Name	Flags	Card.	Type	Description & Constraints
Observation		0..*	Observation	Measurements and simple assertions
text	S	1..1	Narrative	User-defined name for the ROI
Slices for identifier		4..*	Identifier	Business Identifier for observation Slice: Unordered, Open by pattern:type.text
identifier:dicom_reference	S	1..*	Identifier	Unique identifier of the DICOM object
type
text		1..1	string	Plain text representation of the concept Required Pattern: dicom_reference
identifier:series_reference	S	1..1	Identifier	UID series reference
type
text		1..1	string	Plain text representation of the concept Required Pattern: series_reference
identifier:roi	S	1..1	Identifier	Unique identifier ROI
type
text		1..1	string	Plain text representation of the concept Required Pattern: roi
identifier:file	S	1..1	Identifier	File identifier
type
text		1..1	string	Plain text representation of the concept Required Pattern: file
partOf	S	1..1	Reference(Imaging Study)	Part of referenced event
code	S	1..1	CodeableConcept	ROI Type Binding: ROI Type Value Set (required)
subject		0..1	Reference(Oncology Patient)	Who and/or what the observation is about
note	S	0..1	Annotation	User-defined description for the ROI
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.code	required	ROIType https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/ROIType from this IG

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
text	S	1..1	Narrative	User-defined name for the ROI
modifierExtension	?!N	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
Slices for identifier	Σ	4..*	Identifier	Business Identifier for observation Slice: Unordered, Open by pattern:type.text
identifier:dicom_reference	SΣ	1..*	Identifier	Unique identifier of the DICOM object
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
identifier:series_reference	SΣ	1..1	Identifier	UID series reference
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
identifier:roi	SΣ	1..1	Identifier	Unique identifier ROI
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
identifier:file	SΣ	1..1	Identifier	File identifier
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
partOf	SΣC	1..1	Reference(Imaging Study)	Part of referenced event ref-1: SHALL have a contained resource if a local reference is provided
status	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
code	SΣ	1..1	CodeableConcept	ROI Type Binding: ROI Type Value Set (required)
subject	ΣC	0..1	Reference(Oncology Patient)	Who and/or what the observation is about ref-1: SHALL have a contained resource if a local reference is provided
value[x]	ΣC	0..1		Actual 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 result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
note	S	0..1	Annotation	User-defined description for the ROI
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Observation.identifier:dicom_reference.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Observation.identifier:series_reference.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Observation.identifier:roi.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Observation.identifier:file.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.code	required	ROIType https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/ROIType from this IG
Observation.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
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	S	1..1	Narrative	User-defined name for the ROI
contained		0..*	Resource	Contained, inline Resources
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!N	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
Slices for identifier	Σ	4..*	Identifier	Business Identifier for observation Slice: Unordered, Open by pattern:type.text
identifier:dicom_reference	SΣ	1..*	Identifier	Unique identifier of the DICOM object
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: dicom_reference
system	Σ	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	Σ	0..1	string	The value that is unique Example General: 123456
period	ΣC	0..1	Period	Time period when id is/was valid for use per-1: If present, start SHALL have a lower value than end
assigner	ΣC	0..1	Reference(Organization)	Organization that issued id (may be just text) ref-1: SHALL have a contained resource if a local reference is provided
identifier:series_reference	SΣ	1..1	Identifier	UID series reference
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: series_reference
system	Σ	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	Σ	0..1	string	The value that is unique Example General: 123456
period	ΣC	0..1	Period	Time period when id is/was valid for use per-1: If present, start SHALL have a lower value than end
assigner	ΣC	0..1	Reference(Organization)	Organization that issued id (may be just text) ref-1: SHALL have a contained resource if a local reference is provided
identifier:roi	SΣ	1..1	Identifier	Unique identifier ROI
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: roi
system	Σ	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	Σ	0..1	string	The value that is unique Example General: 123456
period	ΣC	0..1	Period	Time period when id is/was valid for use per-1: If present, start SHALL have a lower value than end
assigner	ΣC	0..1	Reference(Organization)	Organization that issued id (may be just text) ref-1: SHALL have a contained resource if a local reference is provided
identifier:file	SΣ	1..1	Identifier	File identifier
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: file
system	Σ	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	Σ	0..1	string	The value that is unique Example General: 123456
period	ΣC	0..1	Period	Time period when id is/was valid for use per-1: If present, start SHALL have a lower value than end
assigner	ΣC	0..1	Reference(Organization)	Organization that issued id (may be just text) ref-1: SHALL have a contained resource if a local reference is provided
basedOn	ΣC	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order ref-1: SHALL have a contained resource if a local reference is provided
partOf	SΣC	1..1	Reference(Imaging Study)	Part of referenced event ref-1: SHALL have a contained resource if a local reference is provided
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	SΣ	1..1	CodeableConcept	ROI Type Binding: ROI Type Value Set (required)
subject	ΣC	0..1	Reference(Oncology Patient)	Who and/or what the observation is about ref-1: SHALL have a contained resource if a local reference is provided
focus	ΣC	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record ref-1: SHALL have a contained resource if a local reference is provided
encounter	ΣC	0..1	Reference(Encounter)	Healthcare event during which this observation is made ref-1: SHALL have a contained resource if a local reference is provided
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	ΣC	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation ref-1: SHALL have a contained resource if a local reference is provided
value[x]	ΣC	0..1		Actual 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 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	S	0..1	Annotation	User-defined description for the ROI
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	C	0..1	Reference(Specimen)	Specimen used for this observation ref-1: SHALL have a contained resource if a local reference is provided
device	C	0..1	Reference(Device | DeviceMetric)	(Measurement) Device ref-1: SHALL have a contained resource if a local reference is provided
referenceRange	C	0..*	BackboneElement	Provides guide for interpretation obs-3: Must have at least a low or a high or text
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	C	0..1	SimpleQuantity	Low Range, if relevant qty-3: If a code for the unit is present, the system SHALL also be present sqty-1: The comparator is not used on a SimpleQuantity
high	C	0..1	SimpleQuantity	High Range, if relevant qty-3: If a code for the unit is present, the system SHALL also be present sqty-1: The comparator is not used on a SimpleQuantity
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	C	0..1	Range	Applicable age range, if relevant rng-2: If present, low SHALL have a lower value than high
text		0..1	string	Text based reference range in an observation
hasMember	ΣC	0..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	Related resource that belongs to the Observation group ref-1: SHALL have a contained resource if a local reference is provided
derivedFrom	ΣC	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from ref-1: SHALL have a contained resource if a local reference is provided
component	Σ	0..*	BackboneElement	Component results
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
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	Conformance	ValueSet	URI
Observation.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
Observation.identifier:dicom_reference.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Observation.identifier:dicom_reference.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Observation.identifier:series_reference.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Observation.identifier:series_reference.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Observation.identifier:roi.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Observation.identifier:roi.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Observation.identifier:file.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Observation.identifier:file.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.code	required	ROIType https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/ROIType from this IG
Observation.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.bodySite	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
Observation.method	example	ObservationMethods http://hl7.org/fhir/ValueSet/observation-methods from the FHIR Standard
Observation.referenceRange.type	preferred	ObservationReferenceRangeMeaningCodes http://hl7.org/fhir/ValueSet/referencerange-meaning from the FHIR Standard
Observation.referenceRange.appliesTo	example	ObservationReferenceRangeAppliesToCodes http://hl7.org/fhir/ValueSet/referencerange-appliesto from the FHIR Standard
Observation.component.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.component.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard

Summary

Mandatory: 6 elements (4 nested mandatory elements)
Must-Support: 8 elements

Structures

This structure refers to these other structures:

• Imaging Study (https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/StructureDefinition/onco-imagingstudy)
• Oncology Patient (https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/StructureDefinition/onco-patient)

Slices

This structure defines the following Slices:

• The element Observation.identifier is sliced based on the value of pattern:type.text

Name	Flags	Card.	Type	Description & Constraints
Observation		0..*	Observation	Measurements and simple assertions
text	S	1..1	Narrative	User-defined name for the ROI
Slices for identifier		4..*	Identifier	Business Identifier for observation Slice: Unordered, Open by pattern:type.text
identifier:dicom_reference	S	1..*	Identifier	Unique identifier of the DICOM object
type
text		1..1	string	Plain text representation of the concept Required Pattern: dicom_reference
identifier:series_reference	S	1..1	Identifier	UID series reference
type
text		1..1	string	Plain text representation of the concept Required Pattern: series_reference
identifier:roi	S	1..1	Identifier	Unique identifier ROI
type
text		1..1	string	Plain text representation of the concept Required Pattern: roi
identifier:file	S	1..1	Identifier	File identifier
type
text		1..1	string	Plain text representation of the concept Required Pattern: file
partOf	S	1..1	Reference(Imaging Study)	Part of referenced event
code	S	1..1	CodeableConcept	ROI Type Binding: ROI Type Value Set (required)
subject		0..1	Reference(Oncology Patient)	Who and/or what the observation is about
note	S	0..1	Annotation	User-defined description for the ROI
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.code	required	ROIType https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/ROIType from this IG

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
text	S	1..1	Narrative	User-defined name for the ROI
modifierExtension	?!N	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
Slices for identifier	Σ	4..*	Identifier	Business Identifier for observation Slice: Unordered, Open by pattern:type.text
identifier:dicom_reference	SΣ	1..*	Identifier	Unique identifier of the DICOM object
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
identifier:series_reference	SΣ	1..1	Identifier	UID series reference
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
identifier:roi	SΣ	1..1	Identifier	Unique identifier ROI
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
identifier:file	SΣ	1..1	Identifier	File identifier
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
partOf	SΣC	1..1	Reference(Imaging Study)	Part of referenced event ref-1: SHALL have a contained resource if a local reference is provided
status	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
code	SΣ	1..1	CodeableConcept	ROI Type Binding: ROI Type Value Set (required)
subject	ΣC	0..1	Reference(Oncology Patient)	Who and/or what the observation is about ref-1: SHALL have a contained resource if a local reference is provided
value[x]	ΣC	0..1		Actual 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 result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
note	S	0..1	Annotation	User-defined description for the ROI
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
Observation.identifier:dicom_reference.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Observation.identifier:series_reference.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Observation.identifier:roi.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Observation.identifier:file.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.code	required	ROIType https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/ROIType from this IG
Observation.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
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	S	1..1	Narrative	User-defined name for the ROI
contained		0..*	Resource	Contained, inline Resources
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!N	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
Slices for identifier	Σ	4..*	Identifier	Business Identifier for observation Slice: Unordered, Open by pattern:type.text
identifier:dicom_reference	SΣ	1..*	Identifier	Unique identifier of the DICOM object
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: dicom_reference
system	Σ	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	Σ	0..1	string	The value that is unique Example General: 123456
period	ΣC	0..1	Period	Time period when id is/was valid for use per-1: If present, start SHALL have a lower value than end
assigner	ΣC	0..1	Reference(Organization)	Organization that issued id (may be just text) ref-1: SHALL have a contained resource if a local reference is provided
identifier:series_reference	SΣ	1..1	Identifier	UID series reference
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: series_reference
system	Σ	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	Σ	0..1	string	The value that is unique Example General: 123456
period	ΣC	0..1	Period	Time period when id is/was valid for use per-1: If present, start SHALL have a lower value than end
assigner	ΣC	0..1	Reference(Organization)	Organization that issued id (may be just text) ref-1: SHALL have a contained resource if a local reference is provided
identifier:roi	SΣ	1..1	Identifier	Unique identifier ROI
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: roi
system	Σ	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	Σ	0..1	string	The value that is unique Example General: 123456
period	ΣC	0..1	Period	Time period when id is/was valid for use per-1: If present, start SHALL have a lower value than end
assigner	ΣC	0..1	Reference(Organization)	Organization that issued id (may be just text) ref-1: SHALL have a contained resource if a local reference is provided
identifier:file	SΣ	1..1	Identifier	File identifier
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: Identifier Type Codes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: file
system	Σ	0..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient
value	Σ	0..1	string	The value that is unique Example General: 123456
period	ΣC	0..1	Period	Time period when id is/was valid for use per-1: If present, start SHALL have a lower value than end
assigner	ΣC	0..1	Reference(Organization)	Organization that issued id (may be just text) ref-1: SHALL have a contained resource if a local reference is provided
basedOn	ΣC	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order ref-1: SHALL have a contained resource if a local reference is provided
partOf	SΣC	1..1	Reference(Imaging Study)	Part of referenced event ref-1: SHALL have a contained resource if a local reference is provided
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	SΣ	1..1	CodeableConcept	ROI Type Binding: ROI Type Value Set (required)
subject	ΣC	0..1	Reference(Oncology Patient)	Who and/or what the observation is about ref-1: SHALL have a contained resource if a local reference is provided
focus	ΣC	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record ref-1: SHALL have a contained resource if a local reference is provided
encounter	ΣC	0..1	Reference(Encounter)	Healthcare event during which this observation is made ref-1: SHALL have a contained resource if a local reference is provided
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	ΣC	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation ref-1: SHALL have a contained resource if a local reference is provided
value[x]	ΣC	0..1		Actual 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 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	S	0..1	Annotation	User-defined description for the ROI
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	C	0..1	Reference(Specimen)	Specimen used for this observation ref-1: SHALL have a contained resource if a local reference is provided
device	C	0..1	Reference(Device | DeviceMetric)	(Measurement) Device ref-1: SHALL have a contained resource if a local reference is provided
referenceRange	C	0..*	BackboneElement	Provides guide for interpretation obs-3: Must have at least a low or a high or text
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	C	0..1	SimpleQuantity	Low Range, if relevant qty-3: If a code for the unit is present, the system SHALL also be present sqty-1: The comparator is not used on a SimpleQuantity
high	C	0..1	SimpleQuantity	High Range, if relevant qty-3: If a code for the unit is present, the system SHALL also be present sqty-1: The comparator is not used on a SimpleQuantity
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	C	0..1	Range	Applicable age range, if relevant rng-2: If present, low SHALL have a lower value than high
text		0..1	string	Text based reference range in an observation
hasMember	ΣC	0..*	Reference(Observation | QuestionnaireResponse | MolecularSequence)	Related resource that belongs to the Observation group ref-1: SHALL have a contained resource if a local reference is provided
derivedFrom	ΣC	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from ref-1: SHALL have a contained resource if a local reference is provided
component	Σ	0..*	BackboneElement	Component results
id		0..1	string	Unique id for inter-element referencing
extension	N	0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
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	Conformance	ValueSet	URI
Observation.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
Observation.identifier:dicom_reference.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Observation.identifier:dicom_reference.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Observation.identifier:series_reference.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Observation.identifier:series_reference.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Observation.identifier:roi.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Observation.identifier:roi.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Observation.identifier:file.use	required	IdentifierUse http://hl7.org/fhir/ValueSet/identifier-use|4.0.1 from the FHIR Standard
Observation.identifier:file.type	extensible	Identifier Type Codes http://hl7.org/fhir/ValueSet/identifier-type from the FHIR Standard
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.code	required	ROIType https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/ROIType from this IG
Observation.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.bodySite	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
Observation.method	example	ObservationMethods http://hl7.org/fhir/ValueSet/observation-methods from the FHIR Standard
Observation.referenceRange.type	preferred	ObservationReferenceRangeMeaningCodes http://hl7.org/fhir/ValueSet/referencerange-meaning from the FHIR Standard
Observation.referenceRange.appliesTo	example	ObservationReferenceRangeAppliesToCodes http://hl7.org/fhir/ValueSet/referencerange-appliesto from the FHIR Standard
Observation.component.code	example	LOINCCodes (a valid code from LOINC) http://hl7.org/fhir/ValueSet/observation-codes from the FHIR Standard
Observation.component.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.component.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard

Summary

Mandatory: 6 elements (4 nested mandatory elements)
Must-Support: 8 elements

Structures

This structure refers to these other structures:

• Imaging Study (https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/StructureDefinition/onco-imagingstudy)
• Oncology Patient (https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/StructureDefinition/onco-patient)

Slices

This structure defines the following Slices:

• The element Observation.identifier is sliced based on the value of pattern:type.text