NHS North West Genomics
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NHS North West Genomics - Local Development build (v2.2.5) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: Observation - Detailed Descriptions

Draft as of 2026-11-05

Definitions for the Observation resource profile

See the documentation on how to interpret the contents of this table

0. Observation
Definition

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 references the atomic results of the study as "has-member" child observations


Measurements and simple assertions made about a patient, device or other subject.

ShortLaboratory result for a simple test or for a panel/studyMeasurements and simple assertions
Comments

Represents either a lab simple observation or the group of observations produced by a laboratory study.


Used for simple observations such as device measurements, laboratory atomic results, vital signs, height, weight, smoking status, comments, etc. Other resources are used to provide context for observations such as laboratory reports, etc.

Control0..*
Is Modifierfalse
Summaryfalse
Alternate NamesVital Signs, Measurement, Results, Tests
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
obs-value-1: 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())
eu-lab-1: 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: 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()))
obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
2. Observation.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. Observation.extension:bodyStructure
Slice NamebodyStructure
Definition

R5: Observation.bodyStructure (new:Reference(BodyStructure))

ShortR5: Observed body structure (new)
Comments

Element Observation.bodyStructure has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.bodyStructure has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). Only used if not implicit in code found in Observation.code or bodySite is used. In many systems, this may be represented as a related observation instead of an inline component.

Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(Extension UK Core Observation Body Structure) (Extension Type: Reference(BodyStructure))
Is Modifierfalse
Summaryfalse
Requirements

EHDSObservation.anatomicLocation

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. Observation.extension:triggeredBy
Slice NametriggeredBy
Definition

R5: Observation.triggeredBy (new:BackboneElement)

ShortR5: Triggering observation(s) (new)
Comments

Element Observation.triggeredBy has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension(Extension UK Core Observation Triggered By) (Complex Extension)
Is Modifierfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
8. Observation.extension:triggeredBy.extension
Definition

An Extension


May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortExtensionAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control20..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Observation.extension.extension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
10. Observation.extension:triggeredBy.extension:observation
Slice Nameobservation
Definition

An Extension

ShortExtensionAdditional content defined by implementations
Control10..1*
TypeExtension
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
12. Observation.extension:triggeredBy.extension:observation.extension
Definition

An Extension


May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortExtensionAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..0*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Observation.extension.extension.extension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
14. Observation.extension:triggeredBy.extension:observation.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Shortidentifies the meaning of the extension
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Control1..1
Typeuri
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
Fixed Value
{
  "url" : "observation"
}
<url value="observation"/>
16. Observation.extension:triggeredBy.extension:observation.value[x]
Definition

Reference to the triggering observation.


Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

ShortTriggering observationValue of extension
Control10..1
TypeReference(Observation: Medical Test Result (EU core)), date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Summaryfalse
Requirements

EHDSObservation.triggeredBy[x]

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
18. Observation.extension:triggeredBy.extension:type
Slice Nametype
Definition

R5: Observation.triggeredBy.type (new:code)

ShortR5: reflex | repeat | re-run (new)Additional content defined by implementations
Comments

Element Observation.triggeredBy.type is part of an existing definition because parent element Observation.triggeredBy requires a cross-version extension. Element Observation.triggeredBy.type has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy.type has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control10..1*
TypeExtension
Is Modifierfalse
Summaryfalse
Requirements

Element Observation.triggeredBy.type is part of an existing definition because parent element Observation.triggeredBy requires a cross-version extension. Element Observation.triggeredBy.type has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy.type has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
20. Observation.extension:triggeredBy.extension:type.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Shortidentifies the meaning of the extension
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Control1..1
Typeuri
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
Fixed Value
{
  "url" : "type"
}
<url value="type"/>
22. Observation.extension:triggeredBy.extension:type.value[x]
Definition

The type of trigger. Reflex | Repeat | Re-run.


Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

Shortreflex | repeat | re-runValue of extension
Control10..1
BindingThe codes SHALL be taken from For codes, see R5ObservationTriggeredbytypeForR4 (0.1.0)
(required to http://hl7.org/fhir/uv/xver/ValueSet/R5-observation-triggeredbytype-for-R4|0.1.0)

The type of TriggeredBy Observation.

Typecode, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
[x] NoteSeeChoice of Data Typesfor further information about how to use [x]
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. Observation.extension:triggeredBy.extension:reason
Slice Namereason
Definition

R5: Observation.triggeredBy.reason (new:string)

ShortR5: Reason that the observation was triggered (new)Additional content defined by implementations
Comments

Element Observation.triggeredBy.reason is part of an existing definition because parent element Observation.triggeredBy requires a cross-version extension. Element Observation.triggeredBy.reason has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy.reason has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Control0..1*
TypeExtension
Is Modifierfalse
Summaryfalse
Requirements

Element Observation.triggeredBy.reason is part of an existing definition because parent element Observation.triggeredBy requires a cross-version extension. Element Observation.triggeredBy.reason has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy.reason has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
26. Observation.extension:triggeredBy.extension:reason.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Shortidentifies the meaning of the extension
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Control1..1
Typeuri
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
Fixed Value
{
  "url" : "reason"
}
<url value="reason"/>
28. Observation.extension:triggeredBy.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Shortidentifies the meaning of the extension
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Control1..1
Typeuri
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
Fixed Value
{
  "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"
}
<url value="http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"/>
30. Observation.extension:triggeredBy.value[x]
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

ShortValue of extension
Control0..01
TypeChoice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. Observation.extension:value-r5
Slice Namevalue-r5
Definition

When the result is a Diagram or Picture (Microbiology), then the Attachment data type should be used. In FHIR R4 this can be done by preadopting the R5 Observation.value[x] element using the cross-version extension.

Shortonly for Diagrams or Pictures
Comments

Element Observation.value[x] is mapped to FHIR R4 element Observation.value[x] as SourceIsBroaderThanTarget. The mappings for Observation.value[x] do not cover the following types: Attachment, Reference. The target context Observation.value[x] is a choice-type element and cannot directly hold extensions. The context is moved up to parent element Observation.

  • An observation may have:
    1. a single value here
    2. both a value and a set of related or component values
    3. only a set of related or component values.
  • If a value is present, the datatype for this element should be determined by the code.
  • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
  • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
  • The usage of valueReference is restricted to the MolecularSequence resource when used as a definitional resource, not as a patient-specific finding. .
  • For additional guidance, see the Notes section below.
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(R5: value additional types) (Extension Type: Choice of: Attachment, Reference(Cross-version Profile for R5.MolecularSequence for use in FHIR R4, MolecularSequence))
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
34. Observation.extension:value-r5.extension
Definition

An Extension


May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortExtensionAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..0*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on Observation.extension.extension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
36. Observation.extension:value-r5.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Shortidentifies the meaning of the extension
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Control1..1
Typeuri
Is Modifierfalse
XML FormatIn the XML format, this property is represented as an attribute.
Summaryfalse
Fixed Value
{
  "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value"
}
<url value="http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value"/>
38. Observation.extension:supportingInfo
Slice NamesupportingInfo
Definition

Other resources from the patient record that may be relevant to the event. The information from these resources was either used to create the instance or is provided to help with its interpretation. This extension should not be used if more specific inline elements or extensions are available. For example, use Observation.hasMember instead of supportingInformation for representing the members of an Observation panel.

ShortOther information that may be relevant to this event.
Control0..*
TypeExtension(Supporting info) (Extension Type: Reference(Resource))
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
40. Observation.extension:labTestKit
Slice NamelabTestKit
Definition

The laboratory test kit used for this test.

ShortLaboratory Test Kit
Control0..*
TypeExtension(Device Laboratory Test Kit) (Extension Type: Reference(Device))
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
42. Observation.extension:certifiedRefMaterialCodeable
Slice NamecertifiedRefMaterialCodeable
Definition

This extension links this observation with the certified reference material used for the calibration. The certified reference material is identified by using a CodeableConcept. This extension should be used when the unit is UCUM [IU].

ShortCertified Reference Material: CodeableConcept
Control0..*
TypeExtension(Certified Reference Material: CodeableConcept) (Extension Type: CodeableConcept)
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
44. Observation.extension:certifiedRefMaterialIdentifer
Slice NamecertifiedRefMaterialIdentifer
Definition

This extension links this observation with the certified reference material used for the calibration. The certified reference material is identified by using an Identifier. This extension should be used when the unit is UCUM [IU].

ShortCertified Reference Material: Identifier
Control0..*
TypeExtension(Certified Reference Material: Identifier) (Extension Type: Identifier)
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
46. Observation.extension:accredited
Slice Nameaccredited
Definition

Indicates that this laboratory test was/is accredited.

ShortAccredited test
Control0..1
TypeExtension(Many: Laboratory Accredited) (Extension Type: boolean)
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
48. Observation.extension:statusReason
Slice NamestatusReason
Definition

Captures the reason for the current state of this observation, which is of interest whenever the result was withdrawn or revised.

ShortReason for the current status
Comments

This is generally only used for "exception" statuses such as "not-done", "suspended" or "cancelled". The reason for performing the event at all is captured in reasonCode, not here. (distinct reason codes for different statuses can be enforced using invariants if they are universal bindings).

Control0..1
TypeExtension(Event status reason) (Extension Type: CodeableConcept)
Is Modifierfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
50. Observation.modifierExtension
Definition

May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Summaryfalse
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
52. Observation.identifier
Definition

A unique identifier assigned to this observation.

ShortBusiness Identifier for observation
NoteThis is a business identifier, not a resource identifier (see discussion)
Control10..*
TypeIdentifier
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

EHDSObservation.header.identifier


Allows observations to be distinguished and referenced.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. Observation.status
Definition

The status of the result value.

ShortObservation Status (HL7 v2 OBX-11)registered | preliminary | final | amended +
Comments

The statuses amended, corrected, cancelled and entered-in-error SHOULD be accompanied by the reason for that status, conveyed in the statusReason extension.


This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

Control1..1
BindingThe codes SHALL be taken from ObservationStatushttp://hl7.org/fhir/ValueSet/observation-status|4.0.1
(required to http://hl7.org/fhir/ValueSet/observation-status|4.0.1)

Codes providing the status of an observation.

Typecode
Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

EHDSObservation.header.status


Need to track the status of individual results. Some results are finalized before the whole report is finalized.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. Observation.category
Definition

A code that classifies the general type of observation being made.

ShortClassification of type of observation
Comments

"laboratory" includes laboratory medicine and pathology


In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

Control10..*
BindingThe codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
(preferred to http://hl7.org/fhir/ValueSet/observation-category|4.0.1)

Codes for high level observation categories.

TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

Used for filtering what observations are retrieved and displayed.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on Observation.category. The slices are Unordered and Open, and can be differentiated using the following discriminators:
  • pattern @ $this
58. Observation.category:laboratory
Slice Namelaboratory
Definition

A code that classifies the general type of observation being made.

ShortClassification of type of observation
Comments

In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

Control10..1*
BindingThe codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
(preferred to http://hl7.org/fhir/ValueSet/observation-category|4.0.1)

Codes for high level observation categories.

TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

Used for filtering what observations are retrieved and displayed.

Pattern Value
{
  "coding" : [
    {
      "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
      "code" : "laboratory"
    }
  ]
}
<category>
  <coding>
    <system value="http://terminology.hl7.org/CodeSystem/observation-category"/>
    <code value="laboratory"/>
  </coding>
</category>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
60. Observation.category:studyType
Slice NamestudyType
Definition

A code that classifies the general type of observation being made.

ShortThe way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.)Classification of type of observation
Comments

In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

Control0..*
BindingThe codes SHALL be taken from The codes SHOULD be taken from Laboratory Study Typeshttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
(required to http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab)
TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

Used for filtering what observations are retrieved and displayed.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. Observation.category:specialty
Slice Namespecialty
Definition

A code that classifies the general type of observation being made.

ShortThe clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry)Classification of type of observation
Comments

In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

Control0..*
BindingThe codes SHALL be taken from The codes SHOULD be taken from Laboratory Specialtyhttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
(required to http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab)
TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

Used for filtering what observations are retrieved and displayed.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
64. Observation.category:geCategory
Slice NamegeCategory
Definition

A code that classifies the general type of observation being made.

ShortClassification of type of observation
Comments

In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

Control0..1*
BindingThe codes SHOULD be taken from ObservationCategoryCodeshttp://hl7.org/fhir/ValueSet/observation-category|4.0.1
(preferred to http://hl7.org/fhir/ValueSet/observation-category|4.0.1)

Codes for high level observation categories.

TypeCodeableConcept
Is Modifierfalse
Summaryfalse
Requirements

Used for filtering what observations are retrieved and displayed.

Pattern Value
{
  "coding" : [
    {
      "system" : "http://terminology.hl7.org/CodeSystem/v2-0074",
      "code" : "GE"
    }
  ]
}
<category>
  <coding>
    <system value="http://terminology.hl7.org/CodeSystem/v2-0074"/>
    <code value="GE"/>
  </coding>
</category>
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
66. Observation.code
Definition

Describes what was observed. Sometimes this is called the observation "name". In this profile this code represents either a simple laboratory test or a laboratory study with multiple child observations


Describes what was observed. Sometimes this is called the observation "name".

ShortThe type of observation (code / type). (HL7 v2 OBX-3)Type of observation (code / type)
Comments

In the context of this Observation-laboratory profile, when the observation plays the role of a grouper of member sub-observations, the code represent the group (for instance a panel code). In case no code is available, at least a text shall be provided.


All code-value and, if present, component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

Control1..1
BindingThe codes SHOULD be taken from For example codes, see Laboratory Codehttp://hl7.org/fhir/ValueSet/observation-codes|4.0.1
(preferred to http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab)
TypeCodeableConcept
Is Modifierfalse
Summarytrue
Requirements

EHDSObservation.code


Knowing what kind of observation is being made is essential to understanding the observation.

Alternate NamesName
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. Observation.subject
Definition

The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.

ShortWho and/or what the observation is about
Comments

One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

Control10..1
TypeReference(Patient, Patient, Group, Device, Location)
Is Modifierfalse
Summarytrue
Requirements

EHDSObservation.header.subject


Observations have no value if you don't know who or what they're about.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
70. Observation.subject.reference
Definition

A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

ShortLiteral reference, Relative, internal or absolute URL
Comments

Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

Control10..1
This element is affected by the following invariants: ref-1
Typestring
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
72. Observation.subject.identifier
Definition

An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

ShortLogical reference, when literal reference is not known
Comments

When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
TypeIdentifier(NHS Identifier)
Is Modifierfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
74. Observation.encounter
Definition

The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.

ShortHealthcare event during which this observation is made
Comments

This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

Control0..1
TypeReference(Encounter)
Is Modifierfalse
Must Supporttrue
Summarytrue
Requirements

For some observations it may be important to know the link between an observation and a particular encounter.

Alternate NamesContext
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
76. Observation.encounter.identifier
Definition

An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

ShortLogical reference, when literal reference is not known
Comments

When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
TypeIdentifier(Correlation Identifier)
Is Modifierfalse
Obligations
    ObligationsActor
    SHALL:populate-if-knownOrder Filler
    SHALL:populate-if-knownOrder Placer
    SHALL:populate-if-knownAutomation Manager
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    78. Observation.effective[x]
    Definition

    The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

    ShortClinically relevant time/time-period for observation (HL7 v2 OBX-14)
    Comments

    At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

    Control10..1
    TypeChoice of: dateTime, Period, Timing, instant
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Obligations
      ObligationsActor
      SHOULD:populate-if-knownOrder Filler
      SHOULD:populate-if-knownOrder Placer
      SHOULD:populate-if-knownAutomation Manager
      Summarytrue
      Requirements

      EHDSObservation.observationDate[x]


      Knowing when an observation was deemed true is important to its relevance as well as determining trends.

      Alternate NamesOccurrence
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      80. Observation.performer
      Definition

      Who was responsible for asserting the observed value as "true".

      ShortWho is responsible for the observation
      Control10..*
      TypeReference(PractitionerRole, Practitioner, PractitionerRole, Organization, CareTeam, Patient, RelatedPerson)
      Is Modifierfalse
      Summarytrue
      Requirements

      EHDSObservation.header.performer


      May give a degree of confidence in the observation and also indicates where follow-up questions should be directed.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      82. Observation.performer.extension:performerFunction
      Slice NameperformerFunction
      Definition

      Distinguishes the type of involvement of the performer in the event. For example, 'author', 'verifier' or 'responsible party'.

      ShortType of performance
      Comments

      If a Practitioner(Role) is involved in multiple roles, the Practitioner(Role) has to be added multiple times.

      Control0..1
      TypeExtension(Performer function) (Extension Type: CodeableConcept)
      Is Modifierfalse
      Summaryfalse
      Requirements

      EHDSObservation.performer.function

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      84. Observation.value[x]
      Definition

      The information determined as a result of making the observation, if the information has a simple value.

      ShortActual result (HL7 v2 OBX-5)
      Comments

      An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

      Control0..1
      This element is affected by the following invariants: obs-7
      TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      EHDSObservation.result.value[x]


      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      SlicingThis element introduces a set of slices on Observation.value[x]. The slices are Unordered and Closed, and can be differentiated using the following discriminators:
      • type @ $this
      86. Observation.value[x]:valueQuantity
      Slice NamevalueQuantity
      Definition

      The information determined as a result of making the observation, if the information has a simple value.

      ShortActual result
      Comments

      An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

      Control0..1
      This element is affected by the following invariants: obs-7
      TypeQuantity(Quantity (Eu Lab)), dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range, CodeableConcept
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      88. Observation.value[x]:valueQuantity.extension:uncertainty
      Slice Nameuncertainty
      Definition

      The primary measure of variance/uncertainty of the value (the square root of the sum of the squares of the differences between all data points and the mean).

      ShortStandard Deviation (same units as the quantity)
      Comments

      standardDeviation has the same units as the quantity. It is used to normalize the data for computing the distribution function. Applications that cannot deal with probability distributions can still get an idea about the confidence level by looking at standardDeviation.

      Control0..1
      TypeExtension(Uncertainty) (Extension Type: decimal)
      Is Modifierfalse
      Summaryfalse
      Requirements

      EHDSObservation.result.uncertainty

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      90. Observation.value[x]:valueQuantity.comparator
      Definition

      How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

      Short< | <= | >= | > - how to understand the value
      Control0..1
      BindingThe codes SHALL be taken from QuantityComparatorhttp://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1
      (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

      How the Quantity should be understood and represented.

      Typecode
      Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

      Meaning if MissingIf there is no comparator, then there is no modification of the value
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      92. Observation.value[x]:valueString
      Slice NamevalueString
      Definition

      The information determined as a result of making the observation, if the information has a simple value.

      ShortActual result
      Comments

      An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

      Control0..1
      This element is affected by the following invariants: obs-7
      Typestring, dateTime, boolean, SampledData, Quantity, Period, Ratio, integer, time, Range, CodeableConcept
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      Requirements

      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      94. Observation.value[x]:valueDateTime
      Slice NamevalueDateTime
      Definition

      The information determined as a result of making the observation, if the information has a simple value.

      ShortActual result
      Comments

      An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

      Control0..1
      This element is affected by the following invariants: obs-7
      TypedateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range, CodeableConcept
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supporttrue
      Summarytrue
      Requirements

      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      96. Observation.value[x]:valueCodeableConcept
      Slice NamevalueCodeableConcept
      Definition

      The information determined as a result of making the observation, if the information has a simple value.

      ShortActual result
      Comments

      An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

      Control0..1
      This element is affected by the following invariants: obs-7
      BindingThe codes SHOULD be taken from For codes, see Results Coded Values Laboratory/Pathology - IPS
      (preferred to http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-pathology-uv-ips)
      TypeCodeableConcept, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, Range
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Must Supporttrue
      Summarytrue
      Requirements

      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      98. Observation.value[x]:valueRange
      Slice NamevalueRange
      Definition

      The information determined as a result of making the observation, if the information has a simple value.

      ShortActual result
      Comments

      An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

      Control0..1
      This element is affected by the following invariants: obs-7
      TypeRange(Range (Eu Lab)), dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, time, CodeableConcept
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Summarytrue
      Requirements

      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      100. Observation.value[x]:valueRatio
      Slice NamevalueRatio
      Definition

      The information determined as a result of making the observation, if the information has a simple value.

      ShortActual result
      Comments

      An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

      Control0..1
      This element is affected by the following invariants: obs-7
      TypeRatio(Ratio (Eu Lab)), dateTime, boolean, string, SampledData, Quantity, Period, integer, time, Range, CodeableConcept
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Summarytrue
      Requirements

      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      102. Observation.value[x]:valueTime
      Slice NamevalueTime
      Definition

      The information determined as a result of making the observation, if the information has a simple value.

      ShortActual result
      Comments

      An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

      Control0..1
      This element is affected by the following invariants: obs-7
      Typetime, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, integer, Range, CodeableConcept
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      104. Observation.value[x]:valuePeriod
      Slice NamevaluePeriod
      Definition

      The information determined as a result of making the observation, if the information has a simple value.

      ShortActual result
      Comments

      An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

      Control0..1
      This element is affected by the following invariants: obs-7
      TypePeriod, dateTime, boolean, string, SampledData, Quantity, Ratio, integer, time, Range, CodeableConcept
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Summarytrue
      Requirements

      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      106. Observation.value[x]:valueBoolean
      Slice NamevalueBoolean
      Definition

      The information determined as a result of making the observation, if the information has a simple value.

      ShortActual result
      Comments

      An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

      Control0..1
      This element is affected by the following invariants: obs-7
      Typeboolean, dateTime, string, SampledData, Quantity, Period, Ratio, integer, time, Range, CodeableConcept
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      108. Observation.value[x]:valueInteger
      Slice NamevalueInteger
      Definition

      The information determined as a result of making the observation, if the information has a simple value.

      ShortActual result
      Comments

      An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

      Control0..1
      This element is affected by the following invariants: obs-7
      Typeinteger, dateTime, boolean, string, SampledData, Quantity, Period, Ratio, time, Range, CodeableConcept
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      110. Observation.value[x]:valueSampledData
      Slice NamevalueSampledData
      Definition

      The information determined as a result of making the observation, if the information has a simple value.

      ShortActual result
      Comments

      An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

      Control0..1
      This element is affected by the following invariants: obs-7
      TypeSampledData, dateTime, boolean, string, Quantity, Period, Ratio, integer, time, Range, CodeableConcept
      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
      Is Modifierfalse
      Summarytrue
      Requirements

      An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      112. Observation.referenceRange
      Definition

      Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two referenceRange elements would be used.

      ShortProvides guide for interpretation
      Comments

      Reference-range bounds are inclusive when no comparator is present. Use lowComparator or highComparator to state the comparator for an exclusive or explicitly inclusive bound. These modifier extensions pre-adopt the comparator on the reference-range bounds introduced in FHIR R6.


      Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

      Control0..*
      TypeBackboneElement
      Is Modifierfalse
      Must Supporttrue
      Summaryfalse
      Requirements

      EHDSObservation.referenceRange


      Knowing what values are considered "normal" can help evaluate the significance of a particular result. Need to be able to provide multiple reference ranges for different contexts.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
      obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
      114. Observation.referenceRange.modifierExtension
      Definition

      An Extension


      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

      ShortExtensionExtensions that cannot be ignored even if unrecognized
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..*
      TypeExtension
      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
      Summarytrue
      Requirements

      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

      Alternate Namesextensions, user content, modifiers
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      SlicingThis element introduces a set of slices on Observation.referenceRange.modifierExtension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      116. Observation.referenceRange.modifierExtension:lowComparator
      Slice NamelowComparator
      Definition

      The comparator for Observation.referenceRange.low. This modifier extension pre-adopts the R6 comparator on the low reference-range bound.

      ShortObservation Reference Range Low Comparator
      Control0..1
      This element is affected by the following invariants: ele-1
      TypeExtension(Observation Reference Range Low Comparator) (Extension Type: code)
      Is Modifiertrue because Changes the interpretation of Observation.referenceRange.low by stating whether the bound is inclusive or exclusive.
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      118. Observation.referenceRange.modifierExtension:highComparator
      Slice NamehighComparator
      Definition

      The comparator for Observation.referenceRange.high. This modifier extension pre-adopts the R6 comparator on the high reference-range bound.

      ShortObservation Reference Range High Comparator
      Control0..1
      This element is affected by the following invariants: ele-1
      TypeExtension(Observation Reference Range High Comparator) (Extension Type: code)
      Is Modifiertrue because Changes the interpretation of Observation.referenceRange.high by stating whether the bound is inclusive or exclusive.
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      120. Observation.derivedFrom
      Definition

      The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

      ShortRelated measurements the observation is made from
      Comments

      All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see Notes below.

      Control0..*
      TypeReference(Observation: Medical Test Result (EU core), ImagingStudy, DocumentReference, ImagingStudy, Media, QuestionnaireResponse, Observation, MolecularSequence)
      Is Modifierfalse
      Summarytrue
      Requirements

      EHDSObservation.derivedFrom[x]

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      SlicingThis element introduces a set of slices on Observation.derivedFrom. The slices are Unordered and Open, and can be differentiated using the following discriminators:
      • profile @ resolve()

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

      See the documentation on how to interpret the contents of this table

      0. Observation
      2. Observation.identifier
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control1..?
      Must Supporttrue
      4. Observation.status
      ShortObservation Status (HL7 v2 OBX-11)
      6. Observation.category:geCategory
      Slice NamegeCategory
      Control0..1
      Pattern Value
      {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/v2-0074",
            "code" : "GE"
          }
        ]
      }
      <category>
        <coding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0074"/>
          <code value="GE"/>
        </coding>
      </category>
      8. Observation.code
      ShortThe type of observation (code / type). (HL7 v2 OBX-3)
      10. Observation.subject
      TypeReference(Patient)
      12. Observation.subject.reference
      Control1..?
      Must Supporttrue
      14. Observation.subject.identifier
      NoteThis is a business identifier, not a resource identifier (see discussion)
      TypeIdentifier(NHS Identifier)
      16. Observation.encounter
      Must Supporttrue
      18. Observation.encounter.identifier
      NoteThis is a business identifier, not a resource identifier (see discussion)
      TypeIdentifier(Correlation Identifier)
      Obligations
        ObligationsActor
        SHALL:populate-if-knownOrder Filler
        SHALL:populate-if-knownOrder Placer
        SHALL:populate-if-knownAutomation Manager
        20. Observation.effective[x]
        ShortClinically relevant time/time-period for observation (HL7 v2 OBX-14)
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Obligations
          ObligationsActor
          SHOULD:populate-if-knownOrder Filler
          SHOULD:populate-if-knownOrder Placer
          SHOULD:populate-if-knownAutomation Manager
          22. Observation.performer
          TypeReference(PractitionerRole)
          24. Observation.value[x]
          ShortActual result (HL7 v2 OBX-5)
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          26. Observation.value[x]:valueQuantity
          Slice NamevalueQuantity
          TypeQuantity(Quantity (Eu Lab))
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Must Supporttrue
          28. Observation.value[x]:valueString
          Slice NamevalueString
          Typestring
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          30. Observation.value[x]:valueDateTime
          Slice NamevalueDateTime
          TypedateTime
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          32. Observation.value[x]:valueCodeableConcept
          Slice NamevalueCodeableConcept
          TypeCodeableConcept
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Must Supporttrue
          34. Observation.referenceRange
          Must Supporttrue
          36. Observation.derivedFrom
          SlicingThis element introduces a set of slices on Observation.derivedFrom. The slices are Unordered and Open, and can be differentiated using the following discriminators:
          • profile @ resolve()

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

          See the documentation on how to interpret the contents of this table

          0. Observation
          Definition

          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 references the atomic results of the study as "has-member" child observations

          ShortLaboratory result for a simple test or for a panel/study
          Comments

          Represents either a lab simple observation or the group of observations produced by a laboratory study.

          Control0..*
          Is Modifierfalse
          Summaryfalse
          Alternate NamesVital Signs, Measurement, Results, Tests
          Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
          dom-3: 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: 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: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
          dom-6: A resource should have narrative for robust management (text.`div`.exists())
          obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
          obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
          obs-value-1: 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())
          eu-lab-1: 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: 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()))
          2. Observation.id
          Definition

          The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

          ShortLogical id of this artifact
          Comments

          The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

          Control0..1
          Typeid
          Is Modifierfalse
          Summarytrue
          4. Observation.meta
          Definition

          The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

          ShortMetadata about the resource
          Control0..1
          TypeMeta
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          6. Observation.implicitRules
          Definition

          A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

          ShortA set of rules under which this content was created
          Comments

          Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.

          Control0..1
          Typeuri
          Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          8. Observation.language
          Definition

          The base language in which the resource is written.

          ShortLanguage of the observation
          Comments

          Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

          Control0..1
          BindingThe codes SHOULD be taken from CommonLanguages
          (preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)

          A human language.

          Additional BindingsPurpose
          AllLanguagesMax Binding
          Typecode
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          10. Observation.text
          Definition

          A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

          ShortText summary of the resource, for human interpretation
          Comments

          Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

          Control0..1
          TypeNarrative
          Is Modifierfalse
          Summaryfalse
          Alternate Namesnarrative, html, xhtml, display
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          12. Observation.contained
          Definition

          These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

          ShortContained, inline Resources
          Comments

          This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.

          Control0..*
          TypeResource
          Is Modifierfalse
          Summaryfalse
          Alternate Namesinline resources, anonymous resources, contained resources
          14. Observation.extension
          Definition

          An Extension

          ShortExtension
          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on Observation.extension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          16. Observation.extension:bodyStructure
          Slice NamebodyStructure
          Definition

          R5: Observation.bodyStructure (new:Reference(BodyStructure))

          ShortR5: Observed body structure (new)
          Comments

          Element Observation.bodyStructure has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.bodyStructure has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element). Only used if not implicit in code found in Observation.code or bodySite is used. In many systems, this may be represented as a related observation instead of an inline component.

          Control0..1
          This element is affected by the following invariants: ele-1
          TypeExtension(Extension UK Core Observation Body Structure) (Extension Type: Reference(BodyStructure))
          Is Modifierfalse
          Summaryfalse
          Requirements

          EHDSObservation.anatomicLocation

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          18. Observation.extension:triggeredBy
          Slice NametriggeredBy
          Definition

          R5: Observation.triggeredBy (new:BackboneElement)

          ShortR5: Triggering observation(s) (new)
          Comments

          Element Observation.triggeredBy has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

          Control0..*
          This element is affected by the following invariants: ele-1
          TypeExtension(Extension UK Core Observation Triggered By) (Complex Extension)
          Is Modifierfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          20. Observation.extension:triggeredBy.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          22. Observation.extension:triggeredBy.extension
          Definition

          An Extension

          ShortExtension
          Control2..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on Observation.extension.extension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          24. Observation.extension:triggeredBy.extension:observation
          Slice Nameobservation
          Definition

          An Extension

          ShortExtension
          Control1..1
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          26. Observation.extension:triggeredBy.extension:observation.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          28. Observation.extension:triggeredBy.extension:observation.extension
          Definition

          An Extension

          ShortExtension
          Control0..0
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on Observation.extension.extension.extension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          30. Observation.extension:triggeredBy.extension:observation.url
          Definition

          Source of the definition for the extension code - a logical name or a URL.

          Shortidentifies the meaning of the extension
          Comments

          The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

          Control1..1
          Typeuri
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          Fixed Value
          {
            "url" : "observation"
          }
          <url value="observation"/>
          32. Observation.extension:triggeredBy.extension:observation.value[x]
          Definition

          Reference to the triggering observation.

          ShortTriggering observation
          Control1..1
          TypeReference(Observation: Medical Test Result (EU core))
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Summaryfalse
          Requirements

          EHDSObservation.triggeredBy[x]

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          34. Observation.extension:triggeredBy.extension:type
          Slice Nametype
          Definition

          R5: Observation.triggeredBy.type (new:code)

          ShortR5: reflex | repeat | re-run (new)
          Comments

          Element Observation.triggeredBy.type is part of an existing definition because parent element Observation.triggeredBy requires a cross-version extension. Element Observation.triggeredBy.type has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy.type has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

          Control1..1
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Requirements

          Element Observation.triggeredBy.type is part of an existing definition because parent element Observation.triggeredBy requires a cross-version extension. Element Observation.triggeredBy.type has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy.type has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          36. Observation.extension:triggeredBy.extension:type.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          38. Observation.extension:triggeredBy.extension:type.extension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on Observation.extension.extension.extension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          40. Observation.extension:triggeredBy.extension:type.url
          Definition

          Source of the definition for the extension code - a logical name or a URL.

          Shortidentifies the meaning of the extension
          Comments

          The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

          Control1..1
          Typeuri
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          Fixed Value
          {
            "url" : "type"
          }
          <url value="type"/>
          42. Observation.extension:triggeredBy.extension:type.value[x]
          Definition

          The type of trigger. Reflex | Repeat | Re-run.

          Shortreflex | repeat | re-run
          Control1..1
          BindingThe codes SHALL be taken from R5ObservationTriggeredbytypeForR4 (0.1.0)
          (required to http://hl7.org/fhir/uv/xver/ValueSet/R5-observation-triggeredbytype-for-R4|0.1.0)

          The type of TriggeredBy Observation.

          Typecode
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          44. Observation.extension:triggeredBy.extension:reason
          Slice Namereason
          Definition

          R5: Observation.triggeredBy.reason (new:string)

          ShortR5: Reason that the observation was triggered (new)
          Comments

          Element Observation.triggeredBy.reason is part of an existing definition because parent element Observation.triggeredBy requires a cross-version extension. Element Observation.triggeredBy.reason has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy.reason has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

          Control0..1
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Requirements

          Element Observation.triggeredBy.reason is part of an existing definition because parent element Observation.triggeredBy requires a cross-version extension. Element Observation.triggeredBy.reason has a context of Observation based on following the parent source element upwards and mapping to Observation. Element Observation.triggeredBy.reason has no mapping targets in FHIR R4. Typically, this is because the element has been added (is a new element).

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          46. Observation.extension:triggeredBy.extension:reason.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          48. Observation.extension:triggeredBy.extension:reason.extension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on Observation.extension.extension.extension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          50. Observation.extension:triggeredBy.extension:reason.url
          Definition

          Source of the definition for the extension code - a logical name or a URL.

          Shortidentifies the meaning of the extension
          Comments

          The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

          Control1..1
          Typeuri
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          Fixed Value
          {
            "url" : "reason"
          }
          <url value="reason"/>
          52. Observation.extension:triggeredBy.extension:reason.value[x]
          Definition

          Provides the reason why this observation was performed as a result of the observation(s) referenced.

          ShortReason that the observation was triggered
          Control0..1
          Typestring
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          54. Observation.extension:triggeredBy.url
          Definition

          Source of the definition for the extension code - a logical name or a URL.

          Shortidentifies the meaning of the extension
          Comments

          The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

          Control1..1
          Typeuri
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          Fixed Value
          {
            "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"
          }
          <url value="http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.triggeredBy"/>
          56. Observation.extension:triggeredBy.value[x]
          Definition

          Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

          ShortValue of extension
          Control0..0
          TypeChoice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          58. Observation.extension:value-r5
          Slice Namevalue-r5
          Definition

          When the result is a Diagram or Picture (Microbiology), then the Attachment data type should be used. In FHIR R4 this can be done by preadopting the R5 Observation.value[x] element using the cross-version extension.

          Shortonly for Diagrams or Pictures
          Comments

          Element Observation.value[x] is mapped to FHIR R4 element Observation.value[x] as SourceIsBroaderThanTarget. The mappings for Observation.value[x] do not cover the following types: Attachment, Reference. The target context Observation.value[x] is a choice-type element and cannot directly hold extensions. The context is moved up to parent element Observation.

          • An observation may have:
            1. a single value here
            2. both a value and a set of related or component values
            3. only a set of related or component values.
          • If a value is present, the datatype for this element should be determined by the code.
          • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
          • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
          • The usage of valueReference is restricted to the MolecularSequence resource when used as a definitional resource, not as a patient-specific finding. .
          • For additional guidance, see the Notes section below.
          Control0..1
          This element is affected by the following invariants: ele-1
          TypeExtension(R5: value additional types) (Extension Type: Choice of: Attachment, Reference(Cross-version Profile for R5.MolecularSequence for use in FHIR R4, MolecularSequence))
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          60. Observation.extension:value-r5.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          62. Observation.extension:value-r5.extension
          Definition

          An Extension

          ShortExtension
          Control0..0
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on Observation.extension.extension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          64. Observation.extension:value-r5.url
          Definition

          Source of the definition for the extension code - a logical name or a URL.

          Shortidentifies the meaning of the extension
          Comments

          The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

          Control1..1
          Typeuri
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          Fixed Value
          {
            "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value"
          }
          <url value="http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value"/>
          66. Observation.extension:value-r5.value[x]
          Definition

          The information determined as a result of making the observation, if the information has a simple value.

          ShortActual result
          Comments
          • An observation may have:
            1. a single value here
            2. both a value and a set of related or component values
            3. only a set of related or component values.
          • If a value is present, the datatype for this element should be determined by the code.
          • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
          • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
          • The usage of valueReference is restricted to the MolecularSequence resource when used as a definitional resource, not as a patient-specific finding. .
          • For additional guidance, see the Notes section below.
          Control0..1
          TypeAttachment
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          68. Observation.extension:supportingInfo
          Slice NamesupportingInfo
          Definition

          Other resources from the patient record that may be relevant to the event. The information from these resources was either used to create the instance or is provided to help with its interpretation. This extension should not be used if more specific inline elements or extensions are available. For example, use Observation.hasMember instead of supportingInformation for representing the members of an Observation panel.

          ShortOther information that may be relevant to this event.
          Control0..*
          TypeExtension(Supporting info) (Extension Type: Reference(Resource))
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          70. Observation.extension:labTestKit
          Slice NamelabTestKit
          Definition

          The laboratory test kit used for this test.

          ShortLaboratory Test Kit
          Control0..*
          TypeExtension(Device Laboratory Test Kit) (Extension Type: Reference(Device))
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          72. Observation.extension:certifiedRefMaterialCodeable
          Slice NamecertifiedRefMaterialCodeable
          Definition

          This extension links this observation with the certified reference material used for the calibration. The certified reference material is identified by using a CodeableConcept. This extension should be used when the unit is UCUM [IU].

          ShortCertified Reference Material: CodeableConcept
          Control0..*
          TypeExtension(Certified Reference Material: CodeableConcept) (Extension Type: CodeableConcept)
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          74. Observation.extension:certifiedRefMaterialIdentifer
          Slice NamecertifiedRefMaterialIdentifer
          Definition

          This extension links this observation with the certified reference material used for the calibration. The certified reference material is identified by using an Identifier. This extension should be used when the unit is UCUM [IU].

          ShortCertified Reference Material: Identifier
          Control0..*
          TypeExtension(Certified Reference Material: Identifier) (Extension Type: Identifier)
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          76. Observation.extension:accredited
          Slice Nameaccredited
          Definition

          Indicates that this laboratory test was/is accredited.

          ShortAccredited test
          Control0..1
          TypeExtension(Many: Laboratory Accredited) (Extension Type: boolean)
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          78. Observation.extension:statusReason
          Slice NamestatusReason
          Definition

          Captures the reason for the current state of this observation, which is of interest whenever the result was withdrawn or revised.

          ShortReason for the current status
          Comments

          This is generally only used for "exception" statuses such as "not-done", "suspended" or "cancelled". The reason for performing the event at all is captured in reasonCode, not here. (distinct reason codes for different statuses can be enforced using invariants if they are universal bindings).

          Control0..1
          TypeExtension(Event status reason) (Extension Type: CodeableConcept)
          Is Modifierfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          80. Observation.modifierExtension
          Definition

          May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

          Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

          ShortExtensions that cannot be ignored
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
          Summaryfalse
          Requirements

          Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          82. Observation.identifier
          Definition

          A unique identifier assigned to this observation.

          ShortBusiness Identifier for observation
          NoteThis is a business identifier, not a resource identifier (see discussion)
          Control1..*
          TypeIdentifier
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Requirements

          EHDSObservation.header.identifier

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          84. Observation.basedOn
          Definition

          A plan, proposal or order that is fulfilled in whole or in part by this event. For example, a MedicationRequest may require a patient to have laboratory test performed before it is dispensed.

          ShortFulfills plan, proposal or order
          Control0..*
          TypeReference(CarePlan, DeviceRequest, ImmunizationRecommendation, MedicationRequest, NutritionOrder, ServiceRequest)
          Is Modifierfalse
          Summarytrue
          Requirements

          EHDSObservation.order

          Alternate NamesFulfills
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          86. Observation.partOf
          Definition

          A larger event of which this particular Observation is a component or step. For example, an observation as part of a procedure.

          ShortPart of referenced event
          Comments

          To link an Observation to an Encounter use encounter. See the Notes below for guidance on referencing another Observation.

          Control0..*
          TypeReference(MedicationAdministration, MedicationDispense, MedicationStatement, Procedure, Immunization, ImagingStudy)
          Is Modifierfalse
          Summarytrue
          Alternate NamesContainer
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          88. Observation.status
          Definition

          The status of the result value.

          ShortObservation Status (HL7 v2 OBX-11)
          Comments

          The statuses amended, corrected, cancelled and entered-in-error SHOULD be accompanied by the reason for that status, conveyed in the statusReason extension.

          Control1..1
          BindingThe codes SHALL be taken from ObservationStatus
          (required to http://hl7.org/fhir/ValueSet/observation-status|4.0.1)

          Codes providing the status of an observation.

          Typecode
          Is Modifiertrue because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          EHDSObservation.header.status

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          90. Observation.category
          Definition

          A code that classifies the general type of observation being made.

          ShortClassification of type of observation
          Comments

          "laboratory" includes laboratory medicine and pathology

          Control1..*
          BindingThe codes SHOULD be taken from ObservationCategoryCodes
          (preferred to http://hl7.org/fhir/ValueSet/observation-category|4.0.1)

          Codes for high level observation categories.

          TypeCodeableConcept
          Is Modifierfalse
          Summaryfalse
          Requirements

          Used for filtering what observations are retrieved and displayed.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          SlicingThis element introduces a set of slices on Observation.category. The slices are Unordered and Open, and can be differentiated using the following discriminators:
          • pattern @ $this
          92. Observation.category:laboratory
          Slice Namelaboratory
          Definition

          A code that classifies the general type of observation being made.

          ShortClassification of type of observation
          Comments

          In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

          Control1..1
          BindingThe codes SHOULD be taken from ObservationCategoryCodes
          (preferred to http://hl7.org/fhir/ValueSet/observation-category|4.0.1)

          Codes for high level observation categories.

          TypeCodeableConcept
          Is Modifierfalse
          Summaryfalse
          Requirements

          Used for filtering what observations are retrieved and displayed.

          Pattern Value
          {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
                "code" : "laboratory"
              }
            ]
          }
          <category>
            <coding>
              <system value="http://terminology.hl7.org/CodeSystem/observation-category"/>
              <code value="laboratory"/>
            </coding>
          </category>
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          94. Observation.category:studyType
          Slice NamestudyType
          Definition

          A code that classifies the general type of observation being made.

          ShortThe way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.)
          Comments

          In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

          Control0..*
          BindingThe codes SHALL be taken from Laboratory Study Types
          (required to http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab)
          TypeCodeableConcept
          Is Modifierfalse
          Summaryfalse
          Requirements

          Used for filtering what observations are retrieved and displayed.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          96. Observation.category:specialty
          Slice Namespecialty
          Definition

          A code that classifies the general type of observation being made.

          ShortThe clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry)
          Comments

          In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

          Control0..*
          BindingThe codes SHALL be taken from Laboratory Specialty
          (required to http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab)
          TypeCodeableConcept
          Is Modifierfalse
          Summaryfalse
          Requirements

          Used for filtering what observations are retrieved and displayed.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          98. Observation.category:geCategory
          Slice NamegeCategory
          Definition

          A code that classifies the general type of observation being made.

          ShortClassification of type of observation
          Comments

          In addition to the required category valueset, this element allows various categorization schemes based on the owner’s definition of the category and effectively multiple categories can be used at once. The level of granularity is defined by the category concepts in the value set.

          Control0..1
          BindingThe codes SHOULD be taken from ObservationCategoryCodes
          (preferred to http://hl7.org/fhir/ValueSet/observation-category|4.0.1)

          Codes for high level observation categories.

          TypeCodeableConcept
          Is Modifierfalse
          Summaryfalse
          Requirements

          Used for filtering what observations are retrieved and displayed.

          Pattern Value
          {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/v2-0074",
                "code" : "GE"
              }
            ]
          }
          <category>
            <coding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0074"/>
              <code value="GE"/>
            </coding>
          </category>
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          100. Observation.code
          Definition

          Describes what was observed. Sometimes this is called the observation "name". In this profile this code represents either a simple laboratory test or a laboratory study with multiple child observations

          ShortThe type of observation (code / type). (HL7 v2 OBX-3)
          Comments

          In the context of this Observation-laboratory profile, when the observation plays the role of a grouper of member sub-observations, the code represent the group (for instance a panel code). In case no code is available, at least a text shall be provided.

          Control1..1
          BindingThe codes SHOULD be taken from Laboratory Code
          (preferred to http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab)
          TypeCodeableConcept
          Is Modifierfalse
          Summarytrue
          Requirements

          EHDSObservation.code

          Alternate NamesName
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          102. Observation.subject
          Definition

          The patient, or group of patients, location, or device this observation is about and into whose record the observation is placed. If the actual focus of the observation is different from the subject (or a sample of, part, or region of the subject), the focus element or the code itself specifies the actual focus of the observation.

          ShortWho and/or what the observation is about
          Comments

          One would expect this element to be a cardinality of 1..1. The only circumstance in which the subject can be missing is when the observation is made by a device that does not know the patient. In this case, the observation SHALL be matched to a patient through some context/channel matching technique, and at this point, the observation should be updated.

          Control1..1
          TypeReference(Patient)
          Is Modifierfalse
          Summarytrue
          Requirements

          EHDSObservation.header.subject

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          104. Observation.subject.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          106. Observation.subject.extension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on Observation.subject.extension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          108. Observation.subject.reference
          Definition

          A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

          ShortLiteral reference, Relative, internal or absolute URL
          Comments

          Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

          Control1..1
          This element is affected by the following invariants: ref-1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          110. Observation.subject.type
          Definition

          The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

          The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

          ShortType the reference refers to (e.g. "Patient")
          Comments

          This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

          Control0..1
          BindingUnless not suitable, these codes SHALL be taken from ResourceType
          (extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

          Aa resource (or, for logical models, the URI of the logical model).

          Typeuri
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          112. Observation.subject.identifier
          Definition

          An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

          ShortLogical reference, when literal reference is not known
          Comments

          When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

          When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

          Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

          Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

          NoteThis is a business identifier, not a resource identifier (see discussion)
          Control0..1
          TypeIdentifier(NHS Identifier)
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          114. Observation.subject.display
          Definition

          Plain text narrative that identifies the resource in addition to the resource reference.

          ShortText alternative for the resource
          Comments

          This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

          Control0..1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          116. Observation.focus
          Definition

          The actual focus of an observation when it is not the patient of record representing something or someone associated with the patient such as a spouse, parent, fetus, or donor. For example, fetus observations in a mother's record. The focus of an observation could also be an existing condition, an intervention, the subject's diet, another observation of the subject, or a body structure such as tumor or implanted device. An example use case would be using the Observation resource to capture whether the mother is trained to change her child's tracheostomy tube. In this example, the child is the patient of record and the mother is the focus.

          ShortWhat the observation is about, when it is not about the subject of record
          Comments

          Typically, an observation is made about the subject - a patient, or group of patients, location, or device - and the distinction between the subject and what is directly measured for an observation is specified in the observation code itself ( e.g., "Blood Glucose") and does not need to be represented separately using this element. Use specimen if a reference to a specimen is required. If a code is required instead of a resource use either bodysite for bodysites or the standard extension focusCode.

          Control0..*
          TypeReference(Patient (EU core), RelatedPerson: AnimalSpecimen, Group, Device, Location (EU core), Substance, BiologicallyDerivedProduct)
          Is Modifierfalse
          Summarytrue
          Requirements

          EHDSObservation.directSubject[x]

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          118. Observation.encounter
          Definition

          The healthcare event (e.g. a patient and healthcare provider interaction) during which this observation is made.

          ShortHealthcare event during which this observation is made
          Comments

          This will typically be the encounter the event occurred within, but some events may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter (e.g. pre-admission laboratory tests).

          Control0..1
          TypeReference(Encounter)
          Is Modifierfalse
          Must Supporttrue
          Summarytrue
          Requirements

          For some observations it may be important to know the link between an observation and a particular encounter.

          Alternate NamesContext
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          120. Observation.encounter.id
          Definition

          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

          ShortUnique id for inter-element referencing
          Control0..1
          Typestring
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          122. Observation.encounter.extension
          Definition

          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on Observation.encounter.extension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          124. Observation.encounter.reference
          Definition

          A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

          ShortLiteral reference, Relative, internal or absolute URL
          Comments

          Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

          Control0..1
          This element is affected by the following invariants: ref-1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          126. Observation.encounter.type
          Definition

          The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

          The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

          ShortType the reference refers to (e.g. "Patient")
          Comments

          This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

          Control0..1
          BindingUnless not suitable, these codes SHALL be taken from ResourceType
          (extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

          Aa resource (or, for logical models, the URI of the logical model).

          Typeuri
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          128. Observation.encounter.identifier
          Definition

          An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

          ShortLogical reference, when literal reference is not known
          Comments

          When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

          When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

          Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

          Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

          NoteThis is a business identifier, not a resource identifier (see discussion)
          Control0..1
          TypeIdentifier(Correlation Identifier)
          Is Modifierfalse
          Obligations
            ObligationsActor
            SHALL:populate-if-knownOrder Filler
            SHALL:populate-if-knownOrder Placer
            SHALL:populate-if-knownAutomation Manager
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            130. Observation.encounter.display
            Definition

            Plain text narrative that identifies the resource in addition to the resource reference.

            ShortText alternative for the resource
            Comments

            This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

            Control0..1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            132. Observation.effective[x]
            Definition

            The time or time-period the observed value is asserted as being true. For biological subjects - e.g. human patients - this is usually called the "physiologically relevant time". This is usually either the time of the procedure or of specimen collection, but very often the source of the date/time is not known, only the date/time itself.

            ShortClinically relevant time/time-period for observation (HL7 v2 OBX-14)
            Comments

            At least a date should be present unless this observation is a historical report. For recording imprecise or "fuzzy" times (For example, a blood glucose measurement taken "after breakfast") use the Timing datatype which allow the measurement to be tied to regular life events.

            Control1..1
            TypeChoice of: dateTime, Period
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Obligations
              ObligationsActor
              SHOULD:populate-if-knownOrder Filler
              SHOULD:populate-if-knownOrder Placer
              SHOULD:populate-if-knownAutomation Manager
              Summarytrue
              Requirements

              EHDSObservation.observationDate[x]

              Alternate NamesOccurrence
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              134. Observation.issued
              Definition

              The date and time this version of the observation was made available to providers, typically after the results have been reviewed and verified.

              ShortDate/Time this result was made available
              Comments

              For Observations that don’t require review and verification, it may be the same as the lastUpdated time of the resource itself. For Observations that do require review and verification for certain updates, it might not be the same as the lastUpdated time of the resource itself due to a non-clinically significant update that doesn’t require the new version to be reviewed and verified again.

              Control0..1
              Typeinstant
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              EHDSObservation.header.authorship.datetime

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              136. Observation.performer
              Definition

              Who was responsible for asserting the observed value as "true".

              ShortWho is responsible for the observation
              Control1..*
              TypeReference(PractitionerRole)
              Is Modifierfalse
              Summarytrue
              Requirements

              EHDSObservation.header.performer

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              138. Observation.performer.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              ShortUnique id for inter-element referencing
              Control0..1
              Typestring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              140. Observation.performer.extension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              ShortAdditional content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on Observation.performer.extension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              142. Observation.performer.extension:performerFunction
              Slice NameperformerFunction
              Definition

              Distinguishes the type of involvement of the performer in the event. For example, 'author', 'verifier' or 'responsible party'.

              ShortType of performance
              Comments

              If a Practitioner(Role) is involved in multiple roles, the Practitioner(Role) has to be added multiple times.

              Control0..1
              TypeExtension(Performer function) (Extension Type: CodeableConcept)
              Is Modifierfalse
              Summaryfalse
              Requirements

              EHDSObservation.performer.function

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              144. Observation.performer.reference
              Definition

              A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

              ShortLiteral reference, Relative, internal or absolute URL
              Comments

              Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

              Control0..1
              This element is affected by the following invariants: ref-1
              Typestring
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              146. Observation.performer.type
              Definition

              The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

              The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

              ShortType the reference refers to (e.g. "Patient")
              Comments

              This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.

              Control0..1
              BindingUnless not suitable, these codes SHALL be taken from ResourceType
              (extensible to http://hl7.org/fhir/ValueSet/resource-types|4.0.1)

              Aa resource (or, for logical models, the URI of the logical model).

              Typeuri
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              148. Observation.performer.identifier
              Definition

              An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

              ShortLogical reference, when literal reference is not known
              Comments

              When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

              When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

              Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

              Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

              NoteThis is a business identifier, not a resource identifier (see discussion)
              Control0..1
              TypeIdentifier
              Is Modifierfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              150. Observation.performer.display
              Definition

              Plain text narrative that identifies the resource in addition to the resource reference.

              ShortText alternative for the resource
              Comments

              This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

              Control0..1
              Typestring
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              152. Observation.value[x]
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual result (HL7 v2 OBX-5)
              Comments

              An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              This element is affected by the following invariants: obs-7
              TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              EHDSObservation.result.value[x]

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              SlicingThis element introduces a set of slices on Observation.value[x]. The slices are Unordered and Closed, and can be differentiated using the following discriminators:
              • type @ $this
              154. Observation.value[x]:valueQuantity
              Slice NamevalueQuantity
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual result
              Comments

              An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              This element is affected by the following invariants: obs-7
              TypeQuantity(Quantity (Eu Lab))
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              156. Observation.value[x]:valueQuantity.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              ShortUnique id for inter-element referencing
              Control0..1
              Typestring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              158. Observation.value[x]:valueQuantity.extension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              ShortAdditional content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on Observation.value[x].extension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              160. Observation.value[x]:valueQuantity.extension:uncertainty
              Slice Nameuncertainty
              Definition

              The primary measure of variance/uncertainty of the value (the square root of the sum of the squares of the differences between all data points and the mean).

              ShortStandard Deviation (same units as the quantity)
              Comments

              standardDeviation has the same units as the quantity. It is used to normalize the data for computing the distribution function. Applications that cannot deal with probability distributions can still get an idea about the confidence level by looking at standardDeviation.

              Control0..1
              TypeExtension(Uncertainty) (Extension Type: decimal)
              Is Modifierfalse
              Summaryfalse
              Requirements

              EHDSObservation.result.uncertainty

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              162. Observation.value[x]:valueQuantity.value
              Definition

              The value of the measured amount. The value includes an implicit precision in the presentation of the value.

              ShortNumerical value (with implicit precision)
              Comments

              The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

              Control0..1
              Typedecimal
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              Precision is handled implicitly in almost all cases of measurement.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              164. Observation.value[x]:valueQuantity.comparator
              Definition

              How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

              Short< | <= | >= | > - how to understand the value
              Control0..1
              BindingThe codes SHALL be taken from QuantityComparator
              (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

              How the Quantity should be understood and represented.

              Typecode
              Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

              Meaning if MissingIf there is no comparator, then there is no modification of the value
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              166. Observation.value[x]:valueQuantity.unit
              Definition

              A human-readable form of the unit.

              ShortUnit representation
              Control0..1
              Typestring
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              168. Observation.value[x]:valueQuantity.system
              Definition

              The identification of the system that provides the coded form of the unit.

              ShortSystem that defines coded unit form
              Control0..1
              This element is affected by the following invariants: qty-3
              Typeuri
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              Need to know the system that defines the coded form of the unit.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              170. Observation.value[x]:valueQuantity.code
              Definition

              A computer processable form of the unit in some unit representation system.

              ShortCoded form of the unit
              Comments

              The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

              Control0..1
              Typecode
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              172. Observation.value[x]:valueString
              Slice NamevalueString
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual result
              Comments

              An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              This element is affected by the following invariants: obs-7
              Typestring
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              174. Observation.value[x]:valueDateTime
              Slice NamevalueDateTime
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual result
              Comments

              An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              This element is affected by the following invariants: obs-7
              TypedateTime
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              176. Observation.value[x]:valueCodeableConcept
              Slice NamevalueCodeableConcept
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual result
              Comments

              An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              This element is affected by the following invariants: obs-7
              BindingThe codes SHOULD be taken from Results Coded Values Laboratory/Pathology - IPS
              (preferred to http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-pathology-uv-ips)
              TypeCodeableConcept
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Must Supporttrue
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              178. Observation.value[x]:valueRange
              Slice NamevalueRange
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual result
              Comments

              An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              This element is affected by the following invariants: obs-7
              TypeRange(Range (Eu Lab))
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              180. Observation.value[x]:valueRatio
              Slice NamevalueRatio
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual result
              Comments

              An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              This element is affected by the following invariants: obs-7
              TypeRatio(Ratio (Eu Lab))
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              182. Observation.value[x]:valueTime
              Slice NamevalueTime
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual result
              Comments

              An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              This element is affected by the following invariants: obs-7
              Typetime
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              184. Observation.value[x]:valuePeriod
              Slice NamevaluePeriod
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual result
              Comments

              An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              This element is affected by the following invariants: obs-7
              TypePeriod
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              186. Observation.value[x]:valueBoolean
              Slice NamevalueBoolean
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual result
              Comments

              An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              This element is affected by the following invariants: obs-7
              Typeboolean
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              188. Observation.value[x]:valueInteger
              Slice NamevalueInteger
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual result
              Comments

              An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              This element is affected by the following invariants: obs-7
              Typeinteger
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              190. Observation.value[x]:valueSampledData
              Slice NamevalueSampledData
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual result
              Comments

              An observation may have; 1) a single value here, 2) both a value and a set of related or component values, or 3) only a set of related or component values. If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              This element is affected by the following invariants: obs-7
              TypeSampledData
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              192. Observation.dataAbsentReason
              Definition

              Provides a reason why the expected value in the element Observation.value[x] is missing.

              ShortProvides a reason why the expected value is missing.
              Comments

              Null or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "specimen unsatisfactory".

              The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Note that an observation may only be reported if there are values to report. For example differential cell counts values may be reported only when > 0. Because of these options, use-case agreements are required to interpret general observations for null or exceptional values.

              Control0..1
              This element is affected by the following invariants: obs-6
              BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
              (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1)

              Codes specifying why the result (Observation.value[x]) is missing.

              TypeCodeableConcept
              Is Modifierfalse
              Summaryfalse
              Requirements

              EHDSObservation.dataAbsentReason

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              194. Observation.interpretation
              Definition

              A categorical assessment of an observation value. For example, high, low, normal.

              ShortHigh, low, normal, etc.
              Comments

              Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

              Control0..*
              BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
              (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation|4.0.1)

              Codes identifying interpretations of observations.

              TypeCodeableConcept
              Is Modifierfalse
              Summaryfalse
              Requirements

              EHDSObservation.interpretation

              Alternate NamesAbnormal Flag
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              196. Observation.note
              Definition

              Comments about the observation or the results.

              ShortComments about the observation
              Comments

              May include general statements about the observation, or statements about significant, unexpected or unreliable results values, or information about its source when relevant to its interpretation.

              Control0..*
              TypeAnnotation
              Is Modifierfalse
              Summaryfalse
              Requirements

              EHDSObservation.resultDescription

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              198. Observation.bodySite
              Definition

              Indicates the site on the subject's body where the observation was made (i.e. the target site).

              ShortObserved body part
              Comments

              Only used if not implicit in code found in Observation.code. In many systems, this may be represented as a related observation instead of an inline component.

              If the use case requires BodySite to be handled as a separate resource (e.g. to identify and track separately) then use the standard extension bodySite.

              Control0..1
              BindingFor example codes, see SNOMEDCTBodyStructures
              (example to http://hl7.org/fhir/ValueSet/body-site|4.0.1)

              Codes describing anatomical locations. May include laterality.

              TypeCodeableConcept
              Is Modifierfalse
              Summaryfalse
              Requirements

              EHDSObservation.anatomicLocation

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              200. Observation.method
              Definition

              Laboratory technigue that has been used

              ShortHow it was done
              Comments

              Laboratory technique (method of measurement) are integral parts of the test specification of some laboratory test coding systems (e.g. NPU), in LOINC hovewer measurement principle is not always present in the test definition. In some cases however knowledge of the used measurment techique is important for proper interpretation of the test result. That's why it is important to explicitly include informaiton about measurement method is such cases.

              Control0..1
              BindingThe codes SHOULD be taken from Laboratory Techniques
              (preferred to http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab)
              TypeCodeableConcept
              Is Modifierfalse
              Summaryfalse
              Requirements

              EHDSObservation.method

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              202. Observation.specimen
              Definition

              The specimen that was used when this observation was made.

              ShortSpecimen used for the observation
              Comments

              When the specimen is applicable and known it shall be documented

              Control0..1
              TypeReference(Specimen: Laboratory)
              Is Modifierfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              204. Observation.device
              Definition

              The device used to generate the observation data.

              ShortMeasuring instrument
              Comments

              Note that this is not meant to represent a device involved in the transmission of the result, e.g., a gateway. Such devices may be documented using the Provenance resource where relevant.

              Control0..1
              TypeReference(Device, DeviceMetric)
              Is Modifierfalse
              Summaryfalse
              Requirements

              Device information for laboratory observations

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              206. Observation.referenceRange
              Definition

              Guidance on how to interpret the value by comparison to a normal or recommended range. Multiple reference ranges are interpreted as an "OR". In other words, to represent two distinct target populations, two referenceRange elements would be used.

              ShortProvides guide for interpretation
              Comments

              Reference-range bounds are inclusive when no comparator is present. Use lowComparator or highComparator to state the comparator for an exclusive or explicitly inclusive bound. These modifier extensions pre-adopt the comparator on the reference-range bounds introduced in FHIR R6.

              Control0..*
              TypeBackboneElement
              Is Modifierfalse
              Must Supporttrue
              Summaryfalse
              Requirements

              EHDSObservation.referenceRange

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
              208. Observation.referenceRange.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              ShortUnique id for inter-element referencing
              Control0..1
              Typestring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              210. Observation.referenceRange.extension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              ShortAdditional content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              212. Observation.referenceRange.modifierExtension
              Definition

              An Extension

              ShortExtension
              Control0..*
              TypeExtension
              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on Observation.referenceRange.modifierExtension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              214. Observation.referenceRange.modifierExtension:lowComparator
              Slice NamelowComparator
              Definition

              The comparator for Observation.referenceRange.low. This modifier extension pre-adopts the R6 comparator on the low reference-range bound.

              ShortObservation Reference Range Low Comparator
              Control0..1
              This element is affected by the following invariants: ele-1
              TypeExtension(Observation Reference Range Low Comparator) (Extension Type: code)
              Is Modifiertrue because Changes the interpretation of Observation.referenceRange.low by stating whether the bound is inclusive or exclusive.
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              216. Observation.referenceRange.modifierExtension:highComparator
              Slice NamehighComparator
              Definition

              The comparator for Observation.referenceRange.high. This modifier extension pre-adopts the R6 comparator on the high reference-range bound.

              ShortObservation Reference Range High Comparator
              Control0..1
              This element is affected by the following invariants: ele-1
              TypeExtension(Observation Reference Range High Comparator) (Extension Type: code)
              Is Modifiertrue because Changes the interpretation of Observation.referenceRange.high by stating whether the bound is inclusive or exclusive.
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              218. Observation.referenceRange.low
              Definition

              The value of the low bound of the reference range. The low bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the low bound is omitted, it is assumed to be meaningless (e.g. reference range is <=2.3).

              ShortLow Range, if relevant
              Control0..1
              This element is affected by the following invariants: obs-3
              TypeQuantity(SimpleQuantity)
              Is Modifierfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              sqty-1: The comparator is not used on a SimpleQuantity (comparator.empty())
              220. Observation.referenceRange.high
              Definition

              The value of the high bound of the reference range. The high bound of the reference range endpoint is inclusive of the value (e.g. reference range is >=5 - <=9). If the high bound is omitted, it is assumed to be meaningless (e.g. reference range is >= 2.3).

              ShortHigh Range, if relevant
              Control0..1
              This element is affected by the following invariants: obs-3
              TypeQuantity(SimpleQuantity)
              Is Modifierfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              sqty-1: The comparator is not used on a SimpleQuantity (comparator.empty())
              222. Observation.referenceRange.type
              Definition

              Codes to indicate the what part of the targeted reference population it applies to. For example, the normal or therapeutic range.

              ShortReference range qualifier
              Comments

              This SHOULD be populated if there is more than one range. If this element is not present then the normal range is assumed.

              Control0..1
              BindingThe codes SHOULD be taken from ObservationReferenceRangeMeaningCodes
              (preferred to http://hl7.org/fhir/ValueSet/referencerange-meaning|4.0.1)

              Code for the meaning of a reference range.

              TypeCodeableConcept
              Is Modifierfalse
              Summaryfalse
              Requirements

              Need to be able to say what kind of reference range this is - normal, recommended, therapeutic, etc., - for proper interpretation.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              224. Observation.referenceRange.appliesTo
              Definition

              Codes to indicate the target population this reference range applies to. For example, a reference range may be based on the normal population or a particular sex or race. Multiple appliesTo are interpreted as an "AND" of the target populations. For example, to represent a target population of African American females, both a code of female and a code for African American would be used.

              ShortReference range population
              Comments

              This SHOULD be populated if there is more than one range. If this element is not present then the normal population is assumed.

              Control0..*
              BindingFor example codes, see ObservationReferenceRangeAppliesToCodes
              (example to http://hl7.org/fhir/ValueSet/referencerange-appliesto|4.0.1)

              Codes identifying the population the reference range applies to.

              TypeCodeableConcept
              Is Modifierfalse
              Summaryfalse
              Requirements

              Need to be able to identify the target population for proper interpretation.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              226. Observation.referenceRange.age
              Definition

              The age at which this reference range is applicable. This is a neonatal age (e.g. number of weeks at term) if the meaning says so.

              ShortApplicable age range, if relevant
              Control0..1
              TypeRange
              Is Modifierfalse
              Summaryfalse
              Requirements

              Some analytes vary greatly over age.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              228. Observation.referenceRange.text
              Definition

              Text based reference range in an observation which may be used when a quantitative range is not appropriate for an observation. An example would be a reference value of "Negative" or a list or table of "normals".

              ShortText based reference range in an observation
              Control0..1
              Typestring
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              230. Observation.hasMember
              Definition

              A reference to another Observation profiled by Observation-results-laboratory-uv-ips. The target observation (for instance an individual test member of a panel) is considered as a sub-observation of the current one, which plays the role of a grouper.

              ShortRelated resource that belongs to the Observation group
              Comments

              This element is used in the context of international patient summary when there is a need to group a collection of observations, because they belong to the same panel, or because they share a common interpretation comment, or a common media attachment (illustrative image or graph). In these cases, the current observation is the grouper, and its set of sub-observations are related observations using the type "has-member". For a discussion on the ways Observations can be assembled in groups together see Observation Grouping.

              Control0..*
              TypeReference(Observation Results: laboratory)
              Is Modifierfalse
              Summarytrue
              Requirements

              EHDSObservation.hasMember[x]

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              232. Observation.derivedFrom
              Definition

              The target resource that represents a measurement from which this observation value is derived. For example, a calculated anion gap or a fetal measurement based on an ultrasound image.

              ShortRelated measurements the observation is made from
              Comments

              All the reference choices that are listed in this element can represent clinical observations and other measurements that may be the source for a derived value. The most common reference will be another Observation. For a discussion on the ways Observations can assembled in groups together, see Notes below.

              Control0..*
              TypeReference(Observation: Medical Test Result (EU core), ImagingStudy)
              Is Modifierfalse
              Summarytrue
              Requirements

              EHDSObservation.derivedFrom[x]

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              SlicingThis element introduces a set of slices on Observation.derivedFrom. The slices are Unordered and Open, and can be differentiated using the following discriminators:
              • profile @ resolve()

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

              234. Observation.component
              Definition

              Some observations have multiple component observations. These component observations are expressed as separate code value pairs that share the same attributes. Examples include systolic and diastolic component observations for blood pressure measurement and multiple component observations for genetics observations.

              ShortLaboratory result
              Comments

              For a discussion on the ways Observations can be assembled in groups together see Notes below.

              Control0..*
              TypeBackboneElement
              Is Modifierfalse
              Summarytrue
              Requirements

              EHDSObservation.component

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              obs-value-2: 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())
              236. Observation.component.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              ShortUnique id for inter-element referencing
              Control0..1
              Typestring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              238. Observation.component.extension
              Definition

              An Extension

              ShortExtension
              Control0..*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on Observation.component.extension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              240. Observation.component.extension:value-r5
              Slice Namevalue-r5
              Definition

              When the result is a Diagram or Picture (Microbiology), then the Attachment data type should be used. In FHIR R4 this can be done by preadopting the R5 Observation.component.value[x] element using the cross-version extension.

              Shortonly for Diagrams or Pictures
              Comments

              Element Observation.component.value[x] is mapped to FHIR R4 element Observation.component.value[x] as SourceIsBroaderThanTarget. The mappings for Observation.component.value[x] do not cover the following types: Attachment, Reference. The target context Observation.component.value[x] is a choice-type element and cannot directly hold extensions. The context is moved up to parent element Observation.component. Used when observation has a set of component observations:

              • An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived).
              • If a value is present, the datatype for this element should be determined by the code.
              • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
              • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
              • If a value is present, the datatype for this element should be determined by the code.
              • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
              • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
              • The usage of valueReference is restricted to the MolecularSequence resource when used as a definitional resource, not as a patient-specific finding. .
              • For additional guidance, see the Notes section below.
              Control0..1
              This element is affected by the following invariants: ele-1
              TypeExtension(R5: value additional types) (Extension Type: Choice of: Attachment, Reference(Cross-version Profile for R5.MolecularSequence for use in FHIR R4, MolecularSequence))
              Is Modifierfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              242. Observation.component.extension:value-r5.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              ShortUnique id for inter-element referencing
              Control0..1
              Typestring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              244. Observation.component.extension:value-r5.extension
              Definition

              An Extension

              ShortExtension
              Control0..0
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on Observation.component.extension.extension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              246. Observation.component.extension:value-r5.url
              Definition

              Source of the definition for the extension code - a logical name or a URL.

              Shortidentifies the meaning of the extension
              Comments

              The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

              Control1..1
              Typeuri
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              Fixed Value
              {
                "url" : "http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value"
              }
              <url value="http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value"/>
              248. Observation.component.extension:value-r5.value[x]
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual component result
              Comments

              Used when observation has a set of component observations:

              • An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived).
              • If a value is present, the datatype for this element should be determined by the code.
              • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
              • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
              • If a value is present, the datatype for this element should be determined by the code.
              • CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the code defines a coded value.
              • Attachment is used if the observation result value is a binary file such as an image. If the observation result value is derived from the binary file (for example 'X' detected and here is the the proof in this image), the binary file may be directly represented using DocumentReference and referenced by derivedFrom.
              • The usage of valueReference is restricted to the MolecularSequence resource when used as a definitional resource, not as a patient-specific finding. .
              • For additional guidance, see the Notes section below.
              Control0..1
              TypeAttachment
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Summaryfalse
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              250. Observation.component.modifierExtension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
              Summarytrue
              Requirements

              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

              Alternate Namesextensions, user content, modifiers
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              252. Observation.component.code
              Definition

              Describes what was observed. Sometimes this is called the observation "code".

              ShortType of component observation (code / type)
              Comments

              All code-value and component.code-component.value pairs need to be taken into account to correctly understand the meaning of the observation.

              Control1..1
              BindingThe codes SHOULD be taken from Laboratory Code
              (preferred to http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab)
              TypeCodeableConcept
              Is Modifierfalse
              Summarytrue
              Requirements

              EHDSObservation.component.code

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              254. Observation.component.value[x]
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual component result
              Comments

              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              TypeChoice of: Quantity, CodeableConcept, string, boolean, integer, Range, Ratio, SampledData, time, dateTime, Period
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              EHDSObservation.component.result.value[x]

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices are Unordered and Closed, and can be differentiated using the following discriminators:
              • type @ $this
              256. Observation.component.value[x]:valueQuantity
              Slice NamevalueQuantity
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual component result
              Comments

              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              TypeQuantity(Quantity (Eu Lab))
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              258. Observation.component.value[x]:valueQuantity.id
              Definition

              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

              ShortUnique id for inter-element referencing
              Control0..1
              Typestring
              Is Modifierfalse
              XML FormatIn the XML format, this property is represented as an attribute.
              Summaryfalse
              260. Observation.component.value[x]:valueQuantity.extension
              Definition

              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              ShortAdditional content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on Observation.component.value[x].extension. The slices are Unordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              262. Observation.component.value[x]:valueQuantity.extension:uncertainty
              Slice Nameuncertainty
              Definition

              The primary measure of variance/uncertainty of the value (the square root of the sum of the squares of the differences between all data points and the mean).

              ShortStandard Deviation (same units as the quantity)
              Comments

              standardDeviation has the same units as the quantity. It is used to normalize the data for computing the distribution function. Applications that cannot deal with probability distributions can still get an idea about the confidence level by looking at standardDeviation.

              Control0..1
              TypeExtension(Uncertainty) (Extension Type: decimal)
              Is Modifierfalse
              Summaryfalse
              Requirements

              EHDSObservation.component.result.uncertainty

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              264. Observation.component.value[x]:valueQuantity.value
              Definition

              The value of the measured amount. The value includes an implicit precision in the presentation of the value.

              ShortNumerical value (with implicit precision)
              Comments

              The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

              Control0..1
              Typedecimal
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              Precision is handled implicitly in almost all cases of measurement.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              266. Observation.component.value[x]:valueQuantity.comparator
              Definition

              How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

              Short< | <= | >= | > - how to understand the value
              Control0..1
              BindingThe codes SHALL be taken from QuantityComparator
              (required to http://hl7.org/fhir/ValueSet/quantity-comparator|4.0.1)

              How the Quantity should be understood and represented.

              Typecode
              Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

              Meaning if MissingIf there is no comparator, then there is no modification of the value
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              268. Observation.component.value[x]:valueQuantity.unit
              Definition

              A human-readable form of the unit.

              ShortUnit representation
              Control0..1
              Typestring
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              270. Observation.component.value[x]:valueQuantity.system
              Definition

              The identification of the system that provides the coded form of the unit.

              ShortSystem that defines coded unit form
              Control0..1
              This element is affected by the following invariants: qty-3
              Typeuri
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              Need to know the system that defines the coded form of the unit.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              272. Observation.component.value[x]:valueQuantity.code
              Definition

              A computer processable form of the unit in some unit representation system.

              ShortCoded form of the unit
              Comments

              The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

              Control0..1
              Typecode
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              274. Observation.component.value[x]:valueString
              Slice NamevalueString
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual component result
              Comments

              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              Typestring
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              276. Observation.component.value[x]:valueRange
              Slice NamevalueRange
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual component result
              Comments

              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              TypeRange(Range (Eu Lab))
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              278. Observation.component.value[x]:valueRatio
              Slice NamevalueRatio
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual component result
              Comments

              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              TypeRatio(Ratio (Eu Lab))
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              280. Observation.component.value[x]:valueTime
              Slice NamevalueTime
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual component result
              Comments

              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              Typetime
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              282. Observation.component.value[x]:valueDateTime
              Slice NamevalueDateTime
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual component result
              Comments

              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              TypedateTime
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              284. Observation.component.value[x]:valuePeriod
              Slice NamevaluePeriod
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual component result
              Comments

              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              TypePeriod
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              286. Observation.component.value[x]:valueBoolean
              Slice NamevalueBoolean
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual component result
              Comments

              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              Typeboolean
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              288. Observation.component.value[x]:valueInteger
              Slice NamevalueInteger
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual component result
              Comments

              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              Typeinteger
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              290. Observation.component.value[x]:valueSampledData
              Slice NamevalueSampledData
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual component result
              Comments

              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              TypeSampledData
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              292. Observation.component.value[x]:valueCodeableConcept
              Slice NamevalueCodeableConcept
              Definition

              The information determined as a result of making the observation, if the information has a simple value.

              ShortActual component result
              Comments

              Used when observation has a set of component observations. An observation may have both a value (e.g. an Apgar score) and component observations (the observations from which the Apgar score was derived). If a value is present, the datatype for this element should be determined by Observation.code. A CodeableConcept with just a text would be used instead of a string if the field was usually coded, or if the type associated with the Observation.code defines a coded value. For additional guidance, see the Notes section below.

              Control0..1
              BindingThe codes SHOULD be taken from Results Coded Values Laboratory/Pathology - IPS
              (preferred to http://hl7.org/fhir/uv/ips/ValueSet/results-coded-values-laboratory-pathology-uv-ips)
              TypeCodeableConcept
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Summarytrue
              Requirements

              An observation exists to have a value, though it might not if it is in error, or if it represents a group of observations.

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              294. Observation.component.dataAbsentReason
              Definition

              Provides a reason why the expected value in the element Observation.component.value[x] is missing.

              ShortWhy the component result is missing
              Comments

              "Null" or exceptional values can be represented two ways in FHIR Observations. One way is to simply include them in the value set and represent the exceptions in the value. For example, measurement values for a serology test could be "detected", "not detected", "inconclusive", or "test not done".

              The alternate way is to use the value element for actual observations and use the explicit dataAbsentReason element to record exceptional values. For example, the dataAbsentReason code "error" could be used when the measurement was not completed. Because of these options, use-case agreements are required to interpret general observations for exceptional values.

              Control0..1
              This element is affected by the following invariants: obs-6
              BindingUnless not suitable, these codes SHALL be taken from DataAbsentReason
              (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1)

              Codes specifying why the result (Observation.value[x]) is missing.

              TypeCodeableConcept
              Is Modifierfalse
              Summaryfalse
              Requirements

              EHDSObservation.component.dataAbsentReason

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              296. Observation.component.interpretation
              Definition

              A categorical assessment of an observation value. For example, high, low, normal.

              ShortHigh, low, normal, etc.
              Comments

              Historically used for laboratory results (known as 'abnormal flag' ), its use extends to other use cases where coded interpretations are relevant. Often reported as one or more simple compact codes this element is often placed adjacent to the result value in reports and flow sheets to signal the meaning/normalcy status of the result.

              Control0..*
              BindingUnless not suitable, these codes SHALL be taken from ObservationInterpretationCodes
              (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation|4.0.1)

              Codes identifying interpretations of observations.

              TypeCodeableConcept
              Is Modifierfalse
              Summaryfalse
              Requirements

              EHDSObservation.component.interpretation

              Alternate NamesAbnormal Flag
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              298. Observation.component.referenceRange
              Definition

              Guidance on how to interpret the value by comparison to a normal or recommended range.

              ShortProvides guide for interpretation of component result
              Comments

              Most observations only have one generic reference range. Systems MAY choose to restrict to only supplying the relevant reference range based on knowledge about the patient (e.g., specific to the patient's age, gender, weight and other factors), but this might not be possible or appropriate. Whenever more than one reference range is supplied, the differences between them SHOULD be provided in the reference range and/or age properties.

              Control0..*
              TypeSeettp://hl7.org/fhir/StructureDefinition/Observation#Observation.referenceRange
              Is Modifierfalse
              Summaryfalse
              Requirements

              EHDSObservation.component.referenceRange

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))