Usage

A tumor marker is a substance found in tissue or blood or other body fluids that may be a sign of cancer or certain benign (non-cancer) conditions. Most tumor markers are made by both normal cells and cancer cells, but they are made in larger amounts by cancer cells. A tumor marker may help to diagnose cancer, plan treatment, or find out how well treatment is working or if cancer has come back. Examples of tumor markers include CA-125 (in ovarian cancer), CA 15-3 (in breast cancer), CEA (in colon cancer), and PSA (in prostate cancer). Tumor markers differ from genomic markers in that they are measured at the levels of the protein and substance post-RNA protein synthesis. (Definition adapted from: NCI Dictionary of Cancer Terms and Cancer.Net).

Conformance

Observation resources associated with an [in-scope patient] with an Observation.code in the value set TumorMarkerTestVS SHALL 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, for example, when employing a code that extends the TumorMarkerTestVS value set. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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

This structure is derived from USCoreLaboratoryResultObservationProfile

Name	Flags	Card.	Type	Description & Constraints
Observation		0..*	USCoreLaboratoryResultObservationProfile	Measurements and simple assertions
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
relatedCondition	S	0..*	CodeableConcept, Reference(Condition)	Condition associated with this test. URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition
code		1..1	CodeableConcept	Laboratory Test Name Binding: Tumor Marker Test Value Set (extensible)
subject		1..1	Reference(Cancer Patient Profile)	Who and/or what the observation is about
effective[x]		0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
value[x]		1..1		Result Value
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueRatio			Ratio
specimen	S	0..1	Reference(Human Specimen Profile)	Specimen used for this observation
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
Observation.code	extensible	TumorMarkerTestVS

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	USCoreLaboratoryResultObservationProfile	Measurements and simple assertions
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
relatedCondition	S	0..*	CodeableConcept, Reference(Condition)	Condition associated with this test. URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!SΣ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required)
Slices for category	S	1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:Laboratory	S	1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. 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: laboratory
code	SΣ	1..1	CodeableConcept	Laboratory Test Name Binding: Tumor Marker Test Value Set (extensible)
subject	SΣ	1..1	Reference(Cancer Patient Profile)	Who and/or what the observation is about
effective[x]	SΣC	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
value[x]	SΣC	1..1		Result Value
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
dataAbsentReason	SC	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible)
specimen	S	0..1	Reference(Human Specimen Profile)	Specimen used for this observation
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
Observation.status	required	ObservationStatus
Observation.category	preferred	ObservationCategoryCodes
Observation.category:Laboratory	preferred	Pattern: laboratory
Observation.code	extensible	TumorMarkerTestVS
Observation.dataAbsentReason	extensible	DataAbsentReason

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	USCoreLaboratoryResultObservationProfile	Measurements and simple assertions
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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
relatedCondition	S	0..*	CodeableConcept, Reference(Condition)	Condition associated with this test. URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition
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	?!SΣ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required)
Slices for category	S	1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:Laboratory	S	1..1	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: laboratory
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
code	SΣ	1..1	CodeableConcept	Laboratory Test Name Binding: Tumor Marker Test Value Set (extensible)
subject	SΣ	1..1	Reference(Cancer Patient Profile)	Who and/or what the observation is about
focus	ΣTU	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
encounter	Σ	0..1	Reference(Encounter)	Healthcare event during which this observation is made
effective[x]	SΣC	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime S
effectivePeriod			Period
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]	SΣC	1..1		Result Value
valueQuantity			Quantity S
valueCodeableConcept			CodeableConcept S
valueString			string S
valueRatio			Ratio
dataAbsentReason	SC	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible)
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note		0..*	Annotation	Comments about the observation
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen	S	0..1	Reference(Human Specimen Profile)	Specimen used for this observation
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
component	Σ	0..*	BackboneElement	Component results
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x]	Σ	0..1		Actual component result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
Observation.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
Observation.status	required	ObservationStatus
Observation.category	preferred	ObservationCategoryCodes
Observation.category:Laboratory	preferred	Pattern: laboratory
Observation.code	extensible	TumorMarkerTestVS
Observation.dataAbsentReason	extensible	DataAbsentReason
Observation.interpretation	extensible	ObservationInterpretationCodes
Observation.bodySite	example	SNOMEDCTBodyStructures
Observation.method	example	ObservationMethods
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

Differential View

This structure is derived from USCoreLaboratoryResultObservationProfile

Name	Flags	Card.	Type	Description & Constraints
Observation		0..*	USCoreLaboratoryResultObservationProfile	Measurements and simple assertions
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
relatedCondition	S	0..*	CodeableConcept, Reference(Condition)	Condition associated with this test. URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition
code		1..1	CodeableConcept	Laboratory Test Name Binding: Tumor Marker Test Value Set (extensible)
subject		1..1	Reference(Cancer Patient Profile)	Who and/or what the observation is about
effective[x]		0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
value[x]		1..1		Result Value
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueRatio			Ratio
specimen	S	0..1	Reference(Human Specimen Profile)	Specimen used for this observation
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
Observation.code	extensible	TumorMarkerTestVS

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	USCoreLaboratoryResultObservationProfile	Measurements and simple assertions
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
relatedCondition	S	0..*	CodeableConcept, Reference(Condition)	Condition associated with this test. URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!SΣ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required)
Slices for category	S	1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:Laboratory	S	1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. 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: laboratory
code	SΣ	1..1	CodeableConcept	Laboratory Test Name Binding: Tumor Marker Test Value Set (extensible)
subject	SΣ	1..1	Reference(Cancer Patient Profile)	Who and/or what the observation is about
effective[x]	SΣC	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
value[x]	SΣC	1..1		Result Value
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
dataAbsentReason	SC	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible)
specimen	S	0..1	Reference(Human Specimen Profile)	Specimen used for this observation
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
Observation.status	required	ObservationStatus
Observation.category	preferred	ObservationCategoryCodes
Observation.category:Laboratory	preferred	Pattern: laboratory
Observation.code	extensible	TumorMarkerTestVS
Observation.dataAbsentReason	extensible	DataAbsentReason

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	USCoreLaboratoryResultObservationProfile	Measurements and simple assertions
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
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
relatedCondition	S	0..*	CodeableConcept, Reference(Condition)	Condition associated with this test. URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition
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	?!SΣ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required)
Slices for category	S	1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:Laboratory	S	1..1	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: laboratory
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
code	SΣ	1..1	CodeableConcept	Laboratory Test Name Binding: Tumor Marker Test Value Set (extensible)
subject	SΣ	1..1	Reference(Cancer Patient Profile)	Who and/or what the observation is about
focus	ΣTU	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
encounter	Σ	0..1	Reference(Encounter)	Healthcare event during which this observation is made
effective[x]	SΣC	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime S
effectivePeriod			Period
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]	SΣC	1..1		Result Value
valueQuantity			Quantity S
valueCodeableConcept			CodeableConcept S
valueString			string S
valueRatio			Ratio
dataAbsentReason	SC	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible)
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note		0..*	Annotation	Comments about the observation
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen	S	0..1	Reference(Human Specimen Profile)	Specimen used for this observation
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
component	Σ	0..*	BackboneElement	Component results
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: LOINCCodes (example): Codes identifying names of simple observations.
value[x]	Σ	0..1		Actual component result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc. Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
Observation.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
Observation.status	required	ObservationStatus
Observation.category	preferred	ObservationCategoryCodes
Observation.category:Laboratory	preferred	Pattern: laboratory
Observation.code	extensible	TumorMarkerTestVS
Observation.dataAbsentReason	extensible	DataAbsentReason
Observation.interpretation	extensible	ObservationInterpretationCodes
Observation.bodySite	example	SNOMEDCTBodyStructures
Observation.method	example	ObservationMethods
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

This structure is derived from USCoreLaboratoryResultObservationProfile

Summary

Mandatory: 1 element
Must-Support: 2 elements

Structures

This structure refers to these other structures:

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

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition

Maturity: 4