The US Core Clinical Test Observation Profile sets minimum expectations for the Observation resource to record, search, and fetch Observations where the Observation is neither a labortory, imaging, vital sign, social history, sexual orientation, survey, SDOH assesment, nor a smoking status observation. It identifies which core elements, extensions, vocabularies and value sets SHALL be present in the resource when using this profile. In addition to the requirements set forth in US Core profile this derived profile is designed to add requirements to the following elements:

• MCCCaregiverConsiderationsObservation.extension:resource-pertainsToGoal (Must Support) to encourage linking to the goal the medication hopes to facilitate and/or to encourage systems to be able to receive and understand a goal linkage if present.

MCC Value sets that may be used with this profile are found on the MCC Clinical Test Value Set library page. Other value sets are not precluded.

Comments are welcome with respect to the pragmatic use of the “Must Support” rules defined on these elements.

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

This structure is derived from USCoreObservationClinicalTestResultProfile

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	USCoreObservationClinicalTestResultProfile	Measurements and simple assertions us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
resource-pertainsToGoal	S	0..*	Reference(Goal)	The resource-pertainsToGoal relates the resource to the goal(s) that pertain to it. Whenever there is a goal associated with a health concern or problem, this extension should be present and populated in activity (event or intent) resources. URL: http://hl7.org/fhir/StructureDefinition/resource-pertainsToGoal
status	S	1..1	code	registered | preliminary | final | amended +
category	S	1..*	CodeableConcept	Classification of type of observation
code	S	1..1	CodeableConcept	Clinical Test Name
subject	S	1..1	Reference(US Core Patient Profile)	Who and/or what the observation is about
effective[x]	SC	0..1	dateTime S, Period, Timing, instant	Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day.
value[x]	SC	0..1	Quantity S, CodeableConcept S, string S, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Result Value us-core-3: SHALL use UCUM for coded quantity units.
dataAbsentReason	S	0..1	CodeableConcept	Why the result is missing
Documentation for this format

Constraints

Id	Grade	Path(s)	Details	Requirements
us-core-1	error	Observation.effective[x]	Datetime must be at least to day. : $this is DateTime implies $this.toString().length() >= 10
us-core-2	warning	Observation	If there is no component or hasMember element then either a value[x] or a data absent reason must be present : (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())
us-core-3	error	Observation.value[x]	SHALL use UCUM for coded quantity units. : valueQuantity.system.empty() or valueQuantity.system = 'http://unitsofmeasure.org'

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	USCoreObservationClinicalTestResultProfile	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
resource-pertainsToGoal	S	0..*	Reference(Goal)	The resource-pertainsToGoal relates the resource to the goal(s) that pertain to it. Whenever there is a goal associated with a health concern or problem, this extension should be present and populated in activity (event or intent) resources. URL: http://hl7.org/fhir/StructureDefinition/resource-pertainsToGoal
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!SΣ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
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:clinical-test	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://hl7.org/fhir/us/core/CodeSystem/us-core-observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: clinical-test
code	SΣ	1..1	CodeableConcept	Clinical Test Name Binding: US Core Clinical Test Codes (extensible)
subject	SΣ	1..1	Reference(US Core 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	0..1		Result Value
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
dataAbsentReason	SC	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
Observation.status	required	ObservationStatus
Observation.category	preferred	ObservationCategoryCodes
Observation.category:clinical-test	preferred	Pattern: clinical-test
Observation.code	extensible	USCoreClinicalTestCodes
Observation.dataAbsentReason	extensible	DataAbsentReason

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()
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()
us-core-1	error	Observation.effective[x]	Datetime must be at least to day. : $this is DateTime implies $this.toString().length() >= 10
us-core-2	error	Observation	If there is no component or hasMember element then either a value[x] or a data absent reason must be present : (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())
us-core-3	error	Observation.value[x]	SHALL use UCUM for coded quantity units. : valueQuantity.system.empty() or valueQuantity.system = 'http://unitsofmeasure.org'

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	USCoreObservationClinicalTestResultProfile	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
resource-pertainsToGoal	S	0..*	Reference(Goal)	The resource-pertainsToGoal relates the resource to the goal(s) that pertain to it. Whenever there is a goal associated with a health concern or problem, this extension should be present and populated in activity (event or intent) resources. URL: http://hl7.org/fhir/StructureDefinition/resource-pertainsToGoal
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): Codes providing the status of an observation.
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:clinical-test	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	id	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	id	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://hl7.org/fhir/us/core/CodeSystem/us-core-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: clinical-test
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	Clinical Test Name Binding: US Core Clinical Test Codes (extensible)
subject	SΣ	1..1	Reference(US Core 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
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]	SΣC	0..1		Result Value
valueQuantity			Quantity S
valueCodeableConcept			CodeableConcept S
valueString			string S
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
dataAbsentReason	SC	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		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen		0..1	Reference(Specimen)	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:clinical-test	preferred	Pattern: clinical-test
Observation.code	extensible	USCoreClinicalTestCodes
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

Constraints

Id	Grade	Path(s)	Details	Requirements
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()
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text : low.exists() or high.exists() or text.exists()
us-core-1	error	Observation.effective[x]	Datetime must be at least to day. : $this is DateTime implies $this.toString().length() >= 10
us-core-3	error	Observation.value[x]	SHALL use UCUM for coded quantity units. : valueQuantity.system.empty() or valueQuantity.system = 'http://unitsofmeasure.org'

Differential View

This structure is derived from USCoreObservationClinicalTestResultProfile

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	USCoreObservationClinicalTestResultProfile	Measurements and simple assertions us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
resource-pertainsToGoal	S	0..*	Reference(Goal)	The resource-pertainsToGoal relates the resource to the goal(s) that pertain to it. Whenever there is a goal associated with a health concern or problem, this extension should be present and populated in activity (event or intent) resources. URL: http://hl7.org/fhir/StructureDefinition/resource-pertainsToGoal
status	S	1..1	code	registered | preliminary | final | amended +
category	S	1..*	CodeableConcept	Classification of type of observation
code	S	1..1	CodeableConcept	Clinical Test Name
subject	S	1..1	Reference(US Core Patient Profile)	Who and/or what the observation is about
effective[x]	SC	0..1	dateTime S, Period, Timing, instant	Clinically relevant time/time-period for observation us-core-1: Datetime must be at least to day.
value[x]	SC	0..1	Quantity S, CodeableConcept S, string S, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Result Value us-core-3: SHALL use UCUM for coded quantity units.
dataAbsentReason	S	0..1	CodeableConcept	Why the result is missing
Documentation for this format

Constraints

Id	Grade	Path(s)	Details	Requirements
us-core-1	error	Observation.effective[x]	Datetime must be at least to day. : $this is DateTime implies $this.toString().length() >= 10
us-core-2	warning	Observation	If there is no component or hasMember element then either a value[x] or a data absent reason must be present : (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())
us-core-3	error	Observation.value[x]	SHALL use UCUM for coded quantity units. : valueQuantity.system.empty() or valueQuantity.system = 'http://unitsofmeasure.org'

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	USCoreObservationClinicalTestResultProfile	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
resource-pertainsToGoal	S	0..*	Reference(Goal)	The resource-pertainsToGoal relates the resource to the goal(s) that pertain to it. Whenever there is a goal associated with a health concern or problem, this extension should be present and populated in activity (event or intent) resources. URL: http://hl7.org/fhir/StructureDefinition/resource-pertainsToGoal
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
status	?!SΣ	1..1	code	registered | preliminary | final | amended + Binding: ObservationStatus (required): Codes providing the status of an observation.
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:clinical-test	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://hl7.org/fhir/us/core/CodeSystem/us-core-observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: clinical-test
code	SΣ	1..1	CodeableConcept	Clinical Test Name Binding: US Core Clinical Test Codes (extensible)
subject	SΣ	1..1	Reference(US Core 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	0..1		Result Value
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
dataAbsentReason	SC	0..1	CodeableConcept	Why the result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code
Observation.status	required	ObservationStatus
Observation.category	preferred	ObservationCategoryCodes
Observation.category:clinical-test	preferred	Pattern: clinical-test
Observation.code	extensible	USCoreClinicalTestCodes
Observation.dataAbsentReason	extensible	DataAbsentReason

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()
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()
us-core-1	error	Observation.effective[x]	Datetime must be at least to day. : $this is DateTime implies $this.toString().length() >= 10
us-core-2	error	Observation	If there is no component or hasMember element then either a value[x] or a data absent reason must be present : (component.empty() and hasMember.empty()) implies (dataAbsentReason.exists() or value.exists())
us-core-3	error	Observation.value[x]	SHALL use UCUM for coded quantity units. : valueQuantity.system.empty() or valueQuantity.system = 'http://unitsofmeasure.org'

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	USCoreObservationClinicalTestResultProfile	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
resource-pertainsToGoal	S	0..*	Reference(Goal)	The resource-pertainsToGoal relates the resource to the goal(s) that pertain to it. Whenever there is a goal associated with a health concern or problem, this extension should be present and populated in activity (event or intent) resources. URL: http://hl7.org/fhir/StructureDefinition/resource-pertainsToGoal
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): Codes providing the status of an observation.
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:clinical-test	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	id	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	id	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://hl7.org/fhir/us/core/CodeSystem/us-core-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: clinical-test
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	Clinical Test Name Binding: US Core Clinical Test Codes (extensible)
subject	SΣ	1..1	Reference(US Core 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
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]	SΣC	0..1		Result Value
valueQuantity			Quantity S
valueCodeableConcept			CodeableConcept S
valueString			string S
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
dataAbsentReason	SC	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		0..1	CodeableConcept	How it was done Binding: ObservationMethods (example): Methods for simple observations.
specimen		0..1	Reference(Specimen)	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:clinical-test	preferred	Pattern: clinical-test
Observation.code	extensible	USCoreClinicalTestCodes
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

Constraints

Id	Grade	Path(s)	Details	Requirements
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()
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text : low.exists() or high.exists() or text.exists()
us-core-1	error	Observation.effective[x]	Datetime must be at least to day. : $this is DateTime implies $this.toString().length() >= 10
us-core-3	error	Observation.value[x]	SHALL use UCUM for coded quantity units. : valueQuantity.system.empty() or valueQuantity.system = 'http://unitsofmeasure.org'

This structure is derived from USCoreObservationClinicalTestResultProfile

Summary

Mandatory: 1 element
Must-Support: 8 elements

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/StructureDefinition/resource-pertainsToGoal