HL7 Europe Laboratory Report, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.2.0-ci built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/laboratory/ and changes regularly. See the Directory of published versions

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Resource Profile: Observation Results: laboratory

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

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

Usage:

• Derived from this Resource Profile: Observation: Obligations
• Use this Resource Profile: Bundle: Laboratory Report
• Refer to this Resource Profile: Composition: Laboratory Report, DiagnosticReport: Laboratory Report and Observation Results: laboratory
• Examples for this Resource Profile: Observation/4335db48-7090-45b3-a2c2-45b45f94a67c, Observation/d29b286d-b99c-410f-af4e-9455ea49d0af, Observation/obs-aerobic-culture, Observation/obs-anaerobic-culture... Show 11 more, Observation/obs-gram-stain, Observation/obs-gs-org1-quant, Observation/obs-gs-org1, Observation/obs-org-id1-growth, Observation/obs-org-id1-susc-1, Observation/obs-org-id1-susc-2, Observation/obs-org-id1-susc-3, Observation/obs-org-id1-susc-4, Observation/obs-org-id1-susc-panel, Observation/obs-org-id1 and Observation/obs-wbc

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Laboratory result for a simple test or for a panel/study eu-lab-1: If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component" eu-lab-2: If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason"
Slices for extension		0..*	Extension	Laboratory Test Kit Slice: Unordered, Open by value:url
supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
triggeredBy-r5		0..*	(Complex)	Optional Extensions Element URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy
Slices for extension				Content/Rules for all slices
extension:observation		0..*	Extension	Triggering observation.
extension:type		0..*	Extension	The type of trigger
certifiedRefMaterialCodeable		0..*	CodeableConcept	Certified Reference Material: CodeableConcept URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example)
certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material: Identifier URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
labTestKit		0..*	Reference(Device)	Device Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
value-r5		0..1	(Complex)	only for result of type Attachment URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
value[x]		1..1	Attachment	Value of extension
status		1..1	code	Status of this observation (e.g. preliminary, final,...)
Slices for category		1..*	CodeableConceptIPS	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: Laboratory Study Types (required)
category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: Laboratory Specialty (required)
code		1..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Laboratory Code (preferred)
subject		1..1	Reference(Patient: Animal | Patient: Person | 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
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: Laboratory Report | Practitioner: Laboratory Report | Organization (IPS) | CareTeam | Patient: Person | RelatedPerson)	Who is responsible for the observation
Slices for extension				Content/Rules for all slices
performerFunction		0..*	CodeableConcept	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: Performer Function Codes (extensible)
Slices for value[x]		0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual result Slice: Unordered, Closed by type:$this
value[x]:valueString		0..1	string	Actual result
value[x]:valueRange		0..1	RangeIPS	Set of values bounded by low and high
value[x]:valueRatio		0..1	RatioEuLab	A measured ratio using UCUM
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	A measured amount using UCUM
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS	​Concept - reference to a terminology or just text Binding: http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips (preferred) Additional Bindings Purpose ​http://hl7.org/fhir/uv/ips/ValueSet/results-blood-group-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-presence-absence-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-microorganism-snomed-ct-ips-free-set candidate
dataAbsentReason		0..1	CodeableConcept	Provides a reason why the expected value is missing.
interpretation		0..*	CodeableConceptIPS	Concept - reference to a terminology or just text
method		0..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Laboratory Techniques (preferred)
specimen		0..1	Reference(Specimen: Laboratory)	Specimen used for this observation
device		0..1	Reference(Device | DeviceMetric)	Measuring instrument
hasMember		0..*	Reference(Observation Results: laboratory)	Related resource that belongs to the Observation group
component		0..*	BackboneElement	Laboratory result
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
value-r5		0..1	(Complex)	only for result of type Attachment URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
value[x]		1..1	Attachment	Value of extension
code		1..1	CodeableConceptIPS	​Concept - reference to a terminology or just text Binding: http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips (preferred)
Slices for value[x]		0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual component result Slice: Unordered, Closed by type:$this
value[x]:valueString		0..1	string	Actual component result
value[x]:valueRange		0..1	RangeIPS	Set of values bounded by low and high
value[x]:valueRatio		0..1	RatioEuLab	A measured ratio using UCUM
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	A measured amount using UCUM
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS	​Concept - reference to a terminology or just text Binding: http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips (preferred) Additional Bindings Purpose ​http://hl7.org/fhir/uv/ips/ValueSet/results-blood-group-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-presence-absence-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-microorganism-snomed-ct-ips-free-set candidate
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.category:studyType	required	LabStudyTypesEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab from this IG
Observation.category:specialty	required	LabSpecialtyEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab from this IG
Observation.code	preferred	LaboratoryResultStandardEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab from this IG
Observation.value[x]:valueCodeableConcept	preferred	​http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips
Observation.method	preferred	LabTechniqueEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab from this IG
Observation.component.code	preferred	​http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips
Observation.component.value[x]:valueCodeableConcept	preferred	​http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips

Constraints

Id	Grade	Path(s)	Details	Requirements
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
Observation	C	0..*	Observation	Laboratory result for a simple test or for a panel/study obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present eu-lab-1: If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component" eu-lab-2: If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason"
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension		0..*	Extension	Laboratory Test Kit Slice: Unordered, Open by value:url
supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
triggeredBy-r5		0..*	(Complex)	Optional Extensions Element URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy
Slices for extension				Content/Rules for all slices
extension:observation		0..*	Extension	Triggering observation.
extension		0..0
url		1..1	uri	"observation"
value[x]		1..1	Reference(Observation)	Value of extension
extension:type		0..*	Extension	The type of trigger
extension		0..0
url		1..1	uri	"type"
value[x]		1..1	code	Value of extension
extension:reason		0..*	Extension	Extension
extension		0..0
url		1..1	uri	"reason"
value[x]		1..1	string	Value of extension
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"
certifiedRefMaterialCodeable		0..*	CodeableConcept	Certified Reference Material: CodeableConcept URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example)
certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material: Identifier URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
labTestKit		0..*	Reference(Device)	Device Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
value-r5		0..1	(Complex)	only for result of type Attachment URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
extension		0..0
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]"
value[x]		1..1	Attachment	Value of extension
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
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	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
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: Laboratory Study Types (required)
category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: Laboratory Specialty (required)
code		1..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Laboratory Code (preferred)
subject	Σ	1..1	Reference(Patient: Animal | Patient: Person | 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
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	Σ	0..1	instant	Date/Time this result was made available
performer	Σ	1..*	Reference(PractitionerRole: Laboratory Report | Practitioner: Laboratory Report | Organization (IPS) | CareTeam | Patient: Person | RelatedPerson)	Who is responsible for the observation
Slices for extension				Content/Rules for all slices
performerFunction		0..*	CodeableConcept	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: Performer Function Codes (extensible)
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
value[x]:valueString	ΣC	0..1	string	Actual result
value[x]:valueRange	C	0..1	RangeIPS	Set of values bounded by low and high rng-2: If present, low SHALL have a lower value than high
value[x]:valueRatio	C	0..1	RatioEuLab	A measured ratio using UCUM rat-1: Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present
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	C	0..1	QuantityEuLab	A measured amount using UCUM qty-3: If a code for the unit is present, the system SHALL also be present
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS	​Concept - reference to a terminology or just text Binding: http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips (preferred) Additional Bindings Purpose ​http://hl7.org/fhir/uv/ips/ValueSet/results-blood-group-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-presence-absence-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/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	Concept - reference to a terminology or just text Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
method		0..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Laboratory Techniques (preferred)
specimen		0..1	Reference(Specimen: Laboratory)	Specimen used for this observation
device		0..1	Reference(Device | DeviceMetric)	Measuring instrument
hasMember	Σ	0..*	Reference(Observation Results: laboratory)	Related resource that belongs to the Observation group
component	Σ	0..*	BackboneElement	Laboratory result
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
value-r5		0..1	(Complex)	only for result of type Attachment URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
extension		0..0
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]"
value[x]		1..1	Attachment	Value of extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code		1..1	CodeableConceptIPS	​Concept - reference to a terminology or just text Binding: http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-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
value[x]:valueString	Σ	0..1	string	Actual component result
value[x]:valueRange	C	0..1	RangeIPS	Set of values bounded by low and high rng-2: If present, low SHALL have a lower value than high
value[x]:valueRatio	C	0..1	RatioEuLab	A measured ratio using UCUM rat-1: Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present
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	C	0..1	QuantityEuLab	A measured amount using UCUM qty-3: If a code for the unit is present, the system SHALL also be present
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS	​Concept - reference to a terminology or just text Binding: http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips (preferred) Additional Bindings Purpose ​http://hl7.org/fhir/uv/ips/ValueSet/results-blood-group-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-presence-absence-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-microorganism-snomed-ct-ips-free-set candidate
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:laboratory	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:studyType	required	LabStudyTypesEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab from this IG
Observation.category:specialty	required	LabSpecialtyEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab from this IG
Observation.code	preferred	LaboratoryResultStandardEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab from this IG
Observation.value[x]:valueCodeableConcept	preferred	​http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips
Observation.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.method	preferred	LabTechniqueEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab from this IG
Observation.component.code	preferred	​http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips
Observation.component.value[x]:valueCodeableConcept	preferred	​http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
eu-lab-1	error	Observation	If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component" : (status in ('registered'|'cancelled')) or value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists()
eu-lab-2	error	Observation	If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason" : component.exists() implies (status in ('registered'|'cancelled')) or component.value.exists() or component.dataAbsentReason.exists()
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-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()
qty-3	error	Observation.value[x]:valueQuantity, Observation.component.value[x]:valueQuantity	If a code for the unit is present, the system SHALL also be present : code.empty() or system.exists()
rat-1	error	Observation.value[x]:valueRatio, Observation.component.value[x]:valueRatio	Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present : (numerator.empty() xor denominator.exists()) and (numerator.exists() or extension.exists())
rng-2	error	Observation.value[x]:valueRange, Observation.component.value[x]:valueRange	If present, low SHALL have a lower value than high : low.empty() or high.empty() or (low <= high)

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Laboratory result for a simple test or for a panel/study obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present eu-lab-1: If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component" eu-lab-2: If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason"
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Laboratory Test Kit Slice: Unordered, Open by value:url
supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
triggeredBy-r5		0..*	(Complex)	Optional Extensions Element URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
extension:observation		0..*	Extension	Triggering observation.
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"observation"
value[x]		1..1	Reference(Observation)	Value of extension
extension:type		0..*	Extension	The type of trigger
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"type"
value[x]		1..1	code	Value of extension
extension:reason		0..*	Extension	Extension
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"reason"
value[x]		1..1	string	Value of extension
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"
certifiedRefMaterialCodeable		0..*	CodeableConcept	Certified Reference Material: CodeableConcept URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example)
certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material: Identifier URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
labTestKit		0..*	Reference(Device)	Device Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
value-r5		0..1	(Complex)	only for result of type Attachment URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]"
value[x]		1..1	Attachment	Value of extension
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business Identifier for observation
basedOn	Σ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	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	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: Laboratory Study Types (required)
category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: Laboratory Specialty (required)
code		1..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Laboratory Code (preferred)
subject	Σ	1..1	Reference(Patient: Animal | Patient: Person | Group | Device | Location)	Who and/or what the observation is about
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	1..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
focus	Σ	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
encounter	Σ	0..1	Reference(Encounter)	Healthcare event during which this observation is made
effective[x]	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
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	Σ	0..1	instant	Date/Time this result was made available
performer	Σ	1..*	Reference(PractitionerRole: Laboratory Report | Practitioner: Laboratory Report | Organization (IPS) | CareTeam | Patient: Person | RelatedPerson)	Who is responsible for the observation
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
performerFunction		0..*	CodeableConcept	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: Performer Function Codes (extensible)
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
Slices for value[x]	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
value[x]:valueString	ΣC	0..1	string	Actual result
value[x]:valueRange	C	0..1	RangeIPS	Set of values bounded by low and high rng-2: If present, low SHALL have a lower value than high
value[x]:valueRatio	C	0..1	RatioEuLab	A measured ratio using UCUM rat-1: Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present
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	C	0..1	QuantityEuLab	A measured amount using UCUM qty-3: If a code for the unit is present, the system SHALL also be present
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS	​Concept - reference to a terminology or just text Binding: http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips (preferred) Additional Bindings Purpose ​http://hl7.org/fhir/uv/ips/ValueSet/results-blood-group-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-presence-absence-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/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	Concept - reference to a terminology or just text Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note		0..*	Annotation	Comments about the observation
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method		0..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Laboratory Techniques (preferred)
specimen		0..1	Reference(Specimen: Laboratory)	Specimen used for this observation
device		0..1	Reference(Device | DeviceMetric)	Measuring instrument
referenceRange	C	0..*	BackboneElement	Provides guide for interpretation obs-3: Must have at least a low or a high or text
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	C	0..1	SimpleQuantity	Low Range, if relevant
high	C	0..1	SimpleQuantity	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: 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		0..1	string	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Observation Results: laboratory)	Related resource that belongs to the Observation group
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
component	Σ	0..*	BackboneElement	Laboratory result
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
value-r5		0..1	(Complex)	only for result of type Attachment URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]"
value[x]		1..1	Attachment	Value of extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code		1..1	CodeableConceptIPS	​Concept - reference to a terminology or just text Binding: http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-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
value[x]:valueString	Σ	0..1	string	Actual component result
value[x]:valueRange	C	0..1	RangeIPS	Set of values bounded by low and high rng-2: If present, low SHALL have a lower value than high
value[x]:valueRatio	C	0..1	RatioEuLab	A measured ratio using UCUM rat-1: Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present
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	C	0..1	QuantityEuLab	A measured amount using UCUM qty-3: If a code for the unit is present, the system SHALL also be present
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS	​Concept - reference to a terminology or just text Binding: http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips (preferred) Additional Bindings Purpose ​http://hl7.org/fhir/uv/ips/ValueSet/results-blood-group-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-presence-absence-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-microorganism-snomed-ct-ips-free-set candidate
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		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	Conformance	ValueSet / Code	URI
Observation.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:laboratory	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:studyType	required	LabStudyTypesEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab from this IG
Observation.category:specialty	required	LabSpecialtyEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab from this IG
Observation.code	preferred	LaboratoryResultStandardEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab from this IG
Observation.subject.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
Observation.performer.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
Observation.value[x]:valueCodeableConcept	preferred	​http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips
Observation.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.bodySite	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
Observation.method	preferred	LabTechniqueEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab from this IG
Observation.referenceRange.type	preferred	ObservationReferenceRangeMeaningCodes http://hl7.org/fhir/ValueSet/referencerange-meaning from the FHIR Standard
Observation.referenceRange.appliesTo	example	ObservationReferenceRangeAppliesToCodes http://hl7.org/fhir/ValueSet/referencerange-appliesto from the FHIR Standard
Observation.component.code	preferred	​http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips
Observation.component.value[x]:valueCodeableConcept	preferred	​http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips
Observation.component.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.component.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
eu-lab-1	error	Observation	If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component" : (status in ('registered'|'cancelled')) or value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists()
eu-lab-2	error	Observation	If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason" : component.exists() implies (status in ('registered'|'cancelled')) or component.value.exists() or component.dataAbsentReason.exists()
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text : low.exists() or high.exists() or text.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
qty-3	error	Observation.value[x]:valueQuantity, Observation.component.value[x]:valueQuantity	If a code for the unit is present, the system SHALL also be present : code.empty() or system.exists()
rat-1	error	Observation.value[x]:valueRatio, Observation.component.value[x]:valueRatio	Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present : (numerator.empty() xor denominator.exists()) and (numerator.exists() or extension.exists())
rng-2	error	Observation.value[x]:valueRange, Observation.component.value[x]:valueRange	If present, low SHALL have a lower value than high : low.empty() or high.empty() or (low <= high)

This structure is derived from Observation

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)
• Patient: Animal (http://hl7.eu/fhir/laboratory/StructureDefinition/Patient-animal-eu-lab)
• Patient: Person (http://hl7.eu/fhir/laboratory/StructureDefinition/Patient-eu-lab)
• PractitionerRole: Laboratory Report (http://hl7.eu/fhir/laboratory/StructureDefinition/PractitionerRole-eu-lab)
• Practitioner: Laboratory Report (http://hl7.eu/fhir/laboratory/StructureDefinition/Practitioner-eu-lab)
• Organization (IPS) (http://hl7.org/fhir/uv/ips/StructureDefinition/Organization-uv-ips)
• Range (IPS) (http://hl7.org/fhir/uv/ips/StructureDefinition/Range-uv-ips)
• Ratio (Eu Lab) (http://hl7.eu/fhir/laboratory/StructureDefinition/Ratio-eu-lab)
• Quantity (Eu Lab) (http://hl7.eu/fhir/laboratory/StructureDefinition/Quantity-eu-lab)
• Specimen: Laboratory (http://hl7.eu/fhir/laboratory/StructureDefinition/Specimen-eu-lab)
• Observation Results: laboratory (http://hl7.eu/fhir/laboratory/StructureDefinition/Observation-resultslab-eu-lab)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
• http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy
• http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable
• http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
• http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
• http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
• http://hl7.org/fhir/StructureDefinition/data-absent-reason
• http://hl7.org/fhir/StructureDefinition/event-performerFunction

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

Differential View

This structure is derived from Observation

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Laboratory result for a simple test or for a panel/study eu-lab-1: If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component" eu-lab-2: If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason"
Slices for extension		0..*	Extension	Laboratory Test Kit Slice: Unordered, Open by value:url
supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
triggeredBy-r5		0..*	(Complex)	Optional Extensions Element URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy
Slices for extension				Content/Rules for all slices
extension:observation		0..*	Extension	Triggering observation.
extension:type		0..*	Extension	The type of trigger
certifiedRefMaterialCodeable		0..*	CodeableConcept	Certified Reference Material: CodeableConcept URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example)
certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material: Identifier URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
labTestKit		0..*	Reference(Device)	Device Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
value-r5		0..1	(Complex)	only for result of type Attachment URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
value[x]		1..1	Attachment	Value of extension
status		1..1	code	Status of this observation (e.g. preliminary, final,...)
Slices for category		1..*	CodeableConceptIPS	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: Laboratory Study Types (required)
category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: Laboratory Specialty (required)
code		1..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Laboratory Code (preferred)
subject		1..1	Reference(Patient: Animal | Patient: Person | 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
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: Laboratory Report | Practitioner: Laboratory Report | Organization (IPS) | CareTeam | Patient: Person | RelatedPerson)	Who is responsible for the observation
Slices for extension				Content/Rules for all slices
performerFunction		0..*	CodeableConcept	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: Performer Function Codes (extensible)
Slices for value[x]		0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual result Slice: Unordered, Closed by type:$this
value[x]:valueString		0..1	string	Actual result
value[x]:valueRange		0..1	RangeIPS	Set of values bounded by low and high
value[x]:valueRatio		0..1	RatioEuLab	A measured ratio using UCUM
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	A measured amount using UCUM
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS	​Concept - reference to a terminology or just text Binding: http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips (preferred) Additional Bindings Purpose ​http://hl7.org/fhir/uv/ips/ValueSet/results-blood-group-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-presence-absence-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-microorganism-snomed-ct-ips-free-set candidate
dataAbsentReason		0..1	CodeableConcept	Provides a reason why the expected value is missing.
interpretation		0..*	CodeableConceptIPS	Concept - reference to a terminology or just text
method		0..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Laboratory Techniques (preferred)
specimen		0..1	Reference(Specimen: Laboratory)	Specimen used for this observation
device		0..1	Reference(Device | DeviceMetric)	Measuring instrument
hasMember		0..*	Reference(Observation Results: laboratory)	Related resource that belongs to the Observation group
component		0..*	BackboneElement	Laboratory result
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
value-r5		0..1	(Complex)	only for result of type Attachment URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
value[x]		1..1	Attachment	Value of extension
code		1..1	CodeableConceptIPS	​Concept - reference to a terminology or just text Binding: http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips (preferred)
Slices for value[x]		0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual component result Slice: Unordered, Closed by type:$this
value[x]:valueString		0..1	string	Actual component result
value[x]:valueRange		0..1	RangeIPS	Set of values bounded by low and high
value[x]:valueRatio		0..1	RatioEuLab	A measured ratio using UCUM
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	A measured amount using UCUM
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS	​Concept - reference to a terminology or just text Binding: http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips (preferred) Additional Bindings Purpose ​http://hl7.org/fhir/uv/ips/ValueSet/results-blood-group-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-presence-absence-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-microorganism-snomed-ct-ips-free-set candidate
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
Observation.category:studyType	required	LabStudyTypesEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab from this IG
Observation.category:specialty	required	LabSpecialtyEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab from this IG
Observation.code	preferred	LaboratoryResultStandardEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab from this IG
Observation.value[x]:valueCodeableConcept	preferred	​http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips
Observation.method	preferred	LabTechniqueEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab from this IG
Observation.component.code	preferred	​http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips
Observation.component.value[x]:valueCodeableConcept	preferred	​http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips

Constraints

Id	Grade	Path(s)	Details	Requirements
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()

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Laboratory result for a simple test or for a panel/study obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present eu-lab-1: If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component" eu-lab-2: If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason"
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension		0..*	Extension	Laboratory Test Kit Slice: Unordered, Open by value:url
supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
triggeredBy-r5		0..*	(Complex)	Optional Extensions Element URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy
Slices for extension				Content/Rules for all slices
extension:observation		0..*	Extension	Triggering observation.
extension		0..0
url		1..1	uri	"observation"
value[x]		1..1	Reference(Observation)	Value of extension
extension:type		0..*	Extension	The type of trigger
extension		0..0
url		1..1	uri	"type"
value[x]		1..1	code	Value of extension
extension:reason		0..*	Extension	Extension
extension		0..0
url		1..1	uri	"reason"
value[x]		1..1	string	Value of extension
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"
certifiedRefMaterialCodeable		0..*	CodeableConcept	Certified Reference Material: CodeableConcept URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example)
certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material: Identifier URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
labTestKit		0..*	Reference(Device)	Device Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
value-r5		0..1	(Complex)	only for result of type Attachment URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
extension		0..0
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]"
value[x]		1..1	Attachment	Value of extension
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
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	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
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: Laboratory Study Types (required)
category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: Laboratory Specialty (required)
code		1..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Laboratory Code (preferred)
subject	Σ	1..1	Reference(Patient: Animal | Patient: Person | 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
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	Σ	0..1	instant	Date/Time this result was made available
performer	Σ	1..*	Reference(PractitionerRole: Laboratory Report | Practitioner: Laboratory Report | Organization (IPS) | CareTeam | Patient: Person | RelatedPerson)	Who is responsible for the observation
Slices for extension				Content/Rules for all slices
performerFunction		0..*	CodeableConcept	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: Performer Function Codes (extensible)
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
value[x]:valueString	ΣC	0..1	string	Actual result
value[x]:valueRange	C	0..1	RangeIPS	Set of values bounded by low and high rng-2: If present, low SHALL have a lower value than high
value[x]:valueRatio	C	0..1	RatioEuLab	A measured ratio using UCUM rat-1: Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present
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	C	0..1	QuantityEuLab	A measured amount using UCUM qty-3: If a code for the unit is present, the system SHALL also be present
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS	​Concept - reference to a terminology or just text Binding: http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips (preferred) Additional Bindings Purpose ​http://hl7.org/fhir/uv/ips/ValueSet/results-blood-group-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-presence-absence-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/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	Concept - reference to a terminology or just text Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
method		0..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Laboratory Techniques (preferred)
specimen		0..1	Reference(Specimen: Laboratory)	Specimen used for this observation
device		0..1	Reference(Device | DeviceMetric)	Measuring instrument
hasMember	Σ	0..*	Reference(Observation Results: laboratory)	Related resource that belongs to the Observation group
component	Σ	0..*	BackboneElement	Laboratory result
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
value-r5		0..1	(Complex)	only for result of type Attachment URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
extension		0..0
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]"
value[x]		1..1	Attachment	Value of extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code		1..1	CodeableConceptIPS	​Concept - reference to a terminology or just text Binding: http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-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
value[x]:valueString	Σ	0..1	string	Actual component result
value[x]:valueRange	C	0..1	RangeIPS	Set of values bounded by low and high rng-2: If present, low SHALL have a lower value than high
value[x]:valueRatio	C	0..1	RatioEuLab	A measured ratio using UCUM rat-1: Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present
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	C	0..1	QuantityEuLab	A measured amount using UCUM qty-3: If a code for the unit is present, the system SHALL also be present
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS	​Concept - reference to a terminology or just text Binding: http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips (preferred) Additional Bindings Purpose ​http://hl7.org/fhir/uv/ips/ValueSet/results-blood-group-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-presence-absence-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-microorganism-snomed-ct-ips-free-set candidate
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:laboratory	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:studyType	required	LabStudyTypesEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab from this IG
Observation.category:specialty	required	LabSpecialtyEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab from this IG
Observation.code	preferred	LaboratoryResultStandardEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab from this IG
Observation.value[x]:valueCodeableConcept	preferred	​http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips
Observation.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.method	preferred	LabTechniqueEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab from this IG
Observation.component.code	preferred	​http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips
Observation.component.value[x]:valueCodeableConcept	preferred	​http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
eu-lab-1	error	Observation	If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component" : (status in ('registered'|'cancelled')) or value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists()
eu-lab-2	error	Observation	If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason" : component.exists() implies (status in ('registered'|'cancelled')) or component.value.exists() or component.dataAbsentReason.exists()
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-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()
qty-3	error	Observation.value[x]:valueQuantity, Observation.component.value[x]:valueQuantity	If a code for the unit is present, the system SHALL also be present : code.empty() or system.exists()
rat-1	error	Observation.value[x]:valueRatio, Observation.component.value[x]:valueRatio	Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present : (numerator.empty() xor denominator.exists()) and (numerator.exists() or extension.exists())
rng-2	error	Observation.value[x]:valueRange, Observation.component.value[x]:valueRange	If present, low SHALL have a lower value than high : low.empty() or high.empty() or (low <= high)

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
Observation	C	0..*	Observation	Laboratory result for a simple test or for a panel/study obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present eu-lab-1: If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component" eu-lab-2: If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason"
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Laboratory Test Kit Slice: Unordered, Open by value:url
supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
triggeredBy-r5		0..*	(Complex)	Optional Extensions Element URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
extension:observation		0..*	Extension	Triggering observation.
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"observation"
value[x]		1..1	Reference(Observation)	Value of extension
extension:type		0..*	Extension	The type of trigger
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"type"
value[x]		1..1	code	Value of extension
extension:reason		0..*	Extension	Extension
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"reason"
value[x]		1..1	string	Value of extension
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"
certifiedRefMaterialCodeable		0..*	CodeableConcept	Certified Reference Material: CodeableConcept URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example)
certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material: Identifier URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
labTestKit		0..*	Reference(Device)	Device Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
value-r5		0..1	(Complex)	only for result of type Attachment URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]"
value[x]		1..1	Attachment	Value of extension
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business Identifier for observation
basedOn	Σ	0..*	Reference(CarePlan | DeviceRequest | ImmunizationRecommendation | MedicationRequest | NutritionOrder | ServiceRequest)	Fulfills plan, proposal or order
partOf	Σ	0..*	Reference(MedicationAdministration | MedicationDispense | MedicationStatement | Procedure | Immunization | ImagingStudy)	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	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: Laboratory Study Types (required)
category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: Laboratory Specialty (required)
code		1..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Laboratory Code (preferred)
subject	Σ	1..1	Reference(Patient: Animal | Patient: Person | Group | Device | Location)	Who and/or what the observation is about
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
reference	ΣC	1..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
focus	Σ	0..*	Reference(Resource)	What the observation is about, when it is not about the subject of record
encounter	Σ	0..1	Reference(Encounter)	Healthcare event during which this observation is made
effective[x]	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
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	Σ	0..1	instant	Date/Time this result was made available
performer	Σ	1..*	Reference(PractitionerRole: Laboratory Report | Practitioner: Laboratory Report | Organization (IPS) | CareTeam | Patient: Person | RelatedPerson)	Who is responsible for the observation
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
performerFunction		0..*	CodeableConcept	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: Performer Function Codes (extensible)
reference	ΣC	0..1	string	Literal reference, Relative, internal or absolute URL
type	Σ	0..1	uri	Type the reference refers to (e.g. "Patient") Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).
identifier	Σ	0..1	Identifier	Logical reference, when literal reference is not known
display	Σ	0..1	string	Text alternative for the resource
Slices for value[x]	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
value[x]:valueString	ΣC	0..1	string	Actual result
value[x]:valueRange	C	0..1	RangeIPS	Set of values bounded by low and high rng-2: If present, low SHALL have a lower value than high
value[x]:valueRatio	C	0..1	RatioEuLab	A measured ratio using UCUM rat-1: Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present
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	C	0..1	QuantityEuLab	A measured amount using UCUM qty-3: If a code for the unit is present, the system SHALL also be present
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS	​Concept - reference to a terminology or just text Binding: http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips (preferred) Additional Bindings Purpose ​http://hl7.org/fhir/uv/ips/ValueSet/results-blood-group-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-presence-absence-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/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	Concept - reference to a terminology or just text Binding: ObservationInterpretationCodes (extensible): Codes identifying interpretations of observations.
note		0..*	Annotation	Comments about the observation
bodySite		0..1	CodeableConcept	Observed body part Binding: SNOMEDCTBodyStructures (example): Codes describing anatomical locations. May include laterality.
method		0..1	CodeableConceptIPS	Concept - reference to a terminology or just text Binding: Laboratory Techniques (preferred)
specimen		0..1	Reference(Specimen: Laboratory)	Specimen used for this observation
device		0..1	Reference(Device | DeviceMetric)	Measuring instrument
referenceRange	C	0..*	BackboneElement	Provides guide for interpretation obs-3: Must have at least a low or a high or text
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	C	0..1	SimpleQuantity	Low Range, if relevant
high	C	0..1	SimpleQuantity	High Range, if relevant
type		0..1	CodeableConcept	Reference range qualifier Binding: 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		0..1	string	Text based reference range in an observation
hasMember	Σ	0..*	Reference(Observation Results: laboratory)	Related resource that belongs to the Observation group
derivedFrom	Σ	0..*	Reference(DocumentReference | ImagingStudy | Media | QuestionnaireResponse | Observation | MolecularSequence)	Related measurements the observation is made from
component	Σ	0..*	BackboneElement	Laboratory result
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
value-r5		0..1	(Complex)	only for result of type Attachment URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
id		0..1	string	Unique id for inter-element referencing
extension		0..0
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]"
value[x]		1..1	Attachment	Value of extension
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code		1..1	CodeableConceptIPS	​Concept - reference to a terminology or just text Binding: http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-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
value[x]:valueString	Σ	0..1	string	Actual component result
value[x]:valueRange	C	0..1	RangeIPS	Set of values bounded by low and high rng-2: If present, low SHALL have a lower value than high
value[x]:valueRatio	C	0..1	RatioEuLab	A measured ratio using UCUM rat-1: Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present
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	C	0..1	QuantityEuLab	A measured amount using UCUM qty-3: If a code for the unit is present, the system SHALL also be present
value[x]:valueCodeableConcept		0..1	CodeableConceptIPS	​Concept - reference to a terminology or just text Binding: http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips (preferred) Additional Bindings Purpose ​http://hl7.org/fhir/uv/ips/ValueSet/results-blood-group-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-presence-absence-snomed-ct-ips-free-set candidate ​http://hl7.org/fhir/uv/ips/ValueSet/results-microorganism-snomed-ct-ips-free-set candidate
dataAbsentReason	C	0..1	CodeableConcept	Why the component result is missing Binding: DataAbsentReason (extensible): Codes specifying why the result (Observation.value[x]) is missing.
interpretation		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	Conformance	ValueSet / Code	URI
Observation.language	preferred	CommonLanguages Additional Bindings Purpose AllLanguages Max Binding http://hl7.org/fhir/ValueSet/languages from the FHIR Standard
Observation.status	required	ObservationStatus http://hl7.org/fhir/ValueSet/observation-status|4.0.1 from the FHIR Standard
Observation.category	preferred	ObservationCategoryCodes http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:laboratory	preferred	Pattern: laboratory http://hl7.org/fhir/ValueSet/observation-category from the FHIR Standard
Observation.category:studyType	required	LabStudyTypesEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab from this IG
Observation.category:specialty	required	LabSpecialtyEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab from this IG
Observation.code	preferred	LaboratoryResultStandardEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab from this IG
Observation.subject.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
Observation.performer.type	extensible	ResourceType http://hl7.org/fhir/ValueSet/resource-types from the FHIR Standard
Observation.value[x]:valueCodeableConcept	preferred	​http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips
Observation.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard
Observation.bodySite	example	SNOMEDCTBodyStructures http://hl7.org/fhir/ValueSet/body-site from the FHIR Standard
Observation.method	preferred	LabTechniqueEuVs http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab from this IG
Observation.referenceRange.type	preferred	ObservationReferenceRangeMeaningCodes http://hl7.org/fhir/ValueSet/referencerange-meaning from the FHIR Standard
Observation.referenceRange.appliesTo	example	ObservationReferenceRangeAppliesToCodes http://hl7.org/fhir/ValueSet/referencerange-appliesto from the FHIR Standard
Observation.component.code	preferred	​http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips http://hl7.org/fhir/uv/ips/ValueSet/results-laboratory-observations-uv-ips
Observation.component.value[x]:valueCodeableConcept	preferred	​http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-uv-ips
Observation.component.dataAbsentReason	extensible	DataAbsentReason http://hl7.org/fhir/ValueSet/data-absent-reason from the FHIR Standard
Observation.component.interpretation	extensible	ObservationInterpretationCodes http://hl7.org/fhir/ValueSet/observation-interpretation from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	Observation	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	Observation	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	Observation	A resource should have narrative for robust management : text.`div`.exists()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
eu-lab-1	error	Observation	If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component" : (status in ('registered'|'cancelled')) or value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists()
eu-lab-2	error	Observation	If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason" : component.exists() implies (status in ('registered'|'cancelled')) or component.value.exists() or component.dataAbsentReason.exists()
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()
obs-3	error	Observation.referenceRange	Must have at least a low or a high or text : low.exists() or high.exists() or text.exists()
obs-6	error	Observation	dataAbsentReason SHALL only be present if Observation.value[x] is not present : dataAbsentReason.empty() or value.empty()
obs-7	error	Observation	If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present : value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty()
qty-3	error	Observation.value[x]:valueQuantity, Observation.component.value[x]:valueQuantity	If a code for the unit is present, the system SHALL also be present : code.empty() or system.exists()
rat-1	error	Observation.value[x]:valueRatio, Observation.component.value[x]:valueRatio	Numerator and denominator SHALL both be present, or both are absent. If both are absent, there SHALL be some extension present : (numerator.empty() xor denominator.exists()) and (numerator.exists() or extension.exists())
rng-2	error	Observation.value[x]:valueRange, Observation.component.value[x]:valueRange	If present, low SHALL have a lower value than high : low.empty() or high.empty() or (low <= high)

This structure is derived from Observation

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)
• Patient: Animal (http://hl7.eu/fhir/laboratory/StructureDefinition/Patient-animal-eu-lab)
• Patient: Person (http://hl7.eu/fhir/laboratory/StructureDefinition/Patient-eu-lab)
• PractitionerRole: Laboratory Report (http://hl7.eu/fhir/laboratory/StructureDefinition/PractitionerRole-eu-lab)
• Practitioner: Laboratory Report (http://hl7.eu/fhir/laboratory/StructureDefinition/Practitioner-eu-lab)
• Organization (IPS) (http://hl7.org/fhir/uv/ips/StructureDefinition/Organization-uv-ips)
• Range (IPS) (http://hl7.org/fhir/uv/ips/StructureDefinition/Range-uv-ips)
• Ratio (Eu Lab) (http://hl7.eu/fhir/laboratory/StructureDefinition/Ratio-eu-lab)
• Quantity (Eu Lab) (http://hl7.eu/fhir/laboratory/StructureDefinition/Quantity-eu-lab)
• Specimen: Laboratory (http://hl7.eu/fhir/laboratory/StructureDefinition/Specimen-eu-lab)
• Observation Results: laboratory (http://hl7.eu/fhir/laboratory/StructureDefinition/Observation-resultslab-eu-lab)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
• http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy
• http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable
• http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
• http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
• http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value[x]
• http://hl7.org/fhir/StructureDefinition/data-absent-reason
• http://hl7.org/fhir/StructureDefinition/event-performerFunction

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