Example Usage Scenarios:

The following are example usage scenarios for this profile:

• Query for clinical observations or assessments about a patient’s health status.
• Record or update clinical observations or assessments about a patient’s health status.

Mandatory and Must Support Data Elements

The following data elements must always be present (Mandatory definition) or must be supported if the data is present in the sending system (Must Support definition). They are presented below in a simple human-readable explanation. Profile specific guidance and examples are provided as well. The Formal Views below provides the formal summary, definitions, and terminology requirements.

Each Observation Must Have:

1. a status
2. a category code
3. a code
4. a patient

Each Observation Must Support:

1. a time indicating when the observation was made
2. who answered the questions
3. a value

1. references to an associated survey, assessment, or screening tool*

*see guidance below

Profile Specific Implementation Guidance:

• The codes can be from LOINC or SNOMED CT.
• The value for these types of observations may be:
  • a string
  • a code
  • a “qualifier” confirming or refuting a statement about findings in code. For example: code: Transport too expensive (SNOMED CT: 160695008)
    value: true

• The Observation.category element provides an efficient way of restricting search on observations to a given context such as sdoh, functional-status, or social history observations. Example searches are shown in the Quick Start section below. However, clients need to understand that data categorization is somewhat subjective. The categorization applied by the source may not align with the client’s expectations. Clients may find it more useful to use queries based on a specific code or set of codes or to perform additional client side filtering of query results.

• See the Screening and Assessments guidance page for how this profile can represent “clinical judgments”.
  • *Observations that are formally part of an assessment tool or surveySHOULD use the US Core Observation Screening Assessment Profile. However, an assertion or determination derived from screening and assessment tools and SHOULD reference them using Observation.derivedFrom.

• *As documented here, when using `Observation.derivedFrom’ to reference an Observation, the referenced Observation SHOULD be a US Core Observation.

  • Although none of the Observation.derivedFrom references are flagged as Must Support, the server SHALL support at least one of them.

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

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints
Observation		0..*	Observation	assessment observation
status	S	1..1	code	registered | preliminary | final | amended +
Slices for category	S	1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by pattern:$this
category:us-core	S	0..*	CodeableConcept	Classification of type of observation Binding: US Core Simple Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
code	S	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (preferred)
subject	S	1..1	Reference(US Core Patient Profile S | Group | Device | US Core Location Profile)	Who and/or what the observation is about
effective[x]	S	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime S
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
performer	S	0..*	Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)	Who is responsible for the observation
value[x]	S	0..1		Actual result
valueQuantity			Quantity S
valueCodeableConcept			CodeableConcept S
valueString			string S
valueBoolean			boolean S
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
derivedFrom		0..*	Reference(Observation | US Core DocumentReference Profile | US Core QuestionnaireResponse Profile | ImagingStudy | Media | MolecularSequence)	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: US Core Profiles or other resource the observation is made from
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
Observation.category:us-core	required	USCoreSimpleObservationCategory
Observation.code	preferred	LOINCCodes (a valid code from LOINC)

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	assessment observation
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
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:us-core	S	0..*	CodeableConcept	Classification of type of observation Binding: US Core Simple Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
code	SΣ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (preferred)
subject	SΣ	1..1	Reference(US Core Patient Profile)	Who and/or what the observation is about
effective[x]	SΣ	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
performer	SΣ	0..*	Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)	Who is responsible for the observation
value[x]	SΣC	0..1		Actual result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
derivedFrom	Σ	0..*	Reference(Observation | US Core DocumentReference Profile | US Core QuestionnaireResponse Profile | ImagingStudy | Media | MolecularSequence)	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: US Core Profiles or other resource the observation is made from
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Observation.status	required	ObservationStatus
Observation.category	preferred	ObservationCategoryCodes
Observation.category:us-core	required	USCoreSimpleObservationCategory
Observation.code	preferred	LOINCCodes (a valid code from LOINC)

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()

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	assessment observation
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	?!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:us-core	S	0..*	CodeableConcept	Classification of type of observation Binding: US Core Simple Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
code	SΣ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (preferred)
subject	SΣ	1..1	Reference(US Core Patient Profile S | Group | Device | US Core Location Profile)	Who and/or what the observation is about
focus	Σ	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]	SΣ	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	SΣ	0..*	Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)	Who is responsible for the observation
value[x]	SΣC	0..1		Actual result
valueQuantity			Quantity S
valueCodeableConcept			CodeableConcept S
valueString			string S
valueBoolean			boolean S
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		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(Observation | US Core DocumentReference Profile | US Core QuestionnaireResponse Profile | ImagingStudy | Media | MolecularSequence)	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: US Core Profiles or other resource 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
Observation.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
Observation.status	required	ObservationStatus
Observation.category	preferred	ObservationCategoryCodes
Observation.category:us-core	required	USCoreSimpleObservationCategory
Observation.code	preferred	LOINCCodes (a valid code from LOINC)
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
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-3	error	Observation.referenceRange	Must have at least a low or a high or text : low.exists() or high.exists() or text.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

Differential View

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints
Observation		0..*	Observation	assessment observation
status	S	1..1	code	registered | preliminary | final | amended +
Slices for category	S	1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by pattern:$this
category:us-core	S	0..*	CodeableConcept	Classification of type of observation Binding: US Core Simple Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
code	S	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (preferred)
subject	S	1..1	Reference(US Core Patient Profile S | Group | Device | US Core Location Profile)	Who and/or what the observation is about
effective[x]	S	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime S
effectivePeriod			Period
effectiveTiming			Timing
effectiveInstant			instant
performer	S	0..*	Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)	Who is responsible for the observation
value[x]	S	0..1		Actual result
valueQuantity			Quantity S
valueCodeableConcept			CodeableConcept S
valueString			string S
valueBoolean			boolean S
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
derivedFrom		0..*	Reference(Observation | US Core DocumentReference Profile | US Core QuestionnaireResponse Profile | ImagingStudy | Media | MolecularSequence)	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: US Core Profiles or other resource the observation is made from
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet
Observation.category:us-core	required	USCoreSimpleObservationCategory
Observation.code	preferred	LOINCCodes (a valid code from LOINC)

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	assessment observation
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
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:us-core	S	0..*	CodeableConcept	Classification of type of observation Binding: US Core Simple Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
code	SΣ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (preferred)
subject	SΣ	1..1	Reference(US Core Patient Profile)	Who and/or what the observation is about
effective[x]	SΣ	0..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
performer	SΣ	0..*	Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)	Who is responsible for the observation
value[x]	SΣC	0..1		Actual result
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
derivedFrom	Σ	0..*	Reference(Observation | US Core DocumentReference Profile | US Core QuestionnaireResponse Profile | ImagingStudy | Media | MolecularSequence)	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: US Core Profiles or other resource the observation is made from
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
Observation.status	required	ObservationStatus
Observation.category	preferred	ObservationCategoryCodes
Observation.category:us-core	required	USCoreSimpleObservationCategory
Observation.code	preferred	LOINCCodes (a valid code from LOINC)

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()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	assessment observation
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	?!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:us-core	S	0..*	CodeableConcept	Classification of type of observation Binding: US Core Simple Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets
code	SΣ	1..1	CodeableConcept	Type of observation (code / type) Binding: LOINCCodes (preferred)
subject	SΣ	1..1	Reference(US Core Patient Profile S | Group | Device | US Core Location Profile)	Who and/or what the observation is about
focus	Σ	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]	SΣ	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	SΣ	0..*	Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)	Who is responsible for the observation
value[x]	SΣC	0..1		Actual result
valueQuantity			Quantity S
valueCodeableConcept			CodeableConcept S
valueString			string S
valueBoolean			boolean S
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		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(Observation | US Core DocumentReference Profile | US Core QuestionnaireResponse Profile | ImagingStudy | Media | MolecularSequence)	𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: US Core Profiles or other resource 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
Observation.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding
Observation.status	required	ObservationStatus
Observation.category	preferred	ObservationCategoryCodes
Observation.category:us-core	required	USCoreSimpleObservationCategory
Observation.code	preferred	LOINCCodes (a valid code from LOINC)
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
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-3	error	Observation.referenceRange	Must have at least a low or a high or text : low.exists() or high.exists() or text.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()

This structure is derived from Observation

Summary

Mandatory: 2 elements
Must-Support: 8 elements

Structures

This structure refers to these other structures:

• US Core Patient Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient)
• US Core Location Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-location)
• US Core Practitioner Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-practitioner)
• US Core Organization Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-organization)
• US Core CareTeam Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-careteam)
• US Core RelatedPerson Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-relatedperson)
• US Core DocumentReference Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-documentreference)
• US Core QuestionnaireResponse Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-questionnaireresponse)

Slices

This structure defines the following Slices:

• The element Observation.category is sliced based on the value of pattern:$this

Maturity: 3

Quick Start

Below is an overview of the required Server RESTful FHIR interactions for this profile - for example, search and read operations - when supporting the US Core interactions to access this profile’s information (Profile Support + Interaction Support). Note that systems that support only US Core Profiles (Profile Only Support) are not required to support these interactions. See the US Core Server CapabilityStatement for a complete list of supported RESTful interactions for this IG.

• The syntax used to describe the interactions is described here.
• See the General Requirements section for additional rules and expectations when a server requires status parameters.
• See the General Guidance section for additional guidance on searching for multiple patients.

Mandatory Search Parameters:

The following search parameters and search parameter combinations SHALL be supported:

1. SHALL support searching using the combination of the patient and category search parameters:

   GET [base]/Observation?patient={Type/}[id]&category={system|}social-history

   Example:

   1. GET [base]/Observation?patient=1134281&category=social-history

   Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and a category code = social-history (how to search by reference and how to search by token)

2. SHALL support searching using the combination of the patient and code search parameters:
   • including optional support for OR search on code (e.g.code={system|}[code],{system|}[code],...)

   GET [base]/Observation?patient={Type/}[id]&code={system|}[code]{,{system|}[code],...}

   Example:

   1. GET [base]/Observation?patient=1134281&code=http://loinc.org|[code]

   Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and observation code(s). SHOULD support search by multiple report codes. The Observation code parameter searches `Observation.code only. (how to search by reference and how to search by token)

3. SHALL support searching using the combination of the patient and category and date search parameters:
   • including support for these date comparators: gt,lt,ge,le
   • including optional support for AND search on date (e.g.date=[date]&date=[date]]&...)

   GET [base]/Observation?patient={Type/}[id]&category={system|}social-history&date={gt|lt|ge|le}[date]{&date={gt|lt|ge|le}[date]&...}

   Example:

   1. GET [base]Observation?patient=555580&category=social-history&date=ge2018-03-14T00:00:00Z

   Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and date and a category code = social-history (how to search by reference and how to search by token and how to search by date)

Optional Search Parameters:

The following search parameter combinations SHOULD be supported:

1. SHOULD support searching using the combination of the patient and category and status search parameters:
   • including support for OR search on status (e.g.status={system|}[code],{system|}[code],...)

   GET [base]/Observation?patient={Type/}[id]&category={system|}social-history&status={system|}[code]{,{system|}[code],...}

   Example:

   1. GET [base]/Observation?patient=1134281&category=social-history&status=final

   Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and category = social-history and status (how to search by reference and how to search by token)

2. SHOULD support searching using the combination of the patient and code and date search parameters:
   • including optional support for OR search on code (e.g.code={system|}[code],{system|}[code],...)
   • including support for these date comparators: gt,lt,ge,le
   • including optional support for AND search on date (e.g.date=[date]&date=[date]]&...)

   GET [base]/Observation?patient={Type/}[id]&code={system|}[code]{,{system|}[code],...}&date={gt|lt|ge|le}[date]{&date={gt|lt|ge|le}[date]&...}

   Example:

   1. GET [base]Observation?patient=555580&code=http://loinc.org|[code]&date=ge2019-01-01T00:00:00Z

   Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and date and report code(s). SHOULD support search by multiple report codes. (how to search by reference and how to search by token and how to search by date)