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

US Core Implementation Guide, published by HL7 International / Cross-Group Projects. This guide is not an authorized publication; it is the continuous build for version 8.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/US-Core/ and changes regularly. See the Directory of published versions

Resource Profile: US Core Laboratory Result Observation Profile

Official URL: http://hl7.org/fhir/us/core/StructureDefinition/us-core-observation-lab Version: 8.0.0-ballot
Standards status: Trial-use Maturity Level: 3 Computable Name: USCoreLaboratoryResultObservationProfile
Other Identifiers: OID:2.16.840.1.113883.4.642.40.2.42.42

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

The US Core Laboratory Result Observation Profile is based upon the US Core Observation Clinical Result Profile and, along with the US Core DiagnosticReport Profile for Laboratory Results Reporting, meets the U.S. Core Data for Interoperability (USCDI) Laboratory requirements. Laboratory results are grouped and summarized using the DiagnosticReport resource, which references Observation resources. Each Observation resource represents an individual laboratory test and result value, a “nested” panel (such as a microbial susceptibility panel) that references other observations, or rarely a laboratory test with component result values. The US Core Laboratory Result Observation Profile sets minimum expectations for the Observation resource to record, search, and fetch laboratory test results associated with a patient 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 lab results belonging to a Patient
  • Record or update lab results belonging to a Patient

Mandatory and Must Support Data Elements

In addition to the Mandatory and Must Support data elements in the US Core Observation Clinical Result Profile, 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 section below provides the formal summary, definitions, and terminology requirements. Note that the "Differential Table" displays elements unique to this profile and the "Key Elements Table” displays a combined view of elements for this profile and the US Core Observation Clinical Result Profile.

Each Observation Must Have:

  1. a category code of 'laboratory'
  2. a laboratory LOINC code, if available, which tells you what is being measured

Each Observation Must Support:

  1. a timestamp when the resource last changed*
  2. a result value*
    • if the result value is a numeric quantity, a standard UCUM unit
    • if the result value is a coded quantity, a standard SNOMED CT
  3. result interpretation
    • if the result value is a numeric quantity, a standard UCUM unit
  4. result reference range
  5. a specimen type (e.g., blood, serum, urine)

* see guidance below

Profile Specific Implementation Guidance:

  • For USCDI, systems are required to use SNOMED CT for coded results if the SCT code exists.
  • The specimen type can be communicated in the mandatory Observation.code (e.g., Blood Glucose), the Must Support Observation.specimen element, or through both elements.
  • The Observation.category element provides an efficient way of restricting search on observations to a given context such as 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 such as 'chemistry', a SNOMED CT concept, or a system-specific code
  • Systems SHOULD support Observation.effectivePeriod to accurately represent measurements over time (for example, a 24-Hour Urine Collection test).
  • *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.
  • *This profile inherits the invariant "us-core-3" from the US Core Observation Clinical Result Profile that requires UCUM to be used as a unit type for Observation.valeQuantity.code.
  • * See the US Core General Guidance page for Searching Using lastUpdated. Updates to Meta.lastUpdated SHOULD reflect:
    • New laboratory observations
    • Changes in the status of laboratory observations, including events that trigger the same status (e.g., amended → amended).

Usage:

Changes since version 7.0.0:

  • No changes

    • Formal Views of Profile Content

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

    This structure is derived from USCoreObservationClinicalResultProfile

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation USCoreObservationClinicalResultProfile
    ... meta S 0..1 Meta Metadata about the resource
    .... lastUpdated S 0..1 instant When the resource last changed
    ... Slices for category Content/Rules for all slices
    .... category:us-core S 1..1 CodeableConcept Classification of type of observation
    Required Pattern: At least the following
    ..... coding 1..* Coding Code defined by a terminology system
    Fixed Value: (complex)
    ...... system 1..1 uri Identity of the terminology system
    Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
    ...... code 1..1 code Symbol in syntax defined by the system
    Fixed Value: laboratory
    ... code S 1..1 CodeableConcept Laboratory Test Name
    Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes

    ... value[x] SC 0..1 Result Value
    us-core-4: SHOULD use Snomed CT for coded Results
    .... 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
    ... interpretation S 0..* CodeableConcept Result interpretation
    Binding: ObservationInterpretationCodes (extensible): Observation Interpretation Codes

    ... specimen S 0..1 Reference(US Core Specimen Profile) Specimen used for this observation
    ... referenceRange SC 0..* BackboneElement Result reference range
    us-core-22: SHALL use UCUM for coded quantity units.

    doco Documentation for this format

    Terminology Bindings (Differential)

    PathConformanceValueSetURI
    Observation.codeextensibleUSCoreLaboratoryTestCodes
    http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
    from this IG
    Observation.interpretationextensibleObservationInterpretationCodes
    http://hl7.org/fhir/ValueSet/observation-interpretation
    from the FHIR Standard

    Constraints

    IdGradePath(s)DetailsRequirements
    us-core-4best practiceObservation.value[x]SHOULD use Snomed CT for coded Results
    : ofType(CodeableConcept).coding.system.empty() or (ofType(CodeableConcept).coding.system contains 'http://snomed.info/sct')
    us-core-22errorObservation.referenceRangeSHALL use UCUM for coded quantity units.
    : (low.system.empty() or low.system = 'http://unitsofmeasure.org') and (high.system.empty() or high.system = 'http://unitsofmeasure.org')
    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation C 0..* USCoreObservationClinicalResultProfile 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
    ... meta SΣ 0..1 Meta Metadata about the resource
    .... lastUpdated SΣ 0..1 instant When the resource last changed
    ... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
    ... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
    ... status ?!SΣ 1..1 code registered | preliminary | final | amended +
    Binding: ObservationStatus (required): Codes providing the status of an observation.

    ... Slices for category S 1..* CodeableConcept Classification of type of observation
    Slice: Unordered, Open by value:$this
    Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


    .... category:us-core S 1..1 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



    Required Pattern: At least the following
    ..... coding 1..* Coding Code defined by a terminology system
    Fixed Value: (complex)
    ...... system 1..1 uri Identity of the terminology system
    Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
    ...... code 1..1 code Symbol in syntax defined by the system
    Fixed Value: laboratory
    ... code SΣ 1..1 CodeableConcept Laboratory Test Name
    Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes

    ... subject SΣ 1..1 Reference(US Core Patient Profile) Who and/or what the observation is about
    ... 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
    ... performer SΣ 0..* Reference(US Core Practitioner Profile) Who is responsible for the observation
    ... value[x] SΣC 0..1 Result Value
    us-core-3: SHALL use UCUM for coded quantity units.
    us-core-4: SHOULD use Snomed CT for coded Results
    .... 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.

    ... interpretation S 0..* CodeableConcept Result interpretation
    Binding: ObservationInterpretationCodes (extensible): Observation Interpretation Codes


    ... specimen S 0..1 Reference(US Core Specimen Profile) Specimen used for this observation
    ... referenceRange SC 0..* BackboneElement Result reference range
    obs-3: Must have at least a low or a high or text
    us-core-22: SHALL use UCUM for coded quantity units.
    .... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized

    doco Documentation for this format

    Terminology Bindings

    PathConformanceValueSet / CodeURI
    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-corerequiredPattern: laboratory
    http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
    from this IG
    Observation.codeextensibleUSCoreLaboratoryTestCodes
    http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
    from this IG
    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

    Constraints

    IdGradePath(s)DetailsRequirements
    us-core-4best practiceObservation.value[x]SHOULD use Snomed CT for coded Results
    : ofType(CodeableConcept).coding.system.empty() or (ofType(CodeableConcept).coding.system contains 'http://snomed.info/sct')
    us-core-22errorObservation.referenceRangeSHALL use UCUM for coded quantity units.
    : (low.system.empty() or low.system = 'http://unitsofmeasure.org') and (high.system.empty() or high.system = 'http://unitsofmeasure.org')
    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation C 0..* USCoreObservationClinicalResultProfile 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 SΣ 0..1 Meta Metadata about the resource
    .... id 0..1 string Unique id for inter-element referencing
    .... extension 0..* Extension Additional content defined by implementations
    Slice: Unordered, Open by value:url
    .... versionId Σ 0..1 id Version specific identifier
    .... lastUpdated SΣ 0..1 instant When the resource last changed
    .... source Σ 0..1 uri Identifies where the resource comes from
    .... profile Σ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
    .... security Σ 0..* Coding Security Labels applied to this resource
    Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


    .... tag Σ 0..* Coding Tags applied to this resource
    Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


    ... 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 1..1 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



    Required Pattern: At least the following
    ..... id 0..1 string Unique id for inter-element referencing
    ..... extension 0..* Extension Additional content defined by implementations
    ..... coding 1..* Coding Code defined by a terminology system
    Fixed Value: (complex)
    ...... id 0..1 string Unique id for inter-element referencing
    ...... extension 0..* Extension Additional content defined by implementations
    ...... system 1..1 uri Identity of the terminology system
    Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
    ...... version 0..1 string Version of the system - if relevant
    ...... code 1..1 code Symbol in syntax defined by the system
    Fixed Value: laboratory
    ...... display 0..1 string Representation defined by the system
    ...... userSelected 0..1 boolean If this coding was chosen directly by the user
    ..... text 0..1 string Plain text representation of the concept
    ... code SΣ 1..1 CodeableConcept Laboratory Test Name
    Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes

    ... 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.
    us-core-4: SHOULD use Snomed CT for coded Results
    .... 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 S 0..* CodeableConcept Result interpretation
    Binding: ObservationInterpretationCodes (extensible): Observation Interpretation Codes


    ... 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 S 0..1 Reference(US Core Specimen Profile) Specimen used for this observation
    ... device 0..1 Reference(Device | DeviceMetric) (Measurement) Device
    ... referenceRange SC 0..* BackboneElement Result reference range
    obs-3: Must have at least a low or a high or text
    us-core-22: SHALL use UCUM for coded quantity units.
    .... 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

    PathConformanceValueSet / CodeURI
    Observation.meta.securityextensibleAll Security Labels
    http://hl7.org/fhir/ValueSet/security-labels
    from the FHIR Standard
    Observation.meta.tagexampleCommonTags
    http://hl7.org/fhir/ValueSet/common-tags
    from the FHIR Standard
    Observation.languagepreferredCommonLanguages
    Additional Bindings Purpose
    AllLanguages Max Binding
    http://hl7.org/fhir/ValueSet/languages
    from the FHIR Standard
    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-corerequiredPattern: laboratory
    http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
    from this IG
    Observation.codeextensibleUSCoreLaboratoryTestCodes
    http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
    from this IG
    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-4best practiceObservation.value[x]SHOULD use Snomed CT for coded Results
    : ofType(CodeableConcept).coding.system.empty() or (ofType(CodeableConcept).coding.system contains 'http://snomed.info/sct')
    us-core-22errorObservation.referenceRangeSHALL use UCUM for coded quantity units.
    : (low.system.empty() or low.system = 'http://unitsofmeasure.org') and (high.system.empty() or high.system = 'http://unitsofmeasure.org')

    This structure is derived from USCoreObservationClinicalResultProfile

    Summary

    Mandatory: 1 element
    Must-Support: 8 elements

    Structures

    This structure refers to these other structures:

    Maturity: 3

    Differential View

    This structure is derived from USCoreObservationClinicalResultProfile

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation USCoreObservationClinicalResultProfile
    ... meta S 0..1 Meta Metadata about the resource
    .... lastUpdated S 0..1 instant When the resource last changed
    ... Slices for category Content/Rules for all slices
    .... category:us-core S 1..1 CodeableConcept Classification of type of observation
    Required Pattern: At least the following
    ..... coding 1..* Coding Code defined by a terminology system
    Fixed Value: (complex)
    ...... system 1..1 uri Identity of the terminology system
    Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
    ...... code 1..1 code Symbol in syntax defined by the system
    Fixed Value: laboratory
    ... code S 1..1 CodeableConcept Laboratory Test Name
    Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes

    ... value[x] SC 0..1 Result Value
    us-core-4: SHOULD use Snomed CT for coded Results
    .... 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
    ... interpretation S 0..* CodeableConcept Result interpretation
    Binding: ObservationInterpretationCodes (extensible): Observation Interpretation Codes

    ... specimen S 0..1 Reference(US Core Specimen Profile) Specimen used for this observation
    ... referenceRange SC 0..* BackboneElement Result reference range
    us-core-22: SHALL use UCUM for coded quantity units.

    doco Documentation for this format

    Terminology Bindings (Differential)

    PathConformanceValueSetURI
    Observation.codeextensibleUSCoreLaboratoryTestCodes
    http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
    from this IG
    Observation.interpretationextensibleObservationInterpretationCodes
    http://hl7.org/fhir/ValueSet/observation-interpretation
    from the FHIR Standard

    Constraints

    IdGradePath(s)DetailsRequirements
    us-core-4best practiceObservation.value[x]SHOULD use Snomed CT for coded Results
    : ofType(CodeableConcept).coding.system.empty() or (ofType(CodeableConcept).coding.system contains 'http://snomed.info/sct')
    us-core-22errorObservation.referenceRangeSHALL use UCUM for coded quantity units.
    : (low.system.empty() or low.system = 'http://unitsofmeasure.org') and (high.system.empty() or high.system = 'http://unitsofmeasure.org')

    Key Elements View

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation C 0..* USCoreObservationClinicalResultProfile 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
    ... meta SΣ 0..1 Meta Metadata about the resource
    .... lastUpdated SΣ 0..1 instant When the resource last changed
    ... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
    ... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
    ... status ?!SΣ 1..1 code registered | preliminary | final | amended +
    Binding: ObservationStatus (required): Codes providing the status of an observation.

    ... Slices for category S 1..* CodeableConcept Classification of type of observation
    Slice: Unordered, Open by value:$this
    Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


    .... category:us-core S 1..1 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



    Required Pattern: At least the following
    ..... coding 1..* Coding Code defined by a terminology system
    Fixed Value: (complex)
    ...... system 1..1 uri Identity of the terminology system
    Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
    ...... code 1..1 code Symbol in syntax defined by the system
    Fixed Value: laboratory
    ... code SΣ 1..1 CodeableConcept Laboratory Test Name
    Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes

    ... subject SΣ 1..1 Reference(US Core Patient Profile) Who and/or what the observation is about
    ... 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
    ... performer SΣ 0..* Reference(US Core Practitioner Profile) Who is responsible for the observation
    ... value[x] SΣC 0..1 Result Value
    us-core-3: SHALL use UCUM for coded quantity units.
    us-core-4: SHOULD use Snomed CT for coded Results
    .... 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.

    ... interpretation S 0..* CodeableConcept Result interpretation
    Binding: ObservationInterpretationCodes (extensible): Observation Interpretation Codes


    ... specimen S 0..1 Reference(US Core Specimen Profile) Specimen used for this observation
    ... referenceRange SC 0..* BackboneElement Result reference range
    obs-3: Must have at least a low or a high or text
    us-core-22: SHALL use UCUM for coded quantity units.
    .... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized

    doco Documentation for this format

    Terminology Bindings

    PathConformanceValueSet / CodeURI
    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-corerequiredPattern: laboratory
    http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
    from this IG
    Observation.codeextensibleUSCoreLaboratoryTestCodes
    http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
    from this IG
    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

    Constraints

    IdGradePath(s)DetailsRequirements
    us-core-4best practiceObservation.value[x]SHOULD use Snomed CT for coded Results
    : ofType(CodeableConcept).coding.system.empty() or (ofType(CodeableConcept).coding.system contains 'http://snomed.info/sct')
    us-core-22errorObservation.referenceRangeSHALL use UCUM for coded quantity units.
    : (low.system.empty() or low.system = 'http://unitsofmeasure.org') and (high.system.empty() or high.system = 'http://unitsofmeasure.org')

    Snapshot View

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation C 0..* USCoreObservationClinicalResultProfile 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 SΣ 0..1 Meta Metadata about the resource
    .... id 0..1 string Unique id for inter-element referencing
    .... extension 0..* Extension Additional content defined by implementations
    Slice: Unordered, Open by value:url
    .... versionId Σ 0..1 id Version specific identifier
    .... lastUpdated SΣ 0..1 instant When the resource last changed
    .... source Σ 0..1 uri Identifies where the resource comes from
    .... profile Σ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
    .... security Σ 0..* Coding Security Labels applied to this resource
    Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


    .... tag Σ 0..* Coding Tags applied to this resource
    Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


    ... 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 1..1 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



    Required Pattern: At least the following
    ..... id 0..1 string Unique id for inter-element referencing
    ..... extension 0..* Extension Additional content defined by implementations
    ..... coding 1..* Coding Code defined by a terminology system
    Fixed Value: (complex)
    ...... id 0..1 string Unique id for inter-element referencing
    ...... extension 0..* Extension Additional content defined by implementations
    ...... system 1..1 uri Identity of the terminology system
    Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
    ...... version 0..1 string Version of the system - if relevant
    ...... code 1..1 code Symbol in syntax defined by the system
    Fixed Value: laboratory
    ...... display 0..1 string Representation defined by the system
    ...... userSelected 0..1 boolean If this coding was chosen directly by the user
    ..... text 0..1 string Plain text representation of the concept
    ... code SΣ 1..1 CodeableConcept Laboratory Test Name
    Binding: US Core Laboratory Test Codes (extensible): Laboratory LOINC Codes

    ... 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.
    us-core-4: SHOULD use Snomed CT for coded Results
    .... 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 S 0..* CodeableConcept Result interpretation
    Binding: ObservationInterpretationCodes (extensible): Observation Interpretation Codes


    ... 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 S 0..1 Reference(US Core Specimen Profile) Specimen used for this observation
    ... device 0..1 Reference(Device | DeviceMetric) (Measurement) Device
    ... referenceRange SC 0..* BackboneElement Result reference range
    obs-3: Must have at least a low or a high or text
    us-core-22: SHALL use UCUM for coded quantity units.
    .... 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

    PathConformanceValueSet / CodeURI
    Observation.meta.securityextensibleAll Security Labels
    http://hl7.org/fhir/ValueSet/security-labels
    from the FHIR Standard
    Observation.meta.tagexampleCommonTags
    http://hl7.org/fhir/ValueSet/common-tags
    from the FHIR Standard
    Observation.languagepreferredCommonLanguages
    Additional Bindings Purpose
    AllLanguages Max Binding
    http://hl7.org/fhir/ValueSet/languages
    from the FHIR Standard
    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-corerequiredPattern: laboratory
    http://hl7.org/fhir/us/core/ValueSet/us-core-clinical-result-observation-category
    from this IG
    Observation.codeextensibleUSCoreLaboratoryTestCodes
    http://hl7.org/fhir/us/core/ValueSet/us-core-laboratory-test-codes
    from this IG
    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-4best practiceObservation.value[x]SHOULD use Snomed CT for coded Results
    : ofType(CodeableConcept).coding.system.empty() or (ofType(CodeableConcept).coding.system contains 'http://snomed.info/sct')
    us-core-22errorObservation.referenceRangeSHALL use UCUM for coded quantity units.
    : (low.system.empty() or low.system = 'http://unitsofmeasure.org') and (high.system.empty() or high.system = 'http://unitsofmeasure.org')

    This structure is derived from USCoreObservationClinicalResultProfile

    Summary

    Mandatory: 1 element
    Must-Support: 8 elements

    Structures

    This structure refers to these other structures:

    Maturity: 3

     

    Other representations of profile: CSV, Excel, Schematron

    Notes:

    Quick Start

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

    • 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 laboratory 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://terminology.hl7.org/CodeSystem/observation-category|laboratory

    Mandatory Search Parameters:

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

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

      GET [base]/Observation?patient={Type/}[id]&category=http://terminology.hl7.org/CodeSystem/observation-category|laboratory

      Example:

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

      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|2339-0
      2. GET [base]/Observation?patient=1134281&amp;code=http://loinc.org|2339-0,http://loinc.org|25428-4,http://loinc.org|2514-8

      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|laboratory&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|laboratory&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|laboratory&_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|2339-0&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)