US Core Implementation Guide
6.1.0 - STU6 United States of America flag

This page is part of the US Core (v6.1.0: STU6 Update) based on FHIR R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: US Core Simple Observation Profile

Official URL: http://hl7.org/fhir/us/core/StructureDefinition/us-core-simple-observation Version: 6.1.0
Active as of 2022-04-20 Computable Name: USCoreSimpleObservationProfile

Copyright/Legal: Used by permission of HL7 International, all rights reserved Creative Commons License

This US Core FHIR Profile is meant to capture any “simple” observations that are not otherwise covered by other US Core Observation profiles. It represents any type of observation that is not classified as vital signs, laboratory, imaging, or other more specific observation types. This profile promotes interoperability and adoption through common implementation by setting minimum expectations for the Observation resource to record, search, and retrieve observations such as a clinical observation or assertion about a patient’s health status or other general observations. This profile identifies which core elements, extensions, vocabularies, and value sets SHALL be present in the resource and constrains the way the elements are used when using this profile. It provides the floor for standards development for specific use cases.

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

Additional USCDI Requirements

For ONC’s USCDI requirements, each Observation Must Support the following additional element. This element is included in the formal definition of the profile and the Observation examples.

  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 ServiceRequest.reasonReference to reference an Observation, the referenced Observation SHOULD be a US Core Observation.

Usage:

Formal Views of Profile Content

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

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..*Observationassessment observation
... status S1..1code(USCDI) registered | preliminary | final | amended +
... Slices for category S1..*CodeableConcept(USCDI) Classification of type of observation
Slice: Unordered, Open by pattern:$this
.... category:us-core S0..*CodeableConcept(USCDI) 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 S1..1CodeableConcept(USCDI) Type of observation (code / type)
Binding: LOINCCodes (preferred)
... subject S1..1Reference(US Core Patient Profile)(USCDI) Who and/or what the observation is about
... effective[x] S0..1(USCDI) Clinically relevant time/time-period for observation
.... effectiveDateTimedateTime S
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... performer S0..*Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)(USCDI) Who is responsible for the observation
... value[x] S0..1(USCDI) Actual result
.... valueQuantityQuantity S
.... valueCodeableConceptCodeableConcept S
.... valueStringstring S
.... valueBooleanboolean S
.... valueIntegerinteger
.... valueRangeRange
.... valueRatioRatio
.... valueSampledDataSampledData
.... valueTimetime
.... valueDateTimedateTime
.... valuePeriodPeriod
... derivedFrom 0..*Reference(Observation | US Core DocumentReference Profile | US Core QuestionnaireResponse Profile | ImagingStudy | Media | MolecularSequence)(USCDI) US Core Profiles or other resource the observation is made from

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
Observation.category:us-corerequiredUSCoreSimpleObservationCategory
Observation.codepreferredLOINCCodes (a valid code from LOINC)
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*Observationassessment observation
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... status ?!SΣ1..1code(USCDI) registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category S1..*CodeableConcept(USCDI) Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


.... category:us-core S0..*CodeableConcept(USCDI) 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 SΣ1..1CodeableConcept(USCDI) Type of observation (code / type)
Binding: LOINCCodes (preferred)
... subject SΣ1..1Reference(US Core Patient Profile)(USCDI) Who and/or what the observation is about
... effective[x] SΣ0..1(USCDI) Clinically relevant time/time-period for observation
.... effectiveDateTimedateTime
... performer SΣ0..*Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)(USCDI) Who is responsible for the observation
... value[x] SΣC0..1(USCDI) Actual result
.... valueQuantityQuantity
.... valueCodeableConceptCodeableConcept
.... valueStringstring
.... valueBooleanboolean
... derivedFrom Σ0..*Reference(Observation | US Core DocumentReference Profile | US Core QuestionnaireResponse Profile | ImagingStudy | Media | MolecularSequence)(USCDI) US Core Profiles or other resource the observation is made from

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Observation.statusrequiredObservationStatus
Observation.categorypreferredObservationCategoryCodes
Observation.category:us-corerequiredUSCoreSimpleObservationCategory
Observation.codepreferredLOINCCodes (a valid code from LOINC)

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf 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-4errorObservationIf 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-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf 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()
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*Observationassessment observation
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness Identifier for observation
... basedOn Σ0..*Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)Fulfills plan, proposal or order
... partOf Σ0..*Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)Part of referenced event
... status ?!SΣ1..1code(USCDI) registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category S1..*CodeableConcept(USCDI) Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


.... category:us-core S0..*CodeableConcept(USCDI) 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 SΣ1..1CodeableConcept(USCDI) Type of observation (code / type)
Binding: LOINCCodes (preferred)
... subject SΣ1..1Reference(US Core Patient Profile)(USCDI) Who and/or what the observation is about
... focus ΣTU0..*Reference(Resource)What the observation is about, when it is not about the subject of record
... encounter Σ0..1Reference(Encounter)Healthcare event during which this observation is made
... effective[x] SΣ0..1(USCDI) Clinically relevant time/time-period for observation
.... effectiveDateTimedateTime S
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... issued Σ0..1instantDate/Time this version was made available
... performer SΣ0..*Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)(USCDI) Who is responsible for the observation
... value[x] SΣC0..1(USCDI) Actual result
.... valueQuantityQuantity S
.... valueCodeableConceptCodeableConcept S
.... valueStringstring S
.... valueBooleanboolean S
.... valueIntegerinteger
.... valueRangeRange
.... valueRatioRatio
.... valueSampledDataSampledData
.... valueTimetime
.... valueDateTimedateTime
.... valuePeriodPeriod
... dataAbsentReason C0..1CodeableConceptWhy the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


... note 0..*AnnotationComments about the observation
... bodySite 0..1CodeableConceptObserved body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

... method 0..1CodeableConceptHow it was done
Binding: ObservationMethods (example): Methods for simple observations.

... specimen 0..1Reference(Specimen)Specimen used for this observation
... device 0..1Reference(Device | DeviceMetric)(Measurement) Device
... referenceRange C0..*BackboneElementProvides guide for interpretation
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... low C0..1SimpleQuantityLow Range, if relevant
.... high C0..1SimpleQuantityHigh Range, if relevant
.... type 0..1CodeableConceptReference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.

.... appliesTo 0..*CodeableConceptReference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.


.... age 0..1RangeApplicable age range, if relevant
.... text 0..1stringText based reference range in an observation
... hasMember Σ0..*Reference(Observation | QuestionnaireResponse | MolecularSequence)Related resource that belongs to the Observation group
... derivedFrom Σ0..*Reference(Observation | US Core DocumentReference Profile | US Core QuestionnaireResponse Profile | ImagingStudy | Media | MolecularSequence)(USCDI) US Core Profiles or other resource the observation is made from
... component Σ0..*BackboneElementComponent results
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... value[x] Σ0..1Actual component result
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueBooleanboolean
..... valueIntegerinteger
..... valueRangeRange
..... valueRatioRatio
..... valueSampledDataSampledData
..... valueTimetime
..... valueDateTimedateTime
..... valuePeriodPeriod
.... dataAbsentReason C0..1CodeableConceptWhy the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

.... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


.... referenceRange 0..*See referenceRange (Observation)Provides guide for interpretation of component result

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Observation.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
Observation.statusrequiredObservationStatus
Observation.categorypreferredObservationCategoryCodes
Observation.category:us-corerequiredUSCoreSimpleObservationCategory
Observation.codepreferredLOINCCodes (a valid code from LOINC)
Observation.dataAbsentReasonextensibleDataAbsentReason
Observation.interpretationextensibleObservationInterpretationCodes
Observation.bodySiteexampleSNOMEDCTBodyStructures
Observation.methodexampleObservationMethods
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
Observation.component.dataAbsentReasonextensibleDataAbsentReason
Observation.component.interpretationextensibleObservationInterpretationCodes

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()

Differential View

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..*Observationassessment observation
... status S1..1code(USCDI) registered | preliminary | final | amended +
... Slices for category S1..*CodeableConcept(USCDI) Classification of type of observation
Slice: Unordered, Open by pattern:$this
.... category:us-core S0..*CodeableConcept(USCDI) 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 S1..1CodeableConcept(USCDI) Type of observation (code / type)
Binding: LOINCCodes (preferred)
... subject S1..1Reference(US Core Patient Profile)(USCDI) Who and/or what the observation is about
... effective[x] S0..1(USCDI) Clinically relevant time/time-period for observation
.... effectiveDateTimedateTime S
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... performer S0..*Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)(USCDI) Who is responsible for the observation
... value[x] S0..1(USCDI) Actual result
.... valueQuantityQuantity S
.... valueCodeableConceptCodeableConcept S
.... valueStringstring S
.... valueBooleanboolean S
.... valueIntegerinteger
.... valueRangeRange
.... valueRatioRatio
.... valueSampledDataSampledData
.... valueTimetime
.... valueDateTimedateTime
.... valuePeriodPeriod
... derivedFrom 0..*Reference(Observation | US Core DocumentReference Profile | US Core QuestionnaireResponse Profile | ImagingStudy | Media | MolecularSequence)(USCDI) US Core Profiles or other resource the observation is made from

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
Observation.category:us-corerequiredUSCoreSimpleObservationCategory
Observation.codepreferredLOINCCodes (a valid code from LOINC)

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*Observationassessment observation
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... status ?!SΣ1..1code(USCDI) registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category S1..*CodeableConcept(USCDI) Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


.... category:us-core S0..*CodeableConcept(USCDI) 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 SΣ1..1CodeableConcept(USCDI) Type of observation (code / type)
Binding: LOINCCodes (preferred)
... subject SΣ1..1Reference(US Core Patient Profile)(USCDI) Who and/or what the observation is about
... effective[x] SΣ0..1(USCDI) Clinically relevant time/time-period for observation
.... effectiveDateTimedateTime
... performer SΣ0..*Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)(USCDI) Who is responsible for the observation
... value[x] SΣC0..1(USCDI) Actual result
.... valueQuantityQuantity
.... valueCodeableConceptCodeableConcept
.... valueStringstring
.... valueBooleanboolean
... derivedFrom Σ0..*Reference(Observation | US Core DocumentReference Profile | US Core QuestionnaireResponse Profile | ImagingStudy | Media | MolecularSequence)(USCDI) US Core Profiles or other resource the observation is made from

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Observation.statusrequiredObservationStatus
Observation.categorypreferredObservationCategoryCodes
Observation.category:us-corerequiredUSCoreSimpleObservationCategory
Observation.codepreferredLOINCCodes (a valid code from LOINC)

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf 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-4errorObservationIf 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-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf 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

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*Observationassessment observation
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional content defined by implementations
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..*IdentifierBusiness Identifier for observation
... basedOn Σ0..*Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)Fulfills plan, proposal or order
... partOf Σ0..*Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)Part of referenced event
... status ?!SΣ1..1code(USCDI) registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... Slices for category S1..*CodeableConcept(USCDI) Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


.... category:us-core S0..*CodeableConcept(USCDI) 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 SΣ1..1CodeableConcept(USCDI) Type of observation (code / type)
Binding: LOINCCodes (preferred)
... subject SΣ1..1Reference(US Core Patient Profile)(USCDI) Who and/or what the observation is about
... focus ΣTU0..*Reference(Resource)What the observation is about, when it is not about the subject of record
... encounter Σ0..1Reference(Encounter)Healthcare event during which this observation is made
... effective[x] SΣ0..1(USCDI) Clinically relevant time/time-period for observation
.... effectiveDateTimedateTime S
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... issued Σ0..1instantDate/Time this version was made available
... performer SΣ0..*Reference(US Core Practitioner Profile | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile)(USCDI) Who is responsible for the observation
... value[x] SΣC0..1(USCDI) Actual result
.... valueQuantityQuantity S
.... valueCodeableConceptCodeableConcept S
.... valueStringstring S
.... valueBooleanboolean S
.... valueIntegerinteger
.... valueRangeRange
.... valueRatioRatio
.... valueSampledDataSampledData
.... valueTimetime
.... valueDateTimedateTime
.... valuePeriodPeriod
... dataAbsentReason C0..1CodeableConceptWhy the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


... note 0..*AnnotationComments about the observation
... bodySite 0..1CodeableConceptObserved body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

... method 0..1CodeableConceptHow it was done
Binding: ObservationMethods (example): Methods for simple observations.

... specimen 0..1Reference(Specimen)Specimen used for this observation
... device 0..1Reference(Device | DeviceMetric)(Measurement) Device
... referenceRange C0..*BackboneElementProvides guide for interpretation
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... low C0..1SimpleQuantityLow Range, if relevant
.... high C0..1SimpleQuantityHigh Range, if relevant
.... type 0..1CodeableConceptReference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.

.... appliesTo 0..*CodeableConceptReference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.


.... age 0..1RangeApplicable age range, if relevant
.... text 0..1stringText based reference range in an observation
... hasMember Σ0..*Reference(Observation | QuestionnaireResponse | MolecularSequence)Related resource that belongs to the Observation group
... derivedFrom Σ0..*Reference(Observation | US Core DocumentReference Profile | US Core QuestionnaireResponse Profile | ImagingStudy | Media | MolecularSequence)(USCDI) US Core Profiles or other resource the observation is made from
... component Σ0..*BackboneElementComponent results
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... code Σ1..1CodeableConceptType of component observation (code / type)
Binding: LOINCCodes (example): Codes identifying names of simple observations.

.... value[x] Σ0..1Actual component result
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueBooleanboolean
..... valueIntegerinteger
..... valueRangeRange
..... valueRatioRatio
..... valueSampledDataSampledData
..... valueTimetime
..... valueDateTimedateTime
..... valuePeriodPeriod
.... dataAbsentReason C0..1CodeableConceptWhy the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

.... interpretation 0..*CodeableConceptHigh, low, normal, etc.
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.


.... referenceRange 0..*See referenceRange (Observation)Provides guide for interpretation of component result

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Observation.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
Observation.statusrequiredObservationStatus
Observation.categorypreferredObservationCategoryCodes
Observation.category:us-corerequiredUSCoreSimpleObservationCategory
Observation.codepreferredLOINCCodes (a valid code from LOINC)
Observation.dataAbsentReasonextensibleDataAbsentReason
Observation.interpretationextensibleObservationInterpretationCodes
Observation.bodySiteexampleSNOMEDCTBodyStructures
Observation.methodexampleObservationMethods
Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
Observation.component.dataAbsentReasonextensibleDataAbsentReason
Observation.component.interpretationextensibleObservationInterpretationCodes

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()

 

Other representations of profile: CSV, Excel, Schematron

Notes:

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.

  • Servers providing access to observation data can use US Core SMART Scopes for:
  • 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)