Pharmaceutical Quality (Industry)
1.0.0 - trial-use International flag

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/uv-dx-pq/ and changes regularly. See the Directory of published versions

Resource Profile: Observation - Test Result

Official URL: http://hl7.org/fhir/uv/pharm-quality/StructureDefinition/Observation-test-result-drug-pq Version: 1.0.0
Active as of 2024-04-11 Computable Name: ObservationTestResultDrugPq
Other Identifiers: OID:2.16.840.1.113883.4.642.40.41.42.31

This Observation profile represents the result of a specific test defined by an ObservationDefinition resource.

Usage:

Formal Views of Profile Content

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

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..* Observation Measurements and simple assertions
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... workflow-triggeredBy S 0..1 canonical(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), Reference(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), uri workflow-triggeredBy
URL: http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy
... status S 1..1 code registered | preliminary | final | amended +
... value[x] S 0..1 Actual result
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Observation.codeexampleVsDevicePropertyPQ (a valid code from Device Property Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceProperty-pq
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* Observation Measurements and simple assertions
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value).
obs-8: bodyStructure SHALL only be present if Observation.bodySite is not present
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... modifierExtension ?!Σ 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.

... code SΣC 1..1 CodeableConcept Type of observation (code / type)
Binding: Device Properties (example)
... value[x] SΣC 0..1 Actual result
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|5.0.0
from the FHIR Standard
Observation.codeexampleVsDevicePropertyPQ (a valid code from Device Property Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceProperty-pq
from this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value).
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
obs-8errorObservationbodyStructure SHALL only be present if Observation.bodySite is not present
: bodySite.exists() implies bodyStructure.empty()
NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* Observation Measurements and simple assertions
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value).
obs-8: bodyStructure SHALL only be present if Observation.bodySite is not 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: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... 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
... workflow-triggeredBy S 0..1 canonical(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), Reference(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), uri workflow-triggeredBy
URL: http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for observation
... instantiates[x] Σ 0..1 canonical(ObservationDefinition), Reference(ObservationDefinition) Instantiates FHIR ObservationDefinition
... basedOn Σ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
... triggeredBy 0..* BackboneElement Triggering observation(s)
.... 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
.... observation Σ 1..1 Reference(Observation) Triggering observation
.... type Σ 1..1 code reflex | repeat | re-run
Binding: TriggeredBytype (required): The type of TriggeredBy Observation.

.... reason 0..1 string Reason that the observation was triggered
... partOf Σ 0..* Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy | GenomicStudy) Part of referenced event
... status ?!SΣ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... category 0..* CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


... code SΣC 1..1 CodeableConcept Type of observation (code / type)
Binding: Device Properties (example)
... subject Σ 0..1 Reference(Patient | Group | Device | Location | Organization | Procedure | Practitioner | Medication | Substance | BiologicallyDerivedProduct | NutritionProduct) 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] Σ 0..1 Clinically relevant time/time-period for observation
.... effectiveDateTime dateTime
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... 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 0..1 Actual result
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... valueAttachment Attachment
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

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


... note 0..* Annotation Comments about the observation
... bodySite C 0..1 CodeableConcept Observed body part
Binding: SNOMEDCTBodyStructures (example): SNOMED CT Body site concepts

... bodyStructure C 0..1 Reference(BodyStructure) Observed body structure
... method 0..1 CodeableConcept How it was done
Binding: ObservationMethods (example): Methods for simple observations.

... specimen C 0..1 Reference(Specimen | Group) Specimen used for this observation
obs-9: If Observation.specimen is a reference to Group, the group can only have specimens
... device 0..1 Reference(Device | DeviceMetric) A reference to the device that generates the measurements or the device settings for the 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
.... normalValue 0..1 CodeableConcept Normal value, if relevant
Binding: ObservationReferenceRangeNormalValueCodes (extensible): Codes identifying the normal value of the observation.

.... 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 C 0..1 markdown 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 | ImagingSelection | QuestionnaireResponse | Observation | MolecularSequence | GenomicStudy) Related resource from which the observation is made
... component ΣC 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 ΣC 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
..... valueAttachment Attachment
..... valueReference Reference(MolecularSequence)
.... dataAbsentReason 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

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


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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Observation.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Observation.triggeredBy.typerequiredTriggeredBytype
http://hl7.org/fhir/ValueSet/observation-triggeredbytype|5.0.0
from the FHIR Standard
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|5.0.0
from the FHIR Standard
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.codeexampleVsDevicePropertyPQ (a valid code from Device Property Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceProperty-pq
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.normalValueextensibleObservationReferenceRangeNormalValueCodes
http://hl7.org/fhir/ValueSet/observation-referencerange-normalvalue
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
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value).
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
obs-8errorObservationbodyStructure SHALL only be present if Observation.bodySite is not present
: bodySite.exists() implies bodyStructure.empty()
obs-9errorObservation.specimenIf Observation.specimen is a reference to Group, the group can only have specimens
: (reference.resolve().exists() and reference.resolve() is Group) implies reference.resolve().member.entity.resolve().all($this is Specimen)

This structure is derived from Observation

Summary

Must-Support: 4 elements

Extensions

This structure refers to these extensions:

Differential View

This structure is derived from Observation

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation 0..* Observation Measurements and simple assertions
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... workflow-triggeredBy S 0..1 canonical(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), Reference(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), uri workflow-triggeredBy
URL: http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy
... status S 1..1 code registered | preliminary | final | amended +
... value[x] S 0..1 Actual result
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
Observation.codeexampleVsDevicePropertyPQ (a valid code from Device Property Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceProperty-pq
from this IG

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* Observation Measurements and simple assertions
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value).
obs-8: bodyStructure SHALL only be present if Observation.bodySite is not present
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
... modifierExtension ?!Σ 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.

... code SΣC 1..1 CodeableConcept Type of observation (code / type)
Binding: Device Properties (example)
... value[x] SΣC 0..1 Actual result
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|5.0.0
from the FHIR Standard
Observation.codeexampleVsDevicePropertyPQ (a valid code from Device Property Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceProperty-pq
from this IG

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value).
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
obs-8errorObservationbodyStructure SHALL only be present if Observation.bodySite is not present
: bodySite.exists() implies bodyStructure.empty()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* Observation Measurements and simple assertions
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value).
obs-8: bodyStructure SHALL only be present if Observation.bodySite is not 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: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... 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
... workflow-triggeredBy S 0..1 canonical(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), Reference(ActivityDefinition | Measure | OperationDefinition | PlanDefinition | Questionnaire), uri workflow-triggeredBy
URL: http://hl7.org/fhir/StructureDefinition/workflow-triggeredBy
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..* Identifier Business Identifier for observation
... instantiates[x] Σ 0..1 canonical(ObservationDefinition), Reference(ObservationDefinition) Instantiates FHIR ObservationDefinition
... basedOn Σ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
... triggeredBy 0..* BackboneElement Triggering observation(s)
.... 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
.... observation Σ 1..1 Reference(Observation) Triggering observation
.... type Σ 1..1 code reflex | repeat | re-run
Binding: TriggeredBytype (required): The type of TriggeredBy Observation.

.... reason 0..1 string Reason that the observation was triggered
... partOf Σ 0..* Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy | GenomicStudy) Part of referenced event
... status ?!SΣ 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

... category 0..* CodeableConcept Classification of type of observation
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


... code SΣC 1..1 CodeableConcept Type of observation (code / type)
Binding: Device Properties (example)
... subject Σ 0..1 Reference(Patient | Group | Device | Location | Organization | Procedure | Practitioner | Medication | Substance | BiologicallyDerivedProduct | NutritionProduct) 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] Σ 0..1 Clinically relevant time/time-period for observation
.... effectiveDateTime dateTime
.... effectivePeriod Period
.... effectiveTiming Timing
.... effectiveInstant instant
... 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 0..1 Actual result
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... valueAttachment Attachment
... dataAbsentReason C 0..1 CodeableConcept Why the result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

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


... note 0..* Annotation Comments about the observation
... bodySite C 0..1 CodeableConcept Observed body part
Binding: SNOMEDCTBodyStructures (example): SNOMED CT Body site concepts

... bodyStructure C 0..1 Reference(BodyStructure) Observed body structure
... method 0..1 CodeableConcept How it was done
Binding: ObservationMethods (example): Methods for simple observations.

... specimen C 0..1 Reference(Specimen | Group) Specimen used for this observation
obs-9: If Observation.specimen is a reference to Group, the group can only have specimens
... device 0..1 Reference(Device | DeviceMetric) A reference to the device that generates the measurements or the device settings for the 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
.... normalValue 0..1 CodeableConcept Normal value, if relevant
Binding: ObservationReferenceRangeNormalValueCodes (extensible): Codes identifying the normal value of the observation.

.... 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 C 0..1 markdown 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 | ImagingSelection | QuestionnaireResponse | Observation | MolecularSequence | GenomicStudy) Related resource from which the observation is made
... component ΣC 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 ΣC 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
..... valueAttachment Attachment
..... valueReference Reference(MolecularSequence)
.... dataAbsentReason 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

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


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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
Observation.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Observation.triggeredBy.typerequiredTriggeredBytype
http://hl7.org/fhir/ValueSet/observation-triggeredbytype|5.0.0
from the FHIR Standard
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|5.0.0
from the FHIR Standard
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.codeexampleVsDevicePropertyPQ (a valid code from Device Property Codes)
http://hl7.org/fhir/uv/pharm-quality/ValueSet/vs-deviceProperty-pq
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.normalValueextensibleObservationReferenceRangeNormalValueCodes
http://hl7.org/fhir/ValueSet/observation-referencerange-normalvalue
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
dom-2errorObservationIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorObservationIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorObservationIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorObservationIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceObservationA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
obs-3errorObservation.referenceRangeMust have at least a low or a high or text
: low.exists() or high.exists() or text.exists()
obs-6errorObservationdataAbsentReason SHALL only be present if Observation.value[x] is not present
: dataAbsentReason.empty() or value.empty()
obs-7errorObservationIf Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value).
: value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
obs-8errorObservationbodyStructure SHALL only be present if Observation.bodySite is not present
: bodySite.exists() implies bodyStructure.empty()
obs-9errorObservation.specimenIf Observation.specimen is a reference to Group, the group can only have specimens
: (reference.resolve().exists() and reference.resolve() is Group) implies reference.resolve().member.entity.resolve().all($this is Specimen)

This structure is derived from Observation

Summary

Must-Support: 4 elements

Extensions

This structure refers to these extensions:

 

Other representations of profile: CSV, Excel, Schematron