Observation Results: laboratory - HL7 Europe Laboratory Report v2.1.0

This page is part of the HL7 Europe Laboratory Report (v2.1.0: STU 2) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: Observation Results: laboratory

Official URL: http://hl7.eu/fhir/laboratory/StructureDefinition/Observation-resultslab-eu-lab		Version: 2.1.0
Standards status: Trial-use	Maturity Level: 2	Computable Name: ObservationResultsLaboratoryEu
Copyright/Legal: Copyright HL7 Europe. Licensed under creative commons public domain (CC0 1.0).

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.

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.

This profile offers two options to indicate the Certified Reference Material used for the calibration (in general when the UCUM International Units are used for the results [IU]).

The first to be used when the Certified Reference Material is represented by a coded concept

The second when the Certified Reference Material is identified with an Identifier.

Adopters are invited to give their feedback about

The most proper way to refer the Certified Reference Material, that is by using an Identifier or a CodeableConcept

If a CodeableReference should be used

If this information should be an extension of the Observation resource, or of other elements (e.g. DeviceMetric.calibration)

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

Key Elements Table
Differential Table
Snapshot Table
Statistics/References
All

Name	Flags	Card.	Type	Description & Constraints 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
Observation.implicitRules	This element is a modifier element. This element is included in summaries.	0..1	uri	A set of rules under which this content was created
Observation.Slices for extension				Content/Rules for all slices
Observation.Slices for extension.extension:bodyStructure		0..1	Reference(Cross-version Profile for R5.BodyStructure for use in FHIR R4(0.1.0) \| BodyStructure)	R5: Observed body structure (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.bodyStructure Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy		0..*	(Complex)	R5: Triggering observation(s) (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension		2..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension				Content/Rules for all slices
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation		1..1	Extension	Extension Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1 Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.url		1..1	uri	"observation"
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.value[x]		1..1	Reference(Observation: Medical Test Result (EU core))	Triggering observation
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type		1..1	Extension	R5: reflex \| repeat \| re-run (new) Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type.url		1..1	uri	"type"
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type.value[x]		1..1	code	reflex \| repeat \| re-run Binding: R5ObservationTriggeredbytypeForR4 (0.1.0) (required): The type of TriggeredBy Observation.
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:reason		0..1	Extension	R5: Reason that the observation was triggered (new) Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:reason.url		1..1	uri	"reason"
Observation.Slices for extension.extension:triggeredBy.url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"
Observation.Slices for extension.extension:value-r5		0..1	(Complex)	only for Diagrams or Pictures URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value Constraints: ext-1
Observation.Slices for extension.extension:value-r5.extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1 Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.Slices for extension.extension:value-r5.url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value"
Observation.Slices for extension.extension:supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
Observation.Slices for extension.extension:labTestKit		0..*	Reference(Device)	Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
Observation.Slices for extension.extension:certifiedRefMaterialCodeable		0..*	CodeableConcept	Certified Reference Material: CodeableConcept URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example)
Observation.Slices for extension.extension:certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material: Identifier URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
Observation.Slices for extension.extension:accredited		0..1	boolean	Accredited test URL: http://hl7.eu/fhir/StructureDefinition/laboratory-accredited
Observation.Slices for extension.extension:statusReason		0..1	CodeableConcept	Reason for the current status URL: http://hl7.org/fhir/StructureDefinition/event-statusReason Binding Description: (example): Codes identifying the reason for the current state of an event.
Observation.modifierExtension	This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
Observation.status	This element is a modifier element. This element is included in summaries.	1..1	code	Status of this observation (e.g. preliminary, final,...) Binding: ObservationStatus (required): Codes providing the status of an observation.
Observation.Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.Slices for category.category:laboratory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: `{ "coding" : [ { "system" : "http://terminology.hl7.org/CodeSystem/observation-category", "code" : "laboratory" } ] }`
Observation.Slices for category.category:studyType		0..*	CodeableConcept	The way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.) Binding: Laboratory Study Types (required)
Observation.Slices for category.category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: Laboratory Specialty (required)
Observation.code	This element is included in summaries.	1..1	CodeableConcept	Type of observation (code / type) Binding: Laboratory Code (preferred)
Observation.subject	This element is included in summaries.	1..1	Reference(Patient (EU core) \| Device \| Group \| Location)	Who and/or what the observation is about
Observation.focus	This element is included in summaries.	0..*	Reference(Patient (EU core) \| RelatedPerson: AnimalSpecimen \| Group \| Device \| Location (EU core) \| Substance \| BiologicallyDerivedProduct)	What the observation is about, when it is not about the subject of record
Observation.effective[x]	This element is included in summaries.	1..1		Clinically relevant time/time-period for observation
Observation.effective[x].effectiveDateTime			dateTime
Observation.effective[x].effectivePeriod			Period
Observation.issued	This element is included in summaries.	0..1	instant	Date/Time this result was made available
Observation.performer	This element is included in summaries.	1..*	Reference(Practitioner (EU core) \| PractitionerRole (EU core) \| Organization (EU core) \| Patient (EU core) \| RelatedPerson)	Who is responsible for the observation
Observation.performer.Slices for extension				Content/Rules for all slices
Observation.performer.Slices for extension.extension:performerFunction		0..1	CodeableConcept	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: Performer Function Codes (extensible)
Observation.Slices for value[x]	This element is included in summaries. C	0..1		Actual result Slice: Unordered, Closed by type:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.Slices for value[x].valueQuantity			Quantity
Observation.Slices for value[x].valueCodeableConcept			CodeableConcept
Observation.Slices for value[x].valueString			string
Observation.Slices for value[x].valueBoolean			boolean
Observation.Slices for value[x].valueInteger			integer
Observation.Slices for value[x].valueRange			Range
Observation.Slices for value[x].valueRatio			Ratio
Observation.Slices for value[x].valueSampledData			SampledData
Observation.Slices for value[x].valueTime			time
Observation.Slices for value[x].valueDateTime			dateTime
Observation.Slices for value[x].valuePeriod			Period
Observation.Slices for value[x].value[x]:valueQuantity	This element is included in summaries. C	0..1	QuantityEuLab	Actual result
Observation.Slices for value[x].value[x]:valueQuantity.Slices for extension				Content/Rules for all slices
Observation.Slices for value[x].value[x]:valueQuantity.Slices for extension.extension:uncertainty		0..1	decimal	Standard Deviation (same units as the quantity) URL: http://hl7.org/fhir/StructureDefinition/iso21090-uncertainty
Observation.Slices for value[x].value[x]:valueQuantity.comparator	This element is a modifier element. This element is included in summaries.	0..1	code	< \| <= \| >= \| > - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
Observation.Slices for value[x].value[x]:valueString	This element is included in summaries. C	0..1	string	Actual result
Observation.Slices for value[x].value[x]:valueRange	This element is included in summaries. C	0..1	RangeEuLab	Actual result
Observation.Slices for value[x].value[x]:valueRatio	This element is included in summaries. C	0..1	RatioEuLab	Actual result
Observation.Slices for value[x].value[x]:valueTime	This element is included in summaries. C	0..1	time	Actual result
Observation.Slices for value[x].value[x]:valueDateTime	This element is included in summaries. C	0..1	dateTime	Actual result
Observation.Slices for value[x].value[x]:valuePeriod	This element is included in summaries. C	0..1	Period	Actual result
Observation.Slices for value[x].value[x]:valueBoolean	This element is included in summaries. C	0..1	boolean	Actual result
Observation.Slices for value[x].value[x]:valueInteger	This element is included in summaries. C	0..1	integer	Actual result
Observation.Slices for value[x].value[x]:valueSampledData	This element is included in summaries. C	0..1	SampledData	Actual result
Observation.Slices for value[x].value[x]:valueCodeableConcept	This element is included in summaries. C	0..1	CodeableConcept	Actual result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred)
Observation.dataAbsentReason	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.
Observation.method		0..1	CodeableConcept	How it was done Binding: Laboratory Techniques (preferred)
Observation.specimen		0..1	Reference(Specimen: Laboratory)	Specimen used for the observation
Observation.device		0..1	Reference(Device \| DeviceMetric)	Measuring instrument
Observation.referenceRange	C	0..*	BackboneElement	Provides guide for interpretation Constraints: obs-3
Observation.referenceRange.Slices for modifierExtension	This element is a modifier element. This element is included in summaries.	0..*	Extension	Extension Slice: Unordered, Open by value:url Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.referenceRange.Slices for modifierExtension.modifierExtension:lowComparator	This element is a modifier element. This element is included in summaries.	0..1	code	Observation Reference Range Low Comparator URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-reference-range-low-comparator Binding: Reference Range Low Comparator (required)
Observation.referenceRange.Slices for modifierExtension.modifierExtension:highComparator	This element is a modifier element. This element is included in summaries.	0..1	code	Observation Reference Range High Comparator URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-reference-range-high-comparator Binding: Reference Range High Comparator (required)
Observation.hasMember	This element is included in summaries.	0..*	Reference(Observation Results: laboratory)	Related resource that belongs to the Observation group
Observation.component	This element is included in summaries. C	0..*	BackboneElement	Laboratory result Constraints: obs-value-2
Observation.component.Slices for extension				Content/Rules for all slices
Observation.component.Slices for extension.extension:value-r5		0..1	(Complex)	only for Diagrams or Pictures URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value Constraints: ext-1
Observation.component.Slices for extension.extension:value-r5.extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1 Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.component.Slices for extension.extension:value-r5.url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value"
Observation.component.modifierExtension	This element is a modifier element. This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Observation.component.code	This element is included in summaries.	1..1	CodeableConcept	Type of component observation (code / type) Binding: Laboratory Code (preferred)
Observation.component.Slices for value[x]	This element is included in summaries.	0..1		Actual component result Slice: Unordered, Closed by type:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.component.Slices for value[x].valueQuantity			Quantity
Observation.component.Slices for value[x].valueCodeableConcept			CodeableConcept
Observation.component.Slices for value[x].valueString			string
Observation.component.Slices for value[x].valueBoolean			boolean
Observation.component.Slices for value[x].valueInteger			integer
Observation.component.Slices for value[x].valueRange			Range
Observation.component.Slices for value[x].valueRatio			Ratio
Observation.component.Slices for value[x].valueSampledData			SampledData
Observation.component.Slices for value[x].valueTime			time
Observation.component.Slices for value[x].valueDateTime			dateTime
Observation.component.Slices for value[x].valuePeriod			Period
Observation.component.Slices for value[x].value[x]:valueQuantity	This element is included in summaries.	0..1	QuantityEuLab	Actual component result
Observation.component.Slices for value[x].value[x]:valueQuantity.Slices for extension				Content/Rules for all slices
Observation.component.Slices for value[x].value[x]:valueQuantity.Slices for extension.extension:uncertainty		0..1	decimal	Standard Deviation (same units as the quantity) URL: http://hl7.org/fhir/StructureDefinition/iso21090-uncertainty
Observation.component.Slices for value[x].value[x]:valueQuantity.comparator	This element is a modifier element. This element is included in summaries.	0..1	code	< \| <= \| >= \| > - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
Observation.component.Slices for value[x].value[x]:valueString	This element is included in summaries.	0..1	string	Actual component result
Observation.component.Slices for value[x].value[x]:valueRange	This element is included in summaries.	0..1	RangeEuLab	Actual component result
Observation.component.Slices for value[x].value[x]:valueRatio	This element is included in summaries.	0..1	RatioEuLab	Actual component result
Observation.component.Slices for value[x].value[x]:valueTime	This element is included in summaries.	0..1	time	Actual component result
Observation.component.Slices for value[x].value[x]:valueDateTime	This element is included in summaries.	0..1	dateTime	Actual component result
Observation.component.Slices for value[x].value[x]:valuePeriod	This element is included in summaries.	0..1	Period	Actual component result
Observation.component.Slices for value[x].value[x]:valueBoolean	This element is included in summaries.	0..1	boolean	Actual component result
Observation.component.Slices for value[x].value[x]:valueInteger	This element is included in summaries.	0..1	integer	Actual component result
Observation.component.Slices for value[x].value[x]:valueSampledData	This element is included in summaries.	0..1	SampledData	Actual component result
Observation.component.Slices for value[x].value[x]:valueCodeableConcept	This element is included in summaries.	0..1	CodeableConcept	Actual component result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred)
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.extension:triggeredBy.extension:type.value[x]	Base	required	Cross-version ValueSet R5.TriggeredBytype for use in FHIR R4	📍0.1.0	Extensions for Using Data Elements from FHIR R5 in FHIR R4 v0.1
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:laboratory	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:studyType	Base	required	Laboratory Study Types	📦2.1.0	This IG
Observation.category:specialty	Base	required	Laboratory Specialty	📦2.1.0	This IG
Observation.code	Base	preferred	Laboratory Code	📦2.1.0	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	📦2.0.1	International Patient Summary Implementation Guide v2.0
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.method	Base	preferred	Laboratory Techniques	📦2.1.0	This IG
Observation.component.code	Base	preferred	Laboratory Code	📦2.1.0	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	📦2.0.1	International Patient Summary Implementation Guide v2.0

Constraints

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

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
Observation.Slices for extension				Content/Rules for all slices
Observation.Slices for extension.extension:supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
Observation.Slices for extension.extension:labTestKit		0..*	Reference(Device)	Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
Observation.Slices for extension.extension:certifiedRefMaterialCodeable		0..*	CodeableConcept	Certified Reference Material: CodeableConcept URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example)
Observation.Slices for extension.extension:certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material: Identifier URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
Observation.Slices for extension.extension:accredited		0..1	boolean	Accredited test URL: http://hl7.eu/fhir/StructureDefinition/laboratory-accredited
Observation.Slices for extension.extension:statusReason		0..1	CodeableConcept	Reason for the current status URL: http://hl7.org/fhir/StructureDefinition/event-statusReason Binding Description: (example): Codes identifying the reason for the current state of an event.
Observation.status		1..1	code	Status of this observation (e.g. preliminary, final,...)
Observation.Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by pattern:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.Slices for category.category:laboratory		1..1	CodeableConcept	Classification of type of observation Required Pattern: `{ "coding" : [ { "system" : "http://terminology.hl7.org/CodeSystem/observation-category", "code" : "laboratory" } ] }`
Observation.Slices for category.category:studyType		0..*	CodeableConcept	The way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.) Binding: Laboratory Study Types (required)
Observation.Slices for category.category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: Laboratory Specialty (required)
Observation.code		1..1	CodeableConcept	Type of observation (code / type) Binding: Laboratory Code (preferred)
Observation.focus		0..*	Reference(Patient (EU core) \| RelatedPerson: AnimalSpecimen \| Group \| Device \| Location (EU core) \| Substance \| BiologicallyDerivedProduct)	What the observation is about, when it is not about the subject of record
Observation.issued		0..1	instant	Date/Time this result was made available
Observation.performer		1..*	Reference(Practitioner (EU core) \| PractitionerRole (EU core) \| Organization (EU core) \| Patient (EU core) \| RelatedPerson)	Who is responsible for the observation
Observation.Slices for value[x]				Content/Rules for all slices
Observation.Slices for value[x].value[x]:valueQuantity		0..1	QuantityEuLab	Actual result
Observation.Slices for value[x].value[x]:valueString		0..1	string	Actual result
Observation.Slices for value[x].value[x]:valueRange		0..1	RangeEuLab	Actual result
Observation.Slices for value[x].value[x]:valueRatio		0..1	RatioEuLab	Actual result
Observation.Slices for value[x].value[x]:valueTime		0..1	time	Actual result
Observation.Slices for value[x].value[x]:valueDateTime		0..1	dateTime	Actual result
Observation.Slices for value[x].value[x]:valuePeriod		0..1	Period	Actual result
Observation.Slices for value[x].value[x]:valueBoolean		0..1	boolean	Actual result
Observation.Slices for value[x].value[x]:valueInteger		0..1	integer	Actual result
Observation.Slices for value[x].value[x]:valueSampledData		0..1	SampledData	Actual result
Observation.Slices for value[x].value[x]:valueCodeableConcept		0..1	CodeableConcept	Actual result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred)
Observation.dataAbsentReason		0..1	CodeableConcept	Provides a reason why the expected value is missing.
Observation.method		0..1	CodeableConcept	How it was done Binding: Laboratory Techniques (preferred)
Observation.specimen		0..1	Reference(Specimen: Laboratory)	Specimen used for the observation
Observation.device		0..1	Reference(Device \| DeviceMetric)	Measuring instrument
Observation.referenceRange		0..*	BackboneElement	Provides guide for interpretation
Observation.referenceRange.Slices for modifierExtension		0..*	Extension	Extension Slice: Unordered, Open by value:url Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.referenceRange.Slices for modifierExtension.modifierExtension:lowComparator		0..1	code	Observation Reference Range Low Comparator URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-reference-range-low-comparator Binding: Reference Range Low Comparator (required)
Observation.referenceRange.Slices for modifierExtension.modifierExtension:highComparator		0..1	code	Observation Reference Range High Comparator URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-reference-range-high-comparator Binding: Reference Range High Comparator (required)
Observation.hasMember		0..*	Reference(Observation Results: laboratory)	Related resource that belongs to the Observation group
Observation.component		0..*	BackboneElement	Laboratory result
Observation.component.code		1..1	CodeableConcept	Type of component observation (code / type) Binding: Laboratory Code (preferred)
Observation.component.Slices for value[x]				Content/Rules for all slices
Observation.component.Slices for value[x].value[x]:valueQuantity		0..1	QuantityEuLab	Actual component result
Observation.component.Slices for value[x].value[x]:valueString		0..1	string	Actual component result
Observation.component.Slices for value[x].value[x]:valueRange		0..1	RangeEuLab	Actual component result
Observation.component.Slices for value[x].value[x]:valueRatio		0..1	RatioEuLab	Actual component result
Observation.component.Slices for value[x].value[x]:valueTime		0..1	time	Actual component result
Observation.component.Slices for value[x].value[x]:valueDateTime		0..1	dateTime	Actual component result
Observation.component.Slices for value[x].value[x]:valuePeriod		0..1	Period	Actual component result
Observation.component.Slices for value[x].value[x]:valueBoolean		0..1	boolean	Actual component result
Observation.component.Slices for value[x].value[x]:valueInteger		0..1	integer	Actual component result
Observation.component.Slices for value[x].value[x]:valueSampledData		0..1	SampledData	Actual component result
Observation.component.Slices for value[x].value[x]:valueCodeableConcept		0..1	CodeableConcept	Actual component result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred)
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.category:studyType	Base	required	Laboratory Study Types	📦2.1.0	This IG
Observation.category:specialty	Base	required	Laboratory Specialty	📦2.1.0	This IG
Observation.code	Base	preferred	Laboratory Code	📦2.1.0	This IG
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	📦2.0.1	International Patient Summary Implementation Guide v2.0
Observation.method	Base	preferred	Laboratory Techniques	📦2.1.0	This IG
Observation.component.code	Base	preferred	Laboratory Code	📦2.1.0	This IG
Observation.component.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	📦2.0.1	International Patient Summary Implementation Guide v2.0

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 with an actual value: "value", the R5 "value[x]" extension, "dataAbsentReason", "hasMember" or "component"	`(status in ('registered'\|'cancelled')) or value.hasValue() or value.children().exclude(value.extension).exists() or extension.where(url='http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value').value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists()`
eu-lab-2	error	Observation	If observation status is other then "registered" or "cancelled", every Observation.component shall provide one of these elements with an actual value: "value", the R5 "component.value[x]" extension or "dataAbsentReason"	`(status in ('registered'\|'cancelled')) or component.all(value.hasValue() or value.children().exclude(value.extension).exists() or extension.where(url='http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value').value.exists() or dataAbsentReason.exists())`

Description & Constraints Filter:

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

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

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

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

language

0..1

code

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

Additional Bindings

Purpose

AllLanguages

Max Binding

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

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

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

Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them

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

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

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

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

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

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

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

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

Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them

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

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

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

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

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

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

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

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

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

Observation.identifier This element is included in summaries. 0..* Identifier Business Identifier for observation

Observation.status This element is a modifier element. This element is included in summaries. 1..1 code Status of this observation (e.g. preliminary, final,...)
Binding: ObservationStatus (required): Codes providing the status of an observation.

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

Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them

category:laboratory

1..1

CodeableConcept

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

Required Pattern:

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

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

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

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

Observation.subject This element is included in summaries. 1..1 Reference(Patient (EU core) | Device | Group | Location) Who and/or what the observation is about

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

Observation.effective[x] This element is included in summaries. 1..1 Clinically relevant time/time-period for observation

Observation.effective[x].effectiveDateTime dateTime

Observation.effective[x].effectivePeriod Period

Observation.issued This element is included in summaries. 0..1 instant Date/Time this result was made available

Observation.performer This element is included in summaries. 1..* Reference(Practitioner (EU core) | PractitionerRole (EU core) | Organization (EU core) | Patient (EU core) | RelatedPerson) Who is responsible for the observation

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

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

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

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

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

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

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

Observation.Slices for value[x] This element is included in summaries. C 0..1 Actual result
Slice: Unordered, Closed by type:$this
Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them

Observation.Slices for value[x].valueQuantity Quantity

Observation.Slices for value[x].valueCodeableConcept CodeableConcept

Observation.Slices for value[x].valueString string

Observation.Slices for value[x].valueBoolean boolean

Observation.Slices for value[x].valueInteger integer

Observation.Slices for value[x].valueRange Range

Observation.Slices for value[x].valueRatio Ratio

Observation.Slices for value[x].valueSampledData SampledData

Observation.Slices for value[x].valueTime time

Observation.Slices for value[x].valueDateTime dateTime

Observation.Slices for value[x].valuePeriod Period

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Observation.dataAbsentReason 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.

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

Observation.note 0..* Annotation Comments about the observation

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

Observation.method 0..1 CodeableConcept How it was done
Binding: Laboratory Techniques (preferred)

Observation.specimen 0..1 Reference(Specimen: Laboratory) Specimen used for the observation

Observation.device 0..1 Reference(Device | DeviceMetric) Measuring instrument

Observation.referenceRange C 0..* BackboneElement Provides guide for interpretation
Constraints: obs-3

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

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

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

Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them

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

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

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

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

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

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

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

Observation.referenceRange.text 0..1 string Text based reference range in an observation

Observation.hasMember This element is included in summaries. 0..* Reference(Observation Results: laboratory) Related resource that belongs to the Observation group

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

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

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

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

Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them

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

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

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

Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them

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

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

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

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

Observation.component.Slices for value[x] This element is included in summaries. 0..1 Actual component result
Slice: Unordered, Closed by type:$this
Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
Observation.extension:triggeredBy.extension:type.value[x]	Base	required	Cross-version ValueSet R5.TriggeredBytype for use in FHIR R4	📍0.1.0	Extensions for Using Data Elements from FHIR R5 in FHIR R4 v0.1
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:laboratory	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:studyType	Base	required	Laboratory Study Types	📦2.1.0	This IG
Observation.category:specialty	Base	required	Laboratory Specialty	📦2.1.0	This IG
Observation.code	Base	preferred	Laboratory Code	📦2.1.0	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	📦2.0.1	International Patient Summary Implementation Guide v2.0
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.
Observation.bodySite	Base	example	SNOMED CT Body Structures	📍4.0.1	FHIR Std.
Observation.method	Base	preferred	Laboratory Techniques	📦2.1.0	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	📦2.1.0	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	📦2.0.1	International Patient Summary Implementation Guide v2.0
Observation.component.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.component.interpretation	Base	extensible	Observation Interpretation Codes	📍4.0.1	FHIR Std.

Constraints

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

This structure is derived from MedicalTestResultEuCore

Summary

Mandatory: 2 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

The element 1 is sliced based on the value of Observation.category

Maturity: 2

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
Observation.implicitRules	This element is a modifier element. This element is included in summaries.	0..1	uri	A set of rules under which this content was created
Observation.Slices for extension				Content/Rules for all slices
Observation.Slices for extension.extension:bodyStructure		0..1	Reference(Cross-version Profile for R5.BodyStructure for use in FHIR R4(0.1.0) \| BodyStructure)	R5: Observed body structure (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.bodyStructure Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy		0..*	(Complex)	R5: Triggering observation(s) (new) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension		2..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension				Content/Rules for all slices
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation		1..1	Extension	Extension Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1 Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.url		1..1	uri	"observation"
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:observation.value[x]		1..1	Reference(Observation: Medical Test Result (EU core))	Triggering observation
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type		1..1	Extension	R5: reflex \| repeat \| re-run (new) Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type.url		1..1	uri	"type"
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:type.value[x]		1..1	code	reflex \| repeat \| re-run Binding: R5ObservationTriggeredbytypeForR4 (0.1.0) (required): The type of TriggeredBy Observation.
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:reason		0..1	Extension	R5: Reason that the observation was triggered (new) Constraints: ext-1
Observation.Slices for extension.extension:triggeredBy.Slices for extension.extension:reason.url		1..1	uri	"reason"
Observation.Slices for extension.extension:triggeredBy.url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"
Observation.Slices for extension.extension:value-r5		0..1	(Complex)	only for Diagrams or Pictures URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value Constraints: ext-1
Observation.Slices for extension.extension:value-r5.extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1 Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.Slices for extension.extension:value-r5.url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value"
Observation.Slices for extension.extension:supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
Observation.Slices for extension.extension:labTestKit		0..*	Reference(Device)	Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
Observation.Slices for extension.extension:certifiedRefMaterialCodeable		0..*	CodeableConcept	Certified Reference Material: CodeableConcept URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example)
Observation.Slices for extension.extension:certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material: Identifier URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
Observation.Slices for extension.extension:accredited		0..1	boolean	Accredited test URL: http://hl7.eu/fhir/StructureDefinition/laboratory-accredited
Observation.Slices for extension.extension:statusReason		0..1	CodeableConcept	Reason for the current status URL: http://hl7.org/fhir/StructureDefinition/event-statusReason Binding Description: (example): Codes identifying the reason for the current state of an event.
Observation.modifierExtension	This element is a modifier element.	0..*	Extension	Extensions that cannot be ignored
Observation.status	This element is a modifier element. This element is included in summaries.	1..1	code	Status of this observation (e.g. preliminary, final,...) Binding: ObservationStatus (required): Codes providing the status of an observation.
Observation.Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by pattern:$this Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.Slices for category.category:laboratory		1..1	CodeableConcept	Classification of type of observation Binding: ObservationCategoryCodes (preferred): Codes for high level observation categories. Required Pattern: `{ "coding" : [ { "system" : "http://terminology.hl7.org/CodeSystem/observation-category", "code" : "laboratory" } ] }`
Observation.Slices for category.category:studyType		0..*	CodeableConcept	The way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.) Binding: Laboratory Study Types (required)
Observation.Slices for category.category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: Laboratory Specialty (required)
Observation.code	This element is included in summaries.	1..1	CodeableConcept	Type of observation (code / type) Binding: Laboratory Code (preferred)
Observation.subject	This element is included in summaries.	1..1	Reference(Patient (EU core) \| Device \| Group \| Location)	Who and/or what the observation is about
Observation.focus	This element is included in summaries.	0..*	Reference(Patient (EU core) \| RelatedPerson: AnimalSpecimen \| Group \| Device \| Location (EU core) \| Substance \| BiologicallyDerivedProduct)	What the observation is about, when it is not about the subject of record
Observation.effective[x]	This element is included in summaries.	1..1		Clinically relevant time/time-period for observation
Observation.effective[x].effectiveDateTime			dateTime
Observation.effective[x].effectivePeriod			Period
Observation.issued	This element is included in summaries.	0..1	instant	Date/Time this result was made available
Observation.performer	This element is included in summaries.	1..*	Reference(Practitioner (EU core) \| PractitionerRole (EU core) \| Organization (EU core) \| Patient (EU core) \| RelatedPerson)	Who is responsible for the observation
Observation.performer.Slices for extension				Content/Rules for all slices
Observation.performer.Slices for extension.extension:performerFunction		0..1	CodeableConcept	Type of performance URL: http://hl7.org/fhir/StructureDefinition/event-performerFunction Binding: Performer Function Codes (extensible)
Observation.Slices for value[x]	This element is included in summaries. C	0..1		Actual result Slice: Unordered, Closed by type:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.Slices for value[x].valueQuantity			Quantity
Observation.Slices for value[x].valueCodeableConcept			CodeableConcept
Observation.Slices for value[x].valueString			string
Observation.Slices for value[x].valueBoolean			boolean
Observation.Slices for value[x].valueInteger			integer
Observation.Slices for value[x].valueRange			Range
Observation.Slices for value[x].valueRatio			Ratio
Observation.Slices for value[x].valueSampledData			SampledData
Observation.Slices for value[x].valueTime			time
Observation.Slices for value[x].valueDateTime			dateTime
Observation.Slices for value[x].valuePeriod			Period
Observation.Slices for value[x].value[x]:valueQuantity	This element is included in summaries. C	0..1	QuantityEuLab	Actual result
Observation.Slices for value[x].value[x]:valueQuantity.Slices for extension				Content/Rules for all slices
Observation.Slices for value[x].value[x]:valueQuantity.Slices for extension.extension:uncertainty		0..1	decimal	Standard Deviation (same units as the quantity) URL: http://hl7.org/fhir/StructureDefinition/iso21090-uncertainty
Observation.Slices for value[x].value[x]:valueQuantity.comparator	This element is a modifier element. This element is included in summaries.	0..1	code	< \| <= \| >= \| > - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
Observation.Slices for value[x].value[x]:valueString	This element is included in summaries. C	0..1	string	Actual result
Observation.Slices for value[x].value[x]:valueRange	This element is included in summaries. C	0..1	RangeEuLab	Actual result
Observation.Slices for value[x].value[x]:valueRatio	This element is included in summaries. C	0..1	RatioEuLab	Actual result
Observation.Slices for value[x].value[x]:valueTime	This element is included in summaries. C	0..1	time	Actual result
Observation.Slices for value[x].value[x]:valueDateTime	This element is included in summaries. C	0..1	dateTime	Actual result
Observation.Slices for value[x].value[x]:valuePeriod	This element is included in summaries. C	0..1	Period	Actual result
Observation.Slices for value[x].value[x]:valueBoolean	This element is included in summaries. C	0..1	boolean	Actual result
Observation.Slices for value[x].value[x]:valueInteger	This element is included in summaries. C	0..1	integer	Actual result
Observation.Slices for value[x].value[x]:valueSampledData	This element is included in summaries. C	0..1	SampledData	Actual result
Observation.Slices for value[x].value[x]:valueCodeableConcept	This element is included in summaries. C	0..1	CodeableConcept	Actual result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred)
Observation.dataAbsentReason	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.
Observation.method		0..1	CodeableConcept	How it was done Binding: Laboratory Techniques (preferred)
Observation.specimen		0..1	Reference(Specimen: Laboratory)	Specimen used for the observation
Observation.device		0..1	Reference(Device \| DeviceMetric)	Measuring instrument
Observation.referenceRange	C	0..*	BackboneElement	Provides guide for interpretation Constraints: obs-3
Observation.referenceRange.Slices for modifierExtension	This element is a modifier element. This element is included in summaries.	0..*	Extension	Extension Slice: Unordered, Open by value:url Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.referenceRange.Slices for modifierExtension.modifierExtension:lowComparator	This element is a modifier element. This element is included in summaries.	0..1	code	Observation Reference Range Low Comparator URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-reference-range-low-comparator Binding: Reference Range Low Comparator (required)
Observation.referenceRange.Slices for modifierExtension.modifierExtension:highComparator	This element is a modifier element. This element is included in summaries.	0..1	code	Observation Reference Range High Comparator URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-reference-range-high-comparator Binding: Reference Range High Comparator (required)
Observation.hasMember	This element is included in summaries.	0..*	Reference(Observation Results: laboratory)	Related resource that belongs to the Observation group
Observation.component	This element is included in summaries. C	0..*	BackboneElement	Laboratory result Constraints: obs-value-2
Observation.component.Slices for extension				Content/Rules for all slices
Observation.component.Slices for extension.extension:value-r5		0..1	(Complex)	only for Diagrams or Pictures URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value Constraints: ext-1
Observation.component.Slices for extension.extension:value-r5.extension		0..0		Extension Slice: Unordered, Open by value:url Constraints: ext-1 Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.component.Slices for extension.extension:value-r5.url		1..1	uri	"http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value"
Observation.component.modifierExtension	This element is a modifier element. This element is included in summaries.	0..*	Extension	Extensions that cannot be ignored even if unrecognized
Observation.component.code	This element is included in summaries.	1..1	CodeableConcept	Type of component observation (code / type) Binding: Laboratory Code (preferred)
Observation.component.Slices for value[x]	This element is included in summaries.	0..1		Actual component result Slice: Unordered, Closed by type:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.component.Slices for value[x].valueQuantity			Quantity
Observation.component.Slices for value[x].valueCodeableConcept			CodeableConcept
Observation.component.Slices for value[x].valueString			string
Observation.component.Slices for value[x].valueBoolean			boolean
Observation.component.Slices for value[x].valueInteger			integer
Observation.component.Slices for value[x].valueRange			Range
Observation.component.Slices for value[x].valueRatio			Ratio
Observation.component.Slices for value[x].valueSampledData			SampledData
Observation.component.Slices for value[x].valueTime			time
Observation.component.Slices for value[x].valueDateTime			dateTime
Observation.component.Slices for value[x].valuePeriod			Period
Observation.component.Slices for value[x].value[x]:valueQuantity	This element is included in summaries.	0..1	QuantityEuLab	Actual component result
Observation.component.Slices for value[x].value[x]:valueQuantity.Slices for extension				Content/Rules for all slices
Observation.component.Slices for value[x].value[x]:valueQuantity.Slices for extension.extension:uncertainty		0..1	decimal	Standard Deviation (same units as the quantity) URL: http://hl7.org/fhir/StructureDefinition/iso21090-uncertainty
Observation.component.Slices for value[x].value[x]:valueQuantity.comparator	This element is a modifier element. This element is included in summaries.	0..1	code	< \| <= \| >= \| > - how to understand the value Binding: QuantityComparator (required): How the Quantity should be understood and represented.
Observation.component.Slices for value[x].value[x]:valueString	This element is included in summaries.	0..1	string	Actual component result
Observation.component.Slices for value[x].value[x]:valueRange	This element is included in summaries.	0..1	RangeEuLab	Actual component result
Observation.component.Slices for value[x].value[x]:valueRatio	This element is included in summaries.	0..1	RatioEuLab	Actual component result
Observation.component.Slices for value[x].value[x]:valueTime	This element is included in summaries.	0..1	time	Actual component result
Observation.component.Slices for value[x].value[x]:valueDateTime	This element is included in summaries.	0..1	dateTime	Actual component result
Observation.component.Slices for value[x].value[x]:valuePeriod	This element is included in summaries.	0..1	Period	Actual component result
Observation.component.Slices for value[x].value[x]:valueBoolean	This element is included in summaries.	0..1	boolean	Actual component result
Observation.component.Slices for value[x].value[x]:valueInteger	This element is included in summaries.	0..1	integer	Actual component result
Observation.component.Slices for value[x].value[x]:valueSampledData	This element is included in summaries.	0..1	SampledData	Actual component result
Observation.component.Slices for value[x].value[x]:valueCodeableConcept	This element is included in summaries.	0..1	CodeableConcept	Actual component result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred)
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Observation.extension:triggeredBy.extension:type.value[x]	Base	required	Cross-version ValueSet R5.TriggeredBytype for use in FHIR R4	📍0.1.0	Extensions for Using Data Elements from FHIR R5 in FHIR R4 v0.1
Observation.status	Base	required	ObservationStatus	📍4.0.1	FHIR Std.
Observation.category	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:laboratory	Base	preferred	Observation Category Codes	📍4.0.1	FHIR Std.
Observation.category:studyType	Base	required	Laboratory Study Types	📦2.1.0	This IG
Observation.category:specialty	Base	required	Laboratory Specialty	📦2.1.0	This IG
Observation.code	Base	preferred	Laboratory Code	📦2.1.0	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	📦2.0.1	International Patient Summary Implementation Guide v2.0
Observation.dataAbsentReason	Base	extensible	DataAbsentReason	📍4.0.1	FHIR Std.
Observation.method	Base	preferred	Laboratory Techniques	📦2.1.0	This IG
Observation.component.code	Base	preferred	Laboratory Code	📦2.1.0	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	📦2.0.1	International Patient Summary Implementation Guide v2.0

Constraints

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

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
Observation.Slices for extension				Content/Rules for all slices
Observation.Slices for extension.extension:supportingInfo		0..*	Reference(Resource)	Other information that may be relevant to this event. URL: http://hl7.org/fhir/StructureDefinition/workflow-supportingInfo
Observation.Slices for extension.extension:labTestKit		0..*	Reference(Device)	Laboratory Test Kit URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-deviceLabTestKit
Observation.Slices for extension.extension:certifiedRefMaterialCodeable		0..*	CodeableConcept	Certified Reference Material: CodeableConcept URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialCodeable Binding: Laboratory Certified Reference Material (example)
Observation.Slices for extension.extension:certifiedRefMaterialIdentifer		0..*	Identifier	Certified Reference Material: Identifier URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-certifiedRefMaterialIdentifer
Observation.Slices for extension.extension:accredited		0..1	boolean	Accredited test URL: http://hl7.eu/fhir/StructureDefinition/laboratory-accredited
Observation.Slices for extension.extension:statusReason		0..1	CodeableConcept	Reason for the current status URL: http://hl7.org/fhir/StructureDefinition/event-statusReason Binding Description: (example): Codes identifying the reason for the current state of an event.
Observation.status		1..1	code	Status of this observation (e.g. preliminary, final,...)
Observation.Slices for category		1..*	CodeableConcept	Classification of type of observation Slice: Unordered, Open by pattern:$this Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.Slices for category.category:laboratory		1..1	CodeableConcept	Classification of type of observation Required Pattern: `{ "coding" : [ { "system" : "http://terminology.hl7.org/CodeSystem/observation-category", "code" : "laboratory" } ] }`
Observation.Slices for category.category:studyType		0..*	CodeableConcept	The way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.) Binding: Laboratory Study Types (required)
Observation.Slices for category.category:specialty		0..*	CodeableConcept	The clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry) Binding: Laboratory Specialty (required)
Observation.code		1..1	CodeableConcept	Type of observation (code / type) Binding: Laboratory Code (preferred)
Observation.focus		0..*	Reference(Patient (EU core) \| RelatedPerson: AnimalSpecimen \| Group \| Device \| Location (EU core) \| Substance \| BiologicallyDerivedProduct)	What the observation is about, when it is not about the subject of record
Observation.issued		0..1	instant	Date/Time this result was made available
Observation.performer		1..*	Reference(Practitioner (EU core) \| PractitionerRole (EU core) \| Organization (EU core) \| Patient (EU core) \| RelatedPerson)	Who is responsible for the observation
Observation.Slices for value[x]				Content/Rules for all slices
Observation.Slices for value[x].value[x]:valueQuantity		0..1	QuantityEuLab	Actual result
Observation.Slices for value[x].value[x]:valueString		0..1	string	Actual result
Observation.Slices for value[x].value[x]:valueRange		0..1	RangeEuLab	Actual result
Observation.Slices for value[x].value[x]:valueRatio		0..1	RatioEuLab	Actual result
Observation.Slices for value[x].value[x]:valueTime		0..1	time	Actual result
Observation.Slices for value[x].value[x]:valueDateTime		0..1	dateTime	Actual result
Observation.Slices for value[x].value[x]:valuePeriod		0..1	Period	Actual result
Observation.Slices for value[x].value[x]:valueBoolean		0..1	boolean	Actual result
Observation.Slices for value[x].value[x]:valueInteger		0..1	integer	Actual result
Observation.Slices for value[x].value[x]:valueSampledData		0..1	SampledData	Actual result
Observation.Slices for value[x].value[x]:valueCodeableConcept		0..1	CodeableConcept	Actual result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred)
Observation.dataAbsentReason		0..1	CodeableConcept	Provides a reason why the expected value is missing.
Observation.method		0..1	CodeableConcept	How it was done Binding: Laboratory Techniques (preferred)
Observation.specimen		0..1	Reference(Specimen: Laboratory)	Specimen used for the observation
Observation.device		0..1	Reference(Device \| DeviceMetric)	Measuring instrument
Observation.referenceRange		0..*	BackboneElement	Provides guide for interpretation
Observation.referenceRange.Slices for modifierExtension		0..*	Extension	Extension Slice: Unordered, Open by value:url Slicing Note: The rules on this element (including its children) apply to all the slices, but are not repeated in them
Observation.referenceRange.Slices for modifierExtension.modifierExtension:lowComparator		0..1	code	Observation Reference Range Low Comparator URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-reference-range-low-comparator Binding: Reference Range Low Comparator (required)
Observation.referenceRange.Slices for modifierExtension.modifierExtension:highComparator		0..1	code	Observation Reference Range High Comparator URL: http://hl7.eu/fhir/laboratory/StructureDefinition/observation-reference-range-high-comparator Binding: Reference Range High Comparator (required)
Observation.hasMember		0..*	Reference(Observation Results: laboratory)	Related resource that belongs to the Observation group
Observation.component		0..*	BackboneElement	Laboratory result
Observation.component.code		1..1	CodeableConcept	Type of component observation (code / type) Binding: Laboratory Code (preferred)
Observation.component.Slices for value[x]				Content/Rules for all slices
Observation.component.Slices for value[x].value[x]:valueQuantity		0..1	QuantityEuLab	Actual component result
Observation.component.Slices for value[x].value[x]:valueString		0..1	string	Actual component result
Observation.component.Slices for value[x].value[x]:valueRange		0..1	RangeEuLab	Actual component result
Observation.component.Slices for value[x].value[x]:valueRatio		0..1	RatioEuLab	Actual component result
Observation.component.Slices for value[x].value[x]:valueTime		0..1	time	Actual component result
Observation.component.Slices for value[x].value[x]:valueDateTime		0..1	dateTime	Actual component result
Observation.component.Slices for value[x].value[x]:valuePeriod		0..1	Period	Actual component result
Observation.component.Slices for value[x].value[x]:valueBoolean		0..1	boolean	Actual component result
Observation.component.Slices for value[x].value[x]:valueInteger		0..1	integer	Actual component result
Observation.component.Slices for value[x].value[x]:valueSampledData		0..1	SampledData	Actual component result
Observation.component.Slices for value[x].value[x]:valueCodeableConcept		0..1	CodeableConcept	Actual component result Binding: Results Coded Values Laboratory/Pathology - IPS (preferred)
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Observation.category:studyType	Base	required	Laboratory Study Types	📦2.1.0	This IG
Observation.category:specialty	Base	required	Laboratory Specialty	📦2.1.0	This IG
Observation.code	Base	preferred	Laboratory Code	📦2.1.0	This IG
Observation.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	📦2.0.1	International Patient Summary Implementation Guide v2.0
Observation.method	Base	preferred	Laboratory Techniques	📦2.1.0	This IG
Observation.component.code	Base	preferred	Laboratory Code	📦2.1.0	This IG
Observation.component.value[x]:valueCodeableConcept	Base	preferred	Results Coded Values Laboratory/Pathology - IPS	📦2.0.1	International Patient Summary Implementation Guide v2.0

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 with an actual value: "value", the R5 "value[x]" extension, "dataAbsentReason", "hasMember" or "component"	`(status in ('registered'\|'cancelled')) or value.hasValue() or value.children().exclude(value.extension).exists() or extension.where(url='http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value').value.exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists()`
eu-lab-2	error	Observation	If observation status is other then "registered" or "cancelled", every Observation.component shall provide one of these elements with an actual value: "value", the R5 "component.value[x]" extension or "dataAbsentReason"	`(status in ('registered'\|'cancelled')) or component.all(value.hasValue() or value.children().exclude(value.extension).exists() or extension.where(url='http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value').value.exists() or dataAbsentReason.exists())`

Snapshot View