HL7 Europe IG Snapshot, published by Lithuanian Medical Library. This guide is not an authorized publication; it is the continuous build for version 0.0.2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7LT/ig-eu-ehds/ and changes regularly. See the Directory of published versions

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Resource Profile: Observation Results: laboratory (Eu Lab)

This profile constrains the Observation resource to represent results produced by laboratory tests or panels/studies for the HL7 Europe project. 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.

Usages:

• Refer to this Profile: Composition: Laboratory Report (Eu Lab), DiagnosticReport: Laboratory Report (Eu Lab) and Observation Results: laboratory (Eu Lab)

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..*	Observation(5.0.0)	Laboratory result for a simple test or for a panel/study Constraints: obs-6, obs-7, obs-8, eu-lab-1, eu-lab-2
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Laboratory Test Kit Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
status	?!Σ	1..1	code	Status of this observation (e.g. preliminary, final,...) Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category		1..*	CodeableConceptIPS(2.0.0)	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: 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: http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab (required)
category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab (required)
code	ΣC	1..1	CodeableConceptIPS(2.0.0)	Type of observation (code / type) Binding: http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab (preferred)
subject	Σ	1..1	Reference(Patient: Animal (EU core)(0.1.0) | Patient (EU base)(0.1.0) | Group | Device | Location)	Who and/or what the observation is about
reference	ΣC	1..1	string	Literal reference, Relative, internal or absolute URL
effective[x]	Σ	1..1		Clinically relevant time/time-period for observation
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) Constraints: ext-1
effectiveDateTime			dateTime
effectivePeriod			Period
issued	Σ	0..1	instant	Date/Time this result was made available
performer	Σ	1..*	Reference(PractitionerRole (EU base)(0.1.0) | Practitioner (EU base)(0.1.0) | Organization (EU base)(0.1.0) | CareTeam | Patient (EU base)(0.1.0) | RelatedPerson)	Who is responsible for the observation
Slices for extension				Content/Rules for all slices
extension:performerFunction		0..1	CodeableConcept	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: PerformerFunctionCodes (extensible) Constraints: ext-1
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
Slices for value[x]	ΣC	0..1		Actual result Slice: Unordered, Open by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
valueAttachment			Attachment
valueReference			Reference(MolecularSequence)
value[x]:valueString	ΣC	0..1	string	Actual result
value[x]:valueRange	ΣC	0..1	RangeIPS(1.1.0)	Actual result
value[x]:valueRatio	ΣC	0..1	RatioEuLab(0.0.2)	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
value[x]:valueQuantity	ΣC	0..1	QuantityEuLab(0.0.2)	Actual result
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConceptIPS(2.0.0)	Actual result Binding: Results Coded Values Laboratory - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Results Presence Absence - SNOMED CT IPS Free Set candidate Results Microorganism - SNOMED CT IPS Free Set candidate
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		0..*	CodeableConceptIPS(2.0.0)	High, low, normal, etc Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
method		0..1	CodeableConceptIPS(2.0.0)	How it was done Binding: http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab (preferred)
specimen	C	0..1	Reference(Specimen: Laboratory (Eu Lab)(0.2.0-ci))	Specimen used for this observation Constraints: obs-9
device		0..1	Reference(Device | DeviceMetric)	Measuring instrument
hasMember	Σ	0..*	Reference(Observation Results: laboratory (Eu Lab)(0.2.0-ci))	Related resource that belongs to the Observation group
component	ΣC	0..*	BackboneElement	Laboratory result
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
code	ΣC	1..1	CodeableConceptIPS(2.0.0)	Type of component observation (code / type) Binding: Results Laboratory Observation - IPS (preferred)
Slices for value[x]	Σ	0..1		Actual component result Slice: Unordered, Open by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
valueAttachment			Attachment
valueReference			Reference(MolecularSequence)
value[x]:valueString	Σ	0..1	string	Actual component result
value[x]:valueRange	Σ	0..1	RangeIPS(1.1.0)	Actual component result
value[x]:valueRatio	Σ	0..1	RatioEuLab(0.0.2)	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
value[x]:valueQuantity	Σ	0..1	QuantityEuLab(0.0.2)	Actual component result
value[x]:valueCodeableConcept	Σ	0..1	CodeableConceptIPS(2.0.0)	Actual component result Binding: Results Coded Values Laboratory - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Results Presence Absence - SNOMED CT IPS Free Set candidate Results Microorganism - SNOMED CT IPS Free Set candidate
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.status	Base	required	Observation Status	📍5.0.0	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍5.0.0	FHIR Std.
Observation.category:laboratory	Base	preferred	Observation Category Codes	📍5.0.0	FHIR Std.
Observation.category:studyType	Base	required	http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab	Not State	Unknown
Observation.category:specialty	Base	required	http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab	Not State	Unknown
Observation.code	Base	preferred	http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab	Not State	Unknown
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory - IPS	⏿1.1.0	tx.hl7europe.eu
Observation.dataAbsentReason	Base	extensible	Data Absent Reason	📍5.0.0	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍5.0.0	FHIR Std.
Observation.method	Base	preferred	http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab	Not State	Unknown
Observation.component.​code	Base	preferred	Results Laboratory Observation - IPS	⏿1.1.0	tx.hl7europe.eu
Observation.component.​value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory - IPS	⏿1.1.0	tx.hl7europe.eu

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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-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	Observation.implicitRules, Observation.extension, Observation.modifierExtension, Observation.status, Observation.category, Observation.category:laboratory, Observation.category:studyType, Observation.category:specialty, Observation.code, Observation.subject, Observation.subject.reference, Observation.effective[x], Observation.effective[x].extension:data-absent-reason, Observation.issued, Observation.performer, Observation.performer.extension:performerFunction, Observation.performer.reference, Observation.value[x], Observation.value[x]:valueString, Observation.value[x]:valueRange, Observation.value[x]:valueRatio, Observation.value[x]:valueTime, Observation.value[x]:valueDateTime, Observation.value[x]:valuePeriod, Observation.value[x]:valueQuantity, Observation.value[x]:valueCodeableConcept, Observation.dataAbsentReason, Observation.interpretation, Observation.method, Observation.specimen, Observation.device, Observation.hasMember, Observation.component, Observation.component.modifierExtension, Observation.component.code, Observation.component.value[x], Observation.component.value[x]:valueString, Observation.component.value[x]:valueRange, Observation.component.value[x]:valueRatio, Observation.component.value[x]:valueTime, Observation.component.value[x]:valueDateTime, Observation.component.value[x]:valuePeriod, Observation.component.value[x]:valueQuantity, Observation.component.value[x]:valueCodeableConcept	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	Observation.extension, Observation.modifierExtension, Observation.effective[x].extension:data-absent-reason, Observation.performer.extension:performerFunction, Observation.component.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present	dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	If Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value).	value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
obs-8	error	Observation	bodyStructure SHALL only be present if Observation.bodySite is not present	bodySite.exists() implies bodyStructure.empty()
obs-9	error	Observation.specimen	If Observation.specimen is a reference to Group, the group can only have specimens	(reference.resolve().exists() and reference.resolve() is Group) implies reference.resolve().member.entity.resolve().all($this is Specimen)

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation(5.0.0)	Laboratory result for a simple test or for a panel/study
extension		0..*	Extension	Laboratory Test Kit
status		1..1	code	Status of this observation (e.g. preliminary, final,...)
Slices for category		1..*	CodeableConceptIPS(2.0.0)	Classification of type of observation Slice: Unordered, Open by pattern:$this
category:laboratory		1..1	CodeableConcept	Classification of type of observation 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: http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab (required)
category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab (required)
code		1..1	CodeableConceptIPS(2.0.0)	Type of observation (code / type) Binding: http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab (preferred)
subject		1..1	Reference(Patient: Animal (EU core)(0.1.0) | Patient (EU base)(0.1.0) | Group | Device | Location)	Who and/or what the observation is about
reference		1..1	string	Literal reference, Relative, internal or absolute URL
effective[x]		1..1		Clinically relevant time/time-period for observation
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)
effectiveDateTime			dateTime
effectivePeriod			Period
issued		0..1	instant	Date/Time this result was made available
performer		1..*	Reference(PractitionerRole (EU base)(0.1.0) | Practitioner (EU base)(0.1.0) | Organization (EU base)(0.1.0) | CareTeam | Patient (EU base)(0.1.0) | RelatedPerson)	Who is responsible for the observation
Slices for extension				Content/Rules for all slices
extension:performerFunction		0..*	CodeableConcept	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: PerformerFunctionCodes (extensible)
Slices for value[x]		0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period, Attachment, Reference(MolecularSequence)	Actual result Slice: Unordered, Closed by type:$this
value[x]:valueString		0..1	string	Actual result
value[x]:valueRange		0..1	RangeIPS(1.1.0)	Actual result
value[x]:valueRatio		0..1	RatioEuLab(0.0.2)	Actual result
value[x]:valueTime		0..1	time	Actual result
value[x]:valueDateTime		0..1	dateTime	Actual result
value[x]:valuePeriod		0..1	Period	Actual result
value[x]:valueQuantity		0..1	QuantityEuLab(0.0.2)	Actual result
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS(2.0.0)	Actual result Binding: Results Coded Values Laboratory - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Results Presence Absence - SNOMED CT IPS Free Set candidate Results Microorganism - SNOMED CT IPS Free Set candidate
dataAbsentReason		0..1	CodeableConcept	Provides a reason why the expected value is missing.
interpretation		0..*	CodeableConceptIPS(2.0.0)	High, low, normal, etc
method		0..1	CodeableConceptIPS(2.0.0)	How it was done Binding: http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab (preferred)
specimen		0..1	Reference(Specimen: Laboratory (Eu Lab)(0.2.0-ci))	Specimen used for this observation
device		0..1	Reference(Device | DeviceMetric)	Measuring instrument
hasMember		0..*	Reference(Observation Results: laboratory (Eu Lab)(0.2.0-ci))	Related resource that belongs to the Observation group
component		0..*	BackboneElement	Laboratory result
code		1..1	CodeableConceptIPS(2.0.0)	Type of component observation (code / type) Binding: Results Laboratory Observation - IPS (preferred)
Slices for value[x]		0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period, Attachment, Reference(MolecularSequence)	Actual component result Slice: Unordered, Closed by type:$this
value[x]:valueString		0..1	string	Actual component result
value[x]:valueRange		0..1	RangeIPS(1.1.0)	Actual component result
value[x]:valueRatio		0..1	RatioEuLab(0.0.2)	Actual component result
value[x]:valueTime		0..1	time	Actual component result
value[x]:valueDateTime		0..1	dateTime	Actual component result
value[x]:valuePeriod		0..1	Period	Actual component result
value[x]:valueQuantity		0..1	QuantityEuLab(0.0.2)	Actual component result
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS(2.0.0)	Actual component result Binding: Results Coded Values Laboratory - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Results Presence Absence - SNOMED CT IPS Free Set candidate Results Microorganism - SNOMED CT IPS Free Set candidate
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.category:studyType	Base	required	http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab	Not State	Unknown
Observation.category:specialty	Base	required	http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab	Not State	Unknown
Observation.code	Base	preferred	http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab	Not State	Unknown
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory - IPS	⏿1.1.0	tx.hl7europe.eu
Observation.method	Base	preferred	http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab	Not State	Unknown
Observation.component.​code	Base	preferred	Results Laboratory Observation - IPS	⏿1.1.0	tx.hl7europe.eu
Observation.component.​value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory - IPS	⏿1.1.0	tx.hl7europe.eu

Constraints

Id	Grade	Path(s)	Description	Expression
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()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation(5.0.0)	Laboratory result for a simple test or for a panel/study Constraints: obs-6, obs-7, obs-8, eu-lab-1, eu-lab-2
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
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
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Laboratory Test Kit Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
identifier	Σ	0..*	Identifier	Business Identifier for observation
instantiates[x]	Σ	0..1	canonical(ObservationDefinition), Reference(ObservationDefinition)	Instantiates FHIR ObservationDefinition
basedOn	Σ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order
triggeredBy		0..*	BackboneElement	Triggering observation(s)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
observation	Σ	1..1	Reference(Observation)	Triggering observation
type	Σ	1..1	code	reflex | repeat | re-run Binding: TriggeredBytype (required): The type of TriggeredBy Observation.
reason		0..1	string	Reason that the observation was triggered
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy | GenomicStudy)	Part of referenced event
status	?!Σ	1..1	code	Status of this observation (e.g. preliminary, final,...) Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category		1..*	CodeableConceptIPS(2.0.0)	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: 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: http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab (required)
category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab (required)
code	ΣC	1..1	CodeableConceptIPS(2.0.0)	Type of observation (code / type) Binding: http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab (preferred)
subject	Σ	1..1	Reference(Patient: Animal (EU core)(0.1.0) | Patient (EU base)(0.1.0) | Group | Device | Location)	Who and/or what the observation is about
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url Constraints: ext-1
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") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	ΣC	0..1	Identifier	Logical reference, when literal reference is not known
display	ΣC	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]	Σ	1..1		Clinically relevant time/time-period for observation
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 Constraints: ext-1
extension:data-absent-reason		0..1	code	effective[x] absence reason URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason Binding: DataAbsentReason (required) Constraints: ext-1
effectiveDateTime			dateTime
effectivePeriod			Period
issued	Σ	0..1	instant	Date/Time this result was made available
performer	Σ	1..*	Reference(PractitionerRole (EU base)(0.1.0) | Practitioner (EU base)(0.1.0) | Organization (EU base)(0.1.0) | CareTeam | Patient (EU base)(0.1.0) | RelatedPerson)	Who is responsible for the observation
id		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url Constraints: ext-1
extension:performerFunction		0..1	CodeableConcept	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: PerformerFunctionCodes (extensible) Constraints: ext-1
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") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	ΣC	0..1	Identifier	Logical reference, when literal reference is not known
display	ΣC	0..1	string	Text alternative for the resource
Slices for value[x]	ΣC	0..1		Actual result Slice: Unordered, Open by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
valueAttachment			Attachment
valueReference			Reference(MolecularSequence)
value[x]:valueString	ΣC	0..1	string	Actual result
value[x]:valueRange	ΣC	0..1	RangeIPS(1.1.0)	Actual result
value[x]:valueRatio	ΣC	0..1	RatioEuLab(0.0.2)	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
value[x]:valueQuantity	ΣC	0..1	QuantityEuLab(0.0.2)	Actual result
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConceptIPS(2.0.0)	Actual result Binding: Results Coded Values Laboratory - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Results Presence Absence - SNOMED CT IPS Free Set candidate Results Microorganism - SNOMED CT IPS Free Set candidate
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		0..*	CodeableConceptIPS(2.0.0)	High, low, normal, etc Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note		0..*	Annotation	Comments about the observation
bodySite	C	0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): SNOMED CT Body site concepts
bodyStructure	C	0..1	Reference(BodyStructure)	Observed body structure
method		0..1	CodeableConceptIPS(2.0.0)	How it was done Binding: http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab (preferred)
specimen	C	0..1	Reference(Specimen: Laboratory (Eu Lab)(0.2.0-ci))	Specimen used for this observation Constraints: obs-9
device		0..1	Reference(Device | DeviceMetric)	Measuring instrument
referenceRange	C	0..*	BackboneElement	Provides guide for interpretation Constraints: obs-3
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
low	C	0..1	SimpleQuantity(5.0.0)	Low Range, if relevant
high	C	0..1	SimpleQuantity(5.0.0)	High Range, if relevant
normalValue		0..1	CodeableConcept	Normal value, if relevant Binding: ObservationReferenceRangeNormalValueCodes (extensible): Codes identifying the normal value of the observation.
type		0..1	CodeableConcept	Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo		0..*	CodeableConcept	Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age		0..1	Range	Applicable age range, if relevant
text	C	0..1	markdown	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Observation Results: laboratory (Eu Lab)(0.2.0-ci))	Related resource that belongs to the Observation group
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | ImagingSelection | QuestionnaireResponse | Observation | MolecularSequence | GenomicStudy)	Related resource from which the observation is made
component	ΣC	0..*	BackboneElement	Laboratory result
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
code	ΣC	1..1	CodeableConceptIPS(2.0.0)	Type of component observation (code / type) Binding: Results Laboratory Observation - IPS (preferred)
Slices for value[x]	Σ	0..1		Actual component result Slice: Unordered, Open by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
valueAttachment			Attachment
valueReference			Reference(MolecularSequence)
value[x]:valueString	Σ	0..1	string	Actual component result
value[x]:valueRange	Σ	0..1	RangeIPS(1.1.0)	Actual component result
value[x]:valueRatio	Σ	0..1	RatioEuLab(0.0.2)	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
value[x]:valueQuantity	Σ	0..1	QuantityEuLab(0.0.2)	Actual component result
value[x]:valueCodeableConcept	Σ	0..1	CodeableConceptIPS(2.0.0)	Actual component result Binding: Results Coded Values Laboratory - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Results Presence Absence - SNOMED CT IPS Free Set candidate Results Microorganism - SNOMED CT IPS Free Set candidate
dataAbsentReason		0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.language	Base	required	All Languages	📍5.0.0	FHIR Std.
Observation.triggeredBy.​type	Base	required	triggered Bytype	📍5.0.0	FHIR Std.
Observation.status	Base	required	Observation Status	📍5.0.0	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍5.0.0	FHIR Std.
Observation.category:laboratory	Base	preferred	Observation Category Codes	📍5.0.0	FHIR Std.
Observation.category:studyType	Base	required	http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab	Not State	Unknown
Observation.category:specialty	Base	required	http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab	Not State	Unknown
Observation.code	Base	preferred	http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab	Not State	Unknown
Observation.subject.​type	Base	extensible	Resource Types	📍5.0.0	FHIR Std.
Observation.performer.​type	Base	extensible	Resource Types	📍5.0.0	FHIR Std.
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory - IPS	⏿1.1.0	tx.hl7europe.eu
Observation.dataAbsentReason	Base	extensible	Data Absent Reason	📍5.0.0	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍5.0.0	FHIR Std.
Observation.bodySite	Base	example	SNOMED CT Body Structures	📍5.0.0	FHIR Std.
Observation.method	Base	preferred	http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab	Not State	Unknown
Observation.referenceRange.​normalValue	Base	extensible	Observation Reference Range Normal Value Codes	📍5.0.0	FHIR Std.
Observation.referenceRange.​type	Base	preferred	Observation Reference Range Meaning Codes	📍5.0.0	FHIR Std.
Observation.referenceRange.​appliesTo	Base	example	Observation Reference Range Applies To Codes	📍5.0.0	FHIR Std.
Observation.component.​code	Base	preferred	Results Laboratory Observation - IPS	⏿1.1.0	tx.hl7europe.eu
Observation.component.​value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory - IPS	⏿1.1.0	tx.hl7europe.eu
Observation.component.​dataAbsentReason	Base	extensible	Data Absent Reason	📍5.0.0	FHIR Std.
Observation.component.​interpretation	Base	extensible	Observation Interpretation Codes	📍5.0.0	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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-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	Observation.meta, Observation.implicitRules, Observation.language, Observation.text, Observation.extension, Observation.modifierExtension, Observation.identifier, Observation.instantiates[x], Observation.basedOn, Observation.triggeredBy, Observation.triggeredBy.extension, Observation.triggeredBy.modifierExtension, Observation.triggeredBy.observation, Observation.triggeredBy.type, Observation.triggeredBy.reason, Observation.partOf, Observation.status, Observation.category, Observation.category:laboratory, Observation.category:studyType, Observation.category:specialty, Observation.code, Observation.subject, Observation.subject.extension, Observation.subject.reference, Observation.subject.type, Observation.subject.identifier, Observation.subject.display, Observation.focus, Observation.encounter, Observation.effective[x], Observation.effective[x].extension, Observation.effective[x].extension:data-absent-reason, Observation.issued, Observation.performer, Observation.performer.extension, Observation.performer.extension:performerFunction, Observation.performer.reference, Observation.performer.type, Observation.performer.identifier, Observation.performer.display, Observation.value[x], Observation.value[x]:valueString, Observation.value[x]:valueRange, Observation.value[x]:valueRatio, Observation.value[x]:valueTime, Observation.value[x]:valueDateTime, Observation.value[x]:valuePeriod, Observation.value[x]:valueQuantity, Observation.value[x]:valueCodeableConcept, Observation.dataAbsentReason, Observation.interpretation, Observation.note, Observation.bodySite, Observation.bodyStructure, Observation.method, Observation.specimen, Observation.device, Observation.referenceRange, Observation.referenceRange.extension, Observation.referenceRange.modifierExtension, Observation.referenceRange.low, Observation.referenceRange.high, Observation.referenceRange.normalValue, Observation.referenceRange.type, Observation.referenceRange.appliesTo, Observation.referenceRange.age, Observation.referenceRange.text, Observation.hasMember, Observation.derivedFrom, Observation.component, Observation.component.extension, Observation.component.modifierExtension, Observation.component.code, Observation.component.value[x], Observation.component.value[x]:valueString, Observation.component.value[x]:valueRange, Observation.component.value[x]:valueRatio, Observation.component.value[x]:valueTime, Observation.component.value[x]:valueDateTime, Observation.component.value[x]:valuePeriod, Observation.component.value[x]:valueQuantity, Observation.component.value[x]:valueCodeableConcept, Observation.component.dataAbsentReason, Observation.component.interpretation, Observation.component.referenceRange	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	Observation.extension, Observation.modifierExtension, Observation.triggeredBy.extension, Observation.triggeredBy.modifierExtension, Observation.subject.extension, Observation.effective[x].extension, Observation.effective[x].extension:data-absent-reason, Observation.performer.extension, Observation.performer.extension:performerFunction, Observation.referenceRange.extension, Observation.referenceRange.modifierExtension, Observation.component.extension, Observation.component.modifierExtension	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.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value).	value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
obs-8	error	Observation	bodyStructure SHALL only be present if Observation.bodySite is not present	bodySite.exists() implies bodyStructure.empty()
obs-9	error	Observation.specimen	If Observation.specimen is a reference to Group, the group can only have specimens	(reference.resolve().exists() and reference.resolve() is Group) implies reference.resolve().member.entity.resolve().all($this is Specimen)

Summary

Mandatory: 6 elements

Structures

This structure refers to these other structures:

• Codeable Concept (IPS) (http://hl7.org/fhir/uv/ips/StructureDefinition/CodeableConcept-uv-ips|2.0.0)
• Patient: Animal (EU core) (http://hl7.eu/fhir/base-r5/StructureDefinition/patient-animal-eu-core|0.1.0)
• Patient (EU base) (http://hl7.eu/fhir/base-r5/StructureDefinition/patient-eu|0.1.0)
• Group (http://hl7.org/fhir/StructureDefinition/Group|5.0.0)
• Device (http://hl7.org/fhir/StructureDefinition/Device|5.0.0)
• Location (http://hl7.org/fhir/StructureDefinition/Location|5.0.0)
• PractitionerRole (EU base) (http://hl7.eu/fhir/base-r5/StructureDefinition/practitionerRole-eu|0.1.0)
• Practitioner (EU base) (http://hl7.eu/fhir/base-r5/StructureDefinition/practitioner-eu|0.1.0)
• Organization (EU base) (http://hl7.eu/fhir/base-r5/StructureDefinition/organization-eu|0.1.0)
• CareTeam (http://hl7.org/fhir/StructureDefinition/CareTeam|5.0.0)
• RelatedPerson (http://hl7.org/fhir/StructureDefinition/RelatedPerson|5.0.0)
• Range (IPS) (http://hl7.org/fhir/uv/ips/StructureDefinition/Range-uv-ips|1.1.0)
• Ratio (Eu Lab) (http://hl7.eu/fhir/laboratory/StructureDefinition/Ratio-eu-lab|0.0.2)
• Quantity (Eu Lab) (http://hl7.eu/fhir/laboratory/StructureDefinition/Quantity-eu-lab|0.0.2)
• Specimen: Laboratory (Eu Lab) (http://hl7.eu/fhir/laboratory/StructureDefinition/Specimen-eu-lab|0.2.0-ci)
• Observation Results: laboratory (Eu Lab) (http://hl7.eu/fhir/laboratory/StructureDefinition/Observation-resultslab-eu-lab|0.2.0-ci)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/StructureDefinition/data-absent-reason|5.2.0
• http://hl7.org/fhir/StructureDefinition/event-performerFunction|5.2.0

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Observation.category
• The element 1 is sliced based on the value of Observation.value[x] (Closed)
• The element 1 is sliced based on the value of Observation.component.value[x] (Closed)

Maturity: 2

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation(5.0.0)	Laboratory result for a simple test or for a panel/study Constraints: obs-6, obs-7, obs-8, eu-lab-1, eu-lab-2
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Laboratory Test Kit Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
status	?!Σ	1..1	code	Status of this observation (e.g. preliminary, final,...) Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category		1..*	CodeableConceptIPS(2.0.0)	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: 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: http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab (required)
category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab (required)
code	ΣC	1..1	CodeableConceptIPS(2.0.0)	Type of observation (code / type) Binding: http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab (preferred)
subject	Σ	1..1	Reference(Patient: Animal (EU core)(0.1.0) | Patient (EU base)(0.1.0) | Group | Device | Location)	Who and/or what the observation is about
reference	ΣC	1..1	string	Literal reference, Relative, internal or absolute URL
effective[x]	Σ	1..1		Clinically relevant time/time-period for observation
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) Constraints: ext-1
effectiveDateTime			dateTime
effectivePeriod			Period
issued	Σ	0..1	instant	Date/Time this result was made available
performer	Σ	1..*	Reference(PractitionerRole (EU base)(0.1.0) | Practitioner (EU base)(0.1.0) | Organization (EU base)(0.1.0) | CareTeam | Patient (EU base)(0.1.0) | RelatedPerson)	Who is responsible for the observation
Slices for extension				Content/Rules for all slices
extension:performerFunction		0..1	CodeableConcept	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: PerformerFunctionCodes (extensible) Constraints: ext-1
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
Slices for value[x]	ΣC	0..1		Actual result Slice: Unordered, Open by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
valueAttachment			Attachment
valueReference			Reference(MolecularSequence)
value[x]:valueString	ΣC	0..1	string	Actual result
value[x]:valueRange	ΣC	0..1	RangeIPS(1.1.0)	Actual result
value[x]:valueRatio	ΣC	0..1	RatioEuLab(0.0.2)	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
value[x]:valueQuantity	ΣC	0..1	QuantityEuLab(0.0.2)	Actual result
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConceptIPS(2.0.0)	Actual result Binding: Results Coded Values Laboratory - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Results Presence Absence - SNOMED CT IPS Free Set candidate Results Microorganism - SNOMED CT IPS Free Set candidate
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		0..*	CodeableConceptIPS(2.0.0)	High, low, normal, etc Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
method		0..1	CodeableConceptIPS(2.0.0)	How it was done Binding: http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab (preferred)
specimen	C	0..1	Reference(Specimen: Laboratory (Eu Lab)(0.2.0-ci))	Specimen used for this observation Constraints: obs-9
device		0..1	Reference(Device | DeviceMetric)	Measuring instrument
hasMember	Σ	0..*	Reference(Observation Results: laboratory (Eu Lab)(0.2.0-ci))	Related resource that belongs to the Observation group
component	ΣC	0..*	BackboneElement	Laboratory result
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
code	ΣC	1..1	CodeableConceptIPS(2.0.0)	Type of component observation (code / type) Binding: Results Laboratory Observation - IPS (preferred)
Slices for value[x]	Σ	0..1		Actual component result Slice: Unordered, Open by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
valueAttachment			Attachment
valueReference			Reference(MolecularSequence)
value[x]:valueString	Σ	0..1	string	Actual component result
value[x]:valueRange	Σ	0..1	RangeIPS(1.1.0)	Actual component result
value[x]:valueRatio	Σ	0..1	RatioEuLab(0.0.2)	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
value[x]:valueQuantity	Σ	0..1	QuantityEuLab(0.0.2)	Actual component result
value[x]:valueCodeableConcept	Σ	0..1	CodeableConceptIPS(2.0.0)	Actual component result Binding: Results Coded Values Laboratory - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Results Presence Absence - SNOMED CT IPS Free Set candidate Results Microorganism - SNOMED CT IPS Free Set candidate
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.status	Base	required	Observation Status	📍5.0.0	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍5.0.0	FHIR Std.
Observation.category:laboratory	Base	preferred	Observation Category Codes	📍5.0.0	FHIR Std.
Observation.category:studyType	Base	required	http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab	Not State	Unknown
Observation.category:specialty	Base	required	http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab	Not State	Unknown
Observation.code	Base	preferred	http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab	Not State	Unknown
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory - IPS	⏿1.1.0	tx.hl7europe.eu
Observation.dataAbsentReason	Base	extensible	Data Absent Reason	📍5.0.0	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍5.0.0	FHIR Std.
Observation.method	Base	preferred	http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab	Not State	Unknown
Observation.component.​code	Base	preferred	Results Laboratory Observation - IPS	⏿1.1.0	tx.hl7europe.eu
Observation.component.​value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory - IPS	⏿1.1.0	tx.hl7europe.eu

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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-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	Observation.implicitRules, Observation.extension, Observation.modifierExtension, Observation.status, Observation.category, Observation.category:laboratory, Observation.category:studyType, Observation.category:specialty, Observation.code, Observation.subject, Observation.subject.reference, Observation.effective[x], Observation.effective[x].extension:data-absent-reason, Observation.issued, Observation.performer, Observation.performer.extension:performerFunction, Observation.performer.reference, Observation.value[x], Observation.value[x]:valueString, Observation.value[x]:valueRange, Observation.value[x]:valueRatio, Observation.value[x]:valueTime, Observation.value[x]:valueDateTime, Observation.value[x]:valuePeriod, Observation.value[x]:valueQuantity, Observation.value[x]:valueCodeableConcept, Observation.dataAbsentReason, Observation.interpretation, Observation.method, Observation.specimen, Observation.device, Observation.hasMember, Observation.component, Observation.component.modifierExtension, Observation.component.code, Observation.component.value[x], Observation.component.value[x]:valueString, Observation.component.value[x]:valueRange, Observation.component.value[x]:valueRatio, Observation.component.value[x]:valueTime, Observation.component.value[x]:valueDateTime, Observation.component.value[x]:valuePeriod, Observation.component.value[x]:valueQuantity, Observation.component.value[x]:valueCodeableConcept	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	Observation.extension, Observation.modifierExtension, Observation.effective[x].extension:data-absent-reason, Observation.performer.extension:performerFunction, Observation.component.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present	dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	If Observation.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value).	value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
obs-8	error	Observation	bodyStructure SHALL only be present if Observation.bodySite is not present	bodySite.exists() implies bodyStructure.empty()
obs-9	error	Observation.specimen	If Observation.specimen is a reference to Group, the group can only have specimens	(reference.resolve().exists() and reference.resolve() is Group) implies reference.resolve().member.entity.resolve().all($this is Specimen)

Differential View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation(5.0.0)	Laboratory result for a simple test or for a panel/study
extension		0..*	Extension	Laboratory Test Kit
status		1..1	code	Status of this observation (e.g. preliminary, final,...)
Slices for category		1..*	CodeableConceptIPS(2.0.0)	Classification of type of observation Slice: Unordered, Open by pattern:$this
category:laboratory		1..1	CodeableConcept	Classification of type of observation 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: http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab (required)
category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab (required)
code		1..1	CodeableConceptIPS(2.0.0)	Type of observation (code / type) Binding: http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab (preferred)
subject		1..1	Reference(Patient: Animal (EU core)(0.1.0) | Patient (EU base)(0.1.0) | Group | Device | Location)	Who and/or what the observation is about
reference		1..1	string	Literal reference, Relative, internal or absolute URL
effective[x]		1..1		Clinically relevant time/time-period for observation
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)
effectiveDateTime			dateTime
effectivePeriod			Period
issued		0..1	instant	Date/Time this result was made available
performer		1..*	Reference(PractitionerRole (EU base)(0.1.0) | Practitioner (EU base)(0.1.0) | Organization (EU base)(0.1.0) | CareTeam | Patient (EU base)(0.1.0) | RelatedPerson)	Who is responsible for the observation
Slices for extension				Content/Rules for all slices
extension:performerFunction		0..*	CodeableConcept	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: PerformerFunctionCodes (extensible)
Slices for value[x]		0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period, Attachment, Reference(MolecularSequence)	Actual result Slice: Unordered, Closed by type:$this
value[x]:valueString		0..1	string	Actual result
value[x]:valueRange		0..1	RangeIPS(1.1.0)	Actual result
value[x]:valueRatio		0..1	RatioEuLab(0.0.2)	Actual result
value[x]:valueTime		0..1	time	Actual result
value[x]:valueDateTime		0..1	dateTime	Actual result
value[x]:valuePeriod		0..1	Period	Actual result
value[x]:valueQuantity		0..1	QuantityEuLab(0.0.2)	Actual result
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS(2.0.0)	Actual result Binding: Results Coded Values Laboratory - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Results Presence Absence - SNOMED CT IPS Free Set candidate Results Microorganism - SNOMED CT IPS Free Set candidate
dataAbsentReason		0..1	CodeableConcept	Provides a reason why the expected value is missing.
interpretation		0..*	CodeableConceptIPS(2.0.0)	High, low, normal, etc
method		0..1	CodeableConceptIPS(2.0.0)	How it was done Binding: http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab (preferred)
specimen		0..1	Reference(Specimen: Laboratory (Eu Lab)(0.2.0-ci))	Specimen used for this observation
device		0..1	Reference(Device | DeviceMetric)	Measuring instrument
hasMember		0..*	Reference(Observation Results: laboratory (Eu Lab)(0.2.0-ci))	Related resource that belongs to the Observation group
component		0..*	BackboneElement	Laboratory result
code		1..1	CodeableConceptIPS(2.0.0)	Type of component observation (code / type) Binding: Results Laboratory Observation - IPS (preferred)
Slices for value[x]		0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period, Attachment, Reference(MolecularSequence)	Actual component result Slice: Unordered, Closed by type:$this
value[x]:valueString		0..1	string	Actual component result
value[x]:valueRange		0..1	RangeIPS(1.1.0)	Actual component result
value[x]:valueRatio		0..1	RatioEuLab(0.0.2)	Actual component result
value[x]:valueTime		0..1	time	Actual component result
value[x]:valueDateTime		0..1	dateTime	Actual component result
value[x]:valuePeriod		0..1	Period	Actual component result
value[x]:valueQuantity		0..1	QuantityEuLab(0.0.2)	Actual component result
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS(2.0.0)	Actual component result Binding: Results Coded Values Laboratory - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Results Presence Absence - SNOMED CT IPS Free Set candidate Results Microorganism - SNOMED CT IPS Free Set candidate
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.category:studyType	Base	required	http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab	Not State	Unknown
Observation.category:specialty	Base	required	http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab	Not State	Unknown
Observation.code	Base	preferred	http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab	Not State	Unknown
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory - IPS	⏿1.1.0	tx.hl7europe.eu
Observation.method	Base	preferred	http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab	Not State	Unknown
Observation.component.​code	Base	preferred	Results Laboratory Observation - IPS	⏿1.1.0	tx.hl7europe.eu
Observation.component.​value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory - IPS	⏿1.1.0	tx.hl7europe.eu

Constraints

Id	Grade	Path(s)	Description	Expression
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()

Snapshot ViewView

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	Observation(5.0.0)	Laboratory result for a simple test or for a panel/study Constraints: obs-6, obs-7, obs-8, eu-lab-1, eu-lab-2
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter
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
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Laboratory Test Kit Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
identifier	Σ	0..*	Identifier	Business Identifier for observation
instantiates[x]	Σ	0..1	canonical(ObservationDefinition), Reference(ObservationDefinition)	Instantiates FHIR ObservationDefinition
basedOn	Σ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order
triggeredBy		0..*	BackboneElement	Triggering observation(s)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
observation	Σ	1..1	Reference(Observation)	Triggering observation
type	Σ	1..1	code	reflex | repeat | re-run Binding: TriggeredBytype (required): The type of TriggeredBy Observation.
reason		0..1	string	Reason that the observation was triggered
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy | GenomicStudy)	Part of referenced event
status	?!Σ	1..1	code	Status of this observation (e.g. preliminary, final,...) Binding: ObservationStatus (required): Codes providing the status of an observation.
Slices for category		1..*	CodeableConceptIPS(2.0.0)	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: 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: http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab (required)
category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab (required)
code	ΣC	1..1	CodeableConceptIPS(2.0.0)	Type of observation (code / type) Binding: http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab (preferred)
subject	Σ	1..1	Reference(Patient: Animal (EU core)(0.1.0) | Patient (EU base)(0.1.0) | Group | Device | Location)	Who and/or what the observation is about
id		0..1	id	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url Constraints: ext-1
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") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	ΣC	0..1	Identifier	Logical reference, when literal reference is not known
display	ΣC	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]	Σ	1..1		Clinically relevant time/time-period for observation
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 Constraints: ext-1
extension:data-absent-reason		0..1	code	effective[x] absence reason URL: http://hl7.org/fhir/StructureDefinition/data-absent-reason Binding: DataAbsentReason (required) Constraints: ext-1
effectiveDateTime			dateTime
effectivePeriod			Period
issued	Σ	0..1	instant	Date/Time this result was made available
performer	Σ	1..*	Reference(PractitionerRole (EU base)(0.1.0) | Practitioner (EU base)(0.1.0) | Organization (EU base)(0.1.0) | CareTeam | Patient (EU base)(0.1.0) | RelatedPerson)	Who is responsible for the observation
id		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url Constraints: ext-1
extension:performerFunction		0..1	CodeableConcept	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: PerformerFunctionCodes (extensible) Constraints: ext-1
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") - must be a resource in resources Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	ΣC	0..1	Identifier	Logical reference, when literal reference is not known
display	ΣC	0..1	string	Text alternative for the resource
Slices for value[x]	ΣC	0..1		Actual result Slice: Unordered, Open by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
valueAttachment			Attachment
valueReference			Reference(MolecularSequence)
value[x]:valueString	ΣC	0..1	string	Actual result
value[x]:valueRange	ΣC	0..1	RangeIPS(1.1.0)	Actual result
value[x]:valueRatio	ΣC	0..1	RatioEuLab(0.0.2)	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
value[x]:valueQuantity	ΣC	0..1	QuantityEuLab(0.0.2)	Actual result
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConceptIPS(2.0.0)	Actual result Binding: Results Coded Values Laboratory - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Results Presence Absence - SNOMED CT IPS Free Set candidate Results Microorganism - SNOMED CT IPS Free Set candidate
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		0..*	CodeableConceptIPS(2.0.0)	High, low, normal, etc Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note		0..*	Annotation	Comments about the observation
bodySite	C	0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): SNOMED CT Body site concepts
bodyStructure	C	0..1	Reference(BodyStructure)	Observed body structure
method		0..1	CodeableConceptIPS(2.0.0)	How it was done Binding: http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab (preferred)
specimen	C	0..1	Reference(Specimen: Laboratory (Eu Lab)(0.2.0-ci))	Specimen used for this observation Constraints: obs-9
device		0..1	Reference(Device | DeviceMetric)	Measuring instrument
referenceRange	C	0..*	BackboneElement	Provides guide for interpretation Constraints: obs-3
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
low	C	0..1	SimpleQuantity(5.0.0)	Low Range, if relevant
high	C	0..1	SimpleQuantity(5.0.0)	High Range, if relevant
normalValue		0..1	CodeableConcept	Normal value, if relevant Binding: ObservationReferenceRangeNormalValueCodes (extensible): Codes identifying the normal value of the observation.
type		0..1	CodeableConcept	Reference range qualifier Binding: ObservationReferenceRangeMeaningCodes (preferred): Code for the meaning of a reference range.
appliesTo		0..*	CodeableConcept	Reference range population Binding: ObservationReferenceRangeAppliesToCodes (example): Codes identifying the population the reference range applies to.
age		0..1	Range	Applicable age range, if relevant
text	C	0..1	markdown	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Observation Results: laboratory (Eu Lab)(0.2.0-ci))	Related resource that belongs to the Observation group
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | ImagingSelection | QuestionnaireResponse | Observation | MolecularSequence | GenomicStudy)	Related resource from which the observation is made
component	ΣC	0..*	BackboneElement	Laboratory result
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
code	ΣC	1..1	CodeableConceptIPS(2.0.0)	Type of component observation (code / type) Binding: Results Laboratory Observation - IPS (preferred)
Slices for value[x]	Σ	0..1		Actual component result Slice: Unordered, Open by type:$this
valueQuantity			Quantity
valueCodeableConcept			CodeableConcept
valueString			string
valueBoolean			boolean
valueInteger			integer
valueRange			Range
valueRatio			Ratio
valueSampledData			SampledData
valueTime			time
valueDateTime			dateTime
valuePeriod			Period
valueAttachment			Attachment
valueReference			Reference(MolecularSequence)
value[x]:valueString	Σ	0..1	string	Actual component result
value[x]:valueRange	Σ	0..1	RangeIPS(1.1.0)	Actual component result
value[x]:valueRatio	Σ	0..1	RatioEuLab(0.0.2)	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
value[x]:valueQuantity	Σ	0..1	QuantityEuLab(0.0.2)	Actual component result
value[x]:valueCodeableConcept	Σ	0..1	CodeableConceptIPS(2.0.0)	Actual component result Binding: Results Coded Values Laboratory - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Results Presence Absence - SNOMED CT IPS Free Set candidate Results Microorganism - SNOMED CT IPS Free Set candidate
dataAbsentReason		0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		0..*	CodeableConcept	High, low, normal, etc Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
referenceRange		0..*	See referenceRange (Observation)	Provides guide for interpretation of component result
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.language	Base	required	All Languages	📍5.0.0	FHIR Std.
Observation.triggeredBy.​type	Base	required	triggered Bytype	📍5.0.0	FHIR Std.
Observation.status	Base	required	Observation Status	📍5.0.0	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍5.0.0	FHIR Std.
Observation.category:laboratory	Base	preferred	Observation Category Codes	📍5.0.0	FHIR Std.
Observation.category:studyType	Base	required	http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab	Not State	Unknown
Observation.category:specialty	Base	required	http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab	Not State	Unknown
Observation.code	Base	preferred	http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab	Not State	Unknown
Observation.subject.​type	Base	extensible	Resource Types	📍5.0.0	FHIR Std.
Observation.performer.​type	Base	extensible	Resource Types	📍5.0.0	FHIR Std.
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory - IPS	⏿1.1.0	tx.hl7europe.eu
Observation.dataAbsentReason	Base	extensible	Data Absent Reason	📍5.0.0	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍5.0.0	FHIR Std.
Observation.bodySite	Base	example	SNOMED CT Body Structures	📍5.0.0	FHIR Std.
Observation.method	Base	preferred	http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab	Not State	Unknown
Observation.referenceRange.​normalValue	Base	extensible	Observation Reference Range Normal Value Codes	📍5.0.0	FHIR Std.
Observation.referenceRange.​type	Base	preferred	Observation Reference Range Meaning Codes	📍5.0.0	FHIR Std.
Observation.referenceRange.​appliesTo	Base	example	Observation Reference Range Applies To Codes	📍5.0.0	FHIR Std.
Observation.component.​code	Base	preferred	Results Laboratory Observation - IPS	⏿1.1.0	tx.hl7europe.eu
Observation.component.​value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory - IPS	⏿1.1.0	tx.hl7europe.eu
Observation.component.​dataAbsentReason	Base	extensible	Data Absent Reason	📍5.0.0	FHIR Std.
Observation.component.​interpretation	Base	extensible	Observation Interpretation Codes	📍5.0.0	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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-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	Observation.meta, Observation.implicitRules, Observation.language, Observation.text, Observation.extension, Observation.modifierExtension, Observation.identifier, Observation.instantiates[x], Observation.basedOn, Observation.triggeredBy, Observation.triggeredBy.extension, Observation.triggeredBy.modifierExtension, Observation.triggeredBy.observation, Observation.triggeredBy.type, Observation.triggeredBy.reason, Observation.partOf, Observation.status, Observation.category, Observation.category:laboratory, Observation.category:studyType, Observation.category:specialty, Observation.code, Observation.subject, Observation.subject.extension, Observation.subject.reference, Observation.subject.type, Observation.subject.identifier, Observation.subject.display, Observation.focus, Observation.encounter, Observation.effective[x], Observation.effective[x].extension, Observation.effective[x].extension:data-absent-reason, Observation.issued, Observation.performer, Observation.performer.extension, Observation.performer.extension:performerFunction, Observation.performer.reference, Observation.performer.type, Observation.performer.identifier, Observation.performer.display, Observation.value[x], Observation.value[x]:valueString, Observation.value[x]:valueRange, Observation.value[x]:valueRatio, Observation.value[x]:valueTime, Observation.value[x]:valueDateTime, Observation.value[x]:valuePeriod, Observation.value[x]:valueQuantity, Observation.value[x]:valueCodeableConcept, Observation.dataAbsentReason, Observation.interpretation, Observation.note, Observation.bodySite, Observation.bodyStructure, Observation.method, Observation.specimen, Observation.device, Observation.referenceRange, Observation.referenceRange.extension, Observation.referenceRange.modifierExtension, Observation.referenceRange.low, Observation.referenceRange.high, Observation.referenceRange.normalValue, Observation.referenceRange.type, Observation.referenceRange.appliesTo, Observation.referenceRange.age, Observation.referenceRange.text, Observation.hasMember, Observation.derivedFrom, Observation.component, Observation.component.extension, Observation.component.modifierExtension, Observation.component.code, Observation.component.value[x], Observation.component.value[x]:valueString, Observation.component.value[x]:valueRange, Observation.component.value[x]:valueRatio, Observation.component.value[x]:valueTime, Observation.component.value[x]:valueDateTime, Observation.component.value[x]:valuePeriod, Observation.component.value[x]:valueQuantity, Observation.component.value[x]:valueCodeableConcept, Observation.component.dataAbsentReason, Observation.component.interpretation, Observation.component.referenceRange	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	Observation.extension, Observation.modifierExtension, Observation.triggeredBy.extension, Observation.triggeredBy.modifierExtension, Observation.subject.extension, Observation.effective[x].extension, Observation.effective[x].extension:data-absent-reason, Observation.performer.extension, Observation.performer.extension:performerFunction, Observation.referenceRange.extension, Observation.referenceRange.modifierExtension, Observation.component.extension, Observation.component.modifierExtension	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.component.code is the same as Observation.code, then Observation.value SHALL NOT be present (the Observation.component.value[x] holds the value).	value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
obs-8	error	Observation	bodyStructure SHALL only be present if Observation.bodySite is not present	bodySite.exists() implies bodyStructure.empty()
obs-9	error	Observation.specimen	If Observation.specimen is a reference to Group, the group can only have specimens	(reference.resolve().exists() and reference.resolve() is Group) implies reference.resolve().member.entity.resolve().all($this is Specimen)

Summary

Mandatory: 6 elements

Structures

This structure refers to these other structures:

• Codeable Concept (IPS) (http://hl7.org/fhir/uv/ips/StructureDefinition/CodeableConcept-uv-ips|2.0.0)
• Patient: Animal (EU core) (http://hl7.eu/fhir/base-r5/StructureDefinition/patient-animal-eu-core|0.1.0)
• Patient (EU base) (http://hl7.eu/fhir/base-r5/StructureDefinition/patient-eu|0.1.0)
• Group (http://hl7.org/fhir/StructureDefinition/Group|5.0.0)
• Device (http://hl7.org/fhir/StructureDefinition/Device|5.0.0)
• Location (http://hl7.org/fhir/StructureDefinition/Location|5.0.0)
• PractitionerRole (EU base) (http://hl7.eu/fhir/base-r5/StructureDefinition/practitionerRole-eu|0.1.0)
• Practitioner (EU base) (http://hl7.eu/fhir/base-r5/StructureDefinition/practitioner-eu|0.1.0)
• Organization (EU base) (http://hl7.eu/fhir/base-r5/StructureDefinition/organization-eu|0.1.0)
• CareTeam (http://hl7.org/fhir/StructureDefinition/CareTeam|5.0.0)
• RelatedPerson (http://hl7.org/fhir/StructureDefinition/RelatedPerson|5.0.0)
• Range (IPS) (http://hl7.org/fhir/uv/ips/StructureDefinition/Range-uv-ips|1.1.0)
• Ratio (Eu Lab) (http://hl7.eu/fhir/laboratory/StructureDefinition/Ratio-eu-lab|0.0.2)
• Quantity (Eu Lab) (http://hl7.eu/fhir/laboratory/StructureDefinition/Quantity-eu-lab|0.0.2)
• Specimen: Laboratory (Eu Lab) (http://hl7.eu/fhir/laboratory/StructureDefinition/Specimen-eu-lab|0.2.0-ci)
• Observation Results: laboratory (Eu Lab) (http://hl7.eu/fhir/laboratory/StructureDefinition/Observation-resultslab-eu-lab|0.2.0-ci)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/StructureDefinition/data-absent-reason|5.2.0
• http://hl7.org/fhir/StructureDefinition/event-performerFunction|5.2.0

Slices

This structure defines the following Slices:

• The element 1 is sliced based on the value of Observation.category
• The element 1 is sliced based on the value of Observation.value[x] (Closed)
• The element 1 is sliced based on the value of Observation.component.value[x] (Closed)

Maturity: 2