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

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Resource Profile: Observation Results: Laboratory

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:

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

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

Name	Flags	Card.	Type	Description & Constraints
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 Obligations Actor 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
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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 Obligations Actor 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 Obligations Actor 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 Obligations Actor 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 Obligations Actor 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 Obligations Actor 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 Obligations Actor 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 Obligations Actor 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 Obligations Actor 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 Obligations Actor SHALL:handle LabReportHandler
device	O	0..1	Reference(Device: measuring)	Measuring instrument ele-1: All FHIR elements must have a @value or children Obligations Actor 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 Obligations Actor 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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:laboratory	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:studyType	required	EHDSILabStudyType http://terminology.ehdsi.eu/ValueSet/eHDSILabStudyType from this IG
Observation.category:specialty	required	LabSpecialtyEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab
Observation.code	required	EHDSILabCodeWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSILabCodeWithExceptions from this IG
Observation.performer.extension:performerFunction.value[x]	extensible	EHDSIPerformerFunction http://terminology.ehdsi.eu/ValueSet/eHDSIPerformerFunction from this IG
Observation.value[x]:valueCodeableConcept	required	EHDSIResultsCodedValueLaboratory http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIResultsCodedValueLaboratory from this IG
Observation.interpretation	required	EHDSIObservationInterpretationWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIObservationInterpretationWithExceptions from this IG
Observation.method	required	EHDSILabTechniqueWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSILabTechniqueWithExceptions from this IG
Observation.referenceRange.type	required	EHDSIReferenceRangeMeaningWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeMeaningWithExceptions from this IG
Observation.referenceRange.appliesTo	required	EHDSIReferenceRangeAppliesToWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeAppliesToWithExceptions from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
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())
eu-lab-1	error	Observation	If 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-2	error	Observation	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" : component.exists() implies (status in ('registered'|'cancelled')) or component.value.exists() or component.dataAbsentReason.exists()
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()

This structure is derived from ObservationResultsLaboratoryEu

Name	Flags	Card.	Type	Description & Constraints
Observation			ObservationResultsLaboratoryEu
text	O	0..1	Narrative	Text summary of the resource, for human interpretation Obligations Actor SHALL:handle LabReportHandler
Slices for extension				Content/Rules for all slices
extension:certifiedRefMaterialIdentifer		0..*	ObservationCertifiedRefMaterialIdentifer	Certified Reference Material
basedOn	O	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order Obligations Actor SHALL:handle LabReportHandler
status		1..1	code	Status of this observation
Slices for category				Content/Rules for all slices
category:laboratory		1..1	CodeableConcept	laboratory (fixed)
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)
code	O	1..1	CodeableConceptIPS	Type of observation (code / type) Binding: eHDSI Laboratory Codes with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
subject		1..1	Reference(Patient: Laboratory)	Who and/or what the observation is about
effective[x]	O	1..1	dateTime, Period	Clinically relevant time/time-period for observation Obligations Actor SHALL:handle LabReportHandler
issued	O	0..1	instant	Date/Time this result was made available Obligations Actor SHALL:handle LabReportHandler
performer	O	1..*	Reference(Practitioner: Laboratory | PractitionerRole: Laboratory | Organization (IPS))	Who is responsible for the observation Obligations Actor SHALL:handle LabReportHandler
Slices for extension				Content/Rules for all slices
extension:performerFunction		0..*	PerformerFunction(5.2.0)	Type of performance
value[x]		1..1	CodeableConcept	Value of extension Binding: eHDSI Performer Function (extensible)
value[x]	O	0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual result Obligations Actor SHALL:handle LabReportHandler
Slices for value[x]				Content/Rules for all slices
value[x]:valueRatio		0..1	RatioMyHealthEu	Actual result
value[x]:valueQuantity		0..1	QuantityMyHealthEu	Actual result
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS	Actual result Binding: eHDSI Results Coded Value Laboratory with exceptions (required)
interpretation	O	0..*	CodeableConceptIPS	High, low, normal, etc. Binding: eHDSI Observation Interpretation with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
method	O	0..1	CodeableConceptIPS	How it was done Binding: eHDSI Laboratory Technique with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
specimen	O	0..1	Reference(Specimen: Laboratory)	Specimen used for this observation Obligations Actor SHALL:handle LabReportHandler
device	O	0..1	Reference(Device: measuring)	Measuring instrument Obligations Actor SHALL:handle LabReportHandler
referenceRange	O	0..*	BackboneElement	Provides guide for interpretation Obligations Actor SHALL:handle LabReportHandler
type		0..1	CodeableConcept	Reference range qualifier Binding: eHDSI Reference Range Meaning with exceptions (required)
appliesTo		0..*	CodeableConcept	Reference range population Binding: eHDSI Reference Range Applies To with exceptions (required)
hasMember		0..*	Reference(Observation Results: Laboratory)	Related resource that belongs to the Observation group
component
code	O	1..1	CodeableConceptIPS	Type of component observation (code / type) Binding: eHDSI Laboratory Codes with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
value[x]	O	0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual component result Obligations Actor SHALL:handle LabReportHandler
Slices for value[x]				Content/Rules for all slices
value[x]:valueRatio		0..1	RatioMyHealthEu	Actual component result
value[x]:valueQuantity		0..1	QuantityMyHealthEu	Actual component result
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS	Actual component result Binding: eHDSI Results Coded Value Laboratory with exceptions (required)
interpretation	O	0..*	CodeableConcept	High, low, normal, etc. Binding: eHDSI Observation Interpretation with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
referenceRange	O	0..*	BackboneElement	Provides guide for interpretation Obligations Actor SHALL:handle LabReportHandler
type		0..1	CodeableConcept	Reference range qualifier Binding: eHDSI Reference Range Meaning with exceptions (required)
appliesTo		0..*	CodeableConcept	Reference range population Binding: eHDSI Reference Range Applies To with exceptions (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.category:studyType	required	EHDSILabStudyType http://terminology.ehdsi.eu/ValueSet/eHDSILabStudyType from this IG
Observation.code	required	EHDSILabCodeWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSILabCodeWithExceptions from this IG
Observation.performer.extension:performerFunction.value[x]	extensible	EHDSIPerformerFunction http://terminology.ehdsi.eu/ValueSet/eHDSIPerformerFunction from this IG
Observation.value[x]:valueCodeableConcept	required	EHDSIResultsCodedValueLaboratory http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIResultsCodedValueLaboratory from this IG
Observation.interpretation	required	EHDSIObservationInterpretationWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIObservationInterpretationWithExceptions from this IG
Observation.method	required	EHDSILabTechniqueWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSILabTechniqueWithExceptions from this IG
Observation.referenceRange.type	required	EHDSIReferenceRangeMeaningWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeMeaningWithExceptions from this IG
Observation.referenceRange.appliesTo	required	EHDSIReferenceRangeAppliesToWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeAppliesToWithExceptions from this IG
Observation.component.code	required	EHDSILabCodeWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSILabCodeWithExceptions from this IG
Observation.component.value[x]:valueCodeableConcept	required	EHDSIResultsCodedValueLaboratory http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIResultsCodedValueLaboratory from this IG
Observation.component.interpretation	required	EHDSIObservationInterpretationWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIObservationInterpretationWithExceptions from this IG
Observation.component.referenceRange.type	required	EHDSIReferenceRangeMeaningWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeMeaningWithExceptions from this IG
Observation.component.referenceRange.appliesTo	required	EHDSIReferenceRangeAppliesToWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeAppliesToWithExceptions from this IG

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	ObservationResultsLaboratoryEu	Laboratory result for a simple test or for a panel/study 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"
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text	O	0..1	Narrative	Text summary of the resource, for human interpretation Obligations Actor SHALL:handle LabReportHandler
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Laboratory Test Kit Slice: Unordered, Open by value:url
extension:supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
extension:triggeredBy-r5		0..*	(Complex)	Optional Extensions Element URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
extension:observation		0..*	Extension	Triggering observation.
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"observation"
value[x]		1..1	Reference(Observation)	Value of extension
extension:type		0..*	Extension	The type of trigger
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"type"
value[x]		1..1	code	Value of extension
extension:reason		0..*	Extension	Extension
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"reason"
value[x]		1..1	string	Value of extension
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)
extension:certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
extension:labTestKit		0..*	Reference(Device)	Device Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
extension:value-r5		0..1	(Complex)	only for result of type Attachment URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
id		0..1	string	Unique id for inter-element referencing
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
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business Identifier for observation
basedOn	OΣ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order Obligations Actor SHALL:handle LabReportHandler
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Part of referenced event
status	?!Σ	1..1	code	Status of this observation Binding: ObservationStatus (required): Codes providing the status of an observation.
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.
category:laboratory		1..1	CodeableConcept	laboratory (fixed) Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
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)
category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: Laboratory Specialty (required)
code	OΣ	1..1	CodeableConceptIPS	Type of observation (code / type) Binding: eHDSI Laboratory Codes with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
subject	Σ	1..1	Reference(Patient: Laboratory)	Who and/or what the observation is about
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	1..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	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).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
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]	OΣ	1..1		Clinically relevant time/time-period for observation Obligations Actor SHALL:handle LabReportHandler
effective[x]All Types				Content/Rules for all Types
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
extension:data-absent-reason		0..1	code	effective[x] absence reason URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason Binding: DataAbsentReason (required)
effectiveDateTime			dateTime
effectivePeriod			Period
issued	OΣ	0..1	instant	Date/Time this result was made available Obligations Actor SHALL:handle LabReportHandler
performer	OΣ	1..*	Reference(Practitioner: Laboratory | PractitionerRole: Laboratory | Organization (IPS))	Who is responsible for the observation Obligations Actor SHALL:handle LabReportHandler
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
extension:performerFunction		0..*	(Complex)	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction
id		0..1	id	Unique id for inter-element referencing
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)
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	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).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
Slices for value[x]	OΣC	0..1		Actual result Slice: Unordered, Closed by type:$this Obligations Actor 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
value[x]:valueQuantity	ΣC	0..1	QuantityMyHealthEu	Actual result
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConceptIPS	Actual result Binding: eHDSI Results Coded Value Laboratory with exceptions (required)
value[x]:valueString	ΣC	0..1	string	Actual result
value[x]:valueRange	ΣC	0..1	RangeIPS	Actual result
value[x]:valueTime	ΣC	0..1	time	Actual result
value[x]:valueDateTime	ΣC	0..1	dateTime	Actual result
value[x]:valuePeriod	ΣC	0..1	Period	Actual result
dataAbsentReason	C	0..1	CodeableConcept	Provides a reason why the expected value is missing. Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation	O	0..*	CodeableConceptIPS	High, low, normal, etc. Binding: eHDSI Observation Interpretation with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
note		0..*	Annotation	Comments about the observation
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method	O	0..1	CodeableConceptIPS	How it was done Binding: eHDSI Laboratory Technique with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
specimen	O	0..1	Reference(Specimen: Laboratory)	Specimen used for this observation Obligations Actor SHALL:handle LabReportHandler
device	O	0..1	Reference(Device: measuring)	Measuring instrument Obligations Actor SHALL:handle LabReportHandler
referenceRange	OC	0..*	BackboneElement	Provides guide for interpretation obs-3: Must have at least a low or a high or text Obligations Actor SHALL:handle LabReportHandler
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	C	0..1	SimpleQuantity	Low Range, if relevant
high	C	0..1	SimpleQuantity	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: eHDSI Reference Range Meaning with exceptions (required)
appliesTo		0..*	CodeableConcept	Reference range population Binding: eHDSI Reference Range Applies To with exceptions (required)
age		0..1	Range	Applicable age range, if relevant
text		0..1	string	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Observation Results: Laboratory)	Related resource that belongs to the Observation group
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
component	Σ	0..*	BackboneElement	Laboratory result
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:value-r5		0..1	(Complex)	only for result of type Attachment URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
id		0..1	string	Unique id for inter-element referencing
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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	OΣ	1..1	CodeableConceptIPS	Type of component observation (code / type) Binding: eHDSI Laboratory Codes with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
Slices for value[x]	OΣ	0..1		Actual component result Slice: Unordered, Closed by type:$this Obligations Actor 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	Σ	0..1	RatioMyHealthEu	Actual component result
value[x]:valueQuantity	Σ	0..1	QuantityMyHealthEu	Actual component result
value[x]:valueCodeableConcept	Σ	0..1	CodeableConceptIPS	Actual component result Binding: eHDSI Results Coded Value Laboratory with exceptions (required)
value[x]:valueString	Σ	0..1	string	Actual component result
value[x]:valueRange	Σ	0..1	RangeIPS	Actual component result
value[x]:valueTime	Σ	0..1	time	Actual component result
value[x]:valueDateTime	Σ	0..1	dateTime	Actual component result
value[x]:valuePeriod	Σ	0..1	Period	Actual component result
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation	O	0..*	CodeableConcept	High, low, normal, etc. Binding: eHDSI Observation Interpretation with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
referenceRange	O	0..*	BackboneElement	Provides guide for interpretation Obligations Actor SHALL:handle LabReportHandler
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	C	0..1	SimpleQuantity	Low Range, if relevant
high	C	0..1	SimpleQuantity	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: eHDSI Reference Range Meaning with exceptions (required)
appliesTo		0..*	CodeableConcept	Reference range population Binding: eHDSI Reference Range Applies To with exceptions (required)
age		0..1	Range	Applicable age range, if relevant
text		0..1	string	Text based reference range in an observation
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages from the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:laboratory	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:studyType	required	EHDSILabStudyType http://terminology.ehdsi.eu/ValueSet/eHDSILabStudyType from this IG
Observation.category:specialty	required	LabSpecialtyEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab
Observation.code	required	EHDSILabCodeWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSILabCodeWithExceptions from this IG
Observation.subject.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
Observation.performer.extension:performerFunction.value[x]	extensible	EHDSIPerformerFunction http://terminology.ehdsi.eu/ValueSet/eHDSIPerformerFunction from this IG
Observation.performer.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
Observation.value[x]:valueCodeableConcept	required	EHDSIResultsCodedValueLaboratory http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIResultsCodedValueLaboratory from this IG
Observation.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.interpretation	required	EHDSIObservationInterpretationWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIObservationInterpretationWithExceptions from this IG
Observation.bodySite	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
Observation.method	required	EHDSILabTechniqueWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSILabTechniqueWithExceptions from this IG
Observation.referenceRange.type	required	EHDSIReferenceRangeMeaningWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeMeaningWithExceptions from this IG
Observation.referenceRange.appliesTo	required	EHDSIReferenceRangeAppliesToWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeAppliesToWithExceptions from this IG
Observation.component.code	required	EHDSILabCodeWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSILabCodeWithExceptions from this IG
Observation.component.value[x]:valueCodeableConcept	required	EHDSIResultsCodedValueLaboratory http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIResultsCodedValueLaboratory from this IG
Observation.component.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.component.interpretation	required	EHDSIObservationInterpretationWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIObservationInterpretationWithExceptions from this IG
Observation.component.referenceRange.type	required	EHDSIReferenceRangeMeaningWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeMeaningWithExceptions from this IG
Observation.component.referenceRange.appliesTo	required	EHDSIReferenceRangeAppliesToWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeAppliesToWithExceptions from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
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())
eu-lab-1	error	Observation	If 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-2	error	Observation	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" : component.exists() implies (status in ('registered'|'cancelled')) or component.value.exists() or component.dataAbsentReason.exists()
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()

This structure is derived from ObservationResultsLaboratoryEu

Summary

Structures

This structure refers to these other structures:

• Patient: Laboratory (http://fhir.ehdsi.eu/laboratory/StructureDefinition/Patient-lab-myhealtheu)
• Practitioner: Laboratory (http://fhir.ehdsi.eu/laboratory/StructureDefinition/Practitioner-eu-myhealth-eu)
• PractitionerRole: Laboratory (http://fhir.ehdsi.eu/laboratory/StructureDefinition/PractitionerRole-eu-myhealth-eu)
• Organization (IPS) (http://hl7.org/fhir/uv/ips/StructureDefinition/Organization-uv-ips)
• Ratio: Laboratory (http://fhir.ehdsi.eu/laboratory/StructureDefinition/Ratio-lab-myhealtheu)
• Quantity: Laboratory (http://fhir.ehdsi.eu/laboratory/StructureDefinition/Quantity-lab-myhealtheu)
• Codeable Concept (IPS) (http://hl7.org/fhir/uv/ips/StructureDefinition/CodeableConcept-uv-ips)
• Specimen: Laboratory (http://fhir.ehdsi.eu/laboratory/StructureDefinition/Specimen-lab-myhealtheu)
• Device: measuring (http://fhir.ehdsi.eu/laboratory/StructureDefinition/Device-measuring-lab-myhealtheu)
• Observation Results: Laboratory (http://fhir.ehdsi.eu/laboratory/StructureDefinition/Observation-resultslab-lab-myhealtheu)

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
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 Obligations Actor 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
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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 Obligations Actor 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 Obligations Actor 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 Obligations Actor 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 Obligations Actor 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 Obligations Actor 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 Obligations Actor 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 Obligations Actor 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 Obligations Actor 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 Obligations Actor SHALL:handle LabReportHandler
device	O	0..1	Reference(Device: measuring)	Measuring instrument ele-1: All FHIR elements must have a @value or children Obligations Actor 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 Obligations Actor 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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:laboratory	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:studyType	required	EHDSILabStudyType http://terminology.ehdsi.eu/ValueSet/eHDSILabStudyType from this IG
Observation.category:specialty	required	LabSpecialtyEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab
Observation.code	required	EHDSILabCodeWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSILabCodeWithExceptions from this IG
Observation.performer.extension:performerFunction.value[x]	extensible	EHDSIPerformerFunction http://terminology.ehdsi.eu/ValueSet/eHDSIPerformerFunction from this IG
Observation.value[x]:valueCodeableConcept	required	EHDSIResultsCodedValueLaboratory http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIResultsCodedValueLaboratory from this IG
Observation.interpretation	required	EHDSIObservationInterpretationWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIObservationInterpretationWithExceptions from this IG
Observation.method	required	EHDSILabTechniqueWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSILabTechniqueWithExceptions from this IG
Observation.referenceRange.type	required	EHDSIReferenceRangeMeaningWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeMeaningWithExceptions from this IG
Observation.referenceRange.appliesTo	required	EHDSIReferenceRangeAppliesToWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeAppliesToWithExceptions from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
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())
eu-lab-1	error	Observation	If 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-2	error	Observation	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" : component.exists() implies (status in ('registered'|'cancelled')) or component.value.exists() or component.dataAbsentReason.exists()
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()

Differential View

This structure is derived from ObservationResultsLaboratoryEu

Name	Flags	Card.	Type	Description & Constraints
Observation			ObservationResultsLaboratoryEu
text	O	0..1	Narrative	Text summary of the resource, for human interpretation Obligations Actor SHALL:handle LabReportHandler
Slices for extension				Content/Rules for all slices
extension:certifiedRefMaterialIdentifer		0..*	ObservationCertifiedRefMaterialIdentifer	Certified Reference Material
basedOn	O	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order Obligations Actor SHALL:handle LabReportHandler
status		1..1	code	Status of this observation
Slices for category				Content/Rules for all slices
category:laboratory		1..1	CodeableConcept	laboratory (fixed)
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)
code	O	1..1	CodeableConceptIPS	Type of observation (code / type) Binding: eHDSI Laboratory Codes with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
subject		1..1	Reference(Patient: Laboratory)	Who and/or what the observation is about
effective[x]	O	1..1	dateTime, Period	Clinically relevant time/time-period for observation Obligations Actor SHALL:handle LabReportHandler
issued	O	0..1	instant	Date/Time this result was made available Obligations Actor SHALL:handle LabReportHandler
performer	O	1..*	Reference(Practitioner: Laboratory | PractitionerRole: Laboratory | Organization (IPS))	Who is responsible for the observation Obligations Actor SHALL:handle LabReportHandler
Slices for extension				Content/Rules for all slices
extension:performerFunction		0..*	PerformerFunction(5.2.0)	Type of performance
value[x]		1..1	CodeableConcept	Value of extension Binding: eHDSI Performer Function (extensible)
value[x]	O	0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual result Obligations Actor SHALL:handle LabReportHandler
Slices for value[x]				Content/Rules for all slices
value[x]:valueRatio		0..1	RatioMyHealthEu	Actual result
value[x]:valueQuantity		0..1	QuantityMyHealthEu	Actual result
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS	Actual result Binding: eHDSI Results Coded Value Laboratory with exceptions (required)
interpretation	O	0..*	CodeableConceptIPS	High, low, normal, etc. Binding: eHDSI Observation Interpretation with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
method	O	0..1	CodeableConceptIPS	How it was done Binding: eHDSI Laboratory Technique with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
specimen	O	0..1	Reference(Specimen: Laboratory)	Specimen used for this observation Obligations Actor SHALL:handle LabReportHandler
device	O	0..1	Reference(Device: measuring)	Measuring instrument Obligations Actor SHALL:handle LabReportHandler
referenceRange	O	0..*	BackboneElement	Provides guide for interpretation Obligations Actor SHALL:handle LabReportHandler
type		0..1	CodeableConcept	Reference range qualifier Binding: eHDSI Reference Range Meaning with exceptions (required)
appliesTo		0..*	CodeableConcept	Reference range population Binding: eHDSI Reference Range Applies To with exceptions (required)
hasMember		0..*	Reference(Observation Results: Laboratory)	Related resource that belongs to the Observation group
component
code	O	1..1	CodeableConceptIPS	Type of component observation (code / type) Binding: eHDSI Laboratory Codes with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
value[x]	O	0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual component result Obligations Actor SHALL:handle LabReportHandler
Slices for value[x]				Content/Rules for all slices
value[x]:valueRatio		0..1	RatioMyHealthEu	Actual component result
value[x]:valueQuantity		0..1	QuantityMyHealthEu	Actual component result
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS	Actual component result Binding: eHDSI Results Coded Value Laboratory with exceptions (required)
interpretation	O	0..*	CodeableConcept	High, low, normal, etc. Binding: eHDSI Observation Interpretation with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
referenceRange	O	0..*	BackboneElement	Provides guide for interpretation Obligations Actor SHALL:handle LabReportHandler
type		0..1	CodeableConcept	Reference range qualifier Binding: eHDSI Reference Range Meaning with exceptions (required)
appliesTo		0..*	CodeableConcept	Reference range population Binding: eHDSI Reference Range Applies To with exceptions (required)
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.category:studyType	required	EHDSILabStudyType http://terminology.ehdsi.eu/ValueSet/eHDSILabStudyType from this IG
Observation.code	required	EHDSILabCodeWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSILabCodeWithExceptions from this IG
Observation.performer.extension:performerFunction.value[x]	extensible	EHDSIPerformerFunction http://terminology.ehdsi.eu/ValueSet/eHDSIPerformerFunction from this IG
Observation.value[x]:valueCodeableConcept	required	EHDSIResultsCodedValueLaboratory http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIResultsCodedValueLaboratory from this IG
Observation.interpretation	required	EHDSIObservationInterpretationWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIObservationInterpretationWithExceptions from this IG
Observation.method	required	EHDSILabTechniqueWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSILabTechniqueWithExceptions from this IG
Observation.referenceRange.type	required	EHDSIReferenceRangeMeaningWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeMeaningWithExceptions from this IG
Observation.referenceRange.appliesTo	required	EHDSIReferenceRangeAppliesToWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeAppliesToWithExceptions from this IG
Observation.component.code	required	EHDSILabCodeWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSILabCodeWithExceptions from this IG
Observation.component.value[x]:valueCodeableConcept	required	EHDSIResultsCodedValueLaboratory http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIResultsCodedValueLaboratory from this IG
Observation.component.interpretation	required	EHDSIObservationInterpretationWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIObservationInterpretationWithExceptions from this IG
Observation.component.referenceRange.type	required	EHDSIReferenceRangeMeaningWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeMeaningWithExceptions from this IG
Observation.component.referenceRange.appliesTo	required	EHDSIReferenceRangeAppliesToWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeAppliesToWithExceptions from this IG

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	ObservationResultsLaboratoryEu	Laboratory result for a simple test or for a panel/study 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"
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text	O	0..1	Narrative	Text summary of the resource, for human interpretation Obligations Actor SHALL:handle LabReportHandler
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Laboratory Test Kit Slice: Unordered, Open by value:url
extension:supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
extension:triggeredBy-r5		0..*	(Complex)	Optional Extensions Element URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
extension:observation		0..*	Extension	Triggering observation.
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"observation"
value[x]		1..1	Reference(Observation)	Value of extension
extension:type		0..*	Extension	The type of trigger
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"type"
value[x]		1..1	code	Value of extension
extension:reason		0..*	Extension	Extension
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"reason"
value[x]		1..1	string	Value of extension
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)
extension:certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
extension:labTestKit		0..*	Reference(Device)	Device Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
extension:value-r5		0..1	(Complex)	only for result of type Attachment URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
id		0..1	string	Unique id for inter-element referencing
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
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business Identifier for observation
basedOn	OΣ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order Obligations Actor SHALL:handle LabReportHandler
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	Part of referenced event
status	?!Σ	1..1	code	Status of this observation Binding: ObservationStatus (required): Codes providing the status of an observation.
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.
category:laboratory		1..1	CodeableConcept	laboratory (fixed) Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
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)
category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: Laboratory Specialty (required)
code	OΣ	1..1	CodeableConceptIPS	Type of observation (code / type) Binding: eHDSI Laboratory Codes with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
subject	Σ	1..1	Reference(Patient: Laboratory)	Who and/or what the observation is about
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	1..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	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).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
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]	OΣ	1..1		Clinically relevant time/time-period for observation Obligations Actor SHALL:handle LabReportHandler
effective[x]All Types				Content/Rules for all Types
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
extension:data-absent-reason		0..1	code	effective[x] absence reason URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason Binding: DataAbsentReason (required)
effectiveDateTime			dateTime
effectivePeriod			Period
issued	OΣ	0..1	instant	Date/Time this result was made available Obligations Actor SHALL:handle LabReportHandler
performer	OΣ	1..*	Reference(Practitioner: Laboratory | PractitionerRole: Laboratory | Organization (IPS))	Who is responsible for the observation Obligations Actor SHALL:handle LabReportHandler
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
extension:performerFunction		0..*	(Complex)	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction
id		0..1	id	Unique id for inter-element referencing
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)
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	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).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
Slices for value[x]	OΣC	0..1		Actual result Slice: Unordered, Closed by type:$this Obligations Actor 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
value[x]:valueQuantity	ΣC	0..1	QuantityMyHealthEu	Actual result
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConceptIPS	Actual result Binding: eHDSI Results Coded Value Laboratory with exceptions (required)
value[x]:valueString	ΣC	0..1	string	Actual result
value[x]:valueRange	ΣC	0..1	RangeIPS	Actual result
value[x]:valueTime	ΣC	0..1	time	Actual result
value[x]:valueDateTime	ΣC	0..1	dateTime	Actual result
value[x]:valuePeriod	ΣC	0..1	Period	Actual result
dataAbsentReason	C	0..1	CodeableConcept	Provides a reason why the expected value is missing. Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation	O	0..*	CodeableConceptIPS	High, low, normal, etc. Binding: eHDSI Observation Interpretation with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
note		0..*	Annotation	Comments about the observation
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method	O	0..1	CodeableConceptIPS	How it was done Binding: eHDSI Laboratory Technique with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
specimen	O	0..1	Reference(Specimen: Laboratory)	Specimen used for this observation Obligations Actor SHALL:handle LabReportHandler
device	O	0..1	Reference(Device: measuring)	Measuring instrument Obligations Actor SHALL:handle LabReportHandler
referenceRange	OC	0..*	BackboneElement	Provides guide for interpretation obs-3: Must have at least a low or a high or text Obligations Actor SHALL:handle LabReportHandler
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	C	0..1	SimpleQuantity	Low Range, if relevant
high	C	0..1	SimpleQuantity	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: eHDSI Reference Range Meaning with exceptions (required)
appliesTo		0..*	CodeableConcept	Reference range population Binding: eHDSI Reference Range Applies To with exceptions (required)
age		0..1	Range	Applicable age range, if relevant
text		0..1	string	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Observation Results: Laboratory)	Related resource that belongs to the Observation group
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
component	Σ	0..*	BackboneElement	Laboratory result
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:value-r5		0..1	(Complex)	only for result of type Attachment URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
id		0..1	string	Unique id for inter-element referencing
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
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	OΣ	1..1	CodeableConceptIPS	Type of component observation (code / type) Binding: eHDSI Laboratory Codes with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
Slices for value[x]	OΣ	0..1		Actual component result Slice: Unordered, Closed by type:$this Obligations Actor 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	Σ	0..1	RatioMyHealthEu	Actual component result
value[x]:valueQuantity	Σ	0..1	QuantityMyHealthEu	Actual component result
value[x]:valueCodeableConcept	Σ	0..1	CodeableConceptIPS	Actual component result Binding: eHDSI Results Coded Value Laboratory with exceptions (required)
value[x]:valueString	Σ	0..1	string	Actual component result
value[x]:valueRange	Σ	0..1	RangeIPS	Actual component result
value[x]:valueTime	Σ	0..1	time	Actual component result
value[x]:valueDateTime	Σ	0..1	dateTime	Actual component result
value[x]:valuePeriod	Σ	0..1	Period	Actual component result
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation	O	0..*	CodeableConcept	High, low, normal, etc. Binding: eHDSI Observation Interpretation with exceptions (required) Obligations Actor SHALL:handle LabReportHandler
referenceRange	O	0..*	BackboneElement	Provides guide for interpretation Obligations Actor SHALL:handle LabReportHandler
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	C	0..1	SimpleQuantity	Low Range, if relevant
high	C	0..1	SimpleQuantity	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: eHDSI Reference Range Meaning with exceptions (required)
appliesTo		0..*	CodeableConcept	Reference range population Binding: eHDSI Reference Range Applies To with exceptions (required)
age		0..1	Range	Applicable age range, if relevant
text		0..1	string	Text based reference range in an observation
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages from the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:laboratory	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:studyType	required	EHDSILabStudyType http://terminology.ehdsi.eu/ValueSet/eHDSILabStudyType from this IG
Observation.category:specialty	required	LabSpecialtyEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab
Observation.code	required	EHDSILabCodeWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSILabCodeWithExceptions from this IG
Observation.subject.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
Observation.performer.extension:performerFunction.value[x]	extensible	EHDSIPerformerFunction http://terminology.ehdsi.eu/ValueSet/eHDSIPerformerFunction from this IG
Observation.performer.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
Observation.value[x]:valueCodeableConcept	required	EHDSIResultsCodedValueLaboratory http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIResultsCodedValueLaboratory from this IG
Observation.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.interpretation	required	EHDSIObservationInterpretationWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIObservationInterpretationWithExceptions from this IG
Observation.bodySite	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
Observation.method	required	EHDSILabTechniqueWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSILabTechniqueWithExceptions from this IG
Observation.referenceRange.type	required	EHDSIReferenceRangeMeaningWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeMeaningWithExceptions from this IG
Observation.referenceRange.appliesTo	required	EHDSIReferenceRangeAppliesToWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeAppliesToWithExceptions from this IG
Observation.component.code	required	EHDSILabCodeWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSILabCodeWithExceptions from this IG
Observation.component.value[x]:valueCodeableConcept	required	EHDSIResultsCodedValueLaboratory http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIResultsCodedValueLaboratory from this IG
Observation.component.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.component.interpretation	required	EHDSIObservationInterpretationWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIObservationInterpretationWithExceptions from this IG
Observation.component.referenceRange.type	required	EHDSIReferenceRangeMeaningWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeMeaningWithExceptions from this IG
Observation.component.referenceRange.appliesTo	required	EHDSIReferenceRangeAppliesToWithExceptions http://fhir.ehdsi.eu/laboratory/ValueSet/eHDSIReferenceRangeAppliesToWithExceptions from this IG

Constraints

Id	Grade	Path(s)	Details	Requirements
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())
eu-lab-1	error	Observation	If 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-2	error	Observation	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" : component.exists() implies (status in ('registered'|'cancelled')) or component.value.exists() or component.dataAbsentReason.exists()
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()

This structure is derived from ObservationResultsLaboratoryEu

Summary

Structures

This structure refers to these other structures:

• Patient: Laboratory (http://fhir.ehdsi.eu/laboratory/StructureDefinition/Patient-lab-myhealtheu)
• Practitioner: Laboratory (http://fhir.ehdsi.eu/laboratory/StructureDefinition/Practitioner-eu-myhealth-eu)
• PractitionerRole: Laboratory (http://fhir.ehdsi.eu/laboratory/StructureDefinition/PractitionerRole-eu-myhealth-eu)
• Organization (IPS) (http://hl7.org/fhir/uv/ips/StructureDefinition/Organization-uv-ips)
• Ratio: Laboratory (http://fhir.ehdsi.eu/laboratory/StructureDefinition/Ratio-lab-myhealtheu)
• Quantity: Laboratory (http://fhir.ehdsi.eu/laboratory/StructureDefinition/Quantity-lab-myhealtheu)
• Codeable Concept (IPS) (http://hl7.org/fhir/uv/ips/StructureDefinition/CodeableConcept-uv-ips)
• Specimen: Laboratory (http://fhir.ehdsi.eu/laboratory/StructureDefinition/Specimen-lab-myhealtheu)
• Device: measuring (http://fhir.ehdsi.eu/laboratory/StructureDefinition/Device-measuring-lab-myhealtheu)
• Observation Results: Laboratory (http://fhir.ehdsi.eu/laboratory/StructureDefinition/Observation-resultslab-lab-myhealtheu)