CertiScan Device Registry Implementation Guide (FHIR R4B)
0.1.0 - ci-build

CertiScan Device Registry Implementation Guide (FHIR R4B) - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: CertiScanExpressScan - Detailed Descriptions

Draft as of 2025-06-05

Definitions for the certiscan-express-scan resource profile.

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

0. Observation
Definition

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

ShortMeasurements and simple assertions
Comments

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
Must Supportfalse
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.exists() and ('#'+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(uri) = '#').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())
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.

Control10..1
Typeid
Is Modifierfalse
Must Supportfalse
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
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. Observation.meta.profile
Definition

A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.


A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

ShortProfiles this resource claims to conform to
Comments

It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

Control10..1*
Typecanonical(StructureDefinition)
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Pattern Valuehttps://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-express-scan
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. 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
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. Observation.extension
Definition

An Extension


May be used to represent additional information that is not part of the basic definition of the resource. 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.

Control10..*
TypeExtension
Is Modifierfalse
Must Supportfalse
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. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 12. Observation.extension:scan-ip
    Slice Namescan-ip
    Definition

    IP address of the device that performed the scan.

    ShortCertiScan Scan IP Address
    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(CertiScan Scan IP Address) (Extension Type: string)
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
    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())
    14. Observation.extension:user-agent
    Slice Nameuser-agent
    Definition

    User agent string of the device that performed the scan.

    ShortCertiScan Scan User Agent
    Control0..1
    This element is affected by the following invariants: ele-1
    TypeExtension(CertiScan Scan User Agent) (Extension Type: string)
    Is Modifierfalse
    Must Supportfalse
    Summaryfalse
    Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
    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())
    16. Observation.extension:payload
    Slice Namepayload
    Definition

    Encapsulated payload and metadata for any CertiScan scan, including origin type and encoding format.

    ShortCertiScan Scan Payload
    Control1..1
    This element is affected by the following invariants: ele-1
    TypeExtension(CertiScan Scan Payload) (Complex Extension)
    Is Modifierfalse
    Must Supportfalse
    Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    18. Observation.extension:payload.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.

    Control30..*
    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. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 20. Observation.extension:payload.extension:source
      Slice Namesource
      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())
      22. Observation.extension:payload.extension:source.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())
      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
      • 24. Observation.extension:payload.extension:source.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 Valuesource
        26. Observation.extension:payload.extension:source.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
        Control10..1
        TypeCodeableConcept, date, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
        [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()))
        SlicingThis element introduces a set of slices on Observation.extension.extension.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
        • type @ $this
        • 28. Observation.extension:payload.extension:source.value[x]:valueCodeableConcept
          Slice NamevalueCodeableConcept
          Definition

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

          ShortValue of extension
          Control10..1
          BindingThe codes SHALL be taken from For codes, see CertiScan Scan Payload Source
          (required to https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-scan-payload-source-vs)
          TypeCodeableConcept, date, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Summaryfalse
          Pattern Value{
            "coding" : [{
              "system" : "https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-scan-payload-source-cs",
              "code" : "express"
            }]
          }
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          30. Observation.extension:payload.extension:source.value[x]:valueCodeableConcept.text
          Definition

          A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

          ShortPlain text representation of the concept
          Comments

          Very often the text is the same as a displayName of one of the codings.

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

          The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          32. Observation.extension:payload.extension:format
          Slice Nameformat
          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())
          34. Observation.extension:payload.extension:format.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())
          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
          • 36. Observation.extension:payload.extension:format.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 Valueformat
            38. Observation.extension:payload.extension:format.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
            Control10..1
            TypeCoding, date, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, 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, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
            [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()))
            SlicingThis element introduces a set of slices on Observation.extension.extension.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
            • type @ $this
            • 40. Observation.extension:payload.extension:format.value[x]:valueCoding
              Slice NamevalueCoding
              Definition

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

              ShortValue of extension
              Control10..1
              TypeCoding, date, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, 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, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, Signature, unsignedInt, time
              [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()))
              42. Observation.extension:payload.extension:format.value[x]:valueCoding.system
              Definition

              The identification of the code system that defines the meaning of the symbol in the code.

              ShortIdentity of the terminology system
              Comments

              The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

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

              Need to be unambiguous about the source of the definition of the symbol.

              Fixed Valuehttp://www.iana.org/assignments/media-types
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              44. Observation.extension:payload.extension:data
              Slice Namedata
              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())
              46. Observation.extension:payload.extension:data.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())
              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
              • 48. Observation.extension:payload.extension:data.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 Valuedata
                50. Observation.extension:payload.extension:data.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
                Control10..1
                Typestring, date, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, 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()))
                SlicingThis element introduces a set of slices on Observation.extension.extension.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                • type @ $this
                • 52. Observation.extension:payload.extension:data.value[x]:valueString
                  Slice NamevalueString
                  Definition

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

                  ShortValue of extension
                  Control10..1
                  Typestring, date, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, CodeableReference, 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()))
                  54. Observation.extension:payload.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 Valuehttps://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-scan-payload
                  56. Observation.extension:payload.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, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage
                  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.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
                  Must Supportfalse
                  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())
                  60. Observation.status
                  Definition

                  The status of the result value.

                  Shortregistered | 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|4.3.0
                  (required to http://hl7.org/fhir/ValueSet/observation-status|4.3.0)

                  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
                  Must Supportfalse
                  Summarytrue
                  Requirements

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

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

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

                  ShortClassification of type of observation
                  Comments

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

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

                  Codes for high level observation categories.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supportfalse
                  Summaryfalse
                  Requirements

                  Used for filtering what observations are retrieved and displayed.

                  Pattern Value{
                    "coding" : [{
                      "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
                      "code" : "procedure",
                      "display" : "Procedure"
                    }]
                  }
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  64. Observation.code
                  Definition

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

                  ShortType of observation (code / type)
                  Comments

                  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
                  BindingFor example codes, see LOINCCodeshttp://hl7.org/fhir/ValueSet/observation-codes
                  (example to http://hl7.org/fhir/ValueSet/observation-codes)

                  Codes identifying names of simple observations.

                  TypeCodeableConcept
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Requirements

                  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()))
                  66. 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, Group, Device, Location, Organization, Procedure, Practitioner, Medication, Substance)
                  Is Modifierfalse
                  Must Supporttrue
                  Summarytrue
                  Requirements

                  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()))
                  68. 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
                  TypedateTime, 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
                  Must Supportfalse
                  Summarytrue
                  Requirements

                  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()))
                  SlicingThis element introduces a set of slices on Observation.effective[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                  • type @ $this
                  • 70. Observation.effective[x]:effectiveDateTime
                    Slice NameeffectiveDateTime
                    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
                    TypedateTime, 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
                    Must Supporttrue
                    Summarytrue
                    Requirements

                    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()))
                    72. Observation.performer
                    Definition

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

                    ShortWho is responsible for the observation
                    Control10..1*
                    TypeReference(Practitioner, Patient, PractitionerRole, Organization, CareTeam, RelatedPerson)
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Requirements

                    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()))
                    74. Observation.device
                    Definition

                    The device used to generate the observation data.

                    Short(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.

                    Control10..1
                    TypeReference(Device, DeviceMetric)
                    Is Modifierfalse
                    Must Supporttrue
                    Summaryfalse
                    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
                    2. Observation.meta
                    4. Observation.meta.profile
                    Pattern Valuehttps://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-express-scan
                    6. Observation.extension:payload
                    Slice Namepayload
                    8. Observation.extension:payload.extension:source
                    Slice Namesource
                    10. Observation.extension:payload.extension:source.value[x]:valueCodeableConcept
                    Slice NamevalueCodeableConcept
                    TypeCodeableConcept
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    Pattern Value{
                      "coding" : [{
                        "system" : "https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-scan-payload-source-cs",
                        "code" : "express"
                      }]
                    }

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

                    0. Observation
                    Definition

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

                    ShortMeasurements and simple assertions
                    Comments

                    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
                    Must Supportfalse
                    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.exists() and ('#'+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(uri) = '#').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())
                    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.

                    Control1..1
                    Typeid
                    Is Modifierfalse
                    Must Supportfalse
                    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
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    6. Observation.meta.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
                    Typeid
                    Is Modifierfalse
                    XML FormatIn the XML format, this property is represented as an attribute.
                    Summaryfalse
                    8. Observation.meta.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.meta.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 10. Observation.meta.versionId
                      Definition

                      The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.

                      ShortVersion specific identifier
                      Comments

                      The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.

                      Control0..1
                      Typeid
                      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()))
                      12. Observation.meta.lastUpdated
                      Definition

                      When the resource last changed - e.g. when the version changed.

                      ShortWhen the resource version last changed
                      Comments

                      This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.

                      Control0..1
                      Typeinstant
                      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()))
                      14. Observation.meta.source
                      Definition

                      A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc.

                      ShortIdentifies where the resource comes from
                      Comments

                      In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.

                      This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.

                      Control0..1
                      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()))
                      16. Observation.meta.profile
                      Definition

                      A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url.

                      ShortProfiles this resource claims to conform to
                      Comments

                      It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.

                      Control1..1
                      Typecanonical(StructureDefinition)
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Must Supporttrue
                      Summarytrue
                      Pattern Valuehttps://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-express-scan
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      18. Observation.meta.security
                      Definition

                      Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.

                      ShortSecurity Labels applied to this resource
                      Comments

                      The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.

                      Control0..*
                      BindingUnless not suitable, these codes SHALL be taken from All Security Labels
                      (extensible to http://hl7.org/fhir/ValueSet/security-labels)
                      TypeCoding
                      Is Modifierfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      20. Observation.meta.tag
                      Definition

                      Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.

                      ShortTags applied to this resource
                      Comments

                      The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.

                      Control0..*
                      BindingFor example codes, see CommonTags
                      (example to http://hl7.org/fhir/ValueSet/common-tags)
                      TypeCoding
                      Is Modifierfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      22. 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
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      24. Observation.language
                      Definition

                      The base language in which the resource is written.

                      ShortLanguage of the resource content
                      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)

                      IETF language tag

                      Additional BindingsPurpose
                      AllLanguagesMax Binding
                      Typecode
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Must Supportfalse
                      Summaryfalse
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      26. 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
                      Must Supportfalse
                      Summaryfalse
                      Alternate Namesnarrative, html, xhtml, display
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      28. 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
                      Must Supportfalse
                      Summaryfalse
                      Alternate Namesinline resources, anonymous resources, contained resources
                      Invariantsdom-r4b: Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems (($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic))
                      30. Observation.extension
                      Definition

                      An Extension

                      ShortExtension
                      Control1..*
                      TypeExtension
                      Is Modifierfalse
                      Must Supportfalse
                      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
                      • 32. Observation.extension:scan-ip
                        Slice Namescan-ip
                        Definition

                        IP address of the device that performed the scan.

                        ShortCertiScan Scan IP Address
                        Control0..1
                        This element is affected by the following invariants: ele-1
                        TypeExtension(CertiScan Scan IP Address) (Extension Type: string)
                        Is Modifierfalse
                        Must Supportfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        34. Observation.extension:user-agent
                        Slice Nameuser-agent
                        Definition

                        User agent string of the device that performed the scan.

                        ShortCertiScan Scan User Agent
                        Control0..1
                        This element is affected by the following invariants: ele-1
                        TypeExtension(CertiScan Scan User Agent) (Extension Type: string)
                        Is Modifierfalse
                        Must Supportfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        36. Observation.extension:payload
                        Slice Namepayload
                        Definition

                        Encapsulated payload and metadata for any CertiScan scan, including origin type and encoding format.

                        ShortCertiScan Scan Payload
                        Control1..1
                        This element is affected by the following invariants: ele-1
                        TypeExtension(CertiScan Scan Payload) (Complex Extension)
                        Is Modifierfalse
                        Must Supportfalse
                        Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        38. Observation.extension:payload.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
                        Typeid
                        Is Modifierfalse
                        XML FormatIn the XML format, this property is represented as an attribute.
                        Summaryfalse
                        40. Observation.extension:payload.extension
                        Definition

                        An Extension

                        ShortExtension
                        Control3..*
                        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
                        • 42. Observation.extension:payload.extension:source
                          Slice Namesource
                          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())
                          44. Observation.extension:payload.extension:source.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
                          Typeid
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          46. Observation.extension:payload.extension:source.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
                          • 48. Observation.extension:payload.extension:source.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 Valuesource
                            50. Observation.extension:payload.extension:source.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
                            Control1..1
                            TypeCodeableConcept
                            [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()))
                            SlicingThis element introduces a set of slices on Observation.extension.extension.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                            • type @ $this
                            • 52. Observation.extension:payload.extension:source.value[x]:valueCodeableConcept
                              Slice NamevalueCodeableConcept
                              Definition

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

                              ShortValue of extension
                              Control1..1
                              BindingThe codes SHALL be taken from CertiScan Scan Payload Source
                              (required to https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-scan-payload-source-vs)
                              TypeCodeableConcept
                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                              Is Modifierfalse
                              Summaryfalse
                              Pattern Value{
                                "coding" : [{
                                  "system" : "https://fhir.certiscan.cloud/device-registry/0.1.0/CodeSystem/certiscan-scan-payload-source-cs",
                                  "code" : "express"
                                }]
                              }
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              54. Observation.extension:payload.extension:source.value[x]:valueCodeableConcept.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
                              Typeid
                              Is Modifierfalse
                              XML FormatIn the XML format, this property is represented as an attribute.
                              Summaryfalse
                              56. Observation.extension:payload.extension:source.value[x]:valueCodeableConcept.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.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                              • value @ url
                              • 58. Observation.extension:payload.extension:source.value[x]:valueCodeableConcept.coding
                                Definition

                                A reference to a code defined by a terminology system.

                                ShortCode defined by a terminology system
                                Comments

                                Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                Control0..*
                                TypeCoding
                                Is Modifierfalse
                                Summarytrue
                                Requirements

                                Allows for alternative encodings within a code system, and translations to other code systems.

                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                60. Observation.extension:payload.extension:source.value[x]:valueCodeableConcept.text
                                Definition

                                A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                ShortPlain text representation of the concept
                                Comments

                                Very often the text is the same as a displayName of one of the codings.

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

                                The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                62. Observation.extension:payload.extension:format
                                Slice Nameformat
                                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())
                                64. Observation.extension:payload.extension:format.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
                                Typeid
                                Is Modifierfalse
                                XML FormatIn the XML format, this property is represented as an attribute.
                                Summaryfalse
                                66. Observation.extension:payload.extension:format.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
                                • 68. Observation.extension:payload.extension:format.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 Valueformat
                                  70. Observation.extension:payload.extension:format.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
                                  Control1..1
                                  TypeCoding
                                  [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()))
                                  SlicingThis element introduces a set of slices on Observation.extension.extension.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                                  • type @ $this
                                  • 72. Observation.extension:payload.extension:format.value[x]:valueCoding
                                    Slice NamevalueCoding
                                    Definition

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

                                    ShortValue of extension
                                    Control1..1
                                    TypeCoding
                                    [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()))
                                    74. Observation.extension:payload.extension:format.value[x]:valueCoding.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
                                    Typeid
                                    Is Modifierfalse
                                    XML FormatIn the XML format, this property is represented as an attribute.
                                    Summaryfalse
                                    76. Observation.extension:payload.extension:format.value[x]:valueCoding.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.value[x].extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                    • value @ url
                                    • 78. Observation.extension:payload.extension:format.value[x]:valueCoding.system
                                      Definition

                                      The identification of the code system that defines the meaning of the symbol in the code.

                                      ShortIdentity of the terminology system
                                      Comments

                                      The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

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

                                      Need to be unambiguous about the source of the definition of the symbol.

                                      Fixed Valuehttp://www.iana.org/assignments/media-types
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      80. Observation.extension:payload.extension:format.value[x]:valueCoding.version
                                      Definition

                                      The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                                      ShortVersion of the system - if relevant
                                      Comments

                                      Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                                      NoteThis is a business version Id, not a resource version Id (see discussion)
                                      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()))
                                      82. Observation.extension:payload.extension:format.value[x]:valueCoding.code
                                      Definition

                                      A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                                      ShortSymbol in syntax defined by the system
                                      Control0..1
                                      Typecode
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Requirements

                                      Need to refer to a particular code in the system.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      84. Observation.extension:payload.extension:format.value[x]:valueCoding.display
                                      Definition

                                      A representation of the meaning of the code in the system, following the rules of the system.

                                      ShortRepresentation defined by the system
                                      Control0..1
                                      Typestring
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Requirements

                                      Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      86. Observation.extension:payload.extension:format.value[x]:valueCoding.userSelected
                                      Definition

                                      Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                                      ShortIf this coding was chosen directly by the user
                                      Comments

                                      Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

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

                                      This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      88. Observation.extension:payload.extension:data
                                      Slice Namedata
                                      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())
                                      90. Observation.extension:payload.extension:data.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
                                      Typeid
                                      Is Modifierfalse
                                      XML FormatIn the XML format, this property is represented as an attribute.
                                      Summaryfalse
                                      92. Observation.extension:payload.extension:data.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
                                      • 94. Observation.extension:payload.extension:data.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 Valuedata
                                        96. Observation.extension:payload.extension:data.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
                                        Control1..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()))
                                        SlicingThis element introduces a set of slices on Observation.extension.extension.value[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                                        • type @ $this
                                        • 98. Observation.extension:payload.extension:data.value[x]:valueString
                                          Slice NamevalueString
                                          Definition

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

                                          ShortValue of extension
                                          Control1..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()))
                                          100. Observation.extension:payload.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 Valuehttps://fhir.certiscan.cloud/device-registry/0.1.0/StructureDefinition/certiscan-scan-payload
                                          102. Observation.extension:payload.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, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage
                                          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()))
                                          104. 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
                                          Must Supportfalse
                                          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())
                                          106. 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
                                          Must Supportfalse
                                          Summarytrue
                                          Requirements

                                          Allows observations to be distinguished and referenced.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          108. 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
                                          Must Supportfalse
                                          Summarytrue
                                          Requirements

                                          Allows tracing of authorization for the event and tracking whether proposals/recommendations were acted upon.

                                          Alternate NamesFulfills
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          110. 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
                                          Must Supportfalse
                                          Summarytrue
                                          Alternate NamesContainer
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          112. Observation.status
                                          Definition

                                          The status of the result value.

                                          Shortregistered | 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 ObservationStatus
                                          (required to http://hl7.org/fhir/ValueSet/observation-status|4.3.0)

                                          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
                                          Must Supportfalse
                                          Summarytrue
                                          Requirements

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

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

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

                                          ShortClassification of type of observation
                                          Comments

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

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

                                          Codes for high level observation categories.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summaryfalse
                                          Requirements

                                          Used for filtering what observations are retrieved and displayed.

                                          Pattern Value{
                                            "coding" : [{
                                              "system" : "http://terminology.hl7.org/CodeSystem/observation-category",
                                              "code" : "procedure",
                                              "display" : "Procedure"
                                            }]
                                          }
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          116. Observation.code
                                          Definition

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

                                          ShortType of observation (code / type)
                                          Comments

                                          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
                                          BindingFor example codes, see LOINCCodes
                                          (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                          Codes identifying names of simple observations.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supporttrue
                                          Summarytrue
                                          Requirements

                                          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()))
                                          118. Observation.code.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
                                          Typeid
                                          Is Modifierfalse
                                          XML FormatIn the XML format, this property is represented as an attribute.
                                          Summaryfalse
                                          120. Observation.code.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.code.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                          • value @ url
                                          • 122. Observation.code.coding
                                            Definition

                                            A reference to a code defined by a terminology system.

                                            ShortCode defined by a terminology system
                                            Comments

                                            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                            Control0..*
                                            BindingThe codes SHALL be taken from CertiScan Scan Type ValueSet
                                            (required to https://fhir.certiscan.cloud/device-registry/0.1.0/ValueSet/certiscan-scan-type-vs)
                                            TypeCoding
                                            Is Modifierfalse
                                            Summarytrue
                                            Requirements

                                            Allows for alternative encodings within a code system, and translations to other code systems.

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

                                            A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                            ShortPlain text representation of the concept
                                            Comments

                                            Very often the text is the same as a displayName of one of the codings.

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

                                            The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

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

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

                                            ShortWho and/or what the observation is about
                                            Comments

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

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

                                            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()))
                                            128. 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(Resource)
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            130. Observation.encounter
                                            Definition

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

                                            ShortHealthcare event during which this observation is made
                                            Comments

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

                                            Control0..1
                                            TypeReference(Encounter)
                                            Is Modifierfalse
                                            Must Supportfalse
                                            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()))
                                            132. Observation.effective[x]
                                            Definition

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

                                            ShortClinically relevant time/time-period for observation
                                            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
                                            TypedateTime
                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                            Is Modifierfalse
                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                            Must Supportfalse
                                            Summarytrue
                                            Requirements

                                            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()))
                                            SlicingThis element introduces a set of slices on Observation.effective[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                                            • type @ $this
                                            • 134. Observation.effective[x]:effectiveDateTime
                                              Slice NameeffectiveDateTime
                                              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
                                              TypedateTime
                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                              Is Modifierfalse
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Must Supporttrue
                                              Summarytrue
                                              Requirements

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

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

                                              ShortWho is responsible for the observation
                                              Control1..1
                                              TypeReference(Practitioner, Patient)
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summarytrue
                                              Requirements

                                              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()))
                                              140. 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
                                              Must Supportfalse
                                              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()))
                                              142. Observation.dataAbsentReason
                                              Definition

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

                                              ShortWhy 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 DataAbsentReason
                                              (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summaryfalse
                                              Requirements

                                              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()))
                                              144. 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)

                                              Codes identifying interpretations of observations.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summaryfalse
                                              Requirements

                                              For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                              Alternate NamesAbnormal Flag
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              146. 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
                                              Must Supportfalse
                                              Summaryfalse
                                              Requirements

                                              Need to be able to provide free text additional information.

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

                                              SNOMED CT Body site concepts

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summaryfalse
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              150. Observation.method
                                              Definition

                                              Indicates the mechanism used to perform the observation.

                                              ShortHow it was done
                                              Comments

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

                                              Control0..1
                                              BindingFor example codes, see ObservationMethods
                                              (example to http://hl7.org/fhir/ValueSet/observation-methods)

                                              Methods for simple observations.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summaryfalse
                                              Requirements

                                              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()))
                                              152. Observation.specimen
                                              Definition

                                              The specimen that was used when this observation was made.

                                              ShortSpecimen used for this observation
                                              Comments

                                              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)
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summaryfalse
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              154. Observation.device
                                              Definition

                                              The device used to generate the observation data.

                                              Short(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.

                                              Control1..1
                                              TypeReference(Device)
                                              Is Modifierfalse
                                              Must Supporttrue
                                              Summaryfalse
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              156. 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
                                              Must Supportfalse
                                              Summaryfalse
                                              Requirements

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

                                              Invariantsele-1: All FHIR elements must have a @value or children unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
                                              obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
                                              158. 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
                                              160. 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())
                                              162. 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())
                                              164. 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
                                              Must Supportfalse
                                              Summaryfalse
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              166. 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
                                              Must Supportfalse
                                              Summaryfalse
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              168. 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)

                                              Code for the meaning of a reference range.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Must Supportfalse
                                              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()))
                                              170. 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)

                                              Codes identifying the population the reference range applies to.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Must Supportfalse
                                              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()))
                                              172. 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
                                              Must Supportfalse
                                              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()))
                                              174. 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
                                              Must Supportfalse
                                              Summaryfalse
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              176. Observation.hasMember
                                              Definition

                                              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

                                              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, QuestionnaireResponse, MolecularSequence)
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              178. 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(DocumentReference, ImagingStudy, Media, QuestionnaireResponse, Observation, MolecularSequence)
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              180. 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.

                                              ShortComponent results
                                              Comments

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

                                              Control0..*
                                              TypeBackboneElement
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summarytrue
                                              Requirements

                                              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 unless an empty Parameters resource (hasValue() or (children().count() > id.count()) or $this is Parameters)
                                              182. 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
                                              184. Observation.component.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())
                                              186. 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())
                                              188. 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
                                              BindingFor example codes, see LOINCCodes
                                              (example to http://hl7.org/fhir/ValueSet/observation-codes)

                                              Codes identifying names of simple observations.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summarytrue
                                              Requirements

                                              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()))
                                              190. 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
                                              Must Supportfalse
                                              Summarytrue
                                              Requirements

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

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

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

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summaryfalse
                                              Requirements

                                              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()))
                                              194. 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)

                                              Codes identifying interpretations of observations.

                                              TypeCodeableConcept
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summaryfalse
                                              Requirements

                                              For some results, particularly numeric results, an interpretation is necessary to fully understand the significance of a result.

                                              Alternate NamesAbnormal Flag
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              196. 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
                                              Must Supportfalse
                                              Summaryfalse
                                              Requirements

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

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