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 Observation Clinical Result Profile

Official URL: http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-clinical-result Version: 8.0.0-ballot
Standards status: Trial-use Maturity Level: 3 Computable Name: USCoreObservationClinicalResultProfile
Other Identifiers: OID:2.16.840.1.113883.4.642.40.2.42.41

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 performer*
  4. a result value
    • if the result value is a numeric quantity, a standard UCUM unit
  5. a reason why the data is absent*

* see guidance below

Profile Specific Implementation Guidance:

  • See the US Core Laboratory Result Observation Profile to represent laboratory test results.
  • <!– include parameters: category (optional) example1 (optional) example2 (optional) recommendation (optional - extra recommendation inserted after first sentence in obs_cat_guidance.md) example usage:

{% include observation_guidance_1.md category="laboratory" example1=" such as 'chemistry'" example2=" (for example, a 24-Hour Urine Collection test)" recommendation="Server SHOULD use Observation Category Codes if applicable." %} –>

  • Servers SHOULD 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 a LOINC code
    • providing a more specific code, a SNOMED CT concept, or a system-specific code
  • Systems SHOULD support Observation.effectivePeriod to accurately represent measurements over 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 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.
  • *The profile elements Observation.performer and Observation.device communicate the individual level provenance author data corresponding to the U.S. Core Data for Interoperability (USCDI) Provenance Author Data Elements.

Usage:

Changes since version 7.0.0:

  • The data elements list has 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 C 0..* Observation Measurements and simple assertions
    us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
    ... 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 S 0..* CodeableConcept Classification 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 S 1..1 CodeableConcept Clinical Test or Procedure Name
    Binding: LOINCCodes (extensible)
    ... subject S 1..1 Reference(US Core Patient Profile S | Group | Device | US Core Location Profile) Who and/or what the observation is about
    ... encounter S 0..1 Reference(US Core Encounter Profile) Encounter associated with Observation
    ... effective[x] SC 0..1 Clinically relevant time/time-period for observation
    us-core-1: Datetime must be at least to day.
    .... effectiveDateTime dateTime S
    .... effectivePeriod Period
    .... effectiveTiming Timing
    .... effectiveInstant instant
    ... performer S 0..* Reference(US Core Practitioner Profile S | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) Who is responsible for the observation
    ... value[x] SC 0..1 Result Value
    us-core-3: SHALL use UCUM for coded quantity units.
    .... valueQuantity Quantity S
    .... valueCodeableConcept CodeableConcept S
    .... valueString string S
    .... valueBoolean boolean
    .... valueInteger integer
    .... valueRange Range
    .... valueRatio Ratio
    .... valueSampledData SampledData
    .... valueTime time
    .... valueDateTime dateTime
    .... valuePeriod Period
    ... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing

    doco Documentation for this format

    Terminology Bindings (Differential)

    PathConformanceValueSetURI
    Observation.category:us-corerequiredUSCoreClinicalResultObservationCategory
    http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
    from this IG
    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 C 0..* Observation Measurements and simple assertions
    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
    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 ?!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 S 0..* CodeableConcept Classification 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


    ele-1: All FHIR elements must have a @value or children
    ... code SΣ 1..1 CodeableConcept Clinical Test or Procedure Name
    Binding: LOINCCodes (extensible)
    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
    ... encounter SΣ 0..1 Reference(US Core Encounter Profile) Encounter associated with Observation
    ele-1: All FHIR elements must have a @value or children
    ... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
    ele-1: All FHIR elements must have a @value or children
    us-core-1: Datetime must be at least to day.
    .... effectiveDateTime dateTime
    ... performer SΣ 0..* Reference(US Core Practitioner Profile) Who is responsible for the observation
    ele-1: All FHIR elements must have a @value or children
    ... value[x] SΣC 0..1 Result Value
    ele-1: All FHIR elements must have a @value or children
    us-core-3: SHALL use UCUM for coded quantity units.
    .... valueQuantity Quantity
    .... valueCodeableConcept CodeableConcept
    .... valueString string
    ... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
    Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.


    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-corerequiredUSCoreClinicalResultObservationCategory
    http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
    from this IG
    Observation.codeextensibleLOINCCodes (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

    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 C 0..* Observation Measurements and simple assertions
    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
    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 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 S 0..* CodeableConcept Classification 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 SΣ 1..1 CodeableConcept Clinical Test or Procedure Name
    Binding: LOINCCodes (extensible)
    ... 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 SΣ 0..1 Reference(US Core Encounter Profile) Encounter associated with Observation
    ... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
    us-core-1: Datetime must be at least to day.
    .... 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 Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) Who is responsible for the observation
    ... value[x] SΣC 0..1 Result Value
    us-core-3: SHALL use UCUM for coded quantity units.
    .... valueQuantity Quantity S
    .... valueCodeableConcept CodeableConcept S
    .... valueString string S
    .... valueBoolean boolean
    .... valueInteger integer
    .... valueRange Range
    .... valueRatio Ratio
    .... valueSampledData SampledData
    .... valueTime time
    .... valueDateTime dateTime
    .... valuePeriod Period
    ... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
    Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

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


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

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

    ... specimen 0..1 Reference(Specimen) Specimen used for this observation
    ... device 0..1 Reference(Device | DeviceMetric) (Measurement) Device
    ... referenceRange C 0..* BackboneElement Provides guide for interpretation
    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(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Related measurements the observation is made from
    ... component Σ 0..* BackboneElement Component results
    .... id 0..1 string Unique id for inter-element referencing
    .... extension 0..* Extension Additional content defined by implementations
    .... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
    .... code Σ 1..1 CodeableConcept Type of component observation (code / type)
    Binding: LOINCCodes (example): Codes identifying names of simple observations.

    .... value[x] Σ 0..1 Actual component result
    ..... valueQuantity Quantity
    ..... valueCodeableConcept CodeableConcept
    ..... valueString string
    ..... valueBoolean boolean
    ..... valueInteger integer
    ..... valueRange Range
    ..... valueRatio Ratio
    ..... valueSampledData SampledData
    ..... valueTime time
    ..... valueDateTime dateTime
    ..... valuePeriod Period
    .... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
    Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

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


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

    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-corerequiredUSCoreClinicalResultObservationCategory
    http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
    from this IG
    Observation.codeextensibleLOINCCodes (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

    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'

    Differential View

    This structure is derived from Observation

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation C 0..* Observation Measurements and simple assertions
    us-core-2: If there is no component or hasMember element then either a value[x] or a data absent reason must be present
    ... 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 S 0..* CodeableConcept Classification 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 S 1..1 CodeableConcept Clinical Test or Procedure Name
    Binding: LOINCCodes (extensible)
    ... subject S 1..1 Reference(US Core Patient Profile S | Group | Device | US Core Location Profile) Who and/or what the observation is about
    ... encounter S 0..1 Reference(US Core Encounter Profile) Encounter associated with Observation
    ... effective[x] SC 0..1 Clinically relevant time/time-period for observation
    us-core-1: Datetime must be at least to day.
    .... effectiveDateTime dateTime S
    .... effectivePeriod Period
    .... effectiveTiming Timing
    .... effectiveInstant instant
    ... performer S 0..* Reference(US Core Practitioner Profile S | US Core Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) Who is responsible for the observation
    ... value[x] SC 0..1 Result Value
    us-core-3: SHALL use UCUM for coded quantity units.
    .... valueQuantity Quantity S
    .... valueCodeableConcept CodeableConcept S
    .... valueString string S
    .... valueBoolean boolean
    .... valueInteger integer
    .... valueRange Range
    .... valueRatio Ratio
    .... valueSampledData SampledData
    .... valueTime time
    .... valueDateTime dateTime
    .... valuePeriod Period
    ... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing

    doco Documentation for this format

    Terminology Bindings (Differential)

    PathConformanceValueSetURI
    Observation.category:us-corerequiredUSCoreClinicalResultObservationCategory
    http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
    from this IG
    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 C 0..* Observation Measurements and simple assertions
    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
    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 ?!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 S 0..* CodeableConcept Classification 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


    ele-1: All FHIR elements must have a @value or children
    ... code SΣ 1..1 CodeableConcept Clinical Test or Procedure Name
    Binding: LOINCCodes (extensible)
    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
    ... encounter SΣ 0..1 Reference(US Core Encounter Profile) Encounter associated with Observation
    ele-1: All FHIR elements must have a @value or children
    ... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
    ele-1: All FHIR elements must have a @value or children
    us-core-1: Datetime must be at least to day.
    .... effectiveDateTime dateTime
    ... performer SΣ 0..* Reference(US Core Practitioner Profile) Who is responsible for the observation
    ele-1: All FHIR elements must have a @value or children
    ... value[x] SΣC 0..1 Result Value
    ele-1: All FHIR elements must have a @value or children
    us-core-3: SHALL use UCUM for coded quantity units.
    .... valueQuantity Quantity
    .... valueCodeableConcept CodeableConcept
    .... valueString string
    ... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
    Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.


    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-corerequiredUSCoreClinicalResultObservationCategory
    http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
    from this IG
    Observation.codeextensibleLOINCCodes (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

    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'

    Snapshot View

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation C 0..* Observation Measurements and simple assertions
    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
    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 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 S 0..* CodeableConcept Classification 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 SΣ 1..1 CodeableConcept Clinical Test or Procedure Name
    Binding: LOINCCodes (extensible)
    ... 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 SΣ 0..1 Reference(US Core Encounter Profile) Encounter associated with Observation
    ... effective[x] SΣC 0..1 Clinically relevant time/time-period for observation
    us-core-1: Datetime must be at least to day.
    .... 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 Organization Profile | US Core Patient Profile | PractitionerRole | US Core CareTeam Profile | US Core RelatedPerson Profile) Who is responsible for the observation
    ... value[x] SΣC 0..1 Result Value
    us-core-3: SHALL use UCUM for coded quantity units.
    .... valueQuantity Quantity S
    .... valueCodeableConcept CodeableConcept S
    .... valueString string S
    .... valueBoolean boolean
    .... valueInteger integer
    .... valueRange Range
    .... valueRatio Ratio
    .... valueSampledData SampledData
    .... valueTime time
    .... valueDateTime dateTime
    .... valuePeriod Period
    ... dataAbsentReason SC 0..1 CodeableConcept Why the result is missing
    Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

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


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

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

    ... specimen 0..1 Reference(Specimen) Specimen used for this observation
    ... device 0..1 Reference(Device | DeviceMetric) (Measurement) Device
    ... referenceRange C 0..* BackboneElement Provides guide for interpretation
    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(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence) Related measurements the observation is made from
    ... component Σ 0..* BackboneElement Component results
    .... id 0..1 string Unique id for inter-element referencing
    .... extension 0..* Extension Additional content defined by implementations
    .... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
    .... code Σ 1..1 CodeableConcept Type of component observation (code / type)
    Binding: LOINCCodes (example): Codes identifying names of simple observations.

    .... value[x] Σ 0..1 Actual component result
    ..... valueQuantity Quantity
    ..... valueCodeableConcept CodeableConcept
    ..... valueString string
    ..... valueBoolean boolean
    ..... valueInteger integer
    ..... valueRange Range
    ..... valueRatio Ratio
    ..... valueSampledData SampledData
    ..... valueTime time
    ..... valueDateTime dateTime
    ..... valuePeriod Period
    .... dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
    Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

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


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

    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-corerequiredUSCoreClinicalResultObservationCategory
    http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
    from this IG
    Observation.codeextensibleLOINCCodes (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

    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'

     

    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 clinical results data SHALL support these US Core SMART Scopes:

    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=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 = 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|44974-4
      2. GET [base]/Observation?patient=1134281&amp;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|laboratory&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 = 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=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 = 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&http://terminology.hl7.org/CodeSystem/observation-category|procedure&_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|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)