US Core Implementation Guide
7.0.0-ballot - Ballot United States of America flag

US Core Implementation Guide, published by HL7 International / Cross-Group Projects. This guide is not an authorized publication; it is the continuous build for version 7.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/US-Core/ and changes regularly. See the Directory of published versions

Resource Profile: US Core Observation Clinical Result Profile

Official URL: http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-clinical-result Version: 7.0.0-ballot
Standards status: Trial-use Maturity Level: 3 Computable Name: USCoreObservationClinicalResultProfile

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

The US Core Observation Clinical Result Profile is based upon the core FHIR Observation Resource and, along with the US Core DiagnosticReport Profile, meets the US Core Data for Interoperability (USCDI) requirements for Diagnostic Imaging and Clinical Tests Data Classes. This profile sets minimum expectations for the Observation resource to record and search non-laboratory clinical test results (e.g., radiology and other clinical observations generated from procedures). An example would be when a gastroenterologist reports the size of a polyp observed during a colonoscopy. This profile is the basis for the US Core Laboratory Result Observation Profile, which defines additional data elements to record and search laboratory test results.

The US Core Observation Clinical Result Profile sets minimum expectations to promote interoperability and adoption through common implementation. It 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 tests or diagnostic imaging results for a patient.
  • Record or update clinical tests or diagnostic imaging results belonging to a Patient

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 LOINC code, if available, which tells you what is being measured
  4. a patient

Each Observation Must Support:

  1. encounter associated with Observation
  2. a time indicating when the measurement was taken
  3. a result value
    • if the result value is a numeric quantity, a standard UCUM unit
  4. a reason why the data is absent*

* see guidance below

Profile Specific Implementation Guidance:

  • ServersSHOULD use the base FHIR Observation Category Codes. The Observation.category element provides an efficient way of restricting search on observations to a given context such as procedure, exam or laboratory 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.
  • Additional codes that translate or map to the Observation code or category codes are allowed. For example:
    • providing both a local code and LOINC code
    • providing a more specific code, a SNOMED CT concept, or a system-specific code.
  • Systems SHOULD support Observation.effectivePeriod to accurately represent procedure tests that are collected over a period of time .
  • *An Observation without a value, SHALL include a reason why the data is absent unless there are 1) component observations, or 2) reporting panel observations using Observation.hasMember.
    • For further guidance see the Observation Grouping section in FHIR Specification.
    • Systems that never provide an observation without a value are not required to support Observation.dataAbsentReason.
  • *An Observation.component without a value, SHALL include a reason why the data is absent.
    • Systems that never provide a component observation without a component value are not required to support Observation.component.dataAbsentReason.
  • See the General Guidance page for further guidance on using SNOMED and UCUM.
  • See the LOINC scale type to FHIR data type mapping for guidance on which Observation.value[x] data type to use based on the LOINC Type of Scale.

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 C0..*ObservationMeasurements 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
... status S1..1coderegistered | preliminary | final | amended +
... Slices for category S1..*CodeableConceptClassification of type of observation
Slice: Unordered, Open by pattern:$this
.... category:us-core S0..*CodeableConceptClassification of type of observation
Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets

... code S1..1CodeableConceptClinical Test or Procedure Name
Binding: LOINCCodes (extensible)
... subject S1..1Reference(US Core Patient Profile S | Group | Device | US Core Location Profile)Who and/or what the observation is about
... encounter S0..1Reference(US Core Encounter Profile)Encounter associated with Observation
... effective[x] SC0..1Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTimedateTime S
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... value[x] SC0..1Result Value
us-core-3: SHALL use UCUM for coded quantity units.
.... valueQuantityQuantity S
.... valueCodeableConceptCodeableConcept S
.... valueStringstring S
.... valueBooleanboolean
.... valueIntegerinteger
.... valueRangeRange
.... valueRatioRatio
.... valueSampledDataSampledData
.... valueTimetime
.... valueDateTimedateTime
.... valuePeriodPeriod
... dataAbsentReason SC0..1CodeableConceptWhy the result is missing

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
Observation.category:us-corerequiredUSCoreClinicalResultObservationCategory
Observation.codeextensibleLOINCCodes (a valid code from LOINC)

Constraints

IdGradePath(s)DetailsRequirements
us-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is dateTime implies $this.toString().length() >= 10
us-core-2errorObservationIf 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-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationMeasurements 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
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... status ?!SΣ1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

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


.... category:us-core S0..*CodeableConceptClassification of type of observation
Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets


... code SΣ1..1CodeableConceptClinical Test or Procedure Name
Binding: LOINCCodes (extensible)
... subject SΣ1..1Reference(US Core Patient Profile)Who and/or what the observation is about
... encounter SΣ0..1Reference(US Core Encounter Profile)Encounter associated with Observation
... effective[x] SΣC0..1Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTimedateTime
... value[x] SΣC0..1Result Value
us-core-3: SHALL use UCUM for coded quantity units.
.... valueQuantityQuantity
.... valueCodeableConceptCodeableConcept
.... valueStringstring
... dataAbsentReason SC0..1CodeableConceptWhy the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Observation.statusrequiredObservationStatus
Observation.categorypreferredObservationCategoryCodes
Observation.category:us-corerequiredUSCoreClinicalResultObservationCategory
Observation.codeextensibleLOINCCodes (a valid code from LOINC)
Observation.dataAbsentReasonextensibleDataAbsentReason

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()
us-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is dateTime implies $this.toString().length() >= 10
us-core-2errorObservationIf 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-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationMeasurements 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
... 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..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

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


.... category:us-core S0..*CodeableConceptClassification of type of observation
Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets


... code SΣ1..1CodeableConceptClinical Test or Procedure Name
Binding: LOINCCodes (extensible)
... subject SΣ1..1Reference(US Core Patient Profile S | Group | Device | US Core Location Profile)Who and/or what the observation is about
... focus Σ0..*Reference(Resource)What the observation is about, when it is not about the subject of record
... encounter SΣ0..1Reference(US Core Encounter Profile)Encounter associated with Observation
... effective[x] SΣC0..1Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTimedateTime S
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... issued Σ0..1instantDate/Time this version was made available
... performer Σ0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)Who is responsible for the observation
... value[x] SΣC0..1Result Value
us-core-3: SHALL use UCUM for coded quantity units.
.... valueQuantityQuantity S
.... valueCodeableConceptCodeableConcept S
.... valueStringstring S
.... valueBooleanboolean
.... valueIntegerinteger
.... valueRangeRange
.... valueRatioRatio
.... valueSampledDataSampledData
.... valueTimetime
.... valueDateTimedateTime
.... valuePeriodPeriod
... dataAbsentReason SC0..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(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)Related measurements 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-corerequiredUSCoreClinicalResultObservationCategory
Observation.codeextensibleLOINCCodes (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
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-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.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()
us-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is dateTime implies $this.toString().length() >= 10
us-core-2errorObservationIf 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-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'

This structure is derived from Observation

Summary

Mandatory: 2 elements
Must-Support: 9 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

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

Maturity: 3

Differential View

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationMeasurements 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
... status S1..1coderegistered | preliminary | final | amended +
... Slices for category S1..*CodeableConceptClassification of type of observation
Slice: Unordered, Open by pattern:$this
.... category:us-core S0..*CodeableConceptClassification of type of observation
Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets

... code S1..1CodeableConceptClinical Test or Procedure Name
Binding: LOINCCodes (extensible)
... subject S1..1Reference(US Core Patient Profile S | Group | Device | US Core Location Profile)Who and/or what the observation is about
... encounter S0..1Reference(US Core Encounter Profile)Encounter associated with Observation
... effective[x] SC0..1Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTimedateTime S
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... value[x] SC0..1Result Value
us-core-3: SHALL use UCUM for coded quantity units.
.... valueQuantityQuantity S
.... valueCodeableConceptCodeableConcept S
.... valueStringstring S
.... valueBooleanboolean
.... valueIntegerinteger
.... valueRangeRange
.... valueRatioRatio
.... valueSampledDataSampledData
.... valueTimetime
.... valueDateTimedateTime
.... valuePeriodPeriod
... dataAbsentReason SC0..1CodeableConceptWhy the result is missing

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
Observation.category:us-corerequiredUSCoreClinicalResultObservationCategory
Observation.codeextensibleLOINCCodes (a valid code from LOINC)

Constraints

IdGradePath(s)DetailsRequirements
us-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is dateTime implies $this.toString().length() >= 10
us-core-2errorObservationIf 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-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'

Key Elements View

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

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


.... category:us-core S0..*CodeableConceptClassification of type of observation
Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets


... code SΣ1..1CodeableConceptClinical Test or Procedure Name
Binding: LOINCCodes (extensible)
... subject SΣ1..1Reference(US Core Patient Profile)Who and/or what the observation is about
... encounter SΣ0..1Reference(US Core Encounter Profile)Encounter associated with Observation
... effective[x] SΣC0..1Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTimedateTime
... value[x] SΣC0..1Result Value
us-core-3: SHALL use UCUM for coded quantity units.
.... valueQuantityQuantity
.... valueCodeableConceptCodeableConcept
.... valueStringstring
... dataAbsentReason SC0..1CodeableConceptWhy the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.


doco Documentation for this format

Terminology Bindings

PathConformanceValueSet
Observation.statusrequiredObservationStatus
Observation.categorypreferredObservationCategoryCodes
Observation.category:us-corerequiredUSCoreClinicalResultObservationCategory
Observation.codeextensibleLOINCCodes (a valid code from LOINC)
Observation.dataAbsentReasonextensibleDataAbsentReason

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()
us-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is dateTime implies $this.toString().length() >= 10
us-core-2errorObservationIf 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-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C0..*ObservationMeasurements 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
... 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..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

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


.... category:us-core S0..*CodeableConceptClassification of type of observation
Binding: US Core Clinical Result Observation Category (required): Note that other codes are permitted, see Required Bindings When Slicing by Value Sets


... code SΣ1..1CodeableConceptClinical Test or Procedure Name
Binding: LOINCCodes (extensible)
... subject SΣ1..1Reference(US Core Patient Profile S | Group | Device | US Core Location Profile)Who and/or what the observation is about
... focus Σ0..*Reference(Resource)What the observation is about, when it is not about the subject of record
... encounter SΣ0..1Reference(US Core Encounter Profile)Encounter associated with Observation
... effective[x] SΣC0..1Clinically relevant time/time-period for observation
us-core-1: Datetime must be at least to day.
.... effectiveDateTimedateTime S
.... effectivePeriodPeriod
.... effectiveTimingTiming
.... effectiveInstantinstant
... issued Σ0..1instantDate/Time this version was made available
... performer Σ0..*Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson)Who is responsible for the observation
... value[x] SΣC0..1Result Value
us-core-3: SHALL use UCUM for coded quantity units.
.... valueQuantityQuantity S
.... valueCodeableConceptCodeableConcept S
.... valueStringstring S
.... valueBooleanboolean
.... valueIntegerinteger
.... valueRangeRange
.... valueRatioRatio
.... valueSampledDataSampledData
.... valueTimetime
.... valueDateTimedateTime
.... valuePeriodPeriod
... dataAbsentReason SC0..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(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)Related measurements 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-corerequiredUSCoreClinicalResultObservationCategory
Observation.codeextensibleLOINCCodes (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
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-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.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()
us-core-1errorObservation.effective[x]Datetime must be at least to day.
: $this is dateTime implies $this.toString().length() >= 10
us-core-2errorObservationIf 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-3errorObservation.value[x]SHALL use UCUM for coded quantity units.
: ofType(Quantity).system.empty() or ofType(Quantity).system = 'http://unitsofmeasure.org'

This structure is derived from Observation

Summary

Mandatory: 2 elements
Must-Support: 9 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

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

Maturity: 3

 

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.
  • 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.

US Core Scopes

Servers providing access to clinical results data SHALL support these US Core SMART Scopes:

  • resource level scopes: patient/Observation.rs
  • granular scopes: patient.Observation.rs?category=http://terminology.hl7.org/CodeSystem/observation-category|imaging and patient.Observation.rs?category=http://terminology.hl7.org/CodeSystem/observation-category|procedure and patient.Observation.rs?category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory.

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={http://terminology.hl7.org/CodeSystem/observation-category|}procedure

    Example:

    1. GET [base]/Observation?patient=1134281&category=http://terminology.hl7.org/CodeSystem/observation-category|procedure

    Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and a category code = procedure (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|44974-4
    2. GET [base]/Observation?patient=1134281&code=http://loinc.org|44974-4,http://loinc.org|44963-7,http://loinc.org|8601-7

    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={http://terminology.hl7.org/CodeSystem/observation-category|}procedure&date={gt|lt|ge|le}[date]{&date={gt|lt|ge|le}[date]&...}

    Example:

    1. GET [base]Observation?patient=555580&category=http://terminology.hl7.org/CodeSystem/observation-category|procedure&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 = procedure (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={http://terminology.hl7.org/CodeSystem/observation-category|}procedure&status={system|}[code]{,{system|}[code],...}

    Example:

    1. GET [base]/Observation?patient=1134281&category=http://terminology.hl7.org/CodeSystem/observation-category|procedure&status=final

    Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and category = procedure 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|44974-4&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)