HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE), v0.9.1

HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE), v0.9.1 FHIR Profiles - Local Development build (v0.9.1). See the Directory of published versions

TumorMarkerTest

 

The official URL for this profile is:

http://mcodeinitiative.org/us/mcode/StructureDefinition/onco-core-TumorMarkerTest

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. 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 (noncancer) 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 genetic markers in that they are measured at the levels of the protein and substance post-RNA protein synthesis. (Source: Adapted from NCI Dictionary of Cancer Terms and Cancer.net)

Implementation note: The data value for TumorMarkerTest has cardinality is 0..1 (required if known) because when the test result is indeterminate, no quantitative data value will be reported. Instead, the reason for the null value will be reported in the DataAbsentReason field.

This profile builds on http://fhir.org/guides/argonaut/StructureDefinition/argo-observationresults.

This profile was published on Wed Oct 23 00:00:00 EDT 2019 as a draft by The MITRE Corporation.

Summary

Must-Support: 1 element
Fixed Value: 1 element
Prohibited: 1 element

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element Observation.identifier is sliced based on the value of value:type.coding.code

Mapping Source

This structure represents the following mapping definition:

onco.core.TumorMarkerTest maps to http://fhir.org/guides/argonaut/StructureDefinition/argo-observationresults:
  Language maps to language
  ImplicitRules maps to implicitRules
  Metadata.VersionId maps to meta.versionId
  Metadata.SourceSystem maps to meta.extension
  Metadata.Profile maps to meta.profile
  Metadata.LastUpdated maps to meta.lastUpdated
  Metadata.SecurityLabel maps to meta.security
  Metadata.Tag maps to meta.tag
  Narrative maps to text
  Identifier maps to identifier (slice on = type.coding.code; slice strategy = includes)
  ObservationBasedOn maps to extension
  ObservationPartOf maps to extension
  Status maps to status
  Category maps to category
  Code maps to code
  ObservationSubjectOfRecord maps to subject
  FocalSubject maps to modifierExtension
  CareContext maps to encounter
  RelevantTime maps to effective[x]
  StatementDateTime maps to issued
  LaboratoryObservationPerformer maps to performer (slice on = target.reference.resolve(); slice on type = profile; slice strategy = includes)
  TumorMarkerTestDataValue maps to value[x]
  DataAbsentReason maps to dataAbsentReason
  Interpretation maps to interpretation
  Annotation maps to extension
  BodyLocation.Code maps to bodySite
  BodyLocation.Laterality maps to bodySite.extension
  BodyLocation.AnatomicalOrientation maps to bodySite.extension
  BodyLocation.RelationToLandmark maps to bodySite.extension
  Method maps to method
  Specimen maps to specimen
  Device maps to device
  ReferenceRange maps to referenceRange
  ReferenceRange.LowerBound maps to referenceRange.low
  ReferenceRange.UpperBound maps to referenceRange.high
  ReferenceRange.Type maps to referenceRange.meaning
  ReferenceRange.ApplicableSubpopulation maps to referenceRange.extension
  ReferenceRange.ApplicableAgeRange maps to referenceRange.age
  ReferenceRange.Text maps to referenceRange.text
  fix related.type to #has-member
  PanelMembers maps to related
  PanelMembers.Observation maps to related.target (slice at = related; slice on = target.reference.resolve(); slice on type = profile; slice strategy = includes)
  ObservationDerivedFrom maps to extension
  Components.ObservationComponent maps to component (slice on = code.coding.code; slice strategy = includes)
  Components.ObservationComponent.Code maps to component.code
  Components.ObservationComponent.DataValue maps to component.value[x]
  Components.ObservationComponent.DataAbsentReason maps to component.dataAbsentReason
  Components.ObservationComponent.ReferenceRange maps to component.referenceRange
  Components.ObservationComponent.ReferenceRange.LowerBound maps to component.referenceRange.low
  Components.ObservationComponent.ReferenceRange.UpperBound maps to component.referenceRange.high
  Components.ObservationComponent.ReferenceRange.Type maps to component.referenceRange.meaning
  Components.ObservationComponent.ReferenceRange.ApplicableAgeRange maps to component.referenceRange.age
  Components.ObservationComponent.ReferenceRange.Text maps to component.referenceRange.text

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation onco-core-TumorMarkerTest
... meta
.... extension Slice: Unordered, Open by value:url
.... obf-SourceSystem-extension 0..1uriSourceSystem
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-SourceSystem-extension
... extension Slice: Unordered, Open by value:url
... obf-ObservationBasedOn-extension 0..*Reference(obf-ProcedureRequest | ReferralRequest)ObservationBasedOn
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-ObservationBasedOn-extension
... obf-ObservationPartOf-extension 0..*Reference(obf-MedicationAdministration | obf-MedicationDispense | obf-MedicationStatement | obf-Procedure)ObservationPartOf
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-ObservationPartOf-extension
... obf-Annotation-extension 0..*AnnotationAnnotation
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-Annotation-extension
... obf-ObservationDerivedFrom-extension 0..*Reference(DocumentReference | Media | obf-QuestionnaireResponse | obf-Observation)ObservationDerivedFrom
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-ObservationDerivedFrom-extension
... modifierExtension (Slice Definition)Slice: Unordered, Open by value:url
... modifierExtension:focalsubject ?!S0..*FocalSubject
.... valueReference Reference(obf-Resource)Resource: Parent class for any item in clinical or administrative health-related system
... identifier (Slice Definition)Slice: Unordered, Open by value:type.coding.code
.... identifier:obf-AccessionIdentifier 0..1AccessionIdentifierAccessionIdentifier: Identifier assigned by the lab
.... identifier:obf-FillerOrderNumber 0..1FillerOrderNumberFillerOrderNumber: Identifier assigned by the lab carrying out the test
.... identifier:obf-PlacerOrderNumber 0..1PlacerOrderNumberPlacerOrderNumber: Identifier assigned by the requester of the lab
... category Binding: Observation Category Codes (extensible)
... code Binding: TumorMarkerTestVS (extensible)
... subject Reference(obf-Patient)The subject of an observation
... performer Reference(Practitioner | Organization)The practitioner that carried out the observation or action
... value[x] A restricted set of value types that could be associated with a tumor marker test
.... valueQuantityQuantity
.... valueCodeableConceptCodeableConcept
.... valueStringstring
.... valueRatioRatio
... bodySite 0..0
... device Reference(http://fhir.org/guides/argonaut/StructureDefinition/argo-device)
... referenceRange 0..1
.... extension Slice: Unordered, Open by value:url
.... obf-ApplicableSubpopulation-extension 0..1CodeableConceptApplicableSubpopulation
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-ApplicableSubpopulation-extension
Binding: referencerange-appliesto (extensible)
.... meaning Binding: Observation Reference Range Meaning Codes (extensible)
... related 0..1
.... type Fixed Value: has-member
.... target Reference(obf-Observation)
... component
.... value[x]
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueRangeRange
..... valueRatioRatio
..... valueSampledDataSampledData
..... valueTimetime
..... valueDateTimedateTime
..... valuePeriodPeriod
.... referenceRange
..... meaning Binding: Observation Reference Range Meaning Codes (extensible)

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation I0..*onco-core-TumorMarkerTest
obs-6: SHALL only be present if Observation.value[x] is not present
obs-7: Component code SHALL not be same as observation code
arg-2: If there is no component or related element then either a value[x] or a data absent reason must be present
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
.... id 0..1idxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
Slice: Unordered, Open by value:url
.... obf-SourceSystem-extension 0..1uriSourceSystem
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-SourceSystem-extension
.... versionId Σ0..1idVersion specific identifier
.... lastUpdated Σ0..1instantWhen the resource version last changed
.... profile Σ0..*uriProfiles this resource claims to conform to
.... security Σ0..*CodingSecurity Labels applied to this resource
Binding: All Security Labels (extensible)
.... tag Σ0..*CodingTags applied to this resource
Binding: (unbound) (example)
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: http://tools.ietf.org/html/bcp47 (required)
... text I0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional Content defined by implementations
Slice: Unordered, Open by value:url
... obf-ObservationBasedOn-extension 0..*Reference(obf-ProcedureRequest | ReferralRequest)ObservationBasedOn
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-ObservationBasedOn-extension
... obf-ObservationPartOf-extension 0..*Reference(obf-MedicationAdministration | obf-MedicationDispense | obf-MedicationStatement | obf-Procedure)ObservationPartOf
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-ObservationPartOf-extension
... obf-Annotation-extension 0..*AnnotationAnnotation
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-Annotation-extension
... obf-ObservationDerivedFrom-extension 0..*Reference(DocumentReference | Media | obf-QuestionnaireResponse | obf-Observation)ObservationDerivedFrom
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-ObservationDerivedFrom-extension
... modifierExtension ?!0..*(Slice Definition)Extensions that cannot be ignored
Slice: Unordered, Open by exists:url
.... modifierExtension:focalsubject ?!S0..*FocalSubject
..... id 0..1idxml:id (or equivalent in JSON)
..... url 1..1uri"http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-FocalSubject-extension"
..... valueReference 1..1Reference(obf-Resource)Resource: Parent class for any item in clinical or administrative health-related system
... identifier 0..*(Slice Definition)Unique Id for this particular observation
Slice: Unordered, Open by value:type.coding.code
.... identifier:obf-AccessionIdentifier 0..1AccessionIdentifierAccessionIdentifier: Identifier assigned by the lab
.... identifier:obf-FillerOrderNumber 0..1FillerOrderNumberFillerOrderNumber: Identifier assigned by the lab carrying out the test
.... identifier:obf-PlacerOrderNumber 0..1PlacerOrderNumberPlacerOrderNumber: Identifier assigned by the requester of the lab
... status ?!S1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required)
... category S1..1CodeableConceptClassification of type of observation
Binding: Observation Category Codes (extensible)
Required Pattern: At least the following
.... id0..1stringxml:id (or equivalent in JSON)
.... extension0..*ExtensionAdditional Content defined by implementations
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... id0..1stringxml:id (or equivalent in JSON)
..... extension0..*ExtensionAdditional Content defined by implementations
..... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/observation-category
..... version0..1stringVersion of the system - if relevant
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: laboratory
..... display0..1stringRepresentation defined by the system
..... userSelected1..1booleanIf this coding was chosen directly by the user
Fixed Value: false
.... text0..1stringPlain text representation of the concept
... code S1..1CodeableConceptLab Test Name
Binding: TumorMarkerTestVS (extensible)
... subject S1..1Reference(obf-Patient)The subject of an observation
... encounter 0..1Reference(Encounter)Healthcare event during which this observation is made
... effective[x] SI0..1Clinically relevant time/time-period for observation
arg-1: Datetime must be at least to day.
.... effectiveDateTimedateTime
.... effectivePeriodPeriod
... issued Σ0..1instantDate/Time this was made available
... performer Σ0..*Reference(Practitioner | Organization)The practitioner that carried out the observation or action
... value[x] SI0..1A restricted set of value types that could be associated with a tumor marker test
arg-3: SHALL use UCUM for coded quantity units.
arg-4: SHOULD use Snomed CT for coded Results
.... valueQuantityQuantity
.... valueCodeableConceptCodeableConcept
.... valueStringstring
.... valueRatioRatio
... dataAbsentReason SI0..1CodeableConceptWhy the result is missing
Binding: Observation Value Absent Reason (extensible)
... interpretation 0..1CodeableConceptHigh, low, normal, etc.
Binding: Observation Interpretation Codes (extensible)
... comments 0..1stringComments about result
... method 0..1CodeableConceptHow it was done
Binding: Observation Methods (example)
... specimen 0..1Reference(Specimen)Specimen used for this observation
... device 0..1Reference(http://fhir.org/guides/argonaut/StructureDefinition/argo-device)(Measurement) Device
... referenceRange I0..1BackboneElementProvides guide for interpretation
obs-3: Must have at least a low or a high or text
.... id 0..1idxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
Slice: Unordered, Open by value:url
.... obf-ApplicableSubpopulation-extension 0..1CodeableConceptApplicableSubpopulation
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-ApplicableSubpopulation-extension
Binding: referencerange-appliesto (extensible)
.... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
.... low I0..1SimpleQuantityLow Range, if relevant
.... high I0..1SimpleQuantityHigh Range, if relevant
.... meaning 0..1CodeableConceptIndicates the meaning/use of this range of this range
Binding: Observation Reference Range Meaning Codes (extensible)
.... age 0..1RangeApplicable age range, if relevant
.... text 0..1stringText based reference range in an observation
... related Σ0..1BackboneElementResource related to this observation
.... id 0..1idxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
.... type 0..1codehas-member | derived-from | sequel-to | replaces | qualified-by | interfered-by
Binding: ObservationRelationshipType (required)
Fixed Value: has-member
.... target 1..1Reference(obf-Observation)Resource that is related to this one
... component Σ0..*BackboneElementComponent results
.... id 0..1idxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
.... code ΣI1..1CodeableConceptType of component observation (code / type)
Binding: LOINC Codes (example)
.... value[x] Σ0..1Actual component result
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueRangeRange
..... valueRatioRatio
..... valueSampledDataSampledData
..... valueTimetime
..... valueDateTimedateTime
..... valuePeriodPeriod
.... dataAbsentReason I0..1CodeableConceptWhy the component result is missing
Binding: Observation Value Absent Reason (extensible)
.... referenceRange 0..*BackboneElementProvides guide for interpretation of component result
..... id 0..1idxml:id (or equivalent in JSON)
..... extension 0..*ExtensionAdditional Content defined by implementations
..... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
..... low I0..1SimpleQuantityLow Range, if relevant
..... high I0..1SimpleQuantityHigh Range, if relevant
..... meaning 0..1CodeableConceptIndicates the meaning/use of this range of this range
Binding: Observation Reference Range Meaning Codes (extensible)
..... age 0..1RangeApplicable age range, if relevant
..... text 0..1stringText based reference range in an observation

doco Documentation for this format

Summary

Must-Support: 1 element
Fixed Value: 1 element
Prohibited: 1 element

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element Observation.identifier is sliced based on the value of value:type.coding.code

Mapping Source

This structure represents the following mapping definition:

onco.core.TumorMarkerTest maps to http://fhir.org/guides/argonaut/StructureDefinition/argo-observationresults:
  Language maps to language
  ImplicitRules maps to implicitRules
  Metadata.VersionId maps to meta.versionId
  Metadata.SourceSystem maps to meta.extension
  Metadata.Profile maps to meta.profile
  Metadata.LastUpdated maps to meta.lastUpdated
  Metadata.SecurityLabel maps to meta.security
  Metadata.Tag maps to meta.tag
  Narrative maps to text
  Identifier maps to identifier (slice on = type.coding.code; slice strategy = includes)
  ObservationBasedOn maps to extension
  ObservationPartOf maps to extension
  Status maps to status
  Category maps to category
  Code maps to code
  ObservationSubjectOfRecord maps to subject
  FocalSubject maps to modifierExtension
  CareContext maps to encounter
  RelevantTime maps to effective[x]
  StatementDateTime maps to issued
  LaboratoryObservationPerformer maps to performer (slice on = target.reference.resolve(); slice on type = profile; slice strategy = includes)
  TumorMarkerTestDataValue maps to value[x]
  DataAbsentReason maps to dataAbsentReason
  Interpretation maps to interpretation
  Annotation maps to extension
  BodyLocation.Code maps to bodySite
  BodyLocation.Laterality maps to bodySite.extension
  BodyLocation.AnatomicalOrientation maps to bodySite.extension
  BodyLocation.RelationToLandmark maps to bodySite.extension
  Method maps to method
  Specimen maps to specimen
  Device maps to device
  ReferenceRange maps to referenceRange
  ReferenceRange.LowerBound maps to referenceRange.low
  ReferenceRange.UpperBound maps to referenceRange.high
  ReferenceRange.Type maps to referenceRange.meaning
  ReferenceRange.ApplicableSubpopulation maps to referenceRange.extension
  ReferenceRange.ApplicableAgeRange maps to referenceRange.age
  ReferenceRange.Text maps to referenceRange.text
  fix related.type to #has-member
  PanelMembers maps to related
  PanelMembers.Observation maps to related.target (slice at = related; slice on = target.reference.resolve(); slice on type = profile; slice strategy = includes)
  ObservationDerivedFrom maps to extension
  Components.ObservationComponent maps to component (slice on = code.coding.code; slice strategy = includes)
  Components.ObservationComponent.Code maps to component.code
  Components.ObservationComponent.DataValue maps to component.value[x]
  Components.ObservationComponent.DataAbsentReason maps to component.dataAbsentReason
  Components.ObservationComponent.ReferenceRange maps to component.referenceRange
  Components.ObservationComponent.ReferenceRange.LowerBound maps to component.referenceRange.low
  Components.ObservationComponent.ReferenceRange.UpperBound maps to component.referenceRange.high
  Components.ObservationComponent.ReferenceRange.Type maps to component.referenceRange.meaning
  Components.ObservationComponent.ReferenceRange.ApplicableAgeRange maps to component.referenceRange.age
  Components.ObservationComponent.ReferenceRange.Text maps to component.referenceRange.text

Differential View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation onco-core-TumorMarkerTest
... meta
.... extension Slice: Unordered, Open by value:url
.... obf-SourceSystem-extension 0..1uriSourceSystem
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-SourceSystem-extension
... extension Slice: Unordered, Open by value:url
... obf-ObservationBasedOn-extension 0..*Reference(obf-ProcedureRequest | ReferralRequest)ObservationBasedOn
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-ObservationBasedOn-extension
... obf-ObservationPartOf-extension 0..*Reference(obf-MedicationAdministration | obf-MedicationDispense | obf-MedicationStatement | obf-Procedure)ObservationPartOf
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-ObservationPartOf-extension
... obf-Annotation-extension 0..*AnnotationAnnotation
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-Annotation-extension
... obf-ObservationDerivedFrom-extension 0..*Reference(DocumentReference | Media | obf-QuestionnaireResponse | obf-Observation)ObservationDerivedFrom
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-ObservationDerivedFrom-extension
... modifierExtension (Slice Definition)Slice: Unordered, Open by value:url
... modifierExtension:focalsubject ?!S0..*FocalSubject
.... valueReference Reference(obf-Resource)Resource: Parent class for any item in clinical or administrative health-related system
... identifier (Slice Definition)Slice: Unordered, Open by value:type.coding.code
.... identifier:obf-AccessionIdentifier 0..1AccessionIdentifierAccessionIdentifier: Identifier assigned by the lab
.... identifier:obf-FillerOrderNumber 0..1FillerOrderNumberFillerOrderNumber: Identifier assigned by the lab carrying out the test
.... identifier:obf-PlacerOrderNumber 0..1PlacerOrderNumberPlacerOrderNumber: Identifier assigned by the requester of the lab
... category Binding: Observation Category Codes (extensible)
... code Binding: TumorMarkerTestVS (extensible)
... subject Reference(obf-Patient)The subject of an observation
... performer Reference(Practitioner | Organization)The practitioner that carried out the observation or action
... value[x] A restricted set of value types that could be associated with a tumor marker test
.... valueQuantityQuantity
.... valueCodeableConceptCodeableConcept
.... valueStringstring
.... valueRatioRatio
... bodySite 0..0
... device Reference(http://fhir.org/guides/argonaut/StructureDefinition/argo-device)
... referenceRange 0..1
.... extension Slice: Unordered, Open by value:url
.... obf-ApplicableSubpopulation-extension 0..1CodeableConceptApplicableSubpopulation
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-ApplicableSubpopulation-extension
Binding: referencerange-appliesto (extensible)
.... meaning Binding: Observation Reference Range Meaning Codes (extensible)
... related 0..1
.... type Fixed Value: has-member
.... target Reference(obf-Observation)
... component
.... value[x]
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueRangeRange
..... valueRatioRatio
..... valueSampledDataSampledData
..... valueTimetime
..... valueDateTimedateTime
..... valuePeriodPeriod
.... referenceRange
..... meaning Binding: Observation Reference Range Meaning Codes (extensible)

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation I0..*onco-core-TumorMarkerTest
obs-6: SHALL only be present if Observation.value[x] is not present
obs-7: Component code SHALL not be same as observation code
arg-2: If there is no component or related element then either a value[x] or a data absent reason must be present
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
.... id 0..1idxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
Slice: Unordered, Open by value:url
.... obf-SourceSystem-extension 0..1uriSourceSystem
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-SourceSystem-extension
.... versionId Σ0..1idVersion specific identifier
.... lastUpdated Σ0..1instantWhen the resource version last changed
.... profile Σ0..*uriProfiles this resource claims to conform to
.... security Σ0..*CodingSecurity Labels applied to this resource
Binding: All Security Labels (extensible)
.... tag Σ0..*CodingTags applied to this resource
Binding: (unbound) (example)
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: http://tools.ietf.org/html/bcp47 (required)
... text I0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... extension 0..*ExtensionAdditional Content defined by implementations
Slice: Unordered, Open by value:url
... obf-ObservationBasedOn-extension 0..*Reference(obf-ProcedureRequest | ReferralRequest)ObservationBasedOn
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-ObservationBasedOn-extension
... obf-ObservationPartOf-extension 0..*Reference(obf-MedicationAdministration | obf-MedicationDispense | obf-MedicationStatement | obf-Procedure)ObservationPartOf
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-ObservationPartOf-extension
... obf-Annotation-extension 0..*AnnotationAnnotation
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-Annotation-extension
... obf-ObservationDerivedFrom-extension 0..*Reference(DocumentReference | Media | obf-QuestionnaireResponse | obf-Observation)ObservationDerivedFrom
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-ObservationDerivedFrom-extension
... modifierExtension ?!0..*(Slice Definition)Extensions that cannot be ignored
Slice: Unordered, Open by exists:url
.... modifierExtension:focalsubject ?!S0..*FocalSubject
..... id 0..1idxml:id (or equivalent in JSON)
..... url 1..1uri"http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-FocalSubject-extension"
..... valueReference 1..1Reference(obf-Resource)Resource: Parent class for any item in clinical or administrative health-related system
... identifier 0..*(Slice Definition)Unique Id for this particular observation
Slice: Unordered, Open by value:type.coding.code
.... identifier:obf-AccessionIdentifier 0..1AccessionIdentifierAccessionIdentifier: Identifier assigned by the lab
.... identifier:obf-FillerOrderNumber 0..1FillerOrderNumberFillerOrderNumber: Identifier assigned by the lab carrying out the test
.... identifier:obf-PlacerOrderNumber 0..1PlacerOrderNumberPlacerOrderNumber: Identifier assigned by the requester of the lab
... status ?!S1..1coderegistered | preliminary | final | amended +
Binding: ObservationStatus (required)
... category S1..1CodeableConceptClassification of type of observation
Binding: Observation Category Codes (extensible)
Required Pattern: At least the following
.... id0..1stringxml:id (or equivalent in JSON)
.... extension0..*ExtensionAdditional Content defined by implementations
.... coding1..*CodingCode defined by a terminology system
Fixed Value: (complex)
..... id0..1stringxml:id (or equivalent in JSON)
..... extension0..*ExtensionAdditional Content defined by implementations
..... system1..1uriIdentity of the terminology system
Fixed Value: http://hl7.org/fhir/observation-category
..... version0..1stringVersion of the system - if relevant
..... code1..1codeSymbol in syntax defined by the system
Fixed Value: laboratory
..... display0..1stringRepresentation defined by the system
..... userSelected1..1booleanIf this coding was chosen directly by the user
Fixed Value: false
.... text0..1stringPlain text representation of the concept
... code S1..1CodeableConceptLab Test Name
Binding: TumorMarkerTestVS (extensible)
... subject S1..1Reference(obf-Patient)The subject of an observation
... encounter 0..1Reference(Encounter)Healthcare event during which this observation is made
... effective[x] SI0..1Clinically relevant time/time-period for observation
arg-1: Datetime must be at least to day.
.... effectiveDateTimedateTime
.... effectivePeriodPeriod
... issued Σ0..1instantDate/Time this was made available
... performer Σ0..*Reference(Practitioner | Organization)The practitioner that carried out the observation or action
... value[x] SI0..1A restricted set of value types that could be associated with a tumor marker test
arg-3: SHALL use UCUM for coded quantity units.
arg-4: SHOULD use Snomed CT for coded Results
.... valueQuantityQuantity
.... valueCodeableConceptCodeableConcept
.... valueStringstring
.... valueRatioRatio
... dataAbsentReason SI0..1CodeableConceptWhy the result is missing
Binding: Observation Value Absent Reason (extensible)
... interpretation 0..1CodeableConceptHigh, low, normal, etc.
Binding: Observation Interpretation Codes (extensible)
... comments 0..1stringComments about result
... method 0..1CodeableConceptHow it was done
Binding: Observation Methods (example)
... specimen 0..1Reference(Specimen)Specimen used for this observation
... device 0..1Reference(http://fhir.org/guides/argonaut/StructureDefinition/argo-device)(Measurement) Device
... referenceRange I0..1BackboneElementProvides guide for interpretation
obs-3: Must have at least a low or a high or text
.... id 0..1idxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
Slice: Unordered, Open by value:url
.... obf-ApplicableSubpopulation-extension 0..1CodeableConceptApplicableSubpopulation
URL: http://mcodeinitiative.org/us/mcode/StructureDefinition/obf-ApplicableSubpopulation-extension
Binding: referencerange-appliesto (extensible)
.... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
.... low I0..1SimpleQuantityLow Range, if relevant
.... high I0..1SimpleQuantityHigh Range, if relevant
.... meaning 0..1CodeableConceptIndicates the meaning/use of this range of this range
Binding: Observation Reference Range Meaning Codes (extensible)
.... age 0..1RangeApplicable age range, if relevant
.... text 0..1stringText based reference range in an observation
... related Σ0..1BackboneElementResource related to this observation
.... id 0..1idxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
.... type 0..1codehas-member | derived-from | sequel-to | replaces | qualified-by | interfered-by
Binding: ObservationRelationshipType (required)
Fixed Value: has-member
.... target 1..1Reference(obf-Observation)Resource that is related to this one
... component Σ0..*BackboneElementComponent results
.... id 0..1idxml:id (or equivalent in JSON)
.... extension 0..*ExtensionAdditional Content defined by implementations
.... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
.... code ΣI1..1CodeableConceptType of component observation (code / type)
Binding: LOINC Codes (example)
.... value[x] Σ0..1Actual component result
..... valueQuantityQuantity
..... valueCodeableConceptCodeableConcept
..... valueStringstring
..... valueRangeRange
..... valueRatioRatio
..... valueSampledDataSampledData
..... valueTimetime
..... valueDateTimedateTime
..... valuePeriodPeriod
.... dataAbsentReason I0..1CodeableConceptWhy the component result is missing
Binding: Observation Value Absent Reason (extensible)
.... referenceRange 0..*BackboneElementProvides guide for interpretation of component result
..... id 0..1idxml:id (or equivalent in JSON)
..... extension 0..*ExtensionAdditional Content defined by implementations
..... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
..... low I0..1SimpleQuantityLow Range, if relevant
..... high I0..1SimpleQuantityHigh Range, if relevant
..... meaning 0..1CodeableConceptIndicates the meaning/use of this range of this range
Binding: Observation Reference Range Meaning Codes (extensible)
..... age 0..1RangeApplicable age range, if relevant
..... text 0..1stringText based reference range in an observation

doco Documentation for this format

Downloads: StructureDefinition: (XML, JSON, TTL), Schema: XML Schematron

 

Terminology Bindings

PathConformanceValueSet / Code
Observation-argoprofile.meta.securityextensibleAll Security Labels
Observation-argoprofile.meta.tagexample
Observation-argoprofile.languagerequiredhttp://tools.ietf.org/html/bcp47
Observation-argoprofile.statusrequiredObservationStatus
Observation-argoprofile.categoryextensiblePattern: laboratory
Observation-argoprofile.codeextensibleTumorMarkerTestVS
Observation-argoprofile.dataAbsentReasonextensibleObservation Value Absent Reason
Observation-argoprofile.interpretationextensibleObservation Interpretation Codes
Observation-argoprofile.methodexampleObservation Methods
Observation-argoprofile.referenceRange.meaningextensibleObservation Reference Range Meaning Codes
Observation-argoprofile.related.typerequiredFixed Value: has-member
Observation-argoprofile.component.codeexampleLOINC Codes
Observation-argoprofile.component.dataAbsentReasonextensibleObservation Value Absent Reason
Observation-argoprofile.component.referenceRange.meaningextensibleObservation Reference Range Meaning Codes

 

Constraints

IdPathDetailsRequirements
obs-6ObservationSHALL only be present if Observation.value[x] is not present
:
obs-7ObservationComponent code SHALL not be same as observation code
:
arg-2ObservationIf there is no component or related element then either a value[x] or a data absent reason must be present
: (component.empty() and related.empty()) implies (dataAbsentReason or value)
arg-1Observation.effective[x]Datetime must be at least to day.
: length() >= 8
arg-3Observation.value[x]SHALL use UCUM for coded quantity units.
: valueQuantity.system.empty() or valueQuantity.system = 'http://unitsofmeasure.org'
arg-4Observation.value[x]SHOULD use Snomed CT for coded Results
: valueCodeableConcept.coding.system.empty() or valueCodeableConcept.coding.system = 'http://snomed.info/sct'
obs-3Observation.referenceRangeMust have at least a low or a high or text
: