HL7 Europe Laboratory Report
2.0.0 - ci-build 150

This page is part of the HL7 Europe Laboratory Report (v2.0.0: STU 2) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: ObservationResultsLaboratoryEu - Detailed Descriptions

Page standards status: Trial-use Maturity Level: 2

Definitions for the Observation-resultslab-eu-lab resource profile.

Guidance on how to interpret the contents of this table can be foundhere

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: "value", "dataAbsentReason", "hasMember" or "component" ((status in ('registered'|'cancelled')) or value.exists() or extension.where(url='http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value').exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists())
eu-lab-2: If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason" (component.exists() implies (status in ('registered'|'cancelled')) or component.value.exists() or component.extension.where(url='http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value').exists() or component.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(R5: Observed body structure (new)) (Extension Type: Reference(Cross-version Profile for R5.BodyStructure for use in FHIR R4, 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(R5: Triggering observation(s) (new)) (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 areUnordered 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 areUnordered 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 Valueobservation
      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 Valuetype
      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 Valuereason
      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 Valuehttp://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 areUnordered 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 Valuehttp://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(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.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())
        50. Observation.status
        Definition

        The status of the result value.

        ShortStatus of this observation (e.g. preliminary, final,...)registered | preliminary | final | amended +
        Comments

        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()))
        52. 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 areUnordered and Open, and can be differentiated using the following discriminators:
        • pattern @ $this
        • 54. 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"
            }]
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          56. 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()))
          58. 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()))
          60. 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".

          ShortType 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()))
          62. 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 (EU core), 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()))
          64. 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), Resource)
          Is Modifierfalse
          Summarytrue
          Requirements

          EHDSObservation.directSubject[x]

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          66. 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
          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
          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()))
          68. 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 availableDate/Time this version 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()))
          70. Observation.performer
          Definition

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

          ShortWho is responsible for the observation
          Control10..*
          TypeReference(Practitioner (EU core), PractitionerRole (EU core), Organization (EU core), 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()))
          72. 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
          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())
          74. Observation.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, 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 areUnordered and Closed, and can be differentiated using the following discriminators:
          • type @ $this
          • 76. 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
            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()))
            78. 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())
            80. 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()))
            82. 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
            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()))
            84. 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

            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()))
            86. 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

            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()))
            88. 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

            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()))
            90. 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
            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()))
            92. 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

            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()))
            94. 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
            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()))
            96. 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.Why the 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 "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 DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason|4.0.1
            (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


            For many results it is necessary to handle exceptional values in measurements.

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

            Laboratory technigue that has been used


            Indicates the mechanism used to perform the observation.

            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.


            Only used if not implicit in code for Observation.code.

            Control0..1
            BindingThe codes SHOULD be taken from For example codes, see Laboratory Techniqueshttp://hl7.org/fhir/ValueSet/observation-methods|4.0.1
            (preferred to http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab)
            TypeCodeableConcept
            Is Modifierfalse
            Summaryfalse
            Requirements

            EHDSObservation.method


            In some cases, method can impact results and is thus used for determining whether results can be compared or determining significance of results.

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

            The specimen that was used when this observation was made.

            ShortSpecimen used for the observationSpecimen used for this observation
            Comments

            When the specimen is applicable and known it shall be documented


            Should only be used if not implicit in code found in Observation.code. Observations are not made on specimens themselves; they are made on a subject, but in many cases by the means of a specimen. Note that although specimens are often involved, they are not always tracked and reported explicitly. Also note that observation resources may be used in contexts that track the specimen explicitly (e.g. Diagnostic Report).

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

            The device used to generate the observation data.

            ShortMeasuring instrument(Measurement) Device
            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()))
            104. 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.


            This observation is a group observation (e.g. a battery, a panel of tests, a set of vital sign measurements) that includes the target as a member of the group.

            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.


            When using this element, an observation will typically have either a value or a set of related resources, although both may be present in some cases. For a discussion on the ways Observations can assembled in groups together, see Notes below. Note that a system may calculate results from QuestionnaireResponse into a final score and represent the score as an Observation.

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

            EHDSObservation.hasMember[x]

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


            Component observations share the same attributes in the Observation resource as the primary observation and are always treated a part of a single observation (they are not separable). However, the reference range for the primary observation value is not inherited by the component values and is required when appropriate for each component observation.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            108. 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.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())
            110. Observation.component.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.component.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 112. 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 Valuehttp://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value
              114. 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())
              116. 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 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.component.code


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

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


              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.component.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
              • type @ $this
              • 120. 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)), dateTime, boolean, string, SampledData, 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()))
                122. 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())
                124. 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 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()))
                126. 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, 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
                Summarytrue
                Requirements

                EHDSObservation.component.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()))
                128. 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)), 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

                EHDSObservation.component.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()))
                130. 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)), 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

                EHDSObservation.component.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()))
                132. 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, 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

                EHDSObservation.component.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()))
                134. 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, 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
                Summarytrue
                Requirements

                EHDSObservation.component.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()))
                136. 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, 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

                EHDSObservation.component.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()))
                138. 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 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
                Summarytrue
                Requirements

                EHDSObservation.component.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()))

                Guidance on how to interpret the contents of this table can be foundhere

                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.

                Invariantseu-lab-1: If observation status is other then "registered" or "cancelled", at least one of these Observation elements shall be provided: "value", "dataAbsentReason", "hasMember" or "component" ((status in ('registered'|'cancelled')) or value.exists() or extension.where(url='http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value').exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists())
                eu-lab-2: If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason" (component.exists() implies (status in ('registered'|'cancelled')) or component.value.exists() or component.extension.where(url='http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value').exists() or component.dataAbsentReason.exists())
                2. Observation.extension:supportingInfo
                Slice NamesupportingInfo
                Control0..*
                TypeExtension(Supporting info) (Extension Type: Reference(Resource))
                4. 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))
                6. Observation.extension:certifiedRefMaterialCodeable
                Slice NamecertifiedRefMaterialCodeable
                Control0..*
                TypeExtension(Certified Reference Material: CodeableConcept) (Extension Type: CodeableConcept)
                8. Observation.extension:certifiedRefMaterialIdentifer
                Slice NamecertifiedRefMaterialIdentifer
                Control0..*
                TypeExtension(Certified Reference Material: Identifier) (Extension Type: Identifier)
                10. Observation.extension:accredited
                Slice Nameaccredited
                Definition

                Indicates that this laboratory test was/is accredited.

                ShortAccredited test
                Control0..1
                TypeExtension(Laboratory Accredited) (Extension Type: boolean)
                12. Observation.status
                ShortStatus of this observation (e.g. preliminary, final,...)
                14. Observation.category
                Comments

                "laboratory" includes laboratory medicine and pathology

                SlicingThis element introduces a set of slices on Observation.category. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • pattern @ $this
                • 16. Observation.category:laboratory
                  Slice Namelaboratory
                  Control1..1
                  Pattern Value{
                    "coding" : [{
                      "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
                      "code" : "laboratory"
                    }]
                  }
                  18. Observation.category:studyType
                  Slice NamestudyType
                  ShortThe way of grouping of the test results into clinically meaningful domains (e.g. hematology study, microbiology study, etc.)
                  Control0..*
                  BindingThe codes SHALL be taken from Laboratory Study Types
                  (required to http://hl7.eu/fhir/laboratory/ValueSet/lab-studyType-eu-lab)
                  20. Observation.category:specialty
                  Slice Namespecialty
                  ShortThe clinical domain of the laboratory performing the observation (e.g. microbiology, toxicology, chemistry)
                  Control0..*
                  BindingThe codes SHALL be taken from Laboratory Specialty
                  (required to http://hl7.eu/fhir/laboratory/ValueSet/lab-specialty-eu-lab)
                  22. 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

                  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.

                  BindingThe codes SHOULD be taken from Laboratory Code
                  (preferred to http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab)
                  24. Observation.focus
                  TypeReference(Patient (EU core), RelatedPerson: AnimalSpecimen, Group, Device, Location (EU core))
                  26. Observation.issued
                  ShortDate/Time this result was made available
                  28. Observation.performer
                  Control1..?
                  30. Observation.value[x]
                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                  SlicingThis element introduces a set of slices on Observation.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                  • type @ $this
                  • 32. Observation.value[x]:valueQuantity
                    Slice NamevalueQuantity
                    TypeQuantity(Quantity (Eu Lab))
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    34. Observation.value[x]:valueString
                    Slice NamevalueString
                    Control0..1
                    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
                    36. Observation.value[x]:valueRange
                    Slice NamevalueRange
                    Control0..1
                    TypeRange(Range (Eu Lab))
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    38. Observation.value[x]:valueRatio
                    Slice NamevalueRatio
                    Control0..1
                    TypeRatio(Ratio (Eu Lab))
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    40. Observation.value[x]:valueTime
                    Slice NamevalueTime
                    Control0..1
                    Typetime
                    [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
                    42. Observation.value[x]:valueDateTime
                    Slice NamevalueDateTime
                    Control0..1
                    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
                    44. Observation.value[x]:valuePeriod
                    Slice NamevaluePeriod
                    Control0..1
                    TypePeriod
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    46. Observation.value[x]:valueCodeableConcept
                    Slice NamevalueCodeableConcept
                    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]
                    48. Observation.dataAbsentReason
                    ShortProvides a reason why the expected value is missing.
                    50. Observation.method
                    Definition

                    Laboratory technigue that has been used

                    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.

                    BindingThe codes SHOULD be taken from Laboratory Techniques
                    (preferred to http://hl7.eu/fhir/laboratory/ValueSet/lab-technique-eu-lab)
                    52. Observation.specimen
                    Comments

                    When the specimen is applicable and known it shall be documented

                    TypeReference(Specimen: Laboratory)
                    54. Observation.device
                    ShortMeasuring instrument
                    56. 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.

                    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.

                    TypeReference(Observation Results: laboratory)
                    58. Observation.component
                    ShortLaboratory result
                    60. Observation.component.code
                    BindingThe codes SHOULD be taken from Laboratory Code
                    (preferred to http://hl7.eu/fhir/laboratory/ValueSet/lab-obsCode-eu-lab)
                    62. Observation.component.value[x]
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    SlicingThis element introduces a set of slices on Observation.component.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                    • type @ $this
                    • 64. Observation.component.value[x]:valueQuantity
                      Slice NamevalueQuantity
                      TypeQuantity(Quantity (Eu Lab))
                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                      66. Observation.component.value[x]:valueString
                      Slice NamevalueString
                      Control0..1
                      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
                      68. Observation.component.value[x]:valueRange
                      Slice NamevalueRange
                      Control0..1
                      TypeRange(Range (Eu Lab))
                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                      70. Observation.component.value[x]:valueRatio
                      Slice NamevalueRatio
                      Control0..1
                      TypeRatio(Ratio (Eu Lab))
                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                      72. Observation.component.value[x]:valueTime
                      Slice NamevalueTime
                      Control0..1
                      Typetime
                      [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
                      74. Observation.component.value[x]:valueDateTime
                      Slice NamevalueDateTime
                      Control0..1
                      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
                      76. Observation.component.value[x]:valuePeriod
                      Slice NamevaluePeriod
                      Control0..1
                      TypePeriod
                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                      78. Observation.component.value[x]:valueCodeableConcept
                      Slice NamevalueCodeableConcept
                      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]

                      Guidance on how to interpret the contents of this table can be foundhere

                      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: "value", "dataAbsentReason", "hasMember" or "component" ((status in ('registered'|'cancelled')) or value.exists() or extension.where(url='http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value').exists() or hasMember.exists() or component.exists() or dataAbsentReason.exists())
                      eu-lab-2: If observation has components and observation status is other then "registered" or "cancelled", at least one of these Observation.component elements shall be provided: "value" or "dataAbsentReason" (component.exists() implies (status in ('registered'|'cancelled')) or component.value.exists() or component.extension.where(url='http://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.component.value').exists() or component.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 areUnordered 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(R5: Observed body structure (new)) (Extension Type: Reference(Cross-version Profile for R5.BodyStructure for use in FHIR R4, 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(R5: Triggering observation(s) (new)) (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 areUnordered 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 areUnordered 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 Valueobservation
                            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 areUnordered 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 Valuetype
                              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 areUnordered 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 Valuereason
                                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 Valuehttp://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 areUnordered 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 Valuehttp://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(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.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())
                                  80. 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)
                                  Control0..*
                                  TypeIdentifier
                                  Is Modifierfalse
                                  Summarytrue
                                  Requirements

                                  EHDSObservation.header.identifier

                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  82. 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()))
                                  84. 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()))
                                  86. Observation.status
                                  Definition

                                  The status of the result value.

                                  ShortStatus of this observation (e.g. preliminary, final,...)
                                  Comments

                                  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 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()))
                                  88. 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 areUnordered and Open, and can be differentiated using the following discriminators:
                                  • pattern @ $this
                                  • 90. 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"
                                      }]
                                    }
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    92. 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()))
                                    94. 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()))
                                    96. 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

                                    ShortType 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.

                                    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()))
                                    98. 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 (EU core))
                                    Is Modifierfalse
                                    Summarytrue
                                    Requirements

                                    EHDSObservation.header.subject

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    100. 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))
                                    Is Modifierfalse
                                    Summarytrue
                                    Requirements

                                    EHDSObservation.directSubject[x]

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    102. 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
                                    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()))
                                    104. 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
                                    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
                                    Summarytrue
                                    Requirements

                                    EHDSObservation.observationDate[x]

                                    Alternate NamesOccurrence
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    106. 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()))
                                    108. Observation.performer
                                    Definition

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

                                    ShortWho is responsible for the observation
                                    Control1..*
                                    TypeReference(Practitioner (EU core), PractitionerRole (EU core), Organization (EU core))
                                    Is Modifierfalse
                                    Summarytrue
                                    Requirements

                                    EHDSObservation.header.performer

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    110. 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
                                    112. 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 areUnordered and Open, and can be differentiated using the following discriminators:
                                    • value @ url
                                    • 114. 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
                                      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())
                                      116. 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()))
                                      118. 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()))
                                      120. 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()))
                                      122. 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()))
                                      124. Observation.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, 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 areUnordered and Closed, and can be differentiated using the following discriminators:
                                      • type @ $this
                                      • 126. 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
                                        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()))
                                        128. 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
                                        130. 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 areUnordered and Open, and can be differentiated using the following discriminators:
                                        • value @ url
                                        • 132. 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())
                                          134. 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()))
                                          136. 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()))
                                          138. 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()))
                                          140. 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()))
                                          142. 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()))
                                          144. 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
                                          Summarytrue
                                          Requirements

                                          EHDSObservation.result.value[x]

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          146. 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

                                          EHDSObservation.result.value[x]

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          148. 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

                                          EHDSObservation.result.value[x]

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          150. 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

                                          EHDSObservation.result.value[x]

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          152. 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
                                          Summarytrue
                                          Requirements

                                          EHDSObservation.result.value[x]

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          154. 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

                                          EHDSObservation.result.value[x]

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          156. 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
                                          Summarytrue
                                          Requirements

                                          EHDSObservation.result.value[x]

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          158. 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()))
                                          160. 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()))
                                          162. 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()))
                                          164. 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()))
                                          166. 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()))
                                          168. 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()))
                                          170. 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()))
                                          172. 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

                                          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
                                          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())
                                          174. 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
                                          176. 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())
                                          178. Observation.referenceRange.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())
                                          180. 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()))
                                          182. 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()))
                                          184. 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()))
                                          186. 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()))
                                          188. 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()))
                                          190. 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()))
                                          192. 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()))
                                          194. 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()))
                                          196. 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()))
                                          198. 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
                                          200. 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 areUnordered and Open, and can be differentiated using the following discriminators:
                                          • value @ url
                                          • 202. 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.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())
                                            204. 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
                                            206. 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 areUnordered and Open, and can be differentiated using the following discriminators:
                                            • value @ url
                                            • 208. 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 Valuehttp://hl7.org/fhir/5.0/StructureDefinition/extension-Observation.value
                                              210. 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 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()))
                                              212. 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())
                                              214. 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()))
                                              216. 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 areUnordered and Closed, and can be differentiated using the following discriminators:
                                              • type @ $this
                                              • 218. 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()))
                                                220. 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
                                                222. 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 areUnordered and Open, and can be differentiated using the following discriminators:
                                                • value @ url
                                                • 224. 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())
                                                  226. 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()))
                                                  228. 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()))
                                                  230. 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()))
                                                  232. 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()))
                                                  234. 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()))
                                                  236. 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

                                                  EHDSObservation.component.result.value[x]

                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  238. 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

                                                  EHDSObservation.component.result.value[x]

                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  240. 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

                                                  EHDSObservation.component.result.value[x]

                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  242. 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

                                                  EHDSObservation.component.result.value[x]

                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  244. 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

                                                  EHDSObservation.component.result.value[x]

                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  246. 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

                                                  EHDSObservation.component.result.value[x]

                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  248. 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

                                                  EHDSObservation.component.result.value[x]

                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  250. 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()))
                                                  252. 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()))
                                                  254. 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()))