ObservationResults: Laboratory - MyHealth@EU Laboratory Report v9.2.0

MyHealth@EU Laboratory Report - Local Development build (v9.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: ObservationResults: Laboratory

Official URL: http://fhir.ehdsi.eu/laboratory/StructureDefinition/Observation-resultslab-lab-myhealtheu				Version: 9.2.0
Standards status: Trial-use			Maturity Level: 2	Computable Name: ObservationResultsLaboratoryMyHealthEu

This profile constrains the Observation resource to represent results produced by laboratory tests or panels/studies for the purpose of this guide. This observation may represent the result of a simple laboratory test such as hematocrit or it may group the set of results produced by a multi-test study or panel such as a complete blood count, a dynamic function test, a urine specimen study. In the latter case, the observation carries the overall conclusion of the study and or a global interpretation by the producer of the study, in the comment element; and references the atomic results of the study as "has-member" child observations.

This profile constrains the Observation resource to represent a laboratory in vitro diagnostic test or panel/study. In case of a panel/study, the results of the panel appear as sub-observations. In this case this top-level Observation acts as a grouper of all the observations belonging to the panel or study. The top-level observation may carry a conclusion in the value element and or a global interpretation by the producer of the study, in the comment element.

Usages:

Use this Profile: Bundle: Laboratory
Refer to this Profile: DiagnosticReport: Laboratory and ObservationResults: Laboratory
Examples for this Profile: Observation/ObservationLaboratoryExample, Observation/SampleBloodGroupObservation and Observation/d29b286d-b99c-410f-af4e-9455ea49d0af

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

Key Elements Table
Differential Table
Snapshot Table
Statistics/References
All

Description & Constraints Filter:

Observation C 0..* MedicalTestResultMyHealthCore Laboratory result for a simple test or for a panel/study
This profile also imposes the profile Observation Results: laboratory
Constraints: obs-6, obs-7, obs-value-1

Observation.implicitRules This element is a modifier element. This element is included in summaries. 0..1 uri A set of rules under which this content was created

Observation.Slices for extension Content/Rules for all slices

Observation.Slices for extension.extension:bodyStructure 0..1 Reference(Cross-version Profile for R5.BodyStructure for use in FHIR R4(0.1.0) | BodyStructure) R5: Observed body structure (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.bodyStructure
Constraints: ext-1

Observation.Slices for extension.extension:triggeredBy 0..* (Complex) R5: Triggering observation(s) (new)
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy
Constraints: ext-1

Observation.Slices for extension.extension:triggeredBy.Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

Observation.Slices for extension.extension:triggeredBy.Slices for extension Content/Rules for all slices

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation 1..1 Extension Extension
Constraints: ext-1

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.extension 0..0 Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.url 1..1 uri "observation"

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.value[x] 1..1 Reference(Observation: Medical Test Result (MyHealth@EU Core)) Triggering observation

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type 1..1 Extension R5: reflex | repeat | re-run (new)
Constraints: ext-1

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type.url 1..1 uri "type"

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type.value[x] 1..1 code reflex | repeat | re-run
Binding: R5ObservationTriggeredbytypeForR4 (0.1.0) (required): The type of TriggeredBy Observation.

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:reason 0..1 Extension R5: Reason that the observation was triggered (new)
Constraints: ext-1

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:reason.url 1..1 uri "reason"

Observation.Slices for extension.extension:triggeredBy.url 1..1 uri "http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"

Observation.Slices for extension.extension:value-r5 0..1 (Complex) only for Diagrams or Pictures
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value
Constraints: ext-1

Observation.Slices for extension.extension:value-r5.extension 0..0 Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

Observation.Slices for extension.extension:value-r5.url 1..1 uri "http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value"

Observation.Slices for extension.extension:supportingInfo 0..* Reference(Resource) Other information that may be relevant to this event.
URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo

Observation.Slices for extension.extension:labTestKit 0..* Reference(Device) Laboratory Test Kit
URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit

Observation.Slices for extension.extension:certifiedRefMaterialCodeable 0..* CodeableConcept Certified Reference Material: CodeableConcept
URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable
Binding: Laboratory Certified Reference Material (example)

Observation.Slices for extension.extension:certifiedRefMaterialIdentifer 0..* Identifier Certified Reference Material: Identifier
URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer

Observation.Slices for extension.extension:accredited 0..1 boolean Accredited test
URL: http://hl7.eu/fhir/StructureDefinition/laboratory-accredited

Observation.modifierExtension This element is a modifier element. 0..* Extension Extensions that cannot be ignored

basedOn

0..*

Fulfills plan, proposal or order

Obligations

Actor

SHOULD:handle

MyHealth@EU Handler

Observation.status This element is a modifier element. This element is included in summaries. 1..1 code registered | preliminary | final | amended +
Binding: ObservationStatus (required): Codes providing the status of an observation.

Observation.Slices for category 1..* CodeableConcept Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: eHDSI Observation category (extensible)

Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them

category:laboratory

1..1

CodeableConcept

Classification of type of observation
Binding: eHDSI Observation category (extensible)

Required Pattern:

{
  "coding" : [
    {
      "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
      "code" : "laboratory"
    }
  ]
}

Observation.Slices for category.category:studyType 0..* CodeableConcept The way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.)
Binding: Laboratory Study Types (required)

Observation.Slices for category.category:specialty 0..* CodeableConcept The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry)
Binding: Laboratory Specialty (required)

code

1..1

CodeableConcept

Type of observation (code / type)
Binding: eHDSI Laboratory Codes With Exceptions (required)

Obligations

Actor

SHALL:handle

MyHealth@EU Handler

Observation.subject This element is included in summaries. 1..1 Reference(Patient (MyHealth@EU Core)) Who and/or what the observation is about

Observation.focus This element is included in summaries. 0..* Reference(Patient (MyHealth@EU Core) | RelatedPerson: Animal specimen source | Location (MyHealth@EU Core)) What the observation is about, when it is not about the subject of record

effective[x]

1..1

Clinically relevant time/time-period for observation

Obligations

Actor

SHALL:handle

MyHealth@EU Handler

Observation.effective[x].effectiveDateTime dateTime

Observation.effective[x].effectivePeriod Period

performer

1..*

Reference(Practitioner (MyHealth@EU Core) | PractitionerRole (MyHealth@EU Core) | Organization (MyHealth@EU Core))

Who is responsible for the observation

Obligations

Actor

SHOULD:handle

MyHealth@EU Handler

Observation.performer.Slices for extension Content/Rules for all slices

Observation.performer.Slices for extension.extension:performerFunction 0..1 CodeableConcept Type of performance
URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction
Binding: Performer Function Codes (extensible)

Observation.Slices for value[x] This element is included in summaries. C 0..1 Laboratory result value
Slice: Unordered, Closed by type:$this
Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them Other type slices that contain no new information are not shown in this view

Observation.Slices for value[x].valueQuantity Quantity

Observation.Slices for value[x].valueCodeableConcept CodeableConcept

Observation.Slices for value[x].valueString string

Observation.Slices for value[x].valueBoolean boolean

Observation.Slices for value[x].valueInteger integer

Observation.Slices for value[x].valueRange Range

Observation.Slices for value[x].valueRatio Ratio

Observation.Slices for value[x].valueSampledData SampledData

Observation.Slices for value[x].valueTime time

Observation.Slices for value[x].valueDateTime dateTime

Observation.Slices for value[x].valuePeriod Period

Observation.Slices for value[x].value[x]:valueCodeableConcept This element is included in summaries. C 0..1 CodeableConcept Actual result
Binding: eHDSI Results Coded Value Laboratory With Exceptions (required)

Observation.Slices for value[x].value[x]:valueRange This element is included in summaries. C 0..1 RangeEuLab Actual result

Observation.Slices for value[x].value[x]:valueQuantity This element is included in summaries. C 0..1 QuantityMyHealth Actual result

Observation.Slices for value[x].value[x]:valueQuantity.Slices for extension Content/Rules for all slices

Observation.Slices for value[x].value[x]:valueQuantity.Slices for extension.extension:uncertainty 0..1 decimal Standard Deviation (same units as the quantity)
URL: http://hl7.org/fhir/StructureDefinition/iso21090-uncertainty

Observation.Slices for value[x].value[x]:valueQuantity.comparator This element is a modifier element. This element is included in summaries. 0..1 code < | <= | >= | > - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

Observation.Slices for value[x].value[x]:valueRatio This element is included in summaries. C 0..1 RatioMyHealth Actual result

Observation.method 0..1 CodeableConcept How it was done
Binding: eHDSI Laboratory Technique With Exceptions (required)

specimen

0..1

Reference(Specimen: Laboratory)

Specimen used for the observation

Obligations

Actor

SHOULD:handle

MyHealth@EU Handler

Observation.device 0..1 Reference(Device: Measuring) (Measurement) Device

Observation.hasMember This element is included in summaries. 0..* Reference(ObservationResults: Laboratory) Related resource that belongs to the Observation group

Observation.component This element is included in summaries. C 0..* BackboneElement Laboratory result
Constraints: obs-value-2

Observation.component.Slices for extension Content/Rules for all slices

Observation.component.Slices for extension.extension:value-r5 0..1 (Complex) only for Diagrams or Pictures
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value
Constraints: ext-1

Observation.component.Slices for extension.extension:value-r5.extension 0..0 Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

Observation.component.Slices for extension.extension:value-r5.url 1..1 uri "http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value"

Observation.component.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized

Observation.component.code This element is included in summaries. 1..1 CodeableConcept Type of component observation (code / type)
Binding: eHDSI Laboratory Codes With Exceptions (required)

Observation.component.Slices for value[x] This element is included in summaries. 0..1 CodeableConcept Actual component result
Slice: Unordered, Closed by type:$this

Observation.component.Slices for value[x].value[x]:valueCodeableConcept This element is included in summaries. 0..1 CodeableConcept Actual component result
Binding: eHDSI Results Coded Value Laboratory With Exceptions (required)

Observation.component.Slices for value[x].value[x]:valueQuantity This element is included in summaries. 0..1 QuantityMyHealth Actual component result

Observation.component.Slices for value[x].value[x]:valueQuantity.Slices for extension Content/Rules for all slices

Observation.component.Slices for value[x].value[x]:valueQuantity.Slices for extension.extension:uncertainty 0..1 decimal Standard Deviation (same units as the quantity)
URL: http://hl7.org/fhir/StructureDefinition/iso21090-uncertainty

Observation.component.Slices for value[x].value[x]:valueQuantity.comparator This element is a modifier element. This element is included in summaries. 0..1 code < | <= | >= | > - how to understand the value
Binding: QuantityComparator (required): How the Quantity should be understood and represented.

Observation.component.Slices for value[x].value[x]:valueRatio This element is included in summaries. 0..1 RatioMyHealth Actual component result

Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.extension:triggeredBy.extension:type.value[x]	Base	required	Cross-version ValueSet R5.TriggeredBytype for use in FHIR R4	📍0.1.0	Extensions for Using Data Elements from FHIR R5 in FHIR R4 v0.1
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	extensible	eHDSI Observation category	📦9.1.0	This IG
Observation.category:laboratory	Base	extensible	eHDSI Observation category	📦9.1.0	This IG
Observation.category:studyType	Base	required	Laboratory Study Types	📦2.1.0	HL7 Europe Laboratory Report v2.1
Observation.category:specialty	Base	required	Laboratory Specialty	📦2.1.0	HL7 Europe Laboratory Report v2.1
Observation.code	Base	required	eHDSI Laboratory Codes With Exceptions	📦1.0.1	This IG
Observation.value[x]:valueCodeableConcept	Base	required	eHDSI Results Coded Value Laboratory With Exceptions	📦1.0.1	This IG
Observation.value[x]:valueQuantity.comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.method	Base	required	eHDSI Laboratory Technique With Exceptions	📦1.0.1	This IG
Observation.component.code	Base	required	eHDSI Laboratory Codes With Exceptions	📦1.0.1	This IG
Observation.component.value[x]:valueCodeableConcept	Base	required	eHDSI Results Coded Value Laboratory With Exceptions	📦1.0.1	This IG
Observation.component.value[x]:valueQuantity.comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources	`contained.contained.empty()`
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	`contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4	error	Observation	If 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-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label	`contained.meta.security.empty()`
dom-6	best practice	Observation	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	ALL elements	All FHIR elements must have a @value or children	`hasValue() or (children().count() > id.count())`
ext-1	error	Observation.extension:bodyStructure, Observation.extension:triggeredBy, Observation.extension:triggeredBy.extension, Observation.extension:triggeredBy.extension:observation, Observation.extension:triggeredBy.extension:type, Observation.extension:triggeredBy.extension:reason, Observation.extension:value-r5, Observation.extension:supportingInfo, Observation.extension:labTestKit, Observation.extension:certifiedRefMaterialCodeable, Observation.extension:certifiedRefMaterialIdentifer, Observation.extension:accredited, Observation.modifierExtension, Observation.performer.extension:performerFunction, Observation.value[x]:valueQuantity.extension:uncertainty, Observation.component.extension:value-r5, Observation.component.modifierExtension, Observation.component.value[x]:valueQuantity.extension:uncertainty	Must have either extensions or value[x], not both	`extension.exists() != value.exists()`
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present	`dataAbsentReason.empty() or value.empty()`
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present	`value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()`
obs-value-1	error	Observation	The elements Observation.extension:value-r5 and Observation.value[x] SHALL not be used simultaneously.	`value.empty() or extension('http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value').empty()`
obs-value-2	error	Observation.component	The elements Observation.component.extension:value-r5 and Observation.component.value[x] SHALL not be used simultaneously.	`value.empty() or extension('http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value').empty()`

This structure is derived from MedicalTestResultMyHealthCore

Description & Constraints Filter:

Observation 0..* MedicalTestResultMyHealthCore Laboratory result for a simple test or for a panel/study
This profile also imposes the profile Observation Results: laboratory

Observation.Slices for extension Content/Rules for all slices

Observation.Slices for extension.extension:labTestKit 0..* Reference(Device) Laboratory Test Kit
URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit

Observation.Slices for extension.extension:accredited 0..1 boolean Accredited test
URL: http://hl7.eu/fhir/StructureDefinition/laboratory-accredited

basedOn

0..*

Fulfills plan, proposal or order

Obligations

Actor

SHOULD:handle

MyHealth@EU Handler

Observation.Slices for category 1..* CodeableConcept Classification of type of observation
Slice: Unordered, Open by pattern:$this
Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them

category:laboratory

1..1

CodeableConcept

Classification of type of observation
Required Pattern:

{
  "coding" : [
    {
      "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
      "code" : "laboratory"
    }
  ]
}

code

1..1

CodeableConcept

Type of observation (code / type)
Binding: eHDSI Laboratory Codes With Exceptions (required)

Obligations

Actor

SHALL:handle

MyHealth@EU Handler

Observation.focus 0..* Reference(Patient (MyHealth@EU Core) | RelatedPerson: Animal specimen source | Location (MyHealth@EU Core)) What the observation is about, when it is not about the subject of record

effective[x]

1..1

dateTime, Period

Clinically relevant time/time-period for observation

Obligations

Actor

SHALL:handle

MyHealth@EU Handler

performer

1..*

Reference(Practitioner (MyHealth@EU Core) | PractitionerRole (MyHealth@EU Core) | Organization (MyHealth@EU Core))

Who is responsible for the observation

Obligations

Actor

SHOULD:handle

MyHealth@EU Handler

Observation.value[x] 0..1 Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period Laboratory result value

Observation.Slices for value[x] Content/Rules for all slices

Observation.Slices for value[x].value[x]:valueCodeableConcept 0..1 CodeableConcept Actual result
Binding: eHDSI Results Coded Value Laboratory With Exceptions (required)

Observation.Slices for value[x].value[x]:valueRange 0..1 RangeEuLab Actual result

Observation.method 0..1 CodeableConcept How it was done
Binding: eHDSI Laboratory Technique With Exceptions (required)

specimen

0..1

Reference(Specimen: Laboratory)

Specimen used for the observation

Obligations

Actor

SHOULD:handle

MyHealth@EU Handler

Observation.device 0..1 Reference(Device: Measuring) (Measurement) Device

Observation.hasMember 0..* Reference(ObservationResults: Laboratory) Related resource that belongs to the Observation group

Observation.component 0..* BackboneElement Laboratory result

Observation.component.code 1..1 CodeableConcept Type of component observation (code / type)
Binding: eHDSI Laboratory Codes With Exceptions (required)

Observation.component.Slices for value[x] Content/Rules for all slices

Observation.component.Slices for value[x].value[x]:valueCodeableConcept 0..1 CodeableConcept Actual component result
Binding: eHDSI Results Coded Value Laboratory With Exceptions (required)

Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.category:studyType	Base	required	Laboratory Study Types	📦2.1.0	HL7 Europe Laboratory Report v2.1
Observation.category:specialty	Base	required	Laboratory Specialty	📦2.1.0	HL7 Europe Laboratory Report v2.1
Observation.code	Base	required	eHDSI Laboratory Codes With Exceptions	📦1.0.1	This IG
Observation.value[x]:valueCodeableConcept	Base	required	eHDSI Results Coded Value Laboratory With Exceptions	📦1.0.1	This IG
Observation.method	Base	required	eHDSI Laboratory Technique With Exceptions	📦1.0.1	This IG
Observation.component.code	Base	required	eHDSI Laboratory Codes With Exceptions	📦1.0.1	This IG
Observation.component.value[x]:valueCodeableConcept	Base	required	eHDSI Results Coded Value Laboratory With Exceptions	📦1.0.1	This IG

Description & Constraints Filter:

Observation.id This element is included in summaries. 0..1 id Logical id of this artifact

Observation.meta This element is included in summaries. 0..1 Meta Metadata about the resource

Observation.implicitRules This element is a modifier element. This element is included in summaries. 0..1 uri A set of rules under which this content was created

Observation.language 0..1 code Language of the observation
Binding: eHDSI Language (required)

Observation.text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

Observation.contained 0..* Resource Contained, inline Resources

Observation.Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url

Observation.Slices for extension.extension:triggeredBy.id 0..1 string Unique id for inter-element referencing

Observation.Slices for extension.extension:triggeredBy.Slices for extension 2..* Extension Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

Observation.Slices for extension.extension:triggeredBy.Slices for extension Content/Rules for all slices

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation 1..1 Extension Extension
Constraints: ext-1

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.id 0..1 string Unique id for inter-element referencing

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.extension 0..0 Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.url 1..1 uri "observation"

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.value[x] 1..1 Reference(Observation: Medical Test Result (MyHealth@EU Core)) Triggering observation

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type 1..1 Extension R5: reflex | repeat | re-run (new)
Constraints: ext-1

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type.id 0..1 string Unique id for inter-element referencing

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type.extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type.url 1..1 uri "type"

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:reason 0..1 Extension R5: Reason that the observation was triggered (new)
Constraints: ext-1

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:reason.id 0..1 string Unique id for inter-element referencing

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:reason.extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
Constraints: ext-1

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:reason.url 1..1 uri "reason"

Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:reason.value[x] 0..1 string Reason that the observation was triggered

Observation.Slices for extension.extension:triggeredBy.url 1..1 uri "http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"

Observation.Slices for extension.extension:value-r5 0..1 (Complex) only for Diagrams or Pictures
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value
Constraints: ext-1

Observation.Slices for extension.extension:value-r5.id 0..1 string Unique id for inter-element referencing

Observation.Slices for extension.extension:value-r5.extension 0..0 Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

Observation.Slices for extension.extension:value-r5.url 1..1 uri "http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value"

Observation.Slices for extension.extension:value-r5.value[x] 0..1 Attachment Actual result

Observation.Slices for extension.extension:labTestKit 0..* Reference(Device) Laboratory Test Kit
URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit

Observation.Slices for extension.extension:accredited 0..1 boolean Accredited test
URL: http://hl7.eu/fhir/StructureDefinition/laboratory-accredited

Observation.modifierExtension This element is a modifier element. 0..* Extension Extensions that cannot be ignored

Observation.identifier This element is included in summaries. 0..* Identifier Business Identifier for observation

basedOn

0..*

Fulfills plan, proposal or order

Obligations

Actor

SHOULD:handle

MyHealth@EU Handler

category:laboratory

1..1

CodeableConcept

Classification of type of observation
Binding: eHDSI Observation category (extensible)

Required Pattern:

{
  "coding" : [
    {
      "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
      "code" : "laboratory"
    }
  ]
}

code

1..1

CodeableConcept

Type of observation (code / type)
Binding: eHDSI Laboratory Codes With Exceptions (required)

Obligations

Actor

SHALL:handle

MyHealth@EU Handler

Observation.subject This element is included in summaries. 1..1 Reference(Patient (MyHealth@EU Core)) Who and/or what the observation is about

Observation.encounter This element is included in summaries. 0..1 Reference(Encounter) Healthcare event during which this observation is made

effective[x]

1..1

Clinically relevant time/time-period for observation

Obligations

Actor

SHALL:handle

MyHealth@EU Handler

Observation.effective[x].effectiveDateTime dateTime

Observation.effective[x].effectivePeriod Period

Observation.issued This element is included in summaries. 0..1 instant Date/Time this version was made available

performer

1..*

Reference(Practitioner (MyHealth@EU Core) | PractitionerRole (MyHealth@EU Core) | Organization (MyHealth@EU Core))

Who is responsible for the observation

Obligations

Actor

SHOULD:handle

MyHealth@EU Handler

Observation.performer.id 0..1 string Unique id for inter-element referencing

Observation.performer.Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url

Observation.performer.reference This element is included in summaries. C 0..1 string Literal reference, Relative, internal or absolute URL

Observation.performer.type This element is included in summaries. 0..1 uri Type the reference refers to (e.g. "Patient")
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

Observation.performer.identifier This element is included in summaries. 0..1 Identifier Logical reference, when literal reference is not known

Observation.performer.display This element is included in summaries. 0..1 string Text alternative for the resource

Observation.Slices for value[x].valueQuantity Quantity

Observation.Slices for value[x].valueCodeableConcept CodeableConcept

Observation.Slices for value[x].valueString string

Observation.Slices for value[x].valueBoolean boolean

Observation.Slices for value[x].valueInteger integer

Observation.Slices for value[x].valueRange Range

Observation.Slices for value[x].valueRatio Ratio

Observation.Slices for value[x].valueSampledData SampledData

Observation.Slices for value[x].valueTime time

Observation.Slices for value[x].valueDateTime dateTime

Observation.Slices for value[x].valuePeriod Period

Observation.Slices for value[x].value[x]:valueRange This element is included in summaries. C 0..1 RangeEuLab Actual result

Observation.Slices for value[x].value[x]:valueQuantity This element is included in summaries. C 0..1 QuantityMyHealth Actual result

Observation.Slices for value[x].value[x]:valueQuantity.id 0..1 string Unique id for inter-element referencing

Observation.Slices for value[x].value[x]:valueQuantity.Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url

Observation.Slices for value[x].value[x]:valueQuantity.Slices for extension Content/Rules for all slices

Observation.Slices for value[x].value[x]:valueQuantity.value This element is included in summaries. 0..1 decimal Numerical value (with implicit precision)

Observation.Slices for value[x].value[x]:valueQuantity.unit This element is included in summaries. 0..1 string Unit representation

Observation.Slices for value[x].value[x]:valueQuantity.system This element is included in summaries. C 0..1 uri System that defines coded unit form

Observation.Slices for value[x].value[x]:valueQuantity.code This element is included in summaries. 0..1 code Coded form of the unit

Observation.Slices for value[x].value[x]:valueRatio This element is included in summaries. C 0..1 RatioMyHealth Actual result

Observation.dataAbsentReason C 0..1 CodeableConcept Why the result is missing
Binding: eHDSI Data Absent Reason (extensible)

Observation.interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: eHDSI Observation Interpretation With Exceptions (required)

Observation.note 0..* Annotation Comments about the observation

Observation.bodySite 0..1 CodeableConcept Observed body part
Binding: eHDSI Body Site With Exceptions (required)

Observation.bodySite.id 0..1 string Unique id for inter-element referencing

Observation.bodySite.Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url

Observation.bodySite.Slices for extension.extension:bodySite 0..1 (Complex) Target anatomic location or structure
URL: http://hl7.org/fhir/StructureDefinition/bodySite

Observation.bodySite.Slices for extension.extension:bodySite.id 0..1 string Unique id for inter-element referencing

Observation.bodySite.Slices for extension.extension:bodySite.extension 0..0 Extension
Slice: Unordered, Open by value:url

Observation.bodySite.Slices for extension.extension:bodySite.url 1..1 uri "http://hl7.org/fhir/StructureDefinition/bodySite"

Observation.bodySite.Slices for extension.extension:bodySite.value[x] 1..1 Reference(BodyStructure (MyHealth@EU Core)) Value of extension

Observation.bodySite.coding This element is included in summaries. 0..* Coding Code defined by a terminology system

Observation.bodySite.text This element is included in summaries. 0..1 string Plain text representation of the concept

Observation.method 0..1 CodeableConcept How it was done
Binding: eHDSI Laboratory Technique With Exceptions (required)

specimen

0..1

Reference(Specimen: Laboratory)

Specimen used for the observation

Obligations

Actor

SHOULD:handle

MyHealth@EU Handler

Observation.device 0..1 Reference(Device: Measuring) (Measurement) Device

Observation.referenceRange C 0..* BackboneElement Provides guide for interpretation
Constraints: obs-3

Observation.referenceRange.id 0..1 string Unique id for inter-element referencing

Observation.referenceRange.extension 0..* Extension Additional content defined by implementations

Observation.referenceRange.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized

Observation.referenceRange.low C 0..1 SimpleQuantity(4.0.1) Low Range, if relevant
Constraints: sqty-1

Observation.referenceRange.high C 0..1 SimpleQuantity(4.0.1) High Range, if relevant
Constraints: sqty-1

Observation.referenceRange.type 0..1 CodeableConcept Reference range qualifier
Binding: eHDSI Reference Range Meaning With Exceptions (required)

Observation.referenceRange.appliesTo 0..* CodeableConcept Reference range population
Binding: eHDSI Reference Range Applies To With Exceptions (required)

Observation.referenceRange.age 0..1 Range Applicable age range, if relevant

Observation.referenceRange.text 0..1 string Text based reference range in an observation

Observation.hasMember This element is included in summaries. 0..* Reference(ObservationResults: Laboratory) Related resource that belongs to the Observation group

Observation.derivedFrom This element is included in summaries. 0..* Reference(Observation: Medical Test Result (MyHealth@EU Core) | ImagingStudy) Related measurements the observation is made from

Observation.component This element is included in summaries. C 0..* BackboneElement Laboratory result
Constraints: obs-value-2

Observation.component.id 0..1 string Unique id for inter-element referencing

Observation.component.Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url

Observation.component.Slices for extension.extension:value-r5.id 0..1 string Unique id for inter-element referencing

Observation.component.Slices for extension.extension:value-r5.extension 0..0 Extension
Slice: Unordered, Open by value:url
Constraints: ext-1

Observation.component.Slices for extension.extension:value-r5.url 1..1 uri "http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value"

Observation.component.Slices for extension.extension:value-r5.value[x] 0..1 Attachment Actual component result

Observation.component.modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extensions that cannot be ignored even if unrecognized

Observation.component.code This element is included in summaries. 1..1 CodeableConcept Type of component observation (code / type)
Binding: eHDSI Laboratory Codes With Exceptions (required)

Observation.component.Slices for value[x] This element is included in summaries. 0..1 CodeableConcept Actual component result
Slice: Unordered, Closed by type:$this

Observation.component.Slices for value[x].value[x]:valueQuantity This element is included in summaries. 0..1 QuantityMyHealth Actual component result

Observation.component.Slices for value[x].value[x]:valueQuantity.id 0..1 string Unique id for inter-element referencing

Observation.component.Slices for value[x].value[x]:valueQuantity.Slices for extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url

Observation.component.Slices for value[x].value[x]:valueQuantity.Slices for extension Content/Rules for all slices

Observation.component.Slices for value[x].value[x]:valueQuantity.value This element is included in summaries. 0..1 decimal Numerical value (with implicit precision)

Observation.component.Slices for value[x].value[x]:valueQuantity.unit This element is included in summaries. 0..1 string Unit representation

Observation.component.Slices for value[x].value[x]:valueQuantity.system This element is included in summaries. C 0..1 uri System that defines coded unit form

Observation.component.Slices for value[x].value[x]:valueQuantity.code This element is included in summaries. 0..1 code Coded form of the unit

Observation.component.Slices for value[x].value[x]:valueRatio This element is included in summaries. 0..1 RatioMyHealth Actual component result

Observation.component.dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: eHDSI Data Absent Reason (extensible)

Observation.component.interpretation 0..* CodeableConcept High, low, normal, etc.
Binding: eHDSI Observation Interpretation With Exceptions (required)

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

Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.language	Base	required	eHDSI Language	📦9.1.0	This IG
Observation.extension:triggeredBy.extension:type.value[x]	Base	required	Cross-version ValueSet R5.TriggeredBytype for use in FHIR R4	📍0.1.0	Extensions for Using Data Elements from FHIR R5 in FHIR R4 v0.1
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	extensible	eHDSI Observation category	📦9.1.0	This IG
Observation.category:laboratory	Base	extensible	eHDSI Observation category	📦9.1.0	This IG
Observation.category:studyType	Base	required	Laboratory Study Types	📦2.1.0	HL7 Europe Laboratory Report v2.1
Observation.category:specialty	Base	required	Laboratory Specialty	📦2.1.0	HL7 Europe Laboratory Report v2.1
Observation.code	Base	required	eHDSI Laboratory Codes With Exceptions	📦1.0.1	This IG
Observation.performer.type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Observation.value[x]:valueCodeableConcept	Base	required	eHDSI Results Coded Value Laboratory With Exceptions	📦1.0.1	This IG
Observation.value[x]:valueQuantity.comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.dataAbsentReason	Base	extensible	eHDSI Data Absent Reason	📦9.1.0	This IG
Observation.interpretation	Base	required	eHDSI Observation Interpretation With Exceptions	📦1.0.1	This IG
Observation.bodySite	Base	required	eHDSI Body Site With Exceptions	📦1.0.1	This IG
Observation.method	Base	required	eHDSI Laboratory Technique With Exceptions	📦1.0.1	This IG
Observation.referenceRange.type	Base	required	eHDSI Reference Range Meaning With Exceptions	📦1.0.1	This IG
Observation.referenceRange.appliesTo	Base	required	eHDSI Reference Range Applies To With Exceptions	📦1.0.1	This IG
Observation.component.code	Base	required	eHDSI Laboratory Codes With Exceptions	📦1.0.1	This IG
Observation.component.value[x]:valueCodeableConcept	Base	required	eHDSI Results Coded Value Laboratory With Exceptions	📦1.0.1	This IG
Observation.component.value[x]:valueQuantity.comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.component.dataAbsentReason	Base	extensible	eHDSI Data Absent Reason	📦9.1.0	This IG
Observation.component.interpretation	Base	required	eHDSI Observation Interpretation With Exceptions	📦1.0.1	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources	`contained.contained.empty()`
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	`contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4	error	Observation	If 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-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label	`contained.meta.security.empty()`
dom-6	best practice	Observation	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	ALL elements	All FHIR elements must have a @value or children	`hasValue() or (children().count() > id.count())`
ext-1	error	ALL extensions	Must have either extensions or value[x], not both	`extension.exists() != value.exists()`
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text	`low.exists() or high.exists() or text.exists()`
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present	`dataAbsentReason.empty() or value.empty()`
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present	`value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()`
obs-value-1	error	Observation	The elements Observation.extension:value-r5 and Observation.value[x] SHALL not be used simultaneously.	`value.empty() or extension('http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value').empty()`
obs-value-2	error	Observation.component	The elements Observation.component.extension:value-r5 and Observation.component.value[x] SHALL not be used simultaneously.	`value.empty() or extension('http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value').empty()`
sqty-1	error	Observation.referenceRange.low, Observation.referenceRange.high	The comparator is not used on a SimpleQuantity	`comparator.empty()`

This structure is derived from MedicalTestResultMyHealthCore

Summary

Mandatory: 2 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

The element 1 is sliced based on the value of Observation.category

Maturity: 2

Key Elements View