US Core Implementation Guide
8.0.0-ballot - STU8 Ballot United States of America flag

This page is part of the US Core (v8.0.0-ballot: STU8 Ballot 1) based on FHIR (HL7® FHIR® Standard) R4. The current version which supersedes this version is 7.0.0. 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: 8.0.0-ballot
Standards status: Trial-use Maturity Level: 3 Computable Name: USCoreSimpleObservationProfile
Other Identifiers: OID:2.16.840.1.113883.4.642.40.2.42.61

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

The US Core Simple Observation Profile inherits from the FHIR Observation resource; refer to it for scope and usage definitions. This US Core FHIR Profile captures any "simple" observations not covered by other US Core Observation profiles. It represents any observation not classified as vital signs, laboratory, imaging, or other specific observation types. This profile sets minimum expectations for the Observation resource to record, search, and retrieve observations such as a clinical observation or assertion about patient health status or other general observations. It specifies which core elements, extensions, vocabularies, and value sets SHALL be present and constrains how the elements are used. Providing the floor for standards development for specific use cases promotes interoperability and adoption.

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 (in other words, a performer)*
  3. a value

Additional USCDI Requirements:

This Additional USCDI Requirements element is not Mandatory or Must Support but is required for ONC Health IT certification testing and is included in the formal definition of the profile and the Observation examples.

  1. a screening and assessments category code*
  2. 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

  • *At a minimum, Certifying Systems SHALL support, the US Core Screening Assessment Observation Category codes, SHOULD support the other US Core Simple Observation Category codes, and MAY support other categories.

    • 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.
  • *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.
  • *Although 'Observation.performer' target profiles US Core Practitioner Profile and US Core Patient Profile are labeled Must Support. Servers are not required to support both, but SHALL support at least one. Clients SHALL support both.</span>

  • 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 formally part of an assessment tool or survey SHOULD use the US Core Observation Screening Assessment Profile. However, an assertion or determination derived from screening and assessment tools SHOULD reference them using Observation.derivedFrom.
  • *Although 'Observation.performer' target profiles US Core Practitioner Profile and US Core Patient Profile are labeled Must Support. Servers are not required to support both, but SHALL support at least one. Clients SHALL support both.
  • *Although none of the Observation.derivedFrom referenced target profiles are flagged as Must Support, Certifying System SHALL support at least one of them. Client Applications SHALL support all.
    • As documented here, when using Observation.derivedFrom to reference an Observation, the referenced Observation SHOULD be a US Core Observation.

Usage:

Changes since version 7.0.0:

  • The data elements list has changed
  • One or more text definitions, invariants or bindings have changed

    • 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..* 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 value:$this
    .... category:us-core 0..* CodeableConcept 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: US Core 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

    Additional BindingsPurpose
    US Core Screening Assessment Observation Category Min Binding
    ... 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 S | US Core Patient Profile S | US Core Organization 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

    doco Documentation for this format

    Terminology Bindings (Differential)

    PathConformanceValueSetURI
    Observation.category:us-corerequiredUSCoreSimpleObservationCategory
    http://hl7.org/fhir/us/core/ValueSet/us-core-simple-observation-category
    from this IG
    Additional Bindings Purpose
    US Core Screening Assessment Observation Category Min Binding
    Observation.codepreferredLOINCCodes (a valid code from LOINC)
    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation C 0..* Observation assessment observation
    dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
    dom-3: 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
    dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
    dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
    dom-6: A resource should have narrative for robust management
    obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
    obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
    ... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
    ele-1: All FHIR elements must have a @value or children
    ... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
    ele-1: All FHIR elements must have a @value or children
    ext-1: Must have either extensions or value[x], not both
    ... status ?!SΣ 1..1 code registered | preliminary | final | amended +
    Binding: ObservationStatus (required): Codes providing the status of an observation.


    ele-1: All FHIR elements must have a @value or children
    ... Slices for category S 1..* CodeableConcept Classification of type of observation
    Slice: Unordered, Open by value:$this
    Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


    ele-1: All FHIR elements must have a @value or children
    .... category:us-core 0..* CodeableConcept 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: US Core 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

    Additional BindingsPurpose
    US Core Screening Assessment Observation Category Min Binding

    ele-1: All FHIR elements must have a @value or children
    ... code SΣ 1..1 CodeableConcept Type of observation (code / type)
    Binding: LOINCCodes (preferred)
    ele-1: All FHIR elements must have a @value or children
    ... subject SΣ 1..1 Reference(US Core Patient Profile) Who and/or what the observation is about
    ele-1: All FHIR elements must have a @value or children
    ... effective[x] SΣ 0..1 Clinically relevant time/time-period for observation
    ele-1: All FHIR elements must have a @value or children
    .... effectiveDateTime dateTime
    ... performer SΣ 0..* Reference(US Core Practitioner Profile | US Core Patient Profile) Who is responsible for the observation
    ele-1: All FHIR elements must have a @value or children
    ... value[x] SΣC 0..1 Actual result
    ele-1: All FHIR elements must have a @value or children
    .... 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
    ele-1: All FHIR elements must have a @value or children

    doco Documentation for this format

    Terminology Bindings

    PathConformanceValueSetURI
    Observation.statusrequiredObservationStatus
    http://hl7.org/fhir/ValueSet/observation-status|4.0.1
    from the FHIR Standard
    Observation.categorypreferredObservationCategoryCodes
    http://hl7.org/fhir/ValueSet/observation-category
    from the FHIR Standard
    Observation.category:us-corerequiredUSCoreSimpleObservationCategory
    http://hl7.org/fhir/us/core/ValueSet/us-core-simple-observation-category
    from this IG
    Additional Bindings Purpose
    US Core Screening Assessment Observation Category Min Binding
    Observation.codepreferredLOINCCodes (a valid code from LOINC)
    http://hl7.org/fhir/ValueSet/observation-codes
    from the FHIR Standard
    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation C 0..* Observation assessment observation
    obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
    obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
    ... 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 BindingsPurpose
    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 value:$this
    Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


    .... category:us-core 0..* CodeableConcept 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: US Core 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

    Additional BindingsPurpose
    US Core Screening Assessment Observation Category Min Binding

    ... 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 S | US Core Patient Profile S | US Core Organization 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
    obs-3: Must have at least a low or a high or text
    .... 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

    doco Documentation for this format

    Terminology Bindings

    PathConformanceValueSetURI
    Observation.languagepreferredCommonLanguages
    http://hl7.org/fhir/ValueSet/languages
    from the FHIR Standard
    Additional Bindings Purpose
    AllLanguages Max Binding
    Observation.statusrequiredObservationStatus
    http://hl7.org/fhir/ValueSet/observation-status|4.0.1
    from the FHIR Standard
    Observation.categorypreferredObservationCategoryCodes
    http://hl7.org/fhir/ValueSet/observation-category
    from the FHIR Standard
    Observation.category:us-corerequiredUSCoreSimpleObservationCategory
    http://hl7.org/fhir/us/core/ValueSet/us-core-simple-observation-category
    from this IG
    Additional Bindings Purpose
    US Core Screening Assessment Observation Category Min Binding
    Observation.codepreferredLOINCCodes (a valid code from LOINC)
    http://hl7.org/fhir/ValueSet/observation-codes
    from the FHIR Standard
    Observation.dataAbsentReasonextensibleDataAbsentReason
    http://hl7.org/fhir/ValueSet/data-absent-reason
    from the FHIR Standard
    Observation.interpretationextensibleObservationInterpretationCodes
    http://hl7.org/fhir/ValueSet/observation-interpretation
    from the FHIR Standard
    Observation.bodySiteexampleSNOMEDCTBodyStructures
    http://hl7.org/fhir/ValueSet/body-site
    from the FHIR Standard
    Observation.methodexampleObservationMethods
    http://hl7.org/fhir/ValueSet/observation-methods
    from the FHIR Standard
    Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
    http://hl7.org/fhir/ValueSet/referencerange-meaning
    from the FHIR Standard
    Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
    http://hl7.org/fhir/ValueSet/referencerange-appliesto
    from the FHIR Standard
    Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
    http://hl7.org/fhir/ValueSet/observation-codes
    from the FHIR Standard
    Observation.component.dataAbsentReasonextensibleDataAbsentReason
    http://hl7.org/fhir/ValueSet/data-absent-reason
    from the FHIR Standard
    Observation.component.interpretationextensibleObservationInterpretationCodes
    http://hl7.org/fhir/ValueSet/observation-interpretation
    from the FHIR Standard

    Differential View

    This structure is derived from Observation

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. 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 value:$this
    .... category:us-core 0..* CodeableConcept 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: US Core 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

    Additional BindingsPurpose
    US Core Screening Assessment Observation Category Min Binding
    ... 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 S | US Core Patient Profile S | US Core Organization 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

    doco Documentation for this format

    Terminology Bindings (Differential)

    PathConformanceValueSetURI
    Observation.category:us-corerequiredUSCoreSimpleObservationCategory
    http://hl7.org/fhir/us/core/ValueSet/us-core-simple-observation-category
    from this IG
    Additional Bindings Purpose
    US Core Screening Assessment Observation Category Min Binding
    Observation.codepreferredLOINCCodes (a valid code from LOINC)

    Key Elements View

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation C 0..* Observation assessment observation
    dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
    dom-3: 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
    dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
    dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
    dom-6: A resource should have narrative for robust management
    obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
    obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
    ... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
    ele-1: All FHIR elements must have a @value or children
    ... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
    ele-1: All FHIR elements must have a @value or children
    ext-1: Must have either extensions or value[x], not both
    ... status ?!SΣ 1..1 code registered | preliminary | final | amended +
    Binding: ObservationStatus (required): Codes providing the status of an observation.


    ele-1: All FHIR elements must have a @value or children
    ... Slices for category S 1..* CodeableConcept Classification of type of observation
    Slice: Unordered, Open by value:$this
    Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


    ele-1: All FHIR elements must have a @value or children
    .... category:us-core 0..* CodeableConcept 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: US Core 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

    Additional BindingsPurpose
    US Core Screening Assessment Observation Category Min Binding

    ele-1: All FHIR elements must have a @value or children
    ... code SΣ 1..1 CodeableConcept Type of observation (code / type)
    Binding: LOINCCodes (preferred)
    ele-1: All FHIR elements must have a @value or children
    ... subject SΣ 1..1 Reference(US Core Patient Profile) Who and/or what the observation is about
    ele-1: All FHIR elements must have a @value or children
    ... effective[x] SΣ 0..1 Clinically relevant time/time-period for observation
    ele-1: All FHIR elements must have a @value or children
    .... effectiveDateTime dateTime
    ... performer SΣ 0..* Reference(US Core Practitioner Profile | US Core Patient Profile) Who is responsible for the observation
    ele-1: All FHIR elements must have a @value or children
    ... value[x] SΣC 0..1 Actual result
    ele-1: All FHIR elements must have a @value or children
    .... 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
    ele-1: All FHIR elements must have a @value or children

    doco Documentation for this format

    Terminology Bindings

    PathConformanceValueSetURI
    Observation.statusrequiredObservationStatus
    http://hl7.org/fhir/ValueSet/observation-status|4.0.1
    from the FHIR Standard
    Observation.categorypreferredObservationCategoryCodes
    http://hl7.org/fhir/ValueSet/observation-category
    from the FHIR Standard
    Observation.category:us-corerequiredUSCoreSimpleObservationCategory
    http://hl7.org/fhir/us/core/ValueSet/us-core-simple-observation-category
    from this IG
    Additional Bindings Purpose
    US Core Screening Assessment Observation Category Min Binding
    Observation.codepreferredLOINCCodes (a valid code from LOINC)
    http://hl7.org/fhir/ValueSet/observation-codes
    from the FHIR Standard

    Snapshot View

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation C 0..* Observation assessment observation
    obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
    obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
    ... 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 BindingsPurpose
    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 value:$this
    Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


    .... category:us-core 0..* CodeableConcept 𝗔𝗗𝗗𝗜𝗧𝗜𝗢𝗡𝗔𝗟 𝗨𝗦𝗖𝗗𝗜: US Core 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

    Additional BindingsPurpose
    US Core Screening Assessment Observation Category Min Binding

    ... 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 S | US Core Patient Profile S | US Core Organization 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
    obs-3: Must have at least a low or a high or text
    .... 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

    doco Documentation for this format

    Terminology Bindings

    PathConformanceValueSetURI
    Observation.languagepreferredCommonLanguages
    http://hl7.org/fhir/ValueSet/languages
    from the FHIR Standard
    Additional Bindings Purpose
    AllLanguages Max Binding
    Observation.statusrequiredObservationStatus
    http://hl7.org/fhir/ValueSet/observation-status|4.0.1
    from the FHIR Standard
    Observation.categorypreferredObservationCategoryCodes
    http://hl7.org/fhir/ValueSet/observation-category
    from the FHIR Standard
    Observation.category:us-corerequiredUSCoreSimpleObservationCategory
    http://hl7.org/fhir/us/core/ValueSet/us-core-simple-observation-category
    from this IG
    Additional Bindings Purpose
    US Core Screening Assessment Observation Category Min Binding
    Observation.codepreferredLOINCCodes (a valid code from LOINC)
    http://hl7.org/fhir/ValueSet/observation-codes
    from the FHIR Standard
    Observation.dataAbsentReasonextensibleDataAbsentReason
    http://hl7.org/fhir/ValueSet/data-absent-reason
    from the FHIR Standard
    Observation.interpretationextensibleObservationInterpretationCodes
    http://hl7.org/fhir/ValueSet/observation-interpretation
    from the FHIR Standard
    Observation.bodySiteexampleSNOMEDCTBodyStructures
    http://hl7.org/fhir/ValueSet/body-site
    from the FHIR Standard
    Observation.methodexampleObservationMethods
    http://hl7.org/fhir/ValueSet/observation-methods
    from the FHIR Standard
    Observation.referenceRange.typepreferredObservationReferenceRangeMeaningCodes
    http://hl7.org/fhir/ValueSet/referencerange-meaning
    from the FHIR Standard
    Observation.referenceRange.appliesToexampleObservationReferenceRangeAppliesToCodes
    http://hl7.org/fhir/ValueSet/referencerange-appliesto
    from the FHIR Standard
    Observation.component.codeexampleLOINCCodes (a valid code from LOINC)
    http://hl7.org/fhir/ValueSet/observation-codes
    from the FHIR Standard
    Observation.component.dataAbsentReasonextensibleDataAbsentReason
    http://hl7.org/fhir/ValueSet/data-absent-reason
    from the FHIR Standard
    Observation.component.interpretationextensibleObservationInterpretationCodes
    http://hl7.org/fhir/ValueSet/observation-interpretation
    from the FHIR Standard

     

    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.

    • See the Scopes Format section for a description of the SMART scopes syntax.
    • See the Search Syntax section for a description of the US Core search syntax.
    • 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 assessment data SHALL support these US Core SMART Scopes:

    • resource level scopes: <patient|user|system>/Observation.rs

    • granular scopes: <patient|user|system>/Observation.rs?category=http://hl7.org/fhir/us/core/CodeSystem/us-core-category|sdoh

    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|laboratory

      Example:

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

      Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and a category code = laboratory (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&amp;code=http://loinc.org|

      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|laboratory&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 = laboratory (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|laboratory&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 = laboratory and status (how to search by reference and how to search by token)

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

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

      Example:

      1. GET [base]Observation?patient=555580&social-history&_lastUpdated=ge2024-01-01T00:00:00Z

      Implementation Notes: Fetches a bundle of all Observation resources for the specified patient and category and _lastUpdated. See the US Core General Guidance page for Searching Using lastUpdated. (how to search by reference and how to search by token and how to search by date)

    3. 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|&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)