MyHealth@Eu Laboratory Report
0.1.1 - trial-use 150

This page is part of the MyHealth@Eu Laboratory Report (v0.1.1: Wave 8) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Resource Profile: Observation Results: Laboratory

Official URL: http://fhir.ehdsi.eu/laboratory/StructureDefinition/Observation-resultslab-lab-myhealtheu Version: 0.1.1
Active as of 2025-03-20 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.

Usage:

Formal Views of Profile Content

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

NameFlagsCard.TypeDescription & Constraintsdoco
.. Observation C 0..* ObservationResultsLaboratoryEu Laboratory result for a simple test or for a panel/study
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-3: 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
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
dom-6: A resource should have narrative for robust management
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present
eu-lab-1: If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component"
eu-lab-2: If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason"
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
ele-1: All FHIR elements must have a @value or children
... text O 0..1 Narrative Text summary of the resource, for human interpretation
ele-1: All FHIR elements must have a @value or children
ObligationsActor
SHALL:handle LabReportHandler
... Slices for extension Content/Rules for all slices
.... extension:supportingInfo 0..* Reference(Resource) Other information that may be relevant to this event.
URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... extension:triggeredBy-r5 0..* (Complex) Optional Extensions Element
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... Slices for extension Content/Rules for all slices
...... extension:observation 0..* Extension Triggering observation.
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
....... extension 0..0
....... url 1..1 uri "observation"
....... value[x] 1..1 Reference(Observation) Value of extension
ele-1: All FHIR elements must have a @value or children
...... extension:type 0..* Extension The type of trigger
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
....... extension 0..0
....... url 1..1 uri "type"
....... value[x] 1..1 code Value of extension
ele-1: All FHIR elements must have a @value or children
...... extension:reason 0..* Extension Extension
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
....... extension 0..0
....... url 1..1 uri "reason"
....... value[x] 1..1 string Value of extension
ele-1: All FHIR elements must have a @value or children
..... url 1..1 uri "http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"
.... extension:certifiedRefMaterialCodeable 0..* CodeableConcept Certified Reference Material: CodeableConcept
URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable
Binding: Laboratory Certified Reference Material (example)
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... extension:certifiedRefMaterialIdentifer 0..* Identifier Certified Reference Material
URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... extension:labTestKit 0..* Reference(Device) Device Laboratory Test Kit
URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... extension:value-r5 0..1 (Complex) only for result of type Attachment
URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... extension 0..0
..... url 1..1 uri "http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]"
..... value[x] 1..1 Attachment Value of extension
ele-1: All FHIR elements must have a @value or children
... basedOn OΣ 0..* Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest) Fulfills plan, proposal or order
ele-1: All FHIR elements must have a @value or children
ObligationsActor
SHALL:handle LabReportHandler
... status ?!Σ 1..1 code Status of this observation
Binding: ObservationStatus (required): Codes providing the status of an observation.


ele-1: All FHIR elements must have a @value or children
... Slices for category 1..* CodeableConceptIPS Classification of type of observation
Slice: Unordered, Open by value:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


ele-1: All FHIR elements must have a @value or children
.... category:laboratory 1..1 CodeableConcept laboratory (fixed)
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.


ele-1: All FHIR elements must have a @value or children

Required Pattern: At least the following
..... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
...... system 1..1 uri Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
...... code 1..1 code Symbol in syntax defined by the system
Fixed Value: laboratory
.... category:studyType 0..* CodeableConcept The way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.)
Binding: eHDSI Laboratory Study Types (required)
ele-1: All FHIR elements must have a @value or children
.... category:specialty 0..* CodeableConcept The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry)
Binding: Laboratory Specialty (required)
ele-1: All FHIR elements must have a @value or children
... code OΣ 1..1 CodeableConceptIPS Type of observation (code / type)
Binding: eHDSI Laboratory Codes with exceptions (required)
ele-1: All FHIR elements must have a @value or children
ObligationsActor
SHALL:handle LabReportHandler
... subject Σ 1..1 Reference(Patient: Laboratory) Who and/or what the observation is about
ele-1: All FHIR elements must have a @value or children
.... reference ΣC 1..1 string Literal reference, Relative, internal or absolute URL
ele-1: All FHIR elements must have a @value or children
... effective[x] OΣ 1..1 Clinically relevant time/time-period for observation
ele-1: All FHIR elements must have a @value or children
ObligationsActor
SHALL:handle LabReportHandler
.... effective[x]All Types Content/Rules for all Types
..... Slices for extension Content/Rules for all slices
...... extension:data-absent-reason 0..1 code effective[x] absence reason
URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason
Binding: DataAbsentReason (required)
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... effectiveDateTime dateTime
.... effectivePeriod Period
... issued OΣ 0..1 instant Date/Time this result was made available
ele-1: All FHIR elements must have a @value or children
ObligationsActor
SHALL:handle LabReportHandler
... performer OΣ 1..* Reference(Practitioner: Laboratory | PractitionerRole: Laboratory | Organization (IPS)) Who is responsible for the observation
ele-1: All FHIR elements must have a @value or children
ObligationsActor
SHALL:handle LabReportHandler
.... Slices for extension Content/Rules for all slices
..... extension:performerFunction 0..* (Complex) Type of performance
URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
...... extension 0..0
...... url 1..1 uri "http://hl7.org/fhir/StructureDefinition/event-performerFunction"
...... value[x] 1..1 CodeableConcept Value of extension
Binding: eHDSI Performer Function (extensible)
ele-1: All FHIR elements must have a @value or children
... Slices for value[x] OΣC 0..1 Actual result
Slice: Unordered, Closed by type:$this
ele-1: All FHIR elements must have a @value or children
ObligationsActor
SHALL:handle LabReportHandler
.... valueQuantity Quantity
.... valueCodeableConcept CodeableConcept
.... valueString string
.... valueBoolean boolean
.... valueInteger integer
.... valueRange Range
.... valueRatio Ratio
.... valueSampledData SampledData
.... valueTime time
.... valueDateTime dateTime
.... valuePeriod Period
.... value[x]:valueRatio ΣC 0..1 RatioMyHealthEu Actual result
ele-1: All FHIR elements must have a @value or children
.... value[x]:valueQuantity ΣC 0..1 QuantityMyHealthEu Actual result
ele-1: All FHIR elements must have a @value or children
.... value[x]:valueCodeableConcept ΣC 0..1 CodeableConceptIPS Actual result
Binding: eHDSI Results Coded Value Laboratory with exceptions (required)
ele-1: All FHIR elements must have a @value or children
.... value[x]:valueString ΣC 0..1 string Actual result
ele-1: All FHIR elements must have a @value or children
.... value[x]:valueRange ΣC 0..1 RangeIPS Actual result
ele-1: All FHIR elements must have a @value or children
.... value[x]:valueTime ΣC 0..1 time Actual result
ele-1: All FHIR elements must have a @value or children
.... value[x]:valueDateTime ΣC 0..1 dateTime Actual result
ele-1: All FHIR elements must have a @value or children
.... value[x]:valuePeriod ΣC 0..1 Period Actual result
ele-1: All FHIR elements must have a @value or children
... interpretation O 0..* CodeableConceptIPS High, low, normal, etc.
Binding: eHDSI Observation Interpretation with exceptions (required)
ele-1: All FHIR elements must have a @value or children
ObligationsActor
SHALL:handle LabReportHandler
... method O 0..1 CodeableConceptIPS How it was done
Binding: eHDSI Laboratory Technique with exceptions (required)
ele-1: All FHIR elements must have a @value or children
ObligationsActor
SHALL:handle LabReportHandler
... specimen O 0..1 Reference(Specimen: Laboratory) Specimen used for this observation
ele-1: All FHIR elements must have a @value or children
ObligationsActor
SHALL:handle LabReportHandler
... device O 0..1 Reference(Device: measuring) Measuring instrument
ele-1: All FHIR elements must have a @value or children
ObligationsActor
SHALL:handle LabReportHandler
... referenceRange OC 0..* BackboneElement Provides guide for interpretation
ele-1: All FHIR elements must have a @value or children
obs-3: Must have at least a low or a high or text
ObligationsActor
SHALL:handle LabReportHandler
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... type 0..1 CodeableConcept Reference range qualifier
Binding: eHDSI Reference Range Meaning with exceptions (required)
ele-1: All FHIR elements must have a @value or children
.... appliesTo 0..* CodeableConcept Reference range population
Binding: eHDSI Reference Range Applies To with exceptions (required)
ele-1: All FHIR elements must have a @value or children
... hasMember Σ 0..* Reference(Observation Results: Laboratory) Related resource that belongs to the Observation group
ele-1: All FHIR elements must have a @value or children

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Observation.statusrequiredObservationStatus
http://hl7.org/fhir/ValueSet/observation-status|4.0.1
from the FHIR Standard
Observation.categorypreferredObservationCategoryCodes
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:laboratorypreferredPattern: laboratory
http://hl7.org/fhir/ValueSet/observation-category
from the FHIR Standard
Observation.category:studyTyperequiredEHDSILabStudyType
http://terminology.ehdsi.eu/ValueSet/eHDSILabStudyType
from this IG
Observation.category:specialtyrequiredLabSpecialtyEuVs
http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab
Observation.coderequiredEHDSILabCodeWithExceptions
http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSILabCodeWithExceptions
from this IG
Observation.performer.extension:performerFunction.value[x]extensibleEHDSIPerformerFunction
http://terminology.ehdsi.eu/ValueSet/eHDSIPerformerFunction
from this IG
Observation.value[x]:valueCodeableConceptrequiredEHDSIResultsCodedValueLaboratory
http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIResultsCodedValueLaboratory
from this IG
Observation.interpretationrequiredEHDSIObservationInterpretationWithExceptions
http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIObservationInterpretationWithExceptions
from this IG
Observation.methodrequiredEHDSILabTechniqueWithExceptions
http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSILabTechniqueWithExceptions
from this IG
Observation.referenceRange.typerequiredEHDSIReferenceRangeMeaningWithExceptions
http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeMeaningWithExceptions
from this IG
Observation.referenceRange.appliesTorequiredEHDSIReferenceRangeAppliesToWithExceptions
http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeAppliesToWithExceptions
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().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-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())
eu-lab-1errorObservationIf observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component"
: (status in ('registered'|'cancelled')) or value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists()
eu-lab-2errorObservationIf observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason"
: component.exists() implies (status in ('registered'|'cancelled')) or component.value.exists() or component.dataAbsentReason.exists()
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.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()

 

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