Usage

Tumor size is modeled as an Observation with components for one required primary dimension (for example, length) and up to two additional optional dimensions (for example, width and depth). Note that the Observation.value[x] is not used for the primary dimension, because secondary dimensions cannot be considered components of the length measurement. Instead, primary and secondary (e.g., length, width and depth) are all components of one tumor size measurement.

For staging and prognostic purposes, it is assumed that reported tumor measurements will include the longest dimension of the tumor. Therefore, this profile requires the longest dimension to be reported in Observation.component.value with Observation.component.code set to LOINC 33728-7 (“Size.maximum dimension in Tumor). To avoid confusion, it is not possible to represent tumor size with this profile without including a measurement of the tumor’s longest dimension.

Conformance

Observation resources associated with an in-scope patient with an Observation.code of LOINC 21889-1 (“Size Tumor”) MUST conform to this profile. Beyond this requirement, a producer of resources SHOULD ensure that any resource instance associated with an in-scope patient that would reasonably be expected to conform to this profile SHOULD be published in this form.

• 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
subject	S	1..1	Reference(Cancer Patient Profile)	The patient whose tumor was measured.
focus	S	0..1	Reference(Tumor Profile)	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
value[x]		0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Not used in this profile
method	S	0..1	CodeableConcept	Method for measuring the tumor Binding: Tumor Size Method Value Set (extensible)
specimen	S	0..1	Reference(Human Specimen Profile)	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:tumorLongestDimension	S	1..1	BackboneElement	Longest tumor dimension (cm or mm)
code	S	1..1	CodeableConcept	Type of component 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: 33728-7
value[x]	S	0..1	Quantity	Actual component result Slice: Unordered, Open by type:$this
valueQuantity		0..1	Quantity	Actual component result Binding: Tumor Size Units Value Set (required)
component:tumorOtherDimension	S	0..2	BackboneElement	2nd or 3rd tumor dimension (cm or mm)
code	S	1..1	CodeableConcept	Type of component observation (code / type) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 33729-5
value[x]	S	0..1	Quantity	Actual component result Slice: Unordered, Open by type:$this
valueQuantity		0..1	Quantity	Actual component result Binding: Tumor Size Units Value Set (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
Observation.method	extensible	TumorSizeMethodVS
Observation.component:tumorLongestDimension.valueQuantity	required	TumorSizeUnitsVS
Observation.component:tumorOtherDimension.valueQuantity	required	TumorSizeUnitsVS

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
subject	SΣ	1..1	Reference(Cancer Patient Profile)	The patient whose tumor was measured.
focus	SΣ	0..1	Reference(Tumor Profile)	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
value[x]	ΣC	0..1		Not used in this profile
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
method	S	0..1	CodeableConcept	Method for measuring the tumor Binding: Tumor Size Method Value Set (extensible)
specimen	S	0..1	Reference(Human Specimen Profile)	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:tumorLongestDimension	SΣ	1..1	BackboneElement	Longest tumor dimension (cm or mm)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣ	1..1	CodeableConcept	Type of component 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: 33728-7
Slices for value[x]	SΣ	0..1	Quantity	Actual component result Slice: Unordered, Closed by type:$this
value[x]:valueQuantity	Σ	0..1	Quantity	Actual component result Binding: Tumor Size Units Value Set (required)
component:tumorOtherDimension	SΣ	0..2	BackboneElement	2nd or 3rd tumor dimension (cm or mm)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 33729-5
Slices for value[x]	SΣ	0..1	Quantity	Actual component result Slice: Unordered, Closed by type:$this
value[x]:valueQuantity	Σ	0..1	Quantity	Actual component result Binding: 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
Observation.method	extensible	TumorSizeMethodVS
Observation.component.code	example	LOINCCodes (a valid code from LOINC)
Observation.component:tumorLongestDimension.code	example	Pattern: LOINC code 33728-7
Observation.component:tumorLongestDimension.value[x]:valueQuantity	required	TumorSizeUnitsVS
Observation.component:tumorOtherDimension.code	example	Pattern: LOINC code 33729-5
Observation.component:tumorOtherDimension.value[x]:valueQuantity	required	TumorSizeUnitsVS

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
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		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	SΣ	1..1	Reference(Cancer Patient Profile)	The patient whose tumor was measured.
focus	SΣ	0..1	Reference(Tumor Profile)	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		Not used in this profile
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: Tumor Size Method Value Set (extensible)
specimen	S	0..1	Reference(Human Specimen Profile)	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:tumorLongestDimension	SΣ	1..1	BackboneElement	Longest tumor dimension (cm or 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	SΣ	1..1	CodeableConcept	Type of component 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: 33728-7
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
Slices for value[x]	SΣ	0..1	Quantity	Actual component result Slice: Unordered, Closed by type:$this
value[x]:valueQuantity	Σ	0..1	Quantity	Actual component result Binding: Tumor Size Units Value Set (required)
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
component:tumorOtherDimension	SΣ	0..2	BackboneElement	2nd or 3rd tumor dimension (cm or mm)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 33729-5
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
Slices for value[x]	SΣ	0..1	Quantity	Actual component result Slice: Unordered, Closed by type:$this
value[x]:valueQuantity	Σ	0..1	Quantity	Actual component result Binding: 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
Observation.dataAbsentReason	extensible	DataAbsentReason
Observation.interpretation	extensible	ObservationInterpretationCodes
Observation.bodySite	example	SNOMEDCTBodyStructures
Observation.method	extensible	TumorSizeMethodVS
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:tumorLongestDimension.code	example	Pattern: LOINC code 33728-7
Observation.component:tumorLongestDimension.value[x]:valueQuantity	required	TumorSizeUnitsVS
Observation.component:tumorLongestDimension.dataAbsentReason	extensible	DataAbsentReason
Observation.component:tumorLongestDimension.interpretation	extensible	ObservationInterpretationCodes
Observation.component:tumorOtherDimension.code	example	Pattern: LOINC code 33729-5
Observation.component:tumorOtherDimension.value[x]:valueQuantity	required	TumorSizeUnitsVS
Observation.component:tumorOtherDimension.dataAbsentReason	extensible	DataAbsentReason
Observation.component:tumorOtherDimension.interpretation	extensible	ObservationInterpretationCodes

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
subject	S	1..1	Reference(Cancer Patient Profile)	The patient whose tumor was measured.
focus	S	0..1	Reference(Tumor Profile)	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
value[x]		0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Not used in this profile
method	S	0..1	CodeableConcept	Method for measuring the tumor Binding: Tumor Size Method Value Set (extensible)
specimen	S	0..1	Reference(Human Specimen Profile)	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:tumorLongestDimension	S	1..1	BackboneElement	Longest tumor dimension (cm or mm)
code	S	1..1	CodeableConcept	Type of component 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: 33728-7
value[x]	S	0..1	Quantity	Actual component result Slice: Unordered, Open by type:$this
valueQuantity		0..1	Quantity	Actual component result Binding: Tumor Size Units Value Set (required)
component:tumorOtherDimension	S	0..2	BackboneElement	2nd or 3rd tumor dimension (cm or mm)
code	S	1..1	CodeableConcept	Type of component observation (code / type) Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 33729-5
value[x]	S	0..1	Quantity	Actual component result Slice: Unordered, Open by type:$this
valueQuantity		0..1	Quantity	Actual component result Binding: Tumor Size Units Value Set (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
Observation.method	extensible	TumorSizeMethodVS
Observation.component:tumorLongestDimension.valueQuantity	required	TumorSizeUnitsVS
Observation.component:tumorOtherDimension.valueQuantity	required	TumorSizeUnitsVS

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
subject	SΣ	1..1	Reference(Cancer Patient Profile)	The patient whose tumor was measured.
focus	SΣ	0..1	Reference(Tumor Profile)	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
value[x]	ΣC	0..1		Not used in this profile
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
method	S	0..1	CodeableConcept	Method for measuring the tumor Binding: Tumor Size Method Value Set (extensible)
specimen	S	0..1	Reference(Human Specimen Profile)	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:tumorLongestDimension	SΣ	1..1	BackboneElement	Longest tumor dimension (cm or mm)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣ	1..1	CodeableConcept	Type of component 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: 33728-7
Slices for value[x]	SΣ	0..1	Quantity	Actual component result Slice: Unordered, Closed by type:$this
value[x]:valueQuantity	Σ	0..1	Quantity	Actual component result Binding: Tumor Size Units Value Set (required)
component:tumorOtherDimension	SΣ	0..2	BackboneElement	2nd or 3rd tumor dimension (cm or mm)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 33729-5
Slices for value[x]	SΣ	0..1	Quantity	Actual component result Slice: Unordered, Closed by type:$this
value[x]:valueQuantity	Σ	0..1	Quantity	Actual component result Binding: 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
Observation.method	extensible	TumorSizeMethodVS
Observation.component.code	example	LOINCCodes (a valid code from LOINC)
Observation.component:tumorLongestDimension.code	example	Pattern: LOINC code 33728-7
Observation.component:tumorLongestDimension.value[x]:valueQuantity	required	TumorSizeUnitsVS
Observation.component:tumorOtherDimension.code	example	Pattern: LOINC code 33729-5
Observation.component:tumorOtherDimension.value[x]:valueQuantity	required	TumorSizeUnitsVS

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()

Snapshot 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
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		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	SΣ	1..1	Reference(Cancer Patient Profile)	The patient whose tumor was measured.
focus	SΣ	0..1	Reference(Tumor Profile)	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		Not used in this profile
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: Tumor Size Method Value Set (extensible)
specimen	S	0..1	Reference(Human Specimen Profile)	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:tumorLongestDimension	SΣ	1..1	BackboneElement	Longest tumor dimension (cm or 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	SΣ	1..1	CodeableConcept	Type of component 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: 33728-7
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
Slices for value[x]	SΣ	0..1	Quantity	Actual component result Slice: Unordered, Closed by type:$this
value[x]:valueQuantity	Σ	0..1	Quantity	Actual component result Binding: Tumor Size Units Value Set (required)
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
component:tumorOtherDimension	SΣ	0..2	BackboneElement	2nd or 3rd tumor dimension (cm or mm)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	SΣ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 33729-5
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
Slices for value[x]	SΣ	0..1	Quantity	Actual component result Slice: Unordered, Closed by type:$this
value[x]:valueQuantity	Σ	0..1	Quantity	Actual component result Binding: 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
Observation.dataAbsentReason	extensible	DataAbsentReason
Observation.interpretation	extensible	ObservationInterpretationCodes
Observation.bodySite	example	SNOMEDCTBodyStructures
Observation.method	extensible	TumorSizeMethodVS
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:tumorLongestDimension.code	example	Pattern: LOINC code 33728-7
Observation.component:tumorLongestDimension.value[x]:valueQuantity	required	TumorSizeUnitsVS
Observation.component:tumorLongestDimension.dataAbsentReason	extensible	DataAbsentReason
Observation.component:tumorLongestDimension.interpretation	extensible	ObservationInterpretationCodes
Observation.component:tumorOtherDimension.code	example	Pattern: LOINC code 33729-5
Observation.component:tumorOtherDimension.value[x]:valueQuantity	required	TumorSizeUnitsVS
Observation.component:tumorOtherDimension.dataAbsentReason	extensible	DataAbsentReason
Observation.component:tumorOtherDimension.interpretation	extensible	ObservationInterpretationCodes

This structure is derived from Observation

Summary

Mandatory: 3 elements
Must-Support: 13 elements

Structures

This structure refers to these other structures:

• Cancer Patient Profile (http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-patient)
• Tumor Profile (http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-tumor)
• Human Specimen Profile (http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-human-specimen)

Slices

This structure defines the following Slices:

• The element Observation.component is sliced based on the value of pattern:code
• The element Observation.component.value[x] is sliced based on the value of type:$this

Maturity: 3