HL7 Europe Imaging Report R5
1.0.0-ballot - ci-build 150

HL7 Europe 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

Resource Profile: Observation: Radiation Dose

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).

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.

Guidance on Observation.value

The 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:

  • SHALL be narrative text, suitable for direct inclusion in a diagnostic report.
  • SHALL be derived from detailed dose information, typically from a DICOM Radiation Dose Structured Report (Radiation Dose Structure Report), when available.
  • SHALL summarise scanner output metrics, not patient‑absorbed dose or risk.
  • SHALL reflect local regulatory and reporting conventions (e.g. modality‑specific metrics and wording).
  • SHALL NOT be interpreted as a complete or quantitative dose analysis.

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:

  • Replace or duplicate the full DICOM Radiation Dose Structure Report.
  • Be used for automated dose calculations, comparisons, or risk estimation.
  • Imply patient‑specific absorbed dose.

Source of information

The content of this observation is typically derived from radiation dose information stored in DICOM or provided directly from dose analysis software.

DICOM templates (from https://build.fhir.org/ig/HL7/fhir-radiation-dose-summary-ig/background.html#minimal-radiation-information):

  • TID 2008 Radiation Exposure and Protection Information
  • Radiopharmaceutical Radiation Dose SR IOD Templates
  • X-Ray Radiation Dose SR IOD Templates

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.

Example values

CT example

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.

Fluoroscopy example

Fluoroscopic coronary angiography. Dose area product (DAP) 45 Gy·cm²; fluoroscopy time 6.2 minutes.

Plain radiography example

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

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7, obs-8
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
.... basedOn:ServiceRequestOrderEuImagingaccession Σ 0..1 Reference(ServiceRequest: Imaging Order) Fulfills plan, proposal or order
..... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
..... identifier ΣC 1..1 AccessionNumberIdentifierEuImaging Logical reference, when literal reference is not known
... partOf Σ 0..* Reference(Procedure: Imaging Acquisition) Part of referenced event
... status ?!Σ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.
... code ΣC 1..1 CodeableConcept Type of observation (code / type)
Binding: ValueSet: All SNOMED CT and LOINC Codes (preferred)
.... Slices for coding Σ 1..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:code, value:system
..... coding:radiation-dose Σ 1..1 Coding Code defined by a terminology system
...... system Σ 0..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
...... code ΣC 0..1 code Symbol in syntax defined by the system
Fixed Value: 73569-6
... subject Σ 1..1 Reference(Patient (EU core)) Who and/or what the observation is about
... value[x] ΣC 1..1 string Dose Summary text.
... device 0..1 Reference(Device: Imaging Device) Irradiating modality
... Slices for derivedFrom Σ 1..* Reference(DocumentReference | ImagingStudy | ImagingSelection | QuestionnaireResponse | Observation | MolecularSequence | GenomicStudy) Related resource from which the observation is made
Slice: Unordered, Open by profile:$this
.... derivedFrom:study Σ 1..1 Reference(ImagingStudy: General) The study the radiation information relates to.
.... derivedFrom:dicomSrInstance Σ 0..* Reference(ImagingSelection: DICOM SR Instance) The DICOM SR Structured Report that is the source of the information in this Observation.

doco Documentation for this format

Terminology Bindings

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

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().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()

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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:$this
.... basedOn:ServiceRequestOrderEuImagingaccession 0..1 Reference(ServiceRequest: Imaging Order) Fulfills plan, proposal or order
..... identifier 1..1 AccessionNumberIdentifierEuImaging Logical reference, when literal reference is not known
... partOf 0..* Reference(Procedure: Imaging Acquisition) Part of referenced event
... code 1..1 CodeableConcept Type of observation (code / type)
Binding: ValueSet: All SNOMED CT and LOINC Codes (preferred)
.... Slices for coding 1..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:code, value:system
..... coding:radiation-dose 1..1 Coding Code defined by a terminology system
...... system 0..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
...... code 0..1 code Symbol in syntax defined by the system
Fixed Value: 73569-6
... value[x] 1..1 string Dose Summary text.
... device 0..1 Reference(Device: Imaging Device) Irradiating modality
... Slices for derivedFrom 1..* Reference(DocumentReference | ImagingStudy | ImagingSelection | QuestionnaireResponse | Observation | MolecularSequence | GenomicStudy) Related resource from which the observation is made
Slice: Unordered, Open by profile:$this
.... derivedFrom:study 1..1 Reference(ImagingStudy: General) 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.

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
Observation.code Base preferred ValueSet: All SNOMED CT and LOINC Codes 📦1.0.0-ballot This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7, obs-8
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... 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 ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for observation
... instantiates[x] Σ 0..1 canonical(ObservationDefinition), Reference(ObservationDefinition) Instantiates FHIR ObservationDefinition
... Slices for basedOn Σ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
Slice: Unordered, Open by type:$this
.... basedOn:ServiceRequestOrderEuImagingaccession Σ 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 ΣC 0..1 string Literal reference, Relative, internal or absolute URL
..... type Σ 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 ΣC 1..1 AccessionNumberIdentifierEuImaging Logical reference, when literal reference is not known
..... display ΣC 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 ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... observation Σ 1..1 Reference(Observation) Triggering observation
.... type Σ 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 Σ 0..* Reference(Procedure: Imaging Acquisition) Part of referenced event
... status ?!Σ 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 ΣC 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 Σ 1..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:code, value:system
..... coding:radiation-dose Σ 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 Σ 0..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 0..1 code Symbol in syntax defined by the system
Fixed Value: 73569-6
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... subject Σ 1..1 Reference(Patient (EU core)) Who and/or what the observation is about
... focus Σ 0..* Reference(Resource) What the observation is about, when it is not about the subject of record
... encounter Σ 0..1 Reference(Encounter) Healthcare event during which this observation is made
... effective[x] Σ 0..1 Clinically relevant time/time-period for observation
.... effectiveDateTime dateTime
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... issued Σ 0..1 instant Date/Time this version was made available
... performer Σ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
... value[x] ΣC 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 ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... low C 0..1 SimpleQuantity(5.0.0) Low Range, if relevant
.... high C 0..1 SimpleQuantity(5.0.0) High Range, if relevant
.... 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 Σ 0..* Reference(Observation | QuestionnaireResponse | MolecularSequence) Related resource that belongs to the Observation group
... Slices for derivedFrom Σ 1..* Reference(DocumentReference | ImagingStudy | ImagingSelection | QuestionnaireResponse | Observation | MolecularSequence | GenomicStudy) Related resource from which the observation is made
Slice: Unordered, Open by profile:$this
.... derivedFrom:study Σ 1..1 Reference(ImagingStudy: General) The study the radiation information relates to.
.... derivedFrom:dicomSrInstance Σ 0..* Reference(ImagingSelection: DICOM SR Instance) The DICOM SR Structured Report that is the source of the information in this Observation.
... component ΣC 0..* BackboneElement Component results
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code ΣC 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... value[x] Σ 0..1 Actual component result
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... valueTime time
..... valueDateTime dateTime
..... valuePeriod Period
..... 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

doco Documentation for this format

Terminology Bindings

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.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().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)

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7, obs-8
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
.... basedOn:ServiceRequestOrderEuImagingaccession Σ 0..1 Reference(ServiceRequest: Imaging Order) Fulfills plan, proposal or order
..... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
..... identifier ΣC 1..1 AccessionNumberIdentifierEuImaging Logical reference, when literal reference is not known
... partOf Σ 0..* Reference(Procedure: Imaging Acquisition) Part of referenced event
... status ?!Σ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.
... code ΣC 1..1 CodeableConcept Type of observation (code / type)
Binding: ValueSet: All SNOMED CT and LOINC Codes (preferred)
.... Slices for coding Σ 1..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:code, value:system
..... coding:radiation-dose Σ 1..1 Coding Code defined by a terminology system
...... system Σ 0..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
...... code ΣC 0..1 code Symbol in syntax defined by the system
Fixed Value: 73569-6
... subject Σ 1..1 Reference(Patient (EU core)) Who and/or what the observation is about
... value[x] ΣC 1..1 string Dose Summary text.
... device 0..1 Reference(Device: Imaging Device) Irradiating modality
... Slices for derivedFrom Σ 1..* Reference(DocumentReference | ImagingStudy | ImagingSelection | QuestionnaireResponse | Observation | MolecularSequence | GenomicStudy) Related resource from which the observation is made
Slice: Unordered, Open by profile:$this
.... derivedFrom:study Σ 1..1 Reference(ImagingStudy: General) The study the radiation information relates to.
.... derivedFrom:dicomSrInstance Σ 0..* Reference(ImagingSelection: DICOM SR Instance) The DICOM SR Structured Report that is the source of the information in this Observation.

doco Documentation for this format

Terminology Bindings

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

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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:$this
.... basedOn:ServiceRequestOrderEuImagingaccession 0..1 Reference(ServiceRequest: Imaging Order) Fulfills plan, proposal or order
..... identifier 1..1 AccessionNumberIdentifierEuImaging Logical reference, when literal reference is not known
... partOf 0..* Reference(Procedure: Imaging Acquisition) Part of referenced event
... code 1..1 CodeableConcept Type of observation (code / type)
Binding: ValueSet: All SNOMED CT and LOINC Codes (preferred)
.... Slices for coding 1..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:code, value:system
..... coding:radiation-dose 1..1 Coding Code defined by a terminology system
...... system 0..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
...... code 0..1 code Symbol in syntax defined by the system
Fixed Value: 73569-6
... value[x] 1..1 string Dose Summary text.
... device 0..1 Reference(Device: Imaging Device) Irradiating modality
... Slices for derivedFrom 1..* Reference(DocumentReference | ImagingStudy | ImagingSelection | QuestionnaireResponse | Observation | MolecularSequence | GenomicStudy) Related resource from which the observation is made
Slice: Unordered, Open by profile:$this
.... derivedFrom:study 1..1 Reference(ImagingStudy: General) 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.

doco Documentation for this format

Terminology Bindings (Differential)

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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Observation C 0..* Observation Measurements and simple assertions
Constraints: obs-6, obs-7, obs-8
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language
Additional BindingsPurpose
CommonLanguages Starter
... 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 ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for observation
... instantiates[x] Σ 0..1 canonical(ObservationDefinition), Reference(ObservationDefinition) Instantiates FHIR ObservationDefinition
... Slices for basedOn Σ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
Slice: Unordered, Open by type:$this
.... basedOn:ServiceRequestOrderEuImagingaccession Σ 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 ΣC 0..1 string Literal reference, Relative, internal or absolute URL
..... type Σ 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 ΣC 1..1 AccessionNumberIdentifierEuImaging Logical reference, when literal reference is not known
..... display ΣC 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 ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... observation Σ 1..1 Reference(Observation) Triggering observation
.... type Σ 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 Σ 0..* Reference(Procedure: Imaging Acquisition) Part of referenced event
... status ?!Σ 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 ΣC 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 Σ 1..* Coding Code defined by a terminology system
Slice: Unordered, Open by value:code, value:system
..... coding:radiation-dose Σ 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 Σ 0..1 uri Identity of the terminology system
Fixed Value: http://loinc.org
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 0..1 code Symbol in syntax defined by the system
Fixed Value: 73569-6
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text Σ 0..1 string Plain text representation of the concept
... subject Σ 1..1 Reference(Patient (EU core)) Who and/or what the observation is about
... focus Σ 0..* Reference(Resource) What the observation is about, when it is not about the subject of record
... encounter Σ 0..1 Reference(Encounter) Healthcare event during which this observation is made
... effective[x] Σ 0..1 Clinically relevant time/time-period for observation
.... effectiveDateTime dateTime
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... issued Σ 0..1 instant Date/Time this version was made available
... performer Σ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
... value[x] ΣC 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 ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... low C 0..1 SimpleQuantity(5.0.0) Low Range, if relevant
.... high C 0..1 SimpleQuantity(5.0.0) High Range, if relevant
.... 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 Σ 0..* Reference(Observation | QuestionnaireResponse | MolecularSequence) Related resource that belongs to the Observation group
... Slices for derivedFrom Σ 1..* Reference(DocumentReference | ImagingStudy | ImagingSelection | QuestionnaireResponse | Observation | MolecularSequence | GenomicStudy) Related resource from which the observation is made
Slice: Unordered, Open by profile:$this
.... derivedFrom:study Σ 1..1 Reference(ImagingStudy: General) The study the radiation information relates to.
.... derivedFrom:dicomSrInstance Σ 0..* Reference(ImagingSelection: DICOM SR Instance) The DICOM SR Structured Report that is the source of the information in this Observation.
... component ΣC 0..* BackboneElement Component results
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code ΣC 1..1 CodeableConcept Type of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.
.... value[x] Σ 0..1 Actual component result
..... valueQuantity Quantity
..... valueCodeableConcept CodeableConcept
..... valueString string
..... valueBoolean boolean
..... valueInteger integer
..... valueRange Range
..... valueRatio Ratio
..... valueSampledData SampledData
..... valueTime time
..... valueDateTime dateTime
..... valuePeriod Period
..... 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

doco Documentation for this format

Terminology Bindings

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.

Constraints

Id Grade Path(s) Description Expression
dom-2 error Observation If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error Observation If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().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)

 

Other representations of profile: CSV, Excel, Schematron

Notes:

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:

  • Imaging modalities that use x-rays (CT, radiography, angiography, mammography, fluoroscopy, etc) should create detailed dose data reports for each imaging procedure using the DICOM Radiation Dose Structured Report (RDSR) format and store those in the DICOM imaging study folder in the PACS when the scan is performed. This is specified in the IHE Radiation Exposure Monitoring (REM) Profile.
  • Dose analysis software or workstations should retrieve RDSRs from the PACS to perform analysis as needed. This is specified in the IHE Radiation Exposure Monitoring (REM) Profile.
  • Dose analysis software should create an appropriate block of radiation dose for each imaging study based on the content of the RDSR, on it’s understanding of the corresponding complexities, and potentially on configuration to reflect local reporting regulations and preferences.
  • The analysis software can send the text block to the EMR in a FHIR Observation as described in the FHIR Radiation Dose Summary IG. The IG focusses on conveying the text block. Quantitative values are not prohibited, but for the reasons discussed here have the potential of encouraging quantitative assessment of incomplete information.
  • IHE Radiology CP-RAD-525 (still in progress) introduces an EMR Extract Option to the IHE REM Profile that has the Dose Information Reporter essentially create a text block observation as described in the FHIR Radiation Dose Summary IG.
  • The IHE IDR Phase 2 Profile describes how a FHIR Procedure Resource can be created to record the details of the image acquisition procedure, and how an Observation such as the one described in FHIR Radiation Dose Summary IG can be referenced from that Procedure. It’s useful to point out here that, as explained by medical physicists, the radiation dose metrics primarily do not reflect the radiation absorbed by the patient but rather the radiation output by the scanner, and thus are capture a characteristic of the imaging procedure.
  • Report creators should incorporate the text block into reports as needed.
    • In the simplest form, the text block is appended directly into the narrative text.
    • If a FHIR Observation is desired, an observation can be created as described above. This is also described in IDR Phase II and a specific code is proposed for the dose summary text Observation.
    • To further connect the dots, the Observation can be referenced from Procedure.outcome as described in IHE Phase II since it is one of the outcomes of the imaging procedure.