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)

• Key Elements Table
• Differential Table
• Snapshot Table
• Statistics/References
• All

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

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.status	Base	required	ObservationStatus	📍4.0.1	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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both	extension.exists() != value.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present	dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present	value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation	Measurements and simple assertions Constraints: obs-6, obs-7
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
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	Σ	0..*	Identifier	Business Identifier for observation
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	string	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") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	1..1	AccessionNumberIdentifierEuImaging	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
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	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: ValueSet: All SNOMED CT and LOINC Codes (preferred)
id		0..1	string	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	string	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	Σ	0..1	code	Symbol in syntax defined by the system Fixed Value: 73569-6
display	Σ	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		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen		0..1	Reference(Specimen)	Specimen used for this observation
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(4.0.1)	Low Range, if relevant
high	C	0..1	SimpleQuantity(4.0.1)	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo		0..*	CodeableConcept	Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age		0..1	Range	Applicable age range, if relevant
text		0..1	string	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	Related resource that belongs to the Observation group
Slices for derivedFrom	Σ	1..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from Slice: Unordered, Open by profile:$this
derivedFrom:study	Σ	1..1	Reference(ImagingStudy: General)	The study the radiation information relates to.
component	Σ	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	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x]	Σ	0..1		Actual component result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
Observation.basedOn:ServiceRequestOrderEuImagingaccession.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.code	Base	preferred	ValueSet: All SNOMED CT and LOINC Codes	📦1.0.0-ballot	This IG
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.
Observation.bodySite	Base	example	SNOMED CT Body Structures	📍4.0.1	FHIR Std.
Observation.method	Base	example	Observation Methods	📍4.0.1	FHIR Std.
Observation.referenceRange.​type	Base	preferred	Observation Reference Range Meaning Codes	📍4.0.1	FHIR Std.
Observation.referenceRange.​appliesTo	Base	example	Observation Reference Range Applies To Codes	📍4.0.1	FHIR Std.
Observation.component.​code	Base	example	LOINC Codes	📍4.0.1	FHIR Std.
Observation.component.​dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.component.​interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	**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.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present	value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

Key Elements View

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

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.status	Base	required	ObservationStatus	📍4.0.1	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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both	extension.exists() != value.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present	dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present	value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

Differential View

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation	Measurements and simple assertions Constraints: obs-6, obs-7
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
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	Σ	0..*	Identifier	Business Identifier for observation
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	string	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") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	1..1	AccessionNumberIdentifierEuImaging	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
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	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: ValueSet: All SNOMED CT and LOINC Codes (preferred)
id		0..1	string	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	string	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	Σ	0..1	code	Symbol in syntax defined by the system Fixed Value: 73569-6
display	Σ	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		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen		0..1	Reference(Specimen)	Specimen used for this observation
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(4.0.1)	Low Range, if relevant
high	C	0..1	SimpleQuantity(4.0.1)	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo		0..*	CodeableConcept	Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age		0..1	Range	Applicable age range, if relevant
text		0..1	string	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	Related resource that belongs to the Observation group
Slices for derivedFrom	Σ	1..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from Slice: Unordered, Open by profile:$this
derivedFrom:study	Σ	1..1	Reference(ImagingStudy: General)	The study the radiation information relates to.
component	Σ	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	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x]	Σ	0..1		Actual component result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
Observation.basedOn:ServiceRequestOrderEuImagingaccession.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.code	Base	preferred	ValueSet: All SNOMED CT and LOINC Codes	📦1.0.0-ballot	This IG
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.
Observation.bodySite	Base	example	SNOMED CT Body Structures	📍4.0.1	FHIR Std.
Observation.method	Base	example	Observation Methods	📍4.0.1	FHIR Std.
Observation.referenceRange.​type	Base	preferred	Observation Reference Range Meaning Codes	📍4.0.1	FHIR Std.
Observation.referenceRange.​appliesTo	Base	example	Observation Reference Range Applies To Codes	📍4.0.1	FHIR Std.
Observation.component.​code	Base	example	LOINC Codes	📍4.0.1	FHIR Std.
Observation.component.​dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.component.​interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	**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.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present	value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

Summary

Mandatory: 6 elements(1 nested mandatory element)
Fixed: 2 elements

Structures

This structure refers to these other structures:

• ServiceRequest: Imaging Order (http://hl7.eu/fhir/imaging/StructureDefinition/ServiceRequestOrderEuImaging)
• Identifier: Accession Number (http://hl7.eu/fhir/imaging/StructureDefinition/AccessionNumberIdentifierEuImaging)
• Procedure: Imaging Acquisition (http://hl7.eu/fhir/imaging/StructureDefinition/ProcedureEuImaging)
• Patient (EU core) (http://hl7.eu/fhir/base/StructureDefinition/patient-eu-core)
• Device: Imaging Device (http://hl7.eu/fhir/imaging/StructureDefinition/DeviceEuImaging)
• ImagingStudy: General (http://hl7.eu/fhir/imaging/StructureDefinition/ImagingStudyEuImaging)

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Observation.basedOn
• The element 2 is sliced based on the values of Observation.code.coding
• The element 1 is sliced based on the value of Observation.derivedFrom

Maturity: 1

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.