HL7 BE Laboratory WG Implementation Guide
1.0.1 - STU Belgium flag

HL7 BE Laboratory WG Implementation Guide, published by eHealth Platform. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-be/lab/ and changes regularly. See the Directory of published versions

Resource Profile: BeObservationLaboratory - Detailed Descriptions

Draft as of 2021-11-08 Maturity Level: 1

Definitions for the be-observation-laboratory resource profile.

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

0. Observation
2. Observation.language
Must Supporttrue
4. Observation.text
6. Observation.text.status
Pattern Valueempty
8. Observation.identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Must Supporttrue
10. Observation.basedOn
Must Supportfalse
12. Observation.partOf
Must Supportfalse
14. Observation.status
Must Supporttrue
16. Observation.category
Must Supporttrue
18. Observation.code
Definition

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

For providing systems, it is RECOMMENDED to express this using a code and consuming software SHALL record this. In general, it shall be noted SNOMED-CT is the preferred national terminology. Other coding systems remain allowed or MAY be preferred in specific flows (e.g. the use of LOINC codes to express a laboratory test.)

TypeCodeableConcept(BeObservationCodeableConcept)
Must Supporttrue
20. Observation.code.coding
SlicingThis element introduces a set of slices on Observation.code.coding. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ system
  • 22. Observation.subject
    ShortIn the initial iteration of the Belgium lab project: when sending to eHealthBox, this is BePatient.
    TypeReference(Group, Device, Location, Patient core BE profile)
    Must Supporttrue
    Must Support TypesNo must-support rules about the choice of types/profiles
    24. Observation.effective[x]
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Must Supporttrue
    26. Observation.issued
    Must Supporttrue
    28. Observation.performer
    ShortIn the initial iteration of the Belgium lab project: when sending to eHealthBox, this is BeOrganization or BePractitioner
    TypeReference(CareTeam, RelatedPerson, Patient core BE profile, Organisation core BE profile, Practitioner role core BE profile, Practitioner core BE profile)
    Must Supporttrue
    Must Support TypesNo must-support rules about the choice of types/profiles
    30. Observation.value[x]
    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
    Must Supporttrue
    32. Observation.dataAbsentReason
    Must Supporttrue
    34. Observation.interpretation
    Must Supporttrue
    36. Observation.note
    TypeAnnotation(Coded Annotation)
    Must Supporttrue
    38. Observation.bodySite
    Must Supporttrue
    40. Observation.method
    Must Supporttrue
    42. Observation.specimen
    TypeReference(BeSpecimenLaboratory)
    Must Supporttrue
    44. Observation.device
    Must Supportfalse
    46. Observation.referenceRange
    Must Supporttrue
    48. Observation.referenceRange.extension
    SlicingThis element introduces a set of slices on Observation.referenceRange.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 50. Observation.referenceRange.extension:Comment
      Slice NameComment
      Control0..*
      TypeExtension(Comment extension for ReferenceRange) (Extension Type: Annotation(Coded Annotation))
      52. Observation.hasMember
      ShortIn the initial iteration of the Belgium lab project: when sending to eHealthBox, this is BeObservationLaboratory
      TypeReference(QuestionnaireResponse, MolecularSequence, BeObservationLaboratory)
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles
      54. Observation.derivedFrom
      ShortIn the initial iteration of the Belgium lab project: when sending to eHealthBox, this can be BeObservationLaboratory or Media
      TypeReference(DocumentReference, ImagingStudy, Media, QuestionnaireResponse, MolecularSequence, BeObservationLaboratory)
      Must Supporttrue
      Must Support TypesNo must-support rules about the choice of types/profiles
      56. Observation.component
      Must Supporttrue
      SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ code.coding.code
      • 58. Observation.component:relativeTimeQualifier
        Slice NamerelativeTimeQualifier
        ShortIf a testing code does not include a time interval but needs one to qualify the code.
        Control0..1
        60. Observation.component:relativeTimeQualifier.code
        62. Observation.component:relativeTimeQualifier.code.coding
        64. Observation.component:relativeTimeQualifier.code.coding.system
        Control1..?
        Fixed Valuehttp://snomed.info/sct
        66. Observation.component:relativeTimeQualifier.code.coding.code
        Control1..?
        Fixed Value118578006
        68. Observation.component:relativeTimeQualifier.code.coding.display
        Control1..?
        Fixed ValueRelative time
        70. Observation.component:relativeTimeQualifier.value[x]
        ShortUCUM
        Control1..?
        TypeQuantity
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        72. Observation.component:substanceAmountQualifier
        Slice NamesubstanceAmountQualifier
        ShortIf a testing code does not include a substance amount but needs one to qualify the code
        Control0..1
        74. Observation.component:substanceAmountQualifier.code
        76. Observation.component:substanceAmountQualifier.code.coding
        78. Observation.component:substanceAmountQualifier.code.coding.system
        Control1..?
        Fixed Valuehttp://snomed.info/sct
        80. Observation.component:substanceAmountQualifier.code.coding.code
        Control1..?
        Fixed Value118555000
        82. Observation.component:substanceAmountQualifier.code.coding.display
        Control1..?
        Fixed ValueSubstance amount
        84. Observation.component:substanceAmountQualifier.value[x]
        ShortUCUM
        Control1..?
        TypeQuantity
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        86. Observation.component:productNameQualifier
        Slice NameproductNameQualifier
        ShortIf a testing code does not include a product name but needs one to qualify the code
        Control0..1
        88. Observation.component:productNameQualifier.code
        90. Observation.component:productNameQualifier.code.coding
        92. Observation.component:productNameQualifier.code.coding.system
        Control1..?
        Fixed Valuehttp://snomed.info/sct
        94. Observation.component:productNameQualifier.code.coding.code
        Control1..?
        Fixed Value774167006
        96. Observation.component:productNameQualifier.code.coding.display
        Control1..?
        Fixed ValueProduct name
        98. Observation.component:productNameQualifier.value[x]
        Control1..?
        TypeChoice of: CodeableConcept, string
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension

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

        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
        Summaryfalse
        Alternate NamesVital Signs, Measurement, Results, Tests
        Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
        dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
        dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
        dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
        dom-6: A resource should have narrative for robust management (text.`div`.exists())
        obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
        obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
        obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
        obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
        2. Observation.implicitRules
        Definition

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

        ShortA set of rules under which this content was created
        Comments

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

        Control0..1
        Typeuri
        Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        4. Observation.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 CommonLanguageshttp://hl7.org/fhir/ValueSet/languages
        (preferred to http://hl7.org/fhir/ValueSet/languages)

        A human language.

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

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

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

        ShortExtensions that cannot be ignored
        Comments

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

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

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

        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        8. 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 Supporttrue
        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()))
        10. 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()))
        12. 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()))
        14. 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|4.0.1
        (required to http://hl7.org/fhir/ValueSet/observation-status|4.0.1)

        Codes providing the status of an observation.

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

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

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

        Used for filtering what observations are retrieved and displayed.

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

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

        For providing systems, it is RECOMMENDED to express this using a code and consuming software SHALL record this. In general, it shall be noted SNOMED-CT is the preferred national terminology. Other coding systems remain allowed or MAY be preferred in specific flows (e.g. the use of LOINC codes to express a laboratory test.)


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

        ShortConcept - reference to a terminology or just textType of observation (code / type)
        Comments

        Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.


        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
        This element is affected by the following invariants: ele-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(BeObservationCodeableConcept)
        Is Modifierfalse
        Must Supporttrue
        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()))
        20. 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..*
        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()))
        SlicingThis element introduces a set of slices on Observation.code.coding. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ system
        • 22. Observation.code.coding:LOINC
          Slice NameLOINC
          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()))
          24. Observation.code.coding:LOINC.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.

          Control10..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://loinc.org
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          26. Observation.code.coding:LOINC.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
          Control10..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()))
          28. Observation.code.coding:SNOMED-CT
          Slice NameSNOMED-CT
          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()))
          30. Observation.code.coding:SNOMED-CT.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.

          Control10..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://snomed.info/sct
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          32. Observation.code.coding:SNOMED-CT.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
          Control10..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()))
          34. 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.

          ShortIn the initial iteration of the Belgium lab project: when sending to eHealthBox, this is BePatient.Who 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.

          Control0..1
          TypeReference(Group, Device, Location, Patient core BE profile, Patient)
          Is Modifierfalse
          Must Supporttrue
          Must Support TypesNo must-support rules about the choice of types/profiles
          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()))
          36. 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.

          Control0..1
          TypeChoice of: dateTime, Period, Timing, instant
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Must Supporttrue
          Must Support TypesNo must-support rules about the choice of types/profiles
          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()))
          38. 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 Supporttrue
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          40. Observation.performer
          Definition

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

          ShortIn the initial iteration of the Belgium lab project: when sending to eHealthBox, this is BeOrganization or BePractitionerWho is responsible for the observation
          Control0..*
          TypeReference(CareTeam, RelatedPerson, Patient core BE profile, Organisation core BE profile, Practitioner role core BE profile, Practitioner core BE profile, Practitioner, PractitionerRole, Organization, Patient)
          Is Modifierfalse
          Must Supporttrue
          Must Support TypesNo must-support rules about the choice of types/profiles
          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()))
          42. 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 Supporttrue
          Must Support TypesNo must-support rules about the choice of types/profiles
          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()))
          44. 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 DataAbsentReasonhttp://hl7.org/fhir/ValueSet/data-absent-reason
          (extensible to http://hl7.org/fhir/ValueSet/data-absent-reason)

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

          TypeCodeableConcept
          Is Modifierfalse
          Must Supporttrue
          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()))
          46. 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 ObservationInterpretationCodeshttp://hl7.org/fhir/ValueSet/observation-interpretation
          (extensible to http://hl7.org/fhir/ValueSet/observation-interpretation)

          Codes identifying interpretations of observations.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supporttrue
          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()))
          48. Observation.note
          Definition

          A text note which also contains information about who made the statement and when.


          Comments about the observation or the results.

          ShortText node with attributionComments about the observation
          Comments

          For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).


          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..*
          This element is affected by the following invariants: ele-1
          TypeAnnotation(Coded Annotation)
          Is Modifierfalse
          Must Supporttrue
          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()))
          50. 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 SNOMEDCTBodyStructureshttp://hl7.org/fhir/ValueSet/body-site
          (example to http://hl7.org/fhir/ValueSet/body-site)

          Codes describing anatomical locations. May include laterality.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supporttrue
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          52. 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 ObservationMethodshttp://hl7.org/fhir/ValueSet/observation-methods
          (example to http://hl7.org/fhir/ValueSet/observation-methods)

          Methods for simple observations.

          TypeCodeableConcept
          Is Modifierfalse
          Must Supporttrue
          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()))
          54. 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(BeSpecimenLaboratory, Specimen)
          Is Modifierfalse
          Must Supporttrue
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          56. 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.

          Control0..1
          TypeReference(Device, DeviceMetric)
          Is Modifierfalse
          Must Supportfalse
          Summaryfalse
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          58. 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 Supporttrue
          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()))
          obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
          obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
          60. Observation.referenceRange.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..*
          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.referenceRange.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 62. Observation.referenceRange.extension:Comment
            Slice NameComment
            Definition

            Extension that adds a comment to Observation.ReferenceRange

            ShortComment extension for ReferenceRange
            Control0..*
            This element is affected by the following invariants: ele-1
            TypeExtension(Comment extension for ReferenceRange) (Extension Type: Annotation(Coded Annotation))
            Is Modifierfalse
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            64. 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())
            66. 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.

            ShortIn the initial iteration of the Belgium lab project: when sending to eHealthBox, this is BeObservationLaboratoryRelated 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.


            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(QuestionnaireResponse, MolecularSequence, BeObservationLaboratory, Observation)
            Is Modifierfalse
            Must Supporttrue
            Must Support TypesNo must-support rules about the choice of types/profiles
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            68. 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.

            ShortIn the initial iteration of the Belgium lab project: when sending to eHealthBox, this can be BeObservationLaboratory or MediaRelated 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, MolecularSequence, BeObservationLaboratory, Observation)
            Is Modifierfalse
            Must Supporttrue
            Must Support TypesNo must-support rules about the choice of types/profiles
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            70. 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 Supporttrue
            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 (hasValue() or (children().count() > id.count()))
            SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ code.coding.code
            • 72. 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())
              74. 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 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
              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()))
              76. Observation.component:relativeTimeQualifier
              Slice NamerelativeTimeQualifier
              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.

              ShortIf a testing code does not include a time interval but needs one to qualify the code.Component results
              Comments

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

              Control0..1*
              TypeBackboneElement
              Is Modifierfalse
              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 (hasValue() or (children().count() > id.count()))
              78. Observation.component:relativeTimeQualifier.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())
              80. Observation.component:relativeTimeQualifier.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 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
              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()))
              82. Observation.component:relativeTimeQualifier.value[x]
              Definition

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

              ShortUCUMActual 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.

              Control10..1
              TypeQuantity, dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range, CodeableConcept
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Summarytrue
              Requirements

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

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              84. Observation.component:substanceAmountQualifier
              Slice NamesubstanceAmountQualifier
              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.

              ShortIf a testing code does not include a substance amount but needs one to qualify the codeComponent results
              Comments

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

              Control0..1*
              TypeBackboneElement
              Is Modifierfalse
              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 (hasValue() or (children().count() > id.count()))
              86. Observation.component:substanceAmountQualifier.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())
              88. Observation.component:substanceAmountQualifier.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 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
              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()))
              90. Observation.component:substanceAmountQualifier.value[x]
              Definition

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

              ShortUCUMActual 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.

              Control10..1
              TypeQuantity, dateTime, boolean, string, SampledData, Period, Ratio, integer, time, Range, CodeableConcept
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Summarytrue
              Requirements

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

              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              92. Observation.component:productNameQualifier
              Slice NameproductNameQualifier
              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.

              ShortIf a testing code does not include a product name but needs one to qualify the codeComponent results
              Comments

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

              Control0..1*
              TypeBackboneElement
              Is Modifierfalse
              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 (hasValue() or (children().count() > id.count()))
              94. Observation.component:productNameQualifier.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())
              96. Observation.component:productNameQualifier.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 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
              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()))
              98. Observation.component:productNameQualifier.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.

              Control10..1
              TypeChoice of: CodeableConcept, string, dateTime, boolean, SampledData, Quantity, Period, Ratio, integer, time, Range
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Summarytrue
              Requirements

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

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

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

              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
              Summaryfalse
              Alternate NamesVital Signs, Measurement, Results, Tests
              Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
              dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
              dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
              dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
              dom-6: A resource should have narrative for robust management (text.`div`.exists())
              obs-6: dataAbsentReason SHALL only be present if Observation.value[x] is not present (dataAbsentReason.empty() or value.empty())
              obs-7: If Observation.code is the same as an Observation.component.code then the value element associated with the code SHALL NOT be present (value.empty() or component.code.where(coding.intersect(%resource.code.coding).exists()).empty())
              2. Observation.id
              Definition

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

              ShortLogical id of this artifact
              Comments

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

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

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

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

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

              ShortA set of rules under which this content was created
              Comments

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

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

              The base language in which the resource is written.

              ShortLanguage of the 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)

              A human language.

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

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

              ShortText summary of the resource, for human interpretation
              Comments

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

              Control0..1
              TypeNarrative
              Is Modifierfalse
              Summaryfalse
              Alternate Namesnarrative, html, xhtml, display
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              12. Observation.text.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
              14. Observation.text.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.text.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 16. Observation.text.status
                Definition

                The status of the narrative - whether it's entirely generated (from just the defined data or the extensions too), or whether a human authored it and it may contain additional data.

                Shortgenerated | extensions | additional | empty
                Control1..1
                BindingThe codes SHALL be taken from NarrativeStatus
                (required to http://hl7.org/fhir/ValueSet/narrative-status|4.0.1)

                The status of a resource narrative.

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

                The actual narrative content, a stripped down version of XHTML.

                ShortLimited xhtml content
                Comments

                The contents of the html element are an XHTML fragment containing only the basic html formatting elements described in chapters 7-11 and 15 of the HTML 4.0 standard, <a> elements (either name or href), images and internally contained stylesheets. The XHTML content SHALL NOT contain a head, a body, external stylesheet references, scripts, forms, base/link/xlink, frames, iframes and objects.

                Control1..1
                Typexhtml
                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()))
                txt-1: The narrative SHALL contain only the basic html formatting elements and attributes described in chapters 7-11 (except section 4 of chapter 9) and 15 of the HTML 4.0 standard, <a> elements (either name or href), images and internally contained style attributes (htmlChecks())
                txt-2: The narrative SHALL have some non-whitespace content (htmlChecks())
                20. Observation.contained
                Definition

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

                ShortContained, inline Resources
                Comments

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

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

                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.

                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())
                24. Observation.modifierExtension
                Definition

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

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

                ShortExtensions that cannot be ignored
                Comments

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

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

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

                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                26. 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 Supporttrue
                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()))
                28. 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()))
                30. 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()))
                32. 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|4.0.1)

                Codes providing the status of an observation.

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

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

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

                Used for filtering what observations are retrieved and displayed.

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

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

                For providing systems, it is RECOMMENDED to express this using a code and consuming software SHALL record this. In general, it shall be noted SNOMED-CT is the preferred national terminology. Other coding systems remain allowed or MAY be preferred in specific flows (e.g. the use of LOINC codes to express a laboratory test.)

                ShortConcept - reference to a terminology or just text
                Comments

                Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.

                Control1..1
                This element is affected by the following invariants: ele-1
                BindingFor example codes, see LOINCCodes
                (example to http://hl7.org/fhir/ValueSet/observation-codes)

                Codes identifying names of simple observations.

                TypeCodeableConcept(BeObservationCodeableConcept)
                Is Modifierfalse
                Must Supporttrue
                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()))
                38. 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
                Typestring
                Is Modifierfalse
                XML FormatIn the XML format, this property is represented as an attribute.
                Summaryfalse
                40. 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
                • 42. 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..*
                  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()))
                  SlicingThis element introduces a set of slices on Observation.code.coding. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ system
                  • 44. Observation.code.coding:LOINC
                    Slice NameLOINC
                    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()))
                    46. Observation.code.coding:LOINC.id
                    Definition

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

                    ShortUnique id for inter-element referencing
                    Control0..1
                    Typestring
                    Is Modifierfalse
                    XML FormatIn the XML format, this property is represented as an attribute.
                    Summaryfalse
                    48. Observation.code.coding:LOINC.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.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 50. Observation.code.coding:LOINC.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.

                      Control1..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://loinc.org
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      52. Observation.code.coding:LOINC.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()))
                      54. Observation.code.coding:LOINC.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
                      Control1..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()))
                      56. Observation.code.coding:LOINC.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()))
                      58. Observation.code.coding:LOINC.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()))
                      60. Observation.code.coding:SNOMED-CT
                      Slice NameSNOMED-CT
                      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()))
                      62. Observation.code.coding:SNOMED-CT.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
                      64. Observation.code.coding:SNOMED-CT.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.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 66. Observation.code.coding:SNOMED-CT.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.

                        Control1..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://snomed.info/sct
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        68. Observation.code.coding:SNOMED-CT.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()))
                        70. Observation.code.coding:SNOMED-CT.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
                        Control1..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()))
                        72. Observation.code.coding:SNOMED-CT.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()))
                        74. Observation.code.coding:SNOMED-CT.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()))
                        76. 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()))
                        78. 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.

                        ShortIn the initial iteration of the Belgium lab project: when sending to eHealthBox, this is BePatient.
                        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.

                        Control0..1
                        TypeReference(Group, Device, Location, Patient core BE profile)
                        Is Modifierfalse
                        Must Supporttrue
                        Must Support TypesNo must-support rules about the choice of types/profiles
                        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()))
                        80. 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
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        82. Observation.encounter
                        Definition

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

                        ShortHealthcare event during which this observation is made
                        Comments

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

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

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

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

                        Control0..1
                        TypeChoice of: dateTime, Period, Timing, instant
                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Must Supporttrue
                        Must Support TypesNo must-support rules about the choice of types/profiles
                        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()))
                        86. 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 Supporttrue
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        88. Observation.performer
                        Definition

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

                        ShortIn the initial iteration of the Belgium lab project: when sending to eHealthBox, this is BeOrganization or BePractitioner
                        Control0..*
                        TypeReference(CareTeam, RelatedPerson, Patient core BE profile, Organisation core BE profile, Practitioner role core BE profile, Practitioner core BE profile)
                        Is Modifierfalse
                        Must Supporttrue
                        Must Support TypesNo must-support rules about the choice of types/profiles
                        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()))
                        90. 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 Supporttrue
                        Must Support TypesNo must-support rules about the choice of types/profiles
                        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()))
                        92. 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 Supporttrue
                        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()))
                        94. 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 Supporttrue
                        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()))
                        96. Observation.note
                        Definition

                        A text note which also contains information about who made the statement and when.

                        ShortText node with attribution
                        Comments

                        For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. Annotations SHOULD NOT be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).

                        Control0..*
                        This element is affected by the following invariants: ele-1
                        TypeAnnotation(Coded Annotation)
                        Is Modifierfalse
                        Must Supporttrue
                        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()))
                        98. 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)

                        Codes describing anatomical locations. May include laterality.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Must Supporttrue
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        100. 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 Supporttrue
                        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()))
                        102. 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(BeSpecimenLaboratory)
                        Is Modifierfalse
                        Must Supporttrue
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        104. 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.

                        Control0..1
                        TypeReference(Device, DeviceMetric)
                        Is Modifierfalse
                        Must Supportfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        106. 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 Supporttrue
                        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()))
                        obs-3: Must have at least a low or a high or text (low.exists() or high.exists() or text.exists())
                        108. 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
                        110. Observation.referenceRange.extension
                        Definition

                        An Extension

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

                          Extension that adds a comment to Observation.ReferenceRange

                          ShortComment extension for ReferenceRange
                          Control0..*
                          This element is affected by the following invariants: ele-1
                          TypeExtension(Comment extension for ReferenceRange) (Extension Type: Annotation(Coded Annotation))
                          Is Modifierfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          114. 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())
                          116. Observation.referenceRange.low
                          Definition

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

                          ShortLow Range, if relevant
                          Control0..1
                          This element is affected by the following invariants: obs-3
                          TypeQuantity(SimpleQuantity)
                          Is Modifierfalse
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          118. Observation.referenceRange.high
                          Definition

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

                          ShortHigh Range, if relevant
                          Control0..1
                          This element is affected by the following invariants: obs-3
                          TypeQuantity(SimpleQuantity)
                          Is Modifierfalse
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          120. 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
                          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()))
                          122. 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
                          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()))
                          124. Observation.referenceRange.age
                          Definition

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

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

                          Some analytes vary greatly over age.

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

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

                          ShortText based reference range in an observation
                          Control0..1
                          Typestring
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Summaryfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          128. 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.

                          ShortIn the initial iteration of the Belgium lab project: when sending to eHealthBox, this is BeObservationLaboratory
                          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(QuestionnaireResponse, MolecularSequence, BeObservationLaboratory)
                          Is Modifierfalse
                          Must Supporttrue
                          Must Support TypesNo must-support rules about the choice of types/profiles
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          130. 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.

                          ShortIn the initial iteration of the Belgium lab project: when sending to eHealthBox, this can be BeObservationLaboratory or Media
                          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, MolecularSequence, BeObservationLaboratory)
                          Is Modifierfalse
                          Must Supporttrue
                          Must Support TypesNo must-support rules about the choice of types/profiles
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          132. 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 Supporttrue
                          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 (hasValue() or (children().count() > id.count()))
                          SlicingThis element introduces a set of slices on Observation.component. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                          • value @ code.coding.code
                          • 134. 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
                            136. 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())
                            138. 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())
                            140. 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
                            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()))
                            142. Observation.component.value[x]
                            Definition

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

                            ShortActual component result
                            Comments

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

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

                            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()))
                            144. 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
                            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()))
                            146. 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
                            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()))
                            148. Observation.component.referenceRange
                            Definition

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

                            ShortProvides guide for interpretation of component result
                            Comments

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

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

                            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()))
                            150. Observation.component:relativeTimeQualifier
                            Slice NamerelativeTimeQualifier
                            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.

                            ShortIf a testing code does not include a time interval but needs one to qualify the code.
                            Comments

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

                            Control0..1
                            TypeBackboneElement
                            Is Modifierfalse
                            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 (hasValue() or (children().count() > id.count()))
                            152. Observation.component:relativeTimeQualifier.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
                            154. Observation.component:relativeTimeQualifier.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())
                            156. Observation.component:relativeTimeQualifier.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())
                            158. Observation.component:relativeTimeQualifier.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
                            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()))
                            160. Observation.component:relativeTimeQualifier.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
                            Typestring
                            Is Modifierfalse
                            XML FormatIn the XML format, this property is represented as an attribute.
                            Summaryfalse
                            162. Observation.component:relativeTimeQualifier.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.component.code.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                            • value @ url
                            • 164. Observation.component:relativeTimeQualifier.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..*
                              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()))
                              166. Observation.component:relativeTimeQualifier.code.coding.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
                              168. Observation.component:relativeTimeQualifier.code.coding.extension
                              Definition

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

                              ShortAdditional content defined by implementations
                              Comments

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

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

                                Control1..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://snomed.info/sct
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                172. Observation.component:relativeTimeQualifier.code.coding.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()))
                                174. Observation.component:relativeTimeQualifier.code.coding.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
                                Control1..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.

                                Fixed Value118578006
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                176. Observation.component:relativeTimeQualifier.code.coding.display
                                Definition

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

                                ShortRepresentation defined by the system
                                Control1..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.

                                Fixed ValueRelative time
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                178. Observation.component:relativeTimeQualifier.code.coding.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()))
                                180. Observation.component:relativeTimeQualifier.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()))
                                182. Observation.component:relativeTimeQualifier.value[x]
                                Definition

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

                                ShortUCUM
                                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.

                                Control1..1
                                TypeQuantity
                                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                Is Modifierfalse
                                Summarytrue
                                Requirements

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

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

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

                                ShortProvides guide for interpretation of component result
                                Comments

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

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

                                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()))
                                190. Observation.component:substanceAmountQualifier
                                Slice NamesubstanceAmountQualifier
                                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.

                                ShortIf a testing code does not include a substance amount but needs one to qualify the code
                                Comments

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

                                Control0..1
                                TypeBackboneElement
                                Is Modifierfalse
                                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 (hasValue() or (children().count() > id.count()))
                                192. Observation.component:substanceAmountQualifier.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
                                194. Observation.component:substanceAmountQualifier.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())
                                196. Observation.component:substanceAmountQualifier.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())
                                198. Observation.component:substanceAmountQualifier.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
                                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()))
                                200. Observation.component:substanceAmountQualifier.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
                                Typestring
                                Is Modifierfalse
                                XML FormatIn the XML format, this property is represented as an attribute.
                                Summaryfalse
                                202. Observation.component:substanceAmountQualifier.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.component.code.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                • value @ url
                                • 204. Observation.component:substanceAmountQualifier.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..*
                                  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()))
                                  206. Observation.component:substanceAmountQualifier.code.coding.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
                                  208. Observation.component:substanceAmountQualifier.code.coding.extension
                                  Definition

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

                                  ShortAdditional content defined by implementations
                                  Comments

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

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

                                    Control1..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://snomed.info/sct
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    212. Observation.component:substanceAmountQualifier.code.coding.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()))
                                    214. Observation.component:substanceAmountQualifier.code.coding.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
                                    Control1..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.

                                    Fixed Value118555000
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    216. Observation.component:substanceAmountQualifier.code.coding.display
                                    Definition

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

                                    ShortRepresentation defined by the system
                                    Control1..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.

                                    Fixed ValueSubstance amount
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    218. Observation.component:substanceAmountQualifier.code.coding.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()))
                                    220. Observation.component:substanceAmountQualifier.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()))
                                    222. Observation.component:substanceAmountQualifier.value[x]
                                    Definition

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

                                    ShortUCUM
                                    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.

                                    Control1..1
                                    TypeQuantity
                                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                    Is Modifierfalse
                                    Summarytrue
                                    Requirements

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

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

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

                                    ShortProvides guide for interpretation of component result
                                    Comments

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

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

                                    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()))
                                    230. Observation.component:productNameQualifier
                                    Slice NameproductNameQualifier
                                    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.

                                    ShortIf a testing code does not include a product name but needs one to qualify the code
                                    Comments

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

                                    Control0..1
                                    TypeBackboneElement
                                    Is Modifierfalse
                                    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 (hasValue() or (children().count() > id.count()))
                                    232. Observation.component:productNameQualifier.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
                                    234. Observation.component:productNameQualifier.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())
                                    236. Observation.component:productNameQualifier.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())
                                    238. Observation.component:productNameQualifier.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
                                    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()))
                                    240. Observation.component:productNameQualifier.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
                                    Typestring
                                    Is Modifierfalse
                                    XML FormatIn the XML format, this property is represented as an attribute.
                                    Summaryfalse
                                    242. Observation.component:productNameQualifier.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.component.code.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                    • value @ url
                                    • 244. Observation.component:productNameQualifier.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..*
                                      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()))
                                      246. Observation.component:productNameQualifier.code.coding.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
                                      248. Observation.component:productNameQualifier.code.coding.extension
                                      Definition

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

                                      ShortAdditional content defined by implementations
                                      Comments

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

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

                                        Control1..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://snomed.info/sct
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        252. Observation.component:productNameQualifier.code.coding.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()))
                                        254. Observation.component:productNameQualifier.code.coding.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
                                        Control1..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.

                                        Fixed Value774167006
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        256. Observation.component:productNameQualifier.code.coding.display
                                        Definition

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

                                        ShortRepresentation defined by the system
                                        Control1..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.

                                        Fixed ValueProduct name
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        258. Observation.component:productNameQualifier.code.coding.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()))
                                        260. Observation.component:productNameQualifier.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()))
                                        262. Observation.component:productNameQualifier.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.

                                        Control1..1
                                        TypeChoice of: CodeableConcept, string
                                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                        Is Modifierfalse
                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                        Summarytrue
                                        Requirements

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

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

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

                                        ShortProvides guide for interpretation of component result
                                        Comments

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

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

                                        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()))