Onconova Implementation Guide - Local Development build (v0.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• JSON

Resource Profile: Imaging Disease Status Profile

A profile representing the imaging-based disease status of a cancer patient.

It constrains the mCODE CancerDiseaseStatus profile to restrict it to imaging-based monitoring evaluated based on RECIST criteria.

Conformance:

Observation resources representing a disease status obtained through imaging techniques in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

Usages:

• CapabilityStatements using this Profile: Onconova FHIR REST Server Capability Statement
• This Profile is not used by any profiles in this Implementation Guide

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	CancerDiseaseStatus	Measurements and simple assertions Constraints: obs-6, obs-7, o-res-req-1, o-res-req-2, o-res-req-3, o-res-req-4
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension				Content/Rules for all slices
extension:evidenceType	S	0..*	(Complex)	Cancer Disease Status Evidence Type Extension URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-disease-status-evidence-type
extension		0..0		Extension Slice: Unordered, Open by value:url
url		1..1	uri	"http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-disease-status-evidence-type"
value[x]		1..1	CodeableConcept	Value of extension Binding: Cancer Disease Status Evidence Type Value Set (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 363679005
display		1..1	string	Representation defined by the system Fixed Value: Imaging (procedure)
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
basedOn	Σ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Not used in this profile
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Not used in this profile
status	?!SΣ	1..1	code	Not used in this profile 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. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: imaging
display		1..1	string	Representation defined by the system Fixed Value: Imaging
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
code	SΣ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 97509-4
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
subject	SOΣ	1..1	Reference(Cancer Patient Profile)	Who and/or what the observation is about Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
focus	SOΣ	1..*	Reference(Primary Cancer Condition Profile | Secondary Cancer Condition Profile)	What the observation is about, when it is not about the subject of record Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
encounter	Σ	0..1	Reference(Encounter)	Not used in this profile
effective[x]	SOΣ	1..1	dateTime	Clinically relevant time/time-period for observation Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
performer	Σ	0..*	Reference(US Core Practitioner Profile)	Not used in this profile
value[x]	SOΣC	1..1	CodeableConcept	Actual result Binding: https://loinc.org/LL4721-8/ (required) Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
Slices for extension				Content/Rules for all slices
extension:interpreted	SO	0..1	boolean	Treatment Response RECIST Is Interpreted URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-treatment-response-recist-is-interpreted Obligations Actor SHOULD:populate-if-known Creator (Onconova) SHOULD:persist Consumer (Onconova)
bodySite	O	0..1	CodeableConcept	Observed body part Binding: Observation Body Sites Value Set (required) Obligations Actor SHALL:populate-if-known Creator (Onconova) SHOULD:persist Consumer (Onconova)
method	O	0..1	CodeableConcept	How it was done Binding: Cancer Imaging Methods Value Set (required) Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Not used in this profile
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.extension:evidenceType.​value[x]	Base	required	Cancer Disease Status Evidence Type Value Set	📦4.0.0	minimal Common Oncology Data Elements v4.0
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	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.value[x]	Base	required	https://loinc.org/LL4721-8/	Not State	Unknown
Observation.bodySite	Base	required	Observation Body Sites Value Set	📦0.2.0	This IG
Observation.method	Base	required	Cancer Imaging Methods Value Set	📦0.2.0	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()
o-res-req-1	error	Observation	The subject element is required and must be provided.	subject.exists()
o-res-req-2	error	Observation	The effectiveDateTime element is required and must be provided.	effectiveDateTime.exists() and effectiveDateTime.hasValue()
o-res-req-3	error	Observation	The valueCodeableConcept element is required and must be provided.	valueCodeableConcept.exists() and valueCodeableConcept.coding.exists()
o-res-req-4	error	Observation	The method element is required and must be provided.	method.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()

This structure is derived from CancerDiseaseStatus

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	CancerDiseaseStatus	Measurements and simple assertions Constraints: o-res-req-1, o-res-req-2, o-res-req-3, o-res-req-4
Slices for extension				Content/Rules for all slices
extension:evidenceType		0..*	CancerDiseaseStatusEvidenceType	Cancer Disease Status Evidence Type Extension
value[x]		1..1	CodeableConcept	Value of extension Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 363679005
display		1..1	string	Representation defined by the system Fixed Value: Imaging (procedure)
basedOn		0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Not used in this profile
partOf		0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Not used in this profile
status		1..1	code	Not used in this profile
category		0..*	CodeableConcept	Classification of type of observation Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: imaging
display		1..1	string	Representation defined by the system Fixed Value: Imaging
subject	O	1..1	Reference(Cancer Patient Profile)	Who and/or what the observation is about Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
focus	O	1..*	Reference(Primary Cancer Condition Profile | Secondary Cancer Condition Profile)	What the observation is about, when it is not about the subject of record Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
encounter		0..1	Reference(Encounter)	Not used in this profile
effective[x]	O	1..1	dateTime	Clinically relevant time/time-period for observation Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
performer		0..*	Reference(US Core Practitioner Profile)	Not used in this profile
value[x]	O	1..1	CodeableConcept	Actual result Binding: https://loinc.org/LL4721-8/ (required) Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
Slices for extension				Content/Rules for all slices
extension:interpreted	SO	0..1	boolean	Treatment Response RECIST Is Interpreted URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-treatment-response-recist-is-interpreted Obligations Actor SHOULD:populate-if-known Creator (Onconova) SHOULD:persist Consumer (Onconova)
bodySite	O	0..1	CodeableConcept	Observed body part Binding: Observation Body Sites Value Set (required) Obligations Actor SHALL:populate-if-known Creator (Onconova) SHOULD:persist Consumer (Onconova)
method	O	0..1	CodeableConcept	How it was done Binding: Cancer Imaging Methods Value Set (required) Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
derivedFrom		0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Not used in this profile
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.value[x]	Base	required	https://loinc.org/LL4721-8/	Not State	Unknown
Observation.bodySite	Base	required	Observation Body Sites Value Set	📦0.2.0	This IG
Observation.method	Base	required	Cancer Imaging Methods Value Set	📦0.2.0	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
o-res-req-1	error	Observation	The subject element is required and must be provided.	subject.exists()
o-res-req-2	error	Observation	The effectiveDateTime element is required and must be provided.	effectiveDateTime.exists() and effectiveDateTime.hasValue()
o-res-req-3	error	Observation	The valueCodeableConcept element is required and must be provided.	valueCodeableConcept.exists() and valueCodeableConcept.coding.exists()
o-res-req-4	error	Observation	The method element is required and must be provided.	method.exists()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	CancerDiseaseStatus	Measurements and simple assertions Constraints: obs-6, obs-7, o-res-req-1, o-res-req-2, o-res-req-3, o-res-req-4
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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:evidenceType	S	0..*	(Complex)	Cancer Disease Status Evidence Type Extension URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-disease-status-evidence-type
id		0..1	string	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url
url		1..1	uri	"http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-disease-status-evidence-type"
value[x]		1..1	CodeableConcept	Value of extension Binding: Cancer Disease Status Evidence Type Value Set (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 363679005
display		1..1	string	Representation defined by the system Fixed Value: Imaging (procedure)
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business Identifier for observation
basedOn	Σ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Not used in this profile
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Not used in this profile
status	?!SΣ	1..1	code	Not used in this profile 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. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: imaging
display		1..1	string	Representation defined by the system Fixed Value: Imaging
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
code	SΣ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 97509-4
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
subject	SOΣ	1..1	Reference(Cancer Patient Profile)	Who and/or what the observation is about Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
focus	SOΣ	1..*	Reference(Primary Cancer Condition Profile | Secondary Cancer Condition Profile)	What the observation is about, when it is not about the subject of record Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
encounter	Σ	0..1	Reference(Encounter)	Not used in this profile
effective[x]	SOΣ	1..1	dateTime	Clinically relevant time/time-period for observation Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
issued	Σ	0..1	instant	Date/Time this version was made available
performer	Σ	0..*	Reference(US Core Practitioner Profile)	Not used in this profile
value[x]	SOΣC	1..1	CodeableConcept	Actual result Binding: https://loinc.org/LL4721-8/ (required) Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
extension:interpreted	SO	0..1	boolean	Treatment Response RECIST Is Interpreted URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-treatment-response-recist-is-interpreted Obligations Actor SHOULD:populate-if-known Creator (Onconova) SHOULD:persist Consumer (Onconova)
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	0..1	string	Plain text representation of the concept
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	O	0..1	CodeableConcept	Observed body part Binding: Observation Body Sites Value Set (required) Obligations Actor SHALL:populate-if-known Creator (Onconova) SHOULD:persist Consumer (Onconova)
method	O	0..1	CodeableConcept	How it was done Binding: Cancer Imaging Methods Value Set (required) Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
specimen		0..1	Reference(Specimen)	Not used in this profile
device		0..1	Reference(Device | DeviceMetric)	Not used in this profile
referenceRange	C	0..*	BackboneElement	Not used in this profile 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	Low Range, if relevant
high	C	0..1	SimpleQuantity	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)	Not used in this profile
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Not used in this profile
component	Σ	0..*	BackboneElement	Not used in this profile
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.extension:evidenceType.​value[x]	Base	required	Cancer Disease Status Evidence Type Value Set	📦4.0.0	minimal Common Oncology Data Elements v4.0
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	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.value[x]	Base	required	https://loinc.org/LL4721-8/	Not State	Unknown
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	required	Observation Body Sites Value Set	📦0.2.0	This IG
Observation.method	Base	required	Cancer Imaging Methods Value Set	📦0.2.0	This IG
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()
o-res-req-1	error	Observation	The subject element is required and must be provided.	subject.exists()
o-res-req-2	error	Observation	The effectiveDateTime element is required and must be provided.	effectiveDateTime.exists() and effectiveDateTime.hasValue()
o-res-req-3	error	Observation	The valueCodeableConcept element is required and must be provided.	valueCodeableConcept.exists() and valueCodeableConcept.coding.exists()
o-res-req-4	error	Observation	The method element is required and must be provided.	method.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()

This structure is derived from CancerDiseaseStatus

Summary

Mandatory: 3 elements
Must-Support: 1 element

Structures

This structure refers to these other structures:

• Cancer Patient Profile (http://onconova.github.io/fhir/StructureDefinition/onconova-cancer-patient)
• Primary Cancer Condition Profile (http://onconova.github.io/fhir/StructureDefinition/onconova-primary-cancer-condition)
• Secondary Cancer Condition Profile (http://onconova.github.io/fhir/StructureDefinition/onconova-secondary-cancer-condition)

Extensions

This structure refers to these extensions:

• http://onconova.github.io/fhir/StructureDefinition/onconova-ext-treatment-response-recist-is-interpreted

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	CancerDiseaseStatus	Measurements and simple assertions Constraints: obs-6, obs-7, o-res-req-1, o-res-req-2, o-res-req-3, o-res-req-4
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension				Content/Rules for all slices
extension:evidenceType	S	0..*	(Complex)	Cancer Disease Status Evidence Type Extension URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-disease-status-evidence-type
extension		0..0		Extension Slice: Unordered, Open by value:url
url		1..1	uri	"http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-disease-status-evidence-type"
value[x]		1..1	CodeableConcept	Value of extension Binding: Cancer Disease Status Evidence Type Value Set (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 363679005
display		1..1	string	Representation defined by the system Fixed Value: Imaging (procedure)
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
basedOn	Σ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Not used in this profile
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Not used in this profile
status	?!SΣ	1..1	code	Not used in this profile 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. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: imaging
display		1..1	string	Representation defined by the system Fixed Value: Imaging
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
code	SΣ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 97509-4
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
subject	SOΣ	1..1	Reference(Cancer Patient Profile)	Who and/or what the observation is about Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
focus	SOΣ	1..*	Reference(Primary Cancer Condition Profile | Secondary Cancer Condition Profile)	What the observation is about, when it is not about the subject of record Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
encounter	Σ	0..1	Reference(Encounter)	Not used in this profile
effective[x]	SOΣ	1..1	dateTime	Clinically relevant time/time-period for observation Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
performer	Σ	0..*	Reference(US Core Practitioner Profile)	Not used in this profile
value[x]	SOΣC	1..1	CodeableConcept	Actual result Binding: https://loinc.org/LL4721-8/ (required) Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
Slices for extension				Content/Rules for all slices
extension:interpreted	SO	0..1	boolean	Treatment Response RECIST Is Interpreted URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-treatment-response-recist-is-interpreted Obligations Actor SHOULD:populate-if-known Creator (Onconova) SHOULD:persist Consumer (Onconova)
bodySite	O	0..1	CodeableConcept	Observed body part Binding: Observation Body Sites Value Set (required) Obligations Actor SHALL:populate-if-known Creator (Onconova) SHOULD:persist Consumer (Onconova)
method	O	0..1	CodeableConcept	How it was done Binding: Cancer Imaging Methods Value Set (required) Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Not used in this profile
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.extension:evidenceType.​value[x]	Base	required	Cancer Disease Status Evidence Type Value Set	📦4.0.0	minimal Common Oncology Data Elements v4.0
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	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.value[x]	Base	required	https://loinc.org/LL4721-8/	Not State	Unknown
Observation.bodySite	Base	required	Observation Body Sites Value Set	📦0.2.0	This IG
Observation.method	Base	required	Cancer Imaging Methods Value Set	📦0.2.0	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()
o-res-req-1	error	Observation	The subject element is required and must be provided.	subject.exists()
o-res-req-2	error	Observation	The effectiveDateTime element is required and must be provided.	effectiveDateTime.exists() and effectiveDateTime.hasValue()
o-res-req-3	error	Observation	The valueCodeableConcept element is required and must be provided.	valueCodeableConcept.exists() and valueCodeableConcept.coding.exists()
o-res-req-4	error	Observation	The method element is required and must be provided.	method.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

This structure is derived from CancerDiseaseStatus

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	CancerDiseaseStatus	Measurements and simple assertions Constraints: o-res-req-1, o-res-req-2, o-res-req-3, o-res-req-4
Slices for extension				Content/Rules for all slices
extension:evidenceType		0..*	CancerDiseaseStatusEvidenceType	Cancer Disease Status Evidence Type Extension
value[x]		1..1	CodeableConcept	Value of extension Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 363679005
display		1..1	string	Representation defined by the system Fixed Value: Imaging (procedure)
basedOn		0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Not used in this profile
partOf		0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Not used in this profile
status		1..1	code	Not used in this profile
category		0..*	CodeableConcept	Classification of type of observation Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: imaging
display		1..1	string	Representation defined by the system Fixed Value: Imaging
subject	O	1..1	Reference(Cancer Patient Profile)	Who and/or what the observation is about Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
focus	O	1..*	Reference(Primary Cancer Condition Profile | Secondary Cancer Condition Profile)	What the observation is about, when it is not about the subject of record Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
encounter		0..1	Reference(Encounter)	Not used in this profile
effective[x]	O	1..1	dateTime	Clinically relevant time/time-period for observation Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
performer		0..*	Reference(US Core Practitioner Profile)	Not used in this profile
value[x]	O	1..1	CodeableConcept	Actual result Binding: https://loinc.org/LL4721-8/ (required) Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
Slices for extension				Content/Rules for all slices
extension:interpreted	SO	0..1	boolean	Treatment Response RECIST Is Interpreted URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-treatment-response-recist-is-interpreted Obligations Actor SHOULD:populate-if-known Creator (Onconova) SHOULD:persist Consumer (Onconova)
bodySite	O	0..1	CodeableConcept	Observed body part Binding: Observation Body Sites Value Set (required) Obligations Actor SHALL:populate-if-known Creator (Onconova) SHOULD:persist Consumer (Onconova)
method	O	0..1	CodeableConcept	How it was done Binding: Cancer Imaging Methods Value Set (required) Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
derivedFrom		0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Not used in this profile
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.value[x]	Base	required	https://loinc.org/LL4721-8/	Not State	Unknown
Observation.bodySite	Base	required	Observation Body Sites Value Set	📦0.2.0	This IG
Observation.method	Base	required	Cancer Imaging Methods Value Set	📦0.2.0	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
o-res-req-1	error	Observation	The subject element is required and must be provided.	subject.exists()
o-res-req-2	error	Observation	The effectiveDateTime element is required and must be provided.	effectiveDateTime.exists() and effectiveDateTime.hasValue()
o-res-req-3	error	Observation	The valueCodeableConcept element is required and must be provided.	valueCodeableConcept.exists() and valueCodeableConcept.coding.exists()
o-res-req-4	error	Observation	The method element is required and must be provided.	method.exists()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	CancerDiseaseStatus	Measurements and simple assertions Constraints: obs-6, obs-7, o-res-req-1, o-res-req-2, o-res-req-3, o-res-req-4
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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:evidenceType	S	0..*	(Complex)	Cancer Disease Status Evidence Type Extension URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-disease-status-evidence-type
id		0..1	string	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url
url		1..1	uri	"http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-disease-status-evidence-type"
value[x]		1..1	CodeableConcept	Value of extension Binding: Cancer Disease Status Evidence Type Value Set (required) Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://snomed.info/sct
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 363679005
display		1..1	string	Representation defined by the system Fixed Value: Imaging (procedure)
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business Identifier for observation
basedOn	Σ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Not used in this profile
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Not used in this profile
status	?!SΣ	1..1	code	Not used in this profile 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. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: imaging
display		1..1	string	Representation defined by the system Fixed Value: Imaging
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
code	SΣ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 97509-4
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
subject	SOΣ	1..1	Reference(Cancer Patient Profile)	Who and/or what the observation is about Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
focus	SOΣ	1..*	Reference(Primary Cancer Condition Profile | Secondary Cancer Condition Profile)	What the observation is about, when it is not about the subject of record Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
encounter	Σ	0..1	Reference(Encounter)	Not used in this profile
effective[x]	SOΣ	1..1	dateTime	Clinically relevant time/time-period for observation Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
issued	Σ	0..1	instant	Date/Time this version was made available
performer	Σ	0..*	Reference(US Core Practitioner Profile)	Not used in this profile
value[x]	SOΣC	1..1	CodeableConcept	Actual result Binding: https://loinc.org/LL4721-8/ (required) Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
extension:interpreted	SO	0..1	boolean	Treatment Response RECIST Is Interpreted URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-treatment-response-recist-is-interpreted Obligations Actor SHOULD:populate-if-known Creator (Onconova) SHOULD:persist Consumer (Onconova)
coding	Σ	0..*	Coding	Code defined by a terminology system
text	Σ	0..1	string	Plain text representation of the concept
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	O	0..1	CodeableConcept	Observed body part Binding: Observation Body Sites Value Set (required) Obligations Actor SHALL:populate-if-known Creator (Onconova) SHOULD:persist Consumer (Onconova)
method	O	0..1	CodeableConcept	How it was done Binding: Cancer Imaging Methods Value Set (required) Obligations Actor SHALL:populate Creator (Onconova) SHOULD:persist Consumer (Onconova)
specimen		0..1	Reference(Specimen)	Not used in this profile
device		0..1	Reference(Device | DeviceMetric)	Not used in this profile
referenceRange	C	0..*	BackboneElement	Not used in this profile 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	Low Range, if relevant
high	C	0..1	SimpleQuantity	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)	Not used in this profile
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Not used in this profile
component	Σ	0..*	BackboneElement	Not used in this profile
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.extension:evidenceType.​value[x]	Base	required	Cancer Disease Status Evidence Type Value Set	📦4.0.0	minimal Common Oncology Data Elements v4.0
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	example	LOINC Codes	📦4.0.1	FHIR Std.
Observation.value[x]	Base	required	https://loinc.org/LL4721-8/	Not State	Unknown
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	required	Observation Body Sites Value Set	📦0.2.0	This IG
Observation.method	Base	required	Cancer Imaging Methods Value Set	📦0.2.0	This IG
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()
o-res-req-1	error	Observation	The subject element is required and must be provided.	subject.exists()
o-res-req-2	error	Observation	The effectiveDateTime element is required and must be provided.	effectiveDateTime.exists() and effectiveDateTime.hasValue()
o-res-req-3	error	Observation	The valueCodeableConcept element is required and must be provided.	valueCodeableConcept.exists() and valueCodeableConcept.coding.exists()
o-res-req-4	error	Observation	The method element is required and must be provided.	method.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()

This structure is derived from CancerDiseaseStatus

Summary

Mandatory: 3 elements
Must-Support: 1 element

Structures

This structure refers to these other structures:

• Cancer Patient Profile (http://onconova.github.io/fhir/StructureDefinition/onconova-cancer-patient)
• Primary Cancer Condition Profile (http://onconova.github.io/fhir/StructureDefinition/onconova-primary-cancer-condition)
• Secondary Cancer Condition Profile (http://onconova.github.io/fhir/StructureDefinition/onconova-secondary-cancer-condition)

Extensions

This structure refers to these extensions:

• http://onconova.github.io/fhir/StructureDefinition/onconova-ext-treatment-response-recist-is-interpreted