Medical and Laboratory Test Results

Medical Test Results

Medical test results represent the outcomes of procedures performed to determine values of properties of the human body or of subjects related to the body (e.g., environment, substances, animals, devices etc.).

This broad category includes laboratory test results typically based on in vitro diagnostic devices that follow In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 and results based on measurements and diagnostic functions by medical devices according to the Medical Device Regulation (MDR) 2017/745. Additionally, the medical test results may include results from direct observation or emerging technologies for minimally invasive tests, such as biosensor monitoring or other non-invasive tests for direct measurement of the properties of saliva, sweat, or tears, as well as techniques for transcutaneous measurement of properties, regardless of whether the measurement is performed in a healthcare provider setting, such as in dedicated outpatient clinics, or at the point of care, or in patient’s home environment.

Medical test results include, but are not limited to:

• laboratory tests typically based on in vitro diagnostic devices regulated under the IVDR (EU) 2017/746;
• results from measurements performed by medical devices regulated under the MDR (EU) 2017/745, such as physiological or functional in vivo measurements;
• measurement results obtained by the imaging observation methods
• examination results from observation of the patient, body parts of the patient and/or their functions
• results generated by emerging technologies, including minimally invasive or non-invasive techniques such as biosensors and direct measurements from saliva, sweat, or tears, as well as transcutaneous measurement techniques.

Laboratory Test Results

Laboratory test results are a subset of medical test results and represent electronic health data produced by studies performed primarily using in vitro diagnostic methods under controlled conditions.

Laboratory test results constitute a major subset of medical test results and represent the primary focus of the specifications defined in this IG. Laboratory test results in electronic form represent results from studies performed through in vitro diagnostics such as clinical biochemistry, haematology, transfusion medicine, microbiology, immunology and related disciplines. Laboratory test results are often provided together with additional information supporting the interpretation of the results.

Laboratory test results are typically produced using in vitro diagnostic devices compliant with IVDR (EU) 2017/746. The results may originate from dedicated laboratories, point of care testing performed in healthcare settings such as doctor’s office or hospital wards, or from supervised testing performed in a non-clinical environment, including patient homes.

Laboratory test results are typically characterized by:

• controlled environmental conditions (e.g. temperature, humidity, lighting);
• standardized and validated standard operating procedures (SOPs);
• use of calibrated and maintained instruments;
• application of internal quality control (IQC) and participation in external quality assessment (EQA) / proficiency testing schemes;
• performance by trained and qualified personnel operating within defined professional roles and responsibilities.

Laboratory results are typically generated in:

• accredited clinical laboratories,
• hospital laboratory departments,
• or certified POCT environments operating under laboratory governance frameworks.

These conditions provide a high level of analytical reliability and support the use of laboratory test results for diagnostic decision-making, clinical monitoring, and secondary use such as research and population health analysis.

Guidance for Use

It is not easy to draw a clear line between general medical test results and laboratory test results as they are rather similar, with only minor differences in content, as shown in the logical models. Nevertheless, FHIR IG developers and implementers of the EHR systems would have to decide which type of observation to use. We propose to take into consideration the following rules:

• Use Laboratory test results when results originate from in vitro diagnostic procedures performed under laboratory governance and quality assurance frameworks.
• Use Medical test results as the broader category for results obtained across different environments and technologies.
• When representing medical including laboratory test results, ensure that the measurement context is available to support appropriate clinical interpretation.

Implementation note: Laboratory panels

Laboratory panels (or batteries) are predefined groups of tests that can be ordered from a laboratory using a single code from a chosen coding system. Upon receiving such an order, the laboratory expands it into its individual component tests and reports results for each test separately.

If it is necessary to preserve the relationship between the panel and its component tests, the panel should be represented as a grouping Observation. In this approach, the panel code is used as the code of the grouping Observation, and each component test is represented as a separate Observation. These individual Observations are then linked to the grouping Observation via the hasMember reference.

Implementation note: Reflex tests

Reflex tests are additional laboratory tests performed automatically based on predefined criteria, such as the result of an initial test. They are not usually ordered directly as part of the original request, but are triggered by the laboratory workflow when specific conditions are met.

When it is necessary to preserve the relationship between the initial test and the reflex test, this relationship should be represented using the triggeredBy element. The original test result is represented as one Observation, and each reflex test result is represented as a separate Observation. The reflex test Observation should reference the Observation that triggered it using triggeredBy.observation, and the appropriate trigger type should be recorded in triggeredBy.type.

This allows the result report to clearly indicate that the reflex test was performed as a consequence of another observation, while keeping each test result as a distinct Observation.

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	MedicalTestResultEuCore	Laboratory result for a simple test or for a panel/study Constraints: obs-6, obs-7, obs-value-1, eu-lab-1, eu-lab-2
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension				Content/Rules for all slices
extension:bodyStructure		0..1	Reference(Cross-version Profile for R5.BodyStructure for use in FHIR R4(0.1.0) | BodyStructure)	R5: Observed body structure (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.bodyStructure Constraints: ext-1
extension:triggeredBy		0..*	(Complex)	R5: Triggering observation(s) (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy Constraints: ext-1
Slices for extension		2..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:observation		1..1	Extension	Extension Constraints: ext-1
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"observation"
value[x]		1..1	Reference(Observation: Medical Test Result (EU core))	Triggering observation
extension:type		1..1	Extension	R5: reflex | repeat | re-run (new) Constraints: ext-1
url		1..1	uri	"type"
value[x]		1..1	code	reflex | repeat | re-run Binding: R5ObservationTriggeredbytypeForR4 (0.1.0) (required): The type of TriggeredBy Observation.
extension:reason		0..1	Extension	R5: Reason that the observation was triggered (new) Constraints: ext-1
url		1..1	uri	"reason"
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"
extension:value-r5		0..1	(Complex)	only for Diagrams or Pictures URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value Constraints: ext-1
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value"
extension:supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
extension:labTestKit		0..*	Reference(Device)	Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
extension:certifiedRefMaterialCodeable		0..*	CodeableConcept	Certified Reference Material: CodeableConcept URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example)
extension:certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material: Identifier URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
extension:accredited		0..1	boolean	Accredited test URL: http://hl7.eu/fhir/StructureDefinition/laboratory-accredited
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..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:laboratory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: 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	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: Laboratory Code (preferred)
subject	Σ	1..1	Reference(Patient (EU core) | Device | Group | Location)	Who and/or what the observation is about
focus	Σ	0..*	Reference(Patient (EU core) | RelatedPerson: AnimalSpecimen | Group | Device | Location (EU core))	What the observation is about, when it is not about the subject of record
effective[x]	Σ	1..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
issued	Σ	0..1	instant	Date/Time this result was made available
performer	Σ	1..*	Reference(Practitioner (EU core) | PractitionerRole (EU core) | Organization (EU core) | Patient (EU core) | RelatedPerson)	Who is responsible for the observation
Slices for extension				Content/Rules for all slices
extension:performerFunction		0..1	CodeableConcept	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: Performer Function Codes (extensible)
Slices for value[x]	ΣC	0..1		Actual result Slice: Unordered, Closed 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]:valueQuantity	ΣC	0..1	QuantityEuLab	Actual result
Slices for extension				Content/Rules for all slices
extension:uncertainty		0..1	decimal	Standard Deviation (same units as the quantity) URL: http://hl7.org/fhir/StructureDefinition/iso21090-uncertainty
comparator	?!Σ	0..1	code	< | <= | >= | > - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
value[x]:valueString	ΣC	0..1	string	Actual result
value[x]:valueRange	ΣC	0..1	RangeEuLab	Actual result
value[x]:valueRatio	ΣC	0..1	RatioEuLab	Actual result
value[x]:valueTime	ΣC	0..1	time	Actual result
value[x]:valueDateTime	ΣC	0..1	dateTime	Actual result
value[x]:valuePeriod	ΣC	0..1	Period	Actual result
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConcept	Actual result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Laboratory Presence and Absence Findings Preferred 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.
method		0..1	CodeableConcept	How it was done Binding: Laboratory Techniques (preferred)
specimen		0..1	Reference(Specimen: Laboratory)	Specimen used for the 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				Content/Rules for all slices
extension:value-r5		0..1	(Complex)	only for Diagrams or Pictures URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value Constraints: ext-1
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value"
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: Laboratory Code (preferred)
Slices for value[x]	Σ	0..1		Actual component result Slice: Unordered, Closed 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]:valueQuantity	Σ	0..1	QuantityEuLab	Actual component result
Slices for extension				Content/Rules for all slices
extension:uncertainty		0..1	decimal	Standard Deviation (same units as the quantity) URL: http://hl7.org/fhir/StructureDefinition/iso21090-uncertainty
comparator	?!Σ	0..1	code	< | <= | >= | > - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
value[x]:valueString	Σ	0..1	string	Actual component result
value[x]:valueRange	Σ	0..1	RangeEuLab	Actual component result
value[x]:valueRatio	Σ	0..1	RatioEuLab	Actual component result
value[x]:valueTime	Σ	0..1	time	Actual component result
value[x]:valueDateTime	Σ	0..1	dateTime	Actual component result
value[x]:valuePeriod	Σ	0..1	Period	Actual component result
value[x]:valueCodeableConcept	Σ	0..1	CodeableConcept	Actual component result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Laboratory Presence and Absence Findings Preferred Results Microorganism - SNOMED CT IPS Free Set candidate
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.extension:triggeredBy.​extension:type.value[x]	Base	required	Cross-version ValueSet R5.TriggeredBytype for use in FHIR R4	📍0.1.0	Extensions for Using Data Elements from FHIR R5 in FHIR R4 v0.1
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:laboratory	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:studyType	Base	required	Laboratory Study Types	📦2.0.0	This IG
Observation.category:specialty	Base	required	Laboratory Specialty	📦2.0.0	This IG
Observation.code	Base	preferred	Laboratory Code	📦2.0.0	This IG
Observation.value[x]:valueQuantity.​comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	⏿2.0.0	tx.hl7europe.eu
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.method	Base	preferred	Laboratory Techniques	📦2.0.0	This IG
Observation.component.​code	Base	preferred	Laboratory Code	📦2.0.0	This IG
Observation.component.​value[x]:valueQuantity.​comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.component.​value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	⏿2.0.0	tx.hl7europe.eu

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().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	Observation.extension:bodyStructure, Observation.extension:triggeredBy, Observation.extension:triggeredBy.extension, Observation.extension:triggeredBy.extension:observation, Observation.extension:triggeredBy.extension:type, Observation.extension:triggeredBy.extension:reason, Observation.extension:value-r5, Observation.extension:supportingInfo, Observation.extension:labTestKit, Observation.extension:certifiedRefMaterialCodeable, Observation.extension:certifiedRefMaterialIdentifer, Observation.extension:accredited, Observation.modifierExtension, Observation.performer.extension:performerFunction, Observation.value[x]:valueQuantity.extension:uncertainty, Observation.component.extension:value-r5, Observation.component.modifierExtension, Observation.component.value[x]:valueQuantity.extension:uncertainty	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()
obs-value-1	error	Observation	The elements Observation.extension:value-r5 and Observation.value[x] SHALL not be used simultaneously.	value.empty() or extension('http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value').empty()

This structure is derived from MedicalTestResultEuCore

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	MedicalTestResultEuCore	Laboratory result for a simple test or for a panel/study Constraints: eu-lab-1, eu-lab-2
Slices for extension				Content/Rules for all slices
extension:supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
extension:labTestKit		0..*	Reference(Device)	Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
extension:certifiedRefMaterialCodeable		0..*	CodeableConcept	Certified Reference Material: CodeableConcept URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example)
extension:certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material: Identifier URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
extension:accredited		0..1	boolean	Accredited test URL: http://hl7.eu/fhir/StructureDefinition/laboratory-accredited
status		1..1	code	Status of this observation (e.g. preliminary, final,...)
Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by pattern:$this
category:laboratory		1..1	CodeableConcept	Classification of type of observation Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
category:studyType		0..*	CodeableConcept	The way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.) Binding: Laboratory Study Types (required)
category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: Laboratory Specialty (required)
code		1..1	CodeableConcept	Type of observation (code / type) Binding: Laboratory Code (preferred)
focus		0..*	Reference(Patient (EU core) | RelatedPerson: AnimalSpecimen | Group | Device | Location (EU core))	What the observation is about, when it is not about the subject of record
issued		0..1	instant	Date/Time this result was made available
performer		1..*	Reference(Practitioner (EU core) | PractitionerRole (EU core) | Organization (EU core) | Patient (EU core) | RelatedPerson)	Who is responsible for the observation
Slices for value[x]		0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual result Slice: Unordered, Closed by type:$this
value[x]:valueQuantity		0..1	QuantityEuLab	Actual result
value[x]:valueString		0..1	string	Actual result
value[x]:valueRange		0..1	RangeEuLab	Actual result
value[x]:valueRatio		0..1	RatioEuLab	Actual result
value[x]:valueTime		0..1	time	Actual result
value[x]:valueDateTime		0..1	dateTime	Actual result
value[x]:valuePeriod		0..1	Period	Actual result
value[x]:valueCodeableConcept		0..1	CodeableConcept	Actual result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Laboratory Presence and Absence Findings Preferred Results Microorganism - SNOMED CT IPS Free Set candidate
dataAbsentReason		0..1	CodeableConcept	Provides a reason why the expected value is missing.
method		0..1	CodeableConcept	How it was done Binding: Laboratory Techniques (preferred)
specimen		0..1	Reference(Specimen: Laboratory)	Specimen used for the 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
code		1..1	CodeableConcept	Type of component observation (code / type) Binding: Laboratory Code (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]:valueQuantity		0..1	QuantityEuLab	Actual component result
value[x]:valueString		0..1	string	Actual component result
value[x]:valueRange		0..1	RangeEuLab	Actual component result
value[x]:valueRatio		0..1	RatioEuLab	Actual component result
value[x]:valueTime		0..1	time	Actual component result
value[x]:valueDateTime		0..1	dateTime	Actual component result
value[x]:valuePeriod		0..1	Period	Actual component result
value[x]:valueCodeableConcept		0..1	CodeableConcept	Actual component result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Laboratory Presence and Absence Findings Preferred Results Microorganism - SNOMED CT IPS Free Set candidate
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.category:studyType	Base	required	Laboratory Study Types	📦2.0.0	This IG
Observation.category:specialty	Base	required	Laboratory Specialty	📦2.0.0	This IG
Observation.code	Base	preferred	Laboratory Code	📦2.0.0	This IG
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	⏿2.0.0	tx.hl7europe.eu
Observation.method	Base	preferred	Laboratory Techniques	📦2.0.0	This IG
Observation.component.​code	Base	preferred	Laboratory Code	📦2.0.0	This IG
Observation.component.​value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	⏿2.0.0	tx.hl7europe.eu

Constraints

Id	Grade	Path(s)	Description	Expression
eu-lab-1	error	Observation	If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component"	(status in ('registered'|'cancelled')) or value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists()
eu-lab-2	error	Observation	If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason"	component.exists() implies (status in ('registered'|'cancelled')) or component.value.exists() or component.dataAbsentReason.exists()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	MedicalTestResultEuCore	Laboratory result for a simple test or for a panel/study Constraints: obs-6, obs-7, obs-value-1, eu-lab-1, eu-lab-2
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 observation Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:bodyStructure		0..1	Reference(Cross-version Profile for R5.BodyStructure for use in FHIR R4(0.1.0) | BodyStructure)	R5: Observed body structure (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.bodyStructure Constraints: ext-1
extension:triggeredBy		0..*	(Complex)	R5: Triggering observation(s) (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
Slices for extension		2..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:observation		1..1	Extension	Extension Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"observation"
value[x]		1..1	Reference(Observation: Medical Test Result (EU core))	Triggering observation
extension:type		1..1	Extension	R5: reflex | repeat | re-run (new) Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"type"
value[x]		1..1	code	reflex | repeat | re-run Binding: R5ObservationTriggeredbytypeForR4 (0.1.0) (required): The type of TriggeredBy Observation.
extension:reason		0..1	Extension	R5: Reason that the observation was triggered (new) Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"reason"
value[x]		0..1	string	Reason that the observation was triggered
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"
extension:value-r5		0..1	(Complex)	only for Diagrams or Pictures URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value"
value[x]		0..1	Attachment	Actual result
extension:supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
extension:labTestKit		0..*	Reference(Device)	Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
extension:certifiedRefMaterialCodeable		0..*	CodeableConcept	Certified Reference Material: CodeableConcept URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example)
extension:certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material: Identifier URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
extension:accredited		0..1	boolean	Accredited test URL: http://hl7.eu/fhir/StructureDefinition/laboratory-accredited
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..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:laboratory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: 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	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: Laboratory Code (preferred)
subject	Σ	1..1	Reference(Patient (EU core) | Device | Group | Location)	Who and/or what the observation is about
focus	Σ	0..*	Reference(Patient (EU core) | RelatedPerson: AnimalSpecimen | Group | Device | Location (EU core))	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
effectiveDateTime			dateTime
effectivePeriod			Period
issued	Σ	0..1	instant	Date/Time this result was made available
performer	Σ	1..*	Reference(Practitioner (EU core) | PractitionerRole (EU core) | Organization (EU core) | Patient (EU core) | 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
extension:performerFunction		0..1	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, Closed 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]:valueQuantity	ΣC	0..1	QuantityEuLab	Actual result
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:uncertainty		0..1	decimal	Standard Deviation (same units as the quantity) URL: http://hl7.org/fhir/StructureDefinition/iso21090-uncertainty
value	Σ	0..1	decimal	Numerical value (with implicit precision)
comparator	?!Σ	0..1	code	< | <= | >= | > - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	Σ	0..1	code	Coded form of the unit
value[x]:valueString	ΣC	0..1	string	Actual result
value[x]:valueRange	ΣC	0..1	RangeEuLab	Actual result
value[x]:valueRatio	ΣC	0..1	RatioEuLab	Actual result
value[x]:valueTime	ΣC	0..1	time	Actual result
value[x]:valueDateTime	ΣC	0..1	dateTime	Actual result
value[x]:valuePeriod	ΣC	0..1	Period	Actual result
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConcept	Actual result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Laboratory Presence and Absence Findings Preferred 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..*	CodeableConcept	High, low, normal, etc. 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	CodeableConcept	How it was done Binding: Laboratory Techniques (preferred)
specimen		0..1	Reference(Specimen: Laboratory)	Specimen used for the observation
device		0..1	Reference(Device | DeviceMetric)	Measuring instrument
referenceRange	C	0..*	BackboneElement	Provides guide for interpretation Constraints: obs-3
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	C	0..1	SimpleQuantity(4.0.1)	Low Range, if relevant
high	C	0..1	SimpleQuantity(4.0.1)	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(Observation: Medical Test Result (EU core) | ImagingStudy)	Related measurements the observation is made from
component	Σ	0..*	BackboneElement	Laboratory result
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:value-r5		0..1	(Complex)	only for Diagrams or Pictures URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value"
value[x]		0..1	Attachment	Actual result
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: Laboratory Code (preferred)
Slices for value[x]	Σ	0..1		Actual component result Slice: Unordered, Closed 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]:valueQuantity	Σ	0..1	QuantityEuLab	Actual component result
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:uncertainty		0..1	decimal	Standard Deviation (same units as the quantity) URL: http://hl7.org/fhir/StructureDefinition/iso21090-uncertainty
value	Σ	0..1	decimal	Numerical value (with implicit precision)
comparator	?!Σ	0..1	code	< | <= | >= | > - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	Σ	0..1	code	Coded form of the unit
value[x]:valueString	Σ	0..1	string	Actual component result
value[x]:valueRange	Σ	0..1	RangeEuLab	Actual component result
value[x]:valueRatio	Σ	0..1	RatioEuLab	Actual component result
value[x]:valueTime	Σ	0..1	time	Actual component result
value[x]:valueDateTime	Σ	0..1	dateTime	Actual component result
value[x]:valuePeriod	Σ	0..1	Period	Actual component result
value[x]:valueCodeableConcept	Σ	0..1	CodeableConcept	Actual component result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Laboratory Presence and Absence Findings Preferred 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	Status	Usage	ValueSet	Version	Source
Observation.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
Observation.extension:triggeredBy.​extension:type.value[x]	Base	required	Cross-version ValueSet R5.TriggeredBytype for use in FHIR R4	📍0.1.0	Extensions for Using Data Elements from FHIR R5 in FHIR R4 v0.1
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:laboratory	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:studyType	Base	required	Laboratory Study Types	📦2.0.0	This IG
Observation.category:specialty	Base	required	Laboratory Specialty	📦2.0.0	This IG
Observation.code	Base	preferred	Laboratory Code	📦2.0.0	This IG
Observation.performer.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Observation.value[x]:valueQuantity.​comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	⏿2.0.0	tx.hl7europe.eu
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.
Observation.bodySite	Base	example	SNOMED CT Body Structures	📍4.0.1	FHIR Std.
Observation.method	Base	preferred	Laboratory Techniques	📦2.0.0	This IG
Observation.referenceRange.​type	Base	preferred	Observation Reference Range Meaning Codes	📍4.0.1	FHIR Std.
Observation.referenceRange.​appliesTo	Base	example	Observation Reference Range Applies To Codes	📍4.0.1	FHIR Std.
Observation.component.​code	Base	preferred	Laboratory Code	📦2.0.0	This IG
Observation.component.​value[x]:valueQuantity.​comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.component.​value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	⏿2.0.0	tx.hl7europe.eu
Observation.component.​dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.component.​interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.

Constraints

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

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	MedicalTestResultEuCore	Laboratory result for a simple test or for a panel/study Constraints: obs-6, obs-7, obs-value-1, eu-lab-1, eu-lab-2
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension				Content/Rules for all slices
extension:bodyStructure		0..1	Reference(Cross-version Profile for R5.BodyStructure for use in FHIR R4(0.1.0) | BodyStructure)	R5: Observed body structure (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.bodyStructure Constraints: ext-1
extension:triggeredBy		0..*	(Complex)	R5: Triggering observation(s) (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy Constraints: ext-1
Slices for extension		2..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:observation		1..1	Extension	Extension Constraints: ext-1
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"observation"
value[x]		1..1	Reference(Observation: Medical Test Result (EU core))	Triggering observation
extension:type		1..1	Extension	R5: reflex | repeat | re-run (new) Constraints: ext-1
url		1..1	uri	"type"
value[x]		1..1	code	reflex | repeat | re-run Binding: R5ObservationTriggeredbytypeForR4 (0.1.0) (required): The type of TriggeredBy Observation.
extension:reason		0..1	Extension	R5: Reason that the observation was triggered (new) Constraints: ext-1
url		1..1	uri	"reason"
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"
extension:value-r5		0..1	(Complex)	only for Diagrams or Pictures URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value Constraints: ext-1
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value"
extension:supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
extension:labTestKit		0..*	Reference(Device)	Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
extension:certifiedRefMaterialCodeable		0..*	CodeableConcept	Certified Reference Material: CodeableConcept URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example)
extension:certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material: Identifier URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
extension:accredited		0..1	boolean	Accredited test URL: http://hl7.eu/fhir/StructureDefinition/laboratory-accredited
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..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:laboratory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: 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	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: Laboratory Code (preferred)
subject	Σ	1..1	Reference(Patient (EU core) | Device | Group | Location)	Who and/or what the observation is about
focus	Σ	0..*	Reference(Patient (EU core) | RelatedPerson: AnimalSpecimen | Group | Device | Location (EU core))	What the observation is about, when it is not about the subject of record
effective[x]	Σ	1..1		Clinically relevant time/time-period for observation
effectiveDateTime			dateTime
effectivePeriod			Period
issued	Σ	0..1	instant	Date/Time this result was made available
performer	Σ	1..*	Reference(Practitioner (EU core) | PractitionerRole (EU core) | Organization (EU core) | Patient (EU core) | RelatedPerson)	Who is responsible for the observation
Slices for extension				Content/Rules for all slices
extension:performerFunction		0..1	CodeableConcept	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: Performer Function Codes (extensible)
Slices for value[x]	ΣC	0..1		Actual result Slice: Unordered, Closed 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]:valueQuantity	ΣC	0..1	QuantityEuLab	Actual result
Slices for extension				Content/Rules for all slices
extension:uncertainty		0..1	decimal	Standard Deviation (same units as the quantity) URL: http://hl7.org/fhir/StructureDefinition/iso21090-uncertainty
comparator	?!Σ	0..1	code	< | <= | >= | > - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
value[x]:valueString	ΣC	0..1	string	Actual result
value[x]:valueRange	ΣC	0..1	RangeEuLab	Actual result
value[x]:valueRatio	ΣC	0..1	RatioEuLab	Actual result
value[x]:valueTime	ΣC	0..1	time	Actual result
value[x]:valueDateTime	ΣC	0..1	dateTime	Actual result
value[x]:valuePeriod	ΣC	0..1	Period	Actual result
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConcept	Actual result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Laboratory Presence and Absence Findings Preferred 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.
method		0..1	CodeableConcept	How it was done Binding: Laboratory Techniques (preferred)
specimen		0..1	Reference(Specimen: Laboratory)	Specimen used for the 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				Content/Rules for all slices
extension:value-r5		0..1	(Complex)	only for Diagrams or Pictures URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value Constraints: ext-1
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value"
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: Laboratory Code (preferred)
Slices for value[x]	Σ	0..1		Actual component result Slice: Unordered, Closed 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]:valueQuantity	Σ	0..1	QuantityEuLab	Actual component result
Slices for extension				Content/Rules for all slices
extension:uncertainty		0..1	decimal	Standard Deviation (same units as the quantity) URL: http://hl7.org/fhir/StructureDefinition/iso21090-uncertainty
comparator	?!Σ	0..1	code	< | <= | >= | > - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
value[x]:valueString	Σ	0..1	string	Actual component result
value[x]:valueRange	Σ	0..1	RangeEuLab	Actual component result
value[x]:valueRatio	Σ	0..1	RatioEuLab	Actual component result
value[x]:valueTime	Σ	0..1	time	Actual component result
value[x]:valueDateTime	Σ	0..1	dateTime	Actual component result
value[x]:valuePeriod	Σ	0..1	Period	Actual component result
value[x]:valueCodeableConcept	Σ	0..1	CodeableConcept	Actual component result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Laboratory Presence and Absence Findings Preferred Results Microorganism - SNOMED CT IPS Free Set candidate
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.extension:triggeredBy.​extension:type.value[x]	Base	required	Cross-version ValueSet R5.TriggeredBytype for use in FHIR R4	📍0.1.0	Extensions for Using Data Elements from FHIR R5 in FHIR R4 v0.1
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:laboratory	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:studyType	Base	required	Laboratory Study Types	📦2.0.0	This IG
Observation.category:specialty	Base	required	Laboratory Specialty	📦2.0.0	This IG
Observation.code	Base	preferred	Laboratory Code	📦2.0.0	This IG
Observation.value[x]:valueQuantity.​comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	⏿2.0.0	tx.hl7europe.eu
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.method	Base	preferred	Laboratory Techniques	📦2.0.0	This IG
Observation.component.​code	Base	preferred	Laboratory Code	📦2.0.0	This IG
Observation.component.​value[x]:valueQuantity.​comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.component.​value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	⏿2.0.0	tx.hl7europe.eu

Constraints

Id	Grade	Path(s)	Description	Expression
dom-2	error	Observation	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	Observation	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().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	Observation.extension:bodyStructure, Observation.extension:triggeredBy, Observation.extension:triggeredBy.extension, Observation.extension:triggeredBy.extension:observation, Observation.extension:triggeredBy.extension:type, Observation.extension:triggeredBy.extension:reason, Observation.extension:value-r5, Observation.extension:supportingInfo, Observation.extension:labTestKit, Observation.extension:certifiedRefMaterialCodeable, Observation.extension:certifiedRefMaterialIdentifer, Observation.extension:accredited, Observation.modifierExtension, Observation.performer.extension:performerFunction, Observation.value[x]:valueQuantity.extension:uncertainty, Observation.component.extension:value-r5, Observation.component.modifierExtension, Observation.component.value[x]:valueQuantity.extension:uncertainty	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()
obs-value-1	error	Observation	The elements Observation.extension:value-r5 and Observation.value[x] SHALL not be used simultaneously.	value.empty() or extension('http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value').empty()

Differential View

This structure is derived from MedicalTestResultEuCore

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	MedicalTestResultEuCore	Laboratory result for a simple test or for a panel/study Constraints: eu-lab-1, eu-lab-2
Slices for extension				Content/Rules for all slices
extension:supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
extension:labTestKit		0..*	Reference(Device)	Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
extension:certifiedRefMaterialCodeable		0..*	CodeableConcept	Certified Reference Material: CodeableConcept URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example)
extension:certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material: Identifier URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
extension:accredited		0..1	boolean	Accredited test URL: http://hl7.eu/fhir/StructureDefinition/laboratory-accredited
status		1..1	code	Status of this observation (e.g. preliminary, final,...)
Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by pattern:$this
category:laboratory		1..1	CodeableConcept	Classification of type of observation Required Pattern: At least the following
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/observation-category
code		1..1	code	Symbol in syntax defined by the system Fixed Value: laboratory
category:studyType		0..*	CodeableConcept	The way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.) Binding: Laboratory Study Types (required)
category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: Laboratory Specialty (required)
code		1..1	CodeableConcept	Type of observation (code / type) Binding: Laboratory Code (preferred)
focus		0..*	Reference(Patient (EU core) | RelatedPerson: AnimalSpecimen | Group | Device | Location (EU core))	What the observation is about, when it is not about the subject of record
issued		0..1	instant	Date/Time this result was made available
performer		1..*	Reference(Practitioner (EU core) | PractitionerRole (EU core) | Organization (EU core) | Patient (EU core) | RelatedPerson)	Who is responsible for the observation
Slices for value[x]		0..1	Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period	Actual result Slice: Unordered, Closed by type:$this
value[x]:valueQuantity		0..1	QuantityEuLab	Actual result
value[x]:valueString		0..1	string	Actual result
value[x]:valueRange		0..1	RangeEuLab	Actual result
value[x]:valueRatio		0..1	RatioEuLab	Actual result
value[x]:valueTime		0..1	time	Actual result
value[x]:valueDateTime		0..1	dateTime	Actual result
value[x]:valuePeriod		0..1	Period	Actual result
value[x]:valueCodeableConcept		0..1	CodeableConcept	Actual result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Laboratory Presence and Absence Findings Preferred Results Microorganism - SNOMED CT IPS Free Set candidate
dataAbsentReason		0..1	CodeableConcept	Provides a reason why the expected value is missing.
method		0..1	CodeableConcept	How it was done Binding: Laboratory Techniques (preferred)
specimen		0..1	Reference(Specimen: Laboratory)	Specimen used for the 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
code		1..1	CodeableConcept	Type of component observation (code / type) Binding: Laboratory Code (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]:valueQuantity		0..1	QuantityEuLab	Actual component result
value[x]:valueString		0..1	string	Actual component result
value[x]:valueRange		0..1	RangeEuLab	Actual component result
value[x]:valueRatio		0..1	RatioEuLab	Actual component result
value[x]:valueTime		0..1	time	Actual component result
value[x]:valueDateTime		0..1	dateTime	Actual component result
value[x]:valuePeriod		0..1	Period	Actual component result
value[x]:valueCodeableConcept		0..1	CodeableConcept	Actual component result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Laboratory Presence and Absence Findings Preferred Results Microorganism - SNOMED CT IPS Free Set candidate
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.category:studyType	Base	required	Laboratory Study Types	📦2.0.0	This IG
Observation.category:specialty	Base	required	Laboratory Specialty	📦2.0.0	This IG
Observation.code	Base	preferred	Laboratory Code	📦2.0.0	This IG
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	⏿2.0.0	tx.hl7europe.eu
Observation.method	Base	preferred	Laboratory Techniques	📦2.0.0	This IG
Observation.component.​code	Base	preferred	Laboratory Code	📦2.0.0	This IG
Observation.component.​value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	⏿2.0.0	tx.hl7europe.eu

Constraints

Id	Grade	Path(s)	Description	Expression
eu-lab-1	error	Observation	If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component"	(status in ('registered'|'cancelled')) or value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists()
eu-lab-2	error	Observation	If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason"	component.exists() implies (status in ('registered'|'cancelled')) or component.value.exists() or component.dataAbsentReason.exists()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Observation	C	0..*	MedicalTestResultEuCore	Laboratory result for a simple test or for a panel/study Constraints: obs-6, obs-7, obs-value-1, eu-lab-1, eu-lab-2
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 observation Binding: CommonLanguages (preferred): A human language. Additional Bindings Purpose AllLanguages Max Binding
text		0..1	Narrative	Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:bodyStructure		0..1	Reference(Cross-version Profile for R5.BodyStructure for use in FHIR R4(0.1.0) | BodyStructure)	R5: Observed body structure (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.bodyStructure Constraints: ext-1
extension:triggeredBy		0..*	(Complex)	R5: Triggering observation(s) (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
Slices for extension		2..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:observation		1..1	Extension	Extension Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"observation"
value[x]		1..1	Reference(Observation: Medical Test Result (EU core))	Triggering observation
extension:type		1..1	Extension	R5: reflex | repeat | re-run (new) Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"type"
value[x]		1..1	code	reflex | repeat | re-run Binding: R5ObservationTriggeredbytypeForR4 (0.1.0) (required): The type of TriggeredBy Observation.
extension:reason		0..1	Extension	R5: Reason that the observation was triggered (new) Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"reason"
value[x]		0..1	string	Reason that the observation was triggered
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"
extension:value-r5		0..1	(Complex)	only for Diagrams or Pictures URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value"
value[x]		0..1	Attachment	Actual result
extension:supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
extension:labTestKit		0..*	Reference(Device)	Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
extension:certifiedRefMaterialCodeable		0..*	CodeableConcept	Certified Reference Material: CodeableConcept URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example)
extension:certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material: Identifier URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
extension:accredited		0..1	boolean	Accredited test URL: http://hl7.eu/fhir/StructureDefinition/laboratory-accredited
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..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories.
category:laboratory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: 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	Σ	1..1	CodeableConcept	Type of observation (code / type) Binding: Laboratory Code (preferred)
subject	Σ	1..1	Reference(Patient (EU core) | Device | Group | Location)	Who and/or what the observation is about
focus	Σ	0..*	Reference(Patient (EU core) | RelatedPerson: AnimalSpecimen | Group | Device | Location (EU core))	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
effectiveDateTime			dateTime
effectivePeriod			Period
issued	Σ	0..1	instant	Date/Time this result was made available
performer	Σ	1..*	Reference(Practitioner (EU core) | PractitionerRole (EU core) | Organization (EU core) | Patient (EU core) | 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
extension:performerFunction		0..1	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, Closed 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]:valueQuantity	ΣC	0..1	QuantityEuLab	Actual result
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:uncertainty		0..1	decimal	Standard Deviation (same units as the quantity) URL: http://hl7.org/fhir/StructureDefinition/iso21090-uncertainty
value	Σ	0..1	decimal	Numerical value (with implicit precision)
comparator	?!Σ	0..1	code	< | <= | >= | > - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	Σ	0..1	code	Coded form of the unit
value[x]:valueString	ΣC	0..1	string	Actual result
value[x]:valueRange	ΣC	0..1	RangeEuLab	Actual result
value[x]:valueRatio	ΣC	0..1	RatioEuLab	Actual result
value[x]:valueTime	ΣC	0..1	time	Actual result
value[x]:valueDateTime	ΣC	0..1	dateTime	Actual result
value[x]:valuePeriod	ΣC	0..1	Period	Actual result
value[x]:valueCodeableConcept	ΣC	0..1	CodeableConcept	Actual result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Laboratory Presence and Absence Findings Preferred 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..*	CodeableConcept	High, low, normal, etc. 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	CodeableConcept	How it was done Binding: Laboratory Techniques (preferred)
specimen		0..1	Reference(Specimen: Laboratory)	Specimen used for the observation
device		0..1	Reference(Device | DeviceMetric)	Measuring instrument
referenceRange	C	0..*	BackboneElement	Provides guide for interpretation Constraints: obs-3
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
low	C	0..1	SimpleQuantity(4.0.1)	Low Range, if relevant
high	C	0..1	SimpleQuantity(4.0.1)	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(Observation: Medical Test Result (EU core) | ImagingStudy)	Related measurements the observation is made from
component	Σ	0..*	BackboneElement	Laboratory result
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Extension Slice: Unordered, Open by value:url
extension:value-r5		0..1	(Complex)	only for Diagrams or Pictures URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value Constraints: ext-1
id		0..1	string	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1
url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value"
value[x]		0..1	Attachment	Actual result
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized
code	Σ	1..1	CodeableConcept	Type of component observation (code / type) Binding: Laboratory Code (preferred)
Slices for value[x]	Σ	0..1		Actual component result Slice: Unordered, Closed 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]:valueQuantity	Σ	0..1	QuantityEuLab	Actual component result
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:uncertainty		0..1	decimal	Standard Deviation (same units as the quantity) URL: http://hl7.org/fhir/StructureDefinition/iso21090-uncertainty
value	Σ	0..1	decimal	Numerical value (with implicit precision)
comparator	?!Σ	0..1	code	< | <= | >= | > - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
unit	Σ	0..1	string	Unit representation
system	ΣC	0..1	uri	System that defines coded unit form
code	Σ	0..1	code	Coded form of the unit
value[x]:valueString	Σ	0..1	string	Actual component result
value[x]:valueRange	Σ	0..1	RangeEuLab	Actual component result
value[x]:valueRatio	Σ	0..1	RatioEuLab	Actual component result
value[x]:valueTime	Σ	0..1	time	Actual component result
value[x]:valueDateTime	Σ	0..1	dateTime	Actual component result
value[x]:valuePeriod	Σ	0..1	Period	Actual component result
value[x]:valueCodeableConcept	Σ	0..1	CodeableConcept	Actual component result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred) Additional Bindings Purpose Results Blood Group - SNOMED CT IPS Free Set candidate Laboratory Presence and Absence Findings Preferred 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	Status	Usage	ValueSet	Version	Source
Observation.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
Observation.extension:triggeredBy.​extension:type.value[x]	Base	required	Cross-version ValueSet R5.TriggeredBytype for use in FHIR R4	📍0.1.0	Extensions for Using Data Elements from FHIR R5 in FHIR R4 v0.1
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:laboratory	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:studyType	Base	required	Laboratory Study Types	📦2.0.0	This IG
Observation.category:specialty	Base	required	Laboratory Specialty	📦2.0.0	This IG
Observation.code	Base	preferred	Laboratory Code	📦2.0.0	This IG
Observation.performer.​type	Base	extensible	ResourceType	📍4.0.1	FHIR Std.
Observation.value[x]:valueQuantity.​comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	⏿2.0.0	tx.hl7europe.eu
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.
Observation.bodySite	Base	example	SNOMED CT Body Structures	📍4.0.1	FHIR Std.
Observation.method	Base	preferred	Laboratory Techniques	📦2.0.0	This IG
Observation.referenceRange.​type	Base	preferred	Observation Reference Range Meaning Codes	📍4.0.1	FHIR Std.
Observation.referenceRange.​appliesTo	Base	example	Observation Reference Range Applies To Codes	📍4.0.1	FHIR Std.
Observation.component.​code	Base	preferred	Laboratory Code	📦2.0.0	This IG
Observation.component.​value[x]:valueQuantity.​comparator	Base	required	QuantityComparator	📍4.0.1	FHIR Std.
Observation.component.​value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	⏿2.0.0	tx.hl7europe.eu
Observation.component.​dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.component.​interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.

Constraints

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

This structure is derived from MedicalTestResultEuCore

Summary

Mandatory: 2 elements

Structures

This structure refers to these other structures:

• Patient (EU core) (http://hl7.eu/fhir/base/StructureDefinition/patient-eu-core)
• RelatedPerson: AnimalSpecimen (http://hl7.eu/fhir/laboratory/StructureDefinition/animal-specimen-eu-lab)
• Location (EU core) (http://hl7.eu/fhir/base/StructureDefinition/location-eu-core)
• Quantity (Eu Lab) (http://hl7.eu/fhir/laboratory/StructureDefinition/Quantity-eu-lab)
• Range (Eu Lab) (http://hl7.eu/fhir/laboratory/StructureDefinition/Range-eu-lab)
• Ratio (Eu Lab) (http://hl7.eu/fhir/laboratory/StructureDefinition/Ratio-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|5.2.0
• http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
• http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable
• http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
• http://hl7.eu/fhir/StructureDefinition/laboratory-accredited

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