRequestOrderEuImagingaccession |
0..1 | Reference(ServiceRequest: Imaging Order) | Fulfills plan, proposal or order | |
| reference |
C | 0..1 | string | Literal reference, Relative, internal or absolute URL |
| identifier |
C | 0..1 | AccessionNumberIdentifierEuImaging | Logical reference, when literal reference is not known |
| partOf |
0..* | Reference(Procedure: Imaging Acquisition) | Part of referenced event | |
| status |
1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. | |
| code |
C | 1..1 | CodeableConcept | Type of observation (code / type) Binding: ValueSet: All SNOMED CT and LOINC Codes (preferred) |
| Slices for coding |
1..* | Coding | Code defined by a terminology system Slice: Unordered, Open by value:code, value:system Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them | |
| coding:radiation-dose |
1..1 | Coding | Code defined by a terminology system | |
| system |
0..1 | uri | Identity of the terminology system Fixed Value: http://loinc.org | |
| code |
C | 0..1 | code | Symbol in syntax defined by the system Fixed Value: 73569-6 |
| subject |
1..1 | Reference(Patient (EU core)) | Who and/or what the observation is about | |
| value[x] |
C | 1..1 | string | Dose Summary text. |
| device |
0..1 | Reference(Device: Imaging Device) | Irradiating modality | |
| Slices for derivedFrom |
1..* | Reference(DocumentReference | ImagingStudy | ImagingSelection | QuestionnaireResponse | Observation | MolecularSequence | GenomicStudy) | Related resource from which the observation is made Slice: Unordered, Open by profile:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them | |
| derivedFrom:study |
1..1 | Reference(ImagingStudy: Reported Study) | The study the radiation information relates to. | |
| derivedFrom:dicomSrInstance |
0..* | Reference(ImagingSelection: DICOM SR Instance) | The DICOM SR Structured Report that is the source of the information in this Observation. | |
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Observation.status | Base | required | Observation Status | 📍5.0.0 | FHIR Std. |
| Observation.code | Base | preferred | ValueSet: All SNOMED CT and LOINC Codes | 📦1.0.0-ballot | This IG |
| 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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()
|
| 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.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value). |
value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
|
| obs-8 | error | Observation | bodyStructure SHALL only be present if Observation.bodySite is not present |
bodySite.exists() implies bodyStructure.empty()
|
Differential View
This structure is derived from Observation
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Observation |
0..* | Observation | Measurements and simple assertions | |
| Slices for basedOn |
0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order Slice: Unordered, Open by type:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them | |
| basedOn:ServiceRequestOrderEuImagingaccession |
0..1 | Reference(ServiceRequest: Imaging Order) | Fulfills plan, proposal or order | |
| identifier |
0..1 | AccessionNumberIdentifierEuImaging | Logical reference, when literal reference is not known | |
| partOf |
0..* | Reference(Procedure: Imaging Acquisition) | Part of referenced event | |
| code |
1..1 | CodeableConcept | Type of observation (code / type) Binding: ValueSet: All SNOMED CT and LOINC Codes (preferred) | |
| Slices for coding |
1..* | Coding | Code defined by a terminology system Slice: Unordered, Open by value:code, value:system Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them | |
| coding:radiation-dose |
1..1 | Coding | Code defined by a terminology system | |
| system |
0..1 | uri | Identity of the terminology system Fixed Value: http://loinc.org | |
| code |
0..1 | code | Symbol in syntax defined by the system Fixed Value: 73569-6 | |
| subject |
1..1 | Reference(Patient (EU core)) | Who and/or what the observation is about | |
| value[x] |
1..1 | string | Dose Summary text. | |
| device |
0..1 | Reference(Device: Imaging Device) | Irradiating modality | |
| Slices for derivedFrom |
1..* | Reference(DocumentReference | ImagingStudy | ImagingSelection | QuestionnaireResponse | Observation | MolecularSequence | GenomicStudy) | Related resource from which the observation is made Slice: Unordered, Open by profile:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them | |
| derivedFrom:study |
1..1 | Reference(ImagingStudy: Reported Study) | The study the radiation information relates to. | |
| derivedFrom:dicomSrInstance |
0..* | Reference(ImagingSelection: DICOM SR Instance) | The DICOM SR Structured Report that is the source of the information in this Observation. | |
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| Observation.code | Base | preferred | ValueSet: All SNOMED CT and LOINC Codes | 📦1.0.0-ballot | This IG |
Snapshot ViewView
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| Observation |
C | 0..* | Observation | Measurements and simple assertions Constraints: obs-6, obs-7, obs-8 | ||||
| id |
0..1 | id | Logical id of this artifact | |||||
| meta |
0..1 | Meta | Metadata about the resource | |||||
| implicitRules |
0..1 | uri | A set of rules under which this content was created | |||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for 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 | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored | |||||
| identifier |
0..* | Identifier | Business Identifier for observation | |||||
| instantiates[x] |
0..1 | canonical(ObservationDefinition), Reference(ObservationDefinition) | Instantiates FHIR ObservationDefinition | |||||
| Slices for basedOn |
0..* | Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) | Fulfills plan, proposal or order Slice: Unordered, Open by type:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them | |||||
| basedOn:ServiceRequestOrderEuImagingaccession |
0..1 | Reference(ServiceRequest: Imaging Order) | Fulfills plan, proposal or order | |||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| reference |
C | 0..1 | string | Literal reference, Relative, internal or absolute URL | ||||
| type |
0..1 | uri | Type the reference refers to (e.g. "Patient") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model). | |||||
| identifier |
C | 0..1 | AccessionNumberIdentifierEuImaging | Logical reference, when literal reference is not known | ||||
| display |
C | 0..1 | string | Text alternative for the resource | ||||
| triggeredBy |
0..* | BackboneElement | Triggering observation(s) | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| observation |
1..1 | Reference(Observation) | Triggering observation | |||||
| type |
1..1 | code | reflex | repeat | re-run Binding: TriggeredBytype (required): The type of TriggeredBy Observation. | |||||
| reason |
0..1 | string | Reason that the observation was triggered | |||||
| partOf |
0..* | Reference(Procedure: Imaging Acquisition) | Part of referenced event | |||||
| status |
1..1 | code | registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation. | |||||
| category |
0..* | CodeableConcept | Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. | |||||
| code |
C | 1..1 | CodeableConcept | Type of observation (code / type) Binding: ValueSet: All SNOMED CT and LOINC Codes (preferred) | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| Slices for coding |
1..* | Coding | Code defined by a terminology system Slice: Unordered, Open by value:code, value:system Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them | |||||
| coding:radiation-dose |
1..1 | Coding | Code defined by a terminology system | |||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| system |
0..1 | uri | Identity of the terminology system Fixed Value: http://loinc.org | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
C | 0..1 | code | Symbol in syntax defined by the system Fixed Value: 73569-6 | ||||
| display |
C | 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 | |||||
| subject |
1..1 | Reference(Patient (EU core)) | Who and/or what the observation is about | |||||
| focus |
0..* | Reference(Resource) | What the observation is about, when it is not about the subject of record | |||||
| encounter |
0..1 | Reference(Encounter) | Healthcare event during which this observation is made | |||||
| effective[x] |
0..1 | Clinically relevant time/time-period for observation | ||||||
| effectiveDateTime |
dateTime | |||||||
| effectivePeriod |
Period | |||||||
| effectiveTiming |
Timing | |||||||
| effectiveInstant |
instant | |||||||
| issued |
0..1 | instant | Date/Time this version was made available | |||||
| performer |
0..* | Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) | Who is responsible for the observation | |||||
| value[x] |
C | 1..1 | string | Dose Summary text. | ||||
| dataAbsentReason |
C | 0..1 | CodeableConcept | 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 |
C | 0..1 | CodeableConcept | Observed body part Binding: SNOMEDCTBodyStructures (example): SNOMED CT Body site concepts | ||||
| bodyStructure |
C | 0..1 | Reference(BodyStructure) | Observed body structure | ||||
| method |
0..1 | CodeableConcept | How it was done Binding: ObservationMethods (example): Methods for simple observations. | |||||
| specimen |
C | 0..1 | Reference(Specimen | Group) | Specimen used for this observation Constraints: obs-9 | ||||
| device |
0..1 | Reference(Device: Imaging Device) | Irradiating modality | |||||
| 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 | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| low |
C | 0..1 | SimpleQuantity(5.0.0) | Low Range, if relevant Constraints: sqty-1 | ||||
| high |
C | 0..1 | SimpleQuantity(5.0.0) | High Range, if relevant Constraints: sqty-1 | ||||
| normalValue |
0..1 | CodeableConcept | Normal value, if relevant Binding: ObservationReferenceRangeNormalValueCodes (extensible): Codes identifying the normal value of the observation. | |||||
| 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 |
C | 0..1 | markdown | Text based reference range in an observation | ||||
| hasMember |
0..* | Reference(Observation | QuestionnaireResponse | MolecularSequence) | Related resource that belongs to the Observation group | |||||
| Slices for derivedFrom |
1..* | Reference(DocumentReference | ImagingStudy | ImagingSelection | QuestionnaireResponse | Observation | MolecularSequence | GenomicStudy) | Related resource from which the observation is made Slice: Unordered, Open by profile:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them | |||||
| derivedFrom:study |
1..1 | Reference(ImagingStudy: Reported Study) | The study the radiation information relates to. | |||||
| derivedFrom:dicomSrInstance |
0..* | Reference(ImagingSelection: DICOM SR Instance) | The DICOM SR Structured Report that is the source of the information in this Observation. | |||||
| component |
C | 0..* | BackboneElement | Component results | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||
| code |
C | 1..1 | CodeableConcept | Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. | ||||
| value[x] |
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 | |||||||
| valueAttachment |
Attachment | |||||||
| valueReference |
Reference(MolecularSequence) | |||||||
| dataAbsentReason |
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 | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| Observation.language | Base | required | All Languages | 📍5.0.0 | FHIR Std. |
| Observation.basedOn:ServiceRequestOrderEuImagingaccession.type | Base | extensible | Resource Types | 📍5.0.0 | FHIR Std. |
| Observation.triggeredBy.type | Base | required | triggered Bytype | 📍5.0.0 | FHIR Std. |
| Observation.status | Base | required | Observation Status | 📍5.0.0 | FHIR Std. |
| Observation.category | Base | preferred | Observation Category Codes | 📍5.0.0 | FHIR Std. |
| Observation.code | Base | preferred | ValueSet: All SNOMED CT and LOINC Codes | 📦1.0.0-ballot | This IG |
| Observation.dataAbsentReason | Base | extensible | Data Absent Reason | 📍5.0.0 | FHIR Std. |
| Observation.interpretation | Base | extensible | Observation Interpretation Codes | 📍5.0.0 | FHIR Std. |
| Observation.bodySite | Base | example | SNOMED CT Body Structures | 📍5.0.0 | FHIR Std. |
| Observation.method | Base | example | Observation Methods | 📍5.0.0 | FHIR Std. |
| Observation.referenceRange.normalValue | Base | extensible | Observation Reference Range Normal Value Codes | 📍5.0.0 | FHIR Std. |
| Observation.referenceRange.type | Base | preferred | Observation Reference Range Meaning Codes | 📍5.0.0 | FHIR Std. |
| Observation.referenceRange.appliesTo | Base | example | Observation Reference Range Applies To Codes | 📍5.0.0 | FHIR Std. |
| Observation.component.code | Base | example | LOINC Codes | 📍5.0.0 | FHIR Std. |
| Observation.component.dataAbsentReason | Base | extensible | Data Absent Reason | 📍5.0.0 | FHIR Std. |
| Observation.component.interpretation | Base | extensible | Observation Interpretation Codes | 📍5.0.0 | 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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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()
|
| 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.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value). |
value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
|
| obs-8 | error | Observation | bodyStructure SHALL only be present if Observation.bodySite is not present |
bodySite.exists() implies bodyStructure.empty()
|
| obs-9 | error | Observation.specimen | If Observation.specimen is a reference to Group, the group can only have specimens |
(reference.resolve().exists() and reference.resolve() is Group) implies reference.resolve().member.entity.resolve().all($this is Specimen)
|
| sqty-1 | error | Observation.referenceRange.low, Observation.referenceRange.high | The comparator is not used on a SimpleQuantity |
comparator.empty()
|
This structure is derived from Observation
Summary
Mandatory: 6 elements
Fixed: 2 elements
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Maturity: 1
Other representations of profile: CSV, Excel, Schematron
Radiation dose information is complex. Many details are needed for proper analysis and the summary metrics selected by the medical physicists to give them a rough understanding of a given imaging procedure differ from modality to modality. This is further complicated by different geographic regions establishing varying regulations for inclusion of this information in diagnostic reports. Such regulations do serve the purpose of raising awareness amongst patients and referring physicians of the existence of radiation dose risks in some types of imaging procedures and demonstrating a commitment to transparency, but proper analysis to assess individual patient risk, patient population risk, or to assess departmental performance in managing protocols and dose, depends on the use of detailed dose information, rather than summary metrics.
With that background in mind, the recommended data flow of radiation dose information is as follows:
IG © 2025+ HL7 Europe.
Package hl7.fhir.eu.imaging-r5#1.0.0-ballot based on FHIR 5.0.0.
Generated
2026-10-13
