Laboratory Result - England Pathology and Laboratory Medicine (PaLM) Technical Framework v0.1.0

England Pathology and Laboratory Medicine (PaLM) Technical Framework - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: Laboratory Result

Official URL: https://examplesihe.org.uk/StructureDefinition/LaboratoryResult				Version: 0.1.0	Highlight text changes?
Draft as of 2026-11-04					Computable Name: LaboratoryResult

Diagnostic - Laboratory A laboratory result (HL7 v2 OBX), or a test group (HL7 v2 OBR with several OBX) acting as an organizer whose hasMember are its results - for example the full blood count. NHS England marks organizers with the http://hl7.org/fhir/6.0/StructureDefinition/extension-Observation.organizer extension. NHS England's Pathology Laboratory Reporting API uses its own England-Observation-Lab-Pathology profile, which is also derived from HL7 Europe Laboratory.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

Key Elements Table
Differential Table
Snapshot Table
Statistics/References
All

Name	Flags	Card.	Type	Description & Constraints Filter: Bindings Constraints Obligations
Observation	C	0..*	ObservationResultsLaboratoryEu	Laboratory result for a simple test or for a panel/study Constraints: obs-6, obs-7, obs-value-1, eu-lab-1, eu-lab-2
Observation.implicitRules	This element is a modifier element. This element is included in summaries.	0..1	uri	A set of rules under which this content was created
Observation.Slices for extension				Content/Rules for all slices
Observation.Slices for extension.extension:bodyStructure		0..1	Reference(Cross-version Profile for R5.BodyStructure for use in FHIR R4(0.1.0) \| BodyStructure)	R5: Observed body structure (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.bodyStructure Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy		0..*	(Complex)	R5: Triggering observation(s) (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension		2..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension				Content/Rules for all slices
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation		1..1	Extension	Extension Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.url		1..1	uri	"observation"
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.value[x]		1..1	Reference(Observation: Medical Test Result (EU core))	Triggering observation
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type		1..1	Extension	R5: reflex \| repeat \| re-run (new) Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type.url		1..1	uri	"type"
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type.value[x]		1..1	code	reflex \| repeat \| re-run Binding: R5ObservationTriggeredbytypeForR4 (0.1.0) (required): The type of TriggeredBy Observation.
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:reason		0..1	Extension	R5: Reason that the observation was triggered (new) Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:reason.url		1..1	uri	"reason"
Observation.Slices for extension.extension:triggeredBy.url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"
Observation.Slices for extension.extension:value-r5		0..1	(Complex)	only for Diagrams or Pictures URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value Constraints: ext-1
Observation.Slices for extension.extension:value-r5.extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
Observation.Slices for extension.extension:value-r5.url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value"
Observation.Slices for extension.extension:supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
Observation.Slices for extension.extension:labTestKit		0..*	Reference(Device)	Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
Observation.Slices for extension.extension:certifiedRefMaterialCodeable		0..*	CodeableConcept	Certified Reference Material: CodeableConcept URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example)
Observation.Slices for extension.extension:certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material: Identifier URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
Observation.Slices for extension.extension:accredited		0..1	boolean	Accredited test URL: http://hl7.eu/fhir/StructureDefinition/laboratory-accredited
Observation.Slices for extension.extension:statusReason		0..1	CodeableConcept	Reason for the current status URL: http://hl7.org/fhir/StructureDefinition/event-statusReason Binding Description: (example): Codes identifying the reason for the current state of an event.
Observation.modifierExtension	This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
Observation.identifier	This element must be supported. This element is included in summaries.	0..*	CorrelationIdentifier	Business Identifier for observation
Observation.basedOn	This element must be supported. This element is included in summaries.	0..*	Reference(Laboratory Order)	Fulfills plan, proposal or order
Observation.status	This element is a modifier element. This element must be supported. This element is included in summaries.	1..1	code	HL7 v2 OBX-11 Observation Result Status - see ConceptMap v2-0085 to Observation.status Binding: ObservationStatus (required): Codes providing the status of an observation.
Observation.Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
Observation.Slices for category.category:laboratory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: `{ "coding" : [ { "system" : "http://terminology.hl7.org/CodeSystem/observation-category", "code" : "laboratory" } ] }`
Observation.Slices for category.category:studyType		0..*	CodeableConcept	The way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.) Binding: Laboratory Study Types (required)
Observation.Slices for category.category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: Laboratory Specialty (required)
Observation.code	This element must be supported. This element is included in summaries.	1..1	CodeableConcept	What was measured (HL7 v2 OBX-3 Observation Identifier). SNOMED CT UK (PaLM) observable entity, optionally with LOINC Binding: Laboratory Code (preferred)
Observation.subject	This element must be supported. This element is included in summaries.	1..1	Reference(Patient)	Who and/or what the observation is about
Observation.effective[x]	This element must be supported. This element is included in summaries.	1..1		HL7 v2 OBX-14 Date/Time of the Observation, otherwise OBR-7
Observation.effective[x].effectiveDateTime			dateTime
Observation.effective[x].effectivePeriod			Period
Observation.issued	This element must be supported. This element is included in summaries.	0..1	instant	HL7 v2 OBR-22 Results Rpt/Status Chng - Date/Time
Observation.performer	This element must be supported. This element is included in summaries.	1..*	Reference(Practitioner (EU core) \| PractitionerRole (EU core) \| Organization (EU core) \| Patient (EU core) \| RelatedPerson)	HL7 v2 OBX-23 Performing Organization Name, OBX-16 Responsible Observer
Observation.performer.Slices for extension				Content/Rules for all slices
Observation.performer.Slices for extension.extension:performerFunction		0..1	CodeableConcept	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: Performer Function Codes (extensible)
Observation.Slices for value[x]	This element must be supported. This element is included in summaries. C	0..1		HL7 v2 OBX-5 Observation Value, typed by OBX-2 Value Type, with OBX-6 Units Slice: Unordered, Closed by type:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.Slices for value[x].valueQuantity			Quantity
Observation.Slices for value[x].valueCodeableConcept			CodeableConcept
Observation.Slices for value[x].valueString			string
Observation.Slices for value[x].valueBoolean			boolean
Observation.Slices for value[x].valueInteger			integer
Observation.Slices for value[x].valueRange			Range
Observation.Slices for value[x].valueRatio			Ratio
Observation.Slices for value[x].valueSampledData			SampledData
Observation.Slices for value[x].valueTime			time
Observation.Slices for value[x].valueDateTime			dateTime
Observation.Slices for value[x].valuePeriod			Period
Observation.Slices for value[x].value[x]:valueQuantity	This element is included in summaries. C	0..1	QuantityEuLab	Actual result
Observation.Slices for value[x].value[x]:valueQuantity.Slices for extension				Content/Rules for all slices
Observation.Slices for value[x].value[x]:valueQuantity.Slices for extension.extension:uncertainty		0..1	decimal	Standard Deviation (same units as the quantity) URL: http://hl7.org/fhir/StructureDefinition/iso21090-uncertainty
Observation.Slices for value[x].value[x]:valueQuantity.comparator	This element is a modifier element. This element is included in summaries.	0..1	code	< \| <= \| >= \| > - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
Observation.Slices for value[x].value[x]:valueString	This element is included in summaries. C	0..1	string	Actual result
Observation.Slices for value[x].value[x]:valueRange	This element is included in summaries. C	0..1	RangeEuLab	Actual result
Observation.Slices for value[x].value[x]:valueRatio	This element is included in summaries. C	0..1	RatioEuLab	Actual result
Observation.Slices for value[x].value[x]:valueTime	This element is included in summaries. C	0..1	time	Actual result
Observation.Slices for value[x].value[x]:valueDateTime	This element is included in summaries. C	0..1	dateTime	Actual result
Observation.Slices for value[x].value[x]:valuePeriod	This element is included in summaries. C	0..1	Period	Actual result
Observation.Slices for value[x].value[x]:valueBoolean	This element is included in summaries. C	0..1	boolean	Actual result
Observation.Slices for value[x].value[x]:valueInteger	This element is included in summaries. C	0..1	integer	Actual result
Observation.Slices for value[x].value[x]:valueSampledData	This element is included in summaries. C	0..1	SampledData	Actual result
Observation.Slices for value[x].value[x]:valueCodeableConcept	This element is included in summaries. C	0..1	CodeableConcept	Actual result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred)
Observation.dataAbsentReason	This element must be supported. C	0..1	CodeableConcept	Why there is no value, e.g. HL7 v2 OBX-11 = X (results cannot be obtained) Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
Observation.interpretation	This element must be supported.	0..*	CodeableConcept	HL7 v2 OBX-8 Abnormal Flags Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
Observation.note	This element must be supported.	0..*	Annotation	HL7 v2 NTE following the OBX
Observation.method		0..1	CodeableConcept	HL7 v2 OBX-17 Observation Method Binding: Laboratory Techniques (preferred)
Observation.specimen	This element must be supported.	0..1	Reference(Specimen)	Specimen used for the observation
Observation.device		0..1	Reference(Device \| DeviceMetric)	HL7 v2 OBX-18 Equipment Instance Identifier
Observation.referenceRange	This element must be supported. C	0..*	BackboneElement	HL7 v2 OBX-7 References Range Constraints: obs-3
Observation.referenceRange.Slices for modifierExtension	This element is a modifier element. This element is included in summaries.	0..*	Extension	Extension Slice: Unordered, Open by value:url
Observation.referenceRange.Slices for modifierExtension.modifierExtension:lowComparator	This element is a modifier element. This element is included in summaries.	0..1	code	Observation Reference Range Low Comparator URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-reference-range-low-comparator Binding: Reference Range Low Comparator (required)
Observation.referenceRange.Slices for modifierExtension.modifierExtension:highComparator	This element is a modifier element. This element is included in summaries.	0..1	code	Observation Reference Range High Comparator URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-reference-range-high-comparator Binding: Reference Range High Comparator (required)
Observation.referenceRange.text		0..1	string	HL7 v2 OBX-7 as sent, where it cannot be parsed into low/high
Observation.hasMember	This element is included in summaries.	0..*	Reference(Observation Results: laboratory)	Results of a test group - the OBX under the OBR (or grouped by HL7 v2 OBX-4 Observation Sub-ID)
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.extension:triggeredBy.extension:type.value[x]	Base	required	Cross-version ValueSet R5.TriggeredBytype for use in FHIR R4	📍0.1.0	Extensions for Using Data Elements from FHIR R5 in FHIR R4 v0.1
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:laboratory	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:studyType	Base	required	Laboratory Study Types	📦2.1.0	HL7 Europe Laboratory Report v2.1
Observation.category:specialty	Base	required	Laboratory Specialty	📦2.1.0	HL7 Europe Laboratory Report v2.1
Observation.code	Base	preferred	Laboratory Code	📦2.1.0	HL7 Europe Laboratory Report v2.1
Observation.value[x]:valueQuantity.comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	📦2.0.1	International Patient Summary Implementation Guide v2.0
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.
Observation.method	Base	preferred	Laboratory Techniques	📦2.1.0	HL7 Europe Laboratory Report v2.1

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources	`contained.contained.empty()`
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	`contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	`contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label	`contained.meta.security.empty()`
dom-6	best practice	Observation	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	ALL elements	All FHIR elements must have a @value or children	`hasValue() or (children().count() > id.count())`
eu-lab-1	error	Observation	If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided with an actual value: "value", the R5 "value[x]" extension, "dataAbsentReason", "hasMember" or "component"	`(status in ('registered'\|'cancelled')) or value.hasValue() or value.children().exclude(value.extension).exists() or extension.where(url='http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value').value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists()`
eu-lab-2	error	Observation	If observation status is other then "registered" or "cancelled", every Observation.component shall provide one of these elements with an actual value: "value", the R5 "component.value[x]" extension or "dataAbsentReason"	`(status in ('registered'\|'cancelled')) or component.all(value.hasValue() or value.children().exclude(value.extension).exists() or extension.where(url='http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value').value.exists() or dataAbsentReason.exists())`
ext-1	error	Observation.extension:bodyStructure, Observation.extension:triggeredBy, Observation.extension:triggeredBy.extension, Observation.extension:triggeredBy.extension:observation, Observation.extension:triggeredBy.extension:type, Observation.extension:triggeredBy.extension:reason, Observation.extension:value-r5, Observation.extension:supportingInfo, Observation.extension:labTestKit, Observation.extension:certifiedRefMaterialCodeable, Observation.extension:certifiedRefMaterialIdentifer, Observation.extension:accredited, Observation.extension:statusReason, Observation.modifierExtension, Observation.performer.extension:performerFunction, Observation.value[x]:valueQuantity.extension:uncertainty, Observation.referenceRange.modifierExtension, Observation.referenceRange.modifierExtension:lowComparator, Observation.referenceRange.modifierExtension:highComparator	Must have either extensions or value[x], not both	`extension.exists() != value.exists()`
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text	`low.exists() or high.exists() or text.exists()`
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present	`dataAbsentReason.empty() or value.empty()`
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present	`value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()`
obs-value-1	error	Observation	The elements Observation.extension:value-r5 and Observation.value[x] SHALL not be used simultaneously.	`value.empty() or extension('http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value').empty()`

This structure is derived from ObservationResultsLaboratoryEu

Name	Flags	Card.	Type	Description & Constraints Filter: Bindings Constraints Obligations
Observation		0..*	ObservationResultsLaboratoryEu	Laboratory result for a simple test or for a panel/study
Observation.identifier	This element must be supported.	0..*	CorrelationIdentifier	Business Identifier for observation
Observation.basedOn	This element must be supported.	0..*	Reference(Laboratory Order)	Fulfills plan, proposal or order
Observation.status	This element must be supported.	1..1	code	HL7 v2 OBX-11 Observation Result Status - see ConceptMap v2-0085 to Observation.status
Observation.code	This element must be supported.	1..1	CodeableConcept	What was measured (HL7 v2 OBX-3 Observation Identifier). SNOMED CT UK (PaLM) observable entity, optionally with LOINC
Observation.subject	This element must be supported.	1..1	Reference(Patient)	Who and/or what the observation is about
Observation.effective[x]	This element must be supported.	1..1	dateTime, Period	HL7 v2 OBX-14 Date/Time of the Observation, otherwise OBR-7
Observation.issued	This element must be supported.	0..1	instant	HL7 v2 OBR-22 Results Rpt/Status Chng - Date/Time
Observation.performer	This element must be supported.	1..*	Reference(Practitioner (EU core) \| PractitionerRole (EU core) \| Organization (EU core) \| Patient (EU core) \| RelatedPerson)	HL7 v2 OBX-23 Performing Organization Name, OBX-16 Responsible Observer
Observation.value[x]	This element must be supported.	0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	HL7 v2 OBX-5 Observation Value, typed by OBX-2 Value Type, with OBX-6 Units
Observation.dataAbsentReason	This element must be supported.	0..1	CodeableConcept	Why there is no value, e.g. HL7 v2 OBX-11 = X (results cannot be obtained)
Observation.interpretation	This element must be supported.	0..*	CodeableConcept	HL7 v2 OBX-8 Abnormal Flags
Observation.note	This element must be supported.	0..*	Annotation	HL7 v2 NTE following the OBX
Observation.method		0..1	CodeableConcept	HL7 v2 OBX-17 Observation Method
Observation.specimen	This element must be supported.	0..1	Reference(Specimen)	Specimen used for the observation
Observation.device		0..1	Reference(Device \| DeviceMetric)	HL7 v2 OBX-18 Equipment Instance Identifier
Observation.referenceRange	This element must be supported.	0..*	BackboneElement	HL7 v2 OBX-7 References Range
Observation.referenceRange.text		0..1	string	HL7 v2 OBX-7 as sent, where it cannot be parsed into low/high
Observation.hasMember		0..*	Reference(Observation Results: laboratory)	Results of a test group - the OBX under the OBR (or grouped by HL7 v2 OBX-4 Observation Sub-ID)
Documentation for this format

Description & Constraints Filter:

Observation C 0..* ObservationResultsLaboratoryEu Laboratory result for a simple test or for a panel/study
Constraints: obs-6, obs-7, obs-value-1, eu-lab-1, eu-lab-2

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

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

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

language

0..1

code

Language of the observation
Binding: CommonLanguages (preferred): A human language.

Additional Bindings

Purpose

AllLanguages

Max Binding

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Observation.Slices for extension.extension:statusReason 0..1 CodeableConcept Reason for the current status
URL: http://hl7.org/fhir/StructureDefinition/event-statusReason
Binding Description: (example): Codes identifying the reason for the current state of an event.

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

Observation.identifier This element must be supported. This element is included in summaries. 0..* CorrelationIdentifier Business Identifier for observation

Observation.basedOn This element must be supported. This element is included in summaries. 0..* Reference(Laboratory Order) Fulfills plan, proposal or order

Observation.status This element is a modifier element. This element must be supported. This element is included in summaries. 1..1 code HL7 v2 OBX-11 Observation Result Status - see ConceptMap v2-0085 to Observation.status
Binding: ObservationStatus (required): Codes providing the status of an observation.

Observation.Slices for category 1..* CodeableConcept Classification of type of observation
Slice: Unordered, Open by pattern:$this
Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.

category:laboratory

1..1

CodeableConcept

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

Required Pattern:

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

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

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

Observation.code This element must be supported. This element is included in summaries. 1..1 CodeableConcept What was measured (HL7 v2 OBX-3 Observation Identifier). SNOMED CT UK (PaLM) observable entity, optionally with LOINC
Binding: Laboratory Code (preferred)

Observation.subject This element must be supported. This element is included in summaries. 1..1 Reference(Patient) Who and/or what the observation is about

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

Observation.effective[x] This element must be supported. This element is included in summaries. 1..1 HL7 v2 OBX-14 Date/Time of the Observation, otherwise OBR-7

Observation.effective[x].effectiveDateTime dateTime

Observation.effective[x].effectivePeriod Period

Observation.issued This element must be supported. This element is included in summaries. 0..1 instant HL7 v2 OBR-22 Results Rpt/Status Chng - Date/Time

Observation.performer This element must be supported. This element is included in summaries. 1..* Reference(Practitioner (EU core) | PractitionerRole (EU core) | Organization (EU core) | Patient (EU core) | RelatedPerson) HL7 v2 OBX-23 Performing Organization Name, OBX-16 Responsible Observer

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

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

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

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

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

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

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

Observation.Slices for value[x] This element must be supported. This element is included in summaries. C 0..1 HL7 v2 OBX-5 Observation Value, typed by OBX-2 Value Type, with OBX-6 Units
Slice: Unordered, Closed by type:$this
Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them

Observation.Slices for value[x].valueQuantity Quantity

Observation.Slices for value[x].valueCodeableConcept CodeableConcept

Observation.Slices for value[x].valueString string

Observation.Slices for value[x].valueBoolean boolean

Observation.Slices for value[x].valueInteger integer

Observation.Slices for value[x].valueRange Range

Observation.Slices for value[x].valueRatio Ratio

Observation.Slices for value[x].valueSampledData SampledData

Observation.Slices for value[x].valueTime time

Observation.Slices for value[x].valueDateTime dateTime

Observation.Slices for value[x].valuePeriod Period

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Observation.Slices for value[x].value[x]:valueCodeableConcept This element is included in summaries. C 0..1 CodeableConcept Actual result
Binding: Results Coded Values Laboratory/Pathology - IPS (preferred)

Observation.dataAbsentReason This element must be supported. C 0..1 CodeableConcept Why there is no value, e.g. HL7 v2 OBX-11 = X (results cannot be obtained)
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

Observation.interpretation This element must be supported. 0..* CodeableConcept HL7 v2 OBX-8 Abnormal Flags
Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.

Observation.note This element must be supported. 0..* Annotation HL7 v2 NTE following the OBX

Observation.bodySite 0..1 CodeableConcept Observed body part
Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.

Observation.method 0..1 CodeableConcept HL7 v2 OBX-17 Observation Method
Binding: Laboratory Techniques (preferred)

Observation.specimen This element must be supported. 0..1 Reference(Specimen) Specimen used for the observation

Observation.device 0..1 Reference(Device | DeviceMetric) HL7 v2 OBX-18 Equipment Instance Identifier

Observation.referenceRange This element must be supported. C 0..* BackboneElement HL7 v2 OBX-7 References Range
Constraints: obs-3

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

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

Observation.referenceRange.Slices for modifierExtension This element is a modifier element. This element is included in summaries. 0..* Extension Extension
Slice: Unordered, Open by value:url

Observation.referenceRange.Slices for modifierExtension.modifierExtension:lowComparator This element is a modifier element. This element is included in summaries. 0..1 code Observation Reference Range Low Comparator
URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-reference-range-low-comparator
Binding: Reference Range Low Comparator (required)

Observation.referenceRange.Slices for modifierExtension.modifierExtension:highComparator This element is a modifier element. This element is included in summaries. 0..1 code Observation Reference Range High Comparator
URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-reference-range-high-comparator
Binding: Reference Range High Comparator (required)

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

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

Observation.referenceRange.type 0..1 CodeableConcept Reference range qualifier
Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.

Observation.referenceRange.appliesTo 0..* CodeableConcept Reference range population
Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.

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

Observation.referenceRange.text 0..1 string HL7 v2 OBX-7 as sent, where it cannot be parsed into low/high

Observation.hasMember This element is included in summaries. 0..* Reference(Observation Results: laboratory) Results of a test group - the OBX under the OBR (or grouped by HL7 v2 OBX-4 Observation Sub-ID)

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

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

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

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

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

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

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

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

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

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

Observation.component.code This element is included in summaries. 1..1 CodeableConcept Type of component observation (code / type)
Binding: Laboratory Code (preferred)

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

Observation.component.Slices for value[x].valueQuantity Quantity

Observation.component.Slices for value[x].valueCodeableConcept CodeableConcept

Observation.component.Slices for value[x].valueString string

Observation.component.Slices for value[x].valueBoolean boolean

Observation.component.Slices for value[x].valueInteger integer

Observation.component.Slices for value[x].valueRange Range

Observation.component.Slices for value[x].valueRatio Ratio

Observation.component.Slices for value[x].valueSampledData SampledData

Observation.component.Slices for value[x].valueTime time

Observation.component.Slices for value[x].valueDateTime dateTime

Observation.component.Slices for value[x].valuePeriod Period

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Observation.component.Slices for value[x].value[x]:valueCodeableConcept This element is included in summaries. 0..1 CodeableConcept Actual component result
Binding: Results Coded Values Laboratory/Pathology - IPS (preferred)

Observation.component.dataAbsentReason C 0..1 CodeableConcept Why the component result is missing
Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.

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

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

Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
Observation.extension:triggeredBy.extension:type.value[x]	Base	required	Cross-version ValueSet R5.TriggeredBytype for use in FHIR R4	📍0.1.0	Extensions for Using Data Elements from FHIR R5 in FHIR R4 v0.1
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:laboratory	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:studyType	Base	required	Laboratory Study Types	📦2.1.0	HL7 Europe Laboratory Report v2.1
Observation.category:specialty	Base	required	Laboratory Specialty	📦2.1.0	HL7 Europe Laboratory Report v2.1
Observation.code	Base	preferred	Laboratory Code	📦2.1.0	HL7 Europe Laboratory Report v2.1
Observation.performer.type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Observation.value[x]:valueQuantity.comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	📦2.0.1	International Patient Summary Implementation Guide v2.0
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.
Observation.bodySite	Base	example	SNOMED CT Body Structures	📍4.0.1	FHIR Std.
Observation.method	Base	preferred	Laboratory Techniques	📦2.1.0	HL7 Europe Laboratory Report v2.1
Observation.referenceRange.type	Base	preferred	Observation Reference Range Meaning Codes	📍4.0.1	FHIR Std.
Observation.referenceRange.appliesTo	Base	example	Observation Reference Range Applies To Codes	📍4.0.1	FHIR Std.
Observation.component.code	Base	preferred	Laboratory Code	📦2.1.0	HL7 Europe Laboratory Report v2.1
Observation.component.value[x]:valueQuantity.comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.component.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	📦2.0.1	International Patient Summary Implementation Guide v2.0
Observation.component.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.component.interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources	`contained.contained.empty()`
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	`contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	`contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label	`contained.meta.security.empty()`
dom-6	best practice	Observation	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	ALL elements	All FHIR elements must have a @value or children	`hasValue() or (children().count() > id.count())`
eu-lab-1	error	Observation	If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided with an actual value: "value", the R5 "value[x]" extension, "dataAbsentReason", "hasMember" or "component"	`(status in ('registered'\|'cancelled')) or value.hasValue() or value.children().exclude(value.extension).exists() or extension.where(url='http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value').value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists()`
eu-lab-2	error	Observation	If observation status is other then "registered" or "cancelled", every Observation.component shall provide one of these elements with an actual value: "value", the R5 "component.value[x]" extension or "dataAbsentReason"	`(status in ('registered'\|'cancelled')) or component.all(value.hasValue() or value.children().exclude(value.extension).exists() or extension.where(url='http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value').value.exists() or 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()`
obs-value-1	error	Observation	The elements Observation.extension:value-r5 and Observation.value[x] SHALL not be used simultaneously.	`value.empty() or extension('http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value').empty()`
obs-value-2	error	Observation.component	The elements Observation.component.extension:value-r5 and Observation.component.value[x] SHALL not be used simultaneously.	`value.empty() or extension('http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value').empty()`
sqty-1	error	Observation.referenceRange.low, Observation.referenceRange.high	The comparator is not used on a SimpleQuantity	`comparator.empty()`

This structure is derived from ObservationResultsLaboratoryEu

Summary

Must-Support: 14 elements

Structures

This structure refers to these other structures:

Key Elements View

Name	Flags	Card.	Type	Description & Constraints Filter: Bindings Constraints Obligations
Observation	C	0..*	ObservationResultsLaboratoryEu	Laboratory result for a simple test or for a panel/study Constraints: obs-6, obs-7, obs-value-1, eu-lab-1, eu-lab-2
Observation.implicitRules	This element is a modifier element. This element is included in summaries.	0..1	uri	A set of rules under which this content was created
Observation.Slices for extension				Content/Rules for all slices
Observation.Slices for extension.extension:bodyStructure		0..1	Reference(Cross-version Profile for R5.BodyStructure for use in FHIR R4(0.1.0) \| BodyStructure)	R5: Observed body structure (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.bodyStructure Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy		0..*	(Complex)	R5: Triggering observation(s) (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension		2..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension				Content/Rules for all slices
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation		1..1	Extension	Extension Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.url		1..1	uri	"observation"
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.value[x]		1..1	Reference(Observation: Medical Test Result (EU core))	Triggering observation
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type		1..1	Extension	R5: reflex \| repeat \| re-run (new) Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type.url		1..1	uri	"type"
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type.value[x]		1..1	code	reflex \| repeat \| re-run Binding: R5ObservationTriggeredbytypeForR4 (0.1.0) (required): The type of TriggeredBy Observation.
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:reason		0..1	Extension	R5: Reason that the observation was triggered (new) Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:reason.url		1..1	uri	"reason"
Observation.Slices for extension.extension:triggeredBy.url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"
Observation.Slices for extension.extension:value-r5		0..1	(Complex)	only for Diagrams or Pictures URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value Constraints: ext-1
Observation.Slices for extension.extension:value-r5.extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
Observation.Slices for extension.extension:value-r5.url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value"
Observation.Slices for extension.extension:supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
Observation.Slices for extension.extension:labTestKit		0..*	Reference(Device)	Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
Observation.Slices for extension.extension:certifiedRefMaterialCodeable		0..*	CodeableConcept	Certified Reference Material: CodeableConcept URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example)
Observation.Slices for extension.extension:certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material: Identifier URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
Observation.Slices for extension.extension:accredited		0..1	boolean	Accredited test URL: http://hl7.eu/fhir/StructureDefinition/laboratory-accredited
Observation.Slices for extension.extension:statusReason		0..1	CodeableConcept	Reason for the current status URL: http://hl7.org/fhir/StructureDefinition/event-statusReason Binding Description: (example): Codes identifying the reason for the current state of an event.
Observation.modifierExtension	This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
Observation.identifier	This element must be supported. This element is included in summaries.	0..*	CorrelationIdentifier	Business Identifier for observation
Observation.basedOn	This element must be supported. This element is included in summaries.	0..*	Reference(Laboratory Order)	Fulfills plan, proposal or order
Observation.status	This element is a modifier element. This element must be supported. This element is included in summaries.	1..1	code	HL7 v2 OBX-11 Observation Result Status - see ConceptMap v2-0085 to Observation.status Binding: ObservationStatus (required): Codes providing the status of an observation.
Observation.Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
Observation.Slices for category.category:laboratory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: `{ "coding" : [ { "system" : "http://terminology.hl7.org/CodeSystem/observation-category", "code" : "laboratory" } ] }`
Observation.Slices for category.category:studyType		0..*	CodeableConcept	The way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.) Binding: Laboratory Study Types (required)
Observation.Slices for category.category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: Laboratory Specialty (required)
Observation.code	This element must be supported. This element is included in summaries.	1..1	CodeableConcept	What was measured (HL7 v2 OBX-3 Observation Identifier). SNOMED CT UK (PaLM) observable entity, optionally with LOINC Binding: Laboratory Code (preferred)
Observation.subject	This element must be supported. This element is included in summaries.	1..1	Reference(Patient)	Who and/or what the observation is about
Observation.effective[x]	This element must be supported. This element is included in summaries.	1..1		HL7 v2 OBX-14 Date/Time of the Observation, otherwise OBR-7
Observation.effective[x].effectiveDateTime			dateTime
Observation.effective[x].effectivePeriod			Period
Observation.issued	This element must be supported. This element is included in summaries.	0..1	instant	HL7 v2 OBR-22 Results Rpt/Status Chng - Date/Time
Observation.performer	This element must be supported. This element is included in summaries.	1..*	Reference(Practitioner (EU core) \| PractitionerRole (EU core) \| Organization (EU core) \| Patient (EU core) \| RelatedPerson)	HL7 v2 OBX-23 Performing Organization Name, OBX-16 Responsible Observer
Observation.performer.Slices for extension				Content/Rules for all slices
Observation.performer.Slices for extension.extension:performerFunction		0..1	CodeableConcept	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: Performer Function Codes (extensible)
Observation.Slices for value[x]	This element must be supported. This element is included in summaries. C	0..1		HL7 v2 OBX-5 Observation Value, typed by OBX-2 Value Type, with OBX-6 Units Slice: Unordered, Closed by type:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.Slices for value[x].valueQuantity			Quantity
Observation.Slices for value[x].valueCodeableConcept			CodeableConcept
Observation.Slices for value[x].valueString			string
Observation.Slices for value[x].valueBoolean			boolean
Observation.Slices for value[x].valueInteger			integer
Observation.Slices for value[x].valueRange			Range
Observation.Slices for value[x].valueRatio			Ratio
Observation.Slices for value[x].valueSampledData			SampledData
Observation.Slices for value[x].valueTime			time
Observation.Slices for value[x].valueDateTime			dateTime
Observation.Slices for value[x].valuePeriod			Period
Observation.Slices for value[x].value[x]:valueQuantity	This element is included in summaries. C	0..1	QuantityEuLab	Actual result
Observation.Slices for value[x].value[x]:valueQuantity.Slices for extension				Content/Rules for all slices
Observation.Slices for value[x].value[x]:valueQuantity.Slices for extension.extension:uncertainty		0..1	decimal	Standard Deviation (same units as the quantity) URL: http://hl7.org/fhir/StructureDefinition/iso21090-uncertainty
Observation.Slices for value[x].value[x]:valueQuantity.comparator	This element is a modifier element. This element is included in summaries.	0..1	code	< \| <= \| >= \| > - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
Observation.Slices for value[x].value[x]:valueString	This element is included in summaries. C	0..1	string	Actual result
Observation.Slices for value[x].value[x]:valueRange	This element is included in summaries. C	0..1	RangeEuLab	Actual result
Observation.Slices for value[x].value[x]:valueRatio	This element is included in summaries. C	0..1	RatioEuLab	Actual result
Observation.Slices for value[x].value[x]:valueTime	This element is included in summaries. C	0..1	time	Actual result
Observation.Slices for value[x].value[x]:valueDateTime	This element is included in summaries. C	0..1	dateTime	Actual result
Observation.Slices for value[x].value[x]:valuePeriod	This element is included in summaries. C	0..1	Period	Actual result
Observation.Slices for value[x].value[x]:valueBoolean	This element is included in summaries. C	0..1	boolean	Actual result
Observation.Slices for value[x].value[x]:valueInteger	This element is included in summaries. C	0..1	integer	Actual result
Observation.Slices for value[x].value[x]:valueSampledData	This element is included in summaries. C	0..1	SampledData	Actual result
Observation.Slices for value[x].value[x]:valueCodeableConcept	This element is included in summaries. C	0..1	CodeableConcept	Actual result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred)
Observation.dataAbsentReason	This element must be supported. C	0..1	CodeableConcept	Why there is no value, e.g. HL7 v2 OBX-11 = X (results cannot be obtained) Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
Observation.interpretation	This element must be supported.	0..*	CodeableConcept	HL7 v2 OBX-8 Abnormal Flags Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
Observation.note	This element must be supported.	0..*	Annotation	HL7 v2 NTE following the OBX
Observation.method		0..1	CodeableConcept	HL7 v2 OBX-17 Observation Method Binding: Laboratory Techniques (preferred)
Observation.specimen	This element must be supported.	0..1	Reference(Specimen)	Specimen used for the observation
Observation.device		0..1	Reference(Device \| DeviceMetric)	HL7 v2 OBX-18 Equipment Instance Identifier
Observation.referenceRange	This element must be supported. C	0..*	BackboneElement	HL7 v2 OBX-7 References Range Constraints: obs-3
Observation.referenceRange.Slices for modifierExtension	This element is a modifier element. This element is included in summaries.	0..*	Extension	Extension Slice: Unordered, Open by value:url
Observation.referenceRange.Slices for modifierExtension.modifierExtension:lowComparator	This element is a modifier element. This element is included in summaries.	0..1	code	Observation Reference Range Low Comparator URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-reference-range-low-comparator Binding: Reference Range Low Comparator (required)
Observation.referenceRange.Slices for modifierExtension.modifierExtension:highComparator	This element is a modifier element. This element is included in summaries.	0..1	code	Observation Reference Range High Comparator URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-reference-range-high-comparator Binding: Reference Range High Comparator (required)
Observation.referenceRange.text		0..1	string	HL7 v2 OBX-7 as sent, where it cannot be parsed into low/high
Observation.hasMember	This element is included in summaries.	0..*	Reference(Observation Results: laboratory)	Results of a test group - the OBX under the OBR (or grouped by HL7 v2 OBX-4 Observation Sub-ID)
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.extension:triggeredBy.extension:type.value[x]	Base	required	Cross-version ValueSet R5.TriggeredBytype for use in FHIR R4	📍0.1.0	Extensions for Using Data Elements from FHIR R5 in FHIR R4 v0.1
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:laboratory	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:studyType	Base	required	Laboratory Study Types	📦2.1.0	HL7 Europe Laboratory Report v2.1
Observation.category:specialty	Base	required	Laboratory Specialty	📦2.1.0	HL7 Europe Laboratory Report v2.1
Observation.code	Base	preferred	Laboratory Code	📦2.1.0	HL7 Europe Laboratory Report v2.1
Observation.value[x]:valueQuantity.comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	📦2.0.1	International Patient Summary Implementation Guide v2.0
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.
Observation.method	Base	preferred	Laboratory Techniques	📦2.1.0	HL7 Europe Laboratory Report v2.1

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources	`contained.contained.empty()`
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	`contained.where((('#'+id in (%resource.descendants().reference \| %resource.descendants().as(canonical) \| %resource.descendants().as(uri) \| %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()`
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	`contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label	`contained.meta.security.empty()`
dom-6	best practice	Observation	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	ALL elements	All FHIR elements must have a @value or children	`hasValue() or (children().count() > id.count())`
eu-lab-1	error	Observation	If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided with an actual value: "value", the R5 "value[x]" extension, "dataAbsentReason", "hasMember" or "component"	`(status in ('registered'\|'cancelled')) or value.hasValue() or value.children().exclude(value.extension).exists() or extension.where(url='http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value').value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists()`
eu-lab-2	error	Observation	If observation status is other then "registered" or "cancelled", every Observation.component shall provide one of these elements with an actual value: "value", the R5 "component.value[x]" extension or "dataAbsentReason"	`(status in ('registered'\|'cancelled')) or component.all(value.hasValue() or value.children().exclude(value.extension).exists() or extension.where(url='http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value').value.exists() or dataAbsentReason.exists())`
ext-1	error	Observation.extension:bodyStructure, Observation.extension:triggeredBy, Observation.extension:triggeredBy.extension, Observation.extension:triggeredBy.extension:observation, Observation.extension:triggeredBy.extension:type, Observation.extension:triggeredBy.extension:reason, Observation.extension:value-r5, Observation.extension:supportingInfo, Observation.extension:labTestKit, Observation.extension:certifiedRefMaterialCodeable, Observation.extension:certifiedRefMaterialIdentifer, Observation.extension:accredited, Observation.extension:statusReason, Observation.modifierExtension, Observation.performer.extension:performerFunction, Observation.value[x]:valueQuantity.extension:uncertainty, Observation.referenceRange.modifierExtension, Observation.referenceRange.modifierExtension:lowComparator, Observation.referenceRange.modifierExtension:highComparator	Must have either extensions or value[x], not both	`extension.exists() != value.exists()`
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text	`low.exists() or high.exists() or text.exists()`
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present	`dataAbsentReason.empty() or value.empty()`
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present	`value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()`
obs-value-1	error	Observation	The elements Observation.extension:value-r5 and Observation.value[x] SHALL not be used simultaneously.	`value.empty() or extension('http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value').empty()`

Differential View

This structure is derived from ObservationResultsLaboratoryEu

Name	Flags	Card.	Type	Description & Constraints Filter: Bindings Constraints Obligations
Observation		0..*	ObservationResultsLaboratoryEu	Laboratory result for a simple test or for a panel/study
Observation.identifier	This element must be supported.	0..*	CorrelationIdentifier	Business Identifier for observation
Observation.basedOn	This element must be supported.	0..*	Reference(Laboratory Order)	Fulfills plan, proposal or order
Observation.status	This element must be supported.	1..1	code	HL7 v2 OBX-11 Observation Result Status - see ConceptMap v2-0085 to Observation.status
Observation.code	This element must be supported.	1..1	CodeableConcept	What was measured (HL7 v2 OBX-3 Observation Identifier). SNOMED CT UK (PaLM) observable entity, optionally with LOINC
Observation.subject	This element must be supported.	1..1	Reference(Patient)	Who and/or what the observation is about
Observation.effective[x]	This element must be supported.	1..1	dateTime, Period	HL7 v2 OBX-14 Date/Time of the Observation, otherwise OBR-7
Observation.issued	This element must be supported.	0..1	instant	HL7 v2 OBR-22 Results Rpt/Status Chng - Date/Time
Observation.performer	This element must be supported.	1..*	Reference(Practitioner (EU core) \| PractitionerRole (EU core) \| Organization (EU core) \| Patient (EU core) \| RelatedPerson)	HL7 v2 OBX-23 Performing Organization Name, OBX-16 Responsible Observer
Observation.value[x]	This element must be supported.	0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	HL7 v2 OBX-5 Observation Value, typed by OBX-2 Value Type, with OBX-6 Units
Observation.dataAbsentReason	This element must be supported.	0..1	CodeableConcept	Why there is no value, e.g. HL7 v2 OBX-11 = X (results cannot be obtained)
Observation.interpretation	This element must be supported.	0..*	CodeableConcept	HL7 v2 OBX-8 Abnormal Flags
Observation.note	This element must be supported.	0..*	Annotation	HL7 v2 NTE following the OBX
Observation.method		0..1	CodeableConcept	HL7 v2 OBX-17 Observation Method
Observation.specimen	This element must be supported.	0..1	Reference(Specimen)	Specimen used for the observation
Observation.device		0..1	Reference(Device \| DeviceMetric)	HL7 v2 OBX-18 Equipment Instance Identifier
Observation.referenceRange	This element must be supported.	0..*	BackboneElement	HL7 v2 OBX-7 References Range
Observation.referenceRange.text		0..1	string	HL7 v2 OBX-7 as sent, where it cannot be parsed into low/high
Observation.hasMember		0..*	Reference(Observation Results: laboratory)	Results of a test group - the OBX under the OBR (or grouped by HL7 v2 OBX-4 Observation Sub-ID)
Documentation for this format

Snapshot ViewView