minimal Common Oncology Data Elements (mCODE) Implementation Guide
4.0.0 - STU4 United States of America flag

minimal Common Oncology Data Elements (mCODE) Implementation Guide, published by HL7 International / Clinical Interoperability Council. This guide is not an authorized publication; it is the continuous build for version 4.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-mCODE-ig/ and changes regularly. See the Directory of published versions

Resource Profile: Tumor Marker Test Profile

Official URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-tumor-marker-test Version: 4.0.0
Active as of 2024-11-20 Maturity Level: 4 Computable Name: TumorMarkerTest
Other Identifiers: OID:2.16.840.1.113883.4.642.40.15.42.61

The result of a tumor marker test. Tumor marker tests are generally used to guide cancer treatment decisions and monitor treatment, as well as to predict the chance of recovery and cancer recurrence.

Usage

A tumor marker is a substance found in tissue or blood or other body fluids that may be a sign of cancer or certain benign (non-cancer) conditions. Most tumor markers are made by both normal cells and cancer cells, but they are made in larger amounts by cancer cells. A tumor marker may help to diagnose cancer, plan treatment, or find out how well treatment is working or if cancer has come back. Examples of tumor markers include CA-125 (in ovarian cancer), CA 15-3 (in breast cancer), CEA (in colon cancer), and PSA (in prostate cancer). Tumor markers differ from genomic markers in that they are measured at the levels of the protein and substance post-RNA protein synthesis. (Definition adapted from: NCI Dictionary of Cancer Terms and Cancer.Net).

Conformance

Observation resources associated with an [in-scope patient] with an Observation.code in the value set TumorMarkerTestVS SHALL conform to this profile. Beyond this requirement, a producer of resources SHOULD ensure that any resource instance associated with an in-scope patient that would reasonably be expected to conform to this profile SHOULD be published in this form, for example, when employing a code that extends the TumorMarkerTestVS value set. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

Usage:

Changes since version true:

  • No changes

    • Formal Views of Profile Content

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

    This structure is derived from USCoreLaboratoryResultObservationProfile

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation 0..* USCoreLaboratoryResultObservationProfile Measurements and simple assertions
    ... Slices for extension 0..* Extension Extension
    Slice: Unordered, Open by value:url
    .... relatedCondition S 0..* CodeableConcept, Reference(Condition) Condition associated with this test.
    URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition
    ... code 1..1 CodeableConcept (USCDI) Laboratory Test Name
    Binding: Tumor Marker Test Value Set (extensible)
    ... subject 1..1 Reference(Cancer Patient Profile) (USCDI) Who and/or what the observation is about
    .... effectiveDateTime dateTime
    .... effectivePeriod Period
    ... value[x] 1..1 (USCDI) Result Value
    .... valueQuantity Quantity
    .... valueCodeableConcept CodeableConcept
    .... valueString string
    .... valueRatio Ratio
    ... specimen 0..1 Reference(Human Specimen Profile) (USCDI) Specimen used for this observation

    doco Documentation for this format

    Terminology Bindings (Differential)

    PathConformanceValueSetURI
    Observation.codeextensibleTumorMarkerTestVS
    http://hl7.org/fhir/us/mcode/ValueSet/mcode-tumor-marker-test-vs
    from this IG
    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation C 0..* USCoreLaboratoryResultObservationProfile 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
    ... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
    ... Slices for extension 0..* Extension Extension
    Slice: Unordered, Open by value:url
    .... relatedCondition S 0..* CodeableConcept, Reference(Condition) Condition associated with this test.
    URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition
    ... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
    ... Slices for category S 1..* CodeableConcept (USCDI) Classification of type of observation
    Slice: Unordered, Open by pattern:$this
    Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


    .... category:us-core S 1..1 CodeableConcept (USCDI) 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 (USCDI) Laboratory Test Name
    Binding: Tumor Marker Test Value Set (extensible)
    ... subject SΣ 1..1 Reference(Cancer Patient Profile) (USCDI) Who and/or what the observation is about
    ... effective[x] SΣC 0..1 (USCDI) Clinically relevant time/time-period for observation
    us-core-1: Datetime must be at least to day.
    .... effectiveDateTime dateTime
    ... value[x] SΣC 1..1 (USCDI) 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 (USCDI) Why the result is missing
    Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

    ... specimen S 0..1 Reference(Human Specimen Profile) (USCDI) Specimen used for this observation

    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
    Observation.codeextensibleTumorMarkerTestVS
    http://hl7.org/fhir/us/mcode/ValueSet/mcode-tumor-marker-test-vs
    from this IG
    Observation.dataAbsentReasonextensibleDataAbsentReason
    http://hl7.org/fhir/ValueSet/data-absent-reason
    from the FHIR Standard
    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation C 0..* USCoreLaboratoryResultObservationProfile 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
    ... Slices for extension 0..* Extension Extension
    Slice: Unordered, Open by value:url
    .... relatedCondition S 0..* CodeableConcept, Reference(Condition) Condition associated with this test.
    URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition
    ... 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 (USCDI) registered | preliminary | final | amended +
    Binding: ObservationStatus (required): Codes providing the status of an observation.

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


    .... category:us-core S 1..1 CodeableConcept (USCDI) 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 (USCDI) Laboratory Test Name
    Binding: Tumor Marker Test Value Set (extensible)
    ... subject SΣ 1..1 Reference(Cancer Patient Profile) (USCDI) Who and/or what the observation is about
    ... focus Σ 0..* Reference(Resource) What the observation is about, when it is not about the subject of record
    ... encounter Σ 0..1 Reference(Encounter) Healthcare event during which this observation is made
    ... effective[x] SΣC 0..1 (USCDI) Clinically relevant time/time-period for observation
    us-core-1: Datetime must be at least to day.
    .... effectiveDateTime dateTime S
    .... effectivePeriod Period
    ... issued Σ 0..1 instant Date/Time this version was made available
    ... performer Σ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
    ... value[x] SΣC 1..1 (USCDI) 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
    .... valueRatio Ratio
    ... dataAbsentReason SC 0..1 CodeableConcept (USCDI) 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 S 0..1 Reference(Human Specimen Profile) (USCDI) 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

    PathConformanceValueSet / CodeURI
    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
    Observation.codeextensibleTumorMarkerTestVS
    http://hl7.org/fhir/us/mcode/ValueSet/mcode-tumor-marker-test-vs
    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

    Differential View

    This structure is derived from USCoreLaboratoryResultObservationProfile

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation 0..* USCoreLaboratoryResultObservationProfile Measurements and simple assertions
    ... Slices for extension 0..* Extension Extension
    Slice: Unordered, Open by value:url
    .... relatedCondition S 0..* CodeableConcept, Reference(Condition) Condition associated with this test.
    URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition
    ... code 1..1 CodeableConcept (USCDI) Laboratory Test Name
    Binding: Tumor Marker Test Value Set (extensible)
    ... subject 1..1 Reference(Cancer Patient Profile) (USCDI) Who and/or what the observation is about
    .... effectiveDateTime dateTime
    .... effectivePeriod Period
    ... value[x] 1..1 (USCDI) Result Value
    .... valueQuantity Quantity
    .... valueCodeableConcept CodeableConcept
    .... valueString string
    .... valueRatio Ratio
    ... specimen 0..1 Reference(Human Specimen Profile) (USCDI) Specimen used for this observation

    doco Documentation for this format

    Terminology Bindings (Differential)

    PathConformanceValueSetURI
    Observation.codeextensibleTumorMarkerTestVS
    http://hl7.org/fhir/us/mcode/ValueSet/mcode-tumor-marker-test-vs
    from this IG

    Key Elements View

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation C 0..* USCoreLaboratoryResultObservationProfile 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
    ... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
    ... Slices for extension 0..* Extension Extension
    Slice: Unordered, Open by value:url
    .... relatedCondition S 0..* CodeableConcept, Reference(Condition) Condition associated with this test.
    URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition
    ... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
    ... Slices for category S 1..* CodeableConcept (USCDI) Classification of type of observation
    Slice: Unordered, Open by pattern:$this
    Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


    .... category:us-core S 1..1 CodeableConcept (USCDI) 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 (USCDI) Laboratory Test Name
    Binding: Tumor Marker Test Value Set (extensible)
    ... subject SΣ 1..1 Reference(Cancer Patient Profile) (USCDI) Who and/or what the observation is about
    ... effective[x] SΣC 0..1 (USCDI) Clinically relevant time/time-period for observation
    us-core-1: Datetime must be at least to day.
    .... effectiveDateTime dateTime
    ... value[x] SΣC 1..1 (USCDI) 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 (USCDI) Why the result is missing
    Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

    ... specimen S 0..1 Reference(Human Specimen Profile) (USCDI) Specimen used for this observation

    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
    Observation.codeextensibleTumorMarkerTestVS
    http://hl7.org/fhir/us/mcode/ValueSet/mcode-tumor-marker-test-vs
    from this IG
    Observation.dataAbsentReasonextensibleDataAbsentReason
    http://hl7.org/fhir/ValueSet/data-absent-reason
    from the FHIR Standard

    Snapshot View

    NameFlagsCard.TypeDescription & Constraintsdoco
    .. Observation C 0..* USCoreLaboratoryResultObservationProfile 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
    ... Slices for extension 0..* Extension Extension
    Slice: Unordered, Open by value:url
    .... relatedCondition S 0..* CodeableConcept, Reference(Condition) Condition associated with this test.
    URL: http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-related-condition
    ... 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 (USCDI) registered | preliminary | final | amended +
    Binding: ObservationStatus (required): Codes providing the status of an observation.

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


    .... category:us-core S 1..1 CodeableConcept (USCDI) 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 (USCDI) Laboratory Test Name
    Binding: Tumor Marker Test Value Set (extensible)
    ... subject SΣ 1..1 Reference(Cancer Patient Profile) (USCDI) Who and/or what the observation is about
    ... focus Σ 0..* Reference(Resource) What the observation is about, when it is not about the subject of record
    ... encounter Σ 0..1 Reference(Encounter) Healthcare event during which this observation is made
    ... effective[x] SΣC 0..1 (USCDI) Clinically relevant time/time-period for observation
    us-core-1: Datetime must be at least to day.
    .... effectiveDateTime dateTime S
    .... effectivePeriod Period
    ... issued Σ 0..1 instant Date/Time this version was made available
    ... performer Σ 0..* Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | RelatedPerson) Who is responsible for the observation
    ... value[x] SΣC 1..1 (USCDI) 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
    .... valueRatio Ratio
    ... dataAbsentReason SC 0..1 CodeableConcept (USCDI) 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 S 0..1 Reference(Human Specimen Profile) (USCDI) 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

    PathConformanceValueSet / CodeURI
    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
    Observation.codeextensibleTumorMarkerTestVS
    http://hl7.org/fhir/us/mcode/ValueSet/mcode-tumor-marker-test-vs
    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

     

    Other representations of profile: CSV, Excel, Schematron