German Oncological Data Standard (GOLD) - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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Resource Profile: Profile Tumor Measurment

Profile for recording measurements of a tumor like the longest diameter or volume. The resource can be used for different measurement methods (e.g. methods in pathology, radiology or physical exams).

Usage:

• Examples for this Resource Profile: Observation/tumor-size-pathology and Observation/tumor-size-radiology

Formal Views of Profile Content

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

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

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions must-have-focus-or-specimen-invariant: Either `focus` OR `specimen` MUST be populated
code	S	1..1	CodeableConcept	Type of observation (code / type) 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://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 21889-1
display		1..1	string	Representation defined by the system Fixed Value: Size Tumor
subject	S	1..1	Reference(Patient)	The patient whose tumor was measured.
focus	S	0..1	Reference(Profile Tumor)	Identifies a tumor that has NOT been removed from the body
effective[x]	S	0..1	dateTime, Period, Timing, instant	Clinically relevant time/time-period for observation
method	S	0..1	CodeableConcept	Method for measuring the tumor Binding: ValueSet Tumor Measurement Methods (extensible)
specimen	S	0..1	Reference(Specimen)	Identifies a tumor that has been removed from the body
Slices for component	S	1..*	BackboneElement	Component results Slice: Unordered, Open by pattern:code
component:longestDimension		1..1	BackboneElement	Longest tumor dimension (mm)
code
Slices for coding		1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 33728-7
display		1..1	string	Representation defined by the system Fixed Value: Size.maximum dimension in Tumor
coding:snomed		0..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 371479009
display		1..1	string	Representation defined by the system Fixed Value: Tumor size, largest dimension
value[x]		0..1	Quantity	Actual component result Binding: ValueSet Tumor Size Units (required)
component:shortAxis		0..1	BackboneElement	short axis of the tumor lesion (mm or cm)
code
Slices for coding		1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 21889-1
display		1..1	string	Representation defined by the system Fixed Value: Size Tumor
coding:snomed		0..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 372299002
display		1..1	string	Representation defined by the system Fixed Value: Tumor size, dimension 1
value[x]		0..1	Quantity	Actual component result Binding: ValueSet Tumor Size Units (required)
component:area		0..1	BackboneElement	area of the tumor (mm²)
code
Slices for coding		1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 33729-5
display		1..1	string	Representation defined by the system Fixed Value: Area of the Tumor
coding:snomed		0..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 2372300005
display		1..1	string	Representation defined by the system Fixed Value: Tumor size, dimension 2
value[x]		0..1	Quantity	Actual component result Binding: ValueSet Tumor Size Units ValueSet (required)
component:volume		0..1	BackboneElement	tumor volume (ml)
code
Slices for coding		1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 33729-5
display		1..1	string	Representation defined by the system Fixed Value: Volume of the Tumor
coding:snomed		0..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 258261001
display		1..1	string	Representation defined by the system Fixed Value: Tumor volume
value[x]		0..1	Quantity	Actual component result Binding: ValueSet Tumor Size Units Value Set (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
Observation.method	extensible	VS_Tumor_Measurement_Methods
Observation.component:longestDimension.value[x]	required	VS_Tumor_Size_Units
Observation.component:shortAxis.value[x]	required	VS_Tumor_Size_Units
Observation.component:area.value[x]	required	VS_Tumor_Area_Units
Observation.component:volume.value[x]	required	VS_Tumor_Volume_Units

Constraints

Id	Grade	Path(s)	Details	Requirements
must-have-focus-or-specimen-invariant	error	Observation	Either `focus` OR `specimen` MUST be populated : (focus.exists() or specimen.exists()) and (focus.exists() and specimen.exists()).not()

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions must-have-focus-or-specimen-invariant: Either `focus` OR `specimen` MUST be populated
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
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
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 21889-1
display		1..1	string	Representation defined by the system Fixed Value: Size Tumor
subject	SΣ	1..1	Reference(Patient)	The patient whose tumor was measured.
focus	SΣ	0..1	Reference(Profile Tumor)	Identifies a tumor that has NOT been removed from the body
effective[x]	SΣ	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
method	S	0..1	CodeableConcept	Method for measuring the tumor Binding: ValueSet Tumor Measurement Methods (extensible)
specimen	S	0..1	Reference(Specimen)	Identifies a tumor that has been removed from the body
Slices for component	SΣ	1..*	BackboneElement	Component results Slice: Unordered, Open by pattern:code
component:All Slices				Content/Rules for all slices
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.
component:longestDimension	Σ	1..1	BackboneElement	Longest tumor dimension (mm)
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.
Slices for coding	Σ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 33728-7
display		1..1	string	Representation defined by the system Fixed Value: Size.maximum dimension in Tumor
coding:snomed	Σ	0..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 371479009
display		1..1	string	Representation defined by the system Fixed Value: Tumor size, largest dimension
value[x]	Σ	0..1	Quantity	Actual component result Binding: ValueSet Tumor Size Units (required)
component:shortAxis	Σ	0..1	BackboneElement	short axis of the tumor lesion (mm or cm)
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.
Slices for coding	Σ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 21889-1
display		1..1	string	Representation defined by the system Fixed Value: Size Tumor
coding:snomed	Σ	0..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 372299002
display		1..1	string	Representation defined by the system Fixed Value: Tumor size, dimension 1
value[x]	Σ	0..1	Quantity	Actual component result Binding: ValueSet Tumor Size Units (required)
component:area	Σ	0..1	BackboneElement	area of the tumor (mm²)
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.
Slices for coding	Σ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 33729-5
display		1..1	string	Representation defined by the system Fixed Value: Area of the Tumor
coding:snomed	Σ	0..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 2372300005
display		1..1	string	Representation defined by the system Fixed Value: Tumor size, dimension 2
value[x]	Σ	0..1	Quantity	Actual component result Binding: ValueSet Tumor Size Units ValueSet (required)
component:volume	Σ	0..1	BackboneElement	tumor volume (ml)
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.
Slices for coding	Σ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 33729-5
display		1..1	string	Representation defined by the system Fixed Value: Volume of the Tumor
coding:snomed	Σ	0..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 258261001
display		1..1	string	Representation defined by the system Fixed Value: Tumor volume
value[x]	Σ	0..1	Quantity	Actual component result Binding: ValueSet Tumor Size Units Value Set (required)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
Observation.status	required	ObservationStatus
Observation.code	example	Pattern: LOINC code 21889-1("Size Tumor")
Observation.method	extensible	VS_Tumor_Measurement_Methods
Observation.component.code	example	LOINCCodes (a valid code from LOINC)
Observation.component:longestDimension.code	example	LOINCCodes (a valid code from LOINC)
Observation.component:longestDimension.value[x]	required	VS_Tumor_Size_Units
Observation.component:shortAxis.code	example	LOINCCodes (a valid code from LOINC)
Observation.component:shortAxis.value[x]	required	VS_Tumor_Size_Units
Observation.component:area.code	example	LOINCCodes (a valid code from LOINC)
Observation.component:area.value[x]	required	VS_Tumor_Area_Units
Observation.component:volume.code	example	LOINCCodes (a valid code from LOINC)
Observation.component:volume.value[x]	required	VS_Tumor_Volume_Units

Constraints

Id	Grade	Path(s)	Details	Requirements
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()
must-have-focus-or-specimen-invariant	error	Observation	Either `focus` OR `specimen` MUST be populated : (focus.exists() or specimen.exists()) and (focus.exists() and specimen.exists()).not()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions must-have-focus-or-specimen-invariant: Either `focus` OR `specimen` MUST be populated
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
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business Identifier for observation
basedOn	Σ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Part of referenced event
status	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
category		0..*	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
code	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: 21889-1
display		1..1	string	Representation defined by the system Fixed Value: Size Tumor
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
subject	SΣ	1..1	Reference(Patient)	The patient whose tumor was measured.
focus	SΣ	0..1	Reference(Profile Tumor)	Identifies a tumor that has NOT been removed from the body
encounter	Σ	0..1	Reference(Encounter)	Healthcare event during which this observation is made
effective[x]	SΣ	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
issued	Σ	0..1	instant	Date/Time this version was made available
performer	Σ	0..*	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)	Who is responsible for the observation
value[x]	ΣC	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		0..*	Annotation	Comments about the observation
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method	S	0..1	CodeableConcept	Method for measuring the tumor Binding: ValueSet Tumor Measurement Methods (extensible)
specimen	S	0..1	Reference(Specimen)	Identifies a tumor that has been removed from the body
device		0..1	Reference(Device | DeviceMetric)	(Measurement) Device
referenceRange	C	0..*	BackboneElement	Provides guide for interpretation
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)	Related resource that belongs to the Observation group
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
Slices for component	SΣ	1..*	BackboneElement	Component results Slice: Unordered, Open by pattern:code
component:All Slices				Content/Rules for all slices
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
component:longestDimension	Σ	1..1	BackboneElement	Longest tumor dimension (mm)
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.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 33728-7
display		1..1	string	Representation defined by the system Fixed Value: Size.maximum dimension in Tumor
userSelected		0..1	boolean	If this coding was chosen directly by the user
coding:snomed	Σ	0..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 371479009
display		1..1	string	Representation defined by the system Fixed Value: Tumor size, largest dimension
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	Quantity	Actual component result Binding: ValueSet Tumor Size Units (required)
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
component:shortAxis	Σ	0..1	BackboneElement	short axis of the tumor lesion (mm or cm)
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.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 21889-1
display		1..1	string	Representation defined by the system Fixed Value: Size Tumor
userSelected		0..1	boolean	If this coding was chosen directly by the user
coding:snomed	Σ	0..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 372299002
display		1..1	string	Representation defined by the system Fixed Value: Tumor size, dimension 1
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	Quantity	Actual component result Binding: ValueSet Tumor Size Units (required)
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
component:area	Σ	0..1	BackboneElement	area of the tumor (mm²)
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.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 33729-5
display		1..1	string	Representation defined by the system Fixed Value: Area of the Tumor
userSelected		0..1	boolean	If this coding was chosen directly by the user
coding:snomed	Σ	0..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 2372300005
display		1..1	string	Representation defined by the system Fixed Value: Tumor size, dimension 2
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	Quantity	Actual component result Binding: ValueSet Tumor Size Units ValueSet (required)
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
component:volume	Σ	0..1	BackboneElement	tumor volume (ml)
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.
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
Slices for coding	Σ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 33729-5
display		1..1	string	Representation defined by the system Fixed Value: Volume of the Tumor
userSelected		0..1	boolean	If this coding was chosen directly by the user
coding:snomed	Σ	0..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 258261001
display		1..1	string	Representation defined by the system Fixed Value: Tumor volume
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept
value[x]	Σ	0..1	Quantity	Actual component result Binding: ValueSet Tumor Size Units Value Set (required)
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 / Code
Observation.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
Observation.status	required	ObservationStatus
Observation.category	preferred	ObservationCategoryCodes
Observation.code	example	Pattern: LOINC code 21889-1("Size Tumor")
Observation.dataAbsentReason	extensible	DataAbsentReason
Observation.interpretation	extensible	ObservationInterpretationCodes
Observation.bodySite	example	SNOMEDCTBodyStructures
Observation.method	extensible	VS_Tumor_Measurement_Methods
Observation.referenceRange.type	preferred	ObservationReferenceRangeMeaningCodes
Observation.referenceRange.appliesTo	example	ObservationReferenceRangeAppliesToCodes
Observation.component.code	example	LOINCCodes (a valid code from LOINC)
Observation.component.dataAbsentReason	extensible	DataAbsentReason
Observation.component.interpretation	extensible	ObservationInterpretationCodes
Observation.component:longestDimension.code	example	LOINCCodes (a valid code from LOINC)
Observation.component:longestDimension.value[x]	required	VS_Tumor_Size_Units
Observation.component:longestDimension.dataAbsentReason	extensible	DataAbsentReason
Observation.component:longestDimension.interpretation	extensible	ObservationInterpretationCodes
Observation.component:shortAxis.code	example	LOINCCodes (a valid code from LOINC)
Observation.component:shortAxis.value[x]	required	VS_Tumor_Size_Units
Observation.component:shortAxis.dataAbsentReason	extensible	DataAbsentReason
Observation.component:shortAxis.interpretation	extensible	ObservationInterpretationCodes
Observation.component:area.code	example	LOINCCodes (a valid code from LOINC)
Observation.component:area.value[x]	required	VS_Tumor_Area_Units
Observation.component:area.dataAbsentReason	extensible	DataAbsentReason
Observation.component:area.interpretation	extensible	ObservationInterpretationCodes
Observation.component:volume.code	example	LOINCCodes (a valid code from LOINC)
Observation.component:volume.value[x]	required	VS_Tumor_Volume_Units
Observation.component:volume.dataAbsentReason	extensible	DataAbsentReason
Observation.component:volume.interpretation	extensible	ObservationInterpretationCodes

Constraints

Id	Grade	Path(s)	Details	Requirements
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()
must-have-focus-or-specimen-invariant	error	Observation	Either `focus` OR `specimen` MUST be populated : (focus.exists() or specimen.exists()) and (focus.exists() and specimen.exists()).not()
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 Observation

Summary

Mandatory: 5 elements (6 nested mandatory elements)
Must-Support: 7 elements

Structures

This structure refers to these other structures:

• Profile Tumor (https://www.vision-zero-oncology.de/fhir/StructureDefinition/tumor)

Slices

This structure defines the following Slices:

• The element Observation.component is sliced based on the value of pattern:code
• The element Observation.component.code.coding is sliced based on the value of pattern:code

Differential View

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions must-have-focus-or-specimen-invariant: Either `focus` OR `specimen` MUST be populated
code	S	1..1	CodeableConcept	Type of observation (code / type) 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://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 21889-1
display		1..1	string	Representation defined by the system Fixed Value: Size Tumor
subject	S	1..1	Reference(Patient)	The patient whose tumor was measured.
focus	S	0..1	Reference(Profile Tumor)	Identifies a tumor that has NOT been removed from the body
effective[x]	S	0..1	dateTime, Period, Timing, instant	Clinically relevant time/time-period for observation
method	S	0..1	CodeableConcept	Method for measuring the tumor Binding: ValueSet Tumor Measurement Methods (extensible)
specimen	S	0..1	Reference(Specimen)	Identifies a tumor that has been removed from the body
Slices for component	S	1..*	BackboneElement	Component results Slice: Unordered, Open by pattern:code
component:longestDimension		1..1	BackboneElement	Longest tumor dimension (mm)
code
Slices for coding		1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 33728-7
display		1..1	string	Representation defined by the system Fixed Value: Size.maximum dimension in Tumor
coding:snomed		0..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 371479009
display		1..1	string	Representation defined by the system Fixed Value: Tumor size, largest dimension
value[x]		0..1	Quantity	Actual component result Binding: ValueSet Tumor Size Units (required)
component:shortAxis		0..1	BackboneElement	short axis of the tumor lesion (mm or cm)
code
Slices for coding		1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 21889-1
display		1..1	string	Representation defined by the system Fixed Value: Size Tumor
coding:snomed		0..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 372299002
display		1..1	string	Representation defined by the system Fixed Value: Tumor size, dimension 1
value[x]		0..1	Quantity	Actual component result Binding: ValueSet Tumor Size Units (required)
component:area		0..1	BackboneElement	area of the tumor (mm²)
code
Slices for coding		1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 33729-5
display		1..1	string	Representation defined by the system Fixed Value: Area of the Tumor
coding:snomed		0..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 2372300005
display		1..1	string	Representation defined by the system Fixed Value: Tumor size, dimension 2
value[x]		0..1	Quantity	Actual component result Binding: ValueSet Tumor Size Units ValueSet (required)
component:volume		0..1	BackboneElement	tumor volume (ml)
code
Slices for coding		1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 33729-5
display		1..1	string	Representation defined by the system Fixed Value: Volume of the Tumor
coding:snomed		0..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 258261001
display		1..1	string	Representation defined by the system Fixed Value: Tumor volume
value[x]		0..1	Quantity	Actual component result Binding: ValueSet Tumor Size Units Value Set (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
Observation.method	extensible	VS_Tumor_Measurement_Methods
Observation.component:longestDimension.value[x]	required	VS_Tumor_Size_Units
Observation.component:shortAxis.value[x]	required	VS_Tumor_Size_Units
Observation.component:area.value[x]	required	VS_Tumor_Area_Units
Observation.component:volume.value[x]	required	VS_Tumor_Volume_Units

Constraints

Id	Grade	Path(s)	Details	Requirements
must-have-focus-or-specimen-invariant	error	Observation	Either `focus` OR `specimen` MUST be populated : (focus.exists() or specimen.exists()) and (focus.exists() and specimen.exists()).not()

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Measurements and simple assertions must-have-focus-or-specimen-invariant: Either `focus` OR `specimen` MUST be populated
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
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
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 21889-1
display		1..1	string	Representation defined by the system Fixed Value: Size Tumor
subject	SΣ	1..1	Reference(Patient)	The patient whose tumor was measured.
focus	SΣ	0..1	Reference(Profile Tumor)	Identifies a tumor that has NOT been removed from the body
effective[x]	SΣ	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
method	S	0..1	CodeableConcept	Method for measuring the tumor Binding: ValueSet Tumor Measurement Methods (extensible)
specimen	S	0..1	Reference(Specimen)	Identifies a tumor that has been removed from the body
Slices for component	SΣ	1..*	BackboneElement	Component results Slice: Unordered, Open by pattern:code
component:All Slices				Content/Rules for all slices
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.
component:longestDimension	Σ	1..1	BackboneElement	Longest tumor dimension (mm)
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.
Slices for coding	Σ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 33728-7
display		1..1	string	Representation defined by the system Fixed Value: Size.maximum dimension in Tumor
coding:snomed	Σ	0..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 371479009
display		1..1	string	Representation defined by the system Fixed Value: Tumor size, largest dimension
value[x]	Σ	0..1	Quantity	Actual component result Binding: ValueSet Tumor Size Units (required)
component:shortAxis	Σ	0..1	BackboneElement	short axis of the tumor lesion (mm or cm)
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.
Slices for coding	Σ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 21889-1
display		1..1	string	Representation defined by the system Fixed Value: Size Tumor
coding:snomed	Σ	0..1	Coding	Code defined by a terminology system Required Pattern: At least the following
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: 372299002
display		1..1	string	Representation defined by the system Fixed Value: Tumor size, dimension 1
value[x]	Σ	0..1	Quantity	Actual component result Binding: ValueSet Tumor Size Units (required)
component:area	Σ	0..1	BackboneElement	area of the tumor (mm²)
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.
Slices for coding	Σ	1..*	Coding	Code defined by a terminology system Slice: Unordered, Open by pattern:code
coding:loinc	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 33729-5
display		1..1	string	Representation defined by the system Fixed Value: Area of the Tumor
coding:snomed	Σ	0..1	Coding	Code defined by a terminology system Required Pattern: At least the following